chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt admitted to hosp due to a fall @ home; left hip fx and unresponsive; O2 sat 66% on RA when found; Hx of COPD, CKD, HTN, arthritis, emphysema, sleep apnea; found positive for COVID; treated with remdesivir, antibiotics, steroids, underwent ORIF; pt's condition declined rapidly; comfort measures; pt died in the hosp
Developed syncope immediately following injection of Tdap. Patient sitting, depressed head between knees, passed ammonia inhalant briefly under his nose, applied cool cloth on the back of his neck. Had pt. remain seated for 10-15 min. BP 110/70
Last menstrual period 8/22/2021. It is now October 10th, day 49 of my cycle. My cycles usually last 29-33 days. I am not and have never been pregnant.
Site: Itching at Injection Site-Mild, Site: Swelling at Injection Site-Medium
Red, inflamed rash on both arms and chest. I took Benadryl and applied anti-itch cream.
Diffuse urticaria (no anaphylaxis), 27 hours after the shot: Prior to that fatigue and aches.
Patient complains that he received a shot in the left deltoid on December 10, 2019 and noticed that his left deltoid area began to be sore a couple of days later.  The pain has persisted somewhat since then and most noticeable when reaching upwards and/or backwards, behind him.
Baby had difficulty breathing, a fast heartbeat, a low fever, small hives on face and back, and wheezing/hoarseness.
Rec'd shots at 11AM 6JUN91 phone call rec'd 5PM 7JUN pt was seen that day fussy, uncontrollable crying MN until 5PM, t102;
Pt was standing and attempting to place her jacket on. Pt fell down on the floor and MOP seemed to think that pt had a small seizure as her eyes rolled back and she was shaking. Ice pack given and vitals taken.  Pt reported 8/10 pain on the back of her head. No blood or swelling of head. No dizziness or nausea. Pt reported feeling numbness in hands that lasted for about 10 mins.
Vomiting about hourly. Had similar symptoms after 6 mo immunizations which included flu dose #1, vomiting then started within 12 hours of vaccination.
sore arm; slight headache; flu like feelings; right shoulder became extremely sore for several days (unable to use right arm).; This is a spontaneous report from a contactable consumer, the patient. A 78-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8732) via an unspecified route of administration in the left arm on 26Mar2021 (at the age of 78-years-old), as a single dose for COVID-19 immunisation. Medical history included dislocated shoulder. The patient was allergic to sulfa and sun screen. Concomitant medications included benazepril (MANUFACTURER UNKNOWN), finasteride (MANUFACTURER UNKNOWN), simvastatin (MANUFACTURER UNKNOWN) and metoprolol (MANUFACTURER UNKNOWN); all from an unknown date for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6198) via an unspecified route of administration in the left arm on 05Mar2021 at 17:30 (at the age of 78-years-old), as a single dose for COVID-19 immunisation. The patient previously received lidocaine (MANUFACTURER UNKNOWN) and epinephrine (MANUFACTURER UNKNOWN); and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-1. Since the vaccination, the patient had not been tested for COVID-19. On 27Mar2021, the patient experienced sore arm, slight headache and flu like feelings for several days. In addition, the right shoulder became extremely sore for several days (unable to use right arm). It was reported that the right shoulder dislocated 3 times beginning in 1965 through 1996 and the shoulder was almost completely normal after 5 days. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the reported events. The clinical outcome of sore arm, slight headache, flu like feelings and right shoulder became extremely sore for several days (unable to use right arm) was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
she is positive and infected with the delta variant which is the new virus right now; she is positive and infected with the delta variant which is the new virus right now; This is a spontaneous report received from a Pfizer sponsored program from Regulatory Authority. A contactable consumer reported for a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number, NDC number, UPC number: Unknown) via an unspecified route of administration on 25Jul2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient would be having the 2nd dose tomorrow that would be 15Aug2021 and unfortunately, she was positive and infected with the delta variant which is the new virus right now (on an unspecified date in 2021) and she was wondering if she could continue getting the Pfizer vaccine tomorrow or she needs to wait for it, she stated that she cannot read it's (lot number) RR what was it SA7485. The events were considered as serious (Medically Significant). The patient underwent lab test and procedure which included Covid-19: Positive, on an unspecified date in 2021. The outcome of the event she is positive and infected with the delta variant which is the new virus right now was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Leg cramps started about 1 hour after the vaccine was administered. About 6 hours after vaccine, debilitating headache. Numbing of hands and feet along with headache.  On the next day: diharrea, joint pain, burning sensation in hands and feet, nausea, mild rash on both arms, increased heart rate, eye twitching
Pt reports swellng an line on arm with warmth. It decreased over several days after followup by pharmacist. Pt declined going to dr to have checked even after suggested by pharmacist. Pt is ok.
