chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Child had temp of 99 during evening of 10/29, but then awakened on 10/30 with fine red rash on trunk, (Grandmother described as "what I would call a heat rash"). By that evening and continuing the next day he had bigger raised spots on chest, back and groin areas. Grandmother described these as "hives". Child did not display any other symptoms or signs of discomfort or distress. On 10/31, child continued to have rash with no further fever or other symptoms. They gave  BENADRYL over the weekend and saw their physician 11/3/09. Physician told them it was possibly exzema and prescribed Eucerin cream which they put on before bedtime. Child awakened 11/4 AM with more of the darker red, raised "hives" and seemed irritable and uncomfortable. They gave him the BENADRYL which made the bigger areas go away, but not the fine, light red rash to the trunk. Their physician advised them to bring the child to the Health Dept. for us to see so that we could determine what to do about any further immunizations. (We had advised family that they would need to get direction from child's physician regarding future immunizations.) On AM of 11/4, child was noted by Health Dept staff to have a fine, light red rash to entire trunk area with 1 or 2 larger, dark red, raised areas noted just under neck in left clavicle area. He was afebrile and did not appear ill or uncomfortable. Comments - Child received exact same immunizations on 9/2/09 without any reaction. Mom received injectable H1N1 vaccine (Sanofi Pasteur multi-dose vial) on 10/29/09 and is exclusively breastfeeding. Would it be possible for this to be an egg allergy in the child? (Maternal grandmother does have an egg allergy)
pt recvd flu vax & the following day, pt devel swelling, redness, & warmth @ the inject site;
Pt noticed soreness in arm 12/14, noticed some redness 12/14, 12/15, pt had welt on arm roughly 4" in diameter sore to the touch, no other symptoms observed/reported.
Jynneos administered intramuscularly; Case reference number US-BN-2022-001692 is a spontaneous case report initially received on 27-Jul-2022 from other health care professional via Communication (reference number: USBAV22-0690) and concerns a *39-year-old male patient.*  The patient's medical history and concomitant medication details were not reported.  On *13-Jul-2022*, the patient was vaccinated with the first dose of Jynneos (Smallpox and Monkeypox Vaccine, Live, Nonreplicating, batch number: FDP00002), at dose of 0.5 mL, administered intramuscularly (IM) in the *right deltoid region*, for pre-exposure prophylaxis (PrEP) (explicitly coded as 'Inappropriate route of vaccination'). As reported, the patient worked in a lab that handled monkeypox samples.  At the time of this report it was known that the patient did not experience any adverse event due to Jynneos vaccination.  This case is linked with cases no. US-BN-2022-001673, US-BN-2022-001687, US-BN-2022-001688, US-BN-2022-001689, US-BN-2022-001690, US-BN-2022-001691, US-BN-2022-001693, US-BN-2022-001694, US-BN-2022-001695, US-BN-2022-001696, US-BN-2022-001697, US-BN-2022-001698, US-BN-2022-001699, US-BN-2022-001700, US-BN-2022-001701, concerning the same reporter.  Non-significant case correction received from on 29-Jul-2022 included an additional reference number.  All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*).  Follow-up information received from a health care professional via on 09-Aug-2022 included patient details and additional information about the administrated dose of Jynneos.; Reporter's Comments: A 39-year-old male patient was vaccinated with the first dose of Jynneos, intramuscularly, at dose of 0.5 mL, in the right deltoid region, for pre-exposure prophylaxis which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company convention. At this point, it was known that the patient did not experience any adverse event due to Jynneos vaccination. The patient's medical history and concomitant medication details were not reported. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 39-year-old male patient was vaccinated with the first dose of Jynneos, intramuscularly, at dose of 0.5 mL, in the right deltoid region, for pre-exposure prophylaxis which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company convention. At this point, it was known that the patient did not experience any adverse event due to Jynneos vaccination. The patient's medical history and concomitant medication details were not reported. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
pt recv vax 08JUN93 & exp redness, swelling, & itching @ the inj site; 01SEP93 lab eval showed anti-HBs neg; No further details were provided;
Seemed to develop a bruise around the injection site initially. But then turned bright red and slightly warm to the touch. Redness is about 3 inches across in diameter, somewhat swollen but not particularly painful.
