chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor, Vomiting
Clinical narrative: vomited like 30 times; super fatigue; pale; achy; shaky; fever of 101 °F; This is a spontaneous report from a contactable consumer (patient mother) reported for her son. A 15-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: unspecified, Pfizer NTEC), via an unspecified route of administration on an unspecified date as 2nd dose, single dose for covid-19 immunization (at the age of 15-years-old). Medical history included peanut allergy (he has a peanut allergy). The patient's concomitant medications were not reported. The patient historical vaccine included first dose of BNT162B2 for COVID-19 immunization. On an unspecified date in 2021, the patient received the second dose and at 5 o clock the next morning he vomited like 30 times, had a super fatigue, pale, achy, shaky fever of 101 degree Fahrenheit. He slept but was still feeling feverish. The clinical outcome for the events was unknown.  Information on Lot/Batch number has been requested.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: sometimes get pain in the area of the heart, which was short in duration; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: ER8792), via an unspecified route of administration, administered in left arm on 13Apr2021 13:00 (at the age of 62-year-old), as 2nd dose, single dose for COVID-19 immunisation in pharmacy. The patient had no have other medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: ER2613) administered in left arm on 23Mar2021 14:00 as single dose for COVID-19 immunisation. After the second dose on 14May2021, the patient sometimes got pain in the area of the heart, which was short in duration. The patient had it for a couple days about a month after the second dose, but it went away. Now (at the time of report), again patient had it for the past two days. It seems to go away if the patient did not exercise (exercise routine is very mild). The patient did not receive treatment for the event. The outcome of the event was resolving.   Information on Lot/Batch number was available. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Retinal exudates, Visual field defect
Clinical narrative: Cotton wool spots prolimission; scotoma OS; This is a spontaneous report from a contactable physician. A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) (Batch/Lot Number: EW0167), dose 2, intramuscularly on 06May2021 (at the age of 29-years-old) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history was not reported. Concomitant medication included insulin (INSULIN) taken for an unspecified indication, start and stop date were not reported; lisinopril (LISINOPRIL) taken for an unspecified indication, start and stop date were not reported; levothyroxine (LEVOTHYROXINE) taken for an unspecified indication, start and stop date were not reported; clonazepam (CLONAZEPAM) taken for an unspecified indication, start and stop date were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) (lot number: EW0162), dose 1, intramuscularly on 15Apr2021 as 1ST DOSE, SINGLE for COVID-19 immunization and experienced retinal vein occlusion, ocular vascular disorder, visual impairment, retinal exudates and visual field defect on 26Apr2021. On 18May2021, the patient experienced cotton wool spots prolimission and scotoma OS. The adverse events required a visit to the physician's office. The events were assessed as serious (important medical events). It was unknown if any treatment was received. Clinical outcome of the events was not resolved.   Follow-up actions are needed. Further information has been requested.; Sender's Comments: Based on chronological connection to the vaccine a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: U
Vaccine: YF
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: Flu like symptoms; Fever  105.1 degree Farad; Initial information was received on 08-Jun-2021 regarding an unsolicited valid  non-serious case from a consumer/non-health care professional.  This case involves a patient (demographics unknown) who experienced fever  105.1 degree Farad (pyrexia) and flu like symptoms (influenza like illness) after receiving YELLOW FEVER VACCINE [YF-VAX].  The patient had no medical history, concomitant disease or risk factor  Medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date back in January, the patient received a dose of suspect YELLOW FEVER VACCINE lot number not reported via unknown route in unknown administration site for prophylactic vaccination, due to a job requirement.  On an unknown date the patient developed a non-serious fever  105.1 degree farad (pyrexia) and flu like symptoms (influenza like illness) (unknown latency) following the administration of YELLOW FEVER VACCINE. The patient had to go to the emergency room  (ER ) to manage the symptoms  It was unknown if the patient experienced any additional symptoms/events.  No other relevant test was reported  It was not reported if the patient received a corrective treatment for the events   At time of reporting, the outcome of events was unknown.  The reporter did not report causality of events with suspect  There will be no information available on the batch number for this case.