Flu symptoms aching fever of 102 incapacitated for  about 8hrs then cold sweating. I woke up on the 8th and feel a lot better. It was a rough day. a lot worse tha the first shot. I had flu symptoms on the first shot also, but no fever.
rash is slightly itchy; the rash quite red and big; Rashes in cheeks, ears, chest, stomach, abdomen, upper thighs, all over neck and back; a sore arm; bruise; sensitive to touch; dry sinus cavity; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (bruise), HYPERAESTHESIA (sensitive to touch), SINUSITIS (dry sinus cavity), RASH ERYTHEMATOUS (the rash quite red and big) and RASH PRURITIC (rash is slightly itchy) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A22A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VITAMIN D3 and DIPHENHYDRAMINE CITRATE, IBUPROFEN (MOTRIN PM) for an unknown indication.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced CONTUSION (bruise), HYPERAESTHESIA (sensitive to touch), SINUSITIS (dry sinus cavity) and PAIN IN EXTREMITY (a sore arm). On 21-Mar-2021, the patient experienced RASH ERYTHEMATOUS (the rash quite red and big) and RASH (Rashes in cheeks, ears, chest, stomach, abdomen, upper thighs, all over neck and back). On 22-Mar-2021, the patient experienced RASH PRURITIC (rash is slightly itchy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (topical) at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, CONTUSION (bruise), HYPERAESTHESIA (sensitive to touch), SINUSITIS (dry sinus cavity), RASH ERYTHEMATOUS (the rash quite red and big), RASH PRURITIC (rash is slightly itchy) and PAIN IN EXTREMITY (a sore arm) outcome was unknown and RASH (Rashes in cheeks, ears, chest, stomach, abdomen, upper thighs, all over neck and back) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator   Patient states that the rash quite red and big, all over from her neck, thighs, back, chest, abdomen, looks better now, slightly itchy, not bothersome at all.   This case was linked to MOD-2021-116648 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow up received on 10MAY2021, updated reporter details, concomitant medications and 2nd dose details and reported the adverse events after 2nd dose was similar to 1st dose.
SEIZURE; This spontaneous report received from a consumer via a company representative via social media (J and J Corporate account) concerned a male of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced seizure. It was reported as "Their vaccine caused a seizure and more for my husband. Dollar 13K in medical bills. No one cares, least of all J and J. I reported it to VAERS anyway". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of seizure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20221222880-seizure. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Mother described a rash to right arm. Rash was decribed as multiple small white bumps to right arm. Area was described as itching. No fever, no redness, white bumps were not fluid filled. Provider was not sure if this was caused by the immunization as the immunization was a flumist, not an intramuscular injection.
Pt reports a "bruise" that developed at the site of the MMR injection shortly after receiving the injection (time frame unclear).  The bruise then became a patch of red, itchy, scaly skin.  Pt reported 1 month later for her 2nd dose of MMR.  On exam, at the site of the MMR injection, pt had a 4 cm well demarcated raised plaque with fine-to-medium size scale.  The plaque was surrounded by hyperpigmentation.  There was underlying tissue edema.  Pt denies prior hx of skin conditions.  Denied systemic symptoms following injections.  Pt was given triamcinolone 0.1% cream for BID use to help resolve the presumed fixed drug reaction.
Swollen arms and hands, Numbness pins and needles whole body over first two days, Swollen Numb Face off and on. First 2 days. Face felt like hives but never surfaced. Itchy Red Eyes, body aches, fever/chills, joint pain, nausea,  Blurry vision twice the first 2 days lasted briefly. euphoria.   Off work for 3 days felt back to normal after 6 days.    Traveled Dec end of 2019.  Returned with bad Cold out of work for a week +
While in observation following vaccination, patient reported itchiness on her mid-back around 9:50am. Small hives noted on mid-back No reports of SOB. Patient given 25 mg of benadryl PO. Patient left vaccine site with no further issues.
