chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Pain in extremity, Pruritus, Sleep disorder
Clinical narrative: She got her vaccine, and had a sore arm the next day, then had itchy, itchy area on her back all over her body with hives.   She also had ringing in her ears.   Now she has diarrhea that she woke up with this morning at 2:00-3:00 AM, and she still has it with stomach pains.   It?s 6 days after the shot and thinking about it and had a similar reaction when she had her vaccine in September.   She had Covid and Tetanus in September and had a similar reaction and had Moderna at that time as well.  She had her RSV vaccine on 2/27/24 and had severe headaches.  She has not taking anything for her symptoms.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus, Urticaria
Clinical narrative: She got her vaccine, and had a sore arm the next day, then had itchy, itchy area on her back all over her body with hives.   She also had ringing in her ears.   Now she has diarrhea that she woke up with this morning at 2:00-3:00 AM, and she still has it with stomach pains.   It?s 6 days after the shot and thinking about it and had a similar reaction when she had her vaccine in September.   She had Covid and Tetanus in September and had a similar reaction and had Moderna at that time as well.  She had her RSV vaccine on 2/27/24 and had severe headaches.  She has not taking anything for her symptoms.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: No adverse reaction noted
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient received three doses of shingrix. she already had her series completed on 08/22/2018/ her ist dose was on 03/07/2018 nad her second dose was on 08/22/2018. we gave her 3rd dose on 01/09/2024. so far patient does not have any side effcts.
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Headache, Muscle spasms, Restlessness
Clinical narrative: Headache; extreme, intense joint aches, spasms, restlessness; intensity same after 48 hours
Age: 0.5
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was inadvertently administered 0.9 mL of the reconstituted Pfizer COVID vaccine 6 months -4 Years instead of the prescribed 0.3 mL dose.  The patient has had no adverse effects since administration.
Age: 5.0
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No Adverse Reactions at this time, pt received vaccination after ordered in Error.
Age: 73.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Cough, Dysstasia, Hyperhidrosis, Pyrexia
Clinical narrative: High temperature, coughing, sweating, for 2 days and I thought I was going to die. Very weak and can barely stand up. Pass out from coughing so much.
Age: 73.0
Sex: M
Vaccine: FLU4
Symptoms: SARS-CoV-2 test
Clinical narrative: High temperature, coughing, sweating, for 2 days and I thought I was going to die. Very weak and can barely stand up. Pass out from coughing so much.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Chills, Dizziness, Dyspnoea
Clinical narrative: Following administration of the Shingrix vaccination, I encountered a severe neurotoxic reaction within 9 hours. Symptoms included over 7 hours of intense rigors accompanied by involuntary shivering, insomnia, chills, joint pains, profound bodily weakness, light-headedness, dizziness, headache, and labored breathing.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Insomnia, Neurotoxicity
Clinical narrative: Following administration of the Shingrix vaccination, I encountered a severe neurotoxic reaction within 9 hours. Symptoms included over 7 hours of intense rigors accompanied by involuntary shivering, insomnia, chills, joint pains, profound bodily weakness, light-headedness, dizziness, headache, and labored breathing.
Age: 70.0
Sex: F
Vaccine: COVID19-2, VARZOS
Symptoms: Peripheral swelling
Clinical narrative: Patient called the pharmacy today stating that her arm was still swollen, despite it being over a week after vaccinations were given.
Age: 74.0
Sex: F
Vaccine: PNC20
Symptoms: Rash erythematous, Rash papular, Rash pruritic, Skin warm
Clinical narrative: RED , SLIGHT RAISED AND ITCHY RASH. SLIGHTLY WARM TO THE TOUCH.  STARTED APPROXIMATELY ON 3/14/24 AND IS LOOKING BETTER ON 3/18/24 WHEN REPORTED TO THE PHARMACY.  NO TREATMENT SEEKED OR MEDICATION TAKEN FOR IT
Age: 69.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Hypoaesthesia, Injection site pain, Pain in extremity
Clinical narrative: Right arm is sore at injection site.  She also is experiencing numbness and pain from her elbow to her fingers.  Went to ER this morning and they prescribed her Prednisone.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Went to the hospital the next day and got shingles
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Spinal pain
Clinical narrative: Patient's mother stated that they felt spinal pain/ache followed by rash on neck on 03/12.
