chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: MENB
Symptoms: Product complaint, Seizure
Clinical narrative: Article states seizures from vaccination; Product complaint; This serious case was reported by a consumer and described the occurrence of seizures in a 10-month-old male patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On 13-DEC-2016, an unknown time after receiving Bexsero, the patient experienced seizures (Verbatim: Article states seizures from vaccination) (serious criteria hospitalization and GSK medically significant). On an unknown date, the patient experienced pharmaceutical product complaint (Verbatim: Product complaint). The outcome of the seizures was not reported and the outcome of the pharmaceutical product complaint was unknown.   The reporter considered the seizures to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     The company considered the seizures to be related to Bexsero and Bexsero 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: 23-JUN-2023 The patient was in hospital for the article states seizures from vaccination. The patient experienced seizures that could be linked to meningitis b vaccine states the child had seizures as a result of the vaccination.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; I had two shingle shots and still got it on my left side of my face; 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: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I had two shingle shots and still got it on my left side of my face). 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 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:26-JUN-2023 The case was received from the patient interactive digital media. The patient had two Shingle shots and still got it on his/her left side of face. The patient stated that worst thing he/she ever had. 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: F
Vaccine: VARZOS
Symptoms: Asthenia, Dyspepsia, Exercise tolerance decreased, Gait disturbance, Loss of personal independence in daily activities
Clinical narrative: Neuropathy; hard time walking; Debilitating; digestive system is not right anymore; Unable to do exercise; hard time doing the dishes or any other task; This serious case was reported by a consumer via interactive digital media and described the occurrence of neuropathy in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced neuropathy (Verbatim: Neuropathy) (serious criteria GSK medically significant), walking difficulty (Verbatim: hard time walking), debility (Verbatim: Debilitating), digestion impaired (Verbatim: digestive system is not right anymore), exercise capacity decreased (Verbatim: Unable to do exercise) and activities of daily living impaired (Verbatim: hard time doing the dishes or any other task). The outcome of the neuropathy was not resolved and the outcome of the walking difficulty, debility, digestion impaired, exercise capacity decreased and activities of daily living impaired were not reported.   It was unknown if the reporter considered the neuropathy, walking difficulty, debility, digestion impaired, exercise capacity decreased and activities of daily living impaired to be related to Shingrix.     It was unknown if the company considered the neuropathy, walking difficulty, debility, digestion impaired, exercise capacity decreased and activities of daily living impaired to be related to Shingrix.   Additional Information: GSK Receipt Date: 26-JUN-2023 The case was received from the patient via (Facebook) interactive digital media. The patient received second dose of Shingrix and four days' after she woke up and had a hard time walking.  She had neuropathy ever since.  She had hard time doing the dishes or any other task. She was livid because they give no warning before they gave the shot. They only told her that her arm would be sore for a few days.  The reporter stated that her body would never be the same. She used to be athletic and now she was unable to do the exercises that she used to do.  Shingrix took away her life and her digestive system was not right anymore. The reporter wish that she had never gotten the Shingrix vaccine. Eventually they would be accountable for this. They were willfully hiding all the information. The patient used to be pro vaccine until she got this one. The patient did not want anyone else to go through this. The patient stated she would rather have shingles for a few weeks that neuropathy for the rest of her life.
