chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Anticoagulant therapy, Chest pain, Computerised tomogram thorax abnormal, Echocardiogram abnormal, Loss of personal independence in daily activities
Clinical narrative: Experienced chest pain two days after shot. I did have covid-19 1 year prior to the shot but was sent to the hospital for myocarditis.  I was in the hospital for 2 days, now in unable to exercise and cannot do any harsh work.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis, Troponin, Wall motion score index abnormal
Clinical narrative: Experienced chest pain two days after shot. I did have covid-19 1 year prior to the shot but was sent to the hospital for myocarditis.  I was in the hospital for 2 days, now in unable to exercise and cannot do any harsh work.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Rectal haemorrhage
Clinical narrative: Rectal bleeding since 5/20/21 through today, 5/26/21 so far.  The Nurse Practioner, Dr.  diagnosed as hemmoroids. from a photograph.  It was not the result of constipation or straining.   I have never experienced rectal bleeding before.  Very unusual.  Doesn't seem like hemmoroids to me.  If it doesn't get better soon, I will see a GI specialist.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Inflammation, Lymphadenopathy
Clinical narrative: Left swelling/inflammation and pain in the left supraclavicular lymph nodes starting approximately 6 days after administration.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Noticed in the afternoon my arm was getting itchy. Removed the bandaid from the injection site, no other issues at that time. Later in the evening noticed significant raised red swelling approximately the size of a silver dollar and increased itching. Will be monitoring for a week as directed and following up with doctor if not resolved.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Polymenorrhoea
Clinical narrative: Heavy menstrual bleeding for 15 days, usually is medium bleeding and only lasts 4-5 days. Menstrual cycle seems to have also shortened.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest pain, Myocardial infarction, Pain, Pain in extremity
Clinical narrative: Pain in arm, chest and whole body, went to emergency center was told she may have had a heart attack
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Minor chest pain left side. Never had this feeling before. Read few reports online, feels like heart inflammation?
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Injection site pain, Muscle twitching, Tinnitus
Clinical narrative: TINNITUS bilateral, loud, persistent Joint soreness Foggy thinking Pain at injection site Headache Weird twinges all over body randomly
Age: 21.0
Sex: M
Vaccine: UNK, COVID19, COVID19, COVID19
Symptoms: Cardiovascular evaluation, Chest pain, Troponin increased
Clinical narrative: Chest pain developed 36 hrs after 2nd dose of Phizer vaccine. Elevated troponin to 2900. Admitted to hospital for Cards eval
Age: 21.0
Sex: M
Vaccine: UNK, COVID19, COVID19, COVID19
Symptoms: Cardiac imaging procedure abnormal, Chest pain, Echocardiogram normal, Ejection fraction normal, Myocarditis
Clinical narrative: Chest pain developed 36 hrs after 2nd dose of Phizer vaccine. Elevated troponin to 2900. Admitted to hospital for Cards eval
Age: 21.0
Sex: M
Vaccine: UNK, COVID19, COVID19, COVID19
Symptoms: Troponin increased
Clinical narrative: Chest pain developed 36 hrs after 2nd dose of Phizer vaccine. Elevated troponin to 2900. Admitted to hospital for Cards eval
Age: 21.0
Sex: M
Vaccine: UNK, COVID19, COVID19, COVID19
Symptoms: Chest X-ray normal, Chest pain, Echocardiogram normal, Electrocardiogram ST segment normal, Electrocardiogram normal
Clinical narrative: Chest pain developed 36 hrs after 2nd dose of Phizer vaccine. Elevated troponin to 2900. Admitted to hospital for Cards eval
Age: 21.0
Sex: M
Vaccine: UNK, COVID19, COVID19, COVID19
Symptoms: Fatigue, Magnetic resonance imaging heart, Myocarditis, Troponin I increased
Clinical narrative: Chest pain developed 36 hrs after 2nd dose of Phizer vaccine. Elevated troponin to 2900. Admitted to hospital for Cards eval
Age: 21.0
Sex: M
Vaccine: UNK, COVID19, COVID19, COVID19
Symptoms: C-reactive protein increased, Chest pain, Echocardiogram normal, Electrocardiogram normal, Full blood count normal
Clinical narrative: Chest pain developed 36 hrs after 2nd dose of Phizer vaccine. Elevated troponin to 2900. Admitted to hospital for Cards eval
Age: 21.0
Sex: M
Vaccine: UNK, COVID19, COVID19, COVID19
Symptoms: Metabolic function test normal, Myocarditis, Troponin
Clinical narrative: Chest pain developed 36 hrs after 2nd dose of Phizer vaccine. Elevated troponin to 2900. Admitted to hospital for Cards eval
Age: 21.0
Sex: M
Vaccine: UNK, COVID19, COVID19, COVID19
Symptoms: Cardiovascular evaluation, Chest pain, Troponin increased
Clinical narrative: 2 discrete episodes of non-exertional, non-positional chest pain without trigger (5/23/21, 5/24/21); presented to hospital after elevated troponin found at urgent care; suspected  myocarditis
