chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I am catching a cold.  It started 5 days after the vaccine.  I am taking Zicam and OTC Severe Daytime cold medicines
pain at the injection site; injection site red; injection site itching; A spontaneous report was received from a  36 year old female consumer who was participating in the mRNA-1273 Emergency Use Program and developed injection site pain, redness and itching.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On 30 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot 025L20A) intramuscularly in the arm for prophylaxis of COVID-19 infection.   After the vaccine was administered, the patient developed injection site pain, redness and itching. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events developed injection site pain, redness and itching, were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
On the clinic day, the vaccine was transported out from the pharmacy to the facility without a digital data logger. The packing used for transport was refrigerated packaging tote to maintain a temperature of 36 F - 46 F.  However, that is not approved by State for COVID-19 vaccine transportation. The total time (from when vaccine left the pharmacy to the clinic completion) was less than 6 hours. There were no adverse events.
Apprx. 2-3 hrs after immunizations, fever increased 103.80 (rectal). Mother reported infant had convulsions was taken to ER and admitted to hospital for dehydration. Had bloody stools. Diagnosed with Roto Virus. Dr. stated maybe vaccines could have triggered episode.  Nurse follow up on 07/22/04 states: "febrile seizure, diarrhea, vomiting, sinusitis ,  otitis media."
Patient has a 2 week old infant and is breastfeeding.  Infant had sudden onset of irritability/crying on 3/16/2021.
Elevated Blood sugar from 107 mg/dl to height of 290 and the fluctuated between 203 and 146 ending at 157 today, 2/28/2021
The patient experienced swelling and the inner triceps area of ??the left arm warm. She took APAP.
feel sick; she began to feel sick and got tested and she also tested positive on April 1st; This is a spontaneous report from a contactable consumer (grandfather) via medical information team. A 19-year-old female patient was administered with first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown,), via an unspecified route of administration on 28Mar2021 as a single dose for COVID-19 immunization. A few days later someone she works with tested positive for Covid, she began to feel sick and got tested and she also tested positive on 01Apr2021 and It was reported that, now patient was feeling much better and her second vaccine dose was scheduled on 18Apr2021. He asked, can she go as planned to get her second dose or does she have to wait since she had covid. Outcome of the events was unknown.  Information about lot and batch number was requested.
Tightness in chest; Tightness in neck area; Light headed; blurry vision; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection Batch/Lot Number: ER8727), via an unspecified route of administration, administered in Arm Left on 24Mar2021 10:30 (at the age of 41-year-old) as dose 1, single for covid-19 immunisation. Medical history included musculoskeletal disorder and known allergies with Pineapple or citrus fruits from an unknown date and unknown if ongoing. Concomitant medication(s) included cyclobenzaprine hydrochloride (FLEXERIL [CYCLOBENZAPRINE HYDROCHLORIDE]) and diclofenac (DICLOFENAC) received within 2 weeks of vaccination taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 24Mar2021 10:30 the patient experienced tightness in chest and neck area, Lightheaded and blurry vision. The patient underwent lab tests and procedures which included electrocardiogram with unknown and myocardial necrosis marker with unknown results on an unspecified date. Therapeutic measures were taken as a result of all events. The adverse events resulted in emergency room visit. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Headache CHILLS-FEVER, INCREASED FATIGUE INCREASED MUSCLE ACHES Narrative:
Vomiting, nausea, headache, muscle aches and muscle weakness, chills for several days after vaccine
I have received 5 other Covid vaccs.  The first 4 were fine no reactions. The 5th one I had 11-3-22 and had chills and joint pain. This one the (6th) had chills, fever of 100. muscle aches, lymph nodes were sore and tired. It lasted for several hours and then went away gradually.
Flu-like symptoms, fever of 99.6, chills, nausea, headache, arm pain, for about 24 hours.  Took Tylenol and Ibuprofen cold and sinus
Heavy menstrual period occurred right after shot was administered. My cycle is usually regular, I was not supposed to have a period for two weeks. Nothing else would have affected it (no birth control, no chance of pregnancy).
Dry cough, low grade fever, body aches Still recovering but worst symptoms lasted two days.
