chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had ibuprofen at 715pm prior to bedtime for teething.  cried out in sleep and began having tonic/clonic arm/leg movements and eye twitching.  lasted several minutes.  vomited afterwards.  had had slight diarrhea the day prior.  no fever.  after vomiting appeard drowsy.  mom drove patient to ER.  en route had another seizure, tonic/clonic with twitching/stiffening, lasted several minutes, vomited afterwards.  in ER vomited twice more.  afebrile on arrival to ER.  no fever noted at home, but had had ibuprofen as noted above prior to bedtime.  appeared post-ictal drowsy afterwards in ER, within 1 hour returned to baseline mental status by 230am in ER.  Admitted to pediatric floor at hospital for further monitoring.  received IV zofran x1 in ER for vomiting.
Pt recv vax 11DEC97 & 13DEC97 devel a varicella rash that consisted of a couple of lesions on back;
Booster was given on 10/11.  At 6:00 am on 10/16, noticed extreme soreness in biceps femoris (both thighs) upon going down stairs. Worse going down than going up the stairs.  Almost no soreness when stationary.   A little better this am (10/17), but still sore when desending stairs.
Give Td 09/23/2003 for laceration on buttocks.  Last DPT 09/18/1998.  09/24, mom noticed 1/2 dollar size redness around shot area.  Seen 09/25: 2.5 inch diameter red area around area-raised-warm to touch.
Sudden onset nausea after vaccine. Rest, water, provided, monitored for 30 min. Family called for transport home. Ambulated off grounds.
Red, LD area of 3 x 3" red swollen hot to touch; where vaccines given. Child eating, sleeping well, plays normal. Some pain off and on. 0 Fever.
flu like symptoms for 36-48 hours; injection site pain; pain on the left side, at the armpit; pain in the swollen lymph nodes; pain in the swollen lymph nodes; This is a spontaneous report from a contactable consumer reported for himself. This male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at left arm on 15Jan2021 night at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had the vaccine on 15Jan2021 night and had a pretty severe reaction (in Jan2021) that were described as flu like symptoms for 36-48 hours. He felt like that's over with now. He got the vaccine on his left arm. The injection site pain lasted for 24 hours. After 34 hours, he had a pain on the left side, at the armpit. He said it got better 36 hours ago. He was wondering if pain in the arm where the shot was administered in the armpits were reported as a side effect and how long will the pain in the swollen lymph nodes last. The outcome of "flu like symptoms" and "injection site pain" was recovered, of "armpit pain" was recovering, of other events was unknown.  Information on the lot/batch number has been requested.
Major Migraine headaches  with nausea started on May 7, 2021, additional migraines on May 9, 2021, May 11, 2021 continuing through May 12, 2021.
felt shitty; histamine response; Chills for about 2 hours; fever of 100.1; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of FEELING ABNORMAL (felt shitty), HYPERSENSITIVITY (histamine response), CHILLS (Chills for about 2 hours) and PYREXIA (fever of 100.1) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced FEELING ABNORMAL (felt shitty), HYPERSENSITIVITY (histamine response), CHILLS (Chills for about 2 hours) and PYREXIA (fever of 100.1). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (MOTRIN CHILDREN) at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (felt shitty), HYPERSENSITIVITY (histamine response), CHILLS (Chills for about 2 hours) and PYREXIA (fever of 100.1) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Feb-2021, Body temperature: 100.1 (Inconclusive) 100.1. On 12-Feb-2021, Heart rate: 125 (High) resting heart rate was 125, it is normally 55.  On walking around and her heart 125 and went up as high as 140.  at 4am and still her heart rate was about 85. On 13-Feb-2021, Heart rate: 55 (Inconclusive) it went down to 55..     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 provided Treatment information provided as Fluids
I recieved my second vaccine 4/8/2021. Beginning of May to mid may range,  I developed chest pains, palpitations,  dyspnea, fatigue on and off. It was never severe enough to go to doctor.  It never got better so I saw my PCP. She ordered lab tests and Holter monitor which came back fine.  I chalked it up to my zoloft not working and had her increase my dose in case it was anxiety related. I saw that we should report things if they seem odd so just wanted to make you aware
my 2 daughters were injected were all poorly by the end of the day; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (my 2 daughters were injected were all poorly by the end of the day) 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 19-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Dec-2021, the patient experienced VACCINATION COMPLICATION (my 2 daughters were injected were all poorly by the end of the day). At the time of the report, VACCINATION COMPLICATION (my 2 daughters were injected were all poorly by the end of the day) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-423275, MOD-2021-423257 (Patient Link).