Age: 21.0
Sex: M
Vaccine: UNK, COVID19, COVID19, COVID19
Symptoms: Cardiac imaging procedure abnormal, Chest pain, Echocardiogram normal, Ejection fraction normal, Myocarditis
Clinical narrative: 2 discrete episodes of non-exertional, non-positional chest pain without trigger (5/23/21, 5/24/21); presented to hospital after elevated troponin found at urgent care; suspected  myocarditis
Age: 21.0
Sex: M
Vaccine: UNK, COVID19, COVID19, COVID19
Symptoms: Troponin increased
Clinical narrative: 2 discrete episodes of non-exertional, non-positional chest pain without trigger (5/23/21, 5/24/21); presented to hospital after elevated troponin found at urgent care; suspected  myocarditis
Age: 21.0
Sex: M
Vaccine: UNK, COVID19, COVID19, COVID19
Symptoms: Chest X-ray normal, Chest pain, Echocardiogram normal, Electrocardiogram ST segment normal, Electrocardiogram normal
Clinical narrative: 2 discrete episodes of non-exertional, non-positional chest pain without trigger (5/23/21, 5/24/21); presented to hospital after elevated troponin found at urgent care; suspected  myocarditis
Age: 21.0
Sex: M
Vaccine: UNK, COVID19, COVID19, COVID19
Symptoms: Fatigue, Magnetic resonance imaging heart, Myocarditis, Troponin I increased
Clinical narrative: 2 discrete episodes of non-exertional, non-positional chest pain without trigger (5/23/21, 5/24/21); presented to hospital after elevated troponin found at urgent care; suspected  myocarditis
Age: 21.0
Sex: M
Vaccine: UNK, COVID19, COVID19, COVID19
Symptoms: C-reactive protein increased, Chest pain, Echocardiogram normal, Electrocardiogram normal, Full blood count normal
Clinical narrative: 2 discrete episodes of non-exertional, non-positional chest pain without trigger (5/23/21, 5/24/21); presented to hospital after elevated troponin found at urgent care; suspected  myocarditis
Age: 21.0
Sex: M
Vaccine: UNK, COVID19, COVID19, COVID19
Symptoms: Metabolic function test normal, Myocarditis, Troponin
Clinical narrative: 2 discrete episodes of non-exertional, non-positional chest pain without trigger (5/23/21, 5/24/21); presented to hospital after elevated troponin found at urgent care; suspected  myocarditis
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Red circle on arm 2 inch diameter pain area feels hard and sensitive to touch. Feels like there is a ball under my skin. This started one day after I got the second dose of the Pfizer vaccine.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Cough, Dyspnoea, Oropharyngeal pain
Clinical narrative: shortness of breath, back pain, cough, sore throat
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal wall cyst, Anticoagulant therapy, Computerised tomogram abnormal, Dyspnoea, Pulmonary embolism
Clinical narrative: I received the first does of the Covid Vaccine on April 13, 2021. Less than two weeks after being vaccinated with the Pfizer brand of vaccine I was hospitalized for an abdominal cyst and whilst in the hospital, I began having difficulty breathing and a CT scan of my chest showed that I had two blood clots [pulmonary embolism] in my right lung. I had to be placed on Heparin and I am currently on Eliquis.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain
Clinical narrative: Nausea,chills,headache,body aches. They went away after the 4th day . He started having symptoms the night he got the vaccine.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Injection site reaction, Rash
Clinical narrative: Severe rash all over body and joint pain in injection site. Went to  pharmacy and they recommended what to do. The rash lasted about 6 days.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Breast tenderness
Clinical narrative: Breast tenderness, starting the day after the vaccine and continuing for over a week. Still ongoing
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness, Blood glucose increased, Chills, Dizziness, Fatigue
Clinical narrative: Within 10 minutes after the vaccine I started to feel very faint and eyes became very blurry and couldn?t see. The pharmacy gave me water and kept making me drink water and kept checking on me. The vaccine spiked my blood sugar. After a little while my sugar went down and I was fine.    That evening I had the worst migraine ever and it lasted 3 days. I also had body aches and chills  for 3 days as well and fatigue.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Pain, Vision blurred
Clinical narrative: Within 10 minutes after the vaccine I started to feel very faint and eyes became very blurry and couldn?t see. The pharmacy gave me water and kept making me drink water and kept checking on me. The vaccine spiked my blood sugar. After a little while my sugar went down and I was fine.    That evening I had the worst migraine ever and it lasted 3 days. I also had body aches and chills  for 3 days as well and fatigue.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Hypersensitivity, Urticaria
