chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebral artery occlusion, Cerebrovascular accident
Clinical narrative: I63.511 ACUTE STROKE DUE TO OCCLUSION OF RIGHT MIDDLE CEREBRAL ARTERY 2/3/2022 ACUTE STROKE DUE TO OCCLUSION OF RIGHT MIDDLE CEREBRAL ARTERY
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy skin, Dermatitis contact, Injection site rash, Neurodermatitis, Pruritus
Clinical narrative: Sometime in April 2022, red bumps appeared on my right ankle. They gradually spread all over the rest of my body over a period of at least six months. The greatest concentration of bumps appeared around one of my vaccine injection sites. I saw my PCP on 4/14/2022. She diagnosed me with irritant contact dermatitis, and she referred me to a dermatologist. At that point, the rash was just on my shoulders, torso, arms, flank, back, and chest. The bumps were also accompanied by itching. I saw the first dermatologist on 5/23/2022. The dermatologist diagnosed prurigo nodularis. The dermatologist noted, "Rash located on right leg and trunk. Rash is bumpy, itchy, painful, red, and moderate in severity. The rash has been present for months." She recommended OTC treatments (e.g. EUCERIN, fragrance-free moisturizers) and hydrocolloid dressing. I took her advice, and my condition seemed to improve. I went back to that dermatologist for a follow-up on 10/25/2022. The dermatologist noted, "Chief complaint prurigo nodularis noted on May 23, 2022. She was seen on May 23, 2022, at which time the following treatment regimen was given, recommend the following: over-the-counter treatments, hydrocolloid dressings daily. Interval history; Rash improved on upper extremities and back." She noted in a separate paragraph that it was "dermatitis unspecified." I underwent a punch biopsy the same day. In the subsequent notes, she wrote, "The pathology shows verruca vulgaris. Reassure benign." I underwent vaccinations for influenza and pneumonia on 10/12/2022. I then received a Pfizer Bivalent booster (GJ5342) on 10/21/2022. The rash worsened between December 2022 and January 2023. I saw a new dermatologist for the first time on 2/15/2023. The notes read, "Follow-up for prurigo nodularis. Two lesions were injected with intralesional KENALOG. The patient followed the treatment plan as directed." He also wrote, "Urticaria on lower sternum, left ulnar palm, and right radial palm. Increase dosage of antihistamine to twice a day and take hydroxyzine for sleep." He then ordered bloodwork, and the results were normal. He prescribed clobetasol topical cream. He then included, "Psoriasis on the right inferior midback. Triamcinolone ointment as needed." I went back to the dermatologist on 4/17/2023. The aforementioned notes were the combined notes for 2/15/2023 and 4/17/2023. On 4/17/2023, he performed two shave biopsies on the skin of my back. He also did two more intralesional KENALOG injections that day. I am currently awaiting the results of the shave biopsies. I am due for a follow-up visit in July 2023.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Psoriasis, Rash, Rash erythematous, Skin lesion, Skin papilloma
Clinical narrative: Sometime in April 2022, red bumps appeared on my right ankle. They gradually spread all over the rest of my body over a period of at least six months. The greatest concentration of bumps appeared around one of my vaccine injection sites. I saw my PCP on 4/14/2022. She diagnosed me with irritant contact dermatitis, and she referred me to a dermatologist. At that point, the rash was just on my shoulders, torso, arms, flank, back, and chest. The bumps were also accompanied by itching. I saw the first dermatologist on 5/23/2022. The dermatologist diagnosed prurigo nodularis. The dermatologist noted, "Rash located on right leg and trunk. Rash is bumpy, itchy, painful, red, and moderate in severity. The rash has been present for months." She recommended OTC treatments (e.g. EUCERIN, fragrance-free moisturizers) and hydrocolloid dressing. I took her advice, and my condition seemed to improve. I went back to that dermatologist for a follow-up on 10/25/2022. The dermatologist noted, "Chief complaint prurigo nodularis noted on May 23, 2022. She was seen