chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP calling to report AE related to Temp Excursion; No additional AE.; This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age or gender. The patient's concurrent conditions, medical history, and concomitant medications were not provided.   On an unspecified date, a call was received stating that a temperature excursion (Product storage error) had occurred; however, it was unknown the date of administration. It was reported that the patient had received either varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number valid, reported as W039294, expiration date 11-DEC-2024) or measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (recombinant Human albumin) (PROQUAD) (lot number valid, reported as X002105, expiration date 18-JUL-2024); both administered for prophylaxis (doses, routes of administrations and anatomical locations, were not provided).  The vaccine presented a temperature excursion at -14.3 degrees Celsius (C) for a timeframe of 1 hour and 14 minutes. There were no product quality complaints and no adverse events reported.; Sender Comments:  US-009507513-2306USA011972:
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP calling to report AE related to Temp Excursion; No additional AE.; This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age or gender. The patient's concurrent conditions, medical history, and concomitant medications were not provided.   On an unspecified date, a call was received stating that a temperature excursion (Product storage error) had occurred; however, it was unknown the date of administration. It was reported that the patient had received either varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number valid, reported as W039294, expiration date 11-DEC-2024) or measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (recombinant Human albumin) (PROQUAD) (lot number valid, reported as X002105, expiration date 18-JUL-2024); both administered for prophylaxis (doses, routes of administrations and anatomical locations, were not provided).  The vaccine presented a temperature excursion at -14.3 degrees Celsius (C) for a timeframe of 1 hour and 14 minutes. There were no product quality complaints and no adverse events reported.; Sender Comments: Keywords : US-009507513-2306USA011972:
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP calling to report AE related to Temp Excursion; No additional AE.; This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age or gender. The patient's concurrent conditions, medical history, and concomitant medications were not provided.   On an unspecified date, a call was received stating that a temperature excursion (Product storage error) had occurred; however, it was unknown the date of administration. It was reported that the patient had received either varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number valid, reported as W039294, expiration date 11-DEC-2024) or measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (recombinant Human albumin) (PROQUAD) (lot number valid, reported as X002105, expiration date 18-JUL-2024); both administered for prophylaxis (doses, routes of administrations and anatomical locations, were not provided).  The vaccine presented a temperature excursion at -14.3 degrees Celsius (C) for a timeframe of 1 hour and 14 minutes. There were no product quality complaints and no adverse events reported. ; Sender Comments: US-009507513-2306USA011972:
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP calling to report AE related to Temp Excursion; No additional AE.; This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age or gender. The patient's concurrent conditions, medical history, and concomitant medications were not provided.   On an unspecified date, a call was received stating that a temperature excursion (Product storage error) had occurred; however, it was unknown the date of administration. It was reported that the patient had received either varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number valid, reported as W039294, expiration date 11-DEC-2024) or measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (recombinant Human albumin) (PROQUAD) (lot number valid, reported as X002105, expiration date 18-JUL-2024); both administered for prophylaxis (doses, routes of administrations and anatomical locations, were not provided).  The vaccine presented a temperature excursion at -14.3 degrees Celsius (C) for a timeframe of 1 hour and 14 minutes. There were no product quality complaints and no adverse events reported. ; Sender Comments: Keywords :  US-009507513-2306USA011972:
Sex: M
Vaccine: FLUN3
Symptoms: Influenza
Clinical narrative: PATIENT CAUGHT FLU AND WAS VACCINATED WITH FLUMIST; A spontaneous report has been received from a health professional. The report concerns a male patient (age not provided).    No medical history was reported. The following demography was reported for the patient's parent:   Sex: Unknown    No concomitant products were reported.    The patient received Flumist (influenza vaccine live reassort 3v) (batch number Unknown), via nasal route, on an unknown date.     A Health Professional administered FLUMIST. No malfunction has been reported for this combination product.    On an unknown date, the patient experienced patient caught flu and was vaccinated with flumist (preferred term: Influenza).     Treatment with Flumist (influenza vaccine live reassort 3v) was not changed.     The outcome of the event was unknown.    The event was considered non-serious.     Device Information:     Combination Product Report: Yes    Product As Reported: FLUMIST  Common Device Name: Nasal Spray  Procode: CCQ  Product Role: Suspect  ; Reporter's Comments: No medical history was reported. No concomitant products were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Pruritus, Vaccination failure
