chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 10-DEC-2018, the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # R001529, expiration date 07-NOV-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccine was exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA001125.
After 1  shot had doctor appt and was notice that my kidneys function has declined slightly, then 7 days after the second shot I notice these blisters on my right lower leg near ankle filled with clear liquid it was a rash of multiple blisters. After about 7days they begin to go down I did not try to pop them I just took pictures each day and now they have went down today is May 19th 2021. and the area has dark scabs that seem to be going away.
Was 18w 6d pregnant. Started experiencing fatigue at about 4pm. Chills, aches from about 6pm. Feverish from about 8pm and no appetite.  Went to sleep at 10pm, woke up at 2am and vomited 3 times between 2am and 5am. Slept until 8am and fever had broken.  Achey and tired the next day, still very little appetite.  Woke up two days later totally fine.
Injected in left arm - net sore at first - but after 2 days very painful when lifting, putting on coat - etc. Lasted about 2 weeks. Daughter was injected as well.
Exactly one week after the MMR was administered, she experienced fever and vomiting for 3 days. In total she was ill for 5 days before she began to hold liquids/soft foods and reduced to mild to no fever.   She had a mild rash on neck and upper body after the MMR, but more than 2 weeks after it was administered.
Pt received vaccine at 10:30am on 9/7/14. She experienced extreme stomach pain and was taken to hospital at 1:30pm. Pt was given 3 doses of morphine and was released at 8:30pm. MD told her that her stomach was about to ulcerate had she delayed coming in. She was told it was a rxn to shot and not to get another for 2 yrs.
Diarrhea and intestinal cramping with bloody stools, muscle aches, chills, pain at site of injection
Mom states pt got heat rash in diaper area knees & elbows 6-7 hrs p/shots; mom call MD & has been giving DPH; also was told by MD to get Calamine lotion for itching; This AM pt has raised white whelps; mom stated pt had low grade fever;
4 hours of supraventricular tachycardia confirmed by ekg started approximately 6 hours after the vaccine administration.  No prior history of such.  A-fibrillation began to occur a week later, and persisted for off and on for 6 weeks.
After reporting decreased fetal movement at 36 weeks in an otherwise normal pregnancy, my OBGYN conducted a nonstress test in her office which showed intermittent fetal heart rate invariability and a single late deceleration.  I was sent to the hospital where the baby?s heart rate had become sinucoidal, and I was taken in for an emergency c section.  My baby was born several anemic and tests revealed she had suffered a massive fetomaternal hemorrhage, the cause of which was unknown.  She had persistent pulmonary hypertension, needed three blood transfusions, and need to be intubated and placed on a ventilator.  Ultimately, she survived but the doctors kept telling us it was a miracle that she did.
having the throbbing pain in the arm that I administered this shot; so my upper muscle, my wrist muscle, my fingers all have the throbbing pain/through out that hand and the shoulder too; so my upper muscle, my wrist muscle, my fingers all have the throbbing pain/through out that hand and the shoulder too; so my upper muscle, my wrist muscle, my fingers all have the throbbing pain/through out that hand and the shoulder too; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 09Mar2021 (Lot number: EN6202) as dose number unknown, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "having the throbbing pain in the arm that I administered this shot"; MYALGIA (non-serious), PAIN IN EXTREMITY (non-serious), ARTHRALGIA (non-serious) all with onset Mar2021, outcome "unknown" and all described as "so my upper muscle, my wrist muscle, my fingers all have the throbbing pain/through out that hand and the shoulder too".  Additional information; Clinical course: Patient had the throbbing pain in the arm that administered this shot, so the upper muscle, wrist muscle, fingers all had the throbbing pain/through out that hand and the shoulder too it come and goes then felt like the nerves were the one that is getting which the patient did not know exactly.   No follow-up attempts are possible. No further information is expected.
Fever next night lasting overnight, arm sore and swelling for next 5 days, hair is starting to fall out about a week afterwards and is still continuing.
