chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a health professional refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, drug reaction/allergies and concomitant medications was not reported. On 20-NOV-2015, the patient was vaccinated with improperly stored pediatric dose of VAQTA (lot # L015460, expiration date: 20-JUL-2017 or lot # K018181, expiration date: 04-JUN-2017 or lot # L018499, expiration date: 25-FEB-2017) (dose and route of administration were not reported). No adverse effect was reported. There was no product quality complaint. This is one of several reports from the same reporter. Additional information has been requested.
Patient experienced numbness in peripheral extremities and lips, headache, hypertension, neck stiffness, tremor, and blurred vision
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Additional Details: per patient he felt little dizzy about 5 minutes after vaccine while sitting. after about 10 minutes total he passed out (for about 5 seconds)while sitting in chair and fell on to ground and appeared to hit his head. he did wake up, was aleart and responsive while 911 was on their way. 911 did come to store they did assess him and he did walk himself out. he felt ok when he left. he did feel very hot and sweaty when he woke up
Myalgia, Arthralgia, Pain/sweling/Redness/Itching/Rash at injection site Narrative:
I woke up the day after I received the Moderna COVID vaccine feeling achy and tired, as expected.  I took 600 mg of Ibuprofen at 0730.  As the day progressed my symptoms became worse and I developed a fever and chills/shivers.  At 1600 I took 1000 MG of Tylenol.  By 1730 my fever had increased to 103.4 and my shivering was intense.  I took a cold shower and another 600 MG of Ibuprofen.  By 1845 my fever had increased to 104.7, so I proceeded to the Hospital.  Before triage I began to sweat. During triage my fever read 103.8 and my heartrate was 120. I was given 1,000 mL of fluids via an IV.  My fever continued to diminish as the IV was administered and was 100.8 at the time of discharge.
Per documentation, fever for 3 days a week before 6/17/2013 office visit. Rash developed 6/16/2013. Macule, papule rash covering body including palms, soles, and diaper area.
This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (extreme dizziness/ dizziness bad after second shot), TRIGEMINAL NEURALGIA (extremely intense Trigeminal Neuralgic pain over the right side of the face/exacerbation of my neurological disorder), ILLNESS (I am completely sick, since 8 days ago), TINNITUS (severe ringing in my ears) and BEDRIDDEN (have been in bed every day) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below. No medical history was reported by the reporter. Concomitant products included TOPIRAMATE (TOPAMAX), GABAPENTIN, CARBAMAZEPINE (TEGRETOL), OXYCODONE and OXYCODONE HYDROCHLORIDE (OXYCONTIN) for an unknown indication. On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 10-May-2021, the patient experienced DIZZINESS (extreme dizziness/ dizziness bad after second shot), TRIGEMINAL NEURALGIA (extremely intense Trigeminal Neuralgic pain over the right side of the face/exacerbation of my neurological disorder), ILLNESS (I am completely sick, since 8 days ago) and FATIGUE (I am tired too). On an unknown date, the patient experienced TINNITUS (severe ringing in my ears), BEDRIDDEN (have been in bed every day) and ASTHENIA (NO ENERGY). The patient was treated with MECLIZINE HCL for Dizziness, at a dose of UNK dosage form. At the time of the report, DIZZINESS (extreme dizziness/ dizziness bad after second shot), TRIGEMINAL NEURALGIA (extremely intense Trigeminal Neuralgic pain over the right side of the face/exacerbation of my neurological disorder), ILLNESS (I am completely sick, since 8 days ago), TINNITUS (severe ringing in my ears), BEDRIDDEN (have been in bed every day), ASTHENIA (NO ENERGY) and FATIGUE (I am tired too) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. This case was linked to MOD21-083491, MOD21-083504 (E2B Linked Report). This case was linked to MOD-2021-094655. Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: New events-Severe ringing in ears, have been bed every day and  No energy was updated.; Sender's Comments: MOD21-083491:MOD21-083504:
Received FluMist 9Dec on 20Dec had development of ataxia and vertigo seen in ER next morning.  Information recieved from Medical records state myasthenia.
on his arm he is seeing 3-4 inch raised rash; Developed hives around belt line; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Developed hives around belt line) and RASH (on his arm he is seeing 3-4 inch raised rash) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included EPINEPHRINE (EPIPEN) for Insect sting allergy.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced URTICARIA (Developed hives around belt line). On 16-Feb-2021, the patient experienced RASH (on his arm he is seeing 3-4 inch raised rash). At the time of the report, URTICARIA (Developed hives around belt line) and RASH (on his arm he is seeing 3-4 inch raised rash) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Woke up in the middle of the night with 100.5 fever, cold sweats, aching all over and blurry vision
Avascular necrosis of both right and left hip. Left hip led to complete and total hip replacement and then hip dislocation.
