chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After approximately 24 hours, developed redness and severe soreness at injection site of Shingrix vaccine.  Pain was severe and lasted 3-4 days, responding only slightly to Ibuprofen (recommended by pharmacy where injection was administered).  Daily activities, including sleeping were disrupted due to the pain. No other adverse affects, other than tiredness due to lack of sleep.  Note, second Shingrix dose was administered on 11/13/2020 (2 months later) with no adverse affects.
Shortly after the first shot, I had severe pain in my LEFT arm (opposite arm of shot), in the same vacinity the shot was given. It was a constant stabbing/throbbing pain that lasted a few days. Then on 5/15 a month later, (LEFT arm, opposite arm of shot, same vacinity as the shot), I had the same stabbing/throbbing, constant pain start and last for at least 24 hours only this time the pain was significantly worse and even difficult to do things like open a jar, etc. I took Tylenol as I am not supposed to take other pain medicine and it did not help. I iced it but that didn't help either.
patient is a doctor, she had occupational  needle stick exposure in Aug-2020 from a HIV- negative source patient. Our patient tested HIV neg by 4th gen test at baseline in Aug-2020 after he exposure. Occupational health inadvertently tested her again on 1/28/2021 for HIV, one month after Moderna vaccine first shot on 12/28/2020.  Her HIV 4th gen ag/ab test was repeatedly positive, and on differentiation assay HIV-1 was negative and HIV-2 was "indeterminate". Her HIV -1 viral load on 2 occasions was negative since. We believe she had a false positive HIV 4th gen Ag/Ab test, about 1 month after her first shot of moderna covid vaccine.
Was a booster shot from Moderna First 2 shots Jan / Feb just sore arm 2-3 days and some diarrhea.  Booster shot next morning for 36 hours fever with Tylenol 99.9 to 102. Booster shot was full dose 100
Received vaccine 7 days before adverse reactions. On the 7th day redness and swelling at the injection site presented. Very warm to touch. Pain under arm, tender lymph nodes.
Started with some discomfort on the injection site after the injection then the next morning there was a purplish blue color mark around the injection site. Four days later the mark was about 6 inches long and 4 inches wide from the injection site to 2 inches above elbow.
I started my period 2 days after the vaccine (I have very irregular periods and hadn't had one in over 6 months).   Today, day 8, I woke up to a red, hot, and very itchy injection site. My skin feels thick and almost like there are a lot of little bug bites concentrated in a palm-sized circle on my arm.
Redness and pain at injection site. Diphenhydramine 1 cap q6 hours PRN.
I began noticing a rash of red itchy bumps on the 25th of January.  It covers my entire body.  I am unsure if it is a delayed reaction to the COVID-19 Moderna vaccine or not, It has lasted over a week and has not cleared up.
fever 102.5; chills; body aches; headaches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever 102.5), CHILLS (chills), MYALGIA (body aches) and HEADACHE (headaches) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever 102.5), CHILLS (chills), MYALGIA (body aches) and HEADACHE (headaches). At the time of the report, PYREXIA (fever 102.5), CHILLS (chills), MYALGIA (body aches) and HEADACHE (headaches) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102.5.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
patient received the booster after 12 hours of puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received the booster after 12 hours of puncture) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received the booster after 12 hours of puncture). On 01-Dec-2021, EXPIRED PRODUCT ADMINISTERED (patient received the booster after 12 hours of puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient was taking other medication. No treatment was provided by the reporter. Patient did not report having side effects.
12 years old patient received expired FLUZONE QUAD with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health care professional via Agency (Reference number- 00786871) and transmitted to Sanofi on 27-Sep-2021.  This case involves a 12-year-old female patient who vaccinated with a 0.5 mL (total, once) dose of expired INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] (lot UJ560AC, expiry date 30-Jun-2021) via intramuscular route in the left deltoid on 23-Sep-2021 for prophylactic vaccination (expired product administered).  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  It was a case of actual medication error due to expired vaccine used (latency was on same day).  At the time of report, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
about a week after my first shot, I had a rash at the site of the injection. It was nothing severe, but i wanted to report it. The rash lasted about 24-36 hours. I also had a full body rash about two weeks after the first vaccine, altho we assumed it was a food allergy at the time. Treated with Benadryl.
