chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After 15 minutes of receiving Pfizer booster shot, patient reports feeling dizzy, clammy, cold, chest pain, shortness of breath. Patient assisted to a chair initially and placed patient on her back with feet elevated. Provided water, snack and ice pack. Patient states she has not had anything to eat the whole day. Patient vital sign shows HR 130, Oxygen Saturation 99%, blood pressure 100/80. 911 called after patient oxygen level desaturated.  Provided reports to Paramedics when they arrived and took over care of her.
103.5+ temp, uncontrollable shakes, headaches, vomiting for 7 days, cough, difficulty catching breath
I fell on February 25 at the grocery store. On the 27th I ended up having Thrombosis or an infection in my right leg. I noticed my leg was really sore. I went to the urgent care and was told to keep hot compresses on it. I did and the infection went up my leg further. On March 04, I went back to urgent care and they started IV antibiotics and prescribed a course of 10 days oral. It got rid of the infection but the vein was so stretched out that I had to go see a vascular specialist. I have a follow up appointment on October 26, where they will evaluate and decide if any other veins need to be treated with additional. My vein a significantly worse now as I have been saving up to have a procedure done to help me.
10OCT sore throat; 11OCT could not talk, completely lost voice; felt bad like real bad cold; cough for several days;
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 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17May2022 at 13:15 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 11Feb2021 at 14:00 as dose 1, single (Batch/Lot number: unknown), in right arm, on 11Mar2021 at 12:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 10Oct2021 at 16:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: OMEPRAZOLE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose 02/22/21pfizer,Lot#EN6198 2nd dose: 03/15/21Pfizer,Lot# EN6207 Diagnosed covid positive:07/27/21 Symptom onset:07/25/21 Exposure:Unknown Symptoms:Cough, fatigue,sore throat
Breakthrough case admission after 3 vaccines Moderna 2/9/21 Lot# 015M20A;  Moderna 3/9/2 Lot# 032M20A;  Moderna 10/26/21 Lot# 041C21A
A report was received from a health care professional on 11/25/03 concerning a 60 year old female vaccinee who received one dose of influenza vaccine (brand unspecified) on an unspecified date in October 2003 and then inadvertently received Fluvirin on 11/25/03. In October 2003, the vaccinee received a dose of influenza vaccine (brand unspecified) and on 11/25/03 the vaccinee received a dose of Fluvirin. At the time of the report, no adverse events have been reported. There was insufficient information to determine the reporter's causality assessment. No follow up pending.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 26-SEP-2017, the patient was vaccinated with a dose of M-M-R II (recombinant human albumin) lot # L035674, expiration date 17-SEP-2017 (dose and route of administration were not provided). No adverse effect was reported.
sore arm; redness; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for Covid-19 immunisation. The patient stated that she got her second dose of the vaccine the day prior and was asking if she can be around people who she is not sure if they are vaccinated. She also asked the days she is fully vaccinated and if she can be around people who have had Covid. The patient then added that she experienced sore arm and redness after getting her vaccine but stated that she is already okay. The patient was also asking if there is a possibility that she could get a fake vaccine or a saltwater vaccine injected in her, and if she can drink alcohol after getting the vaccine. The events resolved in 2021.   No follow-up attempts are possible; information about batch/lot number cannot be obtained. No further information is expected.
Large hard swelling at site of injection, about the size of a baseball. Also to hard swellings on arm.
2 days after PREVNAR 13 she slept late (14 1/2 hrs). Mom woke her, she looked pale and vomited. When mom stood her she looked pale body went limp and starred for a couple of seconds. Vomited 5-6 xs in 1-2 hrs. Seen @ office - normal exam and was better by the pm.
