chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Crying and screaming for 3 hrs or more after 1st set of vaccinations starting 3 1/2 hrs after administration. Mom called me. She was advised to give 0.4cc of acetaminophen and continue every 6 hr, patient was fine thereafter
pt recvd vax 16SEP93 & on 23SEP sl swelling of thighs & feeling of skin tightness; 27SEp limping secondary to rt knee swelling; 30SEP rt lower extremity weakness requiring cane, then crutches to walk; 5OCT hospitalized; MRI; dx trans myelit
VTE legs, large intestine, & lungs  Narrative:  Patient reports received his first COVID vaccine dose of Moderna on 2/17/21 and reports in the early morning of 2/23/21 he began feeling pain in his right side. Patient states he thought his appendix had burst and he went to get checked out. Patient states they ran test and could not determine what was wrong, so he was sent to hospital. Patient states they found clots in his legs, large intestine, and lungs. States he underwent surgery to remove the clot from his large intestine and he now on Eliquis. Patient states he was "perfectly healthy" before receiving the COVID vaccine. Active meds: Ibuprofen 800mg TID for pain, Lidocaine 5% patch; 1 patch daily for 12 hours, and Sodium fluoride 1.1% oral cream; apply to mouth 1-2 times daily when brushing teeth
No Treatment / no adverse event / vaccine was administrated outside Moderna's storage and handing recommendation  as outlined in the fact sheet for health care providers
patient received 1st dose of Menquadfi  ( received menactra on 12/28/16).  After vaccination, patient stated: he felt dizzy and started to turn pale. Subsequently, turned bright red, limbs became stiff started to slide off seat, leaning over, shaking and eyes rolled back.   patient resumed consciousness after 25 seconds. No memory of incident. Patent remembered getting vaccine and stating dizziness and stated he closed his eyes and heard the alarm to wake up to find nursing staff and provider surrounding him .   patient was transported to local ED with parent after provider  assessment.
Right arm was swollen and itching 2 days after. Then Sunday morning, my back was broke out in a raised red rash with pimples. Took BENADRYL and redness went away.
Intense joint/muscle pain returned the same night, beginning in injection site and spreading to hands/legs/back by the next morning. Began taking the normal treatments for chronic inflammation yet again (meloxicam, turmeric, and Epsom salt soaks). It has yet to resolve or lessen. Began to develop a headache ~8/2 that did not go away, but instead grew until it was so severe 8/5 I could barely do my job and 8/6 I had to leave work early because I could feel my pulse in my eyeballs. Could not take other NSAIDs for it while still taking meloxicam for joint/muscle inflammation. Evening of 8/6 also saw me developing a fever that continues to fluctuate between 99 and 101 degrees. Stopped meloxicam 8/6 in order to take an NSAID that would also help the fever. Currently lying in bed on 8/7 with severe body aches, fever of 100.8, severe headache and dizziness.
Heart pain - feelings of heart  attack, heart flutters, heavy weight on chest, light headed, shortness of breath, tired/exhausted, sleepless nights
The pt reported fever, pain, redness and heat to his right biceps 48 hours after injection.
My son was perfectly fine before receiving his shots the night of 4-19-21 he spiked a fever and slept a lot I assumed it was because he get shots then as the days went on he was getting worse and now today he is so sick I had to take him to the emergency room because he is throwing up has liquid poop that just comes out to the point he dose not even have to push he is having very high fevers sleeping a lot can?t stay awake won?t eat or drink anything and keep in mind he was completely fine till he got the shots he received on Monday
patient inadvertently received a fourth dose of GARDASIL 9 as a medication error as the dose was intended for sister; This spontaneous report was received from a nurse and refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapies were not provided.  On 02-MAY-2019, the patient sister inadvertently received a fourth dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, route and vaccination site were not provided), with a lot# of R011630 and expiration date of 12-DEC-2020, for prophylaxis as a medication error as the dose was intended for the patient's relative that came in at same time for an office visit.  This is one of two reports form the same reporter.; Sender's Comments:  US-009507513-1905USA003273:
Vaccinated pt (per family) admitted with covid infection. Unknown vaccine manufacturer/date/time/place etc.
