chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report received from a registered nurse referred to a 6 months old patient of unknown gender. The patient's medical history, current conditions and concomitant medications were not reported. On 02-SEP-2016, the patient was vaccinated with ROTATEQ (lot number: M004883, dose, frequency, expiry date were not reported) which was stored improperly. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1609USA013814: same reporter.
Within 12 hours, I developed a rash on my leg and neck.  Arm pain was so severe that I was barely able to move it.  Had body aches. Now it is 2 days later.  I have an itchy  rash at the injection site and on my chest.  The injection site area is swollen and painful.   The body aches resolved within 24 hours.  The rash did not.
80-year-old male with past medical history of hypertension presents to the emergency department with worsening shortness of breath.   Patient is Spanish-speaking interview was held with translation device.  Patient tested COVID positive a few days ago and has been tolerating home remedies at but symptoms have continued to get worse prompting him to come to the emergency department.  Other family members at home are complaining flu-like symptoms.  No one else has been diagnosed COVID positive.  Also complaining of some abdominal discomfort with nausea and vomiting  8/2/2021 tested positive
Ischemic Stroke on 6/26. Within 7 days she couldn't speak, walk or eat. She is currently residing in a nursing home.
Day after vaccine - arm had edema - erythema, itching per mom - used BENADRYL, TYLENOL - cold compress - office visit if not improving in A.M.
get sicker than a poisoned prairie dog; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media on 19-Oct-2020.  This case is linked to case 2020SA296404 (cluster).  This case involves a patient of unknown demographics who "got sicker than a poisoned prairie dog" (Illness), while the patient received vaccine Influenza Vaccine.  The patient's medical history, Concomitant medication, past medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date were not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date, the patient "got sicker than a poisoned prairie dog" (Illness) (unknown latency) following administration with INFLUENZA VACCINE. The reporter stated that maybe not the flu, but was sickest ever been in life was from a flu shot.  No laboratory data provided.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown, at the time of reporting.  There will be no information about the batch number in this case.
Vaccination adverse reaction; This spontaneous case was reported by an other health care professional and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse reaction) in a 41-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS5051C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 22-Jan-2023, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction). At the time of the report, IMMUNISATION REACTION (Vaccination adverse reaction) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.   Reporter did not allow further contact
Patient recieved a Tdap & Hep-A vaccine Bilat. Deltiods. Approx 10 min later patient had LOC with Petite type Seizure in waiting room. Pt was returned to Izzy Rm with aid of W/C. Patient placed on bed in a supine position with feet elevated. Given cool packs to head & neck. Water & apple jucie provided. Still pale, weak, nauseated. Vital signs Qx10min x3, Q30min x1 WNL. Still confused. Called family member to pick up patient, advised to seek medical evaluation. Left our facility at 3:45PM.
Fever, Weakness, Chills, Body aches Stared on 3/9/21
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 06-JUN-2015 the patient was vaccinated with ZOSTAVAX, subcutaneous (lot #: L000447; expiry: 08-MAR-2016) (dose and frequency unspecified). Pharmacist reports that on 06-JUN-2015 a dose of improperly stored ZOSTAVAX was administered to patient. No adverse reaction was reported. The outcome of medication error was unknown. No product quality complaint involved. Additional information has been requested.
Received Varivax 10/2/95, presented 1/30/2002 multiple varicella lesions
Moderna COVID-19 Vaccine EUA  Rash at injection site that is red, bumpy and itchy, similar to hives. Red area is 2 inches X 4 inches
Severe heartburn with gastric reflux. MD notified antacid prescribed. Pt. provided 15ml of ALOH/MGOH/SIMETHICONE 400/400/40MG/10ML. No SOB or chest pain noted. Heartburn pain decreased from 5/10 to 1/10 15minutes after medication administration.
Supraclavicular lymph node, left side, is very swollen. 4-5 cm in size
Patient was in clinic 01/18/2019 and was given an influenza vaccine around @1650. He presented to the school nurse today 1/18/2019 around @1000 he had a rash around the vaccine site and had fever of 100.9. Patient then presented the Clinic and still had a fever of 100.4 and the vaccine site was red and firm. He did not have any other symptoms.
