chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to male patient possibly in his forties. There was no information about the patient's pertinent medical history, concomitant therapies or drug reactions and allergies provided. On 17-JUL-2018 (also reported as "today"), the patient was improperly vaccinated with a dose of M-M-R II injection, intramuscularly not subcutaneously as recommended, for prophylaxis (exact dose, lot# and expiration date were unknown). No adverse effects reported.
Symptoms began with headache, fatigue and stomach pain but increased with time. I was able to go out the day of the vaccination. However, as the evening wore on, the stomach pain became intense and low back pain began. During the night both intensified. By morning I had body aches, chills and a fever of 100.9 (ear). My hands were cold and clammy and then hot. I fell asleep for four hours, awakening covered in sweat but the stomach and low back pain, as well as the other symptoms, are now subsiding, a little more than 24 hours later.
Influenza vaccine administered on Thursday, November 16th. Noticed soreness at site on Thursday evening.  On Friday, the 17th, woke at 5AM - arm very edematous (softball in size) injection site area black, blue, and purple and very warm to touch with increased soreness.  Went to clinic - patient was given Cefabroxil.  Patient follow-up: Nurse phoned patient who reported that symptoms improving with decreased edema and tenderness.
2 minutes after -> 2 out 10 -> pain. 30 minutes after -> 9 out of 10 -> pain.
Did have chills, body aches, joint pains, fever 101.5, pain into left shoulder blade, and lightheaded. Heart rate increased from 125 to 140 (not within 15 min of vaccination during monitoring period).  Symptoms lasted 36 hrs.
Pt received preservative free H1N1 vaccine on 11/10. She had informed me (son's pediatrician) that she was pregnant. 11/17 reported abo pain, seen at ER pregnancy confirmed by sonogram. 11/18 vaginal bleeding  RTER (returned to ER). Sono confirmed SAB (spontaneous abortion) RTER 11/21 for continued bleeding.
105 degree F temperature in the middle of the night and then, 103 degree temperature for the next several days (4)
I was giving the monkeypox vaccination and it sprayed in my eye; I was giving the monkeypox vaccination and it sprayed in my eye; The vaccine always sprays when removing the dose, while pulling the needle; Case reference number US-BN-2022-004489 is a spontaneous case report initially received on 02-Nov-2022 from a nurse via Communications (reference number: USBAV22-1838) concerning a female patient of unknown age.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient was vaccinated with the Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating, batch number: unknown), at an unknown dose, via an unspecified route of administration, at an unspecified site, for an unknown indication.  During the vaccination, the monkeypox vaccine sprayed in nurses' eye (explicitly coded as 'Accidental occupational exposure to product' and 'Exposure via eye contact'). As reported by nurse, the vaccine always sprays when removing the dose and when pulling the needle (explicitly coded as 'Needle issue').  At the time of this report, the event outcome was unknown.   The reporter assessed the event as non-serious and possibly related to Jynneos vaccine.  Additional information received from on 02-Nov-2022 included the local case ID.; Reporter's Comments: A female nurse had an accidental occupational exposure to Jynneos via eye contact, while attempting to vaccinate a patient. Reportedly, the vaccine sprayed into the nurse's eye while pulling the needle (which is considered needle issue). Accidental exposure to product, exposure via eye contact and needle issue are considered listed per company convention. Medical history and concomitant medications information was not available. The events are considered not related to Jynneos, but to human error. The case is non-serious.; Sender's Comments: A female nurse had an accidental occupational exposure to Jynneos via eye contact, while attempting to vaccinate a patient. Reportedly, the vaccine sprayed into the nurse's eye while pulling the needle (which is considered needle issue). Accidental exposure to product, exposure via eye contact and needle issue are considered listed per company convention. Medical history and concomitant medications information was not available. The events are considered not related to Jynneos, but to human error. The case is non-serious.
