chrisvoncsefalvay/vaers-outcomes huggingface dataset:
small red spot about size of quarter on Thursday PM,  Friday Morning - raised red ring larger than 50 cent piece.  Went back to pharmacy and they advised to take bendryl and if got larger contact physician. Drew circle around ring to monitor.   Took bendryl and tylenol before bed.   Saturday morning more red and outside of circle.  Went to clinic where I was given a shot of decadron 10 mg and shot of Clindamycin HCL 300mg.   Was given 10 mg of Predizone to take 3 times a day for 5 days.  Also given 150 mg of Clindamycin HCL 3 tablets a day for 5 days.    Doctor drew circle again to watch for more reaction.  Sunday afternoon it was beyond circle and again headache.   Took medicines as directed.   Monday Morning site is not as red and is starting to look better.  I have photos of each day if needed.
I have a slight headache; This is a spontaneous report from a non-contactable consumer (patient). A 63-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiration date: unknown), dose 2 via an unknown route of administration on an unknown date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 for COVID-19 immunization. On an unknown date, the patient had a slight headache. The outcome of event was unknown.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. There was no information about concomitant medication, pertinent medication history, drug reactions and allergies reported. On unknown date, the patients were vaccinated with improperly stored VAQTA (lot#, expiration date, dose, frequency, indication, route and site of administration were not reported). No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient presents to the ED with shortness of breath, chest pains and palpitations.  Has noticed rapid heart rates for last 2 months, started immunotherapy. Started on diltiazem and symptoms resolved.  Diagnosed with Afib and COPD exacerbation.  Recently diagnosed with left lung squamous cell carcinoma.  patient will start on eliquis, digoxin and diltiazem. Discharged with symptoms resolved.
Non febrile seizure on 9/12/2009.  Lasted approximately 2 minutes per mom.  Eyes rolled back.  Arms and legs jerk
About 3 hours after receiving the vaccines the 2 year old started having an itchy erythematous rash on bilateral lower extremities with a lesser amount on the bilateral upper extremities. His mother put on 1% hydrocortisone cream and this morning it was improved. He still has some rash now (about 22 hours post vaccine), but his mother reports that it is much improved since yesterday. He no longer seems to be scratching and it is not bothering him. There were no other medications yesterday, no changes in foods, laundry detergents, soaps, or activities.
Information has been received from a certified medical assistant concerning 9 different unspecified patients of unknown age and gender. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. On unspecified dates, the patients were vaccinated with unspecified improperly stored doses of (Oka/Merck) VARIVAX (lot number L042266 with expiration date of 27-OCT-2017) (strength, dosage schedule, route and anatomical location were not reported). No other suspect and concomitant medications were provided. There was no adverse effect reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
A report was received from a physician concerning a female. Medical history and concomitant medications were not reported. The patient received nasal FLUMIST Quadrivalent (Intranasal). Two weeks later, she started having left facial paresthesias, tremor, fever, and headache. Physician stated he thought some of the paresthesias and tremor were still ongoing. At the time of reporting, the outcomes of fever and headache were unknown. The reporter assessed the left facial paresthesias and tremor to be serious as important medical events and the fever and headache to be non-serious.
It was reported by a female nurse that she received a dose of Fluzone (Trivalent types A & B). The last week of October 2000 for the first time, she has developed a "very severe skin condition called Bullous Pemphigoid and Linear IgA disease, which is an autoimmune disease". Currently, both of her hands and feet started to have more lesions. She has been dermatologists and also went to a hospital as well. Biopsy was taken to confirm Bullous Pemphigoid and Linear IgA disease. Follow up # 1. From the pt indicated that she has been visiting her dermotologist every 4-6 weeks in th past 2 years. the rash, which started  around Oct 17 (no year specified) on her face, is still present and spreading. She is experiencing severe itching, is extremely uncomfortable and has redness, swelling, and excessive tearing in her eyes. The lesion on both of her hands which started in 18 dec 2002, has not resolved. the center of her palms are raw, itch, and tight (contracture). She also reported that her whole body is now scar from the rash and lesions that started since Nov 2000. The Fluzone was administered IM n the left deltoid. The pt considered her skin condition resulted in permanent disability due to unable to perform duty. The follow up received on 2/27/03 from the pt reporting that since she is a nurse herself, and due to her ongoing condition since the vaccination, that she is on restrictive duty at work and to see no patients. She also reports that she has been taking many creams and ointments-prednisone, to ease her condition. Both of her hands are still affected and have gotten worse, they are oozing and itching. She has seen at least 3 dermatologists and she states that all of the doctors agree that she has autoimmune disease. Her biopsy results showed linear IgA and possible famkphogoid; pt has had to use all of her vacation time and her scheduled time off because of this condition.
