chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The vial was first punctured on 03-Nov-2022 at 10:45 am and administered on 4-Nov-2022 at 9 am; No Adverse event; administered a dose from a vial that was punctured more than 12 hours ago; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered a dose from a vial that was punctured more than 12 hours ago), PRODUCT STORAGE ERROR (The vial was first punctured on 03-Nov-2022 at 10:45 am and administered on 4-Nov-2022 at 9 am) and NO ADVERSE EVENT (No Adverse event) in a 2-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Nov-2022 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Nov-2022 at 9:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered a dose from a vial that was punctured more than 12 hours ago). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was first punctured on 03-Nov-2022 at 10:45 am and administered on 4-Nov-2022 at 9 am) and NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered a dose from a vial that was punctured more than 12 hours ago), PRODUCT STORAGE ERROR (The vial was first punctured on 03-Nov-2022 at 10:45 am and administered on 4-Nov-2022 at 9 am) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (administered a dose from a vial that was punctured more than 12 hours ago) and PRODUCT STORAGE ERROR (The vial was first punctured on 03-Nov-2022 at 10:45 am and administered on 4-Nov-2022 at 9 am).    No concomitant information was reported. The patient age was reported as 2.5 years. The size of the vial was 2.5 ml. The vial was initially stored in the refrigerator on 31-Oct-2022. The vial was first punctured on 03-Nov-2022 at 10:45 am. The vial was stored in fridge post puncture. The vial did not undergo any temperature excursions. The total amount of time the vial was exposed to room temperature range (8 degree to 25 degree Celsius is equal to 46degree to 77 degree Fahrenheit) was 3 minutes. No treatment information was provided.
12/25/2020 quarter size knot, redness and warmth at injection site 12/27/2020 resolved with warm compresses  12/31/2020- injection site very tender, red, warm to touch, itching, burning, hardened size of 5cm circle  1/1/2020- symptoms persisted 1/2/2020- symptoms persisted  1/3/2020- symptoms resolved with application of hydrocortisone cream
On-going symptoms: extreme muscle pain, soreness and swelling in entire left arm and upper left back and left shoulder. Tingling pain and numbness in entire left arm. Other symptoms: tiredness fatigue headaches diarrhea stomach pain
Patient received his flu shot the afternoon of Tuesday, Oct 25. On Oct 26 he began complaining of a feeling like an abscessed tooth with pain in his left lower jaw. he developed numbness and swelling in his mouth and lips, like a novocaine feeling. he was given Augmentin 875 mg BID on Thursday, Oct 27. He had severe pain, numbness, and swelling in his lower jaw. he actually had swelling in his whole face. His symptoms progressed, and on Sunday, Oct 30, he presented to the ER with very sore eyes. He could not see when he bent over and his eyes were watering a lot. There it was determined that basically he had facial muscle paralysis, he could not move any of the muscles in his face. He could move his jaw up and down and he did have function of his tongue. He could not close his eyes all the way, squint, move the muscles in his forehead, smile, frown, etc. In the ER he underwent a spinal tap, CAT scan, and multiple blood work, and he was admitted for an overnight stay, with a working diagnosis of possible Guillain Barre syndrome. After a neurology consult it was decided that he most likely had a reaction to the flu shot, with his 7th nerve being attacked. He has been placed on prednisone and Famvir with further neurology follow up planned. His neurologist is anticipating a 6 to 12 month recovery period. Information from 60 day follow-up report states: He recovered, hopefully completely, as of mid December. His neurologist feels it was related to the flu shot. Thank you for your interest and your follow up. Discharge summary disproved GBS diagnosis. Medical records state diarrhea.
(R) arm 10 x 10 cm inflammation circumference (+) warm (+) swelling (+) painful. No Rx.
FEELING WEIRD; TREMBLING; SHAKING; This spontaneous report received from a patient concerned an 82 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetic, allergy to codeine, non smoker, and non alcoholic, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug usage.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 04-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the subject experienced trembling. On 06-MAR-2021, the subject experienced shaking. On an unspecified date, the subject experienced feeling weird. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from trembling, and shaking, and the outcome of feeling weird was not reported. This report was non-serious.
