chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Herpes zoster, Neck pain, Pain, Vaccination failure
Clinical narrative: S uspected vaccination failure; I had the shots and still got shingles; pain was nothing compared to the pain from shingles; the pain in my shoulder and neck are still as painful as the first week; neck are still as painful; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included third degree burns (Last year patient had third degree burns on ankle) and pain.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: S uspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: I had the shots and still got shingles), pain (Verbatim: pain was nothing compared to the pain from shingles), shoulder pain (Verbatim: the pain in my shoulder and neck are still as painful as the first week) and neck pain (Verbatim: neck are still as painful). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported and the outcome of the shoulder pain and neck pain were not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain, shoulder pain and neck pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, pain, shoulder pain and neck pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 27-JUN-2023. This case was reported by a patient via interactive digital media. The patient said get your Shingles shot.  Shingles was something you did not want to get.  The shot did not always mean you would not get the shingles, patient had the shots and still got shingles, but why take a chance. Last year patient had third degree burns on his/her ankle, that pain was nothing compared to the pain from shingles. Six weeks and the pain in patient shoulder and neck were still as painful as the first week.Get the shot. This case was considered as suspected vaccination failure as detail regarding completion of primary vaccination schedule, laboratory test confirming shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure decreased, Reaction to excipient
Clinical narrative: Ended up in the hospital due to a drop in blood pressure; Reaction to the Polysorbate 80; This serious case was reported by a consumer via other manufacturer and described the occurrence of blood pressure decreased in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included CHEMOTHERAPY and Meningitis vaccine (received back in 2018/2019 with no problems). Concurrent medical conditions included asplenia.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced blood pressure decreased (Verbatim: Ended up in the hospital due to a drop in blood pressure) (serious criteria hospitalization) and reaction to drug excipient (Verbatim: Reaction to the Polysorbate 80) (serious criteria hospitalization). The outcome of the blood pressure decreased and reaction to drug excipient were not reported.   It was unknown if the reporter considered the blood pressure decreased and reaction to drug excipient to be related to Shingrix.     It was unknown if the company considered the blood pressure decreased and reaction to drug excipient to be related to Shingrix.   Additional Information: GSK Receipt Date: 30-JUN-2023 The patient did not had a spleen and  had to get the meningitis vaccine periodically.  The last meningitis vaccine she had was the Pfizer Trumenba in 2018 and she believes or 2019. Well she's due again for her booster and had no issues.  The situation was that between 2018 and in 2020 she had the Shringrix vaccine. After the vaccination patient had an adverse reaction, ended up in the hospital due to a drop in blood pressure and all that kind of stuff.  Now she was due again for another Trumenba shot.  The pharmacist here in thought that it might have been a reaction to the Polysorbate 80 in the Shingrix vaccine.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: suspected vaccination faliure; Shingles; Pain; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (ZOSTAVAX) for prophylaxis.   On an unknown date, the patient received Shingles vaccine and ZOSTAVAX. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination faliure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and pain (Verbatim: Pain). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were resolved (duration 3 months).   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 01-JUL-2023 This case was reported by a patient's wife via interactive digital media. The patient had a shingles vaccine, Zostavax, was not told you could still get shingles might be a mild case. The patient got shingles with a vengeance, they were so bad and they lasted 3 months with much pain. The reporter stated that did not get the shingles vaccine. It was unknown if the reporter considered the shingles and pain to be related to Zostavax. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: M
Vaccine: VARZOS
Symptoms: Death, Gait inability, General physical health deterioration, White blood cell count decreased
