chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient put in car after receiving shot at Dr's office.  Fell asleep in car on the way home & making odd motion with mouth.  Left in car for a few minutes while at home while the rest of the family entered the vehicle.  She became less responsive, increasing in palor, brought to the ER by father.  Found to be very pale, with cyanosis to lips, not breathing with O2 sats in 60% range.  Posturing motions with arms and gazing to R.10/13/2009 MR from ED visit 9/21/2009, patient presents with sx of unresponsiveness, decreased respirations, odd motions of the mouth, ? seizure like activity, cyanotic episode. Patient required intubation as depressed respirations and O2 sats of 60%. Patient transferred to another hospital for continuing care.
AFTER RECEIVING THE SHOT, THE ARM WHERE THE SHOT WAS GIVEN STARTED TO HURT.  IT HURT THE WORSE THE FIRST THREE DAYS THEN THE PAIN DECREASED BUT HAS NOT COMPLETELY GONE AWAY.  THE SHOULDER IS THE MAIN LOCATION OF THE PAIN.  ALSO, HIS BACK AND NOW KNEE HURTS TOO.  PATIENT HAS TAKEN ASPIRIN, USED AN ICE PACK, AND TAKEN INDOMETHACIN TO HELP WITH THE PAIN.
a little tired; This is a spontaneous report from a contactable consumer or other non hcp. This case is for husband's first dose. A 89-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: Unknown, NDC/UPC number, Expiry date: unknown) via an unspecified route of administration on (age at vaccination: 89-year-old) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included diabetes from an unknown date and unknown if ongoing. Concomitant medication(s) included vitamin C [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) 1000 mg daily, aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) (81, three times a week), nicotinamide (VITAMIN B3) 2000 units, dutasteride (on Monday and Thursday), gabapentin 2.5 mg, daily, lisinopril, repaglinide one half mg at breakfast, atorvastatin calcium (LIPITOR [ATORVASTATIN CALCIUM]) 10mg daily, and hydroxocobalamin acetate (VITAMIN B12 [HYDROXOCOBALAMIN ACETATE]) all the medication taken for an unspecified indication from an unspecified start date and ongoing. It was reported that last week except a little tired, 3 weeks ago for the first one and I'm perfectly fine I feel chilled like for 2 hours and that's all, but he is much better today but I want to make sure I read the book that they gave me and I want to make sure that it's just a side effect and that he will get better." Reporter stated, Lab test was done few months ago and it was normal. The outcome of the event was unknown.  No follow-up attempts possible. No further information expected.
Vaccine attendant properly and appropriately administered the Moderna COVID vaccine to patient in her left deltoid.  Within 5 minutes of receiving the vaccine, patient became unconscious. She was sitting in a chair next to a table in the clinic atrium (just outside the pharmacy) and suddenly slumped into her chair and hit her head quite loudly on the table, which triggered me to respond. When I approached her, her head was tilted backward, she was wheezing/gasping for air and her eyes were rolling back into her head. EMS was immediately notified and remained on the line with us. While retrieving the epinephrine (not administered) she regained consciousness and immediately began using her phone. (As if she didn't realize anything had happened).  She reported feeling thirsty and hot, however was directed not to eat or drink anything until she was seen by EMS. She was escorted to the ambulance by EMT for observation and evaluation. EMT returned her to the building following brief evaluation (5-10 minute) and commented that it was believed to be a syncopal episode. She remained in the same chair in the clinic atrium for an additional 15-20 minutes and was provided with water and a small snack. She called her boyfriend to pick her up. I asked her several times if she was feeling ok and asked her boyfriend to call me if she has any status changes. She reported that she has fainted when having venipuncture, but never with a vaccine. I advised her that going forward, she let future vaccinators know that she may need to be more closely monitored during her observation period. Patient does not have a PCP listed in her chart. Of note, it did not look to be a syncopal episode to me, which is why we called 911.
Developed sore 3 cm nodule with overlying 5 cm pink patch where injection administered 2 days after injection. Tx-ice, ibuprofen PRN (L) arm
I got shingles on the right side of my scalp around my ear, in the hairline, and in my inner ear and outer ear, as well as a few patches on the right jaw and anterior neck, and right hairline of posterior neck. It first started off with sensitivity to the touch of my right ear and around my ear, then it began itching, then the severe nerve pain on right side of my head, inner ear, right side jaw and down my medial arm and right side chest. I had sever blisters in my right side hairline and in back of my outer ear, face and anterior and posterior neck. currently they are in the scabbed phase and the nerve pain is more tolerable. also, before the blisters showed up, I went to the ER with inner ear pain and was told i had otitis media and was given antibiotics, however, once the blisters showed up, I went to minute clinic and was told it was shingles.