Clinical narrative: I developed hives and woke ip covered in them. I ended up in the ER a day after my second vaccine having a severe allergic reaction. I ended up having to visit a dermatologist through an emergency appointment a week after my second vaccine. She diagnosed my  hives as a chronic result of my COVID vaccine.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Swelling, rash, pain in injection site
Sex: U
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: BRUISE ON RIGHT FOOT; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-MAY-2021, the subject experienced bruise. The action taken with covid-19 vaccine  was not applicable. The outcome of bruise was not reported. This report was non-serious.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Diarrhoea, Nausea
Clinical narrative: Abdominal pain; Nausea; Diarrhea; This is a spontaneous report from a contactable consumer (patient).   A 50-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 30Mar2021 08:00 (Batch/Lot Number: EW0151), age at vaccination of 50-years-old, as single dose, for covid-19 immunisation. Medical history included diabetes mellitus from an unknown date and unknown if ongoing. The patient was not pregnant and was not pregnant at the time of vaccination. The patient had no allergy. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1, administered in Arm Left (Batch/Lot Number: EN6206), for covid-19 immunisation. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced abdominal pain, nausea and diarrhea on 20Apr2021 at 13:00. No treatments were given for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient had not recovered from the events.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concurrent condition, pertinent medical history, concomitant medication, drug reactions or allergies were not reported. On 12-APR-2021, the patient was administrated with expired HPV rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # R016970, expiration date was 22-MAR-2021, 1 dosage form, strength and route were not reported) for prophylaxis (Expired vaccine used). No additional adverse event reported.
Sex: U
Vaccine: PPV
Symptoms: Recalled product administered
Clinical narrative: Nurse calling to request information on voluntary recall of PNEUMOV AX 23 / she had vaccines from the affected batch that were administered to 30 patients after 12Aug2020.; This spontaneous non-valid report was received from a registered nurse and refers to 30 unknown patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 12-AUG-2020 (also reported as after this date), voluntary recalled doses of pneumococcal vaccines, polyvalent (23-valent) (PNEUMOVAX 23) 0.5 ml (lot # S036495, expiration date not reported, but upon internal validation established as: 13-SEP-2021) (route of administration and anatomical location were not reported) were administered to 30 patients for prophylaxis.   This case is considered non-valid due to no patients' identifiers. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S036495; expirationdate: 13-SEP-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: No additional AE reported.; the vaccine was inadvertently administered after expiration.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent condition, pertinent medical history, concomitant medication, drug reactions or allergies were not reported.  On 11-MAY-2021, the patient was inadvertently vaccinated with expired hepatitis a vaccine, inactivated (VAQTA) (0.5ml, lot # T014590, expiration date was 15-APR-2021, strength and route were not reported) for prophylaxis (Expired vaccine used). No additional adverse event reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T014590; expirationdate: 15-APR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no other AE/PQC reported; a dose of improperly stored Pedvax HIB and Rotateq were both given to a patient; This spontaneous report was received from a physician assistant and refers to a currently 2-month-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date in 2021, the patient was vaccinated with improperly stored doses of rotavirus vaccine, live, oral, pentavalent(ROTATEQ), lot # 1688825, expiry date: 24-NOV-2021 and haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) T000885, expiry date: 29-MAY-2022 (for both: formulation, strength, dose, dose number, frequency, route of administration, anatomical location were not provided), both for prophylaxis. Administered dose of vaccines experienced the temperature excursion of 33.24 degrees Fahrenheit for 5 hours. There were no previous excursions related. Data logger was involved. No other adverse events were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: outbreak of shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient (pt) of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or around 23-OCT-2017, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not specified) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date, shortly after receiving the vaccine, the pt suffered and outbreaks of shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms resulted in physical limitations not present prior to using the vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of the pt's condition. As a result of the zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the vaccine, the pt suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of shingles was considered to be not recovered. The reporter determined the event of shingles to be related to zoster vaccine live (ZOSTAVAX).   The event of shingles was considered to be disabling.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Ankylosing spondylitis