Difficulty Breathing; Chest Tightness; allergic reaction; A spontaneous report was received from a Healthcare Professional concerning a 69-years-old female patient who received Moderna COVID-19 vaccine (mRNA-1273) and experienced events difficulty breathing and chest tightness.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 29 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 028L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 29 Jan 2021, immediately after the first dose, the patient experienced the events difficulty breathing and chest tightness.  Treatment details included, Benadryl - Given by the ER HCP to alleviate the allergic reaction to the Moderna COVID-19, Vaccine.  The events of difficulty breathing and chest tightness were considered to be serious with criteria of life threatening.  Action taken with mRNA-1273 in response to the events was unknown.   On 29 Jan 2021 the outcome of events difficulty breathing and chest tightness was resolved.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Redness and soreness at injection within one day of vaccine.  Woke in the night with fever and shivering.  When  I got up to use the bathroom and shower at 6;30 am, felt very light headed with slight headache and nauseous.  Had to exit the shower due to increasing extreme dizziness/feeling faint.  Fever at the time was 100.3.  Took acetaminophen 1000mg and laid down with cool cloth on head , but was able to return to normal daily routine about three hours later.  Continued to feel tired with slight headache continued much of the work day. Arm tenderness at injection site continued for two days.
Towards the end of the night my arm started getting sore. I couldn't get out the bed the next day because of the body pain and super sore arm.
rash-itching all over 6PM on 15FEB99;pred-zyrtec;
is_pregnant: Yes; last_menstrual_date: 13May2021;administration_date=01Oct2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 22 year-old female patient (pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Oct2021 11:30 (Batch/Lot number: unknown) at the age of 22 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Date of last menstrual period: 13May2021. The patient was 20 weeks pregnant at the time of exposure to bnt162b2. The patient was 20 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 17Feb2022. Concomitant medication(s) included: PRENATAL VITAMINS. The following information was reported: MATERNAL EXPOSURE DURING PREGNANCY (non-serious) with onset 01Oct2021, outcome "unknown", described as "is_pregnant: Yes; last_menstrual_date: 13May2021;administration_date=01Oct2021".  Additional information: Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. List of any other medications the patient received within 2 weeks of vaccination was prenatal vitamins.
Waited over 20 min without resolution of nausea .Patient with hx of Gerd on PPI . Patient without cardiopulmonary symptoms . Patient encouraged to take PPI and make dietary changes x 24 hrs .Patient reported dizziness during questioning (mild) . Ambulance.
Chills; joint aches; left arm pain; This is a spontaneous report from a contactable consumer (patient). A 46-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6208), via an unspecified route of administration, administered in Arm Left on 11Mar2021 15:15 (at the age of 46-years-old) as dose 2, single for COVID-19 immunisation. Medical history included high blood pressure. Concomitant medications included amlodipine and levothyroxine, both taken for an unspecified indication, start and stop dates were not reported. The patient previously received the first dose of BNT162B2 (Batch/Lot Number: EN6201), administered in Left arm on 19Feb2021 at 04:00 PM for COVID-19 immunisation. The patient experienced chills, joint aches and left arm pain on 12Mar2021 at 06:00. There was no treatment received for the events. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Approx 2" x 1" eczema patch on my calf turned from a whitish dry patch to a purple spot that looked like a very bad bruise. The purple area has slowly resided until 1 month later the area looks similar to before the injection with only a small bruised area.