Information has been received from a pharmacist via a company representative, concerning a 65 year old male patient. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. On an unknown date, the patient was vaccinated with an unspecified dose of PNEUMOVAX 23 in the arm (strength, dosage schedule, route, lot number and expiration date were not reported), and with an unspecified dose of influenza virus vaccine (reported as "flu"), which was also administered in the same arm, on the same date (strength, dosage schedule, route, lot number and expiration date were not reported). Other concomitant medications were not reported. On an unknown date, the patient experienced injection site redness that spread down to the elbow (injection site erythema). Unspecified antibiotics were prescribed to the patient, and the symptoms were gone. the outcome of the injection site erythema was recovered at the time of reporting. the relatedness between the adverse event and therapy with PNEUMOVAX 23 was not reported. No product quality complaint was involved. This is one of two reports received from the same reporter. Additional information has been requested.
Community acquired pneumonia  Transaminitis Hyperlipemia Hospitalization to treat the pneumonia, May 13-15 and May 20. Continued treatment at home with antibiotics and  steroid , nebulizer and rescue inhaler.
Hot to touch at injection site Rash on left arm Body aches  Chills Fever Severe arm soreness  Headache  Cold sweats
I have been dealing with a torn meniscus that developed arthritis and it was discovered I had cyst in my knees that were eating the bones on my left knee. I went in fifteen days ago and had a total knee replacement. I am feeling better, every day I am feeling better every day.
Gave doctor vaccine in left arm early morning of 10/05/17. He woke up during the night with bad pain in left arm starting at the elbow and traveling down to the hand and fingers. Stated it felt like the worst case of arthritis you could imagine. Hard to bend arm and stated it hurt so bad he felt like he needed a sling on it. Checked on him this afternoon (10/06/17) and he said it still was hurting. Had normal local reaction with redness noted at injection site (given intradermal), but he said it did not hurt at the injection site just starting from the elbow down to his fingers.
Day After I experienced fever, as I did with #2 shot.  I treated with low dose Tylenol.  I experienced a slight head ache off and on but not bad.  On the next day the under pit of that arm began to hurt and I noticed lumps in the under pit.  On that same day I had bruises scattered on top and underneath my arm.  On the next day the under pit began hurting really bad and those lumps started turning yellow.  By the fourth day the bruises began to disappear and the yellowed lumps did too.  My fifth day was yesterday and everything was normal.
Tested positive for COVID on 04/25/2022 . However I started feeling symptoms on 4/21/2022 . I had a sore arm, headache, coughing ,chills and fatigue. I saw the physician because I was coughing up blood. I was instructed to gargle with salt water.
Hep B vaccine given within 24 hours of birth. Afterward she began to have tremors (4 known), cry became (in 3 days) weak, hypotonia set in, straight legged, delayed development, eyes crossing, no language, poor balance, first steps at 26 months, mental retardation, neurological disorder. By 2 years static encephalopathy and cerebral palsy (rashes ongoing). Needs excessive stimulation to respond. Poor motor skills. The annual follow up recieved on 7/24/03 states, "poor motor skills, poor balance, non-verbal, poor comprehensive vision and auditory processing dysfunction, digestive problems. She had tremors and became hypotonic and began to develop a rash while still in the hospital and these signs were not recognized as an adverse reaction from vaccine by healthcare worker."
Left arm in which shot administered has redness, swelling, occasional itching, Kw/ grayish bruise at site of injection, pt reported this 6 days after shot, advised to apply ice pack, CLARITIN if needed, call PCP.
Moderna COVID-19 Vaccine EUA On 3/28, I started having occasional, brief, shooting pains up my left arm. It occurred once the first day, three times the next day, and ten or more times each day since.  On 3/30, my injection site became mildly itchy, and I noticed that it was warm to the touch. The itching only lasted a few minutes.  On 3/31 a splotchy rash appeared around the injection site, appx 5 inches in diameter. It is now hot to the touch, and occasionally itchy. As of 4/1 the rash is still present.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Sep2021 as dose 3 (booster), single (Lot number: 301308A) at the age of 64 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "RA" (unspecified if ongoing); "HTN" (unspecified if ongoing); "Raynaud's" (unspecified if ongoing); "Sjogrens" (unspecified if ongoing); "Atypical cranial neuralgia" (unspecified if ongoing); "Arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19.  Clinical information: Treatment drug included Paxlovid (Lot number: Fx4466) from 03May2022.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.
Administered with an expired vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with an expired vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with an expired vaccine). In November 2021, EXPIRED PRODUCT ADMINISTERED (Administered with an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.