When we were on our way home from the shot she said her arm felt funny and she was tired but other than that she was fine. Around 10:30 that night she came to us having trouble with her throat, that she couldn't breath when she was laying down in bed. She started to panic, that time I called the family doctor office and spoke with a physician on call. My husband already had her in the car heading to ER. When they were driving, she kept standing up and drinking a lot of water saying she couldn't breath. My husband called 911 as he was driving to the hospital. She was having trouble answering my husband back due to breathing issues. When they arrived at ER he brought her right back to the nurses and doctors, she was as cold as ice even her feet that were in boots. She was shaking and needed more water. She started to vomit and she was given ondansetron ODT, she was tested for COVID and the flu but was negative. She was still having issues with her throat after hours of vomiting(probably vomited 30 times while at the ER) she was given diphenhydramine.  She was released around 6:30am and we had to continue the Benadryl every 6 hours until Sunday.
feeling sick; sore arm; dull ringing in the ear; a lot of headaches; This spontaneous case was reported by an other caregiver and describes the occurrence of MALAISE (feeling sick), PAIN IN EXTREMITY (sore arm), TINNITUS (dull ringing in the ear) and HEADACHE (a lot of headaches) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 44B21A and 13B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced MALAISE (feeling sick), PAIN IN EXTREMITY (sore arm), TINNITUS (dull ringing in the ear) and HEADACHE (a lot of headaches). At the time of the report, MALAISE (feeling sick), PAIN IN EXTREMITY (sore arm), TINNITUS (dull ringing in the ear) and HEADACHE (a lot of headaches) outcome was unknown. Unknown          No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable.
Flu like symptoms on day after vaccine. (body aches, chills, slight fever, watery eyes) 1-30-21 Red splotchy rash on neck, upper thighs and stomach on morning of 2nd day 1-31-21 flu symptoms have gone away Taking benedryl , ibruprofen. I had same symptoms on the first dose of vaccine.  It took about a week for the splotches to go away.   The  splotches do not hurt, slightly itchy
Patient had redness and selling at location of vaccine and was treated with Hydrocortisone 2.5mg
Nausea; Severe Stomach Cramps; Diarrhea; Elevated Blood Pressure; Initial Report Received 30-Jan-2020 and 31-Jan-2020  A physician reported a 38-year-old female employee received her first injection of HEPLISAV-B (Lot #933621) in Jan-2020.  No concomitant vaccinations were administered.    Two to 3 hours after injection, the employee experienced severe stomach cramps, diarrhea, nausea, no fever, and elevated blood pressure 172/129 mmHg.  The employee was advised to seek medical attention if needed.  No treatment was administered, and all events resolved within a day.     None of the events were reported as serious.    Company comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
Within minutes of receiving the flu vaccine patient reported that she was feeling full body itchiness and mild chest discomfort.  Transported by duty vehicle to branch clinic - approximately 60 second drive.   Patient denied any trouble/difficulty with breathing or chest pain.  Epinephrine was not indicated.   Assessed by provider in clinic and was prescribed Benadryl and monitored for two hours.  Patient started feeling relief 20 minutes after taking the Benadryl.  Assessed by the provider multiple times and after two hours was cleared and released to self care.
Moderna on 3/17 and 4/14. Positive on 9/13
constant stools/ diarrhea; stomach gurgling; full of gas; No appetite; Nauseous/ in between diarrhea and normal stools; Discomfort in the left arm in the muscle; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Discomfort in the left arm in the muscle), DIARRHOEA (constant stools/ diarrhea), ABDOMINAL DISCOMFORT (stomach gurgling), FLATULENCE (full of gas) and DECREASED APPETITE (No appetite) in a 49-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced LIMB DISCOMFORT (Discomfort in the left arm in the muscle). On 13-Feb-2021, the patient experienced DIARRHOEA (constant stools/ diarrhea), ABDOMINAL DISCOMFORT (stomach gurgling), FLATULENCE (full of gas), DECREASED APPETITE (No appetite) and NAUSEA (Nauseous/ in between diarrhea and normal stools). At the time of the report, LIMB DISCOMFORT (Discomfort in the left arm in the muscle), DIARRHOEA (constant stools/ diarrhea), ABDOMINAL DISCOMFORT (stomach gurgling), FLATULENCE (full of gas), DECREASED APPETITE (No appetite) and NAUSEA (Nauseous/ in between diarrhea and normal stools) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided. No treatment information provided. The reporter did not provided a causality assessment.