Face and neck swelling, Nausea, Headache, Fever, Chills, Uncontrollable Full Body Shakes, Foggy Brain, Fatigue, Body Aches, Redness and Swelling at Injection Site with Hot to Touch, Rash.  Took Tylenol 1000mg, Benadryl 25mg and Ibuprofen 800mg every 4 hours rotating for 5 days. Still having Headache, Fatigue and Feeling of Sinus Pressure with Minor Facial Swelling
doses administered past the published expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date). On 15-Oct-2021, EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment medication use was not provided by the reporter.
THIS PATIENT PRESENTED TO OUR ED AFTER RECEIVING THE J&J COVID-19 VACCINE AT AN OUTSIDE CLINIC.  SHE REPORTED RECEIVING THE VACCINE AROUND 1100.  AROUND 1200, SHE REPORTS THAT SHE STARTED DEVELOPING HIVES AND FELT LIKE HER THROAT WAS CLOSING.  SHE REPORTED TAKING 1 DOSE OF BENADRYL WHICH DID NOT ALLEVIATE SYMPTOMS,  SHE REPORTED CALLING HER PCP AROUND 1400 WHO ADVISED HER TO TAKE ANOTHER DOSE OF BENADRYL.  SHE REPORTS THAT SHE DID NOT FEEL IMPROVEMENT IN SYMPTOMS SO SHE ARRIVED TO THE ED AROUND 1500.
pt started w/swelling of rt leg;very red around inj site;very hot to touch & hard;pt given med 3FEB99;4FEB99 pt leg has inc in swelling, warmth & redness;pt started w/ T103.7;pt hosp w/cellulitis for aggressive IV therapy;
On 06/16 right arm slightly red at injection site.  Later that afternoon developed lump in arm, warm and increased redness; favoring arm on 06/17. Right deltoid area 7 X 7 cm area of redness, warmth and induration. Pt treated with Tylenol.
Patient was vaccinated at 1631 6/3/2021.  She came to observation room with many allergies in the past and history of serum sickness.  She was to be watched in the observation room for 30 min. She developed nausea and abdominal pain (6/10) She was flushed and itching.  1645 Benadryl 50 mg given per mom's OK.  30 min later she was still the same but with dizziness too.  Given gatorade to sip on and vitals taken. 125/76 Mean 95, HR 90, RA pox=97%.  Continued to watch with no improvement despite interventions .  RRT called ultimately. Patient taken to ER with Mom at patient's side.
allergic reaction to the first dose (signs and symptoms: raised itchy rash (generalized)); This is a literature report.   A 12-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE), as dose 1, single (lot number unknown) for covid-19 immunisation. The patient's relevant medical history included: "food allergy" (unspecified if ongoing), notes: peanut, sesame, egg, hazelnut; "penicillin allergy" (unspecified if ongoing); "anaphylaxis" (unspecified if ongoing), notes: cause is peanut. The patient's concomitant medications were not reported. The following information was reported: HYPERSENSITIVITY (medically significant), 5 min after the suspect product administration, outcome "unknown", described as "allergic reaction to the first dose (signs and symptoms: raised itchy rash (generalized))". Therapeutic measures were not taken as a result of hypersensitivity. Time to symptoms resolution was several hours. INS (insufficient information to meet case definition) was reported.  A specialized vaccine clinic evaluated patients referred for suspected immediate allergic reactions to the first dose of the Pfizer-BioNTech SARS-CoV-2 mRNA vaccine or suspected PEG/polysorbate allergy. All patients were evaluated from May2021 to February 2022. Nine patients were evaluated after experiencing an allergic reaction to the first dose.; Sender's Comments: There is a reasonable possibility that the event hypersensitivity was related to BNT162b2 based on known drug safety profile and temporal relationship.  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-PV202300015137 Same article/ drug and different patient/ event;
Immediately after injection - muscular pain at site and radiating throughout bicep and tricep of left arm Day of injection - 3 PM - slight headache Day of injection - 8:30 PM  - chills and headache worsening Day of injection - 10:30 PM - fever of 100.5 and headache with nausea - took 650 mg of Tylenol Day after injection - 7:30 AM - fever finally down to 99.7 and headache with nausea - took 650 mg of Tylenol Day after injection - 6 PM - fever still at 99.5 headache lessened to the point nausea is gone - took 650 mg of Tylenol Day after injection - muscular pain at upper half of bicep and tricep of left arm 2 days after injection - muscular pain at upper half of bicep and tricep of left arm finally beginning to lessen
This spontaneous report was received from a pharmacist via company representative refers to a 66 year old female patient. On 10-APR-2014, the patient was vaccinated with ZOSTAVAX Lot # K000726 (dose, route and frequency were not reported). On 11-APR-2014 (also reported as a day after receiving ZOSTAVAX), the patient experienced injection site reaction. The pharmacist stated that there was a large area that was bruised and looks red around the injection site. There was a hard bump and was warm to touch. The pharmacist also stated that he will be contacting the patient on 15-APR-2014 to see how the reaction was doing. The patient did not sought any medical attention and did not received any treatment for the event. The outcome of the event was unknown. The reporter did not assessed the causality between the event and the suspect drug. Additional information has been requested.