on May 23, 2022, at which time the following treatment regimen was given, recommend the following: over-the-counter treatments, hydrocolloid dressings daily. Interval history; Rash improved on upper extremities and back." She noted in a separate paragraph that it was "dermatitis unspecified." I underwent a punch biopsy the same day. In the subsequent notes, she wrote, "The pathology shows verruca vulgaris. Reassure benign." I underwent vaccinations for influenza and pneumonia on 10/12/2022. I then received a Pfizer Bivalent booster (GJ5342) on 10/21/2022. The rash worsened between December 2022 and January 2023. I saw a new dermatologist for the first time on 2/15/2023. The notes read, "Follow-up for prurigo nodularis. Two lesions were injected with intralesional KENALOG. The patient followed the treatment plan as directed." He also wrote, "Urticaria on lower sternum, left ulnar palm, and right radial palm. Increase dosage of antihistamine to twice a day and take hydroxyzine for sleep." He then ordered bloodwork, and the results were normal. He prescribed clobetasol topical cream. He then included, "Psoriasis on the right inferior midback. Triamcinolone ointment as needed." I went back to the dermatologist on 4/17/2023. The aforementioned notes were the combined notes for 2/15/2023 and 4/17/2023. On 4/17/2023, he performed two shave biopsies on the skin of my back. He also did two more intralesional KENALOG injections that day. I am currently awaiting the results of the shave biopsies. I am due for a follow-up visit in July 2023.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Sometime in April 2022, red bumps appeared on my right ankle. They gradually spread all over the rest of my body over a period of at least six months. The greatest concentration of bumps appeared around one of my vaccine injection sites. I saw my PCP on 4/14/2022. She diagnosed me with irritant contact dermatitis, and she referred me to a dermatologist. At that point, the rash was just on my shoulders, torso, arms, flank, back, and chest. The bumps were also accompanied by itching. I saw the first dermatologist on 5/23/2022. The dermatologist diagnosed prurigo nodularis. The dermatologist noted, "Rash located on right leg and trunk. Rash is bumpy, itchy, painful, red, and moderate in severity. The rash has been present for months." She recommended OTC treatments (e.g. EUCERIN, fragrance-free moisturizers) and hydrocolloid dressing. I took her advice, and my condition seemed to improve. I went back to that dermatologist for a follow-up on 10/25/2022. The dermatologist noted, "Chief complaint prurigo nodularis noted on May 23, 2022. She was seen on May 23, 2022, at which time the following treatment regimen was given, recommend the following: over-the-counter treatments, hydrocolloid dressings daily. Interval history; Rash improved on upper extremities and back." She noted in a separate paragraph that it was "dermatitis unspecified." I underwent a punch biopsy the same day. In the subsequent notes, she wrote, "The pathology shows verruca vulgaris. Reassure benign." I underwent vaccinations for influenza and pneumonia on 10/12/2022. I then received a Pfizer Bivalent booster (GJ5342) on 10/21/2022. The rash worsened between December 2022 and January 2023. I saw a new dermatologist for the first time on 2/15/2023. The notes read, "Follow-up for prurigo nodularis. Two lesions were injected with intralesional KENALOG. The patient followed the treatment plan as directed." He also wrote, "Urticaria on lower sternum, left ulnar palm, and right radial palm. Increase dosage of antihistamine to twice a day and take hydroxyzine for sleep." He then ordered bloodwork, and the results were normal. He prescribed clobetasol topical cream. He then included, "Psoriasis on the right inferior midback. Triamcinolone ointment as needed." I went back to the dermatologist on 4/17/2023. The aforementioned notes were the combined notes for 2/15/2023 and 4/17/2023. On 4/17/2023, he performed two shave biopsies on the skin of my back. He also did two more intralesional KENALOG injections that day. I am currently awaiting the results of the shave biopsies. I am due for a follow-up visit in July 2023.