Patient arrived to observation area. After 15 minute observation, patient reports she was experiencing dizziness. Escorted to treatment area. 12:05pm BP 125/70 HR 54. She states she hasn't eaten anything  today in anticipation of getting the vaccine. She also reports a 1 hour commute to vaccine site on 2 very heated buses. Patient given water and granola bar and seated near an open window to receive fresh air.  Patient closely monitored and after some time reports she feels better. 2nd set of vitals: BP - 126/64/ HR - 61. Patient had desire to leave and have a full meal. Left observation area at 12:48pm. ambulated without difficulty.
face was flushed; At 15 minute waiting period, was feeling of opening up lungs, and that continued on drive home so about 30 minutes total.  Did not impede breathing but was like an "opening."; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old female patient (not pregnant) received the first dose of BNT162B2 (Pfizer Covid 19, solution for injection, lot number= EN6202) via an unspecified route of administration on 24Feb2021 at 09:15 AM on left arm as a single dose for COVID-19 immunization at a hospital. Medical history included atrial fibrillation, congestive heart disease. Patient received Latanoprost, Vitamins B12, Vitamin C, Vitamin D, Calcium and fish oil in two weeks. Patient did not receive any other vaccine in four weeks. Patient had no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. At 15-minute waiting period (at 09:45), patient had feeling of opening up lungs, and that continued on drive home, so about 30 minutes total. It did not impede breathing but was like an "opening." When patient got home, so 45 minutes after the shot, patient's face was flushed but that went away in about another 15 minutes. So not particularly "adverse" but a reaction that you should knew about. No treatment was provided for the event. Outcome of the event was recovered.
Rash that started on her torso (over abdomen), spread to her back and arm. Next day rash on her arms, legs and chest only. No breathing difficulty, some itching. No swelling of face, throat or tongue. Benadryl 25 mg X 2 dose, 12 hours apart, then 25mg q6 hours. Hydrocortisone cream to itchy areas. Rash and itching are resolving at approx. 24 hrs post onset.
ON A VENTILATOR; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19; This spontaneous report received from a patient via a company representative concerned a 64 year old male of unknown ethnic origin and race. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included exposure to covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, one total, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On JUN-2021, The patient was hospitalized in intensive care unit, after infectious disease experts confirmed patient had a different variant of COVID-19. On JUN-2021, patient thought he had allergies and on next day patient said that may had getting a cold. Patient stated that he was in contact with someone who tested positive. Patient was breathing with the help of a ventilator. Laboratory data included: COVID-19 virus test (NR: not provided) POSITIVE. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the on a ventilator, suspected clinical vaccination failure and suspected variant covid-19 was not reported. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening).; Sender's Comments: V0: 20210713171-covid-19 vaccine ad26.cov2.s - suspected variant COVID 19, patient on ventilator. This event(s) is considered unassessable. The event(s) 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(s). 20210713171- covid-19 vaccine ad26.cov2.s- suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has an unknown/unclear 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
elevated heart rate; shortness of breath; painful lymph nodes; This is a spontaneous report from a Pfizer-sponsored program Corporate (Pfizer) Social Media Platforms. A non-contactable consumer reported that a patient of unspecified age and gender started to receive bnt162b2 (BNT162B2), via an unspecified route of administration from an unspecified date at a single dose, for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated "I had side effects for 4 days". this patient experienced elevated heart rate, shortness of breath and painful lymph nodes on an unspecified date. Outcome of events was reported as unknown. Patient was nervous about having the second dose but later stated s/he was all in.  No follow-up attempts are possible. Information about Lot/Batch could not be obtained. No further information is expected.
A report has been received from a Health Professional concerning a 50 year old, Male subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent (intranasal) started on 12-Sep-2013. The reporter inadvertently administered FLUMIST quadrivalent to a gentleman who was 50 years old on 12-Sep-2013. The outcome of the event of administered FLUMIST quadrivalent to a 50 YO is unknown. The report was considered to be non-serious.
I had a super soar arm and was tired, I also had a headache. I had a lot of muscular pain in my upper back .   I was feeling off and this lasted for about three weeks, until I got my second dose.    I ran a fever with the second dose and couldn't warm, lasted 24 hours. I have been doing better and  feeling back to myself.
Numbness and tingling in toes about an hour after the injection. Chills, all over body aches, joint pain and fever started a little over 12 hours after the time of the injection. Fever went as high as 102.2. I took Motrin to break fever and then fever would come back again a few hours later. Symptoms lasted about 44 hours before symptoms started to subside and I was feeling better.
sick as a dog ,freezing cold, achy; Feeling really bad flu; weakness; Lethargy; Mental confusion/Feeling confused; not feeling like myself unable to perform at work; I dont feel as hungry as before/loss of appetite; Poor sleep; Freezing cold; Diarrhea; Achy/Aches/Last couple of days gotten better but hurting pretty good; experiencing fatigue; Nausea, felt like im gonna throw up; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick as a dog ,freezing cold, achy), INFLUENZA LIKE ILLNESS (Feeling really bad flu), ASTHENIA (weakness), LETHARGY (Lethargy) and CONFUSIONAL STATE (Mental confusion/Feeling confused) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. lot#049C21A and 001C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Kidney donor.   On 22-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jun-2021, the patient experienced ILLNESS (sick as a dog ,freezing cold, achy), INFLUENZA LIKE ILLNESS (Feeling really bad flu), ASTHENIA (weakness), LETHARGY (Lethargy), CONFUSIONAL STATE (Mental confusion/Feeling confused), IMPAIRED WORK ABILITY (not feeling like myself unable to perform at work), DECREASED APPETITE (I dont feel as hungry as before/loss of appetite), POOR QUALITY SLEEP (Poor sleep), NASOPHARYNGITIS (Freezing cold), DIARRHOEA (Diarrhea), MYALGIA (Achy/Aches/Last couple of days gotten better but hurting pretty good), FATIGUE (experiencing fatigue) and NAUSEA (Nausea, felt like im gonna throw up). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ILLNESS (sick as a dog ,freezing cold, achy), INFLUENZA LIKE ILLNESS (Feeling really bad flu), ASTHENIA (weakness), LETHARGY (Lethargy), CONFUSIONAL STATE (Mental confusion/Feeling confused), IMPAIRED WORK ABILITY (not feeling like myself unable to perform at work), DECREASED APPETITE (I dont feel as hungry as before/loss of appetite), POOR QUALITY SLEEP (Poor sleep), NASOPHARYNGITIS (Freezing cold), DIARRHOEA (Diarrhea), MYALGIA (Achy/Aches/Last couple of days gotten better but hurting pretty good), FATIGUE (experiencing fatigue) and NAUSEA (Nausea, felt like im gonna throw up) was resolving.
Patient came in for 2nd dose of Pfizer.  She instantly had an increase  in heartrate.  We had her recline back in the chair in our observation room, checked her BP, Pulse ox, both of which were in normal range..  I gave her a bottle of water and had her try and relax.  We covered her with a blanket.  After 30 minutes she said she was still not 100% and we had her call a friend to drive her home.  The friend could not come, so I had her rest for another 30 minutes.  She felt better after staying with us for an hour and a half and she left.  She was steady on her feet and reported that she was not dizzy and felt fine.
This spontaneous report was received from a physician assistant referring to a female patient of unknown age, whose concurrent conditions and medical history were not provided. On 07-MAR-2012 and 09-DEC-2012 the patient was vaccinated respectively with her first and second dose of (Oka/Merck) VARIVAX (dose, site of vaccination, route, lot number and expiration date were not provided). Concomitant therapies were not provided. On 15-DEC-2015, she received a third dose of (Oka/Merck) VARIVAX (dose, site of vaccination, route, lot number and expiration date were not provided) because the doctors office told the patient that the first and second dose were spaced too close together. No adverse effects were reported. It was unknown if the patient sought medical attention. No product quality complaint was involved. Additional information has been requested.
Patient's right arm is swollen all the way up to her shoulder. Her arm is red, tender, and itchy.
They were aware about what happened previously, so I had to wait longer. I started getting cotton mouth, so they gave me water. I had a bad rush where I felt like I was about to throw up, I had a migraine and very flush. I started vomiting. My arms started to hurt. I got hives again and they gave me two more Benadryl. They monitored me for another 30 minutes. They said I got super pale. They tried to give me ginger ale and crackers, but my stomach wouldn't allow it. They monitored me for a while longer and I felt better. I went home and woke up the next morning feeling terrible. Vomiting, swelling, muscle aches. I was in bed the whole time and I missed 4 days of work. I went back Tues 19th.
pronounced chills, muscle and overall body aches causing inability to sleep. Exhaustion and feeling dizzy.
Started feeling a little sick in the stomach at 6 PM and advanced to  a fever of 100 and body aches. Lasted about one day and went away as fast as it started about 3 pm the next day.  Had a sore arm.  I am retired and have had many vaccinations.  I have only ever experienced a sore arm.
Five days after my 1st vaccine, I broke out in a rash on my inner arms, back of neck, top of both hands and left side of my stomach area. Small red bumps (welt-like) and extremely itchy.  No other symptoms. Just a rash.