Age: 4.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Wrong patient received product, Wrong product administered
Clinical narrative: The Dr office called and told me they gave my four year old daughter my son's 12 year old shots and gave my 12 year old my four year old shots
Age: 12.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Wrong patient received product, Wrong product administered
Clinical narrative: The Dr office called said that legend got his four year old sister shots and she got his
Age: 43.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Patient received an expired Moderna COVID-19 bivalent booster.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Adult patient received pediatric dose of Moderna COVID-19 vaccine.
Age: 32.0
Sex: M
Vaccine: TDAP
Symptoms: Paraesthesia
Clinical narrative: Patient stated having a tingling sensation in feet. Was sent to ER for observation and released.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Lethargy, Pallor
Clinical narrative: Patient's mother called stating they had labored breathing on 3/8, followed by lethargy, paleness and headaches until 3/11
Age: 10.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: urticaria, starting near the injection site, which spread to whole body
Age: 0.33
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE; HCP calling to report a 4 month old was inadvertently given PROQUAD today, 3/4/2024. No side effects reported. No additional AE/no PQC.; This spontaneous report was received from nurse and refers to a 4-month-old of an unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 04-MAR-2024, the patient was inadvertently given measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD) injection, 0.5 milliliter, lot #X023401 has been verified to be a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD) with expiration date: 20-MAR-2025, administered for prophylaxis (strength, and route of administration were not provided); with its sterile diluent solution for injection/infusion 0.5 milliliter, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (Inappropriate age at vaccine administration).  No additional adverse event was reported.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Improper storage of product in use; This spontaneous report was received from a nurse practitioner refers to a 4-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 17-JAN-2024, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (recombinant Human albumin) (PROQUAD), formulation: subcutaneous injection, lot # X018580, subcutaneously, expiration date: 05-JAN-2025 (exact dose and anatomical location were not provided) for prophylaxis.  Administered dose of vaccine was exposed to the multiple temperature excursions from 19-OCT-2023 to 22-JAN-2024 (product storage error). There were no additional adverse events reported (no adverse event).  Lot number [X018580] has been verified to be a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD), with rHA (recombinant Human albumin) status.
Age: 1.33
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Improper storage of product in use; This spontaneous report was received from a nurse practitioner refers to a 16-month-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 27-NOV-2023, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (recombinant Human albumin) (PROQUAD), formulation: subcutaneous injection, lot # X018580, subcutaneously, expiration date: 05-JAN-2025 (exact dose and anatomical location were not provided) for prophylaxis.  Administered dose of vaccine was exposed to the multiple temperature excursions from 19-OCT-2023 to 22-JAN-2024 (product storage error). There were no additional adverse events reported (no adverse event).
Age: 11.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Improper storage of product in use; This spontaneous report was received from a nurse practitioner refers to a 11-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 01-NOV-2023, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (recombinant Human albumin) (PROQUAD), formulation: subcutaneous injection, lot # X018580, subcutaneously, expiration date: 05-JAN-2025 (exact dose and anatomical location were not provided) for prophylaxis.  Administered dose of vaccine was exposed to the multiple temperature excursions from 19-OCT-2023 to 22-JAN-2024 (product storage error). There were no additional adverse events reported (no adverse event).
Age: 6.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Improper storage of product in use; This spontaneous report was received from a nurse practitioner refers to a 6-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 01-NOV-2023, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (recombinant Human albumin) (PROQUAD), formulation: subcutaneous injection, lot # X018580, subcutaneously, expiration date: 05-JAN-2025 (exact dose and anatomical location were not provided) for prophylaxis.  Administered dose of vaccine was exposed to the multiple temperature excursions from 19-OCT-2023 to 22-JAN-2024 (product storage error). There were no additional adverse events reported (no adverse event).
Age: 7.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Improper storage of product in use; This spontaneous report was received from a nurse practitioner refers to a 7-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 01-NOV-2023, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (recombinant Human albumin) (PROQUAD), formulation: subcutaneous injection, lot # X018580, expiration date: 05-JAN-2025, subcutaneously (exact dose, route of administration and anatomical location were not provided) for prophylaxis.  Administered dose of vaccine was exposed to the multiple temperature excursions from 19-OCT-2023 to 22-JAN-2024 (product storage error). There were no additional adverse events reported (no adverse event).