This spontaneous report as received from a physician refers to a patient of unknown age. On 30-DEC-2013 the patient was vaccinated with a dose of MMR II Injection (lot # H01894, expired date: 18-OCT-2014) 0.5 ml subcutaneous. It was reported that the dose of MMR II injection was exposed to 86 degrees Fahrenheit for 72 hours which was not supported. No adverse events were reported. Additional information has been requested.
Day 2:Woke up very Tired. Under side of arm vacinated Swollen. neck sTiff, Tingling in face. Later That day noticed bottom front Teeth, gum & lower part of Tongue numb. Slept most of 2 days.  Day 3:  Bloody nose, bloody stool, fever over 100. Teeth affected loose. Some numbness remained until Day 18. Even Today Teeth do not Feel normal. Some Tingling around heart. Have had  Echo, heart okay.
Had a sore arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Had a sore arm at the injection site) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced VACCINATION SITE PAIN (Had a sore arm at the injection site). At the time of the report, VACCINATION SITE PAIN (Had a sore arm at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Follow-up information received on 21-May-2021: contains non-significant information.
1) Diarrhea onset 9/6/12. 2) Fever onset 9/6/12. 3) Stuttering onset 9/10/12.
It started the last week of August, pretty severe abdominal pain, diarrhea, nausea and vomiting. I have had chronic diarrhea for four weeks. The last week, it has gone back and forth between constipation then diarrhea. I am still having that and the nausea. Yesterday, I started having chest pain that I am monitoring to let my doctor know. I did go to the doctor on 19th. No treatment but there was an incidental finding that I have fatty liver. He has referred me to GI specialist for GI symptoms and the fatty liver. I don't have an appt yet.
Weak, nauseated, headache on 4/18/21 with weakness and SOB with sx worsening drastically on 5/29/21. Diagnosed with myocarditis by doctor.
This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (Tickle in her throat), SWOLLEN TONGUE (Tongue and throat swelling), PHARYNGEAL SWELLING (Tongue and throat swelling) and ALLERGY TO VACCINE (Allergic reaction) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Penicillin allergy, Drug allergy, Drug allergy and Drug allergy. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROAT IRRITATION (Tickle in her throat), SWOLLEN TONGUE (Tongue and throat swelling), PHARYNGEAL SWELLING (Tongue and throat swelling) and ALLERGY TO VACCINE (Allergic reaction). At the time of the report, THROAT IRRITATION (Tickle in her throat), SWOLLEN TONGUE (Tongue and throat swelling), PHARYNGEAL SWELLING (Tongue and throat swelling) and ALLERGY TO VACCINE (Allergic reaction) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided. No treatment information provided.
Feeling abnormal; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling abnormal ) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 014M20A) for COVID-19 vaccination.     The patient's past medical history included COPD since an unknown date. Concomitant products included PARACETAMOL (TYLENOL) and METOPROLOL for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced FEELING ABNORMAL (Feeling abnormal ). On 12-Feb-2021, FEELING ABNORMAL (Feeling abnormal ) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication included unknown inhaler for COPD.   This case was linked to US-MODERNATX, INC.-MOD-2021-052033 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Follow up received on 26-APR-2021. included new events which are after experienced second dose.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-052033:2nd dose
Information has been received from a woman in a physician's office concerning a 4 year old male with reactive airway disease who on 4/23/01 was vaccinated in the right arm with a first dose of varicella virus vaccine live (lot # 632387/1238K). The patient was at a well visit and had right otitis media at the time of vaccination. On 3/16/04 at 0900 the patient developed a rash all over his body with blisters forming and popping. Subsequently the patient recovered. Additional information is not expected.