chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a nurse via call center representative and described the occurrence of injection site rash in a 59-year-old male patient who received BOOSTRIX (batch number X9YP3, expiry date 2nd October 2020) for prophylaxis. On 13th July 2018, the patient received BOOSTRIX .5 ml. On 16th July 2018, 3 days after receiving BOOSTRIX, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash was recovered/resolved. It was unknown if the reporter considered the injection site rash to be related to BOOSTRIX. Additional information received as follows: At 14:58, the patient received BOOSTRIX on the left deltoid. The patient experienced a dry rash at injection site. It was unknown how long it took to resolve.
Information has been received from a physician concerning a 48 month old female (medical history and drug reactions/allergies reported as none) who on 08-JUN-2006 was vaccinated with Vaqta (lot #653619/0144F). Concomitant medications was reported as none. On 11-JUN-2006, the patient developed red, itchy, raised, maculopapular rash that was non-crusting. The rash was widely distributed over her body and the total number of lesions was about 50. The patient was treated with over the count diphenhydramine hydrochloride (BENADRYL). The patient's red itchy raised maculopapular non-crusting rash persisted. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Admitted overnight for stiff neck and headache. Treated with Tylenol and Ibuprofen.
Patient living at facility house who has a guardian due to a diagnosis of Parkinson associated dementia.  Sent to the emergency room by staff because of change in condition including difficulty talking, hypotension. Chest x-ray is consistent with a left lower lobe pneumonia and he has a very moist cough.    Patient was admitted and treated with IV antibiotics for the potential pneumonia and his vital signs were stable and he clinically improved.  He will be discharged on PO levofloxacin to complete an antibiotic course. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
Patient states has red welts (size of a quarter) warm to the touch around the site of injection. No other symptoms reported.
Information has been received from a physician concerning a 13 year old female patient with asthma, peanut allergy, shellfish allergy, Ipratropium (Atrovent) allergy, and ibuprofen (Motrin) allergy who on 09-Jul-2008 was vaccinated with the first dose of GARDASIL (lot# 660393/ 0067X). 0.5ml, intramuscularly. Concomitant therapy included unspecified asthma drug. The physician stated that on 09-Jul-2009, the patient developed muscle ache, weakness, clammy hands and was feverish for five hours after receiving GARDASIL. The physician reported that the patient received VERO, DTAP at the same office visit. No other symptoms reported. On 10-Jul-2008 the patient had recovered. Additional information has been requested. This is in follow-up to report (s) previously submitted on 10/14/2008.  Initial and follow up information has been receivede from a physician concerning a 13 year old female patient with bronchial asthma, peanut allergy, shellfish allergy, honey allergy, strawberry allergy, ATROVENT allergy, and MOTRIN allergy who on 09-JUL-2008 at private doctor's office /hospital was vaccinated with the first dose of GARDASIL (Lot # 660393/0067X), 0.5 ml, intramuscularly.  Concomitant vaccine include ADACEL.  Concomitant drug included unspecified asthma drug.  The physician stated that on 09-JUL-2008, the patient developed muscle aches, weakness, clammy hands and was feverish for 5 hours after receiving GARDASIL, and then recoved spontaneously the same day.  No further information is available.
DIZZY, ESPECIALLY UPON STANDING/CANNOT STAND WITHOUT ASSISTANCE; BAD FLU; TEMPERATURE WAS "OVER 99 DEGREES AND RISING; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: type 1 diabetic. The patient received covid-19 vaccine  (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 02-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 02-SEP-2021, the patient experienced dizzy, especially upon standing/cannot stand without assistance. On 02-SEP-2021, the patient experienced bad flu. On 02-SEP-2021, the patient experienced temperature was "over 99 degrees and rising. Laboratory data included: Body temperature (NR: not provided) 99 degrees and rising. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from temperature was "over 99 degrees and rising, dizzy, especially upon standing/cannot stand without assistance, and bad flu. This report was non-serious.
Mom states localized redness noted @ inject site 11MAY92; AM of 12MAY92 mom noted redness, some swelling & heat to inject site & including arm-above elbow on posterior side; 13MAY92 mom brought pt to clinic to eval rxn; cellulitis given ATB
SICK FOR 16  HOURS; LOOPY; ACHES; CHILLS; FEVER; 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. As per procedure no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced sick for 16 hours, loopy, aches, chills, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sick for 16 hours, loopy, aches, chills, and fever. This report was non-serious.
Mom told doctors at clinic that child had a seizure and became limp later that day after receiving immunizations. CT scan at clinic was normal but MRI was ordered when child had (R) side weakness and did not recover from sedation after CT scan. Child is in ICU now and cannot move (R) side.