felt nausea and dizziness on day of vaccine. 2-3 days after sore throat, hard to swallow, 5 days after vaccine lost voice and/or voice change. no fever at any time
She still has symptoms of Covid; She still has symptoms of Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Nov2022 as dose 5 (booster), single (Lot number: GH9697) at the age of 74 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 03May2022 as dose 4 (booster), single (Lot number: FJY989) for covid-19 immunisation; BNT162b2 (BNT162B2), on 13Feb2021 as dose 1, single (Lot number: EL9266, Expiration Date: 31May2021), on 06Mar2021 as dose 2, single (Lot number: EN6205, Expiration Date: 30Jun2021) and on 03Nov2021 as dose 3 (booster), single (Lot number: 32030BD) for covid-19 immunisation. The patient's relevant medical history included: "borderline cholesterol" (unspecified if ongoing); "levels were really low" (unspecified if ongoing); "her hair was falling out all the time" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Osteoporosis" (unspecified if ongoing). The patient's medical history, reported also as family history included: "lot of heart problems" (unspecified if ongoing), notes: a lot of heart problems in the family and he wanted to be sure. Concomitant medication(s) included: ATORVASTATIN CALCIUM taken for blood cholesterol abnormal; LEVOTHYROXINE taken for blood parathyroid hormone decreased, alopecia (ongoing); ESCITALOPRAM OXALATE taken for anxiety; ALENDRONATE SODIUM oral taken for osteoporosis; VITAMIN D NOS; CALCIUM. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "not recovered" and all described as "She still has symptoms of Covid". The patient underwent the following laboratory tests and procedures: Weight: lost a lot of weight. Therapeutic measures were taken as a result of vaccination failure, covid-19 including PAXLOVID. It was also reported that her boys had aches, stated sore arms and aches with Covid vaccine.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300114979 same reporter/patient/product, different dose/event.;
Day of shot slight dizziness and weakness, second day minimal adverse reactions; slight chills, 3rd day (early morning) total body aches and pains, nausea and major dizziness; full body chills, extreme loss of strength; site of shot internal and external pain leading up to the back of neck, 4th day complete incapacitation  uncontrollable shacking from chills; bones ached; constipation; nausea without ability to vomit; 5th day same effects if not worse; still unable to vomit but feeling of endless need to stuck in upper chest, 6th day chills begin to break and body pain subsiding; still weak and dizzy with major headaches, 7th day chills are almost completely gone, body (muscles, tendons, etc) ridiculously tight and aching from the constant shaking from chills and restless sleep over 7 days.   Lots and lots of liquids from day 1; day 4 started taking minimal acetaminophen to ease pain and feelings of fever. Temperature never went above 96degrees.  Small portioned meals to get nutrients, and constant liquids to stay hydrated. This did not relieve any symptoms, until night 7 when pain started to subside. Constant stretching now to release the constricting of all my muscles and tendons over the course of side effects. Still constipated and slight nausea, still weak in strength.
Arm of injection painful; Exhausted; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Arm of injection painful) and FATIGUE (Exhausted) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     Concomitant products included AMLODIPINE, MONTELUKAST, CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) and SALBUTAMOL (PROVENTIL [SALBUTAMOL]) for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Jan-2021, the patient experienced INJECTION SITE PAIN (Arm of injection painful) and FATIGUE (Exhausted). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) ongoing since an unknown date at an unspecified dose and frequency; PREDNISONE ongoing since an unknown date at an unspecified dose and frequency and SALBUTAMOL (PROVENTIL [SALBUTAMOL]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, INJECTION SITE PAIN (Arm of injection painful) and FATIGUE (Exhausted) outcome was unknown. Not Provided          Concomitant medications reported were Amlodipine, Breonhaler, Montelukast, Claritin, Proventil inhaler  Treatment medicines include Advil, Prednisone, Massage, Bio Freeze cream, Tessalon Perles, Proventil inhaler   Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to INC.-MOD-2021-061274 (E2B Linked Report).; Sender's Comments:   INC.-MOD-2021-061274:Second Dose
Fatigue; lethargy; diarrhea; dizziness; headache; This is a spontaneous report from a contactable consumer (patient). A 34-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: En6199), via an unspecified route of administration in right arm on 04Mar2021 at 15:30 (at 34-year of age) as single dose for covid-19 immunisation. Facility type vaccine was Other. Patient did not receive any other medication within 4 weeks prior to the covid vaccine. Concomitant vaccinations included Sertraline, bupropion, acetaminophen, Allegra. No covid prior vaccination nor covid tested post vaccination. The patient's medical history was not reported. On 05Mar2021 at 08:00, the patient experienced Fatigue, lethargy, diarrhoea, dizziness and headache. The patient did not receive any treatment medication for the events. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
The next day after receiving the vaccine my arm was very swollen, with severe headaches and body aches to the point my teeth hurt. I was fatigued and had a slight fever. The swelling lasted a week, the fatigue lasted a few days, and everything else went away after 48 hours. Last week however I ended up contracting COVID and got RSV as a result. I am not taking any medication for it but I am recovering slowly, it has been about a week.