Clinical narrative: ankylosing spondylitis; This spontaneous report was received from a registered nurse via a Company representative and refers to the reporter's son, 17-year-old male patient. He has had autoimmune issues throughout his life. There was no information regarding his medical history nor concomitant therapies provided.  In approximately 2019, when he was 15 years old, the patient was vaccinated with a dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 ml, intramuscularly (IM) (anatomical location, lot # and expiration date were not provided) for a routine inoculation. In approximately January 2021 (reported as about 4 months ago and recently), the patient was diagnosed with ankylosing spondylitis. He sought medical attention (details not provided). It was unknown whether he received any treatment for the event. The outcome of the event was unknown.  The reporter believed her son's diagnosis of ankylosing spondylitis was related to HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9).  Upon internal review, the event of ankylosing spondylitis was considered to be medically significant.
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: GARDASIL 9 was stored in fridge with needle attached for 19 days because a patient change her mind about getting the vaccine; No additional AE details; This spontaneous report was received from a registered nurse and refers to an adult female patient (exact age was unknown). There was no information regarding her medical history, concurrent conditions nor concomitant therapies provided.  On an unspecified date, the patient was supposed to be vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (dose, route of administration, anatomical location, lot # and expiration date were not provided) for prophylaxis, however she change her mind about getting the vaccine after the medication was already opened. It was reported, that the vaccine was put right back in the fridge with needle attached and has been stored like that for 19 days. No adverse event (AE) was reported.  The reporter asked how long could opened prefilled syringe (with sterile needle attached) be stored in the fridge and whether it could be still administered. 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.; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: F
Vaccine: MMR
Symptoms: Ill-defined disorder
Clinical narrative: The patient had a bad reaction to MMR; This spontaneous report was received from a consumer concerning a female patient of unknown age. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported.   On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis (strength, dose, route of administration, anatomical location, lot number and expiration date were not provided).         On an unknown date, the patient had a bad reaction to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (ill-defined disorder).  The outcome of ill-defined disorder was unknown.        The causality assessment between the suspect vaccine and the event occurrence was related.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Sudden hearing loss
Clinical narrative: Sudden hearing loss; This regulatory authority case was reported by an other health care professional and describes the occurrence of SUDDEN HEARING LOSS (Sudden hearing loss) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism. Concomitant products included VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR HCL), MULTIVITAMIN & MINERAL and ANTIOXIDANTS NOS for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced SUDDEN HEARING LOSS (Sudden hearing loss) (seriousness criterion medically significant). At the time of the report, SUDDEN HEARING LOSS (Sudden hearing loss) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient reported the hearing loss happen on left ear.  No treatment information for the event was provided.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Hemiparesis, Magnetic resonance imaging, Neurological symptom, Ultrasound Doppler