Sex: F
Vaccine: VARZOS
Symptoms: Neuropathy peripheral
Clinical narrative: Neuropathy; hard time walking; Debilitating; digestive system is not right anymore; Unable to do exercise; hard time doing the dishes or any other task; This serious case was reported by a consumer via interactive digital media and described the occurrence of neuropathy in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced neuropathy (Verbatim: Neuropathy) (serious criteria GSK medically significant), walking difficulty (Verbatim: hard time walking), debility (Verbatim: Debilitating), digestion impaired (Verbatim: digestive system is not right anymore), exercise capacity decreased (Verbatim: Unable to do exercise) and activities of daily living impaired (Verbatim: hard time doing the dishes or any other task). The outcome of the neuropathy was not resolved and the outcome of the walking difficulty, debility, digestion impaired, exercise capacity decreased and activities of daily living impaired were not reported.   It was unknown if the reporter considered the neuropathy, walking difficulty, debility, digestion impaired, exercise capacity decreased and activities of daily living impaired to be related to Shingrix.     It was unknown if the company considered the neuropathy, walking difficulty, debility, digestion impaired, exercise capacity decreased and activities of daily living impaired to be related to Shingrix.   Additional Information: GSK Receipt Date: 26-JUN-2023 The case was received from the patient via (Facebook) interactive digital media. The patient received second dose of Shingrix and four days' after she woke up and had a hard time walking.  She had neuropathy ever since.  She had hard time doing the dishes or any other task. She was livid because they give no warning before they gave the shot. They only told her that her arm would be sore for a few days.  The reporter stated that her body would never be the same. She used to be athletic and now she was unable to do the exercises that she used to do.  Shingrix took away her life and her digestive system was not right anymore. The reporter wish that she had never gotten the Shingrix vaccine. Eventually they would be accountable for this. They were willfully hiding all the information. The patient used to be pro vaccine until she got this one. The patient did not want anyone else to go through this. The patient stated she would rather have shingles for a few weeks that neuropathy for the rest of her life.
Sex: F
Vaccine: VARZOS
Symptoms: Death, Poisoning, Pyrexia
Clinical narrative: Intoxication; high fever; This serious case was reported by a consumer via interactive digital media and described the occurrence of intoxication in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In JUN-2023, the patient received Shingles vaccine. In JUN-2023, an unknown time after receiving Shingles vaccine, the patient experienced intoxication (Verbatim: Intoxication) (serious criteria death and GSK medically significant) and fever (Verbatim: high fever) (serious criteria death). The patient died in JUN-2023. The reported cause of death was intoxication and fever.   It was unknown if the reporter considered the intoxication and fever to be related to Shingles vaccine.     It was unknown if the company considered the intoxication and fever to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 24-JUN-2023 This case was received from patient's friend via interactive digital media. This week (reporting week), the patient received Shingles vaccine and in some time she died of intoxication and the high fever. The reporter stated that it was enough and would not get it done.; Reported Cause(s) of Death: intoxication; high fever
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the shot and shingles to follow/Suspected Vaccination failure; Got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: got the shot and shingles to follow/Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Got shingles). 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: 24-JUN-2023 This case was reported by a patient via interactive digital media. The reporter reported that his/her dad got the Shingles shot and shingles followed up. The patient stated it was worse case ever. 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.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got it done and still have it /suspected Vaccination failure; 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.   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: Got it done and still have it /suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). 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: 23-JUN-2023 This case was reported by a patient via interactive digital media. The patient stated to get yourself vaccinated. The patient reported she/he got Shingles vaccine done and still had shingles; it was not a joke. 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
Symptoms: Herpes zoster, Rash, Rash papular, Rash pruritic, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; raised itchy dots; itchy dots; two small patches; 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 vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles), raised rash (Verbatim: raised itchy dots), itchy rash (Verbatim: itchy dots) and patchy rash (Verbatim: two small patches). The outcome of the vaccination failure was unknown and the outcome of the shingles, raised rash, itchy rash and patchy rash were not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, raised rash, itchy rash and patchy rash to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, raised rash, itchy rash and patchy rash to be related to Shingles vaccine.   Additional Information: GSK receipt date: 24-JUN-2023 The case was received from the patient interactive digital media. The patient stated that not true, as he/she got the shots to prevent getting them.  The patient got the shingles anyway but it was nothing like it could had been.  The patient stated that his/her showed up as two small patches (about size of courter), the patches looking like mosquito bites, raised itchy dots.  There was no pain associated but the itchiness was like a mosquito bite and that did not went away.  The physician told to patient that had he/she not gotten the preventative shots it could had been dreadful.  He said getting the preventative shot probably saved him/her from the horrors of the shingles.  He did seem surprised that did not had pain with his/her only itchiness.  The patient highly recommended that you get the shots (there were two taken 1 shot, then 30 days 2nd shot).  The patient stated that shots do not guarantee that you would not get them but can drastically affect how badly you suffer if you do get them. 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.