Clinical narrative: Dead; couldn't walk; Decompensated; WBC count plummeted; This serious case was reported by a physician via sales rep and described the occurrence of unknown cause of death in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (on an unknown date patient received 1st dose of Shingrix). Concurrent medical conditions included chronic lymphocytic leukemia (had low grade chronic lymphocytic leukemia for 12 to 15 years).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 1 week after receiving Shingrix, the patient experienced unknown cause of death (Verbatim: Dead) (serious criteria death and GSK medically significant), unable to walk (Verbatim: couldn't walk), general physical health deterioration (Verbatim: Decompensated) and white blood cell count decreased (Verbatim: WBC count plummeted). The outcome of the unable to walk, general physical health deterioration and white blood cell count decreased were not reported. The reported cause of death was unknown.   It was unknown if the reporter considered the unknown cause of death, unable to walk, general physical health deterioration and white blood cell count decreased to be related to Shingrix.     It was unknown if the company considered the unknown cause of death, unable to walk, general physical health deterioration and white blood cell count decreased to be related to Shingrix.   Additional Information: GSK Receipt Date: 05-JUL-2023 The patient was around 90 years old.  The patient was not being treated for chronic lymphocytic leukemia.  It was watch and wait at that point for his chronic lymphocytic leukemia.  The patient wanted to get Shingrix. His doctor (reporter) said no, doctor did not thought patient should get it but the patient wanted it as he was afraid that getting shingles would kill him. The patient insisted and took both doses within the scheduled period. Immediately patient white blood cell counts plummeted, he could not walk, patient decompensated and was dead within a week.  The reporter estimated that this happened 2 to 4 years ago from reporting date. The reporter consented to follow up.; Reported Cause(s) of Death: Unknown cause of death
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had both  my shot got the shingles/suspected vaccination failure; Had both  my shot got the shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had both  my shot got the shingles/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Had both  my shot got the shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 02-JUL-2023 The case was received from the patient interactive digital media. The patient had both shot and got the shingles, this was his/her 10th week and had them (at the time of reporting). This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I had another flare up after the second shot/suspected vaccination failure; I had another flare up after the second shot, but; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: I had another flare up after the second shot/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I had another flare up after the second shot, but). The outcome of the vaccination failure was unknown and the outcome of the shingles was resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 2-Jul-2023 The case was received from the patient via interactive digital media. The patient had another flare up after the second shot, but his or her physician and the patient knew what it was and immediately started medication, cleared up right away. The patient stated that the shingles was nothing to play around with. This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had it twice and once before the shots and once after/suspected vaccination failure; Had it twice and once before the shots and once after; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had it twice and once before the shots and once after/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Had it twice and once before the shots and once after). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 01-JUL-2023 This case was reported by a patient via interactive digital media. The patient had shingles twice. The patient stated that once before the shingles shot and once after. The patient further stated that definitely easier time after the shingles shots. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Immune system disorder, Post herpetic neuralgia, Vaccination failure