Clinical narrative: Cerebrovascular accident; Hemiparesis; Neurological symptom; This case was received via VAERS on 11-May-2021 and was forwarded to Moderna on 11-May-2021.    This regulatory authority case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (Cerebrovascular accident) and HEMIPARESIS (Hemiparesis) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     There is no relevant medical history reported.  Concurrent medical conditions included Penicillin allergy. Concomitant products included VENLAFAXINE, FINASTERIDE, TRAMADOL, PARACETAMOL (TYLENOL), ASA, CYCLOBENZAPRINE, ALPRAZOLAM, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), MORNIFLUMATE (FLOMAX [MORNIFLUMATE]), MULTIVITAMIN [VITAMINS NOS], FISH OIL, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]), NAPROXEN SODIUM (ALEVE) and OMEPRAZOLE for an unknown indication.   On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Cerebrovascular accident) (seriousness criterion medically significant), HEMIPARESIS (Hemiparesis) (seriousness criterion medically significant) and NEUROLOGICAL SYMPTOM (Neurological symptom). At the time of the report, CEREBROVASCULAR ACCIDENT (Cerebrovascular accident), HEMIPARESIS (Hemiparesis) and NEUROLOGICAL SYMPTOM (Neurological symptom) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Feb-2021, Magnetic resonance imaging: light stroke but dissolved by itself.. On 24-Feb-2021, Ultrasound Doppler: unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication information was provided. Action taken with mRNA-1273 in response to the drug was not applicable.  Very limited information regarding the events has been provided at this time.  Further information is not expected.; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information is not expected.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling, Nausea, Syncope, Vomiting
Clinical narrative: Syncope; Injection site pain; Injection site swelling; Nausea; Vomiting; This case was received (Reference number: 1063219) on 11-May-2021 and was forwarded to Moderna on 11-May-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of SYNCOPE (Syncope) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hyperlipidemia, Diabetes mellitus, GERD and Hypertension. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF), AMOXICILLIN TRIHYDRATE, CLARITHROMYCIN, ESOMEPRAZOLE MAGNESIUM (NEXIUM 1-2-3), METFORMIN, LISINOPRIL and ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.   On 27-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced SYNCOPE (Syncope) (seriousness criterion medically significant), INJECTION SITE PAIN (Injection site pain), INJECTION SITE SWELLING (Injection site swelling), NAUSEA (Nausea) and VOMITING (Vomiting). At the time of the report, SYNCOPE (Syncope), INJECTION SITE PAIN (Injection site pain), INJECTION SITE SWELLING (Injection site swelling), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram head, Hypoaesthesia, Lacunar infarction, Lacunar stroke, Magnetic resonance imaging head
Clinical narrative: loss of feeling on entire left side; Acute nonhemorrhagic right Thalamic lacunar infarct; Right Lacunar Stroke; This case was received via VAERS on 11-May-2021 and was forwarded to Moderna on 11-May-2021.  This regulatory authority case was reported by an other health care professional and describes the occurrence of HYPOAESTHESIA (loss of feeling on entire left side), LACUNAR INFARCTION (Acute nonhemorrhagic right Thalamic lacunar infarct) and LACUNAR STROKE (Right Lacunar Stroke) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 01UM20A) for COVID-19 vaccination.   Concurrent medical conditions included Drug allergy, Type 2 diabetes mellitus and Hypothyroidism. Concomitant products included METOPROLOL, LEVOTHYROXINE, LIOTHYRONINE (NP THYROID) and ACETYLSALICYLIC ACID (ASPRIN) for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced HYPOAESTHESIA (loss of feeling on entire left side) (seriousness criteria hospitalization and disability), LACUNAR INFARCTION (Acute nonhemorrhagic right Thalamic lacunar infarct) (seriousness criteria hospitalization, disability and medically significant) and LACUNAR STROKE (Right Lacunar Stroke) (seriousness criteria hospitalization, disability and medically significant). At the time of the report, HYPOAESTHESIA (loss of feeling on entire left side), LACUNAR INFARCTION (Acute nonhemorrhagic right Thalamic lacunar infarct) and LACUNAR STROKE (Right Lacunar Stroke) had not resolved.   DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Mar-2021, Computerised tomogram head: no hemorrhagic stroke evidence. On 19-Mar-2021, Magnetic resonance imaging head: (abnormal) Acute nonhemorrhagic right Thalamic lacunar infarc.  mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  No treatment information was provided.  The patient had right lacunar stroke causing loss of feeling on entire left side. Most feeling had returned except in left forearm and hand which has only partially recovered.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: VARZOS
Symptoms: Insomnia, Muscle tightness, Myalgia
Clinical narrative: All the SEs in the label. What can you say to help me sleep?; All the SEs in the label / A muscle relaxant?; All the SEs in the label / And a pain med?; This case was reported by a consumer via interactive digital media and described the occurrence of sleeplessness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th May 2021, the patient received the 1st dose of Shingrix. On 20th May 2021, less than a day after receiving Shingrix, the patient experienced sleeplessness, muscle tension and pain. The patient was treated with ibuprofen (Advil). On an unknown date, the outcome of the sleeplessness, muscle tension and pain were unknown.   It was unknown if the reporter considered the sleeplessness, muscle tension and pain to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient itself. The age at vaccination was not reported. On day of reporting, the patient was vaccinated with Shingrix. The patient had all the side effects (SE) in the label. The patient was asked what could help to sleep.  The patient had a muscle relaxant and a pain medication. The patient was asked for advise.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Nerve injury, Pain, Post herpetic neuralgia, Pruritus