PATIENT CAME IN TO RECEIVE THE COVID VACCINATION. PATIENT RECEIVED THE VACCINE AND WAITED THE RECOMMENDED 15 MINUTES AFTER RECEIVING THE VACCINE. PATIENT GOT UP FROM WAITING AREA AFTER THE 15 MINUTES AND CONTINUED TO SHOP WITH HIS CAREGIVER. UPON REACHING THE CHECKOUT AT THE FRONT, THE PATIENT FELL AND HIT HIS HEAD. PATIENT REFUSED ANY MEDICAL ATTENTION. IT WAS ALSO BROUGHT TO THE MANAGER'S ATTENTION THAT THE PATIENT HAS ALSO FALLEN IN THE AISLE AND THE CAREGIVER CONTINUED TO SHOP INSTEAD OF HAVING HIM SIT AND REST
This spontaneous report as received from a pharmacist and a Licensed practical nurse (LPN) refers to a patient of unknown age and gender who on 27-FEB-2013 received one dose of (Merck) VARIVAX injection (Lot # reported as H015951, expiration date 23-AUG-2014) (dose, route and site of administration not reported) that was exposed to refrigerator temperatures not greater than 46 F for 60 days. (Merck) VARIVAX was placed in the refrigerator of 5 C on 08-NOV-2012 and discovered on 06-MAR-2013 (also reported as for a few months). No adverse effect reported. This is one of two cases from the same source. Additional information has been requested.
UPON ADMINISTRATION THE CONTENTS OF THE SYRINGE ALMOST COMPLETELY SPILLED OUT THE SIDE OF SYRINGE AND DRIPPED DOWN HER ARM.
has had them since getting the shot / Suspected vaccination failure; has had them over 40 times; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 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 case details were reported as follows: The reporter was patient's friend. The age at vaccination was not reported. The patient has had shingles over 40 times since getting the shot. The reporter would take his or her chances of getting them again without the shot. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.
Booster covid vaccine per MD orders; Booster covid vaccine per MD orders; Pt states an increase in pain mainly in shoulder joints; This is a spontaneous report from a contactable Nurse. A 64-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Unknown) via an unspecified route of administration on Sep2021 as DOSE 3, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received first and second dose of BNT162B2 on unspecified date. On Sep2021, Patient stated an increase in pain mainly in shoulder joints. Patient stated was off of Xeljanz for 7 days a week ago due to booster covid vaccine per MD orders. Patient stated pain level was now starting to decrease. MD aware. The outcome of the arthralgia was resolving and outcome of other events was unknown.  The lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.
A non-serious spontaneous report of received expired FLUMIST was received from a nurse concerning a male pediatric patient. No medical history was provided. The product expired on 15-Dec-2010. On 21-Dec-2010, the patient received the expired product. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
Left, vocal cord, right vocal cord, polyps cancer. Lost of voice. Rash in skin complete body. Pain to joints complete body. Gallbladder removal with, multiple polyps.  6/9/09 MR received for several DOS 11/3/2004-1/5/05 with DX: Squamous Cell Carcinoma of the vocal cords. Pt presented in 11/2004 with c/o 1 yr hx of hoarseness. Vocal cord mass noted during laryngoscopy. BX (+) for sqaumous cell cA. vocal cord stripping done 12/10/04. Referred for radiation tx.
Nonstop crying, vomiting, increased T. (high pitched shrill cry), TX by MTR/PMD /w Tylenol & Pedialyte to decrease T & prevent dehydration, resolved S/S /p 12 hrs
pt recv vax in 1995 & pt devel yellowing of the eyes following vax;yellowing subsided by the 3rd dose;
I had a breakthrough case of Covid in December 2022, I had a scratchy throat and cough. I was prescribed PAXLOVID.
Covid-19 Treatment; Covid-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 37-year-old male patient received BNT162b2 (BNT162B2), on 06Nov2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 37 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 29Dec2020 as dose 1, single (Lot number: 025J20A), in left arm and on 26Jan2021 as dose 2, single (Lot number: 028L20A), in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative; (unspecified date) Negative; (unspecified date) Negative; (unspecified date) Positive; (12May2022) Negative; (unspecified date) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient underwent treatment with Paxlovid for COVID-19 from 09May2022 to 13May2022. Other medication was not received within 2 weeks. Vaccine was received. Patient tested negative on Binax home tests starting 12May, then negative on four subsequent tests in the days that followed. Symptoms resumed after 9 days of testing negative (Day 12 from original symptom onset), then tested positive again on home test soon after. Patient received second round of Paxlovid.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Drug ineffective and Covid 19 and the suspect drug cannot be ruled out. The case will be reassessed once new information is available.