Feeling deaf in the left ear/First audiology test 30% hearing loss, second audiology test after steroids hearing loss was at 50%.; Tinnitus; Wind in the ear; This spontaneous case was reported by an other health care professional and describes the occurrence of HYPOACUSIS (Feeling deaf in the left ear/First audiology test 30% hearing loss, second audiology test after steroids hearing loss was at 50%.), TINNITUS (Tinnitus) and EAR DISCOMFORT (Wind in the ear) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017E21A, 011L20A and 004M20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Hypothyroidism and Hypertension. Concomitant products included RAMIPRIL, HYDROCHLOROTHIAZIDE, AMLODIPINE, METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE MONOHYDRATE (JANUMET) and LEVOTHYROXINE for an unknown indication.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Sep-2021, the patient experienced HYPOACUSIS (Feeling deaf in the left ear/First audiology test 30% hearing loss, second audiology test after steroids hearing loss was at 50%.), TINNITUS (Tinnitus) and EAR DISCOMFORT (Wind in the ear). At the time of the report, HYPOACUSIS (Feeling deaf in the left ear/First audiology test 30% hearing loss, second audiology test after steroids hearing loss was at 50%.), TINNITUS (Tinnitus) and EAR DISCOMFORT (Wind in the ear) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Oct-2021, Acoustic stimulation tests: abnormal (abnormal) First audiology test 30% hearing loss, second audiology test after steroids hearing loss was at 50%..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient received 4 doses of steroids in the ear and it had no significant improvement. ENT suggested taking steroids by mouth.  On 18OCT2021 the ringing in the ear has improved a little and she can hear a little better but the problem hearing still exists.
Blurry and double vision in left eye; Blurry and double vision in left eye; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 44-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0169, Expiration date not reported), via an unspecified route of administration, administered in arm Left on 25Mar2021 (at the age of 44-year-old) as a single dose, and  first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8730, Expiration date not reported), via an unspecified route of administration, administered in Arm Left on 25Mar2021 12:00 (at the age of 44-year-old) as a single dose for COVID-19 immunisation at Doctor's office/urgent care. The patient had no medical history and no known allergies. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 25Mar2021, the patient had inappropriate schedule of vaccine administered. On 02May2021 19:00, the patient experienced blurry and double vision in left eye. It was reported that the patient saw an ophthalmologist but could not correct. Ophthalmologist cannot get my vision to 20/20 with any lens at all. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. On an unspecified date in 2021, the patient underwent lab tests and procedures which included eye test: cannot get my vision (Ophthalmologist cannot get my vision to 20/20 with any lens at all). The seriousness of the events was reported as non-serious. Therapeutic measures were taken as a result of blurry and double vision in left eye. The outcome of event blurry and double vision in left eye was not resolved and the outcome of inappropriate schedule of vaccine administered was unknown. Device Date was reported as 12Jul2021.  Follow-Up (15Jul2021): Follow-up attempts are completed. No further information is expected.
pt recv vax 3OCT97 & c/o soreness on 4OCt97;apparent bruising @ inj site w/noticeable white area around inj site on 5OCT97;refer to pvt MD:
After waiting the required 15 minutes after vaccine administration, patient states she felt nauseous and light headed. She was placed in chair, blood pressure taken and questions answered regarding food/drink consumed today, medical history, etc. Co-workers notified, one of which was a nurse. Patient was advised to rest in her office w/supervision and at any time if she felt she needed to leave work, she was free to do so or assistance would be provided if needed. She voiced understanding and agreed.  Later, hospital staff was notified that patient had arranged for a family member to pick her up and take her home for the remainder of her work day, as the symptoms had not yet resolved. Follow up call made at 1444. Patient reports mild nausea and fatigue. She was advised to continue to rest and hydrate. If symptoms worsen, chest pain develops, etc., she is to report to ED for eval.
PATIENT WAS GIVEN IMMUNIZATION 15 MINUTES AFTER THE TWO HOUR ROOM TEMPERATURE STABILITY TEST.  REACTION UNKNOWN DUE TO MANUFACTURER NOT HAVING STUDIES OR LITERATURE CONCERNING THIS POTENTIAL SCENARIO.