Clinical narrative: Got vaccine then got Shingles. Had Shingles for a year  /Suspected vaccination failure; now I have throbbing pain; now I have inching; Got vaccine then got 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 vaccine then got Shingles. Had Shingles for a year  /Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Got vaccine then got Shingles), throbbing pain (Verbatim: now I have throbbing pain) and pruritus (Verbatim: now I have inching). The outcome of the vaccination failure was unknown and the outcome of the shingles was resolved (duration 1 year) and the outcome of the throbbing pain and pruritus were not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, throbbing pain and pruritus to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, throbbing pain and pruritus to be related to Shingles vaccine.   Additional Information: GSK receipt date: 26-Jun-2023 This case was reported the patient via interactive digital media. That happened to the patient. The patient got vaccine then got shingles. The patient had shingles for a year and now (at the time of reporting) the patient had throbbing pain and itching. The patient was really tired of this. 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.  Follow-up not possible as no contact details provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Vaccines didn't work for me/ Suspected vaccination failure; Vaccines didn't work for me; 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: Vaccines didn't work for me/ Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Vaccines didn't work for me). 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 This case was reported by a patient via interactive digital media. The patient reported that the vaccine did not work for him or her. 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.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Our Son got the shot for Shingles and has shingles now/ Suspected vaccination failure; Shingles; Painful; 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: Our Son got the shot for Shingles and has shingles now/ Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and pain (Verbatim: Painful). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved and the outcome of the pain was 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: 25-JUN-2023 This case was reported by a patient's parent via interactive digital media. The reporter reported that his or her son received Shingles vaccine and experienced shingles now. The reporter stated that it was painful. 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.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: have shingles/ Suspected vaccination failure; Shingles; It's painful and aggravating; 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: have shingles/ Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and pain (Verbatim: It's painful and aggravating). 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: 26-JUN-2023 This case was reported by patient via interactive digital media. The patient reported that he or she received Shingles vaccine and experienced shingles.  Patient states that he/she only hope this is considered a mild case since he/she did have the vaccine, It's painful and aggravating. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. Follow up was not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; patients experience a shingles outbreak after the patient completed the full 2-dose series shingrix; This serious case was reported by a physician via sales rep and described the occurrence of vaccination failure in a elderly patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Additional patient notes included had no immunocompromising or immunosuppressing conditions.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: patients experience a shingles outbreak after the patient completed the full 2-dose series shingrix). The outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 27-JUN-2023 The physician reported that the patient over 65 years old experienced a shingles outbreak after the completion of the full 2 dose series. The patient had no immunocompromising or immunosuppressing conditions. The outcomes of Shingles outbreaks was unknown and all other information was unknown. 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. The reporter consented to follow up. This is one link case among 5 cases.; Sender's Comments:  US-GSK-US2023AMR089467:Same reporter US-GSK-US2023AMR089457:Same reporter US-GSK-US2023AMR089464:Same reporter US-GSK-US2023AMR089465:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; Got the vaccine but still got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Got the vaccine but still got shingles). The outcome of the vaccination failure and shingles were unknown.   The reporter considered the vaccination failure and shingles to be possibly related to Shingrix.     The company considered the vaccination failure and shingles to be possibly related to Shingrix.   Additional Information: GSK Receipt date: 09-MAY-2023 This case was received from the patient's friend via interactive digital media. The patient developed shingles after the shot. The reporter said the patient wish she had never took and she did not realize how painful they really could be. 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.