Sex: F
Vaccine: TTOX
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: high fever; arm swollen; Initial information was received on 09-Jun-2021 regarding an unsolicited valid non-serious courtesy case from a physician.  This case involves a female patient (age not reported, elderly) who had high fever (pyrexia) and arm swollen (peripheral swelling) while receiving TETANUS TOXOID.  The patient's past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  It is unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received a dose of suspect TETANUS TOXOID (produced by unknown manufacturer) (lot number and expiry date not reported) via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious high fever (pyrexia) and arm swollen (peripheral swelling) (unknown latency) following the administration of TETANUS TOXOID.  It is unknown if the patient experienced any additional symptoms/events.  It is unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was unknown for the events.  There will be no information available on the batch number for this case.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Visual impairment
Clinical narrative: Numbness of my right hand, and blotchy vision -- white spots on vision
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bloody discharge, Dry skin, Erythema, Headache, Pain
Clinical narrative: DEVELOPED THICK HARD DRY SKIN ON TOP OF FOREHEAD INTO THE BEGINNING OF MY HAIRLINE VERY ITCHY, PAINFUL, IRRITATED, SWOLLEN, RED, OOZING PUS, BLOODY, CRUSTY, THE RASH/LESION CHANGED DRASTICALLY DAY BY DAY. I HAVE PLENTY OF PICTURES TO SHOW WHAT IT LOOKED LIKE AT DIFFERENT STAGES.  IT DID SPREAD AT ONE POINT TO MORE SPOTS ON THE TOP OF MY SCALP. THE FIRST LESION STILL HASNT GONE AWAY, ITS BEEN ABOUT 6 WEEKS NOW. I HAVE REPEATEDLY GONE TO MY DOCTOR, THE ER, AND TWO DERMATOLOGISTS WHO HAVE JUST BEEN HANDING DIFFERENT MEDICATIONS FOR MY "RASH/LESIONS" AND THE TWO DERMATOLOGISTS REFUSED TO TAKE A BIOPSY. I HAVE BEEN ASKING SINCE THIS LESION DEVELOPED, TO RUN SOME TESTS TO FIND OUT WHAT IT IS BECAUSE NO ONE REALLY KNEW OR HAD ANY ANSWERS FOR ME. NONE OF THE MEDICATIONS AND OINTMENTS HAVE WORKED. I EVEN BROUGHT A FEW SAMPLES OF THE THICK HARD LARGE CHUNKS OF SKIN THAT CAME OFF OF MY SCALP.  THE UNKNOWN "RASH/LESION" STARTED TO CAUSE TERRIBLE HEADACHES, WHICH I HAVE NEVER HAD 5/11 TRIAMCHOLONE 0.1% OINTMENT 30MG 5/20 MUPIROCIN CREAM 2% 30MG 5/28 DICLOFENAL SODIUM 50MG - PRESCRIBED FOR PAIN SWELLING OF LESION - DID NOT HELP AT ALL 5/31 GABAPENTIN 100MG CAPSULES - PRESCRIBED FOR PAIN  6/4 BETAMETHASON DIP 0.05% LOTION 6/4 DOXYCYCLINE MONOHYDRATES 50MG
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash, Scab, Skin exfoliation, Skin irritation
Clinical narrative: DEVELOPED THICK HARD DRY SKIN ON TOP OF FOREHEAD INTO THE BEGINNING OF MY HAIRLINE VERY ITCHY, PAINFUL, IRRITATED, SWOLLEN, RED, OOZING PUS, BLOODY, CRUSTY, THE RASH/LESION CHANGED DRASTICALLY DAY BY DAY. I HAVE PLENTY OF PICTURES TO SHOW WHAT IT LOOKED LIKE AT DIFFERENT STAGES.  IT DID SPREAD AT ONE POINT TO MORE SPOTS ON THE TOP OF MY SCALP. THE FIRST LESION STILL HASNT GONE AWAY, ITS BEEN ABOUT 6 WEEKS NOW. I HAVE REPEATEDLY GONE TO MY DOCTOR, THE ER, AND TWO DERMATOLOGISTS WHO HAVE JUST BEEN HANDING DIFFERENT MEDICATIONS FOR MY "RASH/LESIONS" AND THE TWO DERMATOLOGISTS REFUSED TO TAKE A BIOPSY. I HAVE BEEN ASKING SINCE THIS LESION DEVELOPED, TO RUN SOME TESTS TO FIND OUT WHAT IT IS BECAUSE NO ONE REALLY KNEW OR HAD ANY ANSWERS FOR ME. NONE OF THE MEDICATIONS AND OINTMENTS HAVE WORKED. I EVEN BROUGHT A FEW SAMPLES OF THE THICK HARD LARGE CHUNKS OF SKIN THAT CAME OFF OF MY SCALP.  THE UNKNOWN "RASH/LESION" STARTED TO CAUSE TERRIBLE HEADACHES, WHICH I HAVE NEVER HAD 5/11 TRIAMCHOLONE 0.1% OINTMENT 30MG 5/20 MUPIROCIN CREAM 2% 30MG 5/28 DICLOFENAL SODIUM 50MG - PRESCRIBED FOR PAIN SWELLING OF LESION - DID NOT HELP AT ALL 5/31 GABAPENTIN 100MG CAPSULES - PRESCRIBED FOR PAIN  6/4 BETAMETHASON DIP 0.05% LOTION 6/4 DOXYCYCLINE MONOHYDRATES 50MG