PARTIAL DOSE ADMINISTERED; LIQUID LEAKING OUT OF THE SYRINGE, NEEDLE; LIQUID LEAKING OUT OF THE SYRINGE, NEEDLE; LIQUID LEAKING OUT OF ARM; This spontaneous report received from a pharmacist concerned a 67 year old of unspecified sex. 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, batch number: 042A21A, expiry: not reported) dose was not reported, administered on 06-APR-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced partial dose administered. On 06-APR-2021, the subject experienced liquid leaking out of the syringe, needle. On 06-APR-2021, the subject experienced liquid leaking out of the syringe, needle. On 06-APR-2021, the subject experienced liquid leaking out of arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the partial dose administered, liquid leaking out of the syringe, needle, liquid leaking out of the syringe, needle and liquid leaking out of arm was not reported. This report was non-serious.
Woke up with  soreness in my hips.  Later in the day became slightly nauseous.  Both resolved by the next day.
Vaccine administered to left arm. Tingling, burning sensation in left arm, above elbow to neck area below ear. Sensation occurs approximately once every hour. Arm "falls asleep" sensation, goes limp  approximately 4 times a day.
Patient presented with rash, redness, and a knot below site of injection as well as feelings of nausea. These signs and symptoms presented immediately after the vaccine was administered.
mom states that the same day pt recvd vax broke out in red rash & had fever was taken to the MD & was told to apply DPH lotion to the rash;
Two days ago she got a rash around the injection site; now it is all the way down to her elbow; her neck is so bad and so itchy that she could just scratch all the skin off; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 02Nov2021 (Lot number: FF2593, Expiration Date: 02Nov2021) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 immunization; Bnt162b2 (2nd dose), for COVID-19 immunization. The following information was reported: INJECTION SITE RASH (non-serious) with onset 06Nov2021, outcome "unknown", described as "Two days ago she got a rash around the injection site"; RASH (non-serious) with onset 06Nov2021, outcome "unknown", described as "now it is all the way down to her elbow"; RASH PRURITIC (non-serious) with onset 06Nov2021, outcome "unknown", described as "her neck is so bad and so itchy that she could just scratch all the skin off".  Additional information: Is report related to a study or programme: Yes. "I have a consumer on the line. So, she got a booster dose of the Pfizer vaccine six days ago, two days ago she got a rash around the injection site and now it is all the way down to her elbow and her neck is so bad and so itchy that she could just scratch all the skin off. So, when you done talking with her can you please get her over to medical." "She just wants to know if it is a normal thing or not and if it is from the vaccine."  No follow-up attempts are possible. No further information is expected.
The skin at the injection site has become red, creating a large circle about 2 inches in diameter and warm to the touch.
seven patients received wrong doses of the Moderna COVID 19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (seven patients received wrong doses of the Moderna COVID 19 vaccine) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (seven patients received wrong doses of the Moderna COVID 19 vaccine). At the time of the report, ACCIDENTAL OVERDOSE (seven patients received wrong doses of the Moderna COVID 19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were provided.  It was reported that five of the seven patients received a 3rd dose instead of the booster dose, while two of the patients received a double dose of the 3rd dose.
My lymph nodes enlarged and didn't go down for many weeks; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 03Aug2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "recovered" (2021), described as "My lymph nodes enlarged and didn't go down for many weeks".  Additional Information: Patient received her 1st vaccine for Covid 03Aug2021. Her lymph nodes enlarged and didn't go down for many weeks so I never received my second shot. It is over the 42 days so should I start over again or get the second shot? When should I attempt this again? I'm so confused and nervous. Patient have issues with my lymph nodes going up and down for about 10 months now and doctors are not sure why. The vaccine made them go up for months but seems to going down a bit now. Any suggestions are appreciated. No, other important information available.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
On June 28th:  Chest pain Left arm pain Jaw pain  Was hospitalized and diagnosis was ultimately myocarditis
A report was received from a health care professional on 10/16/2003 concerning a 92 year old female vaccine who inadvertently received a accidental overdose of Fluvirin on 10/16/2003. On 10/16/2003 the vaccinee had previously been vaccinated with Fluvirin on 10/03/2003. There was insufficient information to determine the reporter's causality assessment.