Sex: U
Vaccine: VARZOS
Symptoms: Chemotherapy, Herpes zoster, Vaccination failure
Clinical narrative: Got the vaccine done but I suffered this all through /suspected vaccination failure; 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.   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: Got the vaccine done but I suffered this all through /suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The patient was treated with chemotherapy, nos (Chemotherapy). The outcome of the vaccination failure was unknown and the outcome of the shingles was resolving.   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: 25-JUN-2023 This case was reported by a patient via interactive digital media. The patient stated that she/he got the vaccine done but suffered this all through. Patient had to go to his/her country and there they performed a kind of chemotherapy in the front. They invented serums and vitamins, vitamin, the patient did not remember. Patient was fine, just had a little bit of it, not much, but it was like before. 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
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got a bad case of the shingles four years after your taking your vaccine/ Suspected Vaccination failure; Shingles; This serious case was reported by a consumer 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, 4 years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: got a bad case of the shingles four years after your taking your vaccine/ Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). 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: 25-JUN-2023 The reporter wanted to know he/she just got a bad case of the shingles four years after taking shingles vaccine.  The reporter wanted to know what he/she should do and any recommendation or any treatments. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting.
Sex: F
Vaccine: TDAP
Symptoms: Anaphylactic reaction, Death
Clinical narrative: Anaphylactic reaction; This serious case was reported by a consumer via interactive digital media and described the occurrence of anaphylactic reaction in a child female patient who received DTPa (DTPa vaccine) for prophylaxis.   Concurrent medical conditions included allergy (Dairy allergy). Family history included chickenpox and measles.   On an unknown date, the patient received DTPa vaccine. On an unknown date, an unknown time after receiving DTPa vaccine, the patient experienced anaphylactic reaction (Verbatim: Anaphylactic reaction) (serious criteria death and GSK medically significant). The reported cause of death was anaphylactic reaction.   It was unknown if the reporter considered the anaphylactic reaction to be related to DTPa vaccine.     It was unknown if the company considered the anaphylactic reaction to be related to DTPa vaccine.   Additional Information: GSK Receipt Date: 26-JUN-2023 This case was reported by a patient via interactive digital media. The reporter was the parent of the patient. The reporter stated that he/she lost her/his 1st child to an anaphylactic reaction to her 2 month DTap vaccine shots as DTap contains dairy and patient seemed to have dairy allergy. The physician stated that the patient would be fine but the parent stated that he/she buried patient 4 days later. The reporter stated that it would be always be a hard pass for him and her. The reporter also stated that they were perfectly fine and their pediatrician was amazed every year when they went for well checks. The reporter's kids were never sick.  Four were grown with children of their own, all 100 percent unvaxxed and 100 percent completely healthy. The reporter stated that they had those deadly diseases like chicken pox, measles but they did not ruin their natural immune systems with all the poison, they all came through with very mild, easy cases.  The reporter stated to do a little research and be amazed.  The reporter stated that he/she was so glad covid has opened so many people's eyes that nothing was safe and effective and that everything in life had risks, and the science is never settled.  The reporter stated to remember that cigarettes were good until they were not. The reporter stated that experiment was a great place to start, and stated that the government had used the public as their guinea pigs for years. The follow-up could not be possible as no contact details were available.; Reported Cause(s) of Death: Anaphylactic reaction
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Body temperature increased, Herpes zoster, Neck pain, Pain of skin
Clinical narrative: Suspected vaccination failure; I know people that got vaccine and still git them; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in an unspecified number of patients 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 vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I know people that got vaccine and still git them). 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: 22-JUN-2023 This case was reported by a consumer via interactive digital media. The reporter stated that it had been 2.5 years now.  The reporter knew people that got shingles vaccine and still got shingles.  They were the worst thing he/she ever had.  The reporter further stated that it felt like ground glass being continuously grounded into your skin and on shoulder and up side of neck.  The reporter wanted to know when his/her body temperature went up they burnt like mad.  The reporter further stated that lots of praying for them to be gone. 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
Symptoms: Skin burning sensation, Vaccination failure
Clinical narrative: Suspected vaccination failure; I know people that got vaccine and still git them; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in an unspecified number of patients 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 vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I know people that got vaccine and still git them). 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: 22-JUN-2023 This case was reported by a consumer via interactive digital media. The reporter stated that it had been 2.5 years now.  The reporter knew people that got shingles vaccine and still got shingles.  They were the worst thing he/she ever had.  The reporter further stated that it felt like ground glass being continuously grounded into your skin and on shoulder and up side of neck.  The reporter wanted to know when his/her body temperature went up they burnt like mad.  The reporter further stated that lots of praying for them to be gone. 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.