Myocarditis Associated With COVID-19 Vaccination; This is a literature report.  A 39 year-old patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "No adverse event". The following information was reported: MYOCARDITIS (medically significant), outcome "unknown", described as "Myocarditis Associated With COVID-19 Vaccination". The patient underwent the following laboratory tests and procedures: brain natriuretic peptide: 22 pg/mL; ejection fraction: 56 %, notes: Initial; 58 %, notes: Follow-up; electrocardiogram: pr depression, notes: Initial; no st abn, notes: on follow up; investigation (17-37): 32, notes: Units: mL/M2. Initial; 20, notes: Units: mL/M2. Follow-up; investigation: lge along a and l segments, notes: Initial; resolved lge, notes: Follow-up; 970, notes: units: ms; 47, notes: units: ms; magnetic resonance imaging heart: unknown results, notes: Initial. 11 days; unknown results, notes: Follow-up. 200 days; n-terminal prohormone brain natriuretic peptide: 9.6 pg/mL, notes: Follow-up labs; troponin i: 11.0 ng/ml; troponin i: 3.5 ng/L, notes: Follow-up labs; 11.0 ng/ml, notes: Initial labs.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the event cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202200509134 Same article/Event/Drug and different patient;US-PFIZER INC-202200509136 Same article/Event/Drug and different patient;US-PFIZER INC-202200509135 Same article/Event/Drug and different patient
SEIZURE, FOLLOWED BY FEVER (102.4), FATIGUE, MUSCLE PAIN, JOINT PAIN, CHILLS
He states that he received the vaccine on 2/20 and three days later developed a red rash on his chest and back that has not completely gone away.  He states that on 1/25 he developed nausea and vomiting to the extent that he missed work both of those days - this has resolved.
26JAN96 pt exp pain & swelling size of a golf ball on lt leg @  vax inj site;pt devel 2cm induration area w/a 4cm surrounding erythema on the lt thigh;pt was seen in clinic on 30JAN96 & no systemic sx;tender inguinal lymph node
25-year-old male chief complaint of nausea vomiting headache fevers chills and bodyaches.  On arrival vital signs stable.  On exam abdomen soft nontender nondistended.  Patient with no focal neurologic deficits no meningismus.  suspect vaccine reaction.  Patient givenZofran N ED with resolution of vomiting.  Plan for discharge home with continued supportive care and follow-up with primary care physician.
Narrative: COVID infection following COVID vaccine series 02/26, Pfizer, dose #1 03/19, PFIZER, DOSE #2 08/28 covid swab, result: detected 08/28 pt cc: exposure: unknown
Red bruise for quite awhile; Vaccine exposed at 54.5 degree Fahrenheit and was out of range for 1 hour; Initial information regarding an unsolicited valid non-serious case was received from consumer via Agency (Reference number- 00748555) and transmitted to Sanofi on 31-Aug-2021.   This case involves a six-month-old male patient who experienced red bruise for quite awhile (contusion) and reported vaccine exposed at 54.5-degree Fahrenheit and was out of range for 1 hour (product storage error) while receiving IPV (VERO) [IPOL].  Medical history, past medical treatment, past vaccination, concomitant medication and family history were not provided.  Concomitant medication included MENINGOCOCCAL VACCINE for prophylactic vaccination.  On 26-Jul-2021, the patient received a (total, once) dose of suspect IPV (VERO) [lot number and expiry date not reported] via unknown route in the left thigh for prophylactic vaccination.  On 26-Jul-2021, the patient developed non-serious red bruise for quite awhile (contusion) and reported vaccine exposed at 54.5-degree Fahrenheit and was out of range for 1 hour (product storage error) on the same day following the administration of IPV (VERO).  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment for the events.  At time of reporting, the outcome was unknown for both the events  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 the 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.
