chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My sister who had been traveling, came to stay with me. She had a bit of a cough, but we didn't think much of it until it had lasted around 3 days. At that point, on 10/12/2022, we each tested ourselves for COVID-19 and were positive. I contacted my doctor and had a phone consultation. He called in a prescription for PAXLOVID. I began taking that the day after I tested positive. I was feeling really tired but couldn't nap. I had a lot of head congestion and an unproductive cough. However, after the five days of the PAXLOVID, I was feeling fine. I continued to mask for the following five days. I did still have some congestion but was feeling good. After the additional five days of isolating, I felt much better and was able to go to the grocery store. After the recommended isolation time, I tested myself again and was negative. Three days after testing negative, I wanted to go see my elderly mother, so I tested myself again and I was actually positive. I went to my doctor's office to do a drive thru COVID-19 test and it was also positive. Two days before I tested positive again, I had spoken with my doctor who told me that it sounded like I was developing bronchitis. He called in a Z PAK and prednisone which I took to completion. When I tested positive again, my doctor told me that I could not take the PAXLOVID again, so he suggested a cold and flu medication and MUCINEX. 12 days after testing positive again, I was feeling better and tested negative again. I am still feeling a bit of fatigue in the evenings, but I am very active. Also, through all of this illness, I have not been able to sleep well. I have been tired, but unable to sleep through the night. I will sleep for a few hours and wake up and have trouble going back to sleep. Last night was the first night in some time that I was able to sleep for 5-6 hours straight.
Unusual headache, Early start of menstrual cycle (2 weeks); delayed swelling of left arm with rash
Around 10:30pm my roommates heard me make a weird noise and it was funny part of the movies and I wasn?t responding. They notice that the right side dropping, and I couldn?t move that side. They called 911 and they fire department showed up first and kept asking about a coke habit that I don?t or have I ever had. It was very frustration because I didn?t really understand what was going on. They kept asking me question, but the right side wasn?t responding. The first responders finally arrived and were very irritated by the lack of care and the major concern for the coke habit that again I don?t have nor have I ever. I was finally takin into a chair, and they started taking me down the steps and it was 3 flights. I was taken to the closest hospital and was given TPA which they give within 3 hours of a stroke The doctor was doing the stroke evaluation and I was so surprised that one arm moved when I thought they should both move. I starts getting some of my mobility back and I was then taken to another hospital that specialized in Strokes. These tests were repeated throughout my visit which was 24 hours that was required for all stroke patients.
pt recv vax & felt severe pain @ inj site;no redness, swelling;lt arm cont to hurt when using arm or raising arm;5/10 on scale of 1-10;Ibuprofen taken w/some relief;
Shingles diagnosed 5/27/22.  Rash, horrible itching and pain.
SICK AS A DOG FOR 2 DAYS; ARM HURT BAD; LEFT PECTORAL MUSCLE HURT BAD; This spontaneous report received from a patient via a company representative 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 02-APR-2021 to left arm for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On APR-2021, the subject experienced sick as a dog for 2 days. On APR-2021, the subject experienced arm hurt bad. On APR-2021, the subject experienced left pectoral muscle hurt bad. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sick as a dog for 2 days on APR-2021, and the outcome of arm hurt bad and left pectoral muscle hurt bad was not reported. This report was non-serious.
04/14/2021 fever, weak, could not stand up. I had sniffles, headache, body aches all over, slight cough. The next day I was fine. On 04/15/2021 Heart rate went up slightly to 72-resting rate. On 05/06/2021 -06/07/2021 Resting Heart rate increased from 67-89 bpm gradually over this time period. From 06/07/2021 it slowly went down gradually to 08/10/2021-I went from hyperthyroid to hypothyroid.
The morning after the first dose I woke up with facial swelling.  Severe sinus drainage, a sore throat, and minor coughing.  Lymph nodes swollen throughout body.  Later in the date the injection site swelled, became red.  It has been itching  continuously for the last 3 weeks.  Also, since the vaccine when I've been bitten by mosquitos, the bite becomes highly inflamed and sore to the touch.  Almost like a chicken pox.  Digestive issues also started, with diarrhea nearly every day since the first dose.    I missed my period, with my menstrual cycle being delayed two weeks.  Once it did come, it was much heavier than normal.  My lymph nodes are still swollen, especially in my groin area.  I am due for my second dose tomorrow, but don't know if I should still get it with the adverse symptoms of my first dose still very much present and affecting me.