Clinical narrative: Still fighting the nerve pain; her immune system was not up to par; I was fully vaccinated and got shingles in February/suspected vaccination failure; I was fully vaccinated and got shingles in February; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. In FEB-2023, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: I was fully vaccinated and got shingles in February/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I was fully vaccinated and got shingles in February). On an unknown date, the patient experienced post herpetic neuralgia (Verbatim: Still fighting the nerve pain) and immune system disorder (Verbatim: her immune system was not up to par). The outcome of the vaccination failure was unknown and the outcome of the shingles and immune system disorder were not reported and the outcome of the post herpetic neuralgia was not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, post herpetic neuralgia and immune system disorder to be related to Shingles vaccine and Shingles vaccine.  It was unknown if the company considered the vaccination failure, shingles, post herpetic neuralgia and immune system disorder to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 01-JUL-2023 This case was reported by a patient via interactive digital media. The patient was fully vaccinated and got shingles in February.  The patient was still fighting the nerve pain.  The patient was on chemo so his/her immune system was not up to par.  The reporter stated that people need to get the shingles shot. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccinatin failure; gave me up; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccinatin failure) (serious criteria GSK medically significant) and shingles (Verbatim: gave me up). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 04-JUL-2023 The case was received from the patient interactive digital media. The patient reported that it was a lie, he/she was already vaccinated and so he gave me. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Inflammation, Pain, Product administered at inappropriate site, Shoulder injury related to vaccine administration
Clinical narrative: resulting inflammation & pain; resulting inflammation & pain; inappropriate site of vaccine administration/shot was given too high in arm; SIRVA - shot was given too high in arm; have had continuous shoulder pain; SIRVA - shot was given too high in arm; have had continuous shoulder pain; This non-serious case was reported by a consumer and described the occurrence of shoulder injury related to vaccine administration in a 67-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 06-SEP-2022, the patient received Shingles vaccine (unknown arm). On 06-SEP-2022, less than a day after receiving Shingles vaccine, the patient experienced shoulder injury related to vaccine administration (Verbatim: SIRVA - shot was given too high in arm; have had continuous shoulder pain), shoulder pain (Verbatim: SIRVA - shot was given too high in arm; have had continuous shoulder pain) and vaccine administered at inappropriate site (Verbatim: inappropriate site of vaccine administration/shot was given too high in arm). On an unknown date, the patient experienced pain (Verbatim: resulting inflammation & pain) and inflammation (Verbatim: resulting inflammation & pain). On 27-JUN-2023, the outcome of the shoulder injury related to vaccine administration and shoulder pain were resolved (duration 9 months 21 days). The outcome of the pain and inflammation were not reported and the outcome of the vaccine administered at inappropriate site was unknown.   It was unknown if the reporter considered the shoulder injury related to vaccine administration, shoulder pain, pain and inflammation to be related to Shingles vaccine.     It was unknown if the company considered the shoulder injury related to vaccine administration, shoulder pain, pain and inflammation to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 27-JUN-2023 This report was submitted via the online direct entry reporting system. The patient reported SIRVA (Shoulder injury related to vaccine administration) also stated that shot was given too high in arm and had continuous shoulder pain. Patient stated it resulted into inflammation and pain.  She meant that some of the medicine obviously went the wrong place instead of into the bloodstream. The symptoms were treated. The reporter consented to follow up via email. The patient received shot too high in arm which led to vaccine administered at inappropriate site.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Chills, Decreased appetite, Headache, Nausea, Pain
Clinical narrative: Headache; Fever; Nausea; Vomiting; Body ache; chills; No appetite; Thirst; This non-serious case was reported by a nurse via call center representative and described the occurrence of headache in a 16-year-old male patient who received Men B NVS (Bexsero) (batch number 5P2P7PV) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) (batch number AMVA798) for prophylaxis.   On 15-MAR-2023, the patient received the 1st dose of Bexsero (left deltoid) and the 2nd dose of Menveo (right deltoid). On 15-MAR-2023, less than a day after receiving Bexsero and Menveo, the patient experienced headache (Verbatim: Headache), fever (Verbatim: Fever), nausea (Verbatim: Nausea), vomiting (Verbatim: Vomiting), general body pain (Verbatim: Body ache), chills (Verbatim: chills), appetite absent (Verbatim: No appetite) and thirst (Verbatim: Thirst). The outcome of the headache, fever, nausea, vomiting, general body pain, chills, appetite absent and thirst were not reported.   It was unknown if the reporter considered the headache, fever, nausea, vomiting, general body pain, chills, appetite absent and thirst to be related to Bexsero, Bexsero Pre-Filled Syringe Device and Menveo.     