Full blown shingles; left arm was a little bit sore; blisters; Pain in shoulders and upper rib area; Pain in shoulders and upper rib area; This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6201) via an unspecified route of administration, administered in Arm Left (Left Arm Close to the shoulder in the muscle) on 05Mar2021 11:00 (at the age of 77 years old) as dose 1, single for COVID-19 immunisation. Medical history included ongoing arthritis, ongoing Little bit of heart disease. There were no concomitant medications. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. Prior Vaccinations within 4 weeks was none. The patient experienced pain in shoulders and upper rib area, left arm was a little bit sore, blisters on Mar2021, full blown shingles on 12Mar2021. Reported as, he had the first shot on 05Mar2021 and everything went fine except for a couple or three days later he experienced a lot of pain in the shoulders and upper rib area. on 12Mar2021 he got full blown shingles. His left arm was a little bit sore right after the shot but no problem there. The pain started a couple days after the shot. It was painful with touches of pain, after that is got worse. It was after that the blister showed up. He went to his doctor and was told he had full blown shingles. 4 days after vaccine was when he noticed blisters and that skin was painful to touch. Adverse event resulted in physician office visit for Pain in shoulders and upper rib area, full blown shingles. Outcome of the event full blown shingles was not recovered and unknown for other events.  No follow-up attempts are possible. No further information is expected.
Information has been received from a physician concerning a 4 month old patient who was vaccinated PO with the first 2.0 mL dose of rotavirus vaccine live (human-Bovine). No adverse event was reported. It was unknown whether medical attention was sought. There was no product quality complaint. Additional information has been requested.
rash that itches; arm hurts; trouble hearing; itchiness; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on 21Jan2021 at a SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced rash and itchiness on an unspecified date in 2021. The patient reported she had the Covid shot on 21Jan2021 and has a rash now and it itches. On 2021, her arm hurts, but otherwise she was fine. The patient was due for the other one on 11Feb2021 and she wanted to know if she can take it in the same arm. She mentioned trouble with hearing and also puts husband on line. The outcome of the event was unknown.  Information about lot/batch number has been requested.
About 15 hours after the injection, I woke up with symptoms of shock or extremely low blood pressure. I was horizontal (because I?d been asleep), but it felt like I was regaining consciousness after fainting. Extremely fast heart rate, ringing ears, difficulty moving my limbs, extreme thirst, sweating, tunnel vision. I had no breathing difficulty, hyperventilation, or shortness of breath. Breathing was totally fine. After becoming overheated and sweating, it shifted to the cold sweat phase. The whole episode lasted about 15 minutes and once my heart slowed back down, I was able to go back to sleep.  I wouldn?t describe it as fever chills, or even a fever-type of experience. It felt exactly like I?d passed out and was regaining consciousness, but with an extremely high heart rate. (I should mention that my blood pressure is typically pretty low and I?m prone to vasovagal syncope, but this wasn?t that, since I?d been  sleeping.)
3 days p/vax pt devel jaundice LFT's elevated;pt very fatigued, inc malaise sx improved p/10 days;LFTS remained elevated although improved;w/u for other viral causes negative;
Stiff, sore knees. Started with right knee; then left within 2 days.
I sat down and I felt hot and got a little flushing. I experienced paresthesia - tingling of my finger - I only get that as a stress reaction or when one of my nerves is pinched so I thought one of my nerves got pinched when they gave me my vaccine. Had it for about 5 minutes and I kept wiggling my fingers. It only happened on my left hand (and not both hands as normal). I was tired and had insane drowsiness. I went home and took a nap. My arm was pretty sore. I think I took  a Norco. Drowsiness was severe the next morning - couldn't get out of bed. It impaired me so much I couldn't go to work. It felt almost flu-like - my body was sore and I felt cold. I didn't have chills but I didn't want to get out from under the blankets. I didn't leave my bed until Monday and I took acetaminophen. I called my doctor and she asked me to take a COVID test - tested negative. I went to work the next day but didn't feel good. Fatigue went away in just under a week.  Cold sweats -  I started having these on Sunday, the 17th. And they still reoccur every now and then - and those never had occurred for me before the vaccine. Where I wake up drenched in sweat. I don't feel feverish but when I walk out of bed I am cold.