Sex: M
Vaccine: VARZOS
Symptoms: Arteriogram coronary normal, Cardiac imaging procedure abnormal, Chest pain, Echocardiogram abnormal, Ejection fraction normal
Clinical narrative: Shingle vaccine associated myocarditis; myocardial Edema; chest pain radiating to left arm; This serious case was reported in a literature article and described the occurrence of myocarditis in a 50-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.    The patient's past medical history included gastroesophageal reflux disease.   On an unknown date, the patient received Shingrix (unknown arm). On an unknown date, 1 week after receiving Shingrix, the patient experienced myocarditis (Verbatim: Shingle vaccine associated myocarditis) (serious criteria GSK medically significant), myocardial edema (Verbatim: myocardial Edema) (serious criteria GSK medically significant) and chest pain with radiation to left arm (Verbatim: chest pain radiating to left arm). The outcome of the myocarditis, myocardial edema and chest pain with radiation to left arm were not reported.   The reporter considered the myocarditis, myocardial edema and chest pain with radiation to left arm to be related to Shingrix.     The company considered the myocarditis, myocardial edema and chest pain with radiation to left arm to be related to Shingrix.   Additional Information: GSK Receipt date: 22 Jun 2023  A 50 year old male with a history of gastroesophageal reflux disease he received the Shingrix vaccine one week prior to symptoms onset. He presented to the emergency department complaining of chest pain radiating to his left arm that started one day ago.  In the emergency department, his blood pressure was 118 79 mmHg, heart rate 63 bpm, and oxygen saturation 99 percent. Complete blood count and basic metabolic profile were within normal limits. High sensitivity troponin at baseline and one hour after the presentation were above 5000 pg per ml. The Electrocardiogram showed ST depression in leads V4 and T wave inversion on leads III, 2, 4, 5, and 6. A bedside transthoracic echocardiogram demonstrated Normal left ventricular systolic function with EF 55 perecnt, with wall motion abnormalities of the inferior wall. He underwent coronary angiography that revealed no significant disease. Cardiac MRI revealed myocardial edema and subepicardial enhancement in the basal inferior and lateral walls which meet the criteria of findings for myocarditis. On the follow up visit after two months, repeated echocardiography showed normal left ventricular systolic function with normal wall motion.
Sex: M
Vaccine: VARZOS
Symptoms: Electrocardiogram ST segment depression, Electrocardiogram T wave inversion, Full blood count normal, Metabolic function test normal, Myocardial oedema
Clinical narrative: Shingle vaccine associated myocarditis; myocardial Edema; chest pain radiating to left arm; This serious case was reported in a literature article and described the occurrence of myocarditis in a 50-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.    The patient's past medical history included gastroesophageal reflux disease.   On an unknown date, the patient received Shingrix (unknown arm). On an unknown date, 1 week after receiving Shingrix, the patient experienced myocarditis (Verbatim: Shingle vaccine associated myocarditis) (serious criteria GSK medically significant), myocardial edema (Verbatim: myocardial Edema) (serious criteria GSK medically significant) and chest pain with radiation to left arm (Verbatim: chest pain radiating to left arm). The outcome of the myocarditis, myocardial edema and chest pain with radiation to left arm were not reported.   The reporter considered the myocarditis, myocardial edema and chest pain with radiation to left arm to be related to Shingrix.     The company considered the myocarditis, myocardial edema and chest pain with radiation to left arm to be related to Shingrix.   Additional Information: GSK Receipt date: 22 Jun 2023  A 50 year old male with a history of gastroesophageal reflux disease he received the Shingrix vaccine one week prior to symptoms onset. He presented to the emergency department complaining of chest pain radiating to his left arm that started one day ago.  In the emergency department, his blood pressure was 118 79 mmHg, heart rate 63 bpm, and oxygen saturation 99 percent. Complete blood count and basic metabolic profile were within normal limits. High sensitivity troponin at baseline and one hour after the presentation were above 5000 pg per ml. The Electrocardiogram showed ST depression in leads V4 and T wave inversion on leads III, 2, 4, 5, and 6. A bedside transthoracic echocardiogram demonstrated Normal left ventricular systolic function with EF 55 perecnt, with wall motion abnormalities of the inferior wall. He underwent coronary angiography that revealed no significant disease. Cardiac MRI revealed myocardial edema and subepicardial enhancement in the basal inferior and lateral walls which meet the criteria of findings for myocarditis. On the follow up visit after two months, repeated echocardiography showed normal left ventricular systolic function with normal wall motion.