Clinical narrative: I got the 2 vaccines and still ended up with a bad case of Shingles/ Suspected vaccination failure; Ended up with a bad case of Shingles; Now I have nerve damage; A lot of / pain; A lot of itching; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, nerve damage, post herpetic neuralgia and pruritus. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the nerve damage, post herpetic neuralgia and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, nerve damage, post herpetic neuralgia and pruritus to be related to Shingles vaccine and 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 2 shingles vaccines and still ended up with a bad case of Shingles and at the time of reporting, the patient had nerve damage with a lot of itching and pain. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Vaccination failure
Clinical narrative: I got the 2 vaccines and still ended up with a bad case of Shingles/ Suspected vaccination failure; Ended up with a bad case of Shingles; Now I have nerve damage; A lot of / pain; A lot of itching; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, nerve damage, post herpetic neuralgia and pruritus. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the nerve damage, post herpetic neuralgia and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, nerve damage, post herpetic neuralgia and pruritus to be related to Shingles vaccine and 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 2 shingles vaccines and still ended up with a bad case of Shingles and at the time of reporting, the patient had nerve damage with a lot of itching and pain. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuralgia, Post herpetic neuralgia, Vaccination failure
Clinical narrative: Shingles shot and had shingles few years later / had another 2 shots for shinkles/Suspected vaccination failure; Had shingles few years later; Still have nerve pain; 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, several years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and post herpetic neuralgia. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the post herpetic neuralgia was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia 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 Shingles vaccine and had shingles few years later and still had nerve pain.  The patient stated that he/she had another 2 shots for shingles. 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: Peripheral coldness
Clinical narrative: hands and feet are ice cold; This case was reported by a consumer via interactive digital media and described the occurrence of cold hands & feet in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st May 2021, the patient received Shingrix. In May 2021, less than a week after receiving Shingrix, the patient experienced cold hands & feet. On an unknown date, the outcome of the cold hands & feet was unknown.   It was unknown if the reporter considered the cold hands & feet to be related to Shingrix.  Additional information was provided as follows: This case was reported by the patient himself/ herself. The age at vaccination was not provided. The patient received Shingrix shot and developed ice cold hands and feet. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of extremities hot feeling of in a patient who received Herpes zoster (Shingrix) for prophylaxis. In May 2021, the patient received Shingrix. In May 2021, less than a week after receiving Shingrix, the patient experienced extremities hot feeling of. On an unknown date, the outcome of the extremities hot feeling of was unknown. It was unknown if the reporter considered the extremities hot feeling of to be related to Shingrix. Additional details were provided as follows:  The age at vaccination was not reported. The patient received Shingrix and experienced hot spot on arm where vaccine was given 4 days ago.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: Feel a hot spot where Shingrix was given; This case was reported by a consumer via interactive digital media (GSK Chatbot) and described the occurrence of injection site warmth 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 injection site warmth. On an unknown date, the outcome of the injection site warmth was unknown.   It was unknown if the reporter considered the injection site warmth to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported.  The patient received Shingrix vaccine and feels hot spot where vaccine was given.