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Skin lesion, Skin weeping, Swelling
Clinical narrative: DEVELOPED THICK HARD DRY SKIN ON TOP OF FOREHEAD INTO THE BEGINNING OF MY HAIRLINE VERY ITCHY, PAINFUL, IRRITATED, SWOLLEN, RED, OOZING PUS, BLOODY, CRUSTY, THE RASH/LESION CHANGED DRASTICALLY DAY BY DAY. I HAVE PLENTY OF PICTURES TO SHOW WHAT IT LOOKED LIKE AT DIFFERENT STAGES.  IT DID SPREAD AT ONE POINT TO MORE SPOTS ON THE TOP OF MY SCALP. THE FIRST LESION STILL HASNT GONE AWAY, ITS BEEN ABOUT 6 WEEKS NOW. I HAVE REPEATEDLY GONE TO MY DOCTOR, THE ER, AND TWO DERMATOLOGISTS WHO HAVE JUST BEEN HANDING DIFFERENT MEDICATIONS FOR MY "RASH/LESIONS" AND THE TWO DERMATOLOGISTS REFUSED TO TAKE A BIOPSY. I HAVE BEEN ASKING SINCE THIS LESION DEVELOPED, TO RUN SOME TESTS TO FIND OUT WHAT IT IS BECAUSE NO ONE REALLY KNEW OR HAD ANY ANSWERS FOR ME. NONE OF THE MEDICATIONS AND OINTMENTS HAVE WORKED. I EVEN BROUGHT A FEW SAMPLES OF THE THICK HARD LARGE CHUNKS OF SKIN THAT CAME OFF OF MY SCALP.  THE UNKNOWN "RASH/LESION" STARTED TO CAUSE TERRIBLE HEADACHES, WHICH I HAVE NEVER HAD 5/11 TRIAMCHOLONE 0.1% OINTMENT 30MG 5/20 MUPIROCIN CREAM 2% 30MG 5/28 DICLOFENAL SODIUM 50MG - PRESCRIBED FOR PAIN SWELLING OF LESION - DID NOT HELP AT ALL 5/31 GABAPENTIN 100MG CAPSULES - PRESCRIBED FOR PAIN  6/4 BETAMETHASON DIP 0.05% LOTION 6/4 DOXYCYCLINE MONOHYDRATES 50MG
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Alopecia, Anaemia, Blood test, Burning sensation, Discharge
Clinical narrative: DEVELOPED THICK HARD DRY SKIN ON TOP OF FOREHEAD INTO THE BEGINNING OF MY HAIRLINE VERY ITCHY, PAINFUL, IRRITATED, SWOLLEN, RED, OOZING PUS, BLOODY, CRUSTY, THE RASH/LESION CHANGED DRASTICALLY DAY BY DAY. I HAVE PLENTY OF PICTURES TO SHOW WHAT IT LOOKED LIKE AT DIFFERENT STAGES.  IT DID SPREAD AT ONE POINT TO MORE SPOTS ON THE TOP OF MY SCALP. THE FIRST LESION STILL HASNT GONE AWAY, ITS BEEN ABOUT 6 WEEKS NOW. I HAVE REPEATEDLY GONE TO MY DOCTOR, THE ER, AND TWO DERMATOLOGISTS WHO HAVE JUST BEEN HANDING DIFFERENT MEDICATIONS FOR MY "RASH/LESIONS" AND THE TWO DERMATOLOGISTS REFUSED TO TAKE A BIOPSY. I HAVE BEEN ASKING SINCE THIS LESION DEVELOPED, TO RUN SOME TESTS TO FIND OUT WHAT IT IS BECAUSE NO ONE REALLY KNEW OR HAD ANY ANSWERS FOR ME. NONE OF THE MEDICATIONS AND OINTMENTS HAVE WORKED. I EVEN BROUGHT A FEW SAMPLES OF THE THICK HARD LARGE CHUNKS OF SKIN THAT CAME OFF OF MY SCALP.  THE UNKNOWN "RASH/LESION" STARTED TO CAUSE TERRIBLE HEADACHES, WHICH I HAVE NEVER HAD 5/11 TRIAMCHOLONE 0.1% OINTMENT 30MG 5/20 MUPIROCIN CREAM 2% 30MG 5/28 DICLOFENAL SODIUM 50MG - PRESCRIBED FOR PAIN SWELLING OF LESION - DID NOT HELP AT ALL 5/31 GABAPENTIN 100MG CAPSULES - PRESCRIBED FOR PAIN  6/4 BETAMETHASON DIP 0.05% LOTION 6/4 DOXYCYCLINE MONOHYDRATES 50MG
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Elliptocytosis, Haematology test, Helminthic infection, Nervous system disorder, Neurological examination
Clinical narrative: DEVELOPED THICK HARD DRY SKIN ON TOP OF FOREHEAD INTO THE BEGINNING OF MY HAIRLINE VERY ITCHY, PAINFUL, IRRITATED, SWOLLEN, RED, OOZING PUS, BLOODY, CRUSTY, THE RASH/LESION CHANGED DRASTICALLY DAY BY DAY. I HAVE PLENTY OF PICTURES TO SHOW WHAT IT LOOKED LIKE AT DIFFERENT STAGES.  IT DID SPREAD AT ONE POINT TO MORE SPOTS ON THE TOP OF MY SCALP. THE FIRST LESION STILL HASNT GONE AWAY, ITS BEEN ABOUT 6 WEEKS NOW. I HAVE REPEATEDLY GONE TO MY DOCTOR, THE ER, AND TWO DERMATOLOGISTS WHO HAVE JUST BEEN HANDING DIFFERENT MEDICATIONS FOR MY "RASH/LESIONS" AND THE TWO DERMATOLOGISTS REFUSED TO TAKE A BIOPSY. I HAVE BEEN ASKING SINCE THIS LESION DEVELOPED, TO RUN SOME TESTS TO FIND OUT WHAT IT IS BECAUSE NO ONE REALLY KNEW OR HAD ANY ANSWERS FOR ME. NONE OF THE MEDICATIONS AND OINTMENTS HAVE WORKED. I EVEN BROUGHT A FEW SAMPLES OF THE THICK HARD LARGE CHUNKS OF SKIN THAT CAME OFF OF MY SCALP.  THE UNKNOWN "RASH/LESION" STARTED TO CAUSE TERRIBLE HEADACHES, WHICH I HAVE NEVER HAD 5/11 TRIAMCHOLONE 0.1% OINTMENT 30MG 5/20 MUPIROCIN CREAM 2% 30MG 5/28 DICLOFENAL SODIUM 50MG - PRESCRIBED FOR PAIN SWELLING OF LESION - DID NOT HELP AT ALL 5/31 GABAPENTIN 100MG CAPSULES - PRESCRIBED FOR PAIN  6/4 BETAMETHASON DIP 0.05% LOTION 6/4 DOXYCYCLINE MONOHYDRATES 50MG
