chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The vaccination was given and the patient's parent reported that his eyes rolled into the back of his head and he had involuntary movements for 10 to 15 seconds.  When entering the room the patient was pale, he did not have a fever and his blood pressure was a little low (80/60), but starting increasing after a few minutes.  The patient did not have a rash, swollen throat or tongue, or any other signs of anaphylaxis.  Patient was monitored for  30 minutes after the event and started to feel better and gain color.
I began to experience itchiness on my head Saturday night, I then awoke to hives on my stomach, armpit, almost everywhere, I was also having jaw pain, Monday morning, the hive in my eye and ears had almost swelled everything completely shut, bottom lip was swollen, I went to urgent care  then and they gave me a covid-19 test, and then gave me a shot in my right arm a type of steroid, they prescribed me prednisone 2 pills once a day for 5 days, symptoms began to reduce however my stomach was hurting, I was constipated from Monday to Tuesday. Tuesday, I continued to feel stomach pain and around 11 I began to throw up, and then began laboring to breath. This trouble breathing around 1 in the morning on Wednesday I went to the ER, they did a blood test, EKG, I threw up again and got a CT scan as well, expecting appendicitis. Doctor from the ER stated that he should stop taking the prednisone. I threw up two more times and was given a prescription for nausea, Zofran, and Pepcid. Today I woke up in hives again. I then did a visit today, MD, and they prescribed an antibiotic, doxycycline, and I will be taking that starting today. Stomach pain has gone away, constipation has seemed to subside.
Pt. returned to office approx 1 hour after receiving vaccines. Noted raised area to (R) leg at injection site. Child also with bilateral eye swelling with left more than right. No shortness of breath. Given BENADRYL 12.5mg and sent to Emergency Room for evaluation. Pulse ox 100%.
Afternoon fatigue - dinner time felt bad couldn't warm up. Awoke with violent chills almost convulsive. Couldn't get out of bed, lasted several hours, slept and able to then get up. Next day felt mostly fine, like hangover. Next day totally fine with exception of muscle soreness from chills. Shot location tender and achy for several weeks.
A bump and a 3 inch rash at the site of administration of the vaccine; A bump and a 3 inch rash at the site of administration of the vaccine; This spontaneous case from  was received on 24-Sep-2020 from other non-health professional via The Agency (reference number: SEQW20-02263) and concerned a patient of an unknown age and gender.  The patient's medical history and concomitant medications were not reported.   On 17-Sep-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid) for influenza prophylaxis. The batch number reported was 283849 and expiry date was 30-Jun-2021.   On the same day, after receiving Flucelvax QIV, the patient developed a bump and a 3-inch rash at the site of administration of the vaccine. The patient did not receive any treatment measures associated with the events.  On an unspecified date in Sep-2020, the patient recovered from the events.  The reporter did not provide a causality assessment to Flucelvax QIV.   The case was assessed as non-serious.  This case is linked to cases  202004678, 202004696, 202004697, 202004698, 202004699, 202004701, 202004702, 202004703, 202004704, 202004705 and 202004706  due to the same reporter.  Additional non-significant information received on 06-Jan-2021 from other non-health professional via The Agency (reference number: SEQW21-00065) with additional information received on 12-Jan-2021 from other health professional (reference number: SEQW21-00149) (being processed together): Two reporters were added. Reference numbers added. No changes in narrative.  Company comment: A patient of an unknown age and gender was administered Flucelvax QIV vaccine. On the same day, after receiving Flucelvax QIV, the patient developed vaccination site rash and vaccination site mass. The patient's medical history and concomitant medications were not reported. Chronology is plausible. Causality is assessed as possibly related for both events.; Sender's Comments: A patient of an unknown age and gender was administered Flucelvax QIV vaccine. On the same day, after receiving Flucelvax QIV, the patient developed vaccination site rash and vaccination site mass. The patient's medical history and concomitant medications were not reported. Chronology is plausible. Causality is assessed as possibly related for both events.
Information has been received from a consumer and a physician concerning a 46 year old white female pt with no allergies and a history of renal stones, appendectomy and hysterectomy who on 11/14/03 was vaccinated IM in the right deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (Lot # 647028/0564N). Concomitant vaccination on 11/14/03 included an IM dose in the left deltoid of influenza virus split virion 3v vaccine inactivated (Fluzone)(Lot # U1058AA).  There was no illness at the time of vaccination and there were no adverse events following prior vaccination. On 11/15/03, the pt developed a very large red area surrounding the site, a headache and a low grade fever. It was also reported that the pt developed a local reaction and was swollen from the elbow to the shoulder. Medical attention was sought and the pt was treated with Benadryl and Zantac. Lab tests were not performed. It was noted that therapy with pneumococcal 23v polysaccharide vaccine was discontinued. On 11/21/03, the pt recovered from the red area, headache and fever. A product quality complaint was not involved. The reporters also mentioned two other pt's who experienced local reactions following vaccination with pneumococcal 23v polysaccharide vaccine (Lot # 647028/0564N)(WAES#0311USA01984 & 0401USA00073).  Additional information is not expected.