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Fatigue, Influenza like illness, Injection site discolouration
Clinical narrative: General adverse events flu-like symptoms / after the first dose; Feeling tired / after the first dose; Feverish after the first dose; Doctor diagnosed her with cellulitis / first dose; Pain / first dose; Redness / first dose; Hot skin / first dose; Swelling as big as a baseball / that required medical attention; Roundish circle over the site of the injection / first dose; This case was reported by a consumer via market research programs and described the occurrence of cellulitis in a 53-year-old female patient who received Herpes zoster (Hz/su + AS01B) for prophylaxis.   In March 2019, the patient received the 1st dose of Hz/su + AS01B. In March 2019, less than a day after receiving Hz/su + AS01B, the patient experienced cellulitis (serious criteria GSK medically significant), pain, erythema, skin warm and swelling. On an unknown date, the patient experienced injection site discoloration, influenza-like symptoms, tiredness and fever. The subject was treated with antibiotics nos (Antibiotics Therapy (Unknown)). On an unknown date, the outcome of the cellulitis, pain, erythema, skin warm, swelling, influenza-like symptoms, tiredness and fever were unknown and the outcome of the injection site discoloration was recovered/resolved.   It was unknown if the reporter considered the cellulitis, injection site discoloration, pain, erythema, skin warm, swelling, influenza-like symptoms, tiredness and fever to be related to Hz/su + AS01B.  Additional details were reported as follows: The age at vaccination was not reported however it could be 52 or 53 year. The patient had a local adverse events pain, red ness and hot skin on day of vaccination. The patient had swelling as big as baseball a day after vaccination and required medical attention. The doctor dignosed it as cellulitis and provided antibiotics that reduced swelling in 1or 2 days. The patient also had roundish circle over the site of injection that stayed for 1 week. The patient also had general adverse event flu like symptoms such as feeling tired and feverish. For tolerance with 2nd dose refer the case US2021AMR111210.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR111210:Same reporter,same patient 2nd dose
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Skin warm, Swelling
Clinical narrative: General adverse events flu-like symptoms / after the first dose; Feeling tired / after the first dose; Feverish after the first dose; Doctor diagnosed her with cellulitis / first dose; Pain / first dose; Redness / first dose; Hot skin / first dose; Swelling as big as a baseball / that required medical attention; Roundish circle over the site of the injection / first dose; This case was reported by a consumer via market research programs and described the occurrence of cellulitis in a 53-year-old female patient who received Herpes zoster (Hz/su + AS01B) for prophylaxis.   In March 2019, the patient received the 1st dose of Hz/su + AS01B. In March 2019, less than a day after receiving Hz/su + AS01B, the patient experienced cellulitis (serious criteria GSK medically significant), pain, erythema, skin warm and swelling. On an unknown date, the patient experienced injection site discoloration, influenza-like symptoms, tiredness and fever. The subject was treated with antibiotics nos (Antibiotics Therapy (Unknown)). On an unknown date, the outcome of the cellulitis, pain, erythema, skin warm, swelling, influenza-like symptoms, tiredness and fever were unknown and the outcome of the injection site discoloration was recovered/resolved.   It was unknown if the reporter considered the cellulitis, injection site discoloration, pain, erythema, skin warm, swelling, influenza-like symptoms, tiredness and fever to be related to Hz/su + AS01B.  Additional details were reported as follows: The age at vaccination was not reported however it could be 52 or 53 year. The patient had a local adverse events pain, red ness and hot skin on day of vaccination. The patient had swelling as big as baseball a day after vaccination and required medical attention. The doctor dignosed it as cellulitis and provided antibiotics that reduced swelling in 1or 2 days. The patient also had roundish circle over the site of injection that stayed for 1 week. The patient also had general adverse event flu like symptoms such as feeling tired and feverish. For tolerance with 2nd dose refer the case US2021AMR111210.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR111210:Same reporter,same patient 2nd dose
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: had the vaccination / got shingles about a year later/suspected vaccination failure; got shingles about a year later; very painful!; 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, 1 year after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and 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 patient got Shingles about a year after vaccination, which was very painful. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster
Clinical narrative: Got my first shot, flared up; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles for 9 months).   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine, the patient experienced shingles. The patient was treated with antibiotics nos (Antibiotic (Details Unknown)). On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the 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 patient received 1st dose of Shingrix and experienced flared up. The patient was treated with antibiotics. For tolerance of 2nd dose, refer case- US2021AMR111252, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR111252:Same reporter