Age: 57.0
Sex: F
Vaccine: COVID19-2
Symptoms: Wrong product administered
Clinical narrative: patient came in for shingrix shot but the pharmacist gave pfizer bivalent booster by mistake.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Adult T-cell lymphoma/leukaemia, Hypoxia, Pulmonary embolism
Clinical narrative: I26.99 ACUTE PULMONARY EMBOLISM 4/26/2022 ADULT T-CELL LEUKEMIA W LYMPHOMA J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/30/2022 ADULT T-CELL LEUKEMIA W LYMPHOMA R09.02 HYPOXIA 3/30/2022 ADULT T-CELL LEUKEMIA W LYMPHOMA I26.99 ACUTE PULMONARY EMBOLISM 4/26/2022 ADULT T-CELL LEUKEMIA W LYMPHOMA J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/30/2022 ADULT T-CELL LEUKEMIA W LYMPHOMA R09.02 HYPOXIA 3/30/2022 ADULT T-CELL LEUKEMIA W LYMPHOMA
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Cardiogenic shock, Coagulopathy, Coronary artery disease, Hypotension
Clinical narrative: D68.9 COAGULOPATHY, UNSPECIFIED TYPE 9/16/2021 VENTRICULAR TACHYCARDIA, UNSPECIFIED TYPE G62.9 PERIPHERAL NEUROPATHY 3/12/2021 VENTRICULAR TACHYCARDIA, UNSPECIFIED TYPE I95.9 HYPOTENSION 7/20/2021 VENTRICULAR TACHYCARDIA, UNSPECIFIED TYPE J96.00 ACUTE RESPIRATORY FAILURE 7/27/2021 VENTRICULAR TACHYCARDIA, UNSPECIFIED TYPE R57.0 CARDIOGENIC SHOCK 9/16/2021 VENTRICULAR TACHYCARDIA, UNSPECIFIED TYPE D68.9 COAGULOPATHY, UNSPECIFIED TYPE 9/16/2021 CAD (CORONARY ARTERY DISEASE) WO ANGINA    VENTRICULAR TACHYCARDIA, UNSPECIFIED TYPE G62.9 PERIPHERAL NEUROPATHY 3/12/2021 CAD (CORONARY ARTERY DISEASE) WO ANGINA    VENTRICULAR TACHYCARDIA, UNSPECIFIED TYPE I95.9 HYPOTENSION 7/20/2021 CAD (CORONARY ARTERY DISEASE) WO ANGINA    VENTRICULAR TACHYCARDIA, UNSPECIFIED TYPE J96.00 ACUTE RESPIRATORY FAILURE 7/27/2021 CAD (CORONARY ARTERY DISEASE) WO ANGINA    VENTRICULAR TACHYCARDIA, UNSPECIFIED TYPE R57.0 CARDIOGENIC SHOCK 9/16/2021 CAD (CORONARY ARTERY DISEASE) WO ANGINA    VENTRICULAR TACHYCARDIA, UNSPECIFIED TYPE D68.9 COAGULOPATHY, UNSPECIFIED TYPE 9/16/2021 VENTRICULAR TACHYCARDIA, UNSPECIFIED TYPE G62.9 PERIPHERAL NEUROPATHY 3/12/2021 VENTRICULAR TACHYCARDIA, UNSPECIFIED TYPE I95.9 HYPOTENSION 7/20/2021 VENTRICULAR TACHYCARDIA, UNSPECIFIED TYPE J96.00 ACUTE RESPIRATORY FAILURE 7/27/2021 VENTRICULAR TACHYCARDIA, UNSPECIFIED TYPE R57.0 CARDIOGENIC SHOCK 9/16/2021 VENTRICULAR TACHYCARDIA, UNSPECIFIED TYPE D68.9 COAGULOPATHY, UNSPECIFIED TYPE 9/16/2021 VENTRICULAR TACHYCARDIA, NONSUSTAINED G62.9 PERIPHERAL NEUROPATHY 3/12/2021 VENTRICULAR TACHYCARDIA, NONSUSTAINED I95.9 HYPOTENSION 7/20/2021 VENTRICULAR TACHYCARDIA, NONSUSTAINED J96.00 ACUTE RESPIRATORY FAILURE 7/27/2021 VENTRICULAR TACHYCARDIA, NONSUSTAINED R57.0 CARDIOGENIC SHOCK 9/16/2021 VENTRICULAR TACHYCARDIA, NONSUSTAINED