Age: 8.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Improper storage of product in use; This spontaneous report was received from a nurse practitioner refers to a 8-year-old patient of unknown gender.     The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 20-NOV-2023, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (recombinant Human albumin) (PROQUAD), formulation: subcutaneous injection, lot # X018580, expiration date: 05-JAN-2025, subcutaneously (exact dose and anatomical location were not provided) for prophylaxis.  Administered dose of vaccine was exposed to the multiple temperature excursions from 19-OCT-2023 to 22-JAN-2024 (product storage error). There were no additional adverse events reported (no adverse event).
Age: 7.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Improper storage of product in use; This spontaneous report was received from a nurse practitioner refers to a 7-year-old patient of unknown gender.     The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 22-NOV-2023, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (recombinant Human albumin) (PROQUAD), formulation: subcutaneous injection, lot # X018580, expiration date: 05-JAN-2025, subcutaneously (exact dose and anatomical location were not provided) for prophylaxis.  Administered dose of vaccine was exposed to the multiple temperature excursions from 19-OCT-2023 to 22-JAN-2024 (product storage error). There were no additional adverse events reported (no adverse event).
Age: 9.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Improper storage of product in use; This spontaneous report was received from a nurse practitioner refers to a 9-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 22-NOV-2023, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (recombinant Human albumin) (PROQUAD), formulation: subcutaneous injection, lot # X018580, expiration date: 05-JAN-2025, subcutaneously (exact dose and anatomical location were not provided) for prophylaxis.  Administered dose of vaccine was exposed to the multiple temperature excursions from 19-OCT-2023 to 22-JAN-2024 (product storage error). There were no additional adverse events reported (no adverse event).
Age: 11.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Improper storage of product in use; This spontaneous report was received from a nurse practitioner refers to a 11-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 27-NOV-2023, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (recombinant Human albumin) (PROQUAD), formulation: subcutaneous injection, lot # X018580, expiration date: 05-JAN-2025, subcutaneously (exact dose and anatomical location were not provided) for prophylaxis.  Administered dose of vaccine was exposed to the multiple temperature excursions from 19-OCT-2023 to 22-JAN-2024 (product storage error). There were no additional adverse events reported (no adverse event).
Age: 9.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Improper storage of product in use; This spontaneous report was received from a nurse practitioner refers to a 9-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 10-JAN-2024, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (recombinant Human albumin) (PROQUAD), formulation: subcutaneous injection, lot # X018580, expiration date: 05-JAN-2025, subcutaneously (exact dose and anatomical location were not provided) for prophylaxis.  Administered dose of vaccine was exposed to the multiple temperature excursions from 19-OCT-2023 to 22-JAN-2024 (product storage error). There were no additional adverse events reported (no adverse event).
Age: 6.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Improper storage of product in use; This spontaneous report was received from a nurse practitioner refers to a 6-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 10-JAN-2024, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (recombinant Human albumin) (PROQUAD), formulation: subcutaneous injection, lot # X018580, expiration date: 05-JAN-2025, subcutaneously (exact dose and anatomical location were not provided) for prophylaxis.  Administered dose of vaccine was exposed to the multiple temperature excursions from 19-OCT-2023 to 22-JAN-2024 (product storage error). There were no additional adverse events reported (no adverse event).
Age: 11.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Improper storage of product in use; This spontaneous report was received from a nurse practitioner refers to a 11-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 24-JAN-2024, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (recombinant Human albumin) (PROQUAD), formulation: subcutaneous injection, lot # X018580, expiration date: 05-JAN-2025, subcutaneously (exact dose and anatomical location were not provided) for prophylaxis.  Administered dose of vaccine was exposed to the multiple temperature excursions from 19-OCT-2023 to 22-JAN-2024 (product storage error). There were no additional adverse events reported (no adverse event).