LOCALIZED WARMTH AND ERYTHEMA IN AREA OF INJECTION.   MOTRIN AND COLD PACK FOR THE NEXT COUPLE OF DAYS AND FOLLOW-UP IN ONE WEEK SOONER IF HE GETS WORSE.
Within 10 min of the vaccine,  I was very itchy at the injection site. I had typical muscle soreness and fatigue later that day, but continued to be itchy and developed a rad circular rash at the site within a couple of hours. I thought it was just a site reaction. Upon awakening the following day (1/7/21), the rash had formed a hive at the injection site. Being a nurse, I had my physician coworkers examine it. They confirmed a hive and recommended antihistamine. I took a Zyrtec, but the hive only increased in size, redness, itchiness. The area remained there through Saturday (1/9). No redness, only some itchiness to report. Then, Wednesday evening (1/13), I noticed my left arm was increasing itchy. Resisting the urge to scratch, I went to take a shower. While changing, I found the hive had returned, bigger in size and more red. I took Benadryl. Getting checked by my coworker physicians the following morning,  they confirmed  it was a hive. The redness, swelling, and itching increased throughout the day and lasted for 3 days. I took Benadryl around the clock until my skin color returned to normal (1/17)..
VACCINE WAS GIVEN TO THE 17.5 YEARS OLD PATIENT; OFF LABEL USE; This spontaneous report received from a pharmacist concerned a 17 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 203A21A expiry: 23-JUN-2021) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-MAY-2021, the subject experienced vaccine was given to the 17.5 years old subject. On 26-MAY-2021, the subject experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine was given to the 17.5 years old patient and off label use was not reported. This report was non-serious.
Started shaking about 90 minutes after the shot, pain throughout the body, migraine splitting headache, diarrhea and nausea, dizziness, loss of appetite, skin rash and itchiness throughout the body
Very  very bad headache  and dizzy for 2 days now.. The headache is very bad! :(
red hot spot around injection site swelling itching have not sought treatment. have an unexpected result have not had to use any sinus meds forn las 5 days
Runny nose; Running low grade fever 99.2; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny nose) and PYREXIA (Running low grade fever 99.2) 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 23-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RHINORRHOEA (Runny nose) and PYREXIA (Running low grade fever 99.2). At the time of the report, RHINORRHOEA (Runny nose) and PYREXIA (Running low grade fever 99.2) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.2 (Low) 99.2.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient thought runny nose may be due to allergy.  Concomitant product use was not provided by the reporter.  No treatment information was provided.
Shoulder replacement; Chest cold; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (Not Available). The reporter is the patient. Other Case identifier(s): 21K-163-4187943-00.  A 76 year-old male patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) at the age of 76 years as dose number unknown, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SHOULDER ARTHROPLASTY (medically significant), outcome "recovering", described as "Shoulder replacement"; LOWER RESPIRATORY TRACT INFECTION (non-serious), outcome "recovered", described as "Chest cold". On unknown dates, the patient experienced SHOULDER REPLACEMENT and CHEST COLD. On an unknown date, CHEST COLD resolved. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. The patient reported that he had shoulder replacement surgery and contracted chest cold. It was unknown if she was enrolled in a Covid-19 Vaccine Trial. She received COVID-19 Vaccine manufactured by Pfizer/BioNTech. The action taken for adalimumab was unknown. Causality for HUMIRA (ADALIMUMAB): The reporter's causality for the event(s) of SHOULDER REPLACEMENT and CHEST COLD was not provided.  opinion is that there is no reasonable possibility that the event of SHOULDER REPLACEMENT is related to HUMIRA(ADALIMUMAB).  opinion is that the event of CHEST COLD is not assessable. Causality for BNT162B2: Shoulder replacement (Shoulder arthroplasty), Causality as per reporter (Drug/Vaccine): Possible; Chest cold (Lower respiratory tract infection), Causality as per reporter(Drug/Vaccine): Possible.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available and temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Local swelling/redness and vesicular lesion noted at site of MMR. This began 2 days after vaccine given.