After about 10 minutes I felt a wave of heat wash over me. Then I felt brief light-headedness and begin experiencing shortness of breath. The shortness of breath would intensify and then abate but not like a panic attack it was directly related to the shot. After about 20 minutes is subsided 9 days later I still feel weak and fatigued. There was no emergency rescue precautions available for me had at the site had the situation worsen 3 weeks prior I had The first shot of my shingles vaccination.
Presented to ED with weakness from an assisted living. Generalized body aches and headaches started on 2/5/23.
Pneumonia; This is a spontaneous report from a contactable consumer via a Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was due to get her second dose of Pfizer Covid-19 vaccine however she had gotten pneumonia 2 weeks after getting the first dose and she's currently on antibiotics. She wanted to know if it's safe for her to take the second dose. The outcome of the event was unknown. The event was assessed as serious-medically significant.  Information about lot/batch number has been requested.
onset 2PM awoke w/painful lt leg; unable to bear wt w/fever 101 started on APAP 330PM t102.9 progressing to 103.4; given APAP q 4-5 hrs & warm packs to lt thigh QID;
Developed  a few hives 8 hours after vaccination which continue to come and go. On day 8 after vaccination development itching at vaccination site followed by rash. On day 11, rash is itchy, sometimes sore, and continues to spread.
Pneumovax given on 10/20/2003.  Patient reports fever, painful arm on 10/23/2003.  Seen by physicians.  No antibiotic given.
Frozen Left Shoulder, loss of range of motion and pain in left arm, NOVOCAIN shot, NSAIDs, Steroid shots, planned physical therapy.
Mother took child to ER after receiving MMR in the clinic.  ER physician instructed mother the fact child has bronchitis she was having a reaction.  Noted next am round and rashy area.  Treated with Benadryl, rash only on arm.
Vaccine was given in the right thigh.  On the 5th day, the right thigh became swollen to twice the size of the left and normal thigh.  It had a hive like rash that was red and felt hot to the touch.  It was itchy.  There was no fever or pain.  It did NOT respond to Benadryl.  It remained the same for 3 days, but went from red to pink.  It fully disappeared the 4th day.
Symptoms - fever, chills, nausea, dizziness, localized, swelling, redness and pain and myalgia, headache. Developed in 22 hours. After vaccination administered; Treatment - supportive treatment - antipyretics (Motrin and Tylenol)
inner side of left arm is painful the arm pit tomy waistband.; Inner side of left arm is painful the arm pit tomy waistband.; Headache; Body pain; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW62O5) via an unspecified route of administration in the left arm on 09Mar2021 at 11:30 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included migraines.  Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously took axocillin (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date and experienced drug allergy. On 09Mar2021 at 23:00, on the first day, the patient experienced 24 hours of headache and body pain. The same symptoms had carried  on into the second day. On 11Mar2021, the patient's entire inner side of left arm was painful, the arm pit to the waistband. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events inner side of left arm painful, the arm pit pain to the waistband, headache and body pain were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
dull ache in the arm spread down the arm below the elbow to the inside; Very warm; Very hot; Rash continues to grow every day; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Very hot), FEELING HOT (Very warm), PAIN IN EXTREMITY (dull ache in the arm spread down the arm below the elbow to the inside) and RASH (Rash continues to grow every day) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No medical history was provided by the reporter. .  Concomitant products included METFORMIN, LISINOPRIL and FLUTICASONE for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced FEELING HOT (Very hot) and RASH (Rash continues to grow every day). On 27-Feb-2021, the patient experienced FEELING HOT (Very warm). On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (dull ache in the arm spread down the arm below the elbow to the inside). The patient was treated with LORATADINE at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 27-Feb-2021, FEELING HOT (Very hot) had resolved. On 02-Mar-2021, FEELING HOT (Very warm) had resolved. On 14-Mar-2021, PAIN IN EXTREMITY (dull ache in the arm spread down the arm below the elbow to the inside) outcome was unknown. At the time of the report, RASH (Rash continues to grow every day) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
a red rash that itches; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (a red rash that itches) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     Concomitant products included ATENOLOL, PRAVASTATIN, DEXAMETHASONE (MAXIDEX OPHTHALMIC [DEXAMETHASONE]), LORAZEPAM (ATIVAN), CHLORMEZANONE (RESTORIL [CHLORMEZANONE]), AMLODIPINE BESILATE (NORVASC), IBUPROFEN and GABAPENTIN for an unknown indication.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced RASH PRURITIC (a red rash that itches). At the time of the report, RASH PRURITIC (a red rash that itches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications like Alcohol to stop itching, Benadryl capsule and Benadryl cream were included.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow-up received on 25-MAY-2021 and contains no new information
30 minutes after vaccine pt developed rash on arms and had tingling in right arm.  No other symptoms. Gave 1 dose of 50mg benedryl and within 15 minutes the tingling had stopped and the rash went down. Monitored for 30 minutes and the pt was then released.
