chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound scan
Clinical narrative: Swollen Glands on both side of neck /More Swollen glands on the left side of neck /Biopsy revealed abnormal looking glands in neck  /CT Scan Confirmed larger than normal numerous ones/Glands on both side of neck looked like Mononucleosis; Felt very tired after first Booster; Swollen in neck after first booster; This spontaneous case was reported by a patient and describes the occurrence of SWELLING (Swollen in neck after first booster), LYMPHADENOPATHY (Swollen Glands on both side of neck /More Swollen glands on the left side of neck /Biopsy revealed abnormal looking glands in neck  /CT Scan Confirmed larger than normal numerous ones/Glands on both side of neck looked like Mononucleosis) and FATIGUE (Felt very tired after first Booster) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. NDPE 939903, 032M20A and 031L20A) for COVID-19 vaccination.     The patient's past medical history included Tongue dry in 1999. Concurrent medical conditions included Atrial fibrillation, Blood pressure high and High cholesterol.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced SWELLING (Swollen in neck after first booster). On 26-Oct-2021, the patient experienced LYMPHADENOPATHY (Swollen Glands on both side of neck /More Swollen glands on the left side of neck /Biopsy revealed abnormal looking glands in neck  /CT Scan Confirmed larger than normal numerous ones/Glands on both side of neck looked like Mononucleosis) and FATIGUE (Felt very tired after first Booster). At the time of the report, SWELLING (Swollen in neck after first booster), LYMPHADENOPATHY (Swollen Glands on both side of neck /More Swollen glands on the left side of neck /Biopsy revealed abnormal looking glands in neck  /CT Scan Confirmed larger than normal numerous ones/Glands on both side of neck looked like Mononucleosis) and FATIGUE (Felt very tired after first Booster) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Biopsy: Biopsy ruled out cancer after first booster. In 2021, Computerised tomogram: CT Scan Confirmed larger than normal numerous ones after first booster. In 2021, Ultrasound scan: Ultrasound revealed level 4 carotid canal after first booster.         The patient did not have her medication list on her. No concomitant medication were reported. No treatment information were provided.   This case was linked to MOD-2022-581493.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2022: Follow-up contains no new information.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Nausea, Vomiting
Clinical narrative: Patient received under diluted dose of covid 5-11 vaccine. Complaints of nausea and vomiting  7 days after vaccine administration.  Zofran prescribed for patient.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, Cough, Pain, Pyrexia
Clinical narrative: Breakthrough; test positive for Covid19 on 6/4/22. Fever, chills, body aches, cough, etc, noticed onset on evening of 6/3/22.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough; test positive for Covid19 on 6/4/22. Fever, chills, body aches, cough, etc, noticed onset on evening of 6/3/22.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Patient received under diluted dose of Pfizer 5-11 vaccine.  No adverse effect noted at this time from parent.
Age: 10.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Discomfort, Fatigue, Heart rate increased, Pain, Pain in extremity
Clinical narrative: Shaking and increased heart rate tiredness aches sourness heavyness (from second shot )  (First shot) no effects just sosr arm
Age: 10.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test negative, Tremor
Clinical narrative: Shaking and increased heart rate tiredness aches sourness heavyness (from second shot )  (First shot) no effects just sosr arm
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Patient received under diluted dose of Pfizer 5-11 covid vaccine. No adverse events reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram, Chest X-ray, Computerised tomogram thorax, Lymphangiogram, Peripheral swelling
Clinical narrative: Unilateral left arm swelling, unsure of exact start date, but first reported to healthcare provider on 12/6/21, ultrasound negative. Since then has had extensive testing of left arm and no cause of the swelling has been found. Was hospitalized and had complicated course in hospital getting work-up for arm. Lung transplant and other surgeries or risks are significantly in the past, no other major health changes. Arm remains swollen, just getting therapies to manage, such as OT.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Scan with contrast, Ultrasound Doppler
Clinical narrative: Unilateral left arm swelling, unsure of exact start date, but first reported to healthcare provider on 12/6/21, ultrasound negative. Since then has had extensive testing of left arm and no cause of the swelling has been found. Was hospitalized and had complicated course in hospital getting work-up for arm. Lung transplant and other surgeries or risks are significantly in the past, no other major health changes. Arm remains swollen, just getting therapies to manage, such as OT.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; Patient was administered expired VAQTA; This spontaneous report has been received from a registered nurse regarding a patient of unknown age and gender. The patient's medical history, current conditions, previous drug reactions or allergies, and concomitant medications were not reported.  On 03-MAY-2022, the patient was administered an expired hepatitis A vaccine, inactivated (VAQTA) as prophylaxis (lot number U004367, which was determined to be valid for syringe formulation, with an expiration date of 11-APR-2022) (dose, dose number, vaccination scheme, route and anatomical location of administration were not reported) (expired product administered). No additional adverse event was reported.