chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shingles on his face; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (Shingles on his face) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013l2ga and 001b21a) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy (milk causes swelling of mouth and throat usually mild). Concomitant products included ACETYLSALICYLIC ACID (ASPRIN) for an unknown indication.   On 14-Jan-2021 at 6:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021 at 2:40 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In January 2021, the patient experienced HERPES ZOSTER (Shingles on his face). The patient was treated with PREDNISONE ongoing since an unknown date for Shingles, at a dose of 1 dosage form. On 17-Feb-2021, HERPES ZOSTER (Shingles on his face) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  Treatment information included prednisone and antiviral to treat the shingles.    Most recent FOLLOW-UP information incorporated above includes: On 09-Apr-2021: Patient demographics, medical history, suspect product details, concomitant medication, event details and outcome were updated.; Sender's Comments: Limited information regarding this event has been provided at this time.  Further information has been requested.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 80-year-old male patient who received SHINGRIX (batch number B9739, expiry date 22nd November 2020) for prophylaxis. On 14th June 2018, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was recovered/resolved. It was unknown if the reporter considered the injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional reported that the patient developed a small red circle at the injection site after receiving SHINGRIX. It was reported that the area resembled a small ringworm which appeared after receiving injection and had remained for one and a half month. No further information was reported regarding the event.
This case was reported by a consumer via call center representative and described the occurrence of fever in a 57-year-old male patient who received Shingrix for prophylaxis. On 20th June 2018, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced fever, chills and tremor. On an unknown date, the outcome of the fever, chills and tremor were unknown. It was unknown if the reporter considered the fever, chills and tremor to be related to Shingrix. Additional details were provided as follows: This case was not previously reported to any one. The age at vaccination was not reported. The patient reported that he experienced fever and chills to the point he was shaking uncontrollably and had to get into warm bath to help stabilize his temperature. The patient stated that he had no primary care physician at the time of reporting.
Severe itching on face, back and front. Skin is red. Temperature is 97.4, No swelling of lips. No shortness of breath.
Received vaccine ~2:10p 9/1 & when I woke up around ~9:30a 9/2 my arm was sore but also my armpit. Hard to raise arm and keep having to ice my armpit.
I experienced elevated blood pressure, rapid heart rate, shortness of breath, and excruciating chest pain. I had difficulty breathing and I lost ten pounds. On 05/13/2021, I went to the ER via ambulance. On 08/22/2021, I went to the emergency room. I was treated with baby aspirin, GI cocktail, Benadryl, Morphine, and placed on blood pressure medication. I had to go to the ER again on 09/23/2021. I was treated with baby Aspirin, Benadryl, GI cocktail, Morphine, and Nitroglycerin. On 10/11/2021, I was hospitalized for 4 days. I was diagnosed with Left lower lobe atelectasis, pericardial effusion, and pericarditis. Now I'm on a high dose of Ibuprofen 600 mg 3 times a day and colchicine two times day.