Information has been received from a 76 year old female who was allergic to XYLOCAINE and BENADRYL and no pertinent medical history, who in October or November of 2007 was vaccinated with "one shot" of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included lisinopril (manufacturer unknown), LIPITOR, calcium (unspecified) and BELLASPAS. It was reported that within 24 hours of the shot the patient's left arm swelled up and she reported that she couldn't even get out of bed for days. The patient reported that a "couple of days after the shot she recovered." The patient sought medical attention and reported that she went back to her doctor. There were no laboratory studies performed. No additional information was provided. Additional information has been requested.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's concurrent condition, medical history and drug reactions/allergies were not reported. Concomitant therapies included sterile diluent(STERILE DILUENT). On 15-FEB-2018 the patient was vaccinated with one dose of improperly stored VARIVAX (lot # N023960, expiry date: 01-SEP-2019), (dose, frequency and route were not reported) for prophylaxis. No adverse effects reported. Product quality complaint was not involved. VARIVAX was exposed to temperature of 6 degree Fahrenheit (F) to 14 F for 36 minutes. There was no previous temperature excursion reported. The digital data logger was involved.
Lot of congestion; Entire upper right side of her body hurts; Loses sensation when she picks up her phone; Lymph nodes hurts a lot; Headache; A spontaneous report was received from a 26 year old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pain in lymph nodes, headache,  a lot of congestion, upper right side of her body hurts and she loses sensation when she picks up her phone.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 23 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly, in her right deltoid, for prophylaxis of COVID-19 infection.   On 27 Dec 2020, the patient stated that her lymph nodes hurt a lot, she had a headache, a lot of congestion, her entire upper right side of her body hurts and she loses sensation when she picks up her phone. It has been a week and it still hurts. She took paracetamol for the same and guaifenesin for the congestion, which seemed to help a little bit.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the events, lymph node pain,  headache, congestion, her entire upper right side of her body hurts, she loses sensation when she picks up her phone, were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
UTI symptoms - pain; urgency; frequency; urinalysis showed blood; elevated WBC & RBC; antibiotic: nitrofurantoin 100 MG 2X day. Gross hematuria - visible in toilet; urinalysis confirmed. Diarrhea - 3 days.
dose number=3; "My" arm has been sore since November at the site of the i he run. The injection site is still tender.; In addition, "I" have pain in the arm now which "I" did not have before I took the vaccine.; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.   A 50-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Nov2021 at 16:00 (Lot number: unknown)at the age of 50 year(s) as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Sulfonamide allergy" (unspecified if ongoing), notes: Known allergies: Sulfa. Concomitant medication(s) included: TRINTELLIX; PHENTERMINE; LUNESTA and LEVOTHYROXINE. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: Unknown; Anatomical Location: Left arm; Route of Administration: Unspecified; Time of Administration: 16:00), administration date: 05Mar2021, when the patient was 49 year(s) old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot Number: Unknown; Anatomical Location: Left arm; Route of Administration: Unspecified; Time of Administration: 16:00), administration date: 26Mar2021, when the patient was 49 year(s) old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 20Nov2021 at 16:00, outcome "unknown", described as "dose number=3"; VACCINATION SITE PAIN (non-serious) with onset 20Nov2021 at 16:00, outcome "not recovered", described as ""My" arm has been sore since November at the site of the i he run. The injection site is still tender"; PAIN IN EXTREMITY (non-serious) with onset 20Nov2021 at 16:00, outcome "not recovered", described as "In addition, "I" have pain in the arm now which "I" did not have before I took the vaccine". The events ""My" arm has been sore since November at the site of the i he run. The injection site is still tender." and "In addition, "I" have pain in the arm now which "I" did not have before I took the vaccine." were evaluated at the physician office visit. Therapeutic measures were not taken as a result of vaccination site pain and pain in extremity.  Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Left arm where IPV and DTAP were given, very red and swollen from upper arm to elbow. Swollen area is hard and arm is warm to touch. Mom states has been running a fever. Child is complaining of itching. Called on 4/11/01 and mom stated no complaint of itching, swelling or redness but some fever. Saw Pediatrician on 4/10/01 and dx'd severe local reaction. No treatment given and to return if worsens.
Information has been received from a health professional concerning a now 7 year old male who on 12-JUL-1996 was vaccinated, 0.5mL subcutaneously in his left leg, with varicella virus vaccine live (Oka/Merck) (lot# 617073/1662B). On 19-JUN-2002, the patient experienced breakthrough chickenpox on his face, chest, and back. Symptoms were relieved with Tylenol and Benadryl. Subsequently, the patient recovered from breakthrough chickenpox. Additional information has been requested.