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: Caller is nurse reporting administration of expired PNEUMOVAX 23.; Caller is nurse reporting administration of expired PNEUMOVAX 23.; This spontaneous report has been received from a nurse concerning a patient of unknown age and gender. The patient's drug reactions or allergies, concomitant therapies, medical history, and concurrent conditions were not provided.   On 16-MAY-2022, patient received an expired dose (Expired product administered) of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) syringe, piston (FMF) (dose, frequency, route of administration, formulation, strength, vaccination scheme, and anatomical site of vaccination were not reported, lot number T032003, which has been verified to be valid, expiration date reported and validated as 08-MAY-2022), as prophylaxis. The vaccine product had not presented temperature excursions. No additional adverse events were reported.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect dose administered
Clinical narrative: No adverse event; Medical assistant is reporting that a  4 year old female patient received a partial dose (5%) of MMR II on 5/17/2022. No additional AE reported. No PQC reported.; This spontaneous report was received from a medical assistant concerning a 4-year-old female patient.   The patient's medical history, concurrent conditions, concomitant medication, and previous drugs reactions or allergies were not reported.   On 17-MAY-2022, the patient was vaccinated with a partial dose (reported as 5%) (inappropriate dose of vaccine administered) of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (recombinant human albumin (rHA)) (M-M-R II) lot number U013035 and expiration date: 23-APR-2023 (strength, dose, route of administration and anatomical location were not reported) administered for prophylaxis. No adverse events were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Administration of improperly stored vaccines to unknown patients after the temperature excursion; No adverse event; This spontaneous report was received from an office manager referring to a patient of unspecified age and gender.   The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On 20-JAN-2022, temperature excursion occurred. On an unspecified date in 2022 (reported as after temperature excursion), the patient was vaccinated with an improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, (strength, dose, frequency, and route of administration were not provided); which lot # U020244 has been verified to be a valid lot number with expiration date: 28-JUN-2023, administered as prophylaxis. The temperature excursion occurred at a temperature of -14 degrees Celsius for 7 hours (product storage error). No previous temperature excursion was reported. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2205USA004997: US-009507513-2205USA005067:02167789 US-009507513-2205USA005130: US-009507513-2205USA004990: US-009507513-2205USA005126: US-009507513-2205USA005023: US-009507513-2205USA005071: US-009507513-2205USA005229: US-009507513-2205USA005002:
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details; TE evaluation states vaccines have been administered to multiple patients; This spontaneous report was received from a medical assistant, concerning a 1-year-old male patient. His pertinent medical history, concurrent conditions, previous drug reactions, allergies, and concomitant medications were not provided.  On 15-APR-2022, the patient was vaccinated with improperly stored first dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #U025790, expiration date: 19-AUG-2023 (exact dose and anatomical location were not provided) administered subcutaneously for prophylaxis, after the vaccine underwent a temperature excursion of -14 degrees Celsius (C) up to -10 degrees C for 3 hours (h), 0 minutes (min) and 0 seconds (sec); -10 degrees C up to 8 degrees C for 1 h, 30 min, 0 sec on 23-MAR-2022 (Product storage error). No previous temperature excursion was reported. No additional adverse events were reported. The reporter verified viability of the vaccine on the Company hotline.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2205USA008004: US-009507513-2205USA003614: US-009507513-2205USA007703: US-009507513-2205USA007704: US-009507513-2205USA007723: US-009507513-2205USA007809: US-009507513-2205USA007821: US-009507513-2205USA007847: US-009507513-2205USA007852: US-009507513-2205USA007860: US-009507513-2205USA007871: US-009507513-2205USA007957: US-009507513-2205USA007978: US-009507513-2205USA007982: US-009507513-2205USA008006: US-009507513-2205USA008008: US-009507513-2205USA008028: US-009507513-2205USA008051: US-009507513-2205USA008105: US-009507513-2205USA008189:
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE details; TE evaluation states vaccines have been administered to multiple patients; This spontaneous report was received from a certified medical assistant and refers to a 7 year old male patient. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 23-MAR-2022, the varicella virus vaccine live (oka/merck) (VARIVAX) lot number U025790, expiration date: 19-AUG-2023, underwent temperature excursion from -14 Celsius degrees (°C) to -10°C for 3 hours and from -10°C to 8°C for 1 hour and 30 minutes. No previous temperature excursions were reported. Digital Data Logger was used.  On 24-MAR-2022, the patient was vaccinated with the improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot number U025790, expiration date: 19-AUG-2023, administered subcutaneously (strength and exact dose were not provided) for prophylaxis (Product storage error). No adverse events were reported (No adverse event).  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513- 2204USA009330:Original Case : 2204USA009330 US-009507513-2205USA003614: US-009507513-2205USA007821: US-009507513-2205USA007847: US-009507513-2205USA007852: US-009507513-2205USA008028: US-009507513-2205USA008004:
