chrisvoncsefalvay/vaers-outcomes huggingface dataset:
69 M with PMH sig for DM, Type II, aortic stenosis s/p bioprosthetic valve, COVID on 2/8/21 had COVID vaccination with sudden onset loss of appetite, nausea, diarrhea, loss of sense of taste, chills persisting for 1-2 weeks prior to evaluation.   Initial evaluation with elevated procalcitonin (9.904), CRP (9.1), ESR (77), ALT (45), Bili (1.3), WBC (12.8>11.5) neutrophil predominant (10.0).   CT chest/abdomen to r/o occult infection largely unremarkable.    Patient received medrol dose pack with worsening fever/chills/confusion after completion of steroid course.  Blood Culture positive for streptococcus gallolyticus bacteremia.  Patient was admitted to ICU,  received IV ABX then ceftriaxone for 14 days post discharge.   TTE/TEE negative for infective endocarditis.   Patient recovered with residual fatigue at last evaluation.    *17. Streptococcus gallolyticus subsp. gallolyticus Sgg (formerly known as S. bovis type I) is the main causative agent of septicemia and infective endocarditis (IE) in elderly and immunocompromised persons. It belongs to the few opportunistic bacteria, which have been strongly associated to colorectal cancer (CRC). A literature survey covering a period of 40 years (1970?2010) revealed that 65% of patients diagnosed with an invasive Sgg infection had a concomitant colorectal neoplasia. Sgg is associated mainly with early adenomas and may thus constitute an early marker for CRC screening.  Fecal occult blood positive 10/04/2019.  Recommend colonoscopy.
nausea, diarrhea, vomiting, chills, HA, body aches, joint pain, fatigue, and fever 2 hours after vaccine time
Massive extreme diarrhea; Dehydrated; Low blood pressure; Fever; Chills; Shortness of breath; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIARRHOEA (Massive extreme diarrhea), DEHYDRATION (Dehydrated), HYPOTENSION (Low blood pressure), PYREXIA (Fever) and CHILLS (Chills) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 24-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced DYSPNOEA (Shortness of breath). On 25-Mar-2021, the patient experienced PYREXIA (Fever) (seriousness criterion hospitalization) and CHILLS (Chills) (seriousness criterion hospitalization). On 26-Mar-2021, the patient experienced DIARRHOEA (Massive extreme diarrhea) (seriousness criterion hospitalization), DEHYDRATION (Dehydrated) (seriousness criterion hospitalization) and HYPOTENSION (Low blood pressure) (seriousness criterion hospitalization). The patient was hospitalized from 26-Mar-2021 to 27-Mar-2021 due to CHILLS, DEHYDRATION, DIARRHOEA, HYPOTENSION and PYREXIA. On 27-Mar-2021, DIARRHOEA (Massive extreme diarrhea), DEHYDRATION (Dehydrated), PYREXIA (Fever) and CHILLS (Chills) had resolved. At the time of the report, HYPOTENSION (Low blood pressure) and DYSPNOEA (Shortness of breath) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Mar-2021, Body temperature: 102 (High) fever.         Treatment drugs were not reported.  Based on the current available information and temporal association between the use of the product and the start dates of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the event, a causal relationship cannot be excluded.
developed significant red rash all over my breasts, stomach and around navel. Also had large lump and rash on left arm at injection site as well as soreness. Rash went away after 2-3 days. arm was sore for 10 days and is still tender. This happened over the weekend and could not get apt to see my primary care physician. Did call nurse at hospital to discuss situation.  saw Dr following week but rash was gone by then.
Patient received dose of 0.5 ml instead of the recommended 0.25 ml.
A report has been received from a Health Professional an adult, subject of unknown gender, who had been receiving FLUMIST (Intranasal). FLUMIST (Intranasal) started on an unknown date. The patient experienced nasal culture positive for flu type B and nasal culture for positive for flu type A which started on 24-Sep-2013. The outcome of the event of nasal culture positive for flu type A and B and nasal culture positive for flu type A is unknown. The report was considered to be non-serious by the reporter.
Patient returned from vacation and subsequently developed headache, cough, dyspnea. He was found to be COVID+ on 7/12. He was admitted to the hospital on 7/15 due to worsening dyspnea, where he is currently on high-flow nasal cannula.
Had typical symptoms, started noticing ring in ears and dizziness. Last on and off for months; headache. Saw PCP first. Dizziness and ringing got worse. ENT said it was common and would go away with time. Have returned to normal now.