Nurse attempted to administer a FLUZONE QIV NP pre-filled syringe into a patient's right arm and all of the medication leaked from the barrel of the syringe onto the patient's arm with no reported adverse event; Initial information received on 07-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 38 years old female patient and the  nurse attempted to administer a fluzone qiv np pre-filled syringe into a patient's right arm and all of the medication leaked from the barrel of the syringe onto the patient's arm with no reported adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 07-Oct-2022, the patient received a dose of 0.5 ml of suspect INFLUENZA QUADRIVAL A-B VACCINE (formulation: prefilled syringe, strength: unknown) lot UT7689JA, expiration date: 30-Jun-2023 via intramuscular route in the right arm for Influenza.  On 07-OCT-2022 the nurse attempted to administer a fluzone qiv np pre-filled syringe into a patient's right arm and all of the medication leaked from the barrel of the syringe onto the patient's arm with no reported adverse event (accidental exposure to product) same day following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Administering Nurse states that the needle did not click as it normally does when applied to the pre-filled syringe. Patient did not receive any of the dose and FLUZONE QIV NP was re-administered. Leaking occurred during injection and from the bottom of the syringe barrel. PTC First Noticed : 2022-10-07 .PTC assessment medical/Physical : Medical  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (Nurse attempted to administer a FLUZONE QIV NP pre-filled syringe into a patient's right arm and all of the medication leaked from the barrel of the syringe onto the patient's arm with no reported adverse event).  At time of reporting, the outcome was Unknown for the event.    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.
Shortly after vaccination, while waiting here the required 15 min, patient developed symmetric blotchy flushing of chest and upper arms, and upper back, and face. Redness spared her bathing suit lines interestingly, and flushed on sun-exposed areas of chest only. She C/O being hot. She denied itching. Temp normal. Pulse OX 100% and remained so with continuous monitoring. HR 90-92. Lungs CTA. Heart with RRR. OP normal except the previously known tonsillolith. Exam repeated several times over the next hour and remained the same except for a gradual resolution of the flushing. Pt never developed cough, or shortness of breath. She had brief nausea, which resolved. No emesis. We gave 25 mg oral BENADRYL immediately - around 12:05 PM. Pt was observed in office for 30 min or so without resolution. Pt C/O legs hurting. Once pt stated her throat felt funny, then said it did not. After D/W MOC, I called for EMS transport to hospital for further monitoring and EKG. By the arrival of EMS 15 min later, patient was feeling better and flushing was resolving. EMS evaluated her, vitals were normal, and determined pt did not need EMS transport and that pt stable and could go to ER by car, or even go home for observation. Mom reports that patient had a lemonade and donut prior to vaccines, but had not had lunch. We monitored pt another 30 min and she remained stable, with resolution of Sx. Tolerated a POPSICLE and several glasses of water. O2 sats remained 100%. By 1 PM pt had remained stable at her baseline. Denied Sx. Flushing resolved. BP 110/70, HR 90, O2 sat 100%. Lungs CTA and heart with RRR. Pulse strong. Family elected to go home rather that the ER.
This spontaneous report was received from a pharmacist regarding two unspecified infants of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On 19-JUN-2015, the patients were vaccinated with an improperly stored dose of RECOMBIVAX HB (dose and route of administration were not reported, lot number K010535 with expiration date 27-AUG-2016 or lot number K020216 with expiration date 17-SEP-2016). There were no adverse effects reported. This is on of several reports received from the same reporter. Additional information has been requested.
Left thigh - injection site reddened and firm, 10 cm x 8 cm Rx Benadryl syringe 1 tsp 96-98 for 1 week and EES 250 g tid - 1 week
fussy, w/o temp, vomiting, sz, inxonsolable crying; no anaphylaxis;
A patient received improperly stored vaccine; This spontaneous report as received from a medical assistant concerning a patient of unknown age and gender. There was no information regarding the patient's medical history, concurrent conditions or concomitant medications.  On 23-APR-2019, the patient was vaccinated with a dose of improperly stored hepatitis a vaccine, inactivated(VAQTA) lot # S002459 with expiration date of 15-MAY-2020 (route of administration and anatomical location were not reported),  for prophylaxis, which was stored in the range of 52.5 Fahrenheit degrees for 4 hours and 40 minutes. There was no previous temperature excursion.  Digital data logger was involved.