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE details; TE evaluation states vaccines have been administered to multiple patients; This spontaneous report was received from a certified medical assistant and refers to a 4-years-old male patient. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 23-MAR-2022, the varicella virus vaccine live (oka/merck) (VARIVAX) lot number U025790, expiration date: 19-AUG-2023, underwent temperature excursion from -14 Celsius degrees (°C) to -10°C for 3 hours and from -10°C to 8°C for 1 hour and 30 minutes. No previous temperature excursions were reported. Digital Data Logger was used.  On 24-MAR-2022, the patient was vaccinated with the improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX), administered subcutaneously (strength and exact dose were not provided) for prophylaxis (Product storage error). No adverse events were reported (No adverse event).; Sender's Comments:  US-009507513-2205USA008004: US-009507513- 2204USA009330: US-009507513-2205USA003614: US-009507513-2205USA007821: US-009507513-2205USA007847: US-009507513-2205USA007852:
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details; TE evaluation states vaccines have been administered to multiple patients; This spontaneous report was received from a certified medical assistant and refers to a 4-years-old female patient. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 23-MAR-2022, the varicella virus vaccine live (oka/merck) (VARIVAX) lot number U025790, expiration date: 19-AUG-2023, underwent temperature excursion from -14 Celsius degrees (°C) to -10°C for 3 hours and from -10°C to 8°C for 1 hour and 30 minutes. No previous temperature excursions were reported. Digital Data Logger was used.  On 24-MAR-2022, the patient was vaccinated with the improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX), administered subcutaneously (strength and exact dose were not provided) for prophylaxis (Product storage error). No adverse events were reported (No adverse event). ; Sender's Comments:  US-009507513-2205USA008004: US-009507513- 2204USA009330: US-009507513-2205USA003614: US-009507513-2205USA007821: US-009507513-2205USA007847: US-009507513-2205USA007852:
Sex: F
Vaccine: VARZOS
Symptoms: Bell's palsy
Clinical narrative: Bell's palsy; This spontaneous report was received from a lawyer, regarding a case in litigation and refers to a female patient (pt) of unknown age. Medical history, concurrent conditions and concomitant medications were not provided. In or around April 2014, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, site of administration, lot #, and expiry date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered Bell's palsy. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms resulted in physical limitations not present prior to zoster vaccine live (ZOSTAVAX). The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of the pt's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was considered to be not resolved. The reporter determined the event to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of Bell's palsy was considered to be medically significant. The event of Bell's palsy was considered to be disabling by the reporter.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; a patient was administered PROQUAD after a temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. Concomitant therapies were not reported.  On 01-JUN-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection (lot #U024508 with an expiration date on 02-FEB-2023) administered for prophylaxis (strength, dose and route of administration were not provided) after a temperature excursion of 8.3F Fahrenheit (°F) during a time frame of 0 hours, 15 minutes and 0 seconds.  No additional adverse events were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling hot, Hyperaesthesia, Hypersensitivity
Clinical narrative: increase sensitivity along back, feels like sunburn; feels like sunburn; This case was reported by a consumer via call center representative and described the occurrence of hyperesthesia in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 20th April 2022, the patient received Shingles vaccine. On 20th April 2022, less than a day after receiving Shingles vaccine, the patient experienced hyperesthesia and feeling hot. On an unknown date, the outcome of the hyperesthesia and feeling hot were unknown.   It was unknown if the reporter considered the hyperesthesia and feeling hot to be related to Shingles vaccine.  Additional Information: GSK Receipt Date: 02-JUN-2022 Reporter's Comment: The case was reported by the patient. The patient had the shingles vaccination. Since that time, the patient had developed increase sensitivity along his/her back.  The patient felt like it was sunburn.  The reporter wanted to know if this was a possible side effect.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: got the first vaccine, break out on one spot in my bottom; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included chickenpox (The patient had chicken pox as a child, every part of his/her body was covered with chicken pox even in his/her ears and nose including private parts).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. The patient was treated with acyclovir. On an unknown date, the outcome of the shingles was recovering/resolving.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 01-JUN-2022 Reporter's Comment: This case was reported by a consumer via interactive digital media. The patient was told by the doctor when he/she got the shingles vaccine that because he/she had chicken pox and he/she was a candidate for shingles. The patient broke out in one spot on his/her bottom. The patient had been taking Acyclovir it cleared it up pretty fast but he/she would rather not take any medication.  The reporter stated that, please share what homeopathy do we take. Additional Supportive Information: The follow up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had the vaccine and have shingles/suspected vaccination failure; shingles at the moment /Just one spot; This 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, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 2-June-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient  had the vaccine and had shingles at the time of reporting. The patient had just one spot. Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles was not provided.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Scratch