Sex: M
Vaccine: VARZOS
Symptoms: Myocarditis, Troponin, Wall motion score index abnormal
Clinical narrative: Shingle vaccine associated myocarditis; myocardial Edema; chest pain radiating to left arm; This serious case was reported in a literature article and described the occurrence of myocarditis in a 50-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.    The patient's past medical history included gastroesophageal reflux disease.   On an unknown date, the patient received Shingrix (unknown arm). On an unknown date, 1 week after receiving Shingrix, the patient experienced myocarditis (Verbatim: Shingle vaccine associated myocarditis) (serious criteria GSK medically significant), myocardial edema (Verbatim: myocardial Edema) (serious criteria GSK medically significant) and chest pain with radiation to left arm (Verbatim: chest pain radiating to left arm). The outcome of the myocarditis, myocardial edema and chest pain with radiation to left arm were not reported.   The reporter considered the myocarditis, myocardial edema and chest pain with radiation to left arm to be related to Shingrix.     The company considered the myocarditis, myocardial edema and chest pain with radiation to left arm to be related to Shingrix.   Additional Information: GSK Receipt date: 22 Jun 2023  A 50 year old male with a history of gastroesophageal reflux disease he received the Shingrix vaccine one week prior to symptoms onset. He presented to the emergency department complaining of chest pain radiating to his left arm that started one day ago.  In the emergency department, his blood pressure was 118 79 mmHg, heart rate 63 bpm, and oxygen saturation 99 percent. Complete blood count and basic metabolic profile were within normal limits. High sensitivity troponin at baseline and one hour after the presentation were above 5000 pg per ml. The Electrocardiogram showed ST depression in leads V4 and T wave inversion on leads III, 2, 4, 5, and 6. A bedside transthoracic echocardiogram demonstrated Normal left ventricular systolic function with EF 55 perecnt, with wall motion abnormalities of the inferior wall. He underwent coronary angiography that revealed no significant disease. Cardiac MRI revealed myocardial edema and subepicardial enhancement in the basal inferior and lateral walls which meet the criteria of findings for myocarditis. On the follow up visit after two months, repeated echocardiography showed normal left ventricular systolic function with normal wall motion.
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Very bad skin rash on lower extremities; This non-serious case was reported by a consumer and described the occurrence of rash in a 81-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included type ii diabetes mellitus. Concomitant products included sitagliptin (Januvia).   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced rash (Verbatim: Very bad skin rash on lower extremities). The outcome of the rash was resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.     It was unknown if the company considered the rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 24-JUN-2023 This reporter was submitted via online direct entry reporting system. The patient had for Very bad skin rash on lower extremities. The seriousness for Very bad skin rash on lower extremities was Intervention required. Shingrix manufacturer and expiry date was unspecified. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Sore; This non-serious case was reported by a other health professional via sales rep and described the occurrence of pain in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included autoimmune disorder.   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 pain (Verbatim: Sore). The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingrix.     It was unknown if the company considered the pain to be related to Shingrix.   Linked case(s) involving the same patient:  US2023AMR088328   Additional Information: GSK Receipt Date: 23-JUN-2023 The patient received 1st dose of Shingrix and adverse event was just sore. For the tolerance of the 2nd dose, refer linked case US2023AMR088328, reported by the same reporter for same patient. The reporter did not consent to follow up.; Sender's Comments:  US-GSK-US2023AMR088328:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Asthenia, Influenza like illness, Pain, Pain in extremity
Clinical narrative: It was like I had the flu; I was down sore body/my arm and body still hurts; I was weak; my arm still hurts; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of influenza like illness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 15-JUN-2023, the patient received the 1st dose of Shingles vaccine. In JUN-2023, an unknown time after receiving Shingles vaccine, the patient experienced influenza like illness (Verbatim: It was like I had the flu), general body pain (Verbatim: I was down sore body/my arm and body still hurts), weakness (Verbatim: I was weak) and pain in arm (Verbatim: my arm still hurts). The outcome of the influenza like illness, general body pain, weakness and pain in arm were not reported.   It was unknown if the reporter considered the influenza like illness, general body pain, weakness and pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the influenza like illness, general body pain, weakness and pain in arm to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 23-JUN-2023 This case was reported by a consumer via interactive digital media. The patient got my first shingle shot last week Thursday and It was like had the flu was down sore body, I was weak, my arm and body still hurt and need to get the 2nd shot in two months or six months. This is the first time patient reacted to any shot.