Patient discharged. 73 yo F presented to hospital with nausea, vomiting, abdominal pain, cough and weakness related to COVID-19 infection as well as diverticulitis found on previous recent ER visit. She was not able to tolerate oral intake at home and could not take her medications. During her hospitalization her nausea improved and she was tolerating PO intake to her baseline. She did finish course of antibiotics with Cipro (1 dose here) / Flagyl (1 dose here) and 2 days of Ceftriaxone with excellent clinical improvement. An obstructing 5 mm stone seen at the UVJ and evaluated by Urology, recommending continuation of Flomax and close outpatient follow up without any surgical intervention this hospitalization. COVDID-19 - She did require 3 days of oxygen by nasal cannula (3 L max) but was able to be weaned off before discharge. She was discharged home with home health services.    Hypoattenuating area incidentally seen on CT - needs f/u MRI outpatient  Would recommend follow up with PCP/ wound care for chronic venous stasis wounds on bilateral lower extremities, not acutely infected in hospital  Recommend booster COVID-19 vaccine when able    Patient clinically improved and hemodynamically stable for discharge.  Discussed plan of care discharge with patient including outpatient follow-up PCP within 7 days.  She will follow-up outpatient nephrology for ongoing management of nephrolithiasis.  Patient voiced understanding was agreeable with plan of care discharge.
This spontaneous report was received from a pharmacist refers to a 60 year old male patient. On an unknown date in SEP-2014, the patient was vaccinated with ZOSTAVAX. On an unknown date in  SEP-2014, the patient experienced last of efficacy. The pharmacist stated that he had patients who had the vaccine who have had shingles. The outcome of the event was reported as recovered/resolved with sequelae. The reporter considered the event to be related to ZOSTAVAX. Additional information has been requested.
First on Saturday May 22 had sore arm, then pain that thought was possibly heartburn/indigestion, fever over 100. Took acetaminophen and tried Tums. Then on Sunday May 23 chest pain that didn't feel quite like indigestion and fever over 100. Continued acetaminophen and Tums. Monday May 24 felt like heart was fast, hot flash type feeling like could faint and some light headedness/off feeling, continued chest pain. Pediatrician prescribed omeprazole to see if helped, did EKG. Checked in on Wed May 26, no change except no fever and light headedness improving.  Referred to cardiology.
VACCINE DRAWN UP DAY BEFORE AND GIVEN AT THE 15 HOUR MARK. PER MODERNA CLIENT TO BE CALLED TO SEE IF ANY ADVERSE REACTIONS.  CLIENT DENIES ANY REACTIONS AT THIS TIME
MISERABLE LOUD RINGING IN EARS (TINNITUS); 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, route of admin not reported, batch number: Unknown) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On MAR-2021, the subject experienced miserable loud ringing in ears (tinnitus). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of miserable loud ringing in ears (tinnitus) was not reported. This report was non-serious.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Headache-Mild, Systemic: Hypotension-Mild, Additional Details: 10 minutes after receiving vaccine patient felt lightheaded and dizzy.  After being place on her back with legs elevated she started to feel better.  Her blood pressure was 101/66. Patient felt better over some time and left feeling fine.
Patient states that after receiving her second anthrax vaccination on 9 May 2007, she developed multiple nodules across deltoid to axillary region of left arm. Patient was to see provider today but did not return for appointment.
Red, Hot and Swelling from shoulder to Elbow - extended beyond elbow by afternoon and child complained of itching by evening.
Hives on her neck and face on the same side as the injection arm.; Sore arm; Injection site pain; This spontaneous case was reported by a pharmacist and describes the occurrence of URTICARIA (Hives on her neck and face on the same side as the injection arm.), PAIN IN EXTREMITY (Sore arm) and VACCINATION SITE PAIN (Injection site pain) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Hives on her neck and face on the same side as the injection arm.), PAIN IN EXTREMITY (Sore arm) and VACCINATION SITE PAIN (Injection site pain). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency. At the time of the report, URTICARIA (Hives on her neck and face on the same side as the injection arm.), PAIN IN EXTREMITY (Sore arm) and VACCINATION SITE PAIN (Injection site pain) had 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.   No concomitant medications were reported. Treatment for the events included benadryl.
On May 22, 2021 started noticing ringing in my right ear that I never had before.  I didn't seek medical attention to almost June and July!