It was unknown if the company considered the headache, fever, nausea, vomiting, general body pain, chills, appetite absent and thirst to be related to Bexsero, Bexsero Pre-Filled Syringe Device and Menveo.   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: 28-JUN-2023 The reporter stated on 15th March 2023 patient administered both Bexsero and Menveo in same visit in different arm. On same night of vaccine administration symptoms began. They performed the Covid-19 test which was negative. The reporter agrees to follow up from GlaxoSmithKline. Note: Both the vaccines were considered as suspect because both were administered on same time and all the reporter symptoms occurred on the same night after administration of both vaccines. Since on same night (15TH March 2023) symptoms started full event onset date was captured. As per SD the given lot number was conservatively captured even if it was mentioned as last digit was not able to read
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Pyrexia, SARS-CoV-2 test negative, Thirst, Vomiting
Clinical narrative: Headache; Fever; Nausea; Vomiting; Body ache; chills; No appetite; Thirst; This non-serious case was reported by a nurse via call center representative and described the occurrence of headache in a 16-year-old male patient who received Men B NVS (Bexsero) (batch number 5P2P7PV) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) (batch number AMVA798) for prophylaxis.   On 15-MAR-2023, the patient received the 1st dose of Bexsero (left deltoid) and the 2nd dose of Menveo (right deltoid). On 15-MAR-2023, less than a day after receiving Bexsero and Menveo, the patient experienced headache (Verbatim: Headache), fever (Verbatim: Fever), nausea (Verbatim: Nausea), vomiting (Verbatim: Vomiting), general body pain (Verbatim: Body ache), chills (Verbatim: chills), appetite absent (Verbatim: No appetite) and thirst (Verbatim: Thirst). The outcome of the headache, fever, nausea, vomiting, general body pain, chills, appetite absent and thirst were not reported.   It was unknown if the reporter considered the headache, fever, nausea, vomiting, general body pain, chills, appetite absent and thirst to be related to Bexsero, Bexsero Pre-Filled Syringe Device and Menveo.     It was unknown if the company considered the headache, fever, nausea, vomiting, general body pain, chills, appetite absent and thirst to be related to Bexsero, Bexsero Pre-Filled Syringe Device and Menveo.   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: 28-JUN-2023 The reporter stated on 15th March 2023 patient administered both Bexsero and Menveo in same visit in different arm. On same night of vaccine administration symptoms began. They performed the Covid-19 test which was negative. The reporter agrees to follow up from GlaxoSmithKline. Note: Both the vaccines were considered as suspect because both were administered on same time and all the reporter symptoms occurred on the same night after administration of both vaccines. Since on same night (15TH March 2023) symptoms started full event onset date was captured. As per SD the given lot number was conservatively captured even if it was mentioned as last digit was not able to read
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: and three days later broke out with a nasty case of shingles; This non-serious 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.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 3 days after receiving Shingles vaccine, the patient experienced shingles (Verbatim: and three days later broke out with a nasty case of shingles). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 2-Jul-2023 The case was received from the patient via interactive digital media. The patient got his or her first shot and three days later broke out with a nasty case of shingles. The patient was told that it was a fluke as shot would not had taken effect for 2 weeks. The patient stated that sure wish he or she had been vaccinated sooner. The shingles were horrible.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Illness, Loss of personal independence in daily activities, Malaise
Clinical narrative: and later I got shingles; Sick; made me physically ill for 3 days; day off work; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of physically unwell 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, an unknown time after receiving Shingles vaccine, the patient experienced physically unwell (Verbatim: made me physically ill for 3 days), shingles (Verbatim: and later I got shingles), activities of daily living impaired (Verbatim: day off work) and sickness (Verbatim: Sick). The outcome of the physically unwell was resolved (duration 3 days) and the outcome of the shingles and sickness were not reported and the outcome of the activities of daily living impaired was resolved (duration 1 day).   It was unknown if the reporter considered the physically unwell, shingles, activities of daily living impaired and sickness to be related to Shingles vaccine.   