Information has been received from a physician concerning a 65 year old male with hypertension, hypercholesterolemia and anemia and no allergies who on 26-JUN-2007 was vaccinated IM with a first dose of Zostavax (Oka/Merck) (Lot #657767/0740U).  Concomitant therapy included amlodipine besylate (+) atorvastatin calcium (Caduet), lisinopril-HCTZ, "omaprezole" and fenofibrate (Tricor).  On 10-JUL-2007 (previously reported as 30-JUL-2007) the patient developed half-dozen zoster lesions and a rash in the arm pit area after vaccination.  The patient was treated with valacyclovir hydrochloride (Valtrex) and the lesions went away.  At the time of report the patient had recovered.  A product quality complaint was not involved.  Additional information has been received from the physician who stated that the patient had developed erythematous rash with vesicles.  On 01-AUG-2007 the patient recovered.  The patient's experience was considered to be an other important medical event.  No further information is expected.
flushing, difficulty breathing, rapid heart pulse (146), elevated blood pressure (183/103).  Last anaphylaxis 8 years ago with allergy shot; received 2 epi-pens. Fortunately, 2nd dose was done at the Urgent care setting.
General malaise and fever began two hours after vaccination. Diarrhea began three hours after vaccination. Nausea and vomiting began five hours after vaccination.
pt recv vax 30JUL98 & 8 hr p/vax pt exp back pain which was described as severe pain;pt reported that spoke w/MD who recommended NSAID tx;
Rash developed on both forearms from wrists to elbows; This is a spontaneous report from a contactable healthcare professional (patient). A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EN6200, Expiration date was not reported), via an unspecified route of administration (administered on the left arm) on 24Feb2021 at 16:00 (at the age of 52-years-old) as dose 1, single for COVID-19 immunisation. Medical history included high blood pressure and gastroesophageal reflux disease (GERD). The patient has no known allergies. The patient didn't receive any other vaccines within 4 weeks prior to COVID vaccine. Prior to vaccination, the patient has not been diagnosed with COVID-19. Concomitant medications included lisinopril, acetylsalicylic acid (ASPIRIN), ibuprofen, multivitamins and P. The patient experienced rash developed on both forearms from wrists to elbows on 26Feb2021 at 12:00. The event occurred approximately two days after receiving the vaccine. Nothing abnormal at injection site and no other rashes seen. No treatment was received for the event. Since the vaccination the patient has not been tested for COVID-19. The outcome of the event was not recovered.   No follow-up attempts are possible. No further information expected.
Pt presented to hospital ER 2 days post vaccine complained of (L) muscle swelling, muscle pain & swelling at injection site.
shortness of breath; itchy patch under injection; fatigue; body ache; sore; chills; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath), VACCINATION SITE PRURITUS (itchy patch under injection), FATIGUE (fatigue), MYALGIA (body ache) and VACCINATION SITE PAIN (sore) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced DYSPNOEA (shortness of breath), VACCINATION SITE PRURITUS (itchy patch under injection), FATIGUE (fatigue), MYALGIA (body ache), VACCINATION SITE PAIN (sore) and CHILLS (chills). At the time of the report, DYSPNOEA (shortness of breath), VACCINATION SITE PRURITUS (itchy patch under injection), FATIGUE (fatigue), MYALGIA (body ache), VACCINATION SITE PAIN (sore) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
This spontaneous report was received from a licensed practical nurse, referring to a 16 year old, male patient. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On unknown dates the patient was vaccinated with the three dose series of GARDASIL (dose, route, lot # and expiration date were not reported). Then, on 03-AUG-2015, the patient was vaccinated with an additional dose of GARDASIL 9 by intramuscular route in the right arm (reported as RD), lot # K026247 (expiration date was not reported), because a company representative mistakenly told that it was the Centers for Disease Control and Prevention (CDC) recommendation. No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information has been received.
p/vax,w/in 1 1/2hr, had pain & swelling lt deltoid area (site of vax);seen again later in this office given Keflex adm 9/30/99 w/extensive cellulitis;
Fever, lethargy, no appetite, arm pain mom did witness child (at night) eye wide open, staring, and smacking lips. episode stopped after 15 seconds of initial witnessed time, this was observed once on 2/10/22.  missed x2 days of school treated with tylenol and motrin, frequent checks during sleep lasted for 48 hours.