Age: 60.0
Sex: F
Vaccine: DTP
Symptoms: Product administered to patient of inappropriate age, Tinnitus
Clinical narrative: 60 year patient received DTP vaccine; Tinnitus; This non-serious case was reported by a consumer and described the occurrence of tinnitus in a 60-year-old female patient who received DTP (A or W not known) (DTP (A or W not known)) for prophylaxis.   Concurrent medical conditions included ear pain (From 1st June 2023 to ongoing).   On 21-JUN-2023, the patient received DTP (A or W not known). In JUN-2023, an unknown time after receiving DTP (A or W not known), the patient experienced tinnitus (Verbatim: Tinnitus). On 21-JUN-2023, the patient experienced inappropriate age at vaccine administration (Verbatim: 60 year patient received DTP vaccine). The outcome of the tinnitus was not reported and the outcome of the inappropriate age at vaccine administration was unknown.   It was unknown if the reporter considered the tinnitus to be related to DTP (A or W not known).   It was unknown if the company considered the tinnitus to be related to DTP (A or W not known).   Additional Information: GSK Receipt Date: 22-JUN-2023 The patient did not have COPD (Chronic obstructive pulmonary disease) but she had tinnitus. The reporter further stated that your commercial hurt her ear and stop it. The patient received DTP (A or W not known) above than the age recommendation schedule, which led to inappropriate age at vaccine administration.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Injection site pain, Pain
Clinical narrative: Muscle soreness at injection site; Flu-like symptoms; chills; body aches; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of injection site muscle pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included allergy. Concomitant products included ramipril, metoprolol, simvastatin, metformin, iron (Iron Supplement), acetylsalicylic acid (Aspirin) and ascorbic acid (Vitamin C Supplement).   On 22-MAR-2023, the patient received the 1st dose of Shingrix (left deltoid). On 23-MAR-2023, 1 days after receiving Shingrix, the patient experienced injection site muscle pain (Verbatim: Muscle soreness at injection site), influenza-like symptoms (Verbatim: Flu-like symptoms), chills (Verbatim: chills) and general body pain (Verbatim: body aches). On 23-MAR-2023, the outcome of the injection site muscle pain, influenza-like symptoms, chills and general body pain were resolved.   It was unknown if the reporter considered the injection site muscle pain, influenza-like symptoms, chills and general body pain to be related to Shingrix.     It was unknown if the company considered the injection site muscle pain, influenza-like symptoms, chills and general body pain to be related to Shingrix.   Additional Information: GSK receipt date: 20-Jun-2023 The patient had muscle soreness at injection site. Flu-like symptoms for 24 hours, chills and body aches. Follow-up not possible as no contact details provided.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Malaise, Myalgia, Nausea
Clinical narrative: vertigo; Red injection reaction on arm; Fever; Chills; Myalgia; Maybe nausea; Not feel well; This non-serious case was reported by a other health professional via sales rep and described the occurrence of injection site erythema in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included autoimmune disorder. Previously administered products included Shingrix (On unknown day patient received 1st dose).   On 16-JUN-2023, the patient received the 2nd dose of Shingrix. In JUN-2023, an unknown time after receiving Shingrix, the patient experienced injection site erythema (Verbatim: Red injection reaction on arm), fever (Verbatim: Fever), chills (Verbatim: Chills), myalgia (Verbatim: Myalgia) and nausea (Verbatim: Maybe nausea). On an unknown date, the patient experienced vertigo (Verbatim: vertigo) and feeling unwell (Verbatim: Not feel well). The outcome of the injection site erythema, fever, chills and myalgia were not reported and the outcome of the nausea and vertigo were not resolved and the outcome of the feeling unwell was resolved (duration 5 days).   It was unknown if the reporter considered the injection site erythema, fever, chills, myalgia, nausea, vertigo and feeling unwell to be related to Shingrix.     It was unknown if the company considered the injection site erythema, fever, chills, myalgia, nausea, vertigo and feeling unwell to be related to Shingrix.   Linked case(s) involving the same patient:  US2023AMR088326   Additional Information: GSK Receipt Date: 23-JUN-2023 The patient received second shot and experienced baseball size, red injection reaction on arm. Fever, chills, myalgia,maybe nausea (vertigo patient so that comes and goes - the nausea). For 5 days patient did not felt well.  Patient went to work on Tuesday.  Patient 2nd Shingrix shot was on the prior Friday. Patient had a history of Autoimmune disease. The reporter did not consented to follow up.; Sender's Comments:  US-GSK-US2023AMR088326:same patient, diffrent dose
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Vertigo