It was unknown if the company considered the physically unwell, shingles, activities of daily living impaired and sickness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 02-JUL-2023 This case was reported by a patient via interactive digital media. The shingles shot made him/her physically ill for 3 days and cost him/her a day off work because he/she was so sick and later he/she got shingles. The reporter stated that second shingles shot was a hard and no for him/her.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: first left my arm sore for most of a week; This non-serious 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, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: first left my arm sore for most of a week). The outcome of the pain in arm was resolved (duration 1 week).   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2023AMR092464   Additional Information: GSK Receipt Date: 01-Jul-2023 This case was reported by a patient via interactive digital media. The first Shingles shot left his/her arm sore for most of a week. The reporter recommends getting the shot as Just the preview was enough to convince him. For tolerance of 2nd dose, refer case US2023AMR092464, reported by same reporter. The follow-up could not be possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR092464:Case for second dose
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Pain in extremity
Clinical narrative: only my arm hurt; tired; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: only my arm hurt) and tiredness (Verbatim: tired). The outcome of the pain in arm and tiredness were not reported.   It was unknown if the reporter considered the pain in arm and tiredness to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm and tiredness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 04-JUL-2023 This case was reported by a patient via interactive digital media. The patient self reported the case. Only patient arm hurt and patient was tired next day, otherwise fine. The patient reported it was totally worth not getting shingles. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles on left face and nose; This non-serious 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.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 weeks after receiving Shingles vaccine, the patient experienced shingles (Verbatim: shingles on left face and nose). The outcome of the shingles was resolved (duration 2 months).   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 05-JUL-2023 This case was reported by a patient via interactive digital media. The patient stated that it was horrifying.  The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: HEPAB
Symptoms: Off label use
Clinical narrative: she should only get 2 doses of TWINRIX total; This non-serious case was reported by a consumer via call center representative and described the occurrence of off label use in a female patient who received HAB (Twinrix adult) for prophylaxis.   Concomitant products included HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX).   On an unknown date, the patient did not received Twinrix adult. On an unknown date, an unknown time after receiving Twinrix adult and an unknown time after receiving TWINRIX, the patient experienced off label use (Verbatim: she should only get 2 doses of TWINRIX total). The outcome of the off label use 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 28 June 2023 The case was reported by patient who received her first dose of TWINRIX. The reporter stated that her doctor said she should only get 2 doses of TWINRIX total.   As per insert stated that TWINRIX was a 3-dose standard or 4-dose advanced series.  The reporter did not consent to follow-up. The reporter stated that her doctor said she should only get 2 doses of TWINRIX total which led to off label use.
Age: 76.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Injected limb mobility decreased, Injection site pain, Shoulder injury related to vaccine administration, Wrong technique in product usage process
Clinical narrative: Left upper shoulder and arm immobility; Shoulder injury related to vaccine administration; Left shoulder pain; Wrong Injection Technique/Vaccine administered too high on deltoid muscle causing needle to hit bone and shoulder; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injected limb mobility decreased in a 76-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number M4E4A, expiry date 05-OCT-2025) for prophylaxis.   On 08-JUN-2023, the patient received Boostrix (left deltoid). On 08-JUN-2023, less than a day after receiving Boostrix, the patient experienced injected limb mobility decreased (Verbatim: Left upper shoulder and arm immobility), shoulder injury related to vaccine administration (Verbatim: Shoulder injury related to vaccine administration), shoulder pain (Verbatim: Left shoulder pain) and wrong injection technique (Verbatim: Wrong Injection Technique/Vaccine administered too high on deltoid muscle causing needle to hit bone and shoulder). The patient was treated with AMBIGUOUS MEDICATION NOS (CORTISONE (NOS)). The outcome of the injected limb mobility decreased, shoulder injury related to vaccine administration and shoulder pain were not resolved and the outcome of the wrong injection technique was unknown.   