Information has been received from a registered nurse concerning a male who was vaccinated with a dose of ROTATEQ. Subsequently the patient spit up the dose which then splashed into his eye. No adverse events were reported. The patient's eye was rinsed with water by the nurse in the office and the physisican was also spoken to for medical attention. The outcome was unknown. There was no product quality complaint. Additional information has been requested. This is in follow-up to report(s) previously submitted on 1/15/2008. Follow-up information has been received from a health professional concerning a 17 week old, male with no pre-existing medical conditions or allergies who on 13-DEC-2007 at 11:00 was vaccinated PO with his second dose of ROTATEQ (lot# 657670/1108U). There was no illness at the time of vaccination. Concomitant vaccinations administered on the same day at 11:00 included the second IM dose of IPOL (lot# 1069) in the right thigh, the second IM dose of ACTHIB (lot# UF207AP) in the right thigh and the second IM dose of DAPTACEL (lot# C2749BA) in the left thigh. Upon administration of ROTATEQ (lot# 657670/1108U), the baby was resisting and arched his back while also spitting the vaccine out, spilling onto his face and into his right eye. The eye was washed several times with normal saline. No symptoms developed therefore no treatment was needed. On that same day the patient recovered. Additional information has been requested.
This non-serious spontaneous case, initially received from other health professional (nurse) on 19-Oct-2018, concerns a 36-year-old, adult, male patient. The patient had no relevant medical history. The patient was not taking any medication at the time of vaccination. On 09-Oct-2018, the patient was administered FLUCELVAX QIVc [dose: 1.5 ml instead of 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 252235, expiry date: 30-Jun-2019]. At the time of this report, no adverse events were reported (reported as no problems). This case: 201804665 was cross-linked to the source case: 201804657 reported by the same reporter.
covid test date: 15Jan2022 / covid test result: Positive; covid test date: 15Jan2022 / covid test result: Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 43 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 11Jun2021 15:00 (Lot number: EW0183) at the age of 43 years as dose 2, single and administered in arm left, administration date 21May2021 13:30 (Lot number: EW0169) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 15Jan2022, outcome "unknown" and all described as "covid test date: 15Jan2022 / covid test result: Positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (15Jan2022) positive, notes: Nasal swab.  No follow-up attempts are possible. No further information is expected.
Patient called and stated itching followed by redness/hives developed around her right elbow the morning after her vaccination. Later in the day she noticed her left shoulder was red (but no hives developed). The patient applied some hydrocortisone cream and took Benadryl. At this point she has not experienced any further symptoms.
Severe headache. While brushing teeth day before notice had problem rinse. But quickly noticed that I could not se the left side of face. Tried to whistle and smile was only on one side. Thought I had a mild stroke. Went immediately for medical help.
About an hour after my first vaccine, I had an excruciating migraine (took tylenol). Around 3 am (12 hours after vaccine), I woke up with flu like symptoms and began to have myoclonic jerks. I had full body "twitches" for four plus hours. I would have a jerk/twitch 4-5 times in a minute. For example, my right leg would jerk, then my arm, then my neck, etc. It was not a whole body twitch, it was different parts of my body one after another.
Pt received the first dose on 04/30/2021, with no side affects.  She received the second dose, 05/21/21 and tolerated it well that day, the following day she had mild chills and shakes.  Two days after receiving the vaccine she started having episodes of syncope.  When she felt this coming on she would lay down in bed. Had a few episodes where she was nauseas and would vomit.  At approximately 2:00pm she blew her nose and when she did she felt a pop under her right eye. Immediately there was swelling under eye, pockets of blood where bruising started.  She was taken to  Medical Center.  After being seen it was determined that she had a Orbital Floor Blowout in her right eye socket.  She was questioned as to trauma to the eye, abuse, etc. There was none - she had not fallen or hit anything either.  There was no other evidence of an external injury that caused this.  No history of injury to this eye or facial trauma at all. She had to see a plastic surgeon the following day and an ophthalmologist.  She had to have surgery to place a titanium mesh plate under her eye. Follow Up Appointments are still happening.
This spontaneous report was received from a nurse referring to a 4 year old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies and past drug reactions/allergies were not reported. On 14-MAY-2018 the patient was inadvertently vaccinated with an additional dose (third dose) of PROQUAD lot # N023966 with expiration date: 28-FEB-2019 (strength, route, therapy type and anatomical location were not reported) for prophylaxis. The patient had previously been vaccinated with the second dose of PROQUAD in September 2017. Other suspect therapies included sterile diluent (strength, dose, route, anatomical location and indication were not reported). No adverse effects reported. No further adverse event  information provided.