A report has been received from a Health Professional concerning a 47 year old, Female subject, who had been receiving FLUMIST. FLUMIST started on 11-Jan-2013. The patient experienced GAVE EXPIRED FLUMIST which was started on 11-Jan-2013 and SCRATCHY THROAT. The outcome of the event of SCRATCHY THROAT and GAVE EXPIRED FLUMIST is unknown. The report was considered to be non-serious. The reporter considered that there was no causal relationship between SCRATCHY THROAT and FLUMIST. Summary of follow-up information received by AstraZeneca/MedImmune 05-Mar-2013 from consumer: New event of scratchy throat was added. Corrected report 15-Mar-2013: start date of FLUMIST was added.
I am an APRN, and received the vaccine not quite one week ago. I waited 15 minutes within the facility and then left. Sat in my car working for about 8-10 minutes when a sudden rush of heat ran through my body.  I felt lightheaded, my tongue was prickly, and I felt like I was going to pass out.  I was able to get back into the facility to let them know of the sudden symptoms.  At that time I felt like my heart was racing and was diaphoretic. They continued to watch me for another 15-20 minutes, they did have an epi pen but it was not given. I was feeling slightly better and then left again.  I waited in my car approximately 20 minutes before deciding it would be safe to drive away.  After driving for about 10 minutes I had another rush of heat, lightheadedness, and then I started having shortness of breath.  At this time it would have been about 1 hour, maybe longer, since receiving the vaccine.  I was not close to an emergency medical facility at that time, and did not feel like my throat was swelling so thought it would be best to try to drive to the nearest ER.  I knew I had an epi pen from my work that I could use if needed.  I contacted another nurse practitioner who I work with who stayed on the phone with me until I was able to get to a safe place.  At that time the symptoms had improved, not resolved.  It had been able 20 minutes during this episode.  In all, I continued to feel jittery for about 3-4 more hours.  Since my symptoms did improve I did not go to the ER.  I contacted my health department, Louisville health dept, the following day and reported symptoms to the medical director.
11 year old male patient was administered 3 immunizations as stated below. His 2 sisters and mother were in the room with him. After his shots were done, the youngest sister (8 y.o) fainted. She had not had any shots. Shortly after his sister fainted the patient said he felt somewhat queasy. We kept him under observation for the next 15-20 minutes, he said he was feeling better. We moved the family into another waiting room and told them to remain seated for another 15-20 minutes. About 10 minutes later the mother called out as the patient fainted. He was seated at the time so his chair ended up tipping to the left and he fell to the ground. He aroused quickly, pulse and respirations were WNL and regular. He was alert and oriented x3 once aroused. He stated that the side of his left temple and his knees hurt and his neck was a little sore from when he fell. It appeared that he may have had small "rug burns" on the side of his left temple and on both knees. We had him stay with us in the office for another 30 minutes under our observation. He ate a granola bar and after a while stated he felt better. We discussed the signs/symptoms of concussion with mother, advised her to follow-up with MD if he exihibits s/s or any other unusual behavior. Escorted family to car w/out incident.
Extremely cold (while city was in a heat wave!) for 2-3 hours then extremely hot (no temp taken) for next 12 hours; extreme lethargy, muscle and joint pain, injections site pain/itching--all for next 72 hours; temp taken at 36 hours was 102.5f; then at 48 hours temp was 101.9f; then at 56 hours temp was 96.8f.
No additional adverse effects reported; Improperly stored vaccine was administered .; This non-valid spontaneous report was received from a certified medical assistant and refers to an unspecified patients. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.   Since 22-JUN-2020, unspecified patient was vaccinated with unspecified amount of improperly sored dosed of varicella virus vaccine live (Oka/Merck) lot # S031497 was confirmed to be valid, expiration date 07-OCT-2021 and lot # reported as T010318 with expiration date reported as 24-MAR-2022 (exact dose, route and site of administration were not provided), for prophylaxis. No additional adverse effects reported.  Administered doses of vaccine was exposed to the temperature between -9 to 8 degrees Celsius (C) for 1 hour and 5 minutes. It was unknown if there was any previous temperature excursion. The call was because of a digital data logger.  This is non-valid report due to lack of patients' identifiers.
Awoke from sleep at 4 am 2/27/2021 with diffuse cold sweats, sore left arm with mild swelling, chills, body aches, nausea, too weak to stand or walk more than a couple feet, vomiting, muscle cramps, feverish but no fever (98.6). Took 1,000 mg Tylenol. Improved enough to return to sleep but symptoms continued the next day.