Age: 8.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Improper storage of product in use; This spontaneous report was received from a nurse practitioner refers to a 8-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 24-JAN-2024, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (recombinant Human albumin) (PROQUAD), formulation: subcutaneous injection, lot # X018580, expiration date: 05-JAN-2025, subcutaneously (exact dose and anatomical location were not provided) for prophylaxis.  Administered dose of vaccine was exposed to the multiple temperature excursions from 19-OCT-2023 to 22-JAN-2024 (product storage error). There were no additional adverse events reported (no adverse event).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: shingles/ 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, more than a year after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: shingles/ 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 received date: 09-Mar-2024 This case was reported by a patient via (social media) interactive digital media. Patient had shingles last fall and had the shot 2 years prior to the reporting date. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation regarding shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Respiratory syncytial virus infection, Vaccination failure
Clinical narrative: I have had the shingles twice/ Suspected vaccination failure; had the shingles twice; RSV once; 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: I have had the shingles twice/ Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: had the shingles twice) and respiratory syncytial virus infection (Verbatim: RSV once). The outcome of the vaccination failure was unknown and the outcome of the shingles and respiratory syncytial virus infection were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and respiratory syncytial virus infection to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and respiratory syncytial virus infection to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 11-MAR-2024 This case was reported by a patient via (social media) interactive digital media. The patient had the shingles twice and respiratory syncytial virus infection once.  Before he/she got all of them he/she had already received the correct shots. The patient wonder if it was the timing. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation regarding shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Erythema, Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; it's shingles; blistery spot/10 blister; red spot; Hurt from  front through the back; 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), shingles (Verbatim: it's shingles), blister (Verbatim: blistery spot/10 blister), localized erythema (Verbatim: red spot) and pain (Verbatim: Hurt from  front through the back). The outcome of the vaccination failure and pain were unknown and the outcome of the shingles, blister and localized erythema were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, blister, localized erythema and pain to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, blister, localized erythema and pain to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 11-MAR-2024 This case was reported the patient via (social media) interactive digital media. The patient had the Shots, two believed.  And then Came down With a fifty Cent piece size red blistered Spot, hurt from front through the back.  The patient went to the hospital thinking was having a heart attack, it was that bad and physician said no, it was shingles. Only had 10 blisters.  The reporter truly believed the shots kept me out of the hospital.  Lesson learned and asked to take the shots.  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: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Patient took the shingle shots and got shingles anyway/Suspected vaccination failure; got shingles anyway/was really bad; 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: Patient took the shingle shots and got shingles anyway/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got shingles anyway/was really bad). 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: 11-MAR-2024 This case was reported by a reporter via (social media) interactive digital media. The reporter stated that his/her uncle took the shingles shot and got shingles anyway.  The shingles was really bad. 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.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I had the vaccine as well. Insurance company billed me for 200 dollar and I still have them too/ Suspected vaccination failure; I still have them too; 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: I had the vaccine as well. Insurance company billed me for 200 dollar and I still have them too/ Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I still have them too). 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: 13-MAR-2024 This case was reported by a patient via (social media) interactive digital media. The patient had the vaccine as well. The insurance company billed him/her for 200 dollar and the patient still had them too. The patient felt like they injected him/her with water, the patient was bamboozled but learned from a gentleman off the internet (God bless him forever) to rub distilled vinegar on them. The patient reported distilled Vinegar was his/her new boyfriend for 1.99 dollar asking for his/her 200 dollars back. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset and laboratory confirmation regarding shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: I got the shingles from the vaccine, It is one of the most painful things I have ever had/ Suspected vaccination failure; I got the shingles from the vaccine; It is one of the most painful things I have ever had; 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: I got the shingles from the vaccine, It is one of the most painful things I have ever had/ Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: I got the shingles from the vaccine) and pain (Verbatim: It is one of the most painful things I have ever had). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   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: 13-MAR-2024 This case was reported by a patient via (social media) interactive digital media. The patient got the shingles from the vaccine. It was one of the most painful things that the patient have ever had. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Age: 52.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Arthralgia, Inappropriate schedule of product administration, Mobility decreased, Pain in extremity, Sleep disorder