On 1/5/2021- Pt. noticed left eye lid was starting to swell in the corner of her eye at 1 pm. It then became bigger and started to shut her eye. Her right eye then started to swell around 2 pm and she began to have difficulty talking and swallowing. She was not short of breath but felt like her throat was tightening. She arrived to work at 2:50 pm and informed her boss who sent her to the employee health department. She reported having oral Benadryl and  was going to take that. Anesthesiology evaluated her, felt it was a progressive allergic reaction, and recommended evaluation at an urgent care or ED. She later developed hives, her lower lip became swollen.  She was later evaluated at Emergency Department. She will be able to provide you with information on the doctor, treatment. She was prescribed a course of prednisone and will have allergy testing scheduled. MD indicated uncertain if caused by vaccine.   She missed work on 1/6 due to the ongoing reaction which had improved.
Report received on 12/12/00, via telephone from a nurse regarding a possible adverse event associated with Fluvirin. On 11/1/00, an 80 year old male pt (DOB 8/1920), received vaccination with Fluvirin and 1 day later, developed a fever of unknown origin. The pt was seen in the ER and hospitalized. He was dx'd with pneumonia and died on 11/12/00 from respiratory failure secondary to the pneumonia. An influenza titer was done during the pt's hospitalization with negative results. On follow-up, the reporter also stated that the physician felt that it was a coincidence of events that ensued following vaccination. No other information was available at the present time. Attempts are being made to obtain further information. FU shows the pt had a non Q wave myocardial infarction.
chest discomfort and armpit pain on left side of body (shot given in left arm) that lasted 24-36 hours
fatigue; achy body; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history included ongoing psoriatic arthritis. The patient's concomitant medications were not reported. The patient experienced fatigue and achy body on an unspecified date. The outcome of events was unknown.   Information on the lot/batch number has been requested.
Euphoria (ongoing), golf ball size lymph node in left armpit (ongoing), and short-term menstrual cramps with light spotting (I have not had a period for over a year, and I haven't had cramps in several years).
13 YOM fainted shortly after vaccination was given. He had a past history with AE (fainted with last flu shot). His father was present and aided in supporting the patient. He was given water and recovered shortly. No other AE were observed and pt reported feeling fine after that time.
16 yo patient received her second covid (Moderna) dose 21 days from the first Moderna dose.
PT EXPERIENCED SHORTNESS OF BREATH , CHEST PAIN, LUNG PAIN AROUND 1 HOUR AFTER GETTING THE SECOND DOSE OF PFIZER COVID 19 VACCINE. SHE WENT TO THE ER ON 4/20 AND AGAIN ON 4/25 AND WAS ADMITTED FOR 4 DAYS AND WAS DIAGNOSED TO HAVE PERICARDITIS, ATRIAL FIBRILLATION AND ENLARGED HEART.
Pt was admitted to hospital on 4/5/21 with a renal mass, after receiving second dose of vaccine on 4/1/21. Per guidelines, all hospitalizations are reported
Memory issues and a droopy left eye lid about 16 hours after vaccination. The morning of Jan 30 in Hospital to receive evaluation. Memory issues persist, the droopy eyelid a bit better.
Day 3 after Moderna COVID 19 Vaccine EUA : Bilateral leg muscle cramps, "bone" pain and mild weakness Bilateral hand tingling Day 4 mild chills and slight diaphoresis
Redness and rash on skin; Itching after 1 week; Rash on skn; This spontaneous case was reported by a patient and describes the occurrence of ERYTHEMA (Redness and rash on skin), PRURITUS (Itching after 1 week) and RASH (Rash on skn) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In August 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced ERYTHEMA (Redness and rash on skin), PRURITUS (Itching after 1 week) and RASH (Rash on skn). At the time of the report, ERYTHEMA (Redness and rash on skin), PRURITUS (Itching after 1 week) and RASH (Rash on skn) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  The patient had no allergy to any food or drug and was healthy.  Treatment information was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
I had my first dose on 4/23, and I had swelling lymph nodes on my left shoulder near neck area.
This spontaneous report was received from a pharmacist, via a company representative, regarding a 14 years old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. On 27-JUL-2016, the patient was vaccinated with an adult dose of VAQTA injection (strength, dose, lot number, expiration date, route of anatomical location of administration were not reported. No adverse symptoms were reported and no product quality complaint was involved. Additional information has been requested.