It was unknown if the reporter considered the injected limb mobility decreased, shoulder injury related to vaccine administration and shoulder pain to be related to Boostrix and Boostrix Pre-Filled Syringe Device.     It was unknown if the company considered the injected limb mobility decreased, shoulder injury related to vaccine administration and shoulder pain to be related to Boostrix and Boostrix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 29-JUN-2023 The reporter was pharmacist called as a customer on behalf of his father. Reporter states that his father received the BOOSTRIX vaccine on 08-JUN-2023 at his pharmacy.  Reporter father got 9 other vaccines at the same pharmacy in the past.  Reporter stated that his father had pain in his left shoulder immediately after BOOSTRIX injection in his left deltoid and left shoulder. Also his father had left shoulder and arm immobility.  Caller took his father to his doctor on 21-JUN-2023 when he was diagnosed with SIRVA. Caller reported that the doctor said vaccine administered too high on deltoid muscle causing needle to hit bone and shoulder.  Reporter stated that the doctor recommended father go to an Orthopedic Specialist for Cortisone injections in his left shoulder. Reporter also stated that doctor believes these symptoms may not go away for 6 months to a year and a half.  The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Could not lift my arrm; Sore arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of mobility decreased in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16-SEP-2019, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced mobility decreased (Verbatim: Could not lift my arrm) and pain in arm (Verbatim: Sore arm). The outcome of the mobility decreased was resolved and the outcome of the pain in arm was resolved (duration 1 week).   It was unknown if the reporter considered the mobility decreased and pain in arm to be related to Shingrix.     It was unknown if the company considered the mobility decreased and pain in arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 30-JUN-2023 The reporter was the patient who refused to provide demographics. After vaccination she had her arm sore for a week and she could not lift her arm because it hurt. Reporter never completed the series due to the side effects.  No other information provided by the reporter.  The reporter did not consent to follow-up.
Sex: M
Vaccine: HEP, TDAP
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: Engerix-B - Safety of extra dose; patient received a second dose of Boostrix on; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 18-year-old male patient who received HBV (Engerix B) (batch number DD7K7, expiry date 31-MAR-2024) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Previously administered products included Boostrix (received 1st dose when patient was 12 year old).   On 31-MAY-2023, the patient received the 4th dose of Engerix B and the 2nd dose of Boostrix. On 31-MAY-2023, an unknown time after receiving Engerix B and not applicable after receiving Boostrix, the patient experienced extra dose administered (Verbatim: Engerix-B - Safety of extra dose) and drug dose administration interval too short (Verbatim: patient received a second dose of Boostrix on). The outcome of the extra dose administered and drug dose administration interval too short were unknown.   Additional Information: GSK Receipt Date: 30-JUN-2023 The same day the patient received a second dose of Boostrix with 4th dose of Engerix-B.  The healthcare professional asked for safety information. According to healthcare professional, the patient had not reported any adverse reaction following the vaccination. The reporter consented to follow up. The patient received 2nd dose of Boostrix (booster) earlier than the recommended schedule, which led to shortening of vaccination schedule. The patient was administered with a fourth dose of Engerix-B, which led to extra dose administered.
Sex: M
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: administered an expired dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a adult male patient who received HAB (Twinrix) (expiry date 01-JAN-2023) for prophylaxis.   On 30-JUN-2023, the patient received the 1st dose of Twinrix (intramuscular, right arm). On 30-JUN-2023, an unknown time after receiving Twinrix, the patient experienced expired vaccine used (Verbatim: administered an expired dose). 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 Information: GSK receipt date: 03-JUL-2023 The pharmacist reported that she administered an expired dose of Twinrix to a male patient in his late 30's which led to expired vaccine used.