Large reaction on back of arm, covered half of back of arm from injection site to elbow, red, swollen, bruised.
I started having a sore throat and a runny nose, I was congested in my nasal area and was having body aches. I was very fatigued but it was mainly the nose and throat that bothered me. I took an at home COVID-19 Test. My symptoms were very mild so I did not reach out to my doctor as I was managing with OTC medications. I did recover from COVID-19 but by late may and early June I was noticing a lump on my cheek near my ear lobe. I noticed this while putting on make up. It does hurt when I put pressure on it and I do not believe that it has changed. I reached out a dermatologist who wanted to biopsy it but I was not sure I wanted to do that due to possible scaring. I reached out to another dermatologist for a second opinion and they said to see my PCP. I had an X-Ray and an Ultrasound and the results did show a mass and they are sending me an Otolaryngologist to see about next steps.
10 cm by 12 cm erythematous area on the right thigh where the vaccines were given with some an indurated area and cluster of small vesicles, started 2 days after shots were given and has continued to expand 2 days later.
threw up 1 dose of xeljanz xr after receiving covid booster.; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP).  A 57-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "felty's syndrome" (unspecified if ongoing), notes: patient has history of felty's syndrome. Concomitant medication(s) included: XELJANZ XR oral taken for rheumatoid arthritis, start date: 01Oct2022 (ongoing). Past drug history included: Prednisone; Humira. Vaccination history included: Covid-19 vaccine (Primary Immunization Series Complete; unknown manufacturer), for COVID-19 Immunization. The following information was reported: VOMITING (non-serious), outcome "unknown", described as "threw up 1 dose of xeljanz xr after receiving covid booster.".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Information has been received from a registered nurse concerning a 4 year old male patient with asthma intermittent who on 13-APR-2008 was vaccinated with his first dose of VARIVAX (Oka/Merck) (Lot # 652550/1111R), subcutaneously in the right tight.  On 10-DEC-2008 the mother of the patient called the nurse to report that he was sent home from school with 4-5 spots on the trunk.  She also said that the school nursed stated VARICELLA with low-grade fever.  No other symptoms reported.  On 12-DEC-2008 the patient recovered.  No further information is available.
This spontaneous report as received from a consumer via manufacturer (manufacturer control# 16K-163-1721491-00) refers to a currently 51-year-old male patient. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 injection (dose, route of administration, expiration date and lot number were not reported). Concomitant medications were not reported. On an unknown date, the patient experienced allergy to the vaccine. The outcome of the event was not reported. The event of allergy to the vaccine was considered to be related to PNEUMOVAX 23 by the reporter. This is one of two reports received from the same reporter and concerning the same patient. Additional information is not expected as there were no contact details provided.
I had mild arm pain after injection, I developed mild headache and severe dizziness 4days after 1st vaccine that resulted in an ER visit with labs and brain MRI. The dizziness improved between the 1st and 2nd doses but gradually escalated after the second dose on Jan 20th.  I am continuing to experience a mild frontal headache with moderate-severe vertigo   I have to take meclizine 6-8 doses per day alternating with dimenhydrinate and diphenhydramine.  I am otherwise healthy with no history of vertigo except in some instance when I cruise
Developed redness and swelling to right upper thigh 24 hours after shots.  Seen at Hospital ER 10/7/07 and placed on Keflex and Bendadryl for cellulitis.  Had follow up visit with primary doctor 10/9/2007-almost back to normal.
pt recv vax & subsequently devel severe vomiting & diarrhea; pt hosp, no further information available
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with a dose of expired ZOSTAVAX (lot # 670616/0617AA, exp. date 27-Jul-2012) on 01-AUG-2012. No adverse symptoms reported. It was unknown if the patient sought medical attention or not. Additional information has been requested.