Clinical narrative: vertigo; Red injection reaction on arm; Fever; Chills; Myalgia; Maybe nausea; Not feel well; This non-serious case was reported by a other health professional via sales rep and described the occurrence of injection site erythema in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included autoimmune disorder. Previously administered products included Shingrix (On unknown day patient received 1st dose).   On 16-JUN-2023, the patient received the 2nd dose of Shingrix. In JUN-2023, an unknown time after receiving Shingrix, the patient experienced injection site erythema (Verbatim: Red injection reaction on arm), fever (Verbatim: Fever), chills (Verbatim: Chills), myalgia (Verbatim: Myalgia) and nausea (Verbatim: Maybe nausea). On an unknown date, the patient experienced vertigo (Verbatim: vertigo) and feeling unwell (Verbatim: Not feel well). The outcome of the injection site erythema, fever, chills and myalgia were not reported and the outcome of the nausea and vertigo were not resolved and the outcome of the feeling unwell was resolved (duration 5 days).   It was unknown if the reporter considered the injection site erythema, fever, chills, myalgia, nausea, vertigo and feeling unwell to be related to Shingrix.     It was unknown if the company considered the injection site erythema, fever, chills, myalgia, nausea, vertigo and feeling unwell to be related to Shingrix.   Linked case(s) involving the same patient:  US2023AMR088326   Additional Information: GSK Receipt Date: 23-JUN-2023 The patient received second shot and experienced baseball size, red injection reaction on arm. Fever, chills, myalgia,maybe nausea (vertigo patient so that comes and goes - the nausea). For 5 days patient did not felt well.  Patient went to work on Tuesday.  Patient 2nd Shingrix shot was on the prior Friday. Patient had a history of Autoimmune disease. The reporter did not consented to follow up.; Sender's Comments:  US-GSK-US2023AMR088326:same patient, diffrent dose
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: 4 years old patient received a dose of one vial Menveo by mistake; 4 years old patient received a dose of one vial Menveo by mistake; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 4-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA91A, expiry date 08-FEB-2025) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: 4 years old patient received a dose of one vial Menveo by mistake) and inappropriate dose of vaccine administered (Verbatim: 4 years old patient received a dose of one vial Menveo by mistake). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 22-JUN-2023 and 23-JUN-2023 The medical information specialist attempted callback this morning around 10 AM (delayed callback due to different time zone of caller).  The reporter was not in the office and anonymous front office staff informed. The medical information specialist that other medical assistants were busy with other patients.  Front office staff member stated that she did not know any details, so Medical Information Specialist was unable to clarify vaccine brand or any additional details. The reporter reported that the incorrect administration of a vaccines (no data apart from this one) and reported that the patient received a dose of one vial Menveo by mistake (it was approved until the patient was 10 years of age), which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes virus infection
Clinical narrative: herpes returns more frequently than before; This non-serious case was reported by a consumer via call center representative and described the occurrence of herpes virus infection in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced herpes virus infection (Verbatim: herpes returns more frequently than before). The patient was treated with valaciclovir (Valacyclovir). The outcome of the herpes virus infection was not reported.   It was unknown if the reporter considered the herpes virus infection to be related to Shingrix.  It was unknown if the company considered the herpes virus infection to be related to Shingrix.   Additional Information: GSK Receipt Date: 23-JUN-2023 The Pfizer Covid vaccine negated the Shingrix shots. The pharmacy said that he/she could not gave any more Shingrix shots.  Now herpes returned more frequently than before.  He/she could take Valacyclovir but only once he/she sense a bout was starting. The Shingrix was such a welcome improvement.  The reporter wanted to know what did you think he/she might be able to take it again and were you aware of this side effect from the pfizer vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus
Clinical narrative: Red, oval patch; itchy patch on her left shoulder blade; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of localized erythema in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13-JUN-2023, the patient received the 1st dose of Shingrix (left deltoid). On 16-JUN-2023, 3 days after receiving Shingrix, the patient experienced localized erythema (Verbatim: Red, oval patch) and localized itching (Verbatim: itchy patch on her left shoulder blade). The outcome of the localized erythema and localized itching were not resolved.   It was unknown if the reporter considered the localized erythema and localized itching to be related to Shingrix.   It was unknown if the company considered the localized erythema and localized itching to be related to Shingrix.   Additional Information: GSK Receipt Date:20-JUN-2023 The reporter called to gather informatoin on a suspected adverse event following administration of Shingrix. The patient was complaining of a red, oval, itchy patch on her left shoulder blade, which appeared approximately 4-5 days after her Shingrix shot on the same side of the body.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Body temperature increased, Chills, Influenza like illness, Pain, Pyrexia
Clinical narrative: Body Pain; Chills; Elevated temperature; severe flu like symptoms; fever; This non-serious case was reported by a consumer via call center representative and described the occurrence of general body pain in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 09-MAR-2023, the patient received the 1st dose of Shingrix. In MAR-2023, 24 hrs after receiving Shingrix, the patient experienced general body pain (Verbatim: Body Pain), chills (Verbatim: Chills), body temperature increased (Verbatim: Elevated temperature), influenza-like symptoms (Verbatim: severe flu like symptoms) and fever (Verbatim: fever). In MAR-2023, the outcome of the general body pain, chills, body temperature increased, influenza-like symptoms and fever were resolved (duration 48 hrs).   It was unknown if the reporter considered the general body pain, chills, body temperature increased, influenza-like symptoms and fever to be related to Shingrix.   It was unknown if the company considered the general body pain, chills, body temperature increased, influenza-like symptoms and fever to be related to Shingrix.   Additional Information: GSK Receipt Date:20-JUN-2023. The reporter stated that the patient reported having severe flu like symptoms after 1st dose of Shingrix vaccine. The patient also reported having fever or elevated temperature, chills and body pain. The patient had fever or elevated temperature since he did not use a thermometer. The symptoms resolved and recovered within 48 hours . It was not confirmed weather the patient had taken the second dose of vaccination or not. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Shingrix late second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in an unspecified numbers of adult patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in November 2018).   In APR-2023, the patients received the 2nd dose of Shingrix. In APR-2023, an unknown time after receiving Shingrix, the patients experienced drug dose administration interval too long (Verbatim: Shingrix late second dose). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 22-JUN-2023 The patients were over 50 year of age. The health care professional (HCP) mentioned the pronome "they" several times, so it is possible that there is more than one patient on this situation but this could not be clarified. The HCP declined to provided information for Safety.  Follow up (FU) could not be requested as well as permission to create HCP´s account on Medical Information database.       The reporter did not consent to follow-up. The patients received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Extra dose administered, Pain, Paraesthesia, Product storage error, Pruritus
Clinical narrative: second dose received apparently not effective due to a temperature excursion; prickly; stinging; itching; Extra Dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of tingling in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In JAN-2023, the patient received the 3rd dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. In JAN-2023, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced tingling (Verbatim: prickly), stinging (Verbatim: stinging), pruritus (Verbatim: itching) and extra dose administered (Verbatim: Extra Dose). On an unknown date, the patient experienced incorrect storage of drug (Verbatim: second dose received apparently not effective due to a temperature excursion). The patient was treated with desonide. The outcome of the tingling, stinging and pruritus were not resolved and the outcome of the extra dose administered and incorrect storage of drug were unknown.   It was unknown if the reporter considered the tingling, stinging and pruritus to be related to Shingrix.     It was unknown if the company considered the tingling, stinging and pruritus to be related to Shingrix.   Additional Information: GSK receipt date: 22-Jun-2023 The patient was fully vaccinated with 2 doses of Shingrix. The patient was notified by the pharmacist that the 2nd dose received apparently not effective due to a temperature excursion. The patient went to pharmacy and received a third dose. The event happened around 5 months ago.  Since then, the patient has been feeling itching, stinging and prickly in the skin under her right breast by the liver area. The physician prescribed Desonide to alleviate the symptoms. The patient not recovered yet. Patient did not recalled any vaccination dates, stating she would callback to provide that information. The pharmacist informed that the 2nd dose received apparently not effective due to a temperature excursion, which led to incorrect storage of drug. The patient received 3rd dose, which led to extra dose administered. The reporter consented to follow up.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling hot, Injection site pain, Malaise, Skin warm