no adverse effects reported; patient was vaccinated with improperly stored MMR II; This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 20-MAY-2019, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (albumin status rHA) one dose, lot # R024906 with expiration date 30-AUG-2020 (frequency, route and anatomical location were not provided) which was reconstituted with sterile diluent (dose, frequency, route, lot number and expiration date were not provided) for prophylaxis. No adverse effects reported.  The temperature and time frame were unknown by reporter. There was previously temperature excursions and digital data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA011469: US-009507513-1907USA010301: US-009507513-1907USA010302: US-009507513-1907USA010303: US-009507513-1907USA010304: US-009507513-1907USA010305: US-009507513-1907USA010306: US-009507513-1907USA010307: US-009507513-1907USA010308: US-009507513-1907USA010309: US-009507513-1907USA010310: US-009507513-1907USA010311: US-009507513-1907USA010312: US-009507513-1907USA010313: US-009507513-1907USA010314: US-009507513-1907USA010315: US-009507513-1907USA010316: US-009507513-1907USA010317: US-009507513-1907USA010318: US-009507513-1907USA010319: US-009507513-1907USA010320: US-009507513-1907USA010321: US-009507513-1907USA010322: US-009507513-1907USA010323: US-009507513-1907USA010324: US-009507513-1907USA010325: US-009507513-1907USA010326: US-009507513-1907USA010327: US-009507513-1907USA010328: US-009507513-1907USA010329: US-009507513-1907USA010330: US-009507513-1907USA010331: US-009507513-1907USA010332: US-009507513-1907USA010333: US-009507513-1907USA010334: US-009507513-1907USA010335: US-009507513-1907USA010336: US-009507513-1907USA010337: US-009507513-1907USA010338: US-009507513-1907USA010339: US-009507513-1907USA010340: US-009507513-1907USA010341: US-009507513-1907USA010342: US-009507513-1907USA010343: US-009507513-1907USA010344: US-009507513-1907USA010345: US-009507513-1907USA010346: US-009507513-1907USA010347: US-009507513-1907USA010348: US-009507513-1907USA010349: US-009507513-1907USA010350: US-009507513-1907USA010351: US-009507513-1907USA010352: US-009507513-1907USA010353: US-009507513-1907USA010354: US-009507513-1907USA010355: US-009507513-1907USA010356: US-009507513-1907USA010357: US-009507513-1907USA010358: US-009507513-1907USA010359: US-009507513-1907USA010360: US-009507513-1907USA010361: US-009507513-1907USA010362: US-009507513-1907USA010363: US-009507513-1907USA010364: US-009507513-1907USA010365: US-009507513-1907USA010366: US-009507513-1907USA010368: US-009507513-1907USA010369: US-009507513-1907USA010370: US-009507513-1907USA010371: US-009507513-1907USA010372: US-009507513-1907USA010373:
My right arm got a rash and it was warm  and itchy for a week and I had a slight headache. The rash is leaving slowly.
_erythema, tenderness, warmth on 8cm round;itchy raised area on lt deltoid;no other sx;no fever;
pt recv vax 23JUL97 & 30JUL97 pt exp fever of 104;
Severe malaise, fever and local redness and swelling at site of Tdap and PNEUMOVAX ((L) deltoid) not sure if both vaccinations together or just one the cause.
Intense, painful itching with a rash which creates anxiety about when the next response is going to happen.  The issue started almost immediately after my booster. three months ago.
This spontaneous report as received from a other health professional refers to a 14 month old patient. On 10-JUL-2014 the patient was vaccinated with M-M-R II (HSA, lot# J015503, Exp 05-DEC-2015, dose and route not reported) which was stored improperly. There was no adverse effect reported. This is one of several reports received from the same source. Additional information is not expected.
Client states ,via phone call ,that 2 days after vaccine administration 9/28., she experienced blotchy redness on cheek area of her face. No itching or shortness of breath. As of 9/30 redness has faded.
DOSE ADMINISTERED AFTER BEING STORAGE FOR 30 DAYS BETWEEN 2-8 C
Muscle and body aches began the evening I got the shot. At bed time I was shivering and woozy. I slept for many hours, until 5 pm the next day. Body/muscle aches and wooziness continued the next day but shivering was gone. Aches are still ongoing as of today (5 days after shot) but wooziness is gone. Aches are most prominent in the back. Did not take any medication to treat symptoms.
Pt was given the diluent part of the Pentacel vaccine which includes the DTAP and Polio-IPV. The diluent was not mixed with the powder which included the HIB portion of the vaccine.  So the pt did not receive the HIB vaccine on 08/16/2023.
Left upper trapezia silver dollar sized area with raised bumps. Slightly painful, itchy. Went undiagnosed but mimicked shingles. Has slowly gotten better. Still very visible, 90% cleared. Emailed PCP, was not seen in office.
Within ten minutes of administration, patient began experiencing tingling in her throat and phlegm production.  Given patient's history of anaphylactic allergic reactions, RN contacted the code team for additional support.  Pt was transferred to the Emergency Dept. RN unsure of treatments provided there, but patient was discharged within three hours.