Clinical narrative: scratch in my hole body; This case was reported by a consumer via interactive digital media and described the occurrence of scratch in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles, pain and ophthalmic herpes zoster.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced scratch. On an unknown date, the outcome of the scratch was recovered/resolved.   It was unknown if the reporter considered the scratch to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 1-Jun-2022 Reporter's Comments: The patient self-reported the case via interactive digital media. The patient stated that it gave him/ her eye and it lasted two years and it hurts a lot on face and that hurts a lot but they gave the two vaccine and was no longer good. After receiving vaccine, the patient got a scratch on whole body, but it heals at the time of reporting. Additional Supportive Information: The case US2022AMR088279 was identified as duplicate of this case. The case US2022AMR088279 was deleted and all future correspondence would be added in the present case which stands as case of record for this patient. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster, Pain, Vaccination failure
Clinical narrative: Two times was after I took the shingles vaccine/suspected vaccination failure; One busted in my eye; shingles; horrible pain; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles 4 times before vaccination).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, ophthalmic herpes zoster, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK receipt date: 2-June-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient had shingles 6 times. Two times had shingles after the shingles vaccine. The patient was in horrible pain. One busted in patient's eye. Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles was not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: the second time was after I had the vaccine/suspected vaccination failure; I have had it twice; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (experienced shingles before vaccination).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 2-June-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient had shingles twice, the second time was after the shingles vaccine. Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles was not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: just a sore arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In May 2022, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than 2 weeks after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 01-JUN-2022 Reporter's Comments: This case was reported by a patient via interactive digital media. The patient received the dose of Shingles vaccine two weeks ago before the day of reporting and patient experienced just a sore arm, not a big deal.  The patient reported that as far as side affects, patient thought it depends on your body. Additional supportive information: The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure, Vertigo
Clinical narrative: got shingles after my booster/suspected vaccination failure; shingles; severe vertigo; This 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, 3 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and vertigo. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and vertigo were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and vertigo to be related to Shingles vaccine.     Additional Information: GSK receipt date: 2-June-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient got shingles after booster 3 months and counting. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced severe vertigo too.  Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles was not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had chronic shingles, did get shingles shot, had exacerbation/Suspected vaccination failure; had chronic shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (patient had chronic shingles).   On an unknown date, the patient received Shingles vaccine. On an unknown date, 3 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 1-June-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient had chronic shingles. One doctor suggested to get the shingles shot. The patient received shingles shot and three years later the patient only had one exacerbation. Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, and laboratory confirmation of shingles was not provided.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got shingles after getting the vaccines/suspected vaccination failure; shingles; This 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, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 1-June-2022 Reporter's comment:  This case was reported by a patient's wife via interactive digital media. The reporter stated that her husband also got shingles after getting the vaccines a few years ago. Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles was not provided. Note: The pain was not coded as event since from the narrative it seems that the patient did not experienced pain.