Pt recvd 2nd dose of Hep B 24FEB91 & again devel severe fatigue & sleepiness, cough & stuffy nose which resolved in two days; sleepiness persisted pt felt could not go to work;
Patient symptomatic with cough and congestion since 12/17/21 and tested positive on 12/20/21. Isolated x 10 days, ended on 12/27/21. Currently, still symptomatic and taking cough medicine and Sudafed. Advised to update mgmt and to callback the hotline when symptoms improve/resolve. Antibody testing ordered when she feels better.
Patient presented 4 days after administration with a round red rash on the right arm. The rash was approximately 2 inches in width, swollen, and warm to the touch. It was several inches  below the actual site of administration. Patient had self-treated with OTC ibuprofen on the night of the vaccine administration.
Patient states she has been experiencing lower leg pain that happened a few hours after.  This has reoccurred over the past few days as well.
On 2/17/22 patient was administered covid vaccine that expired on 2/12/22.
Fever >101, myalgias, headache, mild itching, nausea, red swollen upper arm.
Patient states shot given in outer aspect of tricep and has been experiencing shooting from tips of finger into neck. No noticeable swelling or warmth around injection site. Patient advised to take Naproxen and follow-up with MD.
Two days after receiving my vaccine, I started getting bumps on my face. It felt like sunburn, my face was really red. It was hurting. I kind of thought it was rosacea and the eye doctor, Because the rash was affecting my eyes, told me it was linked to inflammation. Later I wondered was it connected to the vaccine. It is under control now, I am taking Erythromycin Ointment for eyes, Metronidazole for my skin.
Headache,  Fever, Chills, Muscle pain and hard time breathing.  Fatigue. Currently treating with Tylenol and Ibuprofen and rest.
After I received the injection I got a sore arm and 2 days later I developed a rash on my left arm and it spread all over my legs, arms, stomach. wrists. There are bumps everywhere. The rash does itch. I went to the emergency room.. They performed blood work. Gave me a steroid cream and another oral medicine. Have not gotten the oral medicine because over prior authorization is needed. They believe, but not definite, it is called Licaen Plainus.
covid 19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid 19) in an elderly female patient who received mRNA-1273 (Spikevax) (batch no. ASKU) for COVID-19 prophylaxis.     Concurrent medical conditions included Coronary artery disease.    On 11-May-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (covid 19). At the time of the report, COVID-19 (covid 19) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Reporter reported him and his wife were both seniors and had their previous vaccines all Moderna and had Covid 2 times within the last three years. He reported they just got back from a cruise and have Covid now. His question was for the new Covid vaccine coming out, how long do they have to wait to get the vaccine since they have covid now and going on another cruise in December. .  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-745075 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-745075:husband case
very hot itchy throat inside and out; small hives on throat; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROAT IRRITATION (very hot itchy throat inside and out) and URTICARIA (small hives on throat) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy (penicillin,), Allergy to insect sting (wasp allergic), Allergy to antibiotic (ciprofloxacin) and Blood pressure fluctuation. Concomitant products included LISINOPRIL for Blood pressure management, AMLODIPINE for an unknown indication.    On 02-Apr-2021 at 5:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021 at 8:00 PM, the patient experienced THROAT IRRITATION (very hot itchy throat inside and out) and URTICARIA (small hives on throat). At the time of the report, THROAT IRRITATION (very hot itchy throat inside and out) and URTICARIA (small hives on throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient did not take any treatment.
Pt reported to ED with severe headache, nausea, sinus congestion. Torodol given for headache, Zofran given for nausea, Prednisone; and discharged home. Stay in ER was just under 2 hours.
tested positive for Covid; tested positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 69-year-old male patient received BNT162b2 (COMIRNATY), 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: "high blood pressure" (unspecified if ongoing), notes: controlled well with medication. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 12Apr2022, outcome "unknown" and all described as "tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Apr2022) positive.  Clinical course:The reporter accompanied by her husband, her son and a friend have all been vaccinated and boosted with Pfizer Covid vaccine. While vacationed together on a cruise ship the week from 05Apr2022 to 12Apr2022, they were notified on 12Apr2022 having been tested positive for Covid.They were therefore removed from the shipped and self quarantined in a hotel. Since being quarantined they have all developed mild to moderate Covid symptoms. Symptoms developed by patient: cough, congestion, fever for 2 days  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.