1/26/2021;14:15 Felt dizzy 5 mins after vaccine was given;14:30 Dizziness faded; 16:30 Tiredness and sore feeling began, took 2x200mg of Ibuprofen; 5:15 Chills began, no appetite, got under a heated blanket and slept; 21:40 Woke up with chills and sweats, took 2x200mg Ibuprofen. No fever, light headache. Very tired ;21:50 Tried sleeping, toss and turned a lot; 23:00 Little to no appetite, loss sense of taste and smell; 23:10 Went back to sleep, very tired 1/27/2021; 07:00 Whole body aching, took 2x200mg of ibuprofen. Spine and upper back were painful. Zero energy. Smell and taste returned. Fell back asleep; 07:50 Aches in spine and upper back. Feeling hot with sweats. Tough saving up energy to get food. No appetite until now. No energy to get up. Slept again; 10:30 Woke up and had enough energy to eat a little chicken soup. Sweating began. Went back to sleep; 12:20 Chills returned, took 2x200mg ibuprofen, went back to sleep; 1/28/2021; 06:00 Woke up sweating, spine and upper back hurt, went back to sleep 07:45 Vivid dreams, woke up with headache, no chills or sweats, a little sore, very little energy, took 2x200mg Ibuprofen, went back to sleep; 09:45 Got COVID Tested; 10:00 Negative Results; 10:15 Can finally eat a handful of cereal; 12:00 Back sore, little energy, took 2x200mg Ibuprofen, head felt cloudy
28 year old man without prior history of smallpox vaccination reported rash (onset date of mid-June 2008 approx). Lab testing performed: orthopox/vaccinia PCR positive, anti-vaccinia IgM and IgG ELISA positive (by CDC). Case is linked to 3 other contact transmission cases all of which are members of the same facility.  There has been no identification of further transmission of any of these cases to family members or other close contacts. The source case has not yet been identified but the investigation is ongoing.
swelling of face, bad rash all over body, stomach pain. rash sporadically on her ankles, calves, groin area and arms and she says her throat feels tight. Sought care in ED (benadryl/steroids). Not within 4 hours. Blanchable urticarial rash to the upper and lower extremities
Fainted, followed by low blood pressure and vomiting.  Severe nausea lasted for 3 hours following the event.
Patient was given Pfizer Covid-19 vaccine for age 5-11 undiluted at dose of 0.3ml at 12:34 pm.  At 6:30 pm patient was notified of the error.  Patient reported no adverse events.
The pain in my arm has been severe since a few hours after the second dose shot. Range of motion is extremely limited. Symptoms are not reduced by extra strength Tylenol. Cold compress provides temporary relief of pain, but not increased range of motion.  Pain was less severe at the end of day 4, but has returned to very severe on the morning of day 5.  I am unemployed and uninsured so I have not been able to seek medical care.
Patient started to get hives all over his back one day after receiving the Moderna booster dose.
temp 104 R came down w/APAP & sponge bath then back to 102; cried & whimpered all night; next day 24-48 hrs recovered;
Pt was administered a pediatric monovalent Pfizer vaccine instead of a pediatric bivalent Pfizer booster. Pt was also administered a booster too early as the patient's last vaccine was on 10/25/2022 and the vaccine was administered on 12/13/2022. The patient's mother has been notified and advised to follow up with the patient's pediatrician. the mother reported no adverse effects from the vaccine at the time she was spoken to.
pt recvd 2nd dose of Hep B & p/ routine exam of right ovary a 5 cm cyst noted.
I experienced chills and fever with 8 hours after the vaccine, which I expected as a side effect. Then 36 hours after the vaccine a rash broke out on my arms, neck, stomach, back, and chest - which was unexpected. I took a Benadryl, and the rash cleared in about 24 hours.
Received dose #2 of Pfizer COVID vaccine 1/12/2021.   On 3/27/2021 developed body aches, cough, diarrhea, headache, and nasal congestion.   Tested positive for COVID;.
This spontaneous report was received from a healthcare provider regarding unspecified number of patients of unknown age and gender. The medical history of patients and their concurrent conditions were not reported. On unknown dates in January 2016 (also reported as since 11-JAN-2016) unknown number of patients were administered with improperly stored doses of VAQTA (lot # L008665, expiry date 10-FEB-2017) dose, route unknown. Concomitant medications were not reported. It was reported that there were no previous temperature excursion to the product. No adverse effects were reported. Product quality complaint (PQC) was not filed. This is one of the three reports received from the same reporter. Additional information has been requested.
Received vaccine after temperature excursion; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT STORAGE ERROR (received vaccine after temperature excursion) in a 48-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced PRODUCT STORAGE ERROR (received vaccine after temperature excursion). On 18-Mar-2021, PRODUCT STORAGE ERROR (received vaccine after temperature excursion) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.   No treatment information was provided.
Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Mild, Additional Details: patient has a fear of needles and administration of injections. Patient was anxious and possibly overheated in warm store. Patient fainted when attempting to sit down, No visible injuries, refused trip to hospital.
The child was injected with 0.2ml of Pediatric Pfizer. The vaccination went smoothly --the child was calm. The child was in the waiting area with his family and within 5 min felt nauseous and vomited. The child then became less responsive  and was not focusing with his eyes when family members were talking to him.  He closed his eyes and was not answering when family talked to him. His breathing  seemed normal and he was sitting on his own. Help was called and paramedics responded quickly and took him to the ambulance.
1. Inflammatory Bowel Disease - unable to tolerate foods such as gluten and red meat - this is ongoing
Fainted and began twitching that lasted 10-15 seconds followed by extreme fatigue and trouble staying awake, vomiting, severe headache, nausea
Blotchy red rash. Sore and itchy. Started days later at injection site and nearby.
swollen throat, itching all over body and swelling around base of the head, groin and buttocks.  Treatment- took Benadryl orally  and topical Outcome- swelling and itchiness still exists
On 20 Sep 2021, within 2 minutes of receiving the shot, I began experiencing tightness in chest/heart.  Though, I did not think it was so serious that I needed to report it. I left the pharmacy where I received the shot and went home.  The tightness in heart turned into a pain  as the night went on and has remained somewhat constant since.  I also experienced a burning sensation in the area of my heart the first night of the shot.  On 22 Sep, around 3:00 p.m, I realized the pain I was constantly feeling in my heart, was now also under my left arm in the armpit area.  It hurts to touch and is visibly swollen.
A non-serious spontaneous report of dizziness, nausea, and vomiting has been received from a nurse concerning a 47-year-old female, subsequent to H1N1, Intranasal. Neither relevant medical history nor concomitant medications have been reported for this patient. On 21-Oct-2009, the patient received a single dose of H1N1. On 28-Oct-2009, the patient developed dizziness, nausea, and vomiting. The outcome of the events was not reported.
MD is a 94 y.o. female retired pediatrician with a history of progressive dementia, depression, with a recent ED 2 weeks ago after a fall and had negative CT work-ups who presented to RMH 2/13/2023 with AMS, SOB for 2 weeks. Hospital course complicated by GOC, need for placement, COVID 19 diagnosis delayed discharge further.    1. Acute Metabolic Encephalopathy: For 2 weeks, although seemingly has had a longer and more severe decline. Sluggish, more somnolent at PCP office.  BMP, CBC, TSH, LFT, ammonia unremarkable. CT of the brain showed no acute new changes. Suspect progressive dementia complicated by COVID + pneumonia. Improved overall.  2. COVID 19: O2 was 88% at PCP office. Imprved in the ED. Stopped decadron 2/14/23. Chest x-ray was clear.  CTPA was obtained which showed no acute PE or pneumonia. Isolation per policy.  3. Dementia: Stopped Seroquel due to drowsiness. Consulted palliative due to concern for advanced dementia that has progressed to lack of appetite, bed bound status, incontinence. Transitioned to CC and medications simplified on discharge to align with GOC.
Swollen and painful joints in knuckles, wrists and elbows starting day 10 and still continue using now on day 12.
Received the 2nd Covid-19 vaccine approx 10am, approx 7 hours later she became red, lethargic, felt like she had resistance against her movements, and was "going through jello". She went home, took Benadryl 25 mg, now with rash/hives along various areas, behind her ears. Has an epipen at home but has never had to use.  Denies any throat swelling or scratching, no shortness of breath.
Vomiting, diarrhea, clear runny nose, fussy, morbiliform red color weight loss of 17 ounces. Treatment includes symptomatic treatment, tylenol motrin, phenergan for vomitting, clear fluids.
4/26/12 LA hot to touch, edematous, red down to elbow. No pain on movement. Advised GM to administer ADVIL & BENADRYL as directed, warm compresses to affected area.
allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (allergic reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     NO MEDICAL HISTORY WAS GIVEN.  The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (allergic reaction). At the time of the report, HYPERSENSITIVITY (allergic reaction) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: No specific follow-up information recorded.