fully vaccinated plus booster listed above- all doses Moderna tested as part of follow up to known exposure- tested positive on binax rapid antigen test 1/9/22 asymptomatic has prev hx covid infection 11/30/2020
She took rapid Covid test on Sunday 11/28 and the results were positive.; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (She took rapid Covid test on Sunday 11/28 and the results were positive.) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 50 mcg. On 28-Nov-2021, the patient experienced COVID-19 (She took rapid Covid test on Sunday 11/28 and the results were positive.). At the time of the report, COVID-19 (She took rapid Covid test on Sunday 11/28 and the results were positive.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Nov-2021, Body temperature: 102 (High) 102 Fahrenheit. On 28-Nov-2021, SARS-CoV-2 test: positive (Positive) positive.   No concomitant medications were reported  No treatment medications were reported Company comment: This is a spontaneous case concerning a 58-year-old, female patient with no medical history reported, who experienced the non- serious unexpected, according CCDS, AESI of COVID-19. The event COVID-19 occurred approximately five days after the third dose of mRNA-1273 vaccine.  The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-399707 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Dec-2021: Follow up received contains patient initial ,DOB and new event  and lab data.; Sender's Comments: This is a spontaneous case concerning a 58-year-old, female patient with no medical history reported, who experienced the non- serious unexpected, according CCDS, AESI of COVID-19. The event COVID-19 occurred approximately five days after the third dose of mRNA-1273 vaccine.  The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Flu-like symptoms: 100.4 degree fever, headache, body ache, chills, weakness
Extreme fatigue and passed out in the shower.  Spent entire day in bed.  Felt fine the next day.
Patient received PENTACEL, PREVNAR 13, hepatitis B vaccine, flu vaccine on 3/9/12 in am. After about 12-15 hours, pt developed fever 1-3.5 and generalized seizures for about 2 mins. brought to ER, diagnosed w/ febrile seizure, possible side affect of vaccines; discharged home in few hours; no further seizures since then.
no adverse effect; administration of one dose of an improperly stored vaccine, ROTATEQ, to one patient; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications and drug reactions/allergies were not reported. On 05-NOV-2019, the patient was vaccinated with a dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) vaccine, 2 millilitre, given once via route defaulted to oral for prophylaxis (lot # S005874 and expiration date: 31-OCT-2020) (product storage error). The administered dose of the vaccine experienced temperature excursion at 9.1ºC for a timeframe of 22 minutes. There was no previous temperature excursion. The call was due to digital data logger. No adverse effects were reported. The outcome of product storage error was unknown.
Observed a rash on (L) arm heaviest at site of vaccination; slowly making down to wrist. Itchy if touched.
Sore arm, headache. Became intense within 4 hours. Helped by naproxen.
This spontaneous report as received on 20-APR-2017 from a registered nurse which refers to one patient (age and gender unknown) who received an unspecified dose in PROQUAD (Lot number M038862, Expiration date 13-MAR-2018) immunization series that was improperly stored. The patient's pertinent medical history, current conditions and concomitant medications were not reported. The excursion details reported: The vaccine, PROQUAD (Lot number M038862, Expiration date 13-MAR-2018) was exposed to the Temperature (reported in Fahrenheit (F)) between 6F-14F for the time frame of 18.5 hours plus between 15F-46F for the time frame of 49.15 hours plus 47.8F (between 47F to 77F) for the time frame of 26.25 hours. There were no previous temperature excursions. The call was because of a data logger. No adverse effects reported. No additional information was provided. Additional information has been requested. This is one of two reports from the same reporter.
Heart Attack(03/28/2021), Cognitive issues started soon after that, Severe headaches (TAC-PH) started after dose #3, Still having cognitive issues (Executive Disfunction), and daily (all-day)headaches, confusion, brain fog, Tinnitus, Bright light sensitivity, R-Ear Pressure and pain, R-Eye Pressure, Right Nostril runny nose, Joint Pain
1Nov2021, 12 Nov saw the rash, it was itchy by my neck. 13Nov2021 burning rash like hives in the evening on scalp, 14nov it spread on neck, chest, breast and belly, and on right ear. Started scratching and scabbed edotgraphifism. Not on my arms or legs. 14Nov went to doctors, took antihistamine and took Zyrtec for 5 days, 16Nov saw a dermatologist, it could be the vaccine. The rash is starting to come back if I didn't take Zyrtec (5days). PT was breast feeding.
Rash on her left arm; "Moderna arm" [Rash]; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash on her left arm; "Moderna arm" [Rash]) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Dyskinesia and Parkinson's disease. Concomitant products included AMANTADINE HYDROCHLORIDE (GOCOVRI) from 30-Jan-2018 to an unknown date for Dyskinesia and Parkinson's disease.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE RASH (Rash on her left arm; "Moderna arm" [Rash]). At the time of the report, VACCINATION SITE RASH (Rash on her left arm; "Moderna arm" [Rash]) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Treatment medications was not provided by the reporter   This case was linked to MOD-2021-223796 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Apr-2021: Follow up report included no new information
Patient got vaccine at 1515. She stated at approximately 1545 that her throat was tingly and that her head was fuzzy. She was taken back to triage and was put on a cot. She was having difficulty speaking and breathing. Her face was grey and lips were blue. Epinephrine was given at 1552. Blood pressure was 90/70. Another dose of Epinephrine was given at 1557. Each dose of Epinephrine was 0.3mg. Emergency medical services came and administered 50 mg of IV Benadryl and when she left with EMS in route to the hospital, her blood pressure was 158/84. Her heart rate was 102.