pretty strong reaction which includes injection is quite warm, red, and itchy; soreness; sore throat; pretty strong reaction which includes injection is quite warm, red, and itchy; pretty strong reaction which includes injection is quite warm, red, and itchy; fatigue; headache; This spontaneous case was reported by a patient and describes the occurrence of INJECTION SITE WARMTH (pretty strong reaction which includes injection is quite warm, red, and itchy), PAIN (soreness), OROPHARYNGEAL PAIN (sore throat), INJECTION SITE PRURITUS (pretty strong reaction which includes injection is quite warm, red, and itchy) and INJECTION SITE ERYTHEMA (pretty strong reaction which includes injection is quite warm, red, and itchy) in a 67-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. A57644C) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Patient had no relevant medical history, allergy, concomitant diseases and risk factor. It was reported that patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (1st dose , Lot 037K20A) on 17-Jan-2021, MODERNA COVID-19 VACCINE (2nd dose , Lot 041L20A) on 13-Feb-2021, Moderna COVID-19 Vaccine (3rd dose , Lot 046C21A) on 22-Oct-2021, Moderna COVID-19 Vaccine (4th dose , Lot 058A22A) on 02-Jun-2022, Moderna COVID-19 Vaccine (5th dose  and A57148B) on 09-Sep-2022. Past adverse reactions to the above products included No adverse event with MODERNA COVID-19 VACCINE, Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine.    On 01-Aug-2023, the patient received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 01-Aug-2023, the patient experienced INJECTION SITE WARMTH (pretty strong reaction which includes injection is quite warm, red, and itchy), PAIN (soreness), OROPHARYNGEAL PAIN (sore throat), INJECTION SITE PRURITUS (pretty strong reaction which includes injection is quite warm, red, and itchy), INJECTION SITE ERYTHEMA (pretty strong reaction which includes injection is quite warm, red, and itchy), FATIGUE (fatigue) and HEADACHE (headache). At the time of the report, INJECTION SITE WARMTH (pretty strong reaction which includes injection is quite warm, red, and itchy), PAIN (soreness), OROPHARYNGEAL PAIN (sore throat), INJECTION SITE PRURITUS (pretty strong reaction which includes injection is quite warm, red, and itchy), INJECTION SITE ERYTHEMA (pretty strong reaction which includes injection is quite warm, red, and itchy), FATIGUE (fatigue) and HEADACHE (headache) 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 medication was reported.  Suspect product dosage text was reported as unknown. No treatment medication was reported.
Spontaneous cardiac arterial dissection (SCAD): Starting 5/16/2021, patient had chest pain, shoulder pain, and some nausea. She went to the ER just after midnight on 5/17. She was hospitalized, had angiogram which confirmed blockage in artery off of RCA, was put on medications (Plavix,  aspirin and a statin), and released later on 5/17. She had a recurrence on 5/21, was hospitalized for 3 nights at the University, repeat angiogram, and her medications modified (statin stopped; a beta blocker and calcium channel blocker started).