Clinical narrative: general malaise; tiredness; soreness in the left arm at the injection site; left arm was warm to the touch with heat that lasted a full five days.; This non-serious case was reported by a consumer via call center representative and described the occurrence of general malaise in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16-JUN-2023, the patient received the 1st dose of Shingrix (left arm). In JUN-2023, an unknown time after receiving Shingrix, the patient experienced general malaise (Verbatim: general malaise), tiredness (Verbatim: tiredness), injection site pain (Verbatim: soreness in the left arm at the injection site) and hot feeling in hand (Verbatim: left arm was warm to the touch with heat that lasted a full five days.). The outcome of the general malaise, tiredness, injection site pain and hot feeling in hand were resolved (duration 5 days).   It was unknown if the reporter considered the general malaise, tiredness, injection site pain and hot feeling in hand to be related to Shingrix.     It was unknown if the company considered the general malaise, tiredness, injection site pain and hot feeling in hand to be related to Shingrix.   Additional Information: GSK receipt date: 23-JUN-2023 The reporter reported that after the injection she experienced general malaise, tiredness, soreness in the left arm at the injection site and her left arm was warm to the touch with heat that lasted a full five days. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Incorrect dose administered, Pain
Clinical narrative: Fatigue; Pain; This non-serious case was reported by a physician via call center representative and described the occurrence of fatigue in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced fatigue (Verbatim: Fatigue) and pain (Verbatim: Pain). The outcome of the fatigue and pain were unknown.   It was unknown if the reporter considered the fatigue and pain to be related to Shingrix.     It was unknown if the company considered the fatigue and pain to be related to Shingrix.   Additional Information: GSK receipt date: 23-Jun-2023 The medical physician informed that he received a dose of Shingrix 3 years ago and he had pain and fatigue, and for that reason he never got a second dose to complete the series.  No other information was provided to GlaxoSmithKline sales representative.  The reporter did not want to be contacted by GlaxoSmithKline. The reporter did not consent to follow-up.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate Schedule of Vaccine/ not had any prior vaccinations; This non-serious case was reported by a physician via call center representative and described the occurrence of inappropriate schedule of vaccine administered in a 5-year-old female patient who received DTPa-IPV (Kinrix) for prophylaxis.   In JUN-2023, the patient received the 1st dose of Kinrix. In JUN-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate schedule of vaccine administered (Verbatim: Inappropriate Schedule of Vaccine/ not had any prior vaccinations). The outcome of the inappropriate schedule of vaccine administered 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: 23-JUN-2023 The physician reported that the patient received Kinrix vaccine in clinic this past week.  The reporter stated that afterward it was realized that the patient did not had any prior vaccinations.   The reporter did not have exact date of administration, lot number or expiration date. The vaccine administration facility was the same as primary reporter. The reporter did consent to follow up. The patient received Kinrix as a first dose of IPV and DTaP series, which led to inappropriate schedule of vaccine administered. This case had been linked with US2023088087 reported by same reporter for different patient.; Sender's Comments:  US-GSK-US2023088087:1 of 2
Age: 0.67
Sex: F
Vaccine: RV1
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 8 months and 11 days old child was administered a dose of Rotarix; This non-serious case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 8-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number 7RT75F, expiry date 19-SEP-2024) for prophylaxis.   On 23-JUN-2023, the patient received the 2nd dose of Rotarix lyophilized formulation. On 23-JUN-2023, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced inappropriate age at vaccine administration (Verbatim: 8 months and 11 days old child was administered a dose of Rotarix). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 23-JUN-2023 The physician reported a patient aged 8 months and 11 days was administered a dose of Rotarix (national drug code number 58160-854-52), which led to inappropriate age at vaccine administration. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.