Sex: U
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster, Scar, Vaccination failure, Visual impairment
Clinical narrative: got them n my cornea after having the shots/ suspected vaccination failure; got them n my cornea after having the shots; Scare tissue damaged my vision; Scare tissue damaged my vision; This 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, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant), scar and visual impairment. The patient was treated with ophthalmologicals (nos) (Eye Drop (Nos)) and antivirals nos (Antiviral (Drug Name Unknown)). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster, scar and visual impairment were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, scar and visual impairment to be related to Shingles vaccine.     Additional Information: GSK receipt date: 2-June-2022 Reporter's comment:  This case was reported by a patient via interactive digital media. The patient stated that he/she also got shingles in cornea after having the shingles shots. The patient had shingles 3 times within 9 months. The patient still on drops and antiviral meds indefinitely. Scare tissue damaged patient's vision. Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles was not provided.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: 2 shots and still got shingles/ suspected vaccination failure; shingles; This 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, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 2-June-2022 Reporter's comment:  This case was reported by a patient via interactive digital media. The patient had the expensive 2 shots and still got shingles. The patient stated that it was no joke, Be prepared and if you find a rash go to the doctor immediately. Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles was not provided.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination, Neuropathy peripheral
Clinical narrative: neuropathy; shingles; Incomplete course of vaccination; This case was reported by a consumer via interactive digital media and described the occurrence of neuropathy in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and did not receive the 2nd dose of Shingles vaccine. On an unknown date, between 1 and 2 years after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced neuropathy (serious criteria GSK medically significant), shingles and incomplete course of vaccination. On an unknown date, the outcome of the neuropathy and shingles were not recovered/not resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the neuropathy and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 02-June-2022 Reporter's Comments: This case was reported by the patient via interactive digital media. The patient got the 1st Shingles vaccine about a year and a half before reporting, the patient did not get the 2nd dose. The patient got Shingles 2 months before reporting and was still not well. The patient had no blisters, had neuropathy. The patient wanted to know if he/she could get the second dose or should start over. Additional Supportive Information: Till the time of reporting, the patient did not get the 2nd dose of Shingles vaccine, which led to incomplete course of vaccination. The follow-up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first shingrix shot almost a year ago/ 10 months between Shingrix shots; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose almost a year ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 01-JUN-2022 Reporter's Comments: This case was reported by a patient via interactive digital media. The patient reported he/she still need to get second dose of Shingrix vaccine, and asked was it too late. The patient reported that ten months between Shingrix shots. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Immunisation reaction
Clinical narrative: almost killed me, had a severe allergic reaction; This case was reported by a consumer via interactive digital media and described the occurrence of allergic reaction in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown.   The reporter considered the allergic reaction to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 01-JUN-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient got the shingles shot and it almost killed her The patient had a severe allergic reaction. The patient thanked god as her husband and her son found her when the allergic reaction was experienced.  The doctor in the hospital said it was from the shingles shot. The patient further stated that she would never ever get the shingles shot again. Additional Supportive Information: The follow up would not possible, as no contact details were available.