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Parasitic gastroenteritis, Pruritus, Rash, Red blood cell count
Clinical narrative: DEVELOPED THICK HARD DRY SKIN ON TOP OF FOREHEAD INTO THE BEGINNING OF MY HAIRLINE VERY ITCHY, PAINFUL, IRRITATED, SWOLLEN, RED, OOZING PUS, BLOODY, CRUSTY, THE RASH/LESION CHANGED DRASTICALLY DAY BY DAY. I HAVE PLENTY OF PICTURES TO SHOW WHAT IT LOOKED LIKE AT DIFFERENT STAGES.  IT DID SPREAD AT ONE POINT TO MORE SPOTS ON THE TOP OF MY SCALP. THE FIRST LESION STILL HASNT GONE AWAY, ITS BEEN ABOUT 6 WEEKS NOW. I HAVE REPEATEDLY GONE TO MY DOCTOR, THE ER, AND TWO DERMATOLOGISTS WHO HAVE JUST BEEN HANDING DIFFERENT MEDICATIONS FOR MY "RASH/LESIONS" AND THE TWO DERMATOLOGISTS REFUSED TO TAKE A BIOPSY. I HAVE BEEN ASKING SINCE THIS LESION DEVELOPED, TO RUN SOME TESTS TO FIND OUT WHAT IT IS BECAUSE NO ONE REALLY KNEW OR HAD ANY ANSWERS FOR ME. NONE OF THE MEDICATIONS AND OINTMENTS HAVE WORKED. I EVEN BROUGHT A FEW SAMPLES OF THE THICK HARD LARGE CHUNKS OF SKIN THAT CAME OFF OF MY SCALP.  THE UNKNOWN "RASH/LESION" STARTED TO CAUSE TERRIBLE HEADACHES, WHICH I HAVE NEVER HAD 5/11 TRIAMCHOLONE 0.1% OINTMENT 30MG 5/20 MUPIROCIN CREAM 2% 30MG 5/28 DICLOFENAL SODIUM 50MG - PRESCRIBED FOR PAIN SWELLING OF LESION - DID NOT HELP AT ALL 5/31 GABAPENTIN 100MG CAPSULES - PRESCRIBED FOR PAIN  6/4 BETAMETHASON DIP 0.05% LOTION 6/4 DOXYCYCLINE MONOHYDRATES 50MG
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Red blood cell count decreased, Sepsis, White blood cell count, White blood cell count increased
Clinical narrative: DEVELOPED THICK HARD DRY SKIN ON TOP OF FOREHEAD INTO THE BEGINNING OF MY HAIRLINE VERY ITCHY, PAINFUL, IRRITATED, SWOLLEN, RED, OOZING PUS, BLOODY, CRUSTY, THE RASH/LESION CHANGED DRASTICALLY DAY BY DAY. I HAVE PLENTY OF PICTURES TO SHOW WHAT IT LOOKED LIKE AT DIFFERENT STAGES.  IT DID SPREAD AT ONE POINT TO MORE SPOTS ON THE TOP OF MY SCALP. THE FIRST LESION STILL HASNT GONE AWAY, ITS BEEN ABOUT 6 WEEKS NOW. I HAVE REPEATEDLY GONE TO MY DOCTOR, THE ER, AND TWO DERMATOLOGISTS WHO HAVE JUST BEEN HANDING DIFFERENT MEDICATIONS FOR MY "RASH/LESIONS" AND THE TWO DERMATOLOGISTS REFUSED TO TAKE A BIOPSY. I HAVE BEEN ASKING SINCE THIS LESION DEVELOPED, TO RUN SOME TESTS TO FIND OUT WHAT IT IS BECAUSE NO ONE REALLY KNEW OR HAD ANY ANSWERS FOR ME. NONE OF THE MEDICATIONS AND OINTMENTS HAVE WORKED. I EVEN BROUGHT A FEW SAMPLES OF THE THICK HARD LARGE CHUNKS OF SKIN THAT CAME OFF OF MY SCALP.  THE UNKNOWN "RASH/LESION" STARTED TO CAUSE TERRIBLE HEADACHES, WHICH I HAVE NEVER HAD 5/11 TRIAMCHOLONE 0.1% OINTMENT 30MG 5/20 MUPIROCIN CREAM 2% 30MG 5/28 DICLOFENAL SODIUM 50MG - PRESCRIBED FOR PAIN SWELLING OF LESION - DID NOT HELP AT ALL 5/31 GABAPENTIN 100MG CAPSULES - PRESCRIBED FOR PAIN  6/4 BETAMETHASON DIP 0.05% LOTION 6/4 DOXYCYCLINE MONOHYDRATES 50MG
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Still having pain at injection site   First vaccine given 2/27/2021 Second given 3/20/2021
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Nausea and vomiting starting when waking up day after vaccine; seen in EMD, better w/Zofran, discharged home
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Tinnitus
Clinical narrative: 1. Extreme fatigue on day following both 1st & 2nd COVID-19 vaccination 2. tinnitus started about 5 days following 2nd COVID-19 vaccination and has not stopped since.  Worse at night.  I did experience tinnitus on rare occasions prior to COVID-19 vaccination.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Wrong product administered