This spontaneous report was received from a Medical Assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 13-NOV-2017, the patient was vaccinated with an expired dose of PNEUMOVAX 23 (route, dose, frequency and anatomical location were unknown) with lot # N011867 and expiration date 8-NOV-2017 for prophylaxis. No adverse effects reported. Sender's Comments: US-009507513-1712USA004581.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old male patient received BNT162b2 (BNT162B2), on 20Dec2021 as dose 1, single (Lot number: 33130BA), in left arm and on 13May2022 as dose 2, single (Lot number: FM9992) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: AZITHROMYCIN, start date: 14Sep2022, stop date: 18Sep2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID-19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201184890 same reporter/patient/product, different dose;
Information has been received from a father concerning his daughter who was vaccinated with a 0.5 ml second dose of Gardasil.  Subsequently the patient has been "getting dizzy".  At the time of the report the patient's outcome was unknown.  Additional information has been requested.
Woke up to a burning sensation all over my face that quickly spread to my upper torso. I stumbled into the bathroom and removed my pajama shirt to relieve the heat I was experiencing. I ran my hands under luke warm water and the sensation suddenly disappeared as quickly as it came. Later that same day I experienced fatigue and loss of appetite that lasted about 24 hours.
significant pain in the arm (that had received the vaccination}" The pain was deep in the muscle and stabbing like , prompting him to "yelp''; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (significant pain in the arm (that had received the vaccination}" The pain was deep in the muscle and stabbing like , prompting him to "yelp'') in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced MYALGIA (significant pain in the arm (that had received the vaccination}" The pain was deep in the muscle and stabbing like , prompting him to "yelp''). At the time of the report, MYALGIA (significant pain in the arm (that had received the vaccination}" The pain was deep in the muscle and stabbing like , prompting him to "yelp'') outcome was unknown. Not Provided          Concomitant Medications were not provided by the reporter. Treatment Information was not provided by the reporter.
Teacher noticed they looked pale. Patient felt dizzy upon trying to stand, felt like the world was spinning. Teacher had to catch them. Patient was really upset. Had heart rates from 90s to 120s.
Patient tested positive for COVID-19 on 3/29/21; >2 weeks after fully vaccinated w/ Moderna. Patient was asymptomatic and was tested due to hospital admission for other issues.
No adverse event; Nurse is calling to report that patient received expired vaccine on 12-JUN-2023; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Nurse is calling to report that patient received expired vaccine on 12-JUN-2023) and NO ADVERSE EVENT (No adverse event) in a 6-month-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7170B) for COVID-19 prophylaxis.    Co-suspect products included non-company products PEDIARIX for an unknown indication, HIB VACCINE CONJ (TET TOX) (ACTHIB) for an unknown indication and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for an unknown indication.    No Medical History information was reported.   On 12-Jun-2023, the patient received third dose of PEDIARIX (Intramuscular) 1 dosage form, third dose of HIB VACCINE CONJ (TET TOX) (ACTHIB) (Intramuscular) 1 dosage form and third dose of PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) (Intramuscular) 1 dosage form. On 12-Jun-2023 at 10:00 AM, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 12-Jun-2023 at 10:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Nurse is calling to report that patient received expired vaccine on 12-JUN-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Nurse is calling to report that patient received expired vaccine on 12-JUN-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Nurse is calling to report that patient received expired vaccine on 12-JUN-2023).    Event Outcome was given as Recovered and date of recovery was given as 12-Jun-2023  No concomitant information was reported. No treatment information was provided.  Suspect product dosage text was reported as unknown. The 2.5ml vial was initially stored in refrigerator on 09-Jun-2023 and did not underwent temperature excursions.  This case is reported for 6 month old baby. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-728850 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jul-2023: Follow-up information received and reporter information updated, secondary reporter details was added. Patient details and dose details were updated, other co suspects were added; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-728850:69-year-old patient
Patient presented to the ED and was subsequently hospitalized twice within 6 weeks of receiving COVID vaccination. DOS 04/14/2021, 05/14/2021.
This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. The patient's current conditions and medical history were not reported. On unspecified dates, the patients was vaccinated with improperly stored GARDASIL lot # K006960 and expiry date of 19-FEB-2017 (unknown strength, route and anatomical location). Concomitant medications were not reported. No adverse effects were reported. The outcome of the events was unknown. There was no product quality complaint involved. This is one of the two reports from the same reporter. Additional information has been requested.