Clinical narrative: shoulder hurts, to the point of waking me up at night; waking me up at night; having trouble lifting my arm over my head; Pain in upper arm/hand hurts; This non-serious case was reported by a consumer and described the occurrence of pain in extremity in a 52-year-old female patient who received Herpes zoster (Shingrix) (batch number 3B2YJ) for prophylaxis.   Co-suspect products included Influenza vaccine for prophylaxis.   Concurrent medical conditions included migraine, headache, post herpetic neuralgia and depression. Concomitant products included topiramate (Topamax), tramadol and duloxetine hydrochloride (Cymbalta).   On 21-SEP-2023, the patient received the 1st dose of Shingrix .5 ml and Influenza vaccine. On 21-SEP-2023, less than a day after receiving Shingrix, the patient experienced pain in extremity (Verbatim: Pain in upper arm/hand hurts). On an unknown date, the patient experienced shoulder pain (Verbatim: shoulder hurts, to the point of waking me up at night), nocturnal awakening (Verbatim: waking me up at night) and mobility decreased (Verbatim: having trouble lifting my arm over my head). The patient was treated with ibuprofen (Advil) and paracetamol (Tylenol). The outcome of the pain in extremity, shoulder pain, nocturnal awakening and mobility decreased were not resolved.   It was unknown if the reporter considered the pain in extremity, shoulder pain, nocturnal awakening and mobility decreased to be related to Shingrix.     It was unknown if the company considered the pain in extremity, shoulder pain, nocturnal awakening and mobility decreased to be related to Shingrix.   Additional Information: GSK Receipt Date: 03-MAR-2024 The patient self-reported this case. The patient received first dose of Shingrix vaccine and Flu shot on the same day. The patient thought the arm pain would go away in a couple of days, but it had gotten worse over the last few months. Her shoulder hurts, to the point of waking her up at night and she was having trouble lifting her arm over her head and she had tried Advil and Tylenol and it did not seem to help.  The pain in upper arm was still ongoing and symptoms were treated. The patient just had a virtual visit with her physician on Wednesday (from the date of reporting) and she referred her to PT.  She said that sometime the shingles vaccine could pool in the muscle and that might be the issue.  The patient did not end up getting the 2nd dose because she was afraid it would make the pain worse. Hopefully PT would help this go away, because her hand hurts and the pain goes down her arm at times. The reporter just wanted to make someone aware of this issue. It was unknown if the reporter considered the pain in extremity, shoulder pain, nocturnal awakening and mobility decreased to be related to Flu vaccine (Influenza vaccine).
Sex: U
Vaccine: FLU4
Symptoms: Wrong product administered
Clinical narrative: patient was given the Fluarix vaccine instead of the Boostrix Vaccine; This non-serious case was reported by a other health professional via patient support programs and described the occurrence of wrong vaccine administered in a patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2023-2024 season) for prophylaxis.   On 08-MAR-2024, the patient received Fluarix Tetra 2023-2024 season. On 08-MAR-2024, an unknown time after receiving Fluarix Tetra 2023-2024 season, the patient experienced wrong vaccine administered (Verbatim: patient was given the Fluarix vaccine instead of the Boostrix Vaccine). The outcome of the wrong 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: 08-MAR-2024 This report was submitted via the online direct entry reporting system. The patient was given the Fluarix vaccine instead of the Boostrix Vaccine, which led to wrong vaccine administered.
Age: 11.0
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error, Product preparation issue
Clinical narrative: It looks like the was not mixed with the powder and only the diluent was used; patient received only part of the vaccine; This non-serious case was reported by a consumer via sales rep and described the occurrence of inappropriate preparation of medication in a 11-year-old patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA960A) for prophylaxis.   On 06-MAR-2024, the patient received the 1st dose of Menveo (left deltoid). On 06-MAR-2024, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: It looks like the was not mixed with the powder and only the diluent was used) and inappropriate dose of vaccine administered (Verbatim: patient received only part of the vaccine). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 11-MAR-2024 This report was submitted via the online direct entry reporting system. The patient did not receive both components of the original formulation of Menveo. This was what the reporter said it looked like the was not mixed with the powder and only the diluent was used, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: super painful; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: super painful). The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 06-MAR-2024 This case was reported by a patient via interactive digital media. The patient stated, the shot was super painful, but better than getting actual shingles.  The patient stated, got first one and knowing the second shot going to hurt just as bad.
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: painful; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: painful). The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 06-MAR-2024 This case was reported by a reporter via interactive digital media. The reporter was so angry the pain patient had to deal with. The pharmacist told reporter, some people had reverse reactions. Reporter stated that, if that's the case it needs to be discontinued, not one person should have to live their life dealing with getting it over and over again.  The reporter asked what was shingles.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: shingles; nerve pain; 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, immediately after receiving Shingles vaccine, the patient experienced shingles (Verbatim: shingles) and post herpetic neuralgia (Verbatim: nerve pain). The outcome of the shingles and post herpetic neuralgia were not reported.   It was unknown if the reporter considered the shingles and post herpetic neuralgia to be related to Shingles vaccine.     It was unknown if the company considered the shingles and post herpetic neuralgia to be related to Shingles vaccine.   Additional Information: GSK received date: 11-Mar-2024 This case was reported by a patient via interactive digital media. Patient had the vaccine but got the shingles shortly after and then the shingles nerve pain was worse which happened about every three months.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Pyrexia
Clinical narrative: High fever; headache; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced fever (Verbatim: High fever) and headache (Verbatim: headache). The outcome of the fever and headache were resolved (duration 3 days).   It was unknown if the reporter considered the fever and headache to be related to Shingles vaccine.     It was unknown if the company considered the fever and headache to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 11-MAR-2024 This case was reported by a patient via interactive digital media. The patient stated that he/she got the vaccine.  The patient stated that kicked the butt.  The patient had high fever and headache 3 days.