Patient called to report that he developed pain in right buttocks on 05/20/2007, two days after receiving Zostavax.  He reports a rash developed on right buttocks three days after the pain.  The patient saw Dr. on 05/24/2007 and was diagnosed with Shingles and placed on Famvir 500mg three times a day and Lortab 5 mg every 4 to 6 hours as needed for pain.  The patient also reports pain radiates down entire right leg.
Fever, adominal pain and emesis .started 6 days after last dose of Gardasil.progressed to jaundice and dehydration. MANUFACTURER MERCK.  11/12/2008  MR received for DOS 10/23-11/4/2008 with D/C DX:  Superior mesenteric venous thrombosis.  Direct hyperbilirubinemia. Hyponatremia, Hypokalemia, Acute Renal Insufficiency, Thrombocytosis, Anemia (iron deficiency). Pt presented with a 1 week hx of fevers, emesis, decreased po intake, appetite and urine output, abdominal pain and one episode of diarrhea. Pt noted to be dehydrated and icteric on admission.  On PE abdomen noted to be distended with some tenderness in the RuQ and epigastric regions. Started on Lovenox, coumadin, and abx. No resolution of thrombus but no further extension.  LFTs improved. Creatinine improved with hydration. D/C for continued outpt f/u.
Wrong dose administered patient, no reported adverse events at this time. Patient received pediatric dose instead of adult dose.
Patient's mother calls to report that day after receiving her vaccines (8/6/22) she developed an itchy rash in the front, middle part of her chin spreading down her chest. Patient's mother denies any SOB, difficulty breathing, or any signs of anaphylaxis.  With consult of provider, instructed patient's mother to provide the patient with oral Benadryl and also can apply a topical Benadryl as well. Patient's mother verbalizes an understanding. Will call the patient in 2-3 days to follow up on symptoms. If no improvement is noted, with instruct patient to be seen in the clinic for further evaluation.
p/vax pt exp a moderate case of chickenpox w/approx 50 lesions & no fever;
LEFT ARM SORENESS, RAPID HEARTBEAT, TIGHTNESS IN CHEST, AND CHILLS.
Before having COVID patient received doses of the Moderna COVID19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Before having COVID patient received doses of the Moderna COVID19 vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Before having COVID patient received doses of the Moderna COVID19 vaccine). At the time of the report, COVID-19 (Before having COVID patient received doses of the Moderna COVID19 vaccine) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive. 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 medications were provided.  Reporter wanted to know how long after a patient had COVID they should wait to receive the bivalent booster.  No treatment medication was provided.
at 1355 client stated her tongue felt tingly. Pulse 96, BP 134/84. EMS fire fighter assisting with vaccine administration came over and then client stated tongue felt tingly and then she stated her lips started feeling tingly as well. EMS fire fighter administered epinephrine IM at 1413 and then benedryl IM at 1417. Client did not lose consciousness and was able to answer questions appropriately and move self from chair to gurnee without assist.
Large amount of axillary swelling, pain in the underarm and fluid retention all down left-side of the body. Very tender and painful. Ears plugged and filled with fluid. Numbness and sharp tingling in extremities, muscle spasms in feet, calves, fingers and forearms. Vestibular system inflamed eustachian tube dysfunction causing lack of balance, vertigo and dizziness.
headaches; body pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male 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 and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for Covid-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headaches"; PAIN (non-serious), outcome "unknown", described as "body pain".  Additional information: It was reported that the headache is pretty severe. Also, the body aches. The patient would like to know if these symptoms are known to occur, how long his symptoms typically last, and if he can take ibuprofen.  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.
Hospitalized with dyspnea and tachycardia treated BiPAP with O2, refused intubation. also treated with dexamethasone and remdesivir
Severe burning pain on upper tricep where pt recv Anthrax inj; yellow fever inj was in same area 3/26/99; T100, P118, BP 159/92; on exam pt arm swollen, erythematous w/induration; pt hosp;e lbow stiff w/mild diaphoresis. On 4/9/99 sx improved.
Developed severe shingles on left torso (along T11 dermatome). This was treated with Valtrex 100mg TID x 7 days; pt had so much pain that Percocet 5/325mg and Gabapentin 100mg TID had to be added. He then had to be hospitalized April 18-21, 2020 for progressive LUE & LLE numbness and sphincter weakness (anal and urinary). He had extensive testing (LP, CTs & MRIs) and was seen by neurology and infectious disease specialists whom suspected acute viral myelitis related to recent shingles.