Patient and his mom came in for his scheduled Tdap vaccination at 8:15 am.  I asked all the routine questions regarding vaccine history, reaction, etc.  He was very talkative and  said he didn't like needles.  He sat down in the chair and I administed into his R deltoid.  He sat there for about 10 seconds and then his head slumped down and he went limp for about 3 seconds.  He put his head  up and he was very pale white.  I called for the other nurse to come in and she went and got him some water.  I got two ice pack and put one on his neck and one on his forehead.  He put his head between his legs for a few minutes.  He drank two and a half bottles of water and ate a chocolate Fiber One bar.  He stated he didn't eat breakfast this morning.  He was visibly shaking a little bit and sweaty.  He was talking  the entire time, and even making jokes.  After about 1/2 hour we slowly got him up and he walked to the waiting room to sit down.  He sat there with his mom for about 10 minutes and he said he felt good enough to leave. I instructed mom to call me if there were any further problems or concerns.
Admit 6/30, vaccine 1/19, 2/9. Admit for weakness, cough, syncopal episodes. H/O Type II DM, atrial tachycardia, HTN. COVID +, COVID PNA. Tx w/ short course steroid, abx, did not require O2. DC'd home.
Patient had onset of symptoms within five minutes of the vaccination, felt rapid heart rate and dizzy. Had patient lay down, monitored VS every 10 minutes. 1750 - BP 114/70, P 85, R18, O2 100 1800 BP 127/65, P78, R16, O2 100. Drinking water. After 10 minutes heart rate felt better but c/o itching, flushed chest. Gave oral Benadryl 25mg liquid. VS 1810 BP 120/67, P 70, R 16, O2 100%. VS at 1830 BP 115/61, P70, R 15, O2100%
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Jan2021 at 11:30 as dose 1, single (Lot number: EK9231), in left arm, on 10Feb2021 at 11:45 as dose 2, single (Lot number: EL8982), in left arm and on 26Oct2021 at 15:00 as dose 3 (booster), single (Lot number: FH8020) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Prediabetes" (unspecified if ongoing), notes: prediabetes. There were no concomitant medications. Past drug history included: Codeine, reaction(s): "known allergies codeine", notes: known allergies codeine. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of vaccination failure, covid-19.
Previously noted, but took and take lots of Tylenol, Voltarin and muscle relaxers to sleep
Presented in office on 3/15/06 c/o reaction to shots in both arms. Received Menactra right arm 3/13/06, received DTaP and HEP A left arm 3/13/06. Both arms red and painful and swollen.
Patient received expired Moderna Covid-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    In April 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Patient received the first booster dose. The date of vial initially stored in the refrigerator was unknown.  Dates of administration of vaccine were reported as 2 doses on 05-Apr-2022, 13 doses on 06-Apr-2022, 2 doses on 07-Apr-2022 and 4 doses on 08-Apr-2022.   The vial did not undergo any temperature excursions.  No treatment information was reported.
The immunizing pharmacist had a syringe malfunction upon administering the vaccination, and vaccine leakage occurred down the patient's arm.  Although the dose was injected, how much dose was administered could not be clearly determined.
From telephone contact from patient received on 6/14/01 stated that she received a YF-VAX vaccination on 6/13/01. 40 minutes post immunization she developed hives. Not evaluated by physician, self medicated with Claritin and Benadryl. From mailed correspondence received on 8/27/01 additional patient, county, vaccine administrator, responsible physician and vaccine information was provided. From mailed correspondence received on 12/10/01 it was reported that the patient recovered from this experience. No further information is anticipated. This case is closed.
Pt recvd 1 dose of Engerix-B & exp inject site pain, blotching, redness; these have been resolved @ the time of this report;
upset stomach; headache; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ABDOMINAL DISCOMFORT (upset stomach) and HEADACHE (headache) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: J&J Vaccine (First dose of J&J vaccine). Past adverse reactions to the above products included No adverse event with J&J Vaccine.    On 25-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced ABDOMINAL DISCOMFORT (upset stomach) and HEADACHE (headache). In January 2022, ABDOMINAL DISCOMFORT (upset stomach) and HEADACHE (headache) had resolved.            No concomitant information were reported by the reporter. No treatment information were reported by the reporter.