Clinical narrative: no AE; Inappropriate dose of vaccine administered; it was documented that the patient received MMRlI, but the patient actually received PROQUAD; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.      It was documented that the patient received measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, lot#, expiration date, strength, route and anatomical location were not reported) for prophylaxis, but the patient actually received measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (1 dose, lot# t0050401 has been evaluated and changed to T005401, expiration date 12-AUG-2021, for prophylaxis; strength, route and anatomical location were not reported) on 22-JAN-2021(wrong vaccine administered). On 20-MAY-2021, prior to discovering the error in documentation, the physician ordered varicella virus vaccine live (oka/merck) (VARIVAX) (1 dose, lot# T016000, expiration date 08-MAY-2021, strength, route and anatomical location were not reported) for prophylaxis to be administered (inappropriate dose of vaccine administered). The patient did not experience any adverse events.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; temperature excursion with VAQTA which was administered to a patient; This spontaneous report was received from a medical assistance, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, drug reactions, concurrent conditions and concomitant therapies were not provided.  On 01-JUN-2021, the patient was vaccinated with an incorrect stored dose of hepatitis a vaccine, inactivated(VAQTA) lot # T020109, expiration date reported as 26-JAN-2022, 0.5 milliliter, for prophylaxis (strength and route were not reported). The administered dose experienced a temperature excursion of 47.1 degree Fahrenheit for 15 minutes. No previous temperature excursion. A digital data logger was not involved. No adverse effects were reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T020109; expirationdate: 26-JAN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Cardiac failure congestive, Cardiovascular disorder, Cerebrovascular accident
Clinical narrative: stroke; congestive heart failure; cardiovascular event; Information has been received from a lawyer regarding a case in litigation referring to an elderly female patient (pt) of unknown age. Information about concurrent condition, medical history and concomitant medication was not reported. On or around 22-MAR-2016 (at approximately 67 years old), the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot#, expiration date and route unknown) at a pharmacy for the long-term prevention of shingles and zoster-related conditions. Subsequently, the pt was treated by health care providers (reported as providers) for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: stroke, cardiovascular event and congestive heart failure. The outcome of the events was unknown.   Upon internal review, events stroke and congestive heart failure were determined to be medically significant.
Age: 59.0
Sex: U
Vaccine: VARZOS
Symptoms: Nervous system disorder, Skin infection
Clinical narrative: serious neurological injuries; skin infection; Information has been received from a lawyer regarding a case in litigation referring to a patient (pt) of unknown age and gender. Information about concurrent condition, medical history and concomitant medication was not reported. On or about 12-OCT-2015 (at approximately 59 years old), the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot#, expiration date and route unknown) at a pharmacy for the long-term prevention of shingles and zoster-related conditions. Subsequently, the pt was treated by health care providers (reported as providers) for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: skin infection and serious neurological injuries. The outcome of the events was unknown.   The lawyer considered the event serious neurological injuries to be medically significant.