chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever; Diarrhea; Chills; Aches; Nasal congestion; This is a spontaneous report from a non-contactable consumer, the patient. A 45-year-old, adult male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 29Mar2021 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. No relevant medical history and concomitant medications reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021, the patient experienced fever, diarrhea, chills, aches and nasal congestion. No therapeutic measures were taken as a result of the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of fever, diarrhea, chills, aches and nasal congestion was not resolved.  No follow-up attempts are needed. No further information is expected.
Chief Complaint   pt presents for SOB, cough, abd pain, fever; tested positive for covid 4 days ago; received both covid vaccines  History of Present Illness      Patient is a 82-year-old male with a past medical history of hypertension, hyperlipidemia, type 2 diabetes presented to Hospital endorsing shortness of breath, fever, cough since past 4 days.  Patient stated that he and his wife started experiencing generalized body aches, cough with greenish productive sputum since past 1 week.  Stated that he was having low-grade fever with chills and has been experiencing worsening weakness and generalized malaise.  He was tested positive for COVID-19 on 11/11.  Stated that his shortness of breath progressively worsened which prompted him to visit Hospital.  In the ED patient's white blood cell count was 14.3K but otherwise unremarkable CBC.  D-dimer was elevated to 3.52, CMP revealed creatinine of 2.13.  Patient was requiring 6 L oxygen to maintain saturation greater than 92%.  Patient spiked temperature to 38.9 °C on ED arrival.  Patient was given dexamethasone and admitted to stepdown unit for further care.  CT PE: No evidence of PE but bilateral extensive multifocal infiltrates consistent with COVID-19 pneumonia.  Review of Systems     14 point review of systems negative except for HPI  Physical Exam  Vitals & Measurements  T: 38.9 °C  HR: 104  RR: 12  BP: 134/67  SpO2: 91%  WT: 111.8 kg      Gen: AO x3, NAD  HEENT: MMM, EMOI, PERRLA  Neck: Supple, No LAD  CVS: S1,S2 positive, No MRG  Lungs: Coarse breath sounds thought ling fields, No accessory muscle use  Abd: Soft, NT, ND, no organomegaly, bowel sounds positive  Neuro: Non focal  Extremities: Warm and dry, no edema  Assessment/Plan       82 Y old M admitted to hospital for further management of acute hypoxia 2/2 COVID PNA   Problem list:  Acute hypoxic respiratory failure:  COVID 19 PNA: Symptom onset -- > 11/8 Tested positive -- >11/11 Current O2 requirement -- > 6L Vaccination status -- > Yes  Will cover pt empirically with Levaquin for possible superimposed CAP CTPE -- > no PE Bronchodilator therapy protocol Continue dexamethasone 6 mg daily 6 min walk test before discharge Consider Baricitinib/Tocilizumab if symptoms were to worsen  Will trend inflammatory markers  Remdesivir -- > Hold 2/2 poor renal function   AKI?:  Gentle hydration  Pt received contrast for CTPE, at high risk for contrast induced nephropathy  Will trend Cr   DM2: Hold OGHA's  Insulin sliding scale for now  Hypoglycemic precautions   HTN: Hold ACEI's and HCTZ   HLD: Lipitor 20 mg daily  F: As above  E: Replete PRN  N: regular diet  GI: Not indicated  DVT: Heparin  Fall precautions  Code status: Full code
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 23-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single 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: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Advair, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid treatment from 25Aug2023 to 29Aug2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
symptoms fo cough, headache and runny nose. symptoms started 4/18. tested on 4/21 and then admitted to hospital
Pt referred for eval of smallpox vaccine site. Vaccinated approximately 9 days ago. Positive erythema, warmth, induration approximately 2 in around site. Negative for pus/discharge.
It was reported that a female pt was given a post exposure series of Imovax Rabies for bat exposure. Pt experienced "flu-like" symptoms after the 2nd and 3rd doses. On 2/18/01, the pt developed numbness in left side of face, ear, arm and calf, no sensory perception in left side, now in right side. Was seen in ER on 2/18/01. She was referred to a Neurologist and ENT doctor. All reports were sent to PCP. Unresolved, getting worse. Per the Medical Safety Officer's conversation with PCP on 2/28/01, it was stated that the neurologist evaluated the pt and made a dx of hemianesthesia. From additional correspondence received on 5/7/01, additional lab data was provided.
Rash on elbows and forearms, no difficulty breathing, patient took Benadryl to control rash.
Child went unresponsive in caregivers home . Respiratory arrest. Seizures. Caregiver was charged with abuse due to this incident  because was last person alone with child. The discharge summary received on 3/22/04 states bilateral retinal hemorrhage, subdural hemorrhage, subarachnoid hemorrhage and suspected child abuse.
Severe pain in shoulder where vaccine was administered. After almost 2 months and physical therapy, pain is improving.
Varicella Information has been received from a nurse concerning a 17 year old male patient who was vaccinated with varicella virus vaccine live (Oka/Merck). Subsequently the patient experienced breakthrough varicella. There was no further information available regarding the adverse event or the patient's outcome. There was no product quality complaint reported.
pt recv vax 5JUN95 & on 1JUL95 seen in ofc for severe h/a, vomiting & vesicular lesions (approx 10-15mins) on trunk & extremities; adm to hosp for dehydration;
Pt given influenza, 4 1/2 days later began noticing paresthesias in (L) toes and foot. Over 12 hrs, spread up leg to chest. Admitted and diagnosed with transverse myelitis.
Information has been received from a pharmacist concerning a "college age" female who in August 2008 was vaccinated with GARDASIL (dose and duration not reported).  Two months after vaccination, the patient developed cerebralitis and was hospitalized.  Additional information has been requested.
Subacromial bursitis developed within several hours after vaccine administration, worsening  on day 3, no signs of infection.  Responding well to exercises and NSAIDs at this time
feeling tired; mild heart increase; mild heart palpitations; chills; feeling bad; low-grade fever of 100; This is a spontaneous report from a contactable other healthcare professional (patient). A 60-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, #lot: EL9264) via an unspecified route of administration, administered in Arm Right on 02Feb2021 08:45 (at the age of 60-years-old) as single dose for covid-19 immunisation. The patient's medical history includes history of colon cancer, anaemia, hypertension and asthma and drug hypersensitivity. The patient previously known allergies includes: Sulfa, EES, Augmentin, oxycodone, vancomycin, duramorph. The patient's concomitant medications included budesonide, formoterol fumarate, glycopyrronium bromide (BREZTRI AEROSPHERE), hctz, meloxicam and zolpidem tartrate (AMBIEN). It was reported that on 02Feb2021, at 08: 45 AM initially within five minutes after the vaccine, the patient felt mild heart palpitations with mild heart increase. She monitored on her (company name) watch heart rate, ECG and oxygenation level. This resolved within 15 minutes. During the day following she started having chills just generalized feeling bad. Had a low-grade fever of 100 last evening. This morning feeling tired on 03Feb2021. The outcome of the events was recovering. Therapeutic measures were not taken by the patient for resolving of the events.  Follow-up attempts are completed. No further information is expected.
After flu vaccine, went on camp retreat for 3 days, came home low fever, fatigue and confusion over next month - seen in ER multiple times, (-) CT, neg blood test - by Jan - seemed no longer confused - back to old self. But became more anxious, hitting himself. He high functioning autism.
Pain and quarter size hard lump in arm lasting 3 weeks. Still small hard lump at 5 weeks.
Severe dizziness x 6 hrs  Unrelenting vomiting   Emetrol and ondansetron worked
The injection site started to itch about two hours after the injection. Today 7/20/2021, continuing itching and it is red circle that seems to have a bruised look under it. The circle has grown in size within the last few days. Its about 2 inches wide and about 1 inch in height.
4 year old received a dose appropriate for a 5 year old.  Was this pt.'s first COVID-19 vaccine.  Is newly resettling and is  without health records.  Dose administered on 7/11/23.  Parents contacted 7/12/23 to review dose error, determine if child experiencing unanticipated effects of the vaccine, and review how to access care and have questions addressed.
Vaccinator reports during Intradermal admin of Jynneos pt moved away causing some of the vaccine to squirt into the air.  Pt did not receive the full dose. Per MD advised to revaccinate..  Pt educated and counseled on recommendation then verbalized agreement and understanding.  Pt decided on subcutaneous route of administration.
FEVER; FATIGUE; SLEPT THE WHOLE DAY; ARM LOOKS LIKE IT WAS INFECTED; CAN NOT MOVE ARM; ARM SORE; SWOLLEN AT SITE OF INJECTION (LEFT ARM); RED AT INJECTION SITE (LEFT ARM); HOT AT THE SITE OF INJECTION (LEFT ARM); ITCHY AT SITE OF INJECTION (LEFT ARM); RAISED AT INJECTION SITE (LEFT ARM); HARD AT INJECTION SITE (LEFT ARM); This spontaneous report received from a patient concerned a 26 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A21A, expiry: 11-APR-2022) dose was not reported, administered on 18-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On NOV-2021, the patient experienced itchy at site of injection (left arm). On NOV-2021, the patient experienced raised at injection site (left arm). On NOV-2021, the patient experienced hard at injection site (left arm). On NOV-2021, the patient experienced arm looks like it was infected. On NOV-2021, the patient experienced can not move arm. On NOV-2021, the patient experienced arm sore. On NOV-2021, the patient experienced swollen at site of injection (left arm). On NOV-2021, the patient experienced red at injection site (left arm). On NOV-2021, the patient experienced hot at the site of injection (left arm). On 18-NOV-2021, the patient experienced slept the whole day. On 18-NOV-2021, the patient experienced fever. On 18-NOV-2021, the patient experienced fatigue. Laboratory data included: Body temperature (NR: not provided) 100 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 19-NOV-2021, had not recovered from arm sore, and the outcome of fatigue, swollen at site of injection (left arm), itchy at site of injection (left arm), red at injection site (left arm), raised at injection site (left arm), hard at injection site (left arm), slept the whole day, can not move arm, arm looks like it was infected and hot at the site of injection (left arm) was not reported. This report was non-serious. This case, from the same reporter is linked to 20211149605.
Information has been received on 19-APR-2017 from a lawyer and a female patient of unknown age regarding a case in litigation. The patient was inoculated with ZOSTAVAX (lot number and expiration not reported) subcutaneous on or about 14-DEC-2012 as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 12-AUG-2015, the patient was treated by a physician for a painful rash that was diagnosed as shingles. While shingles is an incurable condition, the patient has been prescribed Acyclovir to manage her symptoms and outbreaks. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. Additional information has been requested.
Blurred vision; Abnormal heart beat; Light headed/ occasional dizziness; Severe headache; Muscle aches; Extreme fatigue; This is a spontaneous report from a contactable consumer, the patient. A 72-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the arm right on 09Apr2021 at 14:30 (at the age of 72-year-old) as a single dose for COVID-19 immunisation. Medical history included coronary artery disease (CAD) and mushrooms (food allergy). Concomitant medications included CRESTOR, 81 mg ASPRIN and 100 mg COQ10 for unknown indication from unknown dates. The patient previously took LEVAQUIN for unknown indication and experienced drug allergy on unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient vaccinated Friday pm (09Apr2021). On 10Apr2021 at 09:00 (Saturday morning), the patient experienced severe headache, muscle aches, blurred vision, abnormal heart beat as indicated by BP machine. Constant for about 24 hours. Extreme fatigue and light headed/occasional dizziness continue into Tuesday (4 days later). All symptoms improving slowly. Therapeutic measures were not taken as a result of these events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events severe headache, muscle aches, blurred vision, abnormal heart beat, extreme fatigue and light headed/occasional dizziness was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
A report had been received from a Pharmacist concerning a 67 year old, female patient, who had been receiving nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent started on 06-NOV-2014. It was reported that administration of FLUMIST Quadrivalent to patient over the age of 64 in the pharmacy. The outcome of the event of wrongful administration was unknown. The report was considered to be non-serious. Reporter as well as company physician considered that there was no casual relation between the event wrongful administration and suspect drug QLAIV.
After receiving covid vaccine, patient started sweating and feeling warm. Patient also had difficulty swallowing and ears felt numb. After a few minutes she was able to recover and feel fine.
Dizziness Chills, fatigue Narrative:  Per nursing report: " 2nd dose of Moderna vaccine yesterday [2/3]. C/o chills, lightheadedness and fatigue all day [2/4] here at work. "
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
This was created to reflect the correct country of origin. The cancelled # was UR-WYE-H15177110. Follow-up information was received regarding recovery status. Information regarding PREVNAR was received from a healthcare professional regarding a 12-year-old male patient who experienced pneumococcal meningitis and drug ineffective. The patient received a dose on an unspecified date at the age of three. In 2010, the date unknown, the patient experienced pneumococcal meningitis and was hospitalized. The patient recovered. No additional information was available at the time of this report. Following the integration of the legacy safety adverse event reporting databases, this case has been migrated from the legacy company database into the current safety database for processing follow-up information. As a consequence of this migration, the follow-up CIOMS I, MedWatch or VAERS report may indicate in the appropriate field that it is an initial report. Follow-up (13Dec2010): This contactable physician reported that the patient recovered.
Patient experienced a slight burn on her arm and couldn't move her arm for 2 days. She was experencing a slight swelling. By Thursday of 3 pm, she noticed that the inside of her arm had a rash, roscea, and it was slight itchy.
Bloody stool (streaks) x 2 today. No vomiting no abdominal distension and no acute distress.
TOOK ANTIBIOTIC WHILE ON VIVOTIF; This spontaneous case report (PVX2019-2096) was received from a consumer on 14-Aug-2019. It described a 68-years-old male consumer who "took antibiotic while on Vivotif" (PT: Labelled drug-drug interaction medication error), while being on Vivotif for an unknown indication. The consumer was taking an unspecified antibiotic for urinary tract infection (UTI).  Case Report: The consumer took Vivotif doses on 08-Aug-2019, 10-Aug-2019, 12-Aug-2019, and 14-Aug-2019, respectively. On 13-Aug-2019, he started taking an antibiotic for UTI, which was started long before Vivotif.  Action taken with Vivotif and the antibiotic was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took antibiotic while on Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took antibiotic while on Vivotif" was considered as not applicable.
This spontaneous report as received from a registered nurse refers to patient of unknown age and gender. No information about medical history, concurrent conditions and concomitant medications were reported. On an unknown date, the patient was vaccinated with PROQUAD (Merck) (dose number, dose, lot # was not reported) that was improperly stored and which had been exposed to temperature as high as 8.5 F. The reporter was unable to locate lots numbers and expiration date of PROQUAD (Merck) that experienced a temperature excursions. No adverse effects were reported. The outcome of the events reported is unknown. This case is linked to the cases 1405USA010621, 1405USA010602, 1405USA008131 via same reporter link. Additional information has been requested.
Developed redness of arms, neck & chest, itching & "blisters" evening of 12-29-09.  Seen on 1-2-10. Liquid BENADRYL prescribed.
Pt given KINRIX and MMRV on 7/14/11. Arm became swollen & red within 1hr of visit. Worsened next 24hrs painful to touch.
2 day post vaccination, fatigue and right arm soreness Day 4 fatigue Day 5 full body ache, low fever, diarrhea, nausea and headache
Got Sick; Abdominal Pain; Inflammation all over body; Low Blood Counts; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Got Sick), ABDOMINAL PAIN (Abdominal Pain), INFLAMMATION (Inflammation all over body) and BLOOD COUNT ABNORMAL (Low Blood Counts) 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 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, the patient experienced ILLNESS (Got Sick), ABDOMINAL PAIN (Abdominal Pain), INFLAMMATION (Inflammation all over body) and BLOOD COUNT ABNORMAL (Low Blood Counts). At the time of the report, ILLNESS (Got Sick), ABDOMINAL PAIN (Abdominal Pain), INFLAMMATION (Inflammation all over body) and BLOOD COUNT ABNORMAL (Low Blood Counts) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (unknown) was not applicable. Concomitant medication use was unknown Treatment information use was unknown
3 hours or so after injection, under my tongue and lips started to swell, my eyes became VERY bloodshot and runny ("goopy" might be a better word for it), my throat began to constrict slightly (enough where I noticed it), and I became lethargic. I took Benadryl and these initial symptoms subsided. Later that evening, I felt like I had the full-blown flu: I had no energy, 102-degree fever, and chills. These symptoms lasted to a lesser degree for another day and a half. No treatment was undergone, beyond the initial Benedryl.