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Neuropathy peripheral, Ventricular tachycardia
Clinical narrative: D68.9 COAGULOPATHY, UNSPECIFIED TYPE 9/16/2021 VENTRICULAR TACHYCARDIA, UNSPECIFIED TYPE G62.9 PERIPHERAL NEUROPATHY 3/12/2021 VENTRICULAR TACHYCARDIA, UNSPECIFIED TYPE I95.9 HYPOTENSION 7/20/2021 VENTRICULAR TACHYCARDIA, UNSPECIFIED TYPE J96.00 ACUTE RESPIRATORY FAILURE 7/27/2021 VENTRICULAR TACHYCARDIA, UNSPECIFIED TYPE R57.0 CARDIOGENIC SHOCK 9/16/2021 VENTRICULAR TACHYCARDIA, UNSPECIFIED TYPE D68.9 COAGULOPATHY, UNSPECIFIED TYPE 9/16/2021 CAD (CORONARY ARTERY DISEASE) WO ANGINA    VENTRICULAR TACHYCARDIA, UNSPECIFIED TYPE G62.9 PERIPHERAL NEUROPATHY 3/12/2021 CAD (CORONARY ARTERY DISEASE) WO ANGINA    VENTRICULAR TACHYCARDIA, UNSPECIFIED TYPE I95.9 HYPOTENSION 7/20/2021 CAD (CORONARY ARTERY DISEASE) WO ANGINA    VENTRICULAR TACHYCARDIA, UNSPECIFIED TYPE J96.00 ACUTE RESPIRATORY FAILURE 7/27/2021 CAD (CORONARY ARTERY DISEASE) WO ANGINA    VENTRICULAR TACHYCARDIA, UNSPECIFIED TYPE R57.0 CARDIOGENIC SHOCK 9/16/2021 CAD (CORONARY ARTERY DISEASE) WO ANGINA    VENTRICULAR TACHYCARDIA, UNSPECIFIED TYPE D68.9 COAGULOPATHY, UNSPECIFIED TYPE 9/16/2021 VENTRICULAR TACHYCARDIA, UNSPECIFIED TYPE G62.9 PERIPHERAL NEUROPATHY 3/12/2021 VENTRICULAR TACHYCARDIA, UNSPECIFIED TYPE I95.9 HYPOTENSION 7/20/2021 VENTRICULAR TACHYCARDIA, UNSPECIFIED TYPE J96.00 ACUTE RESPIRATORY FAILURE 7/27/2021 VENTRICULAR TACHYCARDIA, UNSPECIFIED TYPE R57.0 CARDIOGENIC SHOCK 9/16/2021 VENTRICULAR TACHYCARDIA, UNSPECIFIED TYPE D68.9 COAGULOPATHY, UNSPECIFIED TYPE 9/16/2021 VENTRICULAR TACHYCARDIA, NONSUSTAINED G62.9 PERIPHERAL NEUROPATHY 3/12/2021 VENTRICULAR TACHYCARDIA, NONSUSTAINED I95.9 HYPOTENSION 7/20/2021 VENTRICULAR TACHYCARDIA, NONSUSTAINED J96.00 ACUTE RESPIRATORY FAILURE 7/27/2021 VENTRICULAR TACHYCARDIA, NONSUSTAINED R57.0 CARDIOGENIC SHOCK 9/16/2021 VENTRICULAR TACHYCARDIA, NONSUSTAINED
Age: 79.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Coagulation test normal, Gait disturbance, Magnetic resonance imaging normal, Muscle spasms
Clinical narrative: My issue is that I am now having difficulty walking. I can walk about five minutes and my calves will cramp up. Sitting is the only way to relieve it. I have had an MRI on my back, a blood clot test, and I have an upcoming vascular test. I am also having throbbing pain in my shoulder at night that goes up my neck and into my jaw.