Age: 24.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Exposure during pregnancy, Extra dose administered
Clinical narrative: pregnant patient /received 2 doses of Fluarix; pregnant patient /received 2 doses of Fluarix; one on sept2020 and the other one on 27Jan2021; This prospective pregnancy case was reported by a nurse via call center representative and described the occurrence of vaccine exposure during pregnancy in a 24-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis, Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) for prophylaxis and flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 27th January 2021, the patient received the 2nd dose of Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. In September 2020, the patient received the 1st dose of Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. The patient's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The patient received Fluarix Tetra 2020-2021 season at week 28 of the pregnancy. On 27th January 2021, unknown after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device and not applicable after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, the patient experienced vaccine exposure during pregnancy and vaccine exposure during pregnancy. On an unknown date, the outcome of the vaccine exposure during pregnancy, vaccine exposure during pregnancy and extra dose administered were unknown. The pregnancy was lost to follow up.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: The pregnant patient with 28 weeks, received 2 doses of Fluarix vaccine. The patient received 2nd dose of Fluarix vaccine in same season, which lead to Extra dose administration. The reporter consented to follow up.   Follow-up information received on 03-JUN-2022: This follow-up was considered significant. Reporters comment: After completion of all the follow up attempts, the pregnancy case was considered as lost to follow up. Summary of Changes: Pregnancy outcome was updated.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Mouth haemorrhage, Mouth ulceration, Platelet count decreased, Platelet transfusion, Stomatitis
Clinical narrative: had bleeding sores in his mouth; had bleeding sores in his mouth; platelets were dropping; multiple platelet transfusions; This case was reported by a consumer via call center representative and described the occurrence of oral ulceration in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included immune thrombocytopenia.   On 13th May 2022, the patient received the 1st dose of Shingrix. In May 2022, less than 2 weeks after receiving Shingrix, the patient experienced oral ulceration (serious criteria hospitalization), oral haemorrhage (serious criteria hospitalization), platelets decreased (serious criteria hospitalization) and platelet transfusion (serious criteria hospitalization). On an unknown date, the outcome of the oral ulceration and oral haemorrhage were unknown and the outcome of the platelets decreased and platelet transfusion were not recovered/not resolved.   It was unknown if the reporter considered the oral ulceration, oral haemorrhage, platelets decreased and platelet transfusion to be related to Shingrix.     Additional Information: GSK Receipt Date: 1-Jun-2022 Reporter's Comments: Patient's wife reported this case. The patient received a dose of Shingrix and was hospitalized because he had bleeding sores in his mouth and his platelets were dropping.  The patient's platelets were 123,000 in labs prior to getting the vaccine. It dropped to 2000. The patient was still in hospital, 11 days. During hospital visit he received multiple platelet transfusions and was put on medicine. The reporter did not consent to follow-up.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: was administrated with an expired dose of Menveo; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number amva519a, expiry date 30th April 2022) for prophylaxis.   On 27th May 2022, the patient received Menveo. On 27th May 2022, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 01-JUN-2022 Reporters comment: The patient was administrated with an expired dose of Menveo. The vaccine was expired on 30th April 2022.  No adverse event was reported. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up by fax.  Additional supportive information: The patient received expired dose of Menveo, which led to expired vaccine used.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Accidental underdose
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 56-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number XM2N7, expiry date 1st April 2024) for prophylaxis. On 1st June 2022, the patient received Boostrix (intramuscular). On 1st June 2022, unknown after receiving Boostrix, the patient experienced accidental underdose. On an unknown date, the outcome of the accidental underdose was unknown. Additional Information: GSK receipt date 1 June 2022: Reporter's comment: The pharmacy Tech reports needle leaked with Boostrix administration. Pharmacist predicts that patient only received 1/4 of the dose. The reporter consented to follow up. Additional Supportive Information: The patient received only received 1/4 of the dose of Boostrix due to needle leak which led to accidental underdose.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Is been 3 years since the 1st dose; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date 3 years before date of reporting).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 1-Jun-2022 Reporter's Comments: A nurse mentioned during a Medical Information chat if a patient missed the second dose of shingrix and it had been 3 years since the first one, do they need to restart or was ok to give second dose. The reporter ended chat after providing this information.  No further information including consent to FUP was provided by the reporter. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. This case had been linked with the case US2021AMR172461, reported by the same reporter.