25OCT93 numbness @ waist around 1/2 of body; 9NOV93 numbness of lt leg seen by MD; 11NOV92 couldn't urinate 1035PM; adm to hosp;
When traveling to winter residents, woke up morning of 02/16/21 with feeling of water in left ear. Has never gone away, almost no level of hearing in that ear to this day
03/21/2000 Client felt itchy on chest near neckline - no rash. No medication taken nor any unusual foods and slept normally last night. 03/22  She woke up with severe pain in left arm, numbness in fingers and tingling sensation that traveled from upper arms to fingers. Called health department and was told to put cold compress and call personal doctor as needed if symptoms continued or worsened. Client had already taken 1600 mg Motrin at 8 AM - advised to discuss with doctor. Same day 3:00 PM - notified that she did go to doctor, received injection that seemed to help. Was advised that she had had an allergic reaction.  03/27/2000 she is completely recovered.
lymphadenopathy; Fever; a lot of ulcers in all of the the upper and lower lips, gums, inside the mouth, throat and tonsils.; a lot of ulcers in all of the the upper and lower lips, gums, inside the mouth, throat and tonsils.; a lot of ulcers in all of the the upper and lower lips, gums, inside the mouth, throat and tonsils.; a lot of ulcers in all of the the upper and lower lips, gums, inside the mouth, throat and tonsils.; a lot of ulcers in all of the the upper and lower lips, gums, inside the mouth, throat and tonsils.; They are super painful.; I can't even eat and talk. As the days go by, more appear; I can't even eat and talk. As the days go by, more appear; This is a spontaneous report from a contactable consumer. A 26-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 07Mar2021 17:30 (Batch/Lot Number: EN6199) as SINGLE DOSE for covid-19 immunisation.  The patient's medical history was not reported. On 08Mar2021 10:00, the patient experienced Fever, lymphadenopathy, a lot of ulcers in all of the the upper and lower lips, gums, inside the mouth, throat and tonsils. They are super painful. I can't even eat and talk. As the days go by, more appear. Ae resulted in: [Emergency room/department or urgent care]. The patient received treatment for the events. Ae treatment: Acyclovir. Maalox and Benadryl mouth rinses. The outcome of the events was not recovered. Covid test post vaccination: [covid test type post vaccination=Nasal Swab, covid test name post vaccination=PCR, covid test date=10Mar2021, covid test result=Negative}]
passed out for at least 30 seconds, dizziness, lightheaded, black out, hot/clammy skin, sweating, ringing in the ears, disoriented  911 was called and responded to by both fire and medical paramedics  vitals were taken and patient was observed for an additional 20 minutes before leaving when he had returned to a stable condition
I do not know if the above selected flu shot is the one received. I do not have any paperwork. Check with the pharmacy. Received a flu shot on 09/10 in the morning. Woke up 2AM the next day with severe pain in all limbs. Alternated between feeling hot and cold with a likely fever. Limb pain relieved some with ibuprofen. Had significant pain with movement for the next three days. Experienced muscle weakness throughout body but most prominently in the forearms. Great pain even with lifting less than 20 lbs objects. Some pain even in operating door handles or a steering wheel. By the third day some numbness was experienced in my hands. Pain was mostly relieved by the fourth day with muscle weakness lingering. After one week I was at about 80% strength in arms. Back to normal at about day 9.
diarrhea; has hardly eaten anything; stomach constantly growling; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), DECREASED APPETITE (has hardly eaten anything) and ABDOMINAL PAIN UPPER (stomach constantly growling) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced DIARRHOEA (diarrhea), DECREASED APPETITE (has hardly eaten anything) and ABDOMINAL PAIN UPPER (stomach constantly growling). At the time of the report, DIARRHOEA (diarrhea), DECREASED APPETITE (has hardly eaten anything) and ABDOMINAL PAIN UPPER (stomach constantly growling) outcome was unknown.            Treatment and concomitant medicines were not reported  Action taken with mRNA-1273 in response to the event was not applicable.
A red rash showed up on my lower left leg  about a inch above my ankle. the patch is about a  inch in diameter
This case was reported by a health professional on 12 October 2007.  A 17-year-old female patient, with a history of chondromalacia of the knee and allergies to morphine and aspirin, received an intramuscular right deltoid injection of Menactra (lot number U2428AA) and an intramuscular left deltoid injection of Gardasil (Merck, lot number 1265U) on 11 October 2007.  Approximately eight hours later, she developed a low grade fever and pain at the back of the neck, which traveled down her spine.  Her mother took her to the emergency room, where she was seen and sent home.  Per the reporter, no tests were performed, and the symptoms recovered completely by noon on 12 October 2007.  Concomitant medication included Wellbutrin daily.