Age: 79.0
Sex: F
Vaccine: COVID19-2
Symptoms: Neck pain, Pain, Pain in jaw
Clinical narrative: My issue is that I am now having difficulty walking. I can walk about five minutes and my calves will cramp up. Sitting is the only way to relieve it. I have had an MRI on my back, a blood clot test, and I have an upcoming vascular test. I am also having throbbing pain in my shoulder at night that goes up my neck and into my jaw.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Pain
Clinical narrative: Left deltoid area appears red, swollen, and hard to the touch. Pt. appears to be doing well, no other s/s of adverse reactions.  Mother advised to apply cold/warm compress periodically and to administer Tylenol for pain. Mother verbalized understanding.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Lactic acidosis, Status epilepticus
Clinical narrative: STATUS EPILEPTICUS 9/28/2021 LACTIC ACIDOSIS, UNSPECIFIED STATUS EPILEPTICUS 9/28/2021 STATUS EPILEPTICUS
Age: 77.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse events, patient received vaccine after BUD.
Age: 44.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was given expired MMR. Vaccine expired on 03/09/2023. Patient did not have any adverse events.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test abnormal, Computerised tomogram thorax abnormal, Cough, Muscle spasms, Pneumonia
Clinical narrative: I developed pneumonia, with a cough and was taken by ambulance to a local Medical Center. I had blood test which were positive for bacterial pneumonia and a CT that was positive for pneumonia. I was also experiencing spasms in my hand. The pneumonia is clearing up but the spasms have returned.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pneumonia bacterial
Clinical narrative: I developed pneumonia, with a cough and was taken by ambulance to a local Medical Center. I had blood test which were positive for bacterial pneumonia and a CT that was positive for pneumonia. I was also experiencing spasms in my hand. The pneumonia is clearing up but the spasms have returned.
Age: 59.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Administration error.
Age: 77.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse events, patient received vaccine after BUD.
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse events, patient received vaccine after BUD.
Age: 56.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product administration error
Clinical narrative: Administration error.
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: New guidelines were implemented yesterday where peds 6 month-5 yrs now receive Moderna Bivalent "Dark Blue Cap" for 1st & 2nd dose of vaccine. I was confused and thought peds 6 months-5 years only got Moderna Bivalent "Pink Cap".  I administered 0.25mL of Moderna Bivalent "Pink Cap" to patient as first dose. No adverse reaction noted during 15 minute wait period.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Aortic arteriosclerosis, Hypoxia, Pneumonia streptococcal
Clinical narrative: R09.02 HYPOXIA 1/18/2022 ATHEROSCLEROSIS OF AORTA STREP PNEUMONIA R09.02 HYPOXIA 1/18/2022 HX OF SUBSTANCE USE DISORDER
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, Pain in extremity
Clinical narrative: Sore arm, reporting that vaccine was  administered  after BUD.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Leukocytosis, Respiratory failure
Clinical narrative: J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 12/17/2021 LEUKOCYTOSIS
Age: 1.25
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: New guidelines were implemented yesterday where peds 6 month-5 yrs. now receive Moderna Bivalent "Dark Blue Cap" for 1st & 2nd dose of vaccine. I was confused and thought peds 6 months-5 years only got Moderna Bivalent "Pink Cap".  I administered 0.25mL of Moderna Bivalent "Pink Cap" to patient as first dose.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Papilloma viral infection
Clinical narrative: positive for HPV; This spontaneous report was received from a nurse and referred to a currently 39-year-old female patient. Pertinent medical history, concomitant medications and drug reactions/allergies were unknown.  On unknown dates in 2010, the patient received series of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) 0.5 ml/series, administered intramuscularly for HPV prevention (strength, lot #, and expiry date were not provided).  On an unknown date (reported as later), the patient tested positive for HPV. The patient sought medical attention and was treated for the event. At the time of reporting, the outcome of the event positive for HPV was not known.  The causal relationship between positive for HPV and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was not reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Additional AE/PQC; HCP called in to inform patient received expired dose of VAQTA.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies, or medical history provided.  On 28-MAR-2023, the patient was vaccinated with expired dose of hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (units not provided) intramuscular injection, 1ml/x1, lot #U036184, expiration date: 02-MAR-2023, administered for prophylaxis (anatomical location and route of administration were not provided) (expired product administered). No additional adverse event (AE) reported.