Lower eyelid stye, swelling and bruising under and around right eye, stye on the lid, large, painful, swollen purplish lump below Headaches Muscle aches Fatigue
SHORT OF BREATH ON ACTIVITY LIKE WALKING; FELT SO BAD, CHANGED SO QUICK; FEVER/LOW GRADE FEVER; TIREDNESS; NAUSEA; VOMITING; This spontaneous report received from a patient concerned a 45 year old female. The patient's height, and weight were not reported. The patient's past medical history included: covid-19, and intensive care unit (icu). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855194 expiry: UNKNOWN) dose was not reported, administered on 29-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced short of breath on activity like walking, felt so bad, changed so quick, fever/low grade fever, tiredness, nausea, and vomiting. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102.4 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever/low grade fever, and short of breath on activity like walking, and the outcome of felt so bad, changed so quick, tiredness, nausea and vomiting was not reported. This report was non-serious.
Information has been received from a healthcare worker concerning an unspecified number of patients of an unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date in 2015, "since 07-JAN-2015", the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX (lot # K006136, expired date as 29-APR-2016; lot# reported as K011799, expired ate as 21-AUG-2016) (strength, dosage and route were not reported). No adverse effects were reported. This is one of several reports that received from the same reporter. Additional information has been requested.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. Information about concurrent conditions, concomitant medication and medical history was not provided. Since 01-OCT-2014, the unspecified number of patients had been vaccinated with doses of VAQTA (lot#, dose, route and frequency were not provided), which had underwent supported and unsupported temperature excursions, (on unspecified dates of 2014). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
hair started falling out / still ongoing; severe joint pain/ severe pain in the knees / hip pain; severe back pain; trouble getting up and down / trouble getting up and down stairs; trouble walking; she could not sleep.; This case was reported by a consumer and described the occurrence of joint pain in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of influenza like illness (1st dose received on 24th july 2020 in left arm, refer case US2020AMR229141).   On 24th September 2020, the patient received the 2nd dose of Shingrix. In September 2020, less than a day after receiving Shingrix, the patient experienced insomnia. On 24th September 2020, the patient experienced joint pain, back pain, mobility decreased and walking difficulty. On 29th September 2020, the patient experienced alopecia. On 28th September 2020, the outcome of the joint pain, back pain, mobility decreased, walking difficulty and insomnia were recovered/resolved. On an unknown date, the outcome of the alopecia was not recovered/not resolved.   It was unknown if the reporter considered the joint pain, back pain, mobility decreased, walking difficulty, insomnia and alopecia to be related to Shingrix.  Additional details were reported as follows: On 24th September 2020, the patient received 2nd dose of Shingrix in the left arm and later on that same day had severe joint pain, severe pain in the knees, severe back and hip pain, trouble getting up and down and trouble walking, and trouble getting up and down stairs and the same night the patient could not sleep. The patient reported the pain came on immediately that same day as the vaccine. On 26th September 2020, the patient went to the physician and the week before about these events. The patient stated that these events lasted 3 days and then resolved by 28th September 2020. On 29th September 2020, the patient's hair started falling out and this was still ongoing currently. The patient reported she had been in contact with a nutritionist twice to discuss these side effects. The reporter consented to follow up. This case had been linked with US2020228560, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020228560:same reporter (sister´s case) US-GLAXOSMITHKLINE-US2020AMR229141:same reporter
Approximately 1 week after shot was given, patient noticed area of injection swell to size of golf ball. Looked red and inflamed with heat per patient. Patient took TYLENOL and BENADRYL and iced area. Also was prescribed steroids by MD.
Scratchy throat, left upper arm pain, pain later moved down entire left arm to all fingers in both hands, later developed trembling (trembling resolved after 3 hours), mild abdominal pain, decreased appetite, headache.
pt recv vax 1DEC approx 1 wk later arms swelled & became very tender;pt visited hlth dept today 15DEC & reporter saw no erythema;denies fever;swelling significant & covers entire deltoid;
Initial unsolicited report received from a nurse on 30 June 2016. This case involves a male patient (age not reported) who was vaccinated with a fifth dose of DAPTACEL (batch number: C31130AA, expiry date, dose and site of administration were not reported) by intramuscular route on 02 June 2010. Illness at time of vaccination was reported as none. Pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as amoxil. Concomitant medications were not reported. On 04 June 2010, two days (reported as 48 hours) following the vaccination, the patient experienced fever and remembered room spinning with vertigo. Lab data and corrective treatment were not reported. On unspecified date, the patient recovered from events. List of documents held by sender: none.
Woke up with a headache, took some Excedrin to clear it, no pain after that.  Also was fatigued and light headed on and off the rest of 4/27.
pt devel fever to 102 1st 24 hrs p/shots then returned to nl; pt devel emesis @ 5AM 9MAY; pt had apneic episode @ home w/color change; pt had 2nd apneic episode while on way to hosp; pt had 3rd apneic spell 0200 poss assoc w/sz;