Soreness at injection site for 2 days. On the third day, I awoke with muscle tightness, abdominal cramping, severe headache, diarrhea, lymphadenopathy, and cough. Sunday I took my temperature and it was slightly elevated at 99 with a baseline of 97.6. Fever and headache broke on Monday, other symptoms still persisting with diarrhea improving.
presented to hospital on 1/2/23 for evaluation of shortness of breath and chest pressure, ongoing for two days
THROMBOSIS IN RIGHT HAND MIDDLE FINGER KNUCKLE; RIGHT ARM AND HAND COLD; RIGHT ARM AND HAND NUMB,LEFT HAND NUMB; WEAK LEFT HAND AND WEAK LEGS; CRAMP IN INNER MIDDLE FOOT LEFT FOOT; PAIN ALL OVER BODY; CHILLS; FEVER; HAND AND LEG STIFFNESS,STIFF NECK; RED/BLUE BRUISE; This spontaneous report received from a patient concerned a 38 year old white and Hispanic or Latino female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 205A21A expiry: UNKNOWN) dose was not reported, 1 total administered on 03-MAY-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On MAY-2021, the patient experienced red/blue bruise. On 03-MAY-2021, the patient experienced pain all over body, hand and leg stiffness for 10 minutes, stiff neck, chills and fever. On 04-MAY-2021, the patient experienced cramp in inner middle foot left foot. On 09-MAY-2021, the patient experienced thrombosis in right hand middle finger knuckle, right arm and hand cold, right arm and hand numb, left hand numb and weak left hand and weak legs.  Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cramp in inner middle foot left foot on 04-MAY-2021, pain all over body on MAY-2021, and chills, and fever on 03-MAY-2021, was recovering from right arm and hand cold, right arm and hand numb, left hand numb, and weak left hand and weak legs, had not recovered from thrombosis in right hand middle finger knuckle, and hand and leg stiffness, stiff neck, and the outcome of red/blue bruise was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210516231-covid-19 vaccine ad26.cov2.s - thrombosis in right hand middle finger in Hispanic or Latino patient. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
I felt like I was having a heart attack I had a very sick stomach too. I had to go to the emergency room and get fentanyl and Benadryl in an IV.
Vomiting and diarrhea the morning after Mother's day. And I thought it was the flu. By June 9th or so, I wasn't eating at all and was vomiting constantly and couldn't hold down any liquids. Called the doctor and they sent me to ER  - on  (onteh 11th) there I was treated for awhile in outpatient with IVs and was admitted to the  hospital the night of the 12th . - Treated for vomiting and diarrhea and I tested positive for COVID - with an Asymptomatic result. I don't have vomiting and diarrhea anymore but slowly starting back up on soft food - eggs, oatmeal; chicken but not other meat (that comes up). I'm having trouble with bowel movements - I have the urge but when I do have one it is difficult to pass and they are small and hard.
herpes sore on my lip; Vaccination site erythema; Vaccination site swelling; Vaccination site pruritus; Vaccination site warmth; Cellulitis of arm; diarrhea; Vaccination site reaction; Headache; Nausea; Fever; Vaccine administered at inappropriate site; This spontaneous case was reported by a consumer and describes the occurrence of CELLULITIS (Cellulitis of arm) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Aug-2021, the patient experienced DIARRHOEA (diarrhea), VACCINATION SITE REACTION (Vaccination site reaction), HEADACHE (Headache), NAUSEA (Nausea), PYREXIA (Fever) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Vaccine administered at inappropriate site). On 20-Aug-2021, the patient experienced CELLULITIS (Cellulitis of arm) (seriousness criterion medically significant), VACCINATION SITE ERYTHEMA (Vaccination site erythema), VACCINATION SITE SWELLING (Vaccination site swelling), VACCINATION SITE PRURITUS (Vaccination site pruritus) and VACCINATION SITE WARMTH (Vaccination site warmth). On 23-Aug-2021, the patient experienced ORAL HERPES (herpes sore on my lip). At the time of the report, CELLULITIS (Cellulitis of arm), ORAL HERPES (herpes sore on my lip), VACCINATION SITE ERYTHEMA (Vaccination site erythema), VACCINATION SITE SWELLING (Vaccination site swelling), VACCINATION SITE PRURITUS (Vaccination site pruritus), VACCINATION SITE WARMTH (Vaccination site warmth), DIARRHOEA (diarrhea), VACCINATION SITE REACTION (Vaccination site reaction), HEADACHE (Headache), NAUSEA (Nausea), PYREXIA (Fever) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Vaccine administered at inappropriate site) outcome was unknown.            No concomitant medication was reported. Treatment information was not provided by reporter.   This case was linked to MOD-2021-265574 (Patient Link).