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AE reported; Customer called for a temperature excursion and reported PROQUAD that had undergone temperature excursion was administered to patients before calling. No additional AE reported. No PQC reported. No patient demographics was provided. No further i; This spontaneous report has been received from a medical assistant, regarding a 4-years-old female patient. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 10-DEC-2022, a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) underwent a temperature excursion between 6- and 14-degrees Fahrenheit (F) for one hour, this as a result of data logger. On 15-DEC-2022, the patient was vaccinated with the improperly storage dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) subcutaneous injection, intramuscularly in the right thigh as prophylaxis (lot number: W019628, which was determined to be valid, with an expiration date on 19-DEC-2023) (strength, dose and scheme were not reported). There was not any report on previous temperature excursion.   This case is one of multiple reports from the same reporter.; Sender's Comments:  US-009507513-2304USA007822: US-009507513-2304USA007836: US-009507513-2304USA007837: US-009507513-2304USA007843: US-009507513-2304USA007869:
Age: 1.17
Sex: M
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE reported; Customer called for a temperature excursion and reported VARIVAX that had undergone temperature excursion was administered to patients before calling; This spontaneous report has been received from a medical assistant, regarding a 14-months-old male patient. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 20-JAN-2023, a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) underwent a temperature excursion between 6- and 14-degrees Fahrenheit (F) for one hour, this as a result of digital data logger.  On 22-JAN-2023, the patient was vaccinated with the improperly storage dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, intramuscularly in the left thigh as prophylaxis (lot number: W006412, which was determined to be valid, with an expiration date on 23-FEB-2024) (strength, dose and scheme were not reported). There was not any report on previous temperature excursion.   This case is one of multiple reports from the same reporter.  ; Sender's Comments:  US-009507513-2304USA007822: US-009507513-2304USA007836: US-009507513-2304USA007837: US-009507513-2304USA007843: US-009507513-2304USA007869:
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AE reported; Customer called for a temperature excursion and reported PROQUAD that had undergone temperature excursion was administered to patients before calling. No additional AE reported. No PQC reported. No patient demographics was provided. No further i; This spontaneous report has been received from a medical assistant, regarding a 4-years-old male patient. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 20-JAN-2023, a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) underwent a temperature excursion between 6- and 14-degrees Fahrenheit (F) for one hour, this as a result of data logger. On 02-FEB-2023, the patient was vaccinated with the improperly storage dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) subcutaneous injection, intramuscularly in the right thigh as prophylaxis (lot number: W019627, which was determined to be valid, with an expiration date on 19-DEC-2023) (strength, dose and scheme were not reported). There was not any report on previous temperature excursion.   This case is one of multiple reports from the same reporter.; Sender's Comments:  US-009507513-2304USA007822: US-009507513-2304USA007836: US-009507513-2304USA007837: US-009507513-2304USA007843: US-009507513-2304USA007869:
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had both shots and still got them; got them; This serious case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: had both shots and still got them) (serious criteria GSK medically significant) and shingles (Verbatim: got them). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 21-Mar-2023 The patient's boyfriend reported this reported the case via interactive digital media. The reporter's girlfriend had both shots and still got them.  The reporter asked what was with the shot. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation were unknown at the time of reporting. The follow up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR058178:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Myocardial infarction, Vaccination failure