Sex: U
Vaccine: VARZOS
Symptoms: Hypokinesia
Clinical narrative: still barely get off the couch; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of movements reduced 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 movements reduced (Verbatim: still barely get off the couch). The outcome of the movements reduced was not resolved.   It was unknown if the reporter considered the movements reduced to be related to Shingles vaccine.     It was unknown if the company considered the movements reduced to be related to Shingles vaccine.   Additional Information: GSK receipt date: 25-Jun-2023 This case was reported the patient via interactive digital media. The patient stated he/ she was apparently one of the few who had a severe reaction to shot. 60 hours since receiving the dose and still the patient could barely get off the couch. The patient was nervous about receiving the booster now. Follow-up not possible as no contact details provided.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: pharmacist reported that a patient received a 2nd early dose of shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19-MAY-2023, the patient received the 2nd dose of Shingrix. On 19-MAY-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: pharmacist reported that a patient received a 2nd early dose of shingrix). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 28-JUN-2023 The reporter did not consent to follow up. The patient received the 2nd dose of Shingrix before recommended interval, which led to shorting of vaccination schedule.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received a dose of Zoster vaccine back in October 8th 2018 and according to the records the patient missed the appointment 1 month after the first dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose in 8th October 2018).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: received a dose of Zoster vaccine back in October 8th 2018 and according to the records the patient missed the appointment 1 month after the first dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 23-Jun-2023 A pharmacist called in to request information about a patient which received a dose of Zoster vaccine back and according to the records the patient missed the appointment 1 month after the first dose.  The reporter assumed that the patient was immunocompromised since the appointment for the second dose was settle 1 month apart from the first dose. The reporter asked if the patient could receive the second dose or if the series needed to be restarted. The reporter did not provide information about the first dose (lot number, expiry date).  The reporter could not confirm that the Zoster vaccine administered in 2018 was Shingrix. Did not consent to follow-up Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination.
Age: 4.0
Sex: F
Vaccine: MNQ
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Menveo 1 vial plus administration to 4 yo patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA91A, expiry date 08-FEB-2025) for prophylaxis.   On 22-JUN-2023, the patient received Menveo. On 22-JUN-2023, an unknown time after receiving Menveo, the patient experienced inappropriate age at vaccine administration (Verbatim: Menveo 1 vial plus administration to 4 yo patient). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 23-JUN-2023 Office manager reported that she left a voicemail with the incorrect administration of a vaccines (no data apart from this one ) on June 22nd 2023. Today (June 23rd 2026) reported that 4 years old patient received a dose of one vial Menveo by mistake (it is approved until the patient is 10 years of age), which led to Inappropriate age of vaccine administration. The reporter consented to follow up. The vaccine administration facility is the same as primary reporter.
Sex: M
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Inappropriate age./ a pediatric dose of Engerix-B was administered to an adult patient; Inappropriate age./ a pediatric dose of Engerix-B was administered to an adult patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a 22-year-old male patient who received HBV (Engerix B pediatric) (batch number 5M93R, expiry date 05-APR-2024) for prophylaxis.   On 23-JUN-2023, the patient received the 1st dose of Engerix B pediatric. On 23-JUN-2023, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: Inappropriate age./ a pediatric dose of Engerix-B was administered to an adult patient) and adult use of a child product (Verbatim: Inappropriate age./ a pediatric dose of Engerix-B was administered to an adult patient). The outcome of the underdose and adult use of a child product 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: 23-Jul-2023 The reporter did not consent to follow-up. Earlier on the day of reporting, a pediatric dose of Engerix-B was administered to an adult patient, which led to underdose and adult use of a child product.
Sex: M
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: inadvertent administration of an expired dose of Kinrix; 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 male patient who received DTPa-IPV (Kinrix) (batch number 5R3KX, expiry date 26-MAY-2023) for prophylaxis.   On 15-JUN-2023, the patient received Kinrix. On 15-JUN-2023, an unknown time after receiving Kinrix, the patient experienced expired vaccine used (Verbatim: inadvertent administration of an expired dose of Kinrix). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 23-JUN-2023 The healthcare professional called to inform about the inadvertent administration of an expired dose of Kinrix which led to expired vaccine used. According to healthcare professional, the patient had no more than 10 years old The Vaccine Administration Facility is the same as Primary Reporter.  The reporter consented to follow up.