Patient's dad came in without a vaccine card and said they were due, was given Second dose in series, but afterword was discovered that it was only 2 weeks not 3 weeks after their first shot.
P woke 130AM on 22APR92 w/vomiting & t104.5 oral was not able to retain APAP; cont w/t102-104 fever & vomiting until 5PM on 22APR92; ate small amt of dinner which was retained-fever was 98.9 oral; 23APR92 t102 advised to contact MD;
C/O cough,fevers,fatigue,SOB x 7 days. Diagnosed with COVID .
tingling in face 30  minutes after, wheezing and trouble breathing about 4 hours after
Right arm was warm, red, swollen and tender to the touch. Reaction to GARDASIL 9. Told to apply cold compress.
Information has been received from a healthcare worker (Medical Assistant) referring to a 6 year old patient of unknown gender. The patient's pertinent medical history and drug allergies were not reported. On 27-AUG-2015 the patient was vaccinated with M-M-R  II (lot # and expiration date unknown, 0.5 ml) subcutaneously in the left thigh and at the same time administered (Oka/Merck) PROQUAD (lot #, expiration date, dose unknown) subcutaneously in the right thigh (overdose). No adverse effects reported. Additional information is not expected as the physician couldn't be contacted.
having an itchy rash; Soreness around the site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (having an itchy rash) and VACCINATION SITE PAIN (Soreness around the site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced VACCINATION SITE RASH (having an itchy rash) and VACCINATION SITE PAIN (Soreness around the site). At the time of the report, VACCINATION SITE RASH (having an itchy rash) and VACCINATION SITE PAIN (Soreness around the site) outcome was unknown.        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.
Egg size mass formed on right side mid-calf under skin of right leg - no known injury - no bruise - very painful to touch & even walk - no apparent improvement yet.
severe stabbing pain-began in lt hand-cont in hand & moved up to elbow, shoulder, neck, spinal column, hip, rt side; can't sleep well;dx fibromyalgia-can't carry anything;  Annual follow-up received on 11/08/00 states that the pt still has joint pain and on 4/27/00 went to the ER for abdominal pain. CT scan shwoed inflammation of the colon. Tests revealed inflammatory bowel disease differentiated colitis or possible Crohns disease. The pt had a rapid onset of fever and severe pain.
Tired headache for over a week; 600 mg ibuprofen; 1000mg Tylenol.
CHILLS; BODY ACHES; FATIGUE; 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 ad26.cov2.s (suspension for injection, intramuscular, and batch number: 1802072 expiry: UNKNOWN) .5 ml, administered on 07-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced body aches. On MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, body aches, and fatigue. This report was non-serious.
Erythema and mild induration at vax site immediately post IZ. Given ice pack at site. Approximately 15 minutes post vax, decreased induration, still with mild erythema.
has covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (has covid) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (has covid). At the time of the report, COVID-19 (has covid) outcome was unknown.            Concomitant medication was not reported. Treatment medication was not reported.  Company comment: This is a spontaneous case concerning a female patient of unknown age, no reported medical history, who experienced the non-serious unexpected, AESI of COVID-19. The event occurred on an unknown date after the second dose of mRNA-1273 vaccine. The outcome of the event was not reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 05-Jan-2022: Additional information received included No new information.; Sender's Comments: This is a spontaneous case concerning a female patient of unknown age, no reported medical history, who experienced the non-serious unexpected, AESI of COVID-19. The event occurred on an unknown date after the second dose of mRNA-1273 vaccine. The outcome of the event was not reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
sore arm; felt tired; dulling headache that hasn't gone away; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), FATIGUE (felt tired) and HEADACHE (dulling headache that hasn't gone away) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm), FATIGUE (felt tired) and HEADACHE (dulling headache that hasn't gone away). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. On 20-Feb-2021, PAIN IN EXTREMITY (sore arm) and FATIGUE (felt tired) outcome was unknown. At the time of the report, HEADACHE (dulling headache that hasn't gone away) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.