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; Improperly stored administered vaccine; This spontaneous report was received from a physician assistant and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 20-APR-2021, the patient was vaccinated with incorrectly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 ml, lot # 1691180 with expiration date on 15-NOV-2022 (route of administration was unknown) for prophylaxis. The vaccine underwent temperature excursion of 28.8 degrees Fahrenheit for 2 hours and 35 minutes and 31.4 degrees Fahrenheit for 15 minutes. There was no previous excursions and the digital data logger was not involved. No adverse event was reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1691180; expirationdate: 15-NOV-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: packed a punch for me; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient itself. The age at vaccination was not reported. The 2nd shot of shingles packed a punch for the patient. The patient stated that beat getting shingles though. The patient was asked if the covid antivaxers shun and shingles too.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster, Vaccination failure, Visual impairment
Clinical narrative: Suspected vaccination failure; Shingles; Shingles; This case was reported by a consumer via media and described the occurrence of vaccination failure 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 vaccination failure (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure, ophthalmic herpes zoster and shingles were unknown.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster and shingles to be related to Shingles vaccine.  Additional details were provided as follows:  The age at vaccination was not reported.  The patient received Shingles vaccine and later got shingles, almost lost her eye sight. The reporter stated that dam if you do and dam if you dont. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation for shingles infection and time to event onset was unknown. This case has been linked with US2021AMR128529, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR128529:Same reporter. "a few people" master case.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got his shot and ended up getting them anyway/Suspected vaccination failure; got his shot and ended up getting them anyway; This case was reported by a consumer via media and described the occurrence of suspected 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 details were reported as follows: The case was reported by the patient's child. The age at vaccination was not reported. The patient had his Shingle shot and ended up getting shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. The follow up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Musculoskeletal stiffness, Neuropathy peripheral
Clinical narrative: had a bad nerves on my right arm; had tight right upper shoulder; headache; chill; very tired for 3 days then four days I felt great; This case was reported by a consumer via media and described the occurrence of peripheral neuropathy in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine, the patient experienced peripheral neuropathy (serious criteria GSK medically significant), stiffness shoulder, headache, chills and tiredness. On an unknown date, the outcome of the peripheral neuropathy was unknown and the outcome of the stiffness shoulder, headache, chills and tiredness were recovered/resolved.   It was unknown if the reporter considered the peripheral neuropathy, stiffness shoulder, headache, chills and tiredness to be related to Shingles vaccine.  Additional details were provided as follows: The patient was the reporter. The age at vaccination was not reported. The patient received Shingrix and had a bad nerve on right arm, tight right upper shoulder, headache, chill and was very tired for 3 days then four days felt great.  The reporter mentioned that after second dose of shingles vaccine the patient felt strong fine.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Product administered to patient of inappropriate age, Vaccination failure