Ok I am going to read what I wrote to my DR who is an ENT specialist. On 1/21/2021 I was feeling fine and got my first vaccine. On 1/24/2021 and 1/25/2021 I noticed a pressure and hearing problems in my ears. On 1/26/2021 I went to urgent care, he examined me and he thought I had ETD (tube disfunction). I relayed my concerns about my recent covid vaccine and he said not to be concerned about that. He recommended taking Flonase and Sudafed. The problem came and went periodically. I saw another DR and they did a base hearing test done. on 2/22/2021 the problem seemed to be resolved upon waking up in the morning. On 2/23/2021, it was back with a lot of pressure in the ears. A hearing test revealed at my next appnt that there was hearing loss. At that time it was a possible cochlear issue, they were not sure. I have been symptom free now for about three months,
MD ordered flu vaccination to be given. INFANRIX was given accidentally. Within 5 minutes, patient and guardian pulled back to room and informed of error. S/S given to patient to look out for. Flu vaccination then given in other arm. MD made aware. No adverse reactions noted.
pain, redness, soreness and swelling at injection site  (current) most significantly from this dose is : headache, muscle aches, fever, fatigue, shivering the next day.  In bed or in recliner the entire day.  Currently  a bit better, but muscle aches  and headache persist.
Had my first  vaccine shot on Thursday 2 day later on Saturday evening.  I started getting a headache within an hour very achy body, headache and chills, did not seem to have a fever.  continued all day Sunday.  Monday body felt better weak and still had a headache. kinda felt a heavy feeling in my lungs.
no adverse event; Expired vaccine used; This spontaneous report was received from a licensed practical nurse, concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, and previous drug reactions or allergies.   On 03-MAY-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II), at a dose of 0.5 milliliter (ml) (lot # S032825, which was verified to be a valid lot number, expiration date reported and upon internal validation established as 16-OCT-2021) (frequency, route of administration, anatomical location and vaccination scheme were not reported) as prophylaxis (expired product administered). No additional adverse events were reported.
Stated nausea, loose stools, fever at 100.0 F. Lasted less than 24 hours.
Pt stated that left arm started to hurt about two hours after injection. Pt is having difficulty raising left arm. Pt was given an rx for ibuprofen by Dr.
Caller's mother received both doses of the Pfizer covid vaccine; within a month of receiving the vaccine, the caller's mother died.; This is a spontaneous report from a contactable consumer reported for the mother.   A female patient of unknown age received both doses of vaccine BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), on unknown dates at single dose for COVID-19 immunization. Medical history and Concomitant medications were not reported. Within a month of receiving the vaccine, the patient died. It was unknown if an autopsy was performed.   Information on the Lot/Batch number has been requested ; Reported Cause(s) of Death: within a month of receiving the vaccine, the caller's mother died
Throat constriction, stomach pains & diarhea, Shaking chills, Extreme exhaustion, Red eyes, itching, rash on forearms, confusion
severe anxiety, nerve pain over body, GI Upset.  Patient states it feels as if he has covid again but worse
On 10/27/2022, I noticed itchiness at the injection site and redness. It was a red rash. I took 200 mg ibuprofen for a couple of days. In December, I noticed tingling in my fingertips and pain down my forearm. I went to my primary doctor for my annual visit in February of 2023. She said it sounded like nerve entrapment, so I started physical therapy on March 8, 2023.
Diarrhea that began as annoying but progressed and became a problem 13 days after first dose.; Diarrhea; This is a spontaneous report received from a contactable patient. A 48-year-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202) via an unspecified route of administration in the left arm on 06Mar2021 at 11:30 as a single dose for COVID-19 immunisation. Medical history included supravalvular aortic stenosis, familial hypercholesterolemia, coronary artery disease, three heart surgeries including one bypass and ascending aorta graft with aortic valve repair on unspecified date. Concomitant medication received within 2 weeks of vaccination included lipitor ( ATORVASTATIN) and REPATHA from an unspecified date for unknown indication. The patient was allergic to penicillin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 07Mar2021, the patient experienced diarrhea, that began as annoying but progressed (condition aggravated)and became a problem on 19Mar2021 (13 days after the vaccination). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care visit. No therapeutic measures were taken in response to the event. The clinical outcome of diarrhea and condition aggravated was not recovered.  No follow-up attempts are possible. No further information is expected.
Pt recvd vax on 26MAY92 & approx 29MAY92 exp flu-like sx, & menses were delayed for 10 days; seen by MD treated w/med; exp pain in joints & knees;
Fever, convulsion within 1 day after receipt of DTP and oral polio vaccine.
I haven?t started my periods since the second dose of vaccine I am over 18 days late