Clinical narrative: CARDIAC EPISODE, heart attack; had VACCINE AND HAD A HORRIFIC OUTBREAK, SHINGLES FOLLOWED/Suspected Vaccination Failure; HAD A HORRIFIC OUTBREAK, SHINGLES FOLLOWED; This serious case was reported by a nurse via interactive digital media and described the occurrence of heart attack 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 heart attack (Verbatim: CARDIAC EPISODE, heart attack) (serious criteria hospitalization and GSK medically significant), vaccination failure (Verbatim: had VACCINE AND HAD A HORRIFIC OUTBREAK, SHINGLES FOLLOWED/Suspected Vaccination Failure) (serious criteria GSK medically significant) and shingles (Verbatim: HAD A HORRIFIC OUTBREAK, SHINGLES FOLLOWED). The outcome of the heart attack and shingles were not reported and the outcome of the vaccination failure was unknown.   It was unknown if the reporter considered the heart attack, vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the heart attack, vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 22-MAR-2023 and 23-MAR-2023 The case  was received from the patient via interactive digital media. The patient stated that he/she had vaccine and then later heart attack (cardiac episode) and that left him/her hospitalization and horrific initial outbreak and lasting days . The patient was a retired nurse and had not a clue how horrible shingles truly were until he/she experienced first hand. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: did, too, but still got them/Suspected Vaccination Failure; got them; 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: did, too, but still got them/Suspected Vaccination Failure) (serious criteria GSK medically significant) and shingles (Verbatim: got them). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 22MAR2023 The case  was received from the patient via interactive digital media. The patient stated that he/she did too, but still got them. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had shot after 2nd time, did not work/ suspected vaccination failure; Had shingles 3 times /around abdomen and ribcage, head, neck, ears; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had shot after 2nd time, did not work/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Had shingles 3 times /around abdomen and ribcage, head, neck, ears). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 22-MAR-2023 This case was reported by patient via interactive digital media. The patient had shingle 3 times, twice around abdomen and ribcage, 3rd time on head, neck and ears. The patient had shot after first or 2nd, did not work. No more shots for himself/herself. 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
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had the shot and still got them/ suspected vaccination failure; got them; 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: Had the shot and still got them/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got them). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 22-MAR-2023 This case was reported by patient's friend via interactive digital media. The reporter had friends who had the shot and still got them. so reporter asked was it worth the shot? 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.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure/that thing you get after you get the shingles vaccine; that thing you get after you get the shingles vaccine; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure/that thing you get after you get the shingles vaccine) (serious criteria GSK medically significant) and shingles (Verbatim: that thing you get after you get the shingles vaccine). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 22-Mar-2023 The case was received from the patient via interactive digital media. The patient stated that it was that thing you get after you get the shingles vaccine, like him or her. 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. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had them and shot/suspected vaccination failure; had them; 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.   Concurrent medical conditions included allergy to vaccine (was allergic to shot).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: had them and shot/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had them). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 22-Apr-2023 The case was received from the patient via interactive digital media. The patient had them, was not bad for him or her because he or she went to the physician quick. 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. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had shingles vaccine still got it; still got it; This serious case was reported by a consumer via interactive digital media and described the occurrence of suspected 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: had shingles vaccine still got it) (serious criteria GSK medically significant) and shingles (Verbatim: still got it). 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: 21-Mar-2023 The reporter was patient and reported the case via interactive digital media. The patient had the shingles vaccine and still got it. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Pruritus, Scab, Vaccination failure