Slight tenderness on deep palpation - 8/29/11. 8/27/11 on Lt arm increased swelling & redness per Dad.
Information has been received from a health professional concerning a 10 year old female with asthma, egg allergy since 1992 and peanut allergy and a history of tachycardia who on 08/10/1995 was vaccinated with a dose of varicella virus vaccine live. Concomitant therapy included Serevent and Pulmicort for her asthma. On approximately 01/21/2002 the pt experienced a fever and "spots." The pt was seen in the office on 01/24/2002 with 150 itchy vesicles. The pt was treated with calamine lotion, aveeno and Tylenol prn. Additional info has been requested.
0.5ml H1N1 vaccine was given to a 9 mo old instead of 0.25ml.
Pt felt pain w/inj.About 10 minutes later felt warm sensation from left jaw line, left arm and left torso. Pt given one Benadryl capsule. Sytems subsided with in a half hour. During that time pt. went from hot to cold,then normal feeling.
Vesicular rash in the T9 dermatome, right abdomen and right back, consistent with shingles.
STABLE ANGINA ACUTE PULMONARY EMBOLISM 5/11/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
PT DEVELOPED A 1 CM AREA OF ERYTHEMA AND EDEMA,(POSS STERILE ABSCESS) WHICH PERSISTED 4 WEEKS FOLLOWING INJECT. OF TETANUS AND DIPHTHERIA TOXOIDS ADS.LESION WILL BE DRAINED BY FLANAGAN TO DETERMINE IF STERILE ABSCESS.
Patient experienced bleeding but more so immediate swelling and bump at the injection site. Pressure applied for 5 minutes, no excessive bleeding however excessive bump present under skin.
Patient returned after her injection with complaints of redness and warmth about her face. She did have erythema covering her nose, cheeks and chin. She is not having any shortness of breath, difficulties breathing or any swelling. She was observed for 30 minutes and returned with no change in symptoms. She was advised to take Zyrtec 10 mg when she gets home and to seek urgent medical attention if her symptoms worsen or if any new symptoms arise.
Patient was scheduled for booster dose 1 week and 2 days early. The MA and doctor did not review the vaccine record correctly and the patient was given the booster too early. The patient was informed and is doing well with no adverse signs and symptoms. The patient will return to the office in another 8 weeks to repeat the booster dose.
Vaccination site gota nod; Injection site itching real bad; injection site swelled back up; Hot injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot injection site), VACCINATION SITE NODULE (Vaccination site gota nod), VACCINATION SITE PRURITUS (Injection site itching real bad) and VACCINATION SITE SWELLING (injection site swelled back up) 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 28-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form(s). On 05-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Hot injection site), VACCINATION SITE PRURITUS (Injection site itching real bad) and VACCINATION SITE SWELLING (injection site swelled back up). On an unknown date, the patient experienced VACCINATION SITE NODULE (Vaccination site gota nod). At the time of the report, VACCINATION SITE WARMTH (Hot injection site), VACCINATION SITE NODULE (Vaccination site gota nod), VACCINATION SITE PRURITUS (Injection site itching real bad) and VACCINATION SITE SWELLING (injection site swelled back up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This spontaneous report as received from a nurse refers to a 7 year old female patient. It was reported that patient was not using concomitant medications and no medical history and no concurrent conditions. The reporter stated that patient was vaccinated with first dose of VARIVAX (Merck) on 28-JUL-2008. On 18-SEP-2012 the patient was vaccinated with second dose of VARIVAX (Merck) lot number G007850, expiration date 31-AUG-2013. The physician stated to the nurse that patient had spots on her arms and face on 01-MAY-2014 and that physician diagnosed as chickenpox. It was also reported that no treatment was given. The outcome of chickenpox was reported as recovered/resolved on an unspecified date. It was reported that Varicella zoster virus identification program (VZVIP) packet was declined. No product quality complaint was involved. Additional information has been requested.
Shortness of breath, chest pain, high blood pressure and BPM, fever, chest pounding
Site: Pain at Injection Site-Medium, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe