chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Muscle aches; fatigue; slight headache; no appetite; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 61 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Mar2021 18:30 (Lot number: EN6207) at the age of 61 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Pre diabetic" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing); "Covid" (unspecified if ongoing), notes: If Covid prior vaccination: Yes. Concomitant medication(s) included: SINGULAIR; METFORMIN; CETRIZINE; IBUPROFEN. The following information was reported: MYALGIA (non-serious) with onset 12Mar2021 18:45, outcome "not recovered", described as "Muscle aches"; FATIGUE (non-serious) with onset 12Mar2021 18:45, outcome "not recovered", described as "fatigue"; HEADACHE (non-serious) with onset 12Mar2021 18:45, outcome "not recovered", described as "slight headache"; DECREASED APPETITE (non-serious) with onset 12Mar2021 18:45, outcome "not recovered", described as "no appetite". Therapeutic measures were taken as a result of myalgia, fatigue, headache, decreased appetite.  Additional information: Patient had not received other vaccine in four weeks. Patient has received covid prior vaccination and was not tested positive post vaccination. No follow-up attempts are possible. No further information is expected.
Patient's injection site was swollen the size of a baseball and warm to touch according to mom. She declined appointment and used ice pack. Swelling and pain gone.
1 hour after receiving this vaccine pt reported to Medical Squadron with c/o metallic taste in mouth and hiccups. Hiccups continued for 2 days. Was seen in ER given Phenergan 25mg IM. Reglan 10mg and viscous Lidocaine.
Injection site:  pain, tenderness, hardness, and redness, General:  fatigue, headache, muscle and  joint pain, chills and nausea.,
Extreme pain and swelling in left arm for a week after each dose.; Extreme pain and swelling in left arm for a week after each dose.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Lot number: EN6205), in left arm and on 01Apr2021 as dose 2, single (Lot number: EN6205) at the age of 44 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: latex" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Aspirin, reaction(s): "Known allergies: Aspirin". The following information was reported: PAIN IN EXTREMITY (non-serious), PERIPHERAL SWELLING (non-serious) all with onset 2021, outcome "not recovered" and all described as "Extreme pain and swelling in left arm for a week after each dose.". The events "extreme pain and swelling in left arm for a week after each dose." required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain in extremity, peripheral swelling.  Additional Information: No other vaccine in four weeks. Multi vitamins medications was in two weeks. No COVID prior vaccination. Prior to vaccination, the patient has not diagnosed with COVID. Since the vaccination, the patient has been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Patient received two doses of Janssen vaccine. No adverse event has been noticed at the time of reporting.  Patient is an inmate at the time of administration of second vaccine on 07/20/2021. When asked if the individual had received a COVID-19 vaccine, he stated he had not. First vaccine was administered on 05/18/2021.
I present rashes all over the skin red colors, every day it got worse it lasted almost two weeks.
Patient presented at clinic for 2nd dose of covid vaccine.  He was not found to be on the schedule at one clinic, but at another clinic.  The provider was having the admission team get his appointment switched over to our clinic.  Our clinic had a split day, with Moderna  in the morning and Pfizer in the afternoon.  While the admission team was fixing the appointment time, the provider went ahead and gave the dose of vaccine and the patient was sent to observation.  Once the patient was on the schedule, the provider went to document the dose and was alerted that the patient should be receiving Moderna, not the Pfizer dose he had received.  The patient was alerted of this mistake and at the time of conversation yesterday reported no adverse effects.
MUSCLE PAIN; FEVER; HEADACHE; EYES HURT; RED EYES; This spontaneous report received from a parent concerned a 23 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: UNKNOWN) dose was not reported, administered on 22-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced eyes hurt. On MAY-2021, the subject experienced red eyes. On 22-MAY-2021, the subject experienced muscle pain. On 22-MAY-2021, the subject experienced fever. On 22-MAY-2021, the subject experienced headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from fever, headache, and muscle pain, and the outcome of eyes hurt and red eyes was not reported. This report was non-serious. This case, from the same reporter is linked to 20210545645.
Information has been received from a registered nurse referring to a currently 18 year old female patient. The patient had no pertinent medical history or drug allergies. The patient's last menstrual period was in December 2014 and the due date was calculated as approximate September 2015 based on the patient's last menstrual period. On 24-JUN-2015 the pregnant patient was vaccinated with GARDASIL (lot # K007828, expiration date 2-MAR-2017, dose 1, concentration was unknown, 0.5 ml/once) intramuscularly (drug exposure during pregnancy). The patient had no concomitant medication. No adverse effect was reported. The pregnancy outcome was unknown. Additional information has been requested.
About 40 mins after I felt my throat closing and felt like I couldn't breathe. Since then I have had several other instances of feeling similar (though none of them went to full anaphylaxis. I went to the ER Saturday and my PCP today, still for shortness of breath.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Pertinent medical history, drug allergies or reactions were not reported. On 26-SEP-2014, the patient was vaccinated with a dose of (Oka/Merck) PROQUAD lot # K008185, expiry date: 05-DEC-2015 (dose and route were not reported) that underwent temperature excursion. Concomitant medication was not reported. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested
diarrhea; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot number were not reported), dose 2 via an unspecified route of administration on 31Mar2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that he got his 2nd shot last 31Mar2021 and after 10 days he experienced really bad diarrhea on Apr2021. The outcome of event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Pt had fever of 103. Fever was only symptom symptom. Fever was resolved 24-48 hours. Mom took patient to ER.
Pfizer-BioNTech COVID-19 Vaccine EUA Pt presented to ED on 4/10/21 @0523 with c/o SOB, F/C and cough.  Admitted to ICU with acute  hypoxic respiratory failure on BiPAP, non-STEMI, acute decompensated heart failure, acute kidney injury and suspected severe sepsis.  Reportedly received 2nd dose of COVID-19 vaccine 2 days prior.  Shortly after admit, pt developed worsening respiratory status requiring intubation @1045.  Pt with continued hypoxemia despite 100% FiO2 and PEEP of 15.  Pt experienced cardiac arrest with PEA @1100 with return of spontaneous circulation.  Repeat arrest with PEA@1135 with return of spontaneous circulation.  Family decision to change code status to DNR CCA, repeat arrest- time of death 1203.
Burning sensation began on her upper right shoulder; Swelling at the injection site; Severe headache; This case was reported by a consumer via call center representative and described the occurrence of headache in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th November 2019, the patient received the 1st dose of Shingrix. On 16th November 2019, 1 days after receiving Shingrix, the patient experienced headache and injection site swelling. On 25th March 2020, the patient experienced burning sensation. On an unknown date, the outcome of the headache and injection site swelling were recovered/resolved and the outcome of the burning sensation was not recovered/not resolved.   It was unknown if the reporter considered the headache, burning sensation and injection site swelling to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix and experienced a severe headache and swelling at the injection site the day following the vaccine.   The headache lasted 24-30 hours and the swelling lasted 2 days.   Six weeks ago, from the day reporting a burning sensation began on her upper right shoulder. There were no visible marks.The area was next to her bra strap and was approximately a 3"x1/2" strip. It has not been diagnosed as shingles.Her dermatologist was not sure what it was. Reporter consented to follow up.
From initial information received on 28Jan04 from a physician's office, regarding an adverse event occurring in it was reported that approx four or five pt's received Daptacel, lot number C1612AA, on an unspecified date. The pt's ranged in age from 15 to 18 months and four to five years. During the two week time period (exact dates not specified), the pt returned to the clinic with cellulitis at the sit of the Daptacel injection. It was not reported whether the pts recovered. The reporter of this case is the same as for case 200400378.
Immediate debilaitating headache for 2 days , lose of use of left fingers left arm was so numb that could not use it for 3 days
Pt here for H1N! flu shot approx 10 min after injection after walking out of room began vomiting small amounts of yellow sucrets, c/o feeling flushed and faint. Allowed pt to lie down. Lungs clear denies SOB or itching, no rash noted B/P 73/34, HR 55, approx 10 min later B/P 88/51, HR 56, drinking sips of mountain dew, still nauseated. Unable to eat crackers, approx 10 min later B/P 92/48 HR51 R20. Feeling some what better. Rechecked B/P 10 min later 85/44 HR48. Allowed pt to sit up, eating peanut butter and cracker and sipping on coke, color fluids B/P 109/69 HR 52. Made appt with practitioner in AM, Hadn't eaten since 10 am this morning. Clust to push fluids and eat and if symptoms worsen - go to ER.
This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On 03-FEB-2018, the patient was vaccinated with an expired dose of VARIVAX expiration date 02-FEB-2018, (strength, dose, route, anatomical location and lot number were not provided) for prophylaxis. No adverse effects were reported.
He got his vaccine, had a vasovagal syncope from the vaccines.  They laid him down on the form, got the usual BP and pulse ox, kept him for another 20 minutes, repeated the BP and pulse ox, got a BS.  He recovered and was sent home.
Post vax, the pt experienced injection site redness, swelling, heat, and discomfort. Subsequently, the pt recovered.
Mother reports flu vaccine was given 10/22/2018, 7:50 pm that night noticed site was red, swollen, and hard.
arm pain; Fever; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain), PYREXIA (Fever) and FATIGUE (Fatigue) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced PAIN IN EXTREMITY (arm pain), PYREXIA (Fever) and FATIGUE (Fatigue). At the time of the report, PAIN IN EXTREMITY (arm pain), PYREXIA (Fever) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
First I had chills, high temp, nausea, almost vomit, terrible headache, slept a lot, fatigue and dizzy too. Lasted 2 days plus. Haven't seen my doctor yet, she is very busy.
Fibromyalgia; Pain in joint involving shoulder region; This spontaneous case was reported by a consumer and describes the occurrence of FIBROMYALGIA (Fibromyalgia) and ARTHRALGIA (Pain in joint involving shoulder region) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced FIBROMYALGIA (Fibromyalgia) and ARTHRALGIA (Pain in joint involving shoulder region). The patient was treated with CAFFEINE, PARACETAMOL (EXCEDRIN [CAFFEINE;PARACETAMOL]) for Migraine, at an unspecified dose and frequency. At the time of the report, FIBROMYALGIA (Fibromyalgia) outcome was unknown and ARTHRALGIA (Pain in joint involving shoulder region) had not resolved.            Concomitant medications details were not reported by the reporter.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The patient was treated with EXCEDRIN for Migraine. Formulation for HUMIRA was reported as Solution for injection in pre-filled pen.  Company Comment: This is a spontaneous case concerning an adult female patient with intake of the co-suspect, non-company product Adalimumab (Humira) as treatment for Psoriatic Arthritis, who experienced the unexpected, non-serious, adverse event of special interest, Fibromyalgia and the, expected, non-serious event of Arthralgia. The events occurred on an unknown date after receiving a dose of mRNA-1273 Vaccine and the co-suspect Adalimumab (Humira). No further information on risk factors, co morbidities, clinical course and management of the events was available in the report. It was reported that the outcome of the event Arthralgia has not resolved while Fibromyalgia was unknown. The medical condition of Psoriatic Arthritis that is being treated with Adalimumab remains a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning an adult female patient with intake of the co-suspect, non-company product Adalimumab (Humira) as treatment for Psoriatic Arthritis, who experienced the unexpected, non-serious, adverse event of special interest, Fibromyalgia and the, expected, non-serious event of Arthralgia. The events occurred on an unknown date after receiving a dose of mRNA-1273 Vaccine and the co-suspect Adalimumab (Humira). No further information on risk factors, co morbidities, clinical course and management of the events was available in the report. It was reported that the outcome of the event Arthralgia has not resolved while Fibromyalgia was unknown. The medical condition of Psoriatic Arthritis that is being treated with Adalimumab remains a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
moderna COVID=19 EUA.  Sore arm, small lump that itched.  reddish/pink around injection site.  Symptoms disappeared within 2 days
Muscle Spasms, Tonsils swollen, Arm Swollen, bottom lip involuntary shaking, Teary eyes,  Pain in Arm, warmness in the arm around injection site, pulsating arms
Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Medical history was not provided.).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication use was not provided. Treatment information was not provided.   This case was linked to MOD21-065665 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  MOD21-065665:cross-linked no
I might have noticed it occasionally before the date I listed it started? that?s just the day I noticed it had started and never stopped. I had not been going to any loud places, and after 4 weeks I sought medical advice and my doctor said she couldn?t tell that anything was wrong. She recommended Flonase, which I used twice a day for 10 weeks with no improvements and still have constant ringing to this day. Never had it before in my life that I can recall
C/O Nausea/Dizziness/Sweating. Vital signs: B/P 149/98 Pulse:83 Sats: 98% Room air; seen by in house EMT's Discharged home at 13:25 p.m. Recorded by (Name), RN
This spontaneous report was received from a company representative refers to a 8 year old female patient. On an unknown date the patient was vaccinated with GARDASIL lot # K008621, expiry date: 04-MAR-2017 (also reported as 20-MAR-2017). It was reported that this product was exposed to temperatures outside of the required temperature range and the efficacy of this product outside the temperature range was not established. No allergic reaction was observed. No medical attention was needed. Outcome of the event was not reported. Causality assessment was not provided. This is one of several reports received from the same source (MARRS # 1412USA003042). Additional information has been requested.
Hives on face, slightly short of breath, anxious. Had taken 50 mg Benadryl OTC before going to Urgent Care, reported feeling better once there. Denied wheezing or any other symptoms. Prescribed 20 mg Prednisone, two per day for 3 days to take if needed but no indication of needed
Initial report received from a health care professional on 12 April 2012. A 17-year-old female patient received an injection of MENACTRA, sanofi pasteur Inc. lot number U2729AA and an injection of GARDASIL, Merck lot number 0067X, on 23 December 2008. On 06 October 2011 the patient went to the Emergency Department (ED) with a fever, headache, vomiting and raised red rash which was generalized. The patient was treated with dopamine and epinephrine (Epi) drip for hypotension and dehydration, post fluid challenge. She was admitted to the hospital intensive care unit (ICU) on 06 October 2011 and started on vancomycin one gram every six hours and ROCEPHIN two grams every 12 hours. The patient was diagnosed with meningococcemia Y-strain. Her laboratory and diagnostic testing was as follows: Complete blood count (CBC), cultures, lumbar puncture and gram stain were negative. The patient had a white blood cell (WBC) count of 33.8, glucose of 79, protein of 27 and a chest x-ray (result not reported). Her meningococcal vaccine titers were negative and found to be zero. She was discharged from the hospital on 13 October 2011. The outcome was reported as recovered. Documents held by sender: None.
The child received her 6 month vaccinations on 28 March 2014. This included PEDIARIX #3 left thigh and PREVNAR 13 right thigh. At the time of vaccination the child had had a cough and runny nose for 2 weeks. According to the mother the infant had a low grade fever (at 100.0 rectal). On 3/31/14 the mother noted a rash on her legs and arms. At that time it appeared as a papulopustular dermatitis mostly with clusters on the extremities with some involvement of the trunk and neck--it spared the palms/soles/mouth. It did not appear to cause the infant any discomfort and was dx as a viral exanthema. On 4/1/14 the infant was referred to Dermatology due to worsening of the rash--the infant was fussy and not sleeping well; the mother reported that the infant was scratching. On exam the child had numerous 0.2-1.5cm erythematous papules on the forearms, dorsal hands and buttocks; 3 targetoid lesions with central dusty appearance and peripheral lightening; and numerous 0.3-1.0 papules and papulovesicles. The differential diagnosis included Erythema Multiforme (EM), Urticaria Multiforme and Cutaneous Bullous Multiforme. The infant was prescribed Hydroxyzine and Fluocinolone topical ointment and was referred to the Allergy Clinic. When the infant was seen by in the Dermatology Clinic on 4/4/14 all previous papulovesicles were crusted over and there was no evidence of new lesions. The mother was noted to have vesicopapules of the palms, soles and vesicles of the soft palate; thought to be Hand-Foot-Mouth Disease (HFMD--current outbreak at the childcare institution where the child is cared for). At this time the infant was diagnosed with HFMD (atypical). Of note, the father of the child was diagnosed with HFMD on 4/5/14. The infant was seen by Pediatrics on 4/8/14 for ongoing URI symptoms. At her visit with Dermatology on 4/11/14 it was noted that the rash "was much improved since the last visit". On 4/21/14 the infant had a 1cm abnormal dry patch on her left upper cheek, numerous 3mm-1.5cm erythematous papules and plaques with central clearing on her arms, legs and dorsum of her hands/feet. Additionally, peeling was noted on the pad of the left little toe and right great toe. The mother reports that the rash completely resolved at 2-3 weeks later. Of note the child received Hib-PRP-T on 6/11/14 without adverse event.
patient with large pulmonary embolism, hypoxia, tachycardia, respiratory distress & near syncope
Patient received 3rd dose of Pfizer vaccine; upon documentation it was noted that patient already had 2nd dose Pfizer in January 2021
25AUG93 pt had a temp of 102, rash & vomiting; As of 2SEP93 pt had rash over all body & face; afebrile but still lethargic has little appetite; PHN advised mom of child to have pt seen by pvt MD: dx scarlet fever;