01/23/22 presents to ED for "epigastric abdominal pain, constipation and decreased appetite". PMHx of "CAD s/p DES (2018), Uncontrolled DM II, and HTN"
numbness in face started the day of shot most feeling has come back joint , muscular pain (feels like I am having a flair up) and fatigue still happening
itchiness in her left arm; rash in her left arm; swelling in her left arm; redness in her left arm; soreness; sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (soreness), VACCINATION SITE PRURITUS (itchiness in her left arm), VACCINATION SITE PAIN (sore left arm), VACCINATION SITE ERYTHEMA (rash in her left arm) and VACCINATION SITE SWELLING (swelling in her left arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced VACCINATION SITE PAIN (sore left arm). On 17-Apr-2021, the patient experienced PAIN (soreness). On 19-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (itchiness in her left arm), VACCINATION SITE ERYTHEMA (rash in her left arm), VACCINATION SITE SWELLING (swelling in her left arm) and VACCINATION SITE ERYTHEMA (redness in her left arm). The patient was treated with NEOMYCIN SULFATE, POLYMYXIN B SULFATE (NEOSPORIN [NEOMYCIN SULFATE;POLYMYXIN B SULFATE]) at an unspecified dose and frequency. On 10-Apr-2021, VACCINATION SITE PAIN (sore left arm) had resolved. On 17-Apr-2021, PAIN (soreness) had resolved. At the time of the report, VACCINATION SITE PRURITUS (itchiness in her left arm), VACCINATION SITE ERYTHEMA (rash in her left arm), VACCINATION SITE SWELLING (swelling in her left arm) and VACCINATION SITE ERYTHEMA (redness in her left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided Treatment for the event included ice presses
couple of hrs later her arm got sore; had tingling and tingling sensation it was bizarre, scary; pain was on her left side down neck and 2ft of back side, also all the way down fingers and arm,; starting having pain at injecting to her fingers; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (couple of hrs later her arm got sore), PARAESTHESIA (had tingling and tingling sensation it was bizarre, scary), PAIN (pain was on her left side down neck and 2ft of back side, also all the way down fingers and arm,) and VACCINATION SITE PAIN (starting having pain at injecting to her fingers) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced PAIN IN EXTREMITY (couple of hrs later her arm got sore), PARAESTHESIA (had tingling and tingling sensation it was bizarre, scary), PAIN (pain was on her left side down neck and 2ft of back side, also all the way down fingers and arm,) and VACCINATION SITE PAIN (starting having pain at injecting to her fingers). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. On 12-Feb-2021, PARAESTHESIA (had tingling and tingling sensation it was bizarre, scary), PAIN (pain was on her left side down neck and 2ft of back side, also all the way down fingers and arm,) and VACCINATION SITE PAIN (starting having pain at injecting to her fingers) had resolved. At the time of the report, PAIN IN EXTREMITY (couple of hrs later her arm got sore) had not 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.
10/28/03 received influenza vaccine c/o feeling nauseated during car trip home at 4:30pm. Next day, c/o nausea, chills, fever increase 101 deg, extreme fatigue, muscle aches. 11/3/03 still feels dizzy, nauseated, joint pain.
Swelling and redness at site that increased. She had Jello 4/18/2010 increased swelling in am Mother gave Benadryl 12.5 mg at 8 am on 4/19/10 and rubbing alcohol
SIDE EFFECTS; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. 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, expiry: UNKNOWN) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from side effects on MAR-2021. This report was non-serious.
Severe headache, malaise, flushing or low grade fever, disorientation. Slept 10.5 hours the night of 9/30 and felt relatively normal the next day.
From telephone contact received at manufacturer on 05/28/2002, it was reported that a 15-month-old male received ActHIB to the left thigh and MMR to the right thigh on 05/21/2002. Two days after vaccination, pt developed fever of 101.5 degrees F rectally. Pt's left thigh was swollen 25% more than the right thigh with splotchy red rash 2-3 inches around injection site (left thigh). CBC was normal and Amoxicillin administered.