Vaccine given too high up on left arm at shoulder joint. Intense pain in shoulder and arm. Shoulder and arm warm to the touch, low grade fever, heaviness feeling in arm. Still having pain 6 weeks later.
Headache & Myalgia Narrative: dose 1 day 1 sore arm dose 2 day 1 ha; day 2 fatigue; day 3 chills
colds; This is a spontaneous report from a Pfizer sponsored program, a contactable consumer (Patient).   A 87-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: unknown) via an unspecified route of administration (at the age of 87 years old) on 26Feb2021 as dose 1, single for COVID-19 immunization. On an unspecified date the patient experienced colds. The patient received tylenol as treatment for cold. The patient reported that that 5 days before the second dose, patient took Tylenol to get rid of a cold. Patient took second dose on 19Mar2021. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Physician).  An adult male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Sep2022 as dose 4 (booster), single (Lot number: GH9694), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Paxlovid, oral, from 31Aug2023 to 04Sep2023  for treatment of COVID-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162b2, BNT162b2 omi ba.4-5 in this patient cannot be completely excluded.
Bilious emesis, diarrhea, lethargy, leukocytosis, dehydration requiring hospitalization and IVF. 1/23/07 Medical records received with report & considered complete as is.  Admitted 1/10-1/11/07 for bilious emesis, diarrhea, dehydration, lethargy & leukocytosis.  Received IVF.  No further emesis & afebrile. FINAL DX: bilious emesis.
Information has been received from a patient and a certified nurse midwife, for GARDASIL, a Pregnancy Registry product, concerning a 36 year old female patient with a history of one miscarriage and D&C (dilation and curettage) procedure while on prior therapy with GARDASIL (MSD, WAES 1202USA02959) and drug reaction/allergy to "sulfa" who was vaccinated with the first dose of GARDASIL, 0.5ml, IM., (lot number 666931/0337Z) on 02-MAR-2011, the second dose of with GARDASIL, 0.5ml, IM., (lot number 667930/1561Z) on 02-MAY-2011 and the third dose of with GARDASIL, 0.5ml, IM., (lot number 668554/0306AA) on 12-SEP-2011. The patient did not receive any concomitant vaccinations when the GARDASIL vaccinations were administered. Concomitant therapy included CYMBALTA. Consumer reported that on 12-SEP-2011, she received the third dose of GARDASIL and on unknown date, also reported as "recently" became pregnant. Consumer stated that on 17-FEB-2012 she lost the baby again. Consumer reported that she contacted her physician. Pregnancy test, "blood work" and HCG (beta-human chorionic gonadotropin) levels studies were performed. The patient's outcome was unknown at the time of report. Upon internal review, "lost the baby again" was considered to be other important medical event. Additional information has been requested.
Booster immunization administered at 0.5ml instead of 0.25ml.  Patient c/o body aches, tired, chills and missed work 1/13/22 and 1/14/22
Starting from about  9:30 or 10:30 pm on Tues night,  I had about 5 bouts of liquid stools and cramping over an hr or so.   I went to bed and woke up and threw up at about 1:00pm.   I was awake until at least 4 feeling very thirsty, a bit dizzy, light headed and in general sick.  I was extremely thirsty and got up on the hour and drank 8 to 10 oz of water until about 4 am or so.    I slept then for a while and woke up again around 7 am or so, by then my stomach and cramps were ok but then I had a little ringing in the left hear and had a low grade head ache.    I called the Dr. around the time the office opened and spoke with the nurse and ate a breakfast cookie.    We decided that I was much better than during the night but that I should get gatorade or coconut milk to replace electrolytes.  Over the next couple of hours I drank 2 cans of coconut milk ,stayed in bed feeling like I had the flu and slept pretty much all day until I got up and had rice when my husband had dinner.    The next day, I felt like I had a mild flu and was up and out of bed all day.  I took my temperature with a mercury oral themometer just once and it read 101.2 at about 7 am.   Usually I would be 98 or a little below.   The following day I felt a bit better yet.     It is now a week out on Wed.   Except for my stomach and intestines getting back to normal, I feel fine.  Except, I went out to dinner last night, had a substantial meal and had one liquid stool and one throwing up episode.  Because , I feel like I should be fine, I saw my Dr. today who ran some blood work to make sure that nothing else is brewing along with this "reaction."  Temperature at the Dr. office was 98. The first shot, I had mild flu like symptoms for a couple of days but this was far worse.    My arm did hurt and had a little bump at the site but was not red over any of the three days.