Pleuritic chest pain, seen in ED, 12/31/2020, had elevated ddimer, CT negative for PE,  EKG and troponin normal, Covid swab negative, diagnosed with pleurisy
aches; stiffness; numbness; tingling/needle like feeling in her  left arm.; ache in her neck and left shoulder; upon pressing the injection; tiredness; ache in her neck and left shoulder; soreness; fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aches), MUSCULOSKELETAL STIFFNESS (stiffness), HYPOAESTHESIA (numbness), PARAESTHESIA (tingling/needle like feeling in her  left arm.) and NECK PAIN (ache in her neck and left shoulder) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A and 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included IRON for an unknown indication.   On 17-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (aches), MUSCULOSKELETAL STIFFNESS (stiffness), HYPOAESTHESIA (numbness), PARAESTHESIA (tingling/needle like feeling in her  left arm.), NECK PAIN (ache in her neck and left shoulder), VACCINATION SITE PAIN (upon pressing the injection), FATIGUE (tiredness), ARTHRALGIA (ache in her neck and left shoulder), MYALGIA (soreness), PYREXIA (fever) and HEADACHE (headache). The patient was treated with MELOXICAM at a dose of 15 mg once a day. At the time of the report, PAIN (aches), HYPOAESTHESIA (numbness), PARAESTHESIA (tingling/needle like feeling in her  left arm.), NECK PAIN (ache in her neck and left shoulder), VACCINATION SITE PAIN (upon pressing the injection), FATIGUE (tiredness), ARTHRALGIA (ache in her neck and left shoulder), MYALGIA (soreness), PYREXIA (fever) and HEADACHE (headache) outcome was unknown and MUSCULOSKELETAL STIFFNESS (stiffness) was resolving.            Patient was referred to physical therapy for 6 week  Patient was  ordered EMG test by her doctor.
Large,  raised, warm red welt at injection site that started that night and worsened over 24-36 hours and then lasted for 2-3 more full days (4 days total)
My son received the IPOL vaccine on 6/3/20.  In less than 24 hours after the vaccine was administered he developed red blotchy hives on his chest, sides, under arms, back, and chin.  He had a fever of 102.  For the next few days he wasn't himself.  He was very irritable, glassy/red eyes (he looked high/disoriented) and slightly warm.  On 6/7 he developed a rash on his back, belly, and neck.
Nurse working in Emergency Dept, developed first COVID sxm (mild cough) on 03 Jan 2021. On 05 Jan 2021, he received dose #2 of COVID vaccine (Pfizer lot EL1284). On 06 Jan 2021, sxms progressed to include fever, congestion, impaired taste and smell. On 06 Jan 2021, NP swab for PCR was performed and confirmed positive... patient being managed as outpatient.
5 hrs after injection started getting a headache,10 hrs after started getting constant aching injection site arm, from elbow to shoulder, swelling, no redness, no heat. Low grade temp. Took 2 Tylenol 650 mgs. Unable to sleep even with elevated arm and ice.. Continued through the next day but headache gone.Arm pain constant if left down.Next day swelling reduced, but still constant ache, muscle, bone and joints. Today improved, still aching, but tolerable.
Pt started getting cold chills at 11pm 2Mar, went to bed and woke up with sweats/chills.  Was sent home from work and noted HR on smart watch was 90s-140s BPM with associated labored breathing/"unable to take a deep breath", lightheadedness and HA while sitting on couch.  Noted HR at 150-160 with walking.  Pt call help line through and was referred to ER.
Information has been received from an LPN concerning a 65 year old female patient with a urinary tract infection (UTI), rheumatoid arthritis, hyperlipidemia, GERD, COPD, and no known allergies and a recent history of hospitalization for right flank pain (diagnosed with UTI) who on 05/04/2006 or 05/05/2006 before being discharged from hospital was vaccinated IM in the deltoid with a dos of pneumococcal 23v polysaccharide vaccine Concomitant therapy included atorvastatin calcium (Lipitor) and ciprofloxacin hydrochloride (Cipro). Three to four days post vaccination (approximately 05/07/06), the patient went back to the hospital with rash. The diagnosis at that time was rash and UTI, and the patient was told she had an allergic reaction to the vaccine. The patient was hospitalized for 3 days. She was treated with Iv Steroids. The nurse stated that the patient had vasculitis, and that the rash was painful, all over her body, on palms of hands and her feet which were wrapped. No laboratory studies were performed for rash. As of the reporting date the patient hand not improved. Additional information has been requested. The nurse considered the events to be other important medical events and to be disabling. (OMIC)
Severe fatigue & H/A since vaccination on 7/31/15 she experienced an extremely painful headache, nausea & hand tremors (she has not begun oral typhoid).
my upper central abdomen starting hurting severely 24 hours a day, I thought it was my stomach but my doctor thought it was my pancreas or liver and did an ultrasound which showed nothing unusual and ordered labs (normal),  she added a GERD medication and doubled the other one I was taking and I chewed lots and lots of TUMS and laid down every time it hurt, it gradually hurt less and for less time and now it is just about back to normal
2 pts recvd 3 dose series of Engerix-B & were recently titered & were reported as non-converted; Booster doses will be given;
This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death), outcome "fatal", described as "died days after receiving a coronavirus vaccination". The patient date of death was unknown. The reported cause of death was "died days after receiving a coronavirus vaccination". It was not reported if an autopsy was performed. Patient was a teenager. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Reported Cause(s) of Death: died days after receiving a coronavirus vaccination.
