chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Febrile throughout the night. Chills when I woke