60mm X 60mm induration on left upper arm. Cephalexin 500mg po q 12 hr X 7 days. Instructions.
Mother phone on 7/29/15 3 pm stating red area on (L) shoulder. Mother and pt came to our facility. (L) shoulder red, hard area 2" x 2", sore to touch. Afebrile.
diarrhea 22 & 23OCT97 nausea, chills 24OCT through 31OCT severe earache & h/a;MD prescribed Tetracycline & entex-also sinusitis & fever;examined by MD on 30OCT97
Patient received vaccine dose 2. Waited 15 minutes in observation area. Upon leaving observation area, patient passed out. Hit eyebrow and had laceration. Patient recently dx with Shingles 3 days ago and on valcyclovir for treatment. Patient also stated he did not eat at all today. Blood Glucose was 135.
got her first dose in Aug 2019 and due to Covid 19, patient received 2nd dose on Dec 2020; This case was reported by a pharmacist via call center representative and described the occurrence of social problem in a 86-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st dose received in August 2019).   In December 2020, the patient received the 2nd dose of Shingrix. In December 2020, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The patient received her 1st dose in August 2019 and due to Covid 19, patient received 2nd dose on December 2020. All patient identifiers reported.  No Batch Number or Expiration Date when asked, as HCP reported it was administered on a different facility.  No further clarifications
SMALL BRUISES ON LEGS WHICH CONSTANTLY APPEAR; POLYPS IN UTERUS; FIBROIDS; TILTED UTERUS; BACK PAIN/BACK ISSUES; UMBILICAL HERNIA; SLUGGISH AND SLOW; LETHARGIC; UNABLE TO WALK AND SWIM; 2 POLYPS FOUND DURING COLONOSCOPY; A BIG HOT FLASH RIGHT AFTER GETTING THE VACCINE; This spontaneous pregnancy report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was not pregnant at the time of reporting. The patient had no relevant medical history and had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: 23-JUN-2021) dose was not reported, administered on 10-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-JUN-2021, the patient experienced a big hot flash right after getting the vaccine. On OCT-2021, the patient experienced 2 polyps found during colonoscopy. Laboratory data included: Colonoscopy (NR: not provided) 2 polyps were found. On an unspecified date, the patient experienced small bruises on legs which constantly appear, polyps in uterus, fibroids, tilted uterus, back pain/back issues, umbilical hernia, sluggish and slow, lethargic, and unable to walk and swim. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the a big hot flash right after getting the vaccine, small bruises on legs which constantly appear, polyps in uterus, fibroids, tilted uterus, back pain/back issues, 2 polyps found during colonoscopy, umbilical hernia, sluggish and slow, lethargic and unable to walk and swim was not reported. This report was non-serious.
Patient stated that her arm got very sore and she has a hard time lifting it as normal, she said it is painful to use in range of other arm. Guest came by and told me today, I advised her to contact physician as soon as possible.
Mom describes that around 7pm the day of vaccination, she began to have movement of her arms and legs that she describes as a "shivering" motion or what most people do when they have chills. She had a "blank" look in her eyes, and they were unable to get her attention or make eye contact with her. This happened intermittently for about 40-60 minutes. She later went to bed and seemed normal when she woke up the next morning.
may have only received one COVID-19 dose; caller thinks 1st dose Moderna, 2nd dose Pfizer; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (may have only received one COVID-19 dose) and INTERCHANGE OF VACCINE PRODUCTS (caller thinks 1st dose Moderna, 2nd dose Pfizer) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (may have only received one COVID-19 dose) and INTERCHANGE OF VACCINE PRODUCTS (caller thinks 1st dose Moderna, 2nd dose Pfizer). At the time of the report, PRODUCT DOSE OMISSION ISSUE (may have only received one COVID-19 dose) and INTERCHANGE OF VACCINE PRODUCTS (caller thinks 1st dose Moderna, 2nd dose Pfizer) had resolved.            Patient thinks she received Moderna for the first dose and Pfizer for the second dose but is unsure. Concomitant medication was not provided. Treatment information was not provided.
Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Additional Details: Itching and redness at the injection site following the injection. Since the date the injection was administered, the rash/inflammation has spread down the arm, and 2 weeks later continues to itch.
05/27/2003: Mother reports child spiked fever (did not have thermometer) then generalized seizure lasting about 4 minutes.  This occured at 12:50pm.  Vaccines examination at 10:00am.  Did not fall asleep after seizure.  Was coherent.  Advised or declined.  Called back later in day.  Child up running around and playing.  Brought in for OR 05/28/2003-family state:  Fever again, pulling up arms, sergamens, irritable.  Discussed use of Valium suppository.  Parents to discuss.