Clinical narrative: been vaccinated, but still a little outbreak/Suspected vaccination failure; little outbreak on face; painful, hurt; itched; crusted; 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: been vaccinated, but still a little outbreak/Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: little outbreak on face), pain (Verbatim: painful, hurt), pruritus (Verbatim: itched) and crust (Verbatim: crusted). The outcome of the vaccination failure was unknown and the outcome of the shingles, pain, pruritus and crust were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, pain, pruritus and crust to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, pain, pruritus and crust to be related to Shingles vaccine.   Additional Information: GSK receipt date: 22-Mar-2023 The case was received from the patient via interactive digital media. The patient stated painful, had been vaccinated years ago against shingles, but still managed a little outbreak on his or her face. Talk about surprised that it hurt, itched, oozed, crusted and was so freaking ugly. The patient stated that anyone who knew him or her knows how vane he or she was about his or her appearance so  the patient was very thankful to be wearing his or her mask. The patient stated that imagine how much worse it could have been if I had not been vaccinated. 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. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Discomfort, Herpes zoster, Pain, Vaccination failure
Clinical narrative: had the shot and still got shingles/suspected vaccination failure; little outbreak on face, uncomfortable; painful; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: had the shot and still got shingles/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: little outbreak on face, uncomfortable) and pain (Verbatim: painful). 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: 22-Mar-2023 The case was received from the patient via interactive digital media. The patient have had them three times, they were an uncomfortable and sometimes painful burden they seem to last a life time before they were gone and you were no longer contagious. The patient stated get the shot.  Yes the patient had the shot and still got shingles, but the impact lessens.  The patient stated that shingles might also be followed by neuropathy.  For the patient that was like getting stuck by a hat pin without warning.  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. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: had the vaccine and still got shingles/suspected vaccination failure; shingles; very painful don´t know what to do; 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: had the vaccine and still got shingles/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles) and pain (Verbatim: very painful don´t know what to do). The patient was treated with calamine. 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: 22-MAR-2023 This case was reported by a patient via interactive digital media. The patient had the shingles vaccine and still got shingles. The patient had shingles five years ago and he/she had shingles now.  The reporter stated that they were very painful and sometimes you just did not know what to do.  The patient used calamine lotion on shingles and that helped them from spreading. 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. The follow up would not possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Blindness unilateral, Facial pain, Herpes zoster, Vaccination failure
Clinical narrative: took the shot got shingles/suspected vaccination failure; no vision in left eye; got shingles left side of face; pain in face terrible; 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, several months after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: took the shot got shingles/suspected vaccination failure) (serious criteria GSK medically significant), unilateral blindness (Verbatim: no vision in left eye) (serious criteria GSK medically significant), shingles (Verbatim: got shingles left side of face) and facial pain (Verbatim: pain in face terrible). The outcome of the vaccination failure was unknown and the outcome of the unilateral blindness and facial pain were not resolved and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure, unilateral blindness, shingles and facial pain to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure, unilateral blindness, shingles and facial pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 22-MAR-2023 This case was reported by a patient's wife via interactive digital media The patient took the shingles shot and a few months later got the shingles in the left side of his face.  It had been a year this month.  He would still under a doctor's care and had no vision in the left eye and pain in his face.  The reporter sated that it was terrible. 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. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: had 2 shots and have shingles/Suspected Vaccination Failure; have shingles; severe pain, pain is terrible; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: had 2 shots and have shingles/Suspected Vaccination Failure) (serious criteria GSK medically significant), shingles (Verbatim: have shingles) and pain (Verbatim: severe pain, pain is terrible). The patient was treated with analgesic, nos (Pain Medication). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.   It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 22-MAR-2023 This case was reported by a patient via interactive digital media The patient had two shingles shots for shingles and he/she had shingles now and severe pain on his/her right side. The pain medicine did not help it had been 3 weeks and pain was terrible. 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 follow up would not possible as no contact details were available.