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 46-year-old female patient (not pregnant) received bnt162b2 (BNT162B2 NOS), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hashimotos" (unspecified if ongoing), notes: other medical history: Hashimotos, EDS, Meiges Syndrome; "wheat" (unspecified if ongoing), notes: known allergies: Peanuts, legumes, wheat; "Peanuts" (unspecified if ongoing), notes: known allergies: Peanuts, legumes, wheat; "legumes" (unspecified if ongoing), notes: known allergies: Peanuts, legumes, wheat; "EDS" (unspecified if ongoing), notes: other medical history: Hashimotos, EDS, Meiges Syndrome; "Meige's Syndrome" (unspecified if ongoing), notes: other medical history: Hashimotos, EDS, Meiges Syndrome. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 25Sep2023 to 29Sep2023.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
About 5 minutes or more of receiving vaccines, pt was sitting an a chair in the clinic and slumped to floor on her abdomen, apparently unconscious and having involuntary jerking of lower extremities.  Was immediately orally responsive when approached by this RN & stood up on her own, responded appropriately and got up on exam table on her own.  Pulse, resp and responses normal.  Denied dizziness and not certain she hit her head.  After returning home had chills and dizziness and the next 2 days had a migraine.  No further dizziness on 10/12 and did return to school.
The day after the shot I noticed a redness and swelling around the vaccination site. It's hard to the touchy and itchy. It feels and looks like a huge welt.
The message from this patient's insurance was they had already received their annual influenza vaccine. This person received 2 in one calendar year
Information unavailable.  Medical records have not been received from  facility.  Patient tested positive for Covid 19 on 11/08/2021 and passed away on 12/04/2021 with Covid 19 listed as a cause of death on certificate.
This spontaneous report as received from a Registered Nurse regarding a 4 year old Child patient of unknown gender. There was no information about concurrent condition, historical medication and concomitant medication. On 31-OCT-2018, the patient was vaccinated with improperly stored PROQUAD for prophylaxis (product storage error). Vaccine was stored out of range at -6 degrees for an approximate time of 15 minutes. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1902USA001085.
Mother states that child developed "pseudogout" of left foot 1 week post vaccine; reported by mother to child's health care provider; prescribed Celebrex; resolved within 1 week
largest fluid filled blisters was the size of a dime; Bullous episode; Diagnosed with bullous pemphigoid/areas affected include the hands, arms and under arm area of chest/recent outbreaks on right lower leg; This spontaneous case was reported by a consumer and describes the occurrence of DERMATITIS BULLOUS (Bullous episode) and PEMPHIGOID (Diagnosed with bullous pemphigoid/areas affected include the hands, arms and under arm area of chest/recent outbreaks on right lower leg) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced PEMPHIGOID (Diagnosed with bullous pemphigoid/areas affected include the hands, arms and under arm area of chest/recent outbreaks on right lower leg) (seriousness criterion medically significant). On 24-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DERMATITIS BULLOUS (Bullous episode) (seriousness criterion medically significant). On an unknown date, the patient experienced BLISTER (largest fluid filled blisters was the size of a dime). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency and DOXYCYCLINE ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, DERMATITIS BULLOUS (Bullous episode), PEMPHIGOID (Diagnosed with bullous pemphigoid/areas affected include the hands, arms and under arm area of chest/recent outbreaks on right lower leg) and BLISTER (largest fluid filled blisters was the size of a dime) outcome was unknown.            No relevant concomitant medications were reported.   This case was linked to MOD-2021-417920 (Patient Link).; Sender's Comments: This case concerns a 72-year-old, male patient with no relevant medical history, who experienced the unexpected event of Bullous Pemphigus. The event occurred approximately 7 days after the second dose of mRNA-1273 (Moderna covid-19 vaccine). The rechallenge was not applicable as event occurred after second dose. The benefit-risk relationship of mRNA-1273 (Moderna covid-19 vaccine) is not affected by this report.
Flushed at first. Extreme fatigue for two days. Rash on chest which is most visible after showering. Rash seems to be lessening with each passing day.
Pat. developed a 12cm in diameter red, hot, swollen area on left deltoid on 22nd April where the vaccine had been administered. Pat. received antibiotic treatment for cellulitis of left deltoid and was discharged on 04/23/12.
Swelling, redness and itching at injection site  Approx 3 to 4 inch diameter Achy, headache, chills, nausea