On 4/12/01, 8 hours, post vax, pt complained of pain in both legs in thigh areas. Mom stayed home from work. Gave Motrin every 6-8 hours and applied moist compresses to legs. Child weighs about 35 lbs, very thin legs. Complained of inability to walk and refused to stand up and walk. Was crawling and crying. By 16:00, began using legs. Felt feverish to mom. On 4/19/01, per mom, pt is totally recovered and no more symptoms.
Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cerebral palsy, Bipolar disorder and Generalized anxiety disorder. Concomitant products included LITHIUM, LAMOTRIGINE (LAMICTAL), LORAZEPAM, DARIFENACIN and LEVOCETIRIZINE for an unknown indication.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Birth control was used as concomitant medication.  After the first dose, the patient experienced headache. The patient had surgery the same day on her finger, so had medications from the surgery.  No treatment medications was provided.   This case was linked to MOD-2021-291046 (Patient Link).
itching at the injection site; Redness at the injection site; looks like a rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itching at the injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE RASH (looks like a rash) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (itching at the injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE RASH (looks like a rash). At the time of the report, VACCINATION SITE PRURITUS (itching at the injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE RASH (looks like a rash) 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.   Treatment a beta blocker, a blood thinner and thyroid medicine.
I had general malaise, fever of 101.8, muscle aches, vertigo once during the morning getting up to use the restroom.
I vomited a lot of the afternoon after I got the second dose of moderna. So very nauseated and lots of vomiting.
Patient hasn't received 2nd dose yet; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient hasn't received 2nd dose yet) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 23-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient hasn't received 2nd dose yet). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient hasn't received 2nd dose yet) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication provided.  No treatment medication provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Non significant follow up received on 27-MAY-2021, no new information
Cough, excessive phlegm in lungs/bronchia; excessive tiredness (sleep 10-11 hours a day)
Swollen tongue, facial swelling, sore throat, headache>>>allergic reaction lasted 5 days; responded to Benedryl and Claritin. Headache continues off and on for 2 weeks.
Rheumatoid arthritis flare up; Pain; FACILITATED COLLECT  This is a non-interventional study report from the marketing program received from a Non-contactable consumer (patient) based on information received by Pfizer (manufacturer control number: 21K-163-3887413-00).  A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported), intramuscular on 26Mar2021 as single dose for COVID-19 immunisation. Medical history included alcohol (alcohol specify type social drinker two to three night during a week) from 1981, tobacco (tobacco specify type vape e cigarette) from 1983, and broken ankle from 20Jan2020. Concomitant medications included adalimumab (HUMIRA), from Jun2018 and ongoing for moderate to severe rheumatoid arthritis, atenolol (ATEROL) for attention deficit hyperactivity disorder (ADHD), progesterone for hormone, estrogen nos; testosterone for hormone, hydroxychloroquine phosphate (PLAQUENIL) for rheumatoid arthritis, and hydroxychloroquine for rheumatoid arthritis. The patient experienced rheumatoid arthritis flare up and pain on Apr2021. The outcome of the events was not recovered.  The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the information currently available, there was not a reasonable possibility that the reported events of rheumatoid arthritis flare up and pain were related to BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE. The events are attributed to underlying medical conditions.
Patient did not have symptoms. He was given two doses of Moderna after having already received Janssen.
Pt. experienced tingling in hands and feet 15 min. after receiving the H1N1 vaccine. She felt that her knees were "swollen"' but had no visible edema. C/o sore thighs for two days after.
30 hours post-injection I experienced intense body aches, fatigue, headache and fever (100.9F).  Following the first injection in the series I experienced very mild body aches and minor fatigue, also noted at approx 30 hours post-injection.  Symptoms following the second injection were much more intense, included a fever and headache, and lasted longer (12-13 hours).  Symptoms experienced following the second injection caused a missed work day.