Immunizations at 130pm 7-16-08; child ate well at 5am, 7-17-08; 8am-he was noticed to be blue, temp 106 degrees (ax), & unresponsive; hospitalized-seizures. 8/21/08-records received for DOS 7/17/08-ER report Fever, DC status epilepticus.  Patient transferred. 10/16/08-records received for DOS 7/17-7/31/08-DC DX: Encephalopathy/seizures. Presented to ED unresponsive, sweat and perioral cyanosis. Breathing funny, temperature 106. Jerking of arms and legs and stiffening. Intubation. decreased visual function, sluggish pupils, increased tone, trouble tracking. NG feedings. Transferred to rehabilitation facility.
floaters in her left eye which are still there; Fever; sore arm; very tired and run down afterwards; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VITREOUS FLOATERS (floaters in her left eye which are still there), FATIGUE (very tired and run down afterwards), MYALGIA (sore arm), PYREXIA (Fever) and PAIN IN EXTREMITY (sore arm) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 006C21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced FATIGUE (very tired and run down afterwards), MYALGIA (sore arm) and PAIN IN EXTREMITY (sore arm). On 30-Apr-2021, the patient experienced PYREXIA (Fever). On 01-May-2021, the patient experienced VITREOUS FLOATERS (floaters in her left eye which are still there). On 01-Apr-2021, FATIGUE (very tired and run down afterwards), MYALGIA (sore arm) and PAIN IN EXTREMITY (sore arm) had resolved. On 01-May-2021, PYREXIA (Fever) had resolved. At the time of the report, VITREOUS FLOATERS (floaters in her left eye which are still there) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported by the reporter.   No treatment medications provided by the reporter.   This case was linked to MOD-2021-176004 (Patient Link).
Client states that at 10:30am she ate breakfast. Shortly thereafter, she became quite nauseated and vomited. Also running a low grade fever. Did go to the ER and was given plenergen States she is still nauseated and will see her PCP 3/8. Went to PCP 3/8 no further nausea. Had Tb test done.
Information has been received from a medical assistant reporting that her son's girlfriend, 24 year old female, received her second dose of GARDASIL recently and within 4 hours the patient noticed a "pimple on her neck." When she woke up the next morning, the patient reported that her whole left arm and neck were extremely sore and that there was a circle approximately 4 to 6 inches above the injection site with about 12 bumps that the patient reported were "very sore to touch." The patient took a picture of the circular rash and sent it to the medical assistant. The medical assistant said that they were looking like shingles and that she told the patient to go to her doctor to be examined. Medical assistant said that the patient was convinced that her rash was a reaction to "the shot" of GARDASIL. The patient made an appointment with her Health Care Physician (HCP). The patient had not recovered from the events. Follow up information received from the medical assistant reporting that the GARDASIL injection was part of a dept of health. The patient went to her doctor and was diagnosed with a shingles outbreak. The GARDASIL injection had nothing to do with this while her first lesion appeared only 4 hours after the injection and she did have some discomfort in the site pain to the injection. Follow up information received from the medical assistant reporting that her son's girlfriend got unusual rash that day after her GARDASIL vaccine on 11-MAR-2011. The cluster of lesions on her neck ended up being herpes zoster (shingles). It had nothing to do with the GARDASIL vaccine. The patient was treated with antiviral medications and prednisone and was healed and was fine. The patient was due to have her third dose vaccine this summer. Her physician gave no contraindication to receiving this injection. Additional information has been requested.
pregnant; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (pregnant) in a 40-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Pregnancy on 09-Nov-2018 and Miscarriage on 01-Jun-2020. Concurrent medical conditions included Pregnancy since 25-Aug-2020. Concomitant products included VITAMIN D NOS, IRON, PARACETAMOL (TYLENOL) and CALCIUM MEFOLINATE (L METHYLFOLATE) for an unknown indication.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 01-Aug-2020 and the estimated date of delivery was 04-May-2021. On 05-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-second week of the pregnancy.  On 05-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Aug-2020, Pregnancy test: positive (Positive) Positive. In November 2020, Genetic counselling: ok normal. In November 2020, Puncture site haemorrhage: failed Failed. In November 2020, Ultrasound uterus normal: ok ok.     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.   Patient had Live full-term birth on 09NOV2018 and  had  Miscarriage one 01JUN2020.  patient took Tylenol 7times in pregnancy. 2nd dose is schedule on 2-feb-2021.