Exactly a week after receiving the J&J vaccine, I was out on my morning walk when my head became very fuzzy and my vision was altered (seeing jagged zigzags-fuzzy ones with my left eye).  The vision issue persisted when I closed my eyes.  The fuzzy head issue continued during a very difficult walk home and when I arrived and things didn't clear, my husband ended up taking me to the emergency room.  I got in quickly because the symptoms I described sounded to them like a stroke.  But, I didn't have a stroke.  They did a CT scan.  It was fine.  The vision thing they thought sounded like the effect of a migraine.  But, I've never experienced migraines.  (Note: this incident occurred the day before the news of the J&J blood clots became public).  Anyway, after a couple of hours in the emergency room, I was fine and went home.  So, I don't know what happened and it probably didn't have anything to do with the vaccine.  I'm not prone to being alarmist and I would only consent to go to the emergency room if I thought I were in a serious situation.  The blood work indicated my platelets were in the normal range.  And, I'm too old to be in the category of the six women who experienced blood clots.  However, I just thought I should report this in case anyone else experiences something similar.
Initial adverse reactions evening of 6/30/2021, days of 7/1-2/21:  extreme fatigue, low grade fever, body aches, bad headache. chills. 2nd more severe adverse reaction - 7/10/21: Upon awakening Saturday, 7/10: extreme pain, swelling of right hand below third joint of thumb to past the right wrist.  swollen lump on surface vein below thumb. Tender to touch, warmer than surrounding skin, with red, purplish discoloration.  Unable to turn wrist, overwhelming pain.  Unable to use hand.  Lasted a couple of days.  Hard lump in vein still remains.  Consulting with a Cardiologist, he diagnosed it as a Superficial Thrombophlebitis and recommended taking an NSAID med and using warm compresses, as well as raising arm above heart.
Insomnia for first two days.  However, the dizziness began the day after and has not stopped (Currently on Day 12).  Have had ulnar nerve pain in side of injection, resulting in numbness and tingling in hand.  Visited a doctor who performed basic check ups, and just told me to wait it out.  Have also had weakness in muscles and lowered stamina for simple things like walking. Used to walk 2+ miles per day, can barely manage 15 minutes now.
Itching under arm after about a week followed by slight redness near injection site over the next 4-5 days. I it has been 13 days and today the rash has gotten much bigger.
Red and swollen arm (R upper) 2 days after vaccination on 10/21/09. Glands under R arm tender to touch. Date of doctor visit 10/23/09. R deltoid 4" x 1" erythematous and maculopapular warm to touch. Dx Cellulitis treated with CEPHALEXIN 500 mg 1 cap tid x 10 days.
started taking Paxlovid last Sunday and is on her 4th day of the treatment; started taking Paxlovid last Sunday and is on her 4th day of the treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 82-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "started taking Paxlovid last Sunday and is on her 4th day of the treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
About 10 hours after the injection, I woke up with fever, extreme shaking, muscle pain and bad headache.   The fever and chills lasted until the middle of the next day.  The muscle pain lasted 2 days, and the headache lasted 3 days.
She reports poking sensation between her scapulae along with initially left then also right sided paresthesias down to her wrists
Information has been received from a physician referring to a patient of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was not reported. On 27-OCT-2015 the patient was vaccinated with a dose of improperly stored ROTATEQ (lot # L008031 with expiration date of 03-AUG-2016; strength, dosage and frequency unspecified) orally. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
p/vax pt devel a 3inch by 5 inch area of swelling @ the inj site;pt recovered;devel an inj site rxn;
1) 3/19/2021 Rash - both legs + inner thighs 2) 4/19/2021 Groin infection 3) 4/23/2021 Check up of above 4) 5/26/2021 Rash over right eye 6) 6/19/2021 "        "      "      ', etc (above) 7) 7/8/2021   "        "     eyes +above 8) 12/30/2021 Groin infection + Rash nose 9) 1/27/2022 Check up above
Red, Streaky Rash on thigh where DTaP vaccine was injected.  It is about 4 inches by 4 inches.  Hot, red, swollen, and stiff.  The injection site is light purple.
Information has been received from a pharmacist referring to an immunocompetent currently 72 years old female patient. The patient's current conditions, concomitant medication and medical history were not reported. On 10-OCT-2018, the patient was administered a dose of PNEUMOVAX 23 (lot # R016640, expiration date 28-JAN-2020) intramuscularly for prophylaxis. The patient thought she had never received PNEUMOVAX 23. The patient discovered a receipt from an unknown date in "2013" that showed she was administered PNEUMOVAX 23 (lot # and expiration date were unknown) when she was 67 or 68 years old, therefore the dose she was administered on 10-OCT-2018 was actually a second dose. No adverse effect reported.
Fever (fluctuates between 99-102 F), nausea, diarrhea, dizziness, vertigo, no appetite, extreme fatigue, headaches, body aches, joint pain. Symptoms have been ongoing since a few hours after vaccine and still continue today and have not improved. ER administered fluids and gave zofran and toradol and recommended I reach out for further treatment options.