Information has been received from a health professional, via a company representative, concerning a female patient who was vaccinated with a dose, 0.5ml, of Gardasil vaccine (yeast) (date not specified). It was reported that the patient "developed auto immune disease soon after the injection." The patient sought unspecified medical attention. No further information is expected.
Partial dose was given in left arm. Vaccine was noted to be dribbling down the arm to her elbow, from the injection site.
INJECTION ARM AND SHOULDER ARE SORE TO THE TOUCH AND CAUSE PAIN TO MOVE.  INJECTION SITE IS WARM TO THE TOUCH.
patient passed out after 5 minutes of taking the flu shot. I raised his legs up and he was breathing.  His pulse was99. called 911 .His blood sugar and pressure were checked and then he was fine and went home.
0915-Called to 30 minute observation. MD responded. Pt feeling nauseous . Walked back to first aid station. Ate breakfast this morning. 0920-99%, 80HR, rates GERD @7/10 0925- 122/87, had nausea with 1st vaccine 0928-tearful, feeling more heartburn, 0945- Able to tolerate water with a couple of goldfish crackers 0950-Pt requesting to go home. States she is feeling, "much better" rates GERD @ 3/10.  Cleared by MD. Mother at side will stay with pt today. Discharged with instructions or when to go to ER and symptoms to look out for. MDX: Renal reflux with birth- mentally delayed, GERD Allergies: seasonal, nitro
After receiving my first booster of Moderna on 10/29/21 I began to notice shakiness and small tremors in my right foot and fingers on both hands (mainly right side) on occasion. I also received a 2nd booster of Pfizer on 6/3/2022 and noticed an increase of the tremors progressively getting worse. I will be seeing a neurologist but I'm concerned because I had no issues before the vaccines and now I do.
I felt a bit worse after the second shot, but still not too bad; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 21 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Feb2021 14:00 (Batch/Lot number: unknown) at the age of 20 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: IBUPROFEN; BENADRYL. Vaccination history included: Bnt162b2 (dose number-1, lot unknown-True,, lot unknown reason-Unable to locate or read the details,, administration date-19Jan2021,, administration time-02:00 PM,, vaccine location-Left arm), administration date: 19Jan2021, when the patient was 20 years old, for Covid-19 immunization. The following information was reported: FEELING ABNORMAL (non-serious), outcome "not recovered", described as "I felt a bit worse after the second shot, but still not too bad". Therapeutic measures were not taken as a result of feeling abnormal.  Additional information: The patient receive any other medications within 2 weeks of vaccination includes Ibuprofen, Benadryl . The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. Patient had no allergies.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
5/3/04 at 8:45 OV left upper arm deltoid red, warm to touch , slightly swollen. Dad stated noticed 5/1/04 left arm red and swollen; applied ice pack right upper arm some redness. None noted today at right arm. Dad denies fever but rash 5/1/04 after getting out of tub. rash noted left arm inside of elbow area. Dad said was dermatitis. Child no c/o's with when arm moved hurts. Child normal behavior per dad. Eyes red and swollen underneath. 5/5/04 pl arm better. Eyes slightly red underneath.
Hospitalization for acute respiratory failure and pneumonia from COVID-19  on dates 1/21/2023-  2/9/2023. Treated with  baricitinib, Remdesivir, vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
This spontaneous report has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not reported. On unknown dates, the patients were vaccinated with improperly stored PROQUAD (lot # M044020 / expiration date 01-MAY-2018, lot # N013268 / expiration date 25-NOV-2018, dose and route were not reported) for prophylaxis, which was reconstituted with sterile diluent (lot # and expiration date were unknown). The vaccine was exposed to temperature excursion between 6 degrees Fahrenheit for 2.5 hours and 6.2 degrees Fahrenheit for 1 hour. There was no previous temperature excursion and the data logger was involved. No adverse symptoms were reported. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1708USA003262: US-009507513-1708USA012210: US-009507513-1708USA012211: US-009507513-1708USA012212: US-009507513-1708USA012214:
Information has been received from a nurse concerning a 25 year old female who on 13-NOV-2007 was vaccinated (site and route not reported) with the 1st dose of the Gardasil vaccine (lot #655154/1210U). Subsequently, after receiving the 1st dose of Gardasil vaccine the patient complained of pain in her arm that lasted for 2 weeks and being unable to raise her arm. The patient did receive unspecified medical attention. At the time of this report, the patient had not recovered. Additional information has been requested.