Age: 1.0
Sex: M
Vaccine: HEPA
Symptoms: Overdose
Clinical narrative: 15 month old male patient received a 1 mL dose of Havrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a 15-month-old male patient who received HAV (Havrix) (batch number 3J9G4, expiry date 30-AUG-2025) for prophylaxis.   On 26-JUN-2023, the patient received Havrix 1 ml. On 26-JUN-2023, an unknown time after receiving Havrix, the patient experienced overdose (Verbatim: 15 month old male patient received a 1 mL dose of Havrix). The outcome of the overdose was unknown.   Additional Information: GSK Receipt date: 26-JUN-2023 A medical assistant reported that the patient received a 1 mL dose of Havrix, which led to overdose. No symptoms reported.  The reporter consented to follow up.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered
Clinical narrative: received less than 0.5ml of a Shingrix second dose (Lot number: 92E7E; expiration date: 8/6/2024), probably 0.2ml were injected; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 60-year-old male patient who received Herpes zoster (Shingrix) (batch number 92E7E, expiry date 06-AUG-2024) for prophylaxis.   On 24-JUN-2023, the patient received the 2nd dose of Shingrix. On 24-JUN-2023, an unknown time after receiving Shingrix, the patient experienced incomplete dose administered (Verbatim: received less than 0.5ml of a Shingrix second dose (Lot number: 92E7E; expiration date: 8/6/2024), probably 0.2ml were injected). The outcome of the incomplete dose administered was unknown.   Additional Information: GSK Receipt Date: 26-JUN-2023 The permission to have an account on medical information database was declined. The reporter consented to follow up via phone. The reporter reported that due a malfunction of a syringe, a patient received less than 0.5ml of a Shingrix and probably 0.2 ml were injected, which led to incomplete dose administered.
Age: 93.0
Sex: F
Vaccine: VARZOS
Symptoms: Hallucination
Clinical narrative: developed hallucinations that lasted for one day; This serious case was reported by a other health professional via sales rep and described the occurrence of hallucination in a 93-year-old female patient who received Herpes zoster (Shingrix) (batch number K4TG5, expiry date 31-MAY-2024) for prophylaxis.   On 27-JAN-2023, the patient received the 1st dose of Shingrix. On 27-JAN-2023, less than a day after receiving Shingrix, the patient experienced hallucination (Verbatim: developed hallucinations that lasted for one day) (serious criteria GSK medically significant). On 28-JAN-2023, the outcome of the hallucination was resolved (duration 1 day).   It was unknown if the reporter considered the hallucination to be related to Shingrix.     It was unknown if the company considered the hallucination to be related to Shingrix.   Additional Information: GSK Receipt Date: 26-JUN-2023. The reporter was a care coordinator who informed GSK sales representative that a patient received first dose of Shingrix and developed hallucinations that lasted for one day.  According to reporter doctor was not aware of the adverse event and adverse event filed.  The reporter consented to follow up
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Pain at the injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In APR-2023, the patient received the 1st dose of Shingrix (intramuscular, left arm). In MAY-2023, less than 2 months after receiving Shingrix, the patient experienced injection site pain (Verbatim: Pain at the injection site). The outcome of the injection site pain was not resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.     It was unknown if the company considered the injection site pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 27-JUN-2023 The patient self-reported this case. The patient got his 1st dose of Shingrix vaccine the 2nd week of April 2023.  Patient reported pain at the injection site, and it had not gone away for 6 weeks.  Patient reported it started in the morning and when moving the arm, it hurts and gets worse. The lot number and expiry date were not provided.  No additional information was reported.  Consented for follow up could not be obtained.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration
Clinical narrative: subcutaneous injection rather than intramuscularly; This non-serious case was reported by a nurse via call center representative and described the occurrence of intramuscular formulation administered by other route in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received her 1st dose of Shingrix 28-SEP-2019 as a intramuscular injection in her left arm.).   On 30-DEC-2019, the patient received the 2nd dose of Shingrix (subcutaneous, left arm). On 30-DEC-2019, an unknown time after receiving Shingrix, the patient experienced intramuscular formulation administered by other route (Verbatim: subcutaneous injection rather than intramuscularly). The outcome of the intramuscular formulation administered by other route was unknown.   Additional Information: GSK receipt date: 27 June 2023 The reporter was a patient who was a nurse, and reported that she received her 2nd dose of Shingrix, 30-DEC-2019 in her left arm as a subcutaneous injection rather than intramuscularly. The reporter consented to follow up. This case was linked with the case US2023089239 reported by same reporter. The patient received shingrix as subcutaneous injection rather than intramuscular which led to intramuscular formulation administered by other route.; Sender's Comments:  US-GSK-US2023089239:Same reporter