Age: 13.0
Sex: M
Vaccine: HEP
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: 13 year old was administered adult dose of Engerix B vaccine; 13 year old was administered adult dose of Engerix B vaccine; This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a 13-year-old male patient who received HBV (Engerix B adult) (batch number 475S4, expiry date 04-APR-2025) for prophylaxis.   On 22-JUN-2023, the patient received the 3rd dose of Engerix B adult. On 22-JUN-2023, an unknown time after receiving Engerix B adult, the patient experienced overdose (Verbatim: 13 year old was administered adult dose of Engerix B vaccine) and inappropriate age at vaccine administration (Verbatim: 13 year old was administered adult dose of Engerix B vaccine). The outcome of the overdose and inappropriate age at vaccine administration were unknown.   Additional Information: GSK receipt date: 03-JUL-2023 The practice manager reported that 13 year old male patient was administered an adult dose of Engerix B vaccine which led to inappropriate age at vaccine administration and overdose. This was the patient's third dose in the series. The reporter consented to follow up. The vaccine administration facility is the same as primary reporter. The reporter gave permission for follow up
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Social problem, Vaccination site pain
Clinical narrative: felt isolation; the side effects of previous vaccinations were painful/Vaccination site pain; This spontaneous case was reported by a non-health professional and describes the occurrence of SOCIAL PROBLEM (felt isolation) and VACCINATION SITE PAIN (the side effects of previous vaccinations were painful/Vaccination site pain) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form and third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. and fourth dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SOCIAL PROBLEM (felt isolation) and VACCINATION SITE PAIN (the side effects of previous vaccinations were painful/Vaccination site pain). At the time of the report, SOCIAL PROBLEM (felt isolation) and VACCINATION SITE PAIN (the side effects of previous vaccinations were painful/Vaccination site pain) outcome was unknown.            No concomitant medication was reported. No treatment information was reported.
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Covid-19 positive; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19 positive) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 in 2022. Previously administered products included for Product used for unknown indication: JANSSEN COVID-19 VACCINE (Dose 1, Lot number: 213021A, administered in right arm) on 22-Mar-2021, Janssen COVID-19 Vaccine (Dose 2 (First booster) and administered in right arm) in November 2021. Past adverse reactions to the above products included No adverse event with JANSSEN COVID-19 VACCINE and Janssen COVID-19 Vaccine. Concurrent medical conditions included COPD (Late Stage 3 of COPD) and Cancer (On his 5th year of remission on one cancer).    On 06-Dec-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 27-Jun-2023, the patient experienced COVID-19 (Covid-19 positive). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) (oral) on 27-Jun-2023 for COVID-19, at a dose of 3 dosage form twice a day. At the time of the report, COVID-19 (Covid-19 positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jun-2023, SARS-CoV-2 test: Positive.         No concomitant drug information was provided.  It was reported that the patient had a lot of problems that had been going on for years. Patient called the doctor because he knew he felt like he did when first got sick before. He called his primary physician right away. He did home test kits. Patient was prescribed Paxlovid to take along with other medications, since he tested positive for Covid. He was also prescribed Dexamethasone and Doxycycline Mono 100mg. None of these were on the list one had to make sure was not also taking.  He clarified further he was calling because regular pharmacy did not have Paxlovid. He then had to call another one in town to get it. The first day he had it, but had no mood to read the stuff that came with it. He just started dosing. A day before reporting, patient was looking at the packaging. Everything was right on pills. The numbers that should be on them were on them. On the outside of box it had a lot number. However, the expiration date was listed as Apr 2023 which had already passed. He saw the expiration date and it was now the end of June almost July. The patient however, was not sick from it and he was on his third day of it.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; 1st dose received on 11Dec2021,2nd dose received on 12Jun2022; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose received on 11Dec2021,2nd dose received on 12Jun2022) and NO ADVERSE EVENT (No adverse event) in a 55-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 031H21A and 059A22A) for COVID-19 prophylaxis.     It was reported that HCP did not report any medical history or condition for the patient. Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.    On 11-Dec-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-Jun-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 12-Jun-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose received on 11Dec2021,2nd dose received on 12Jun2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose received on 11Dec2021,2nd dose received on 12Jun2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose received on 11Dec2021,2nd dose received on 12Jun2022).    No concomitant medication was reported. The patient took 3rd dose of expired bivalent moderna  vaccine on 10-Jun-2023(AS7185B). No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-731750 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-731750:bivalent case