This spontaneous report as received from a doctor of pharmacy refers to a 62 years old female patient with hypertension and no drug reactions/allergies who on 13-OCT-2012, was vaccinated IM with a 0.5 ml dose of PNEUMOVAX 23 (lot# H012650, exp date 27-FEB-2014). Concomitantly, the patient had been vaccinated on 06-OCT-2012 with a dose of influenza virus vaccine (unknown) given in the same arm. It was reported that on 14-OCT-2012, the patient returned to the pharmacy complaining of soreness at injection site along with swelling around surrounding area. The pharmacist checked the patient's blood pressure which was "fine". The pharmacist stated that this morning "on 15-OCT-2012" the patient had a little bit of soreness and swelling went down. Compressions did help. The patient was treated with TYLENOL. At the time of the report, the patient's soreness was recovering. The patient recovered from swelling around surrounding area. The relatedness for soreness at injection site and swelling around surrounding area was unknown for PNEUMOVAX 23. Additional information has been requested.
Severe flare up of inflammatory condition, reactive arthritis, mainly in colon (colitis) and joints; Severe flare up of inflammatory condition, reactive arthritis, mainly in colon (colitis) and joints; Severe flare up of inflammatory condition, reactive arthritis, mainly in colon (colitis) and joints; Severe flare up of inflammatory condition, reactive arthritis, mainly in colon (colitis) and joints; This is a spontaneous report from a contactable consumer reported for herself. A 58-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Left on 27Mar2021 13:30 (Batch/Lot Number: Er8737) as 1st dose, single for covid-19 immunisation. No pregnancy at time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included arthritis reactive. The patient's concomitant medications were not reported. The patient experienced severe flare up of inflammatory condition, reactive arthritis, mainly in colon (colitis) and joints on 16Apr2021 09:00. The adverse events resulted in doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Therapeutic measures were taken as a result of severe flare up of inflammatory condition, reactive arthritis, mainly in colon (colitis) and joints included Anti-inflammatory prescriptions. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient had been tested for COVID-19, Nasal Swab on 24Apr2021 with result of negative. Outcome of the events was recovering.
1 of 3 pts vaxed who exp inj site rxn;pt devel swelling, erythema & pain from elbow to shoulder following vax;this was pt's 1st pneumococcal vax;no hx of pneumococcal infect;
WARM, INDURATION  CEPHALEXIN AND DIPHENHYDRAMINE PRESCRIVED BY PROVIDER
Heat rash broke out on her face and right arm.  Rash was light red in color and small and bumpy.
Muscle Soreness; Not feeling herself; being sick; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle Soreness), FEELING ABNORMAL (Not feeling herself) and ILLNESS (being sick) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Muscle Soreness), FEELING ABNORMAL (Not feeling herself) and ILLNESS (being sick). At the time of the report, MYALGIA (Muscle Soreness), FEELING ABNORMAL (Not feeling herself) and ILLNESS (being sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.
Fever; Congestion, head congestion, chest congestion; Congestion, head congestion, chest congestion; Cough; Stiff neck, it is in upper shoulder, it is real tight; Forearm ache; Sluggish and tired; Sluggish and tired; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL3247) via an unspecified route of administration in right arm on 27Jan2021 09:00 as single dose for covid-19 immunization. The patient was 72-years-old at the time of vaccination. The vaccination facility type was hospital. No prior Vaccinations within 4 weeks.The patients medical history included diabetes mellitus, blood pressure abnormal, blood cholesterol abnormal, thyroid disorder, cardiac disorder, neuropathy peripheral, anxiety from an unknown date and unknown if ongoing. The patient's concomitant medication(s) included atorvastatin strength 80 mg and at a dose of 80 mg once a day at night time, taken for blood cholesterol,  levothyroxine sodium (SYNTHROID), strength 50 mg and at a dose of 50 mg once a day in the morning, taken for thyroid disorder; bisoprolol, strength 5 mg and at a dose of 5mg half a tablet once a day, taken for blood pressure abnormal and cardiac disorder; hydrochlorothiazide, strength 25 mg and at a dose of 25mg once a day, taken for blood pressure abnormal; gabapentin, strength 300 mg and at a dose of 300mg capsule; up to three times a day as needed, taken for neuropathy peripheral, venlafaxine hydrochloride strength 75 mg at a dose of 75mg one capsule once a day, taken for anxiety; aspirin [acetylsalicylic acid] at a dose of 81mg at night, taken for an unspecified indication. The concomitant medications started from an unknown date and were ongoing. The patient experienced sluggish and tired on 27Jan2021, forearm ache on 27Jan2021, fever on 28Jan2021, , congestion, head congestion, chest congestion on 28Jan2021, cough on 28Jan2021, stiff neck, it is in upper shoulder, it is real tight on 28Jan2021. The outcome of the events sluggish and tired, fever, congestion, head congestion, chest congestion were recovering and unknown for the other events.  He is scheduled for the second vaccine on 18Feb2021. He wants to know if that is still recommended? Follow-up attempts are completed. No further information is expected.
almost two weeks after injection a really red spot showed up with welts on it. The  spot is also warm to touch.