Age: 11.0
Sex: M
Vaccine: MENB
Symptoms: Product prescribing error, Wrong product administered
Clinical narrative: accidently gave Bexsero instead of Menveo; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old male patient who received Men B NVS (Bexsero) (batch number X4BK3, expiry date 30-SEP-2026) for prophylaxis.   On 01-MAR-2024, the patient received Bexsero. On 01-MAR-2024, an unknown time after receiving Bexsero, the patient experienced wrong vaccine administered (Verbatim: accidently gave Bexsero instead of Menveo). The outcome of the wrong 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: 05-MAR-2024 The pharmacists reported that a wrong vaccine was ordered and accidently gave Bexsero instead of Menveo on March 1st, 2024, to a patient. Bexsero vaccine administered instead of Menveo which led to Wrong vaccine administered. The reporter consented to follow up.
Age: 1.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: patient who received the Kinrix when they were twelve months old; patient who received the Kinrix/it was the 4th dose of the DTap/IPV series; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 12-month-old female patient who received DTPa-IPV (Kinrix) (batch number 34MSN, expiry date 13-FEB-2026) for prophylaxis.   Previously administered products included IPV (received 3 doses of IPV vaccine on unknown date) and DTap (received 3 doses of DTap vaccine on unknown date).   On 10-NOV-2023, the patient received Kinrix. On 10-NOV-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: patient who received the Kinrix when they were twelve months old) and inappropriate schedule of vaccine administered (Verbatim: patient who received the Kinrix/it was the 4th dose of the DTap/IPV series). The outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 06-MAR-2024 The patient received the Kinrix when she was twelve months old, which led to inappropriate age at vaccine administration. According to reporter, the dose was the 4th dose of the DTap/IPV series, which led to inappropriate schedule of vaccine administered. The vaccine administration facility was the same as primary reporter.
Age: 26.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: expired dose administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 26-year-old female patient who received HAV (Havrix) (batch number 7YA99, expiry date 30-MAR-2022) for prophylaxis.   On 05-MAR-2024, the patient received the 1st dose of Havrix. On 05-MAR-2024, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: expired dose administered). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 06-MAR-2024 The medical assistant reported that an expired dose of Havrix was administered to a patient, which led to an expired vaccine used. The patient also received other vaccine like Hepatitis B, MMR and Tdap.  The reporter wanted to know if patient needs to be revaccinate. The reporter consented to follow up.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error, Product preparation issue
Clinical narrative: Inappropriate Reconstitution Technique; received only the diluent portion of the Menveo; 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 patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   In DEC-2023, the patient received Menveo. In DEC-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Inappropriate Reconstitution Technique) and inappropriate dose of vaccine administered (Verbatim: received only the diluent portion of the Menveo). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 08-MAR-2024 Office Manager requested data on the use of titer to detect whether a patient has received the complete Menveo (2-vial). The reporter reported that one of 5 patients received only the diluent portion of the Menveo (2-vial), which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The vaccine was administered in December 2023, exact date and patient unknown. The reporter consented to follow up.
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: did not receive second dose until 30Jan2024; 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 a 64-year-old female patient who received HAB (Twinrix) (batch number H7RF2, expiry date 17-JAN-2026) for prophylaxis.   Previously administered products included Twinrix (received first dose on 21-AUG-2023).   On 30-JAN-2024, the patient received the 2nd dose of Twinrix. On 30-JAN-2024, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: did not receive second dose until 30Jan2024). The outcome of the drug dose administration interval too long 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: 08-MAR-2024 The pharmacist reported that the patient received first dose of Twinrix and did not receive second dose until 30-Jan-2024. At the time of reporting, the third dose has not yet been administered. The reporter consented to follow up. The Vaccine Administration Facility is the same as Primary Reporter. The reporter did not have lot number of first dose, stated it must have been given at a different pharmacy. The reporter gave permission for follow-up, but declined to provide email address. The patient received 2nd dose of Twinrix, later than the recommended interval, which led to lengthening of vaccination schedule.