Noticed some kind of paralysis of my right side of my face including eye not being able to blink.  Approximately 3 hours after vaccine.  My face dropped with difficult mobility.  Went to see my eye doctor the next day thinking it had to do with my eye but was sent to the emergency room to rule out a stroke.  Was diagnosed with Bells palsy after a stroke was ruled out.  Cat scan was taken as well as bloodwork.  Was sent home with Prednisone 20 mg.  Instructed to take 60 mg a day for 6 days.   Was also given Valacyclovir hcl 1 gram.  3 times a day for 7 days.   Was also given eye drops from my doctor.  Currently scheduled to  see a doctor this coming Friday.
3 days after receiving the vaccination patient started to urine blood for a week. After a week it stopped, but after receiving the second dose of the vaccination the bleeding in the urine returned. Was examined by healthcare provider there were no problems found.
pt recv flu vax during the 1st trimester of pregnancy;recently,20wk gestation pt underwent ultrasound exam;It was noted on ultrasound that the fetus only has one hand;no addtl info is known @ this time
Chest pain>ED visit>EMERGENCY  cardiac cath> dx tako tsubo>ICU admit.
It is unknown if this related , however due to the COVID vaccine being new I am reporting . I received Pfizer Vaccine for COVID 19 in March and April. On august 4th I was diagnosed with 5 blood clots in my right leg and referred to ER. I had blood taken and my platelets were 131 for a range of 140-440.  At my last annual check up in February the same value was164 on a scale of 140-440
Patient reported that she had a high fever with nausea chills muscle pains and sweats, body lurching x 36 hours.
Shot given on 2/6/21, about 10 hours later my husband started getting dizzy light headed, aching body and sore arm where the injection.  Today 2/9/2021 he's still not feeling well, still weak and aching.
Diarrhea; Congestion nasal; sniffles, runny nose aching; sniffles, runny nose aching; Coughing; Left arm sore; Hot and cold; Throat sore; Hard time swallowing and feels like she has to force to swallow; "COVID - like symptoms" /side effects she was having almost feels like she has COVID; Fatigue/exhausted/no energy; This is a spontaneous report from a contactable consumer (patient). This 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: ER8731) injected intramuscularly in left arm on 12Apr2021 12:30 at single dose for COVID-19 immunization. Medical history and concomitant medications were none. No prior vaccinations within 4 weeks. The patient just got the first vaccine on 12Apr2021. On 13Apr2021, the patient experienced fatigue/ felt exhausted/ no energy.  On 13Apr2021 01:00, she was having coughing/ hadn't stopped coughing, sore left arm, hot and cold, throat was very sore, congestion nasal, sniffles, runny nose aching.  She was nervous about getting second dose.  She was thinking about calling yesterday, but she did not have the energy.  She was having a hard time swallowing and felt like she was having to force herself to swallow. The diarrhea was just twice, on 13Apr2021 14:00 and 17:00. She was concerned about feeling like her throat was closing.  She just kept drinking water.  She was not swollen though. Patient reported that the symptoms were "COVID - like symptoms", the side effects she was having almost feels like she has COVID. No ER or physician's office required. No relevant tests. The outcome of diarrhea was recovering, outcome of fatigue was unknown, outcome of other events was not recovered.    No follow-up attempts are possible; No further information expected.
vaccine reaction,headache,vomiting. PT presents with bodyaches, chills, HA, n/v x 2 episodes since 2300. received JJ vaccine yesterday.
Erythema and Induration surrounding DTP injection site extending out 6cm from center of left deltoid, started within 24 hrs of shots
Pt received Gardasil and Menactra vaccine while seated on exam table. Was told to stay for 15 minutes. She got up to talk to the chair from the exam table, made it to the chair but passed out, was unconscious for 30 seconds-1 minute. This is a hospital based clinic so hospital rapid response called and evaluate pt, recommended transfer to ER.
Redness & swelling with thickening. Treatment: Watching for increase in size & pain over the next 48 hours.
Patient complained of pain in neck but the pain was gon when I called him today. The only pain he still had, was the pain around the injection site.
Small bumps on her face, then arms, and neck, she started swelling and itching.  Later that night she had trouble swallowing.