Left upper arm with marked erythema and increase calor of 4-5cm, indurated. Reaction allergic to drug Adacell, I am unsure if this is cellulitis but suspect it is just a strong immune response to the vaccine.
patient described injection site as swollen and painful, warm to the touch, and getting worse. advised patient to seek medical attention via walk-in clinic or emergency room if symptoms became unbearable/concerning
Within an hour of receiving flu shot, patient was throwing up. This is unusual behavior as he does not spit up or throw up. He could not keep anything down until 2am, 11 hours after receiving the shot. This morning, he does not have an appetite but has not thrown up. Took his temperature around 7:15am and he had a temperature of 100.2 degree Fahrenheit. Called doctor around 4:05 pm on 12.05.2017 and was told there was no link between patient throwing up and the flu shot.
After the second dose the reaction occurs in different part of the body, in the arms, on the face and on the breast; Feels like it's burning; Blisters; Itching; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (After the second dose the reaction occurs in different part of the body, in the arms, on the face and on the breast), BURNING SENSATION (Feels like it's burning), BLISTER (Blisters) and PRURITUS (Itching) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 021C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METOPROLOL, CHLORPROMAZINE, LOSARTAN and ALLOPURINOL for an unknown indication.   On 22-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced BLISTER (Blisters) and PRURITUS (Itching). On 18-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION COMPLICATION (After the second dose the reaction occurs in different part of the body, in the arms, on the face and on the breast) and BURNING SENSATION (Feels like it's burning). At the time of the report, VACCINATION COMPLICATION (After the second dose the reaction occurs in different part of the body, in the arms, on the face and on the breast) and BURNING SENSATION (Feels like it's burning) outcome was unknown and BLISTER (Blisters) and PRURITUS (Itching) had resolved.            Treatment information was not provided. After the second dose patient experienced the reaction  in different part of the body, in the arms, on the face and on the breast. It's where it gets the reactions  most. After the itches went away it burns where the blisters was and lasts 1 or two minutes. Doesn't know if it's  because of the itch. Patient Felts l it was like burning.   This case was linked to MOD-2021-358723 (Patient Link).
Information has been received from a physician concerning a male who was vaccinated with ZOSTAVAX (Oka/Merck). The physician reported that the patient received ZOSTAVAX (Oka/Merck) and had a little bump at the injection site for about 2 weeks then it turned into vasculitis. The patient sought unspecified medical attention. There was no product quality complaint. Additional information is not expected.
This spontaneous report was received from a Certified Medical Assistant referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 14-JUL-2016, the patient was vaccinated with an expired dose of ROTATEQ orally, lot # L000569, expiration date on 13-JUL-2016 (strength, dose number and anatomical location were not provided). Concomitant therapies were not provided. No adverse event reported. Additional information has been requested.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 46 year adult 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204B21A, and expiry: 11-DEC-2021) dose was not reported, 1 total, administered on left arm on 13-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient reported having symptoms of covid after receiving the JnJ/Janssen Covid 19 vaccine(Suspected COVID-19) and hence experienced suspected clinical vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Sender's Comments: V0:20220310221- Covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Within 5 hours of shot,  onset of severe physical shaking with unremitting chills, fever, muscle cramps, body aches and headache. These symptoms were largely unrelieved with Tylenol and Aspirin.   Within 8 hours of shot, development of frequent and sustained cardiac premature ventricular contractions,  necessitating a visit to hospital emergency room.   Cardiac monitoring 10 hours, blood tests and a VQ scan to rule out pulmonary embolism were performed.  Discharged home with instructions to contact cardiologist and primary care doctor for immediate follow-up.  PVC's, constant sweating and exhaustion continued into the third day.  Doctors appointments pending for follow-up care.
Due to h/o anaphylaxis was observed for 30 minutes post COVID vaccine.  Received both COVID and flu vaccines.  10 minutes into observation reported generalized itching (arms, legs, back).  Skin assessed.  NO visible rash/hives/edema noted.  Throat inspected.  No edema noted.  No complaints from pt.  Benadryl 25mg self-administered after 20 minutes.  VS obtained and stable.  released at 30 minutes post.