Sex: M
Vaccine: HEPAB
Symptoms: Wrong product administered
Clinical narrative: Wrong Vaccine Administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong vaccine administered in a 18-year-old male patient who received HAB (Twinrix) (batch number H3SG9, expiry date 03-JAN-2025) for prophylaxis.   Previously administered products included Hepatits vaccine (the patient had already received their Hepatitis vaccine).   On 26-JUN-2023, the patient received Twinrix. On 26-JUN-2023, an unknown time after receiving Twinrix, the patient experienced wrong vaccine administered (Verbatim: Wrong Vaccine Administered). 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: 27 June 2023 The pharmacist stated a patient was supposed to get a Meningococcal vaccine but was inadvertently administered Twinrix. The patient had already received their Hepatitis vaccine (HCP did not know if they have already received Hep A/Hep B or both). The Vaccine Administration Facility is the same as primary reporter. The reporter consented to follow up via postal. The patient was supposed to get a Meningococcal vaccine but was inadvertently administered Twinrix which led to wrong vaccine administered.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: expired dose of flulaval; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 4-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) (batch number DM4FM, expiry date 18-JUN-2023) for prophylaxis.   On 20-JUN-2023, the patient received FluLaval Quadrivalent 2022-2023 season. On 20-JUN-2023, an unknown time after receiving FluLaval Quadrivalent 2022-2023 season, the patient experienced expired vaccine used (Verbatim: expired dose of flulaval). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 27-Jun-2023 The reporter consented to follow-up. The patient received an expired dose of Flulaval quadrivalent, which led to expired vaccine used.
Sex: F
Vaccine: HEP
Symptoms: Wrong product administered
Clinical narrative: Engerix-B administered instead of Twinrix second dose; 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 38-year-old female patient who received HBV (Engerix B) (batch number 79S54, expiry date 04-APR-2022) for prophylaxis.   Concomitant products included HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX).   On 26-JUN-2023, the patient received Engerix B. On 26-JUN-2023, an unknown time after receiving Engerix B, the patient experienced wrong vaccine administered (Verbatim: Engerix-B administered instead of Twinrix second dose). The outcome of the wrong vaccine administered was unknown.   Additional Information: GSK receipt date: 27-Jun-2023 The nurse reported that the patient was intended vaccine was second dose of Twinrix. The reporter consented to follow-up via email. The patient received Engerix-B by mistake, which led to wrong vaccine administered.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles two weeks after Shingrix first dose; This non-serious case was reported by a physician via call center representative and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 2 weeks after receiving Shingrix, the patient experienced shingles (Verbatim: shingles two weeks after Shingrix first dose). The outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK receipt date: 27-Jun-2023 Medical information department had received a question which stated that reporter enquired if their was a correlation between a patient presenting with Shingles after receiving 1st dose of Shingrix, presenting with Shingles two weeks after 1st Shingrix dose. The reporter did not consent for follow up.
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Menveo - Administration of the liquid portion; Menveo - Administration of the liquid portion; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA756A, expiry date 31-OCT-2023) for prophylaxis.   On 26-JUN-2023, the patient received Menveo. On 26-JUN-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Menveo - Administration of the liquid portion) and inappropriate dose of vaccine administered (Verbatim: Menveo - Administration of the liquid portion). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 27-JUN-2023 The nurse reported the administration of the MenCYW liquid conjugate vaccine component without the menA lyophilized conjugate component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter asked when they could administer a valid dose of Menveo to this patient. The reporter consented to follow up.