Localized redness and swelling around injection site in round shaped area of approximately 3x3 inches.
pt recv 2 doses of vax & on 16OCT97 lab eval revealed a neg result;
Immediately after getting the vaccine she complained of headache. She had warm feeling at injection site She H/A Thursday, Friday  and Saturday at mid-day her boyfriend  called and said weakness in Right arm right face droop, no speech she was taken to the ER at 1 pm approximately. She was admitted and was dx was CVA .  2 TIA on left side of brain. Stopped Birth control and physician said it could be a combination of both birth control and vaccine.
Patient presented with caregiver to school health clinic for vaccine update. Immunization record indicated child was due for DTaP, IPV, MMR, Varicella. Child received Vaxelis (DTaP, IPV, Hib, and Hep B), IPV, and ProQuad (MMR, varicella) at 0900 on 9/23/22. No signs or symptoms of local or systemic reaction immediately noted after immunization administration in office. Vaccine error was noted by provider at 1000. Medical director for school clinic was notified of event. Caregiver contacted by phone at 1053 and was notified with vaccine error, potential local/systemic reactions, instructed to monitor and report known adverse reactions, provider contact information, and plan to follow up by phone in 48 hours. No adverse reactions reported by caregiver at time of phone call.
Tingling on the left side of the face, feeling unwell, dizziness, nausea, body aching.
Chicken pox vaccine given 6 days ago, ER visit 07/06/02, Has had fever "jerking" for 2 days, Slight jaundice cast to skin, ER reports says trouble breathing t 98.2 P 152, R 35, vaccinated 06/02/02, fever for 3 days , cough, fussy, skin rash,runny nose congested, red eyes, phargeal, erythema, tonsillar exudate
Pain in arm day of vaccination, 24 hours later felt sick. Had fever, body aches, chills, and  dizziness. Next day felt ok but very dizzy.  Kept feeling waves of dizziness every 20 minutes or so.  Felt feverish that night, but just low grade fever. Also pain in the arm is now in my armpit area, down by my left breast.
I had a sore arm and didn't feel well after the vaccine for a couple of days. I tested for COVID-19 via a home test on 09/11/2022 and it was not positive but I felt achy and tired. I had a fever for a few days prior to testing for COVID-19 again. On 09/14 I tested again with a home test and it was positive for COVID-19. I had a telehealth visit with my doctor and was prescribed PAXLOVID. I felt recovered by 09/25/2022.
Stated had localized discomfort, right deltoid area 1-2 days after injection. Had increased pain and tingling and some arm immobility after dog on leash pulled arm, is seeing chiropractor. Is still in pain.
Sore left arm - 15 hours after dose administration  Body Aches and Chills - 24 hours after administration
Migraine x 3 day at 0700 pm Burning shoulders  Left leg nerve pain  Sore arm  Rash on bilateral arms and chest
on 1/7/2021 day of vaccine, during the evening  i began to feel  flu like symptoms,  Cognitive lethargy, all over lethargy, muscle pains, and chills.100.4  I had severe shaking and chills. I took 1/3 of percocet 7.5mg and went to bed. I shivered most of the night, sleeping in my clothes, which is not norm for me. I also had 3 blankets on.    On 1/8/2021 I woke with fever of 100.4 and it receded to 99.8 during the day. Chills were diminshed greatly, moderate muscle pain all over . . I relaxed all day, slept.   I sweated during the night requiring me to change once.  On 1/9/2021 I  woke with normal temp, still feeling lethargic, muscle pain. still present but less than yesterday. My cognitive clarity is better.
Pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006821A and 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (Pain). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Pain, at an unspecified dose and frequency. At the time of the report, PAIN (Pain) outcome was unknown.
Complained of pain in the arm while in school, was sent to the nurse after he fell into a deep sleep in class. Teacher contacted me and told me he was lethargic. No fever at nurses office but I picked him up from school to allow him to rest comfortably at home.
My daughter's arm is warm, itchy, red, and I took a picture. It has progressively gotten worse. It remains sore & untouchable. 9 days later.
pt received Pneumnovax injection 06/06/07, 30 minutes later, he notice gradual increasing swelling and pain in shoulder and upper arm.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 07-MAY-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB, lot # N022167, expiration date: 08-FEB-2020 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 47 to 77 degrees Fahrenheit for 5 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1806USA001505: US-009507513-1806USA009026: US-009507513-1806USA009027: US-009507513-1806USA009028: US-009507513-1806USA009029: US-009507513-1806USA009030: US-009507513-1806USA009031: US-009507513-1806USA009032: US-009507513-1806USA009033: US-009507513-1806USA009034: US-009507513-1806USA009035: US-009507513-1806USA009037: US-009507513-1806USA009038: US-009507513-1806USA009039: US-009507513-1806USA009040: US-009507513-1806USA009041: US-009507513-1806USA009042: US-009507513-1806USA009043: US-009507513-1806USA009044: US-009507513-1806USA009045: US-009507513-1806USA009046: US-009507513-1806USA009047: US-009507513-1806USA009048: US-009507513-1806USA009049: US-009507513-1806USA009050: US-009507513-1806USA009051: US-009507513-1806USA009052: US-009507513-1806USA009053: US-009507513-1806USA009054: US-009507513-1806USA009055: US-009507513-1806USA009056:
Late in the evening  of 9/23 I started getting chills and body aches especially to my left arm near the injections site.  On 9/24 my left arm was more sore and tender and I felt more tired.  The next few days the fatigue went away but I still felt sore on my arm and it radiated to my left side of my chest and abdomen.  Today, 9/27 some of the pain to my left side of my chest and abdomen has subsided.  The only pain is located on my left arm and left armpit.
patient called reporting that she had a hard lump in the left deltoid. her arm was painful to lift. no fever, no redness, no warmth at injection site. she was advised to consult on-call md for assessment who referred her to ED for assessment. we have not been able to contact patient to confirm outcome.
arm became red, itchy, and hot  from the top of the shoulder down to the elbow.  No other adverse reactions reported.
Child developed bloody stools 2 days after receiving ROTATEQ. Child was seen in office, exam done and hematochezia confirmed. Child sent for barium enema which was negative for intussusception.
9-14-08 Mother noticed spacing out / staring spells. 9-15-08 episodes  observed in office per Dr. 9-18-08 Neurology consult,  Dx Epilepsy / complex partial vs absence seizures. Started Keppra 2 weeks later when episodes persisted. Medication changed to Trileptal on 10-11-08
This spontaneous report was received from a registered medical assistant referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported.  On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # M000761 with expiration date of 06-JAN-2018; strength, dose, route and anatomical location were not provided), for prophylaxis. Concomitant therapies included sterile diluent (manufacturer unknown).  It was also reported that the administered dose experienced a temperature excursion during 1 hour and 20 minutes at a temperature of 24.7 degrees Celsius on unspecified date. A data logger issue was involved. No previous temperature excursion and no adverse effects were reported.; Sender's Comments: US-009507513-1708USA003626:
This spontaneous report was received from a pharmacist refers to a 55 year old male patient. The patient had no pertinent medical history or drug reactions or allergies. On 11-SEP-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot # J003806, expiry date 03-JUL-2014, subcutaneous). Concomitant therapies included testosterone injection. On 12-SEP-2013, the patient experienced large rash, approximately four inches in height and two inches in width with extreme pain, burning, itching and hot to touch after received ZOSTAVAX. The physician stated that hte patient should have been four fingers below shoulder, the patient was seen in the pharmacy on 14-SEP-2013 and there ws improvement demonstrated by decrease in size of reaction. The patient was treated with KEFLEX and triamcinolone. There was no lab tests performed. The outcom eof the events were reported as recovering, the patient sought medical attention. Additional information has been requested.
had a cold; This is a spontaneous report received from a contactable consumer for a Pfizer sponsored program. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 03Mar2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious) with onset Mar2021, outcome "unknown", described as "had a cold".  Additional information: The patient mentioned that she missed the 2nd dose on March 24th because she had a cold.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Brain frog; Fever of 101.1 F; Slight headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Brain frog), PYREXIA (Fever of 101.1 F) and HEADACHE (Slight headache) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced FEELING ABNORMAL (Brain frog), PYREXIA (Fever of 101.1 F) and HEADACHE (Slight headache). At the time of the report, FEELING ABNORMAL (Brain frog), PYREXIA (Fever of 101.1 F) and HEADACHE (Slight headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, Body temperature: fever (High) 101.1 F at 3:15 pm 99F at the time of the report.         No relevant concomitant medications were reported.  No treatment information was provided.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Apr2021 as dose 1, single (Batch/Lot number: unknown), on 04May2021 as dose 2, single (Batch/Lot number: unknown) and on 10Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "BMI of 33.2" (unspecified if ongoing), notes: BMI of 33.2 No other serious health conditions. Concomitant medication(s) included: VITAMIN D3; LORATADINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 30Nov2022 at 23:30, outcome "recovered" (15Dec2022) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Nov2022) Positive, notes: I tested positive for Covid-19 on 30Nov22 at 11:30 pm; (30Nov2022) Negative, notes: testing negative the same day at 4:30 am; (03Dec2022) Negative, notes: on 03Dec I tested negative; (05Dec2022) Negative, notes: 05Dec I was still negative; (07Dec2022) Negative, notes: but I still tested negative; (10Dec2022) Positive, notes: I was positive again; (15Dec2022) Negative, notes: on 15Dec, when I tested negative again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Rebound Covid. I tested positive for Covid-19 on 30Nov2022 at 11:30 pm, after testing negative the same day at 4:30 am. On 31Nov2022 I was prescribed Paxlovid and began taking it that evening. I improved quickly and finished the Paxlovid the morning of 03Dec. At 4:30 pm on 03Dec I tested negative. I was not completely symptom free but felt much better. The afternoon of 05Dec I was still negative with minimal symptoms. I went out on 06Dec and developed a scratchy throat. On 07Dec I thought I felt a strange feeling in my nose again but I still tested negative. On 08Dec I had full-blown cold symptoms again but did not test again until 10Dec; I was positive again. My doctor did not prescribe more medicine. It took longer for the symptoms to improve after the rebound. I began improving the evening of 12Dec and finally had minimal symptoms on 15Dec, when I tested negative again. Known Allergies: No. Other medical history: BMI of 33.2 No other serious health conditions.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
A localized reaction with erythema and tenderness in the arm; A localized reaction with erythema and tenderness in the arm; This spontaneous case was received on 11-Dec-2020 via agency (reference number: SEQW20-05718), reported by a physician and concerned a 20-year-old, female patient.  The patient's relevant medical history and concomitant medications were not reported.  On 04-Sep-2020, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, route of administration: intramuscular and anatomical location: not reported) for influenza prophylaxis. The batch number reported was 279847 and expiry date was 30-Jun-2021.  On an unreported date in 2020, after receiving Flucelvax Quadrivalent, the patient developed a localized reaction with erythema and tenderness in the arm. The patient did not receive any treatment.  On an unreported date in 2020, within 48h to 72h, the patient recovered from the events.  The reporter did not provide a causality assessment.  The reporter assessed the events as non-serious.  This case is linked to cases 202007626, 202007627 and 202007628 due to the same reporter.  Company comment: A 20-year-old patient was administered Flucelvax Quadrivalent. An unknown amount of time after receiving Flucelvax Quadrivalent, the patient developed a localized reaction with erythema and tenderness in the arm. Causality is assessed as possibly related for both events.; Sender's Comments: A 20-year-old patient was administered Flucelvax Quadrivalent. An unknown amount of time after receiving Flucelvax Quadrivalent, the patient developed a localized reaction with erythema and tenderness in the arm. Causality is assessed as possibly related for both events.
Information has been received from the mother concerning her 21 year old daughter with no pertinent medical history who in January 2007, was vaccinated with a first dose of Gardasil.  On unspecified dates the patient was vaccinated with the second and third dose of Gardasil.  There was no concomitant medication.  On approximately 03-AUG-2007 the patient had an atypical Pap smear.  On 14-AUG-2007 the patient was scheduled to receive another Pap smear.  The patient did not seek medical attention.  At the time of the report the patient had not recovered.  Additional information has been requested.
Chest pain in the left side of the body and toward the outer pec.. I had a hard time taking a deep breath pain around the longue when coughing
Myalgia, Arthralgia,  Leg cramping, arm pain, head cloudy, fatigue Narrative:
Initial information received on 18-Dec-2018 regarding an unsolicited valid non-serious case received from a consumer/non HCP (office staff). This case involves a 12 months old male patient who was vaccinated with the only diluent dose of ACT-HIB lot UA905AA via unknown route in the left thigh on 17-Dec-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS A VACCINE; MMR; and PNEUMOCOCCAL VACCINE POLYSACCH 23V and Varicella vaccine for Immunisation on 17-Dec-2018. It was an actual medication error case due to inappropriate reconstitution technique. It was reported that the patient was given just the diluent from the ACTHIB vaccination. It was not reported whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Right deltoid and posterior lateral fat of upper left arm golf ball size bump with red, hot, itching and burning.
dizziness, fever, headache, neck pain, back pain, overall body ache, severe pain at injection site, trouble breathing, blurry vision, trouble speaking
2-3 days after had shot had aching in bones all over, contacted this office, encouraged to see his doctor. Was told that shot stimulated his immune system and was given Rx for antibiotics. Returns 5/16/05 to office c/o body aches in the bones. Hurts in right arm and it is weak. Feels he had fever last night. Also state his stomach hurts when he tries to eat. Worked on his van until late last night. Went back to local ER today and was diagnosed with bladder infection. Pt reports was given another prescription for antibiotics. Right arm has no redness or swelling today, T 98.6.