Pt contacted clinic two days after receiving vaccine. Pt states that site of injection is swollen, hard lump about the size of a golf ball, sore to touch with a rash. Pt was icing area and did take BENADRYL.
48 y/o female, with no past medical history, who presents with pressure to the side of her head/temples, weakness, dryness and numbness to mouth post vaccination administration. Patient received her 2nd vaccination to the patients Right deltoid. Patient denies previous reaction with 1st vaccination administration. NP and Paramedics at patient side. Patient appears pale, including her lips. Patient denies sore throat, difficulty breathing, itch or chest pain. Water was provided and patients legs elevated on chair. Patient vitals within normal limits (initial vitals: 136/86 BP, 99%RA, 83 HR, 12 Resp. Vitals prior to discharge: 123/85 BP, 99% RA, 79 HR, 10 Resp. EKG: NSR ). Patient was monitored by the NP with no further interventions needed. Patient returned to baseline, with symptom resolution within 15 mins. Patient cleared to go home in stable condition.
Three weeks post Shingrix vaccine multiple outbreaks of genital herpes have occurred, all  in multiple spots on the body that do not respond to acyclovir.  Prior to the vaccine outbreaks occurred in one spot typically once per year lasting typically 4 days. Post Shingrix vaccine the breakout is spread across multiple locations - face, hands, arms, back, and lasting multiple weeks.
Nausea, retching, diarrhea, racing heart, crusted eyes, weakness.
Patient became flushed - face about 5 minutes after vaccination. Denies any other symptoms. No swelling or rash noted. No respiratory symptoms noted. Unlikely to be allergic RX.
Information has been received from a pharmacist concerning his 22 year old daughter with a sulfonamide allergy who on 08-MAY-2007 was vaccinated with her first dose of Gardasil, 0.5ml intramuscularly.  There was no concomitant medication.  "Forty-eight hours post vaccination" on 09-MAY-2007 the patient experienced mild swelling in her throat.  No other symptoms were noted.  Unspecified medical attention was sought.  As of 11-MAY-2007, the patient was recovering.  Additional information has been requested.
Lt anterior thigh slightly red and warm to touch swollen area. Measuring 10.5cm x 7.5cm wide. Patient carried into office, medicated during meeting with Ibuprofen 100mg/5ml, 7.4ml given in office. After 30 mins patient was encouraged to stand and walked short distance without facial grimace. Nurse practitioner observed pt walking with normal gait outside of the office.
Approx 2 1/2 cm x 3 cm area of redness R upper arm.
CHILLS; NOT FEELING WELL/ FEELING ABNORMAL; SWEATING; DRY COUGH; FEELING LETHARGIC; ELEVATED PULSE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: bladder cancer, neuropathy in r leg, abstains from alcohol, and non smoker, and other pre-existing medical conditions included: The patient had no known allergies, no drug abuse or illicit drug usage. The patient previously received with covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin was not reported, batch number:1805018, expiry: unknown) dose was not reported, 1 total administered on 02-APR-2021 for covid-19 prophylaxis. The patient was previously treated with metoprolol tartrate and ketorolac tromethamine used for unknown indication.  It was unknown whether the patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1855835 expiry: unknown) dose was not reported, 1 total administered to left arm on 15-DEC-2021 for covid-19 prophylaxis. No concomitant medications were reported.  On 01-JUN-2022, the patient experienced chills, not feeling well, feeling abnormal, sweating, dry cough, feeling lethargic, and elevated pulse (Dose number in series 2). Laboratory data included: Pulse rate Elevated (188). The consumer claimed that the consumer feels symptoms throughout the day.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sweating, dry cough, feeling lethargic, not feeling well, feeling abnormal, elevated pulse, and chills. This report was non-serious.
PT REPORTED REDNESS AND ITCHING AT THE INJECTION SITE THE DAY FOLLOWING VACCINATION. OVER THE NEXT COUPLE OF DAYS THE REDNESS EXPANDED FROM BEYOND THE INJECTION SITE OUTWARD AND DOWN THE ARM, RESULTING IN A RED TO PINK CIRCLE ABOUT 3 INCHES IN DIAMETER BY 1/19/15. PATIENT CALLED HER DOCTOR'S OFFICE AND WAS TOLD IT WAS AN INJECTION SITE REACTION. PATIENT WAS PRESCRIBED A COURSE OF KEFLEX TO PREVENT CELLULITIS.