Clinical narrative: Got shingles shot.got shingals in my 30 s/ Suspected vaccination failure; Got shingles shot.got shingals in my 30 s; Got shingles shot.got shingals in my 30 s; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult 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), shingles and inappropriate age at vaccine administration. On an unknown date, the outcome of the vaccination failure, shingles and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The reporter got Shingles shot and got shingles in his or her 30s, which led to inappropriate age at vaccine administration. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the vaccine and 6 months later got the shingles/ suspected vaccination failure; got the shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure 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, 6 months 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 details were provided as follows: The case was reported by the patient's sibling. The age at vaccination was not reported. The reporter stated that, the patient got the vaccine and 6 months later got the shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation regarding shingles were unknown at the time of reporting.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received / only the lyophilized portion of Menveo / liquid component /not administered; received / only the lyophilized portion of Menveo / liquid component /not administered; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 14th June 2021, the patient received Menveo. On 14th June 2021, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were reported are as follows: The age at vaccination was not applicable for this report. The nurse reported that, the patient received the only the lyophilized portion of Menveo, they were not sure if the vaccines were reconstituted with another diluent than recommended but the liquid component of Menveo was not administered, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. They did not had any patient's data yet This was 2 of the 2 cases reported by same reporter The reporter was consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021130498:same reporter (1st patient)
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had received Shingrix vaccine / afterward, pt had a shingles outbreak/ Suspected Vaccination failure; pt had a shingles outbreak; This case was reported by a physician via sales rep and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, 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 Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received the Shingrix and at some time afterward, had a shingles outbreak. The reporter could not remember anything else about patient/case. The reporter consented to follow-up. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site erythema, Injection site swelling
Clinical narrative: 3 days later I got shingles in my one nasal passage; Received second dose / with adverse reactions ( swelling / at site); Received second dose / with adverse reactions ( / redness at site); This case was reported by a consumer and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th June 2021, the patient received the 2nd dose of Shingrix. In June 2021, 3 days after receiving Shingrix, the patient experienced shingles, injection site swelling and injection site erythema. On an unknown date, the outcome of the shingles, injection site swelling and injection site erythema were not recovered/not resolved.   It was unknown if the reporter considered the shingles, injection site swelling and injection site erythema to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient herself/himself. The age at vaccination was not reported. After receiving 2nd dose of shingrix vaccine, the patient experienced  injection site swelling ,injection site erythema and shingles. Shingles was happened 3 days after getting the 2nd dose of Shingrix  vaccine. No further information was reported. Follow up was not possible as no contact details were provided.
Sex: U
Vaccine: VARZOS
Symptoms: Neuralgia
Clinical narrative: Horrible nerve pain for 3 years can't wear jeans anymore; This case was reported by a consumer via interactive digital media and described the occurrence of nerve pain 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 nerve pain. On an unknown date, the outcome of the nerve pain was not recovered/not resolved.   It was unknown if the reporter considered the nerve pain to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported for patient herself/himself. The age at vaccination was not reported. The patient had horrible nerve pain for 3 years and could not wear jeans anymore. The people thought that the patient was pretending this horrible pain. No further information was reported. Follow up was not possible as no contact details were provided. This case has been linked with US2021AMR129910, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR129910:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: You got it from the Shot/ Suspected vaccination failure; You got it from the Shot; This case was reported by a consumer via 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, 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.   The reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient received the Shingles vaccine and got shingles from it. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting. This case had been linked with US2021AMR100406 and US2021AMR100411, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR100406:Same reporter. US-GLAXOSMITHKLINE-US2021AMR100411:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: redness; swelling; This case was reported by a other health professional via sales rep and described the occurrence of erythema in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced erythema and swelling. On an unknown date, the outcome of the erythema and swelling were unknown.   It was unknown if the reporter considered the erythema and swelling to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. It was reported that a patient who received Shingrix experienced redness and swelling. No further information was reported. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: My husband had Shingrix yesterday. Fever today; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th June 2021, the patient received Shingrix. On 16th June 2021, 1 days after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was not recovered/not resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were reported as follows: The case was reported by the wife of the patient. The age at vaccination was not reported. The patient received dose of shingrix and experienced fever and the patient was asking how long it would usually last. Follow up was not possible as no contact details were provided.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first Shingrix dose 6/17/2020 /  received his second dose 6/11/2121; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix on 17th June 2020).   On 10th June 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 10th June 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: This case was reported by patient himself. The patient received 2nd dose of Shingrix, more than recommended interval, which led to lengthening of vaccination schedule. At that time of 1st dose the pharmacist told him it would be a year before he needed his 2nd dose. The reporter also mentioned that, he should had gotten it within 2 to 6 months after the 1st dose and would like to know if he was ok, or should restart the series. The reporter consented to follow up.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received / only the lyophilized portion of Menveo / liquid component /not administered; received / only the lyophilized portion of Menveo / liquid component /not administered; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 4th June 2021, the patient received Menveo. On 4th June 2021, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were reported are as follows: The age at vaccination was not applicable for this report. The nurse reported that, the patient received the only the lyophilized portion of Menveo, they were not sure if the vaccines were reconstituted with another diluent than recommended but the liquid component of Menveo was not administered, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. They did not had any patient's data yet. This was 1of the 2 cases reported by same reporter The reporter was consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR131072:same reporter (2nd patient)
Sex: F
Vaccine: MENB
Symptoms: Extra dose administered
Clinical narrative: 3rd dose of bexsero was administered to a patient; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 18-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB05BA, expiry date 31st March 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Bexsero (received 1st dose on an unknown date) and Bexsero (received 2nd dose on an unknown date).   On 14th June 2021, the patient received the 3rd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 14th June 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: Age at vaccination was not reported. The patient received 3rd dose of bexsero on 14th June 2021, which led to extra dose administered. The reporter would like to know any possible effect and any info on 3 doses. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient didn´t received Shingrix 2nd dose after one year since 1st dose; This case was reported by a pharmacist 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 in 2020, 1 year prior to reporting date).   On an unknown date, the patient received 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 details were reported as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix after one year since 1st dose administration, which led to incomplete course of vaccination.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered, No adverse event
Clinical narrative: received expired dose of Pediarix  on 6/15/2021/  expired on 6/14/2021; This case was reported by a consumer via call center representative and described the occurrence of expired vaccine used in a 6-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number unknown, expiry date 14th June 2021) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th June 2021, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 15th June 2021, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter was the mother of the patient. On 15th June 2021, patient received Pediarix, which was expired on 14th June 2021. The reporter mentioned that, patient was not experiencing any adverse events. The reporter consented to follow up.