Fever, unspecified fever cause. Diarrhea, unspecified type. Shivering, Myalgia. Adverse effect of vaccine, initial encounter.
Information has been received from a physician concerning a patient who on an unspecified date was vaccinated with a dose of GARDASIL (LOT# not reported). Subsequently the patient experienced injection site pain. The physician did not see the patient himself and he heard this through a pediatric colleague. Additional information has been requested.
nausea, vomiting, weakness, fatigue, site hot/red-2hrs p/vax;
cardiovascular event; Tightness in chest; Difficulty Breathing; Bronchitis; A Spontaneous report  was received from a health care professional concerning a 79 year old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Cardiovascular symptom, Chest discomfort, Dyspnea, Bronchitis.  The patient's medical history as provided by the reporter included Neuropathy of feet, elevated Cholesterol, Osteoarthritis, Aortic aneurysm. Concomitant medication included Levothyroxine sodium, Sumatriptan, Rosuvastatin, Piroxicam and Vitamin D  On 11 Feb 2021, prior to the onset of events the patient received first dose of their two planned doses of mRNA-1273 (Batch N0: MOD012M20A ) intramuscularly in the right arm for prophylaxis of covid 19 infection.  On 12 Feb 2021, the patient had tightness in chest and difficulty in breathing. Went to local urgent care and ambulance called to transport her to hospital as was feared a cardiovascular event. Admitted to hospital on 12 Feb 2021 and  discharged on 13 Feb 2021. She had stress test, echo, CT and x-rays all were normal. She followed up with her PCP on 15 Feb 2021 and was told that she might have starting of something like bronchitis. The events caused hospitalization and was serious.  Treatment included  antibiotics and steroid shot and prescribed inhaler.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of events, Cardiovascular symptom, Chest discomfort, Dyspnea, considered recovered on 13 Feb 2021 and outcome of the event Bronchitis considered recovered on an unknown date.; 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.
First shot / arm was sore; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Tetanus with an associated reaction of no adverse event (received tetanus shot on an unknown date.).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient age was reported as over 50 years. The physician told the patient to go and get the shingles shot. The patient received 1st dose of Shingrix and his/her arm was sore. The follow up would not possible as no contact details were available. For tolerance of 2nd dose, refer case US2021AMR103510, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR103510:same patient (2nd dose)
After receiving the Pfizer vaccine, patient experienced severe vertigo that made her unable to work, walk, drive for many months; nonstop migraines; extreme fatigue. It was a disabling event that caused her to miss weeks of work and then have to change from full time to part time employment eventually. To this day she experiences extreme fatigue after any mild physical or mental exertion lasting more than a day; vertigo; loud noises make her feel nasueas and she cannot work full time.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Mar2021 at 14:00 as dose 1, single (Lot number: EP7533), in right arm, on 13Apr2021 at 14:00 as dose 2, single (Lot number: EW0161), in left arm, on 03Dec2021 at 13:00 as dose 3 (booster), single (Lot number: FJ8757), in right arm and on 27May2022 at 11:00 as dose 4 (booster), single (Lot number: FM7553) at the age of 59 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: sulfa" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Indication: Covid-19 treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Product: COVID 19 Treatment, brand: Paxlovid, treatment start date: 18Jun2022, treatment stop date: 22Jun2022, lot number: FY6826, Indication: treatment of COVID-19, developed change in taste (metallic) almost right away 9 days after completing treatment, woke up with small, round bumps on shoulders, which later turned into full-blown hives everywhere. Also had (apparently) a rash inside my mouth, and any food caused a stinging pain, lasted a few days.
Patient had aching in shoulder and neck. Was treated in emergency room. Treated with antibiotic (unknown).
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. On 03-DEC-2015, the patient was vaccinated with VARIVAX (Merck) (strength, dose, route unknown) (lot# L019130, expiration date 27-MAY-2015 and lot# L026407, expiration date 15-JUL-2015) after being improperly stored (incorrect product storage) (Temperature: 9.5 F, Time frame: 2 hours). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Injection is swollen to 3 inches in diameter. It is red and hot to the touch. Full body aches/pains. Swollen lymph nodes in left arm pit. Painful to touch. Running fever. Nausea. Painful to be touched anywhere on body. Inability to get warm.