Approximately 3 hours after getting his shots (on 4/28/15), the patient started to have an unusual inconsolable cry and irritability.  The mother checked his legs and both injection sites (R and L thighs) were minimally erythematous, but she noted unremarkable overall. The finding that surprised the mother the most was the L pretibial area (knee to ankle) that was very red, swollen, mildly tensed, appeared tender, hot to touch (celullitis-like picture), with multiple petechiae. In the L leg received 2 shots: Hib and PCV. The mother applied cool compresses, gave him Tylenol, which helped with redness/ swelling/ warmth, but more petechiae appeared later that evening. He stopped crying, fed well and then fell asleep. On 4/29 his leg looked improved but not completely resolved with same petechiae, only mild swelling, no erythema/ warmth. And he seemed happy. He has been a healthy baby so far, except for one episode of AOM requring Amoxicillin x 10 days, at approx 74 DOL.
Information has been received from a physician concerning an 11 year old male who on approx. 10/30/00, was vaccinated with MMR II and on approx. 11/5/00, the pt experienced a macular body rash and a low-grade fever. On approx. 11/6/00, he had a severe headache and was seen by his doctor. He was dx'd with aseptic meningitis and hospitalized. The child showed moderate improvement and was then discharged. He returned on approx. 11/7/00 and admitted to the hospital with encephalitis. At the time of the report, the child was in a "light" coma. The outcome of the encephalitis and renal failure was unknown. The child's experience was considered to be immediately life-threatening. In follow-up, the physician stated that the child "did not have a vaccine induced encephalitis and that the vaccine was temporarily related to the events. The child had a four fold increase in his mycoplasma titers and clearly got better on Zithromax. In fact, 4 other people in the child's family had a cough. I can not say strongly enough that this is clearly not associated with the MMR II vaccination." Subsequently, the pt recovered from his experience. Additional information has been requested.
Headache, muscular ache, fatigue up to and including 2 weeks after vaccine
Mast cell disease; Shortness of breath; Dizziness; Palpitations; Vertigo; Allergic reaction; Weird feeling; Pruritus; This spontaneous case was received on 12-Mar-2021 from other non-health professional via Med Communication (reference number: SEQW21-00979) and concerned female patient of an unknown age.  The patient's medical history and concomitant medications were not reported.   On 27-Oct-2018, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml; route of administration and anatomical location: not reported) for prevention of seasonal influenza. The batch number reported was 252674 and expiry date was 30-Jun-2019.  On the same day, after receiving Flucelvax Quadrivalent, the patient had had an allergic reaction. She experienced shortness of breath, dizziness, palpitations and also vertigo, 'a weird feeling' and pruritus.   On an unknown date in 2018, the patient was treated with Benadryl (diphenhydramine hydrochloride) and 'some other stuff'. It was reported that the patient was not hospitalized.   On an unspecified date, all of these things caused mast cell disease as reported.  The outcome of the events was not reported.  The reporter did not provide a causality assessment.  The event of 'mast cell activation syndrome' was considered to be medically significant by a Physician.  Company comment: A patient of unreported age was vaccinated with Flucelvax Quadrivalent. On the same day, after receiving Flucelvax Quadrivalent, the patient experienced allergic reaction, dyspnoea, dizziness, palpitations, vertigo, a weird feeling (Feeling abnormal) and pruritus. On an unspecified date, these events caused mast cell disease as reported. Causal role of the suspect vaccine is assessed as possibly related for all events. Per Brighton collaboration criteria, presented information correspond to level 3 diagnostic certainty for anaphylaxis.; Sender's Comments: A patient of unreported age was vaccinated with Flucelvax Quadrivalent. On the same day, after receiving Flucelvax Quadrivalent, the patient experienced allergic reaction, dyspnoea, dizziness, palpitations, vertigo, a weird feeling (Feeling abnormal) and pruritus. On an unspecified date, these events caused mast cell disease as reported. Causal role of the suspect vaccine is assessed as possibly related for all events. Per Brighton collaboration criteria, presented information correspond to level 3 diagnostic certainty for anaphylaxis.
This spontaneous report was received from a registered nurse referring to an 11 year old female patient. The patient's concomitant medication, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 11-SEP-2017, the patient was vaccinated with either GARDASIL lot # N000326, expiration date 14-OCT-2019 or GARDASIL 9 lot # N000326, expiration date: not reported (strength, dose, dose number and route of administration were not provided) for prophylaxis which were improperly stored. This is one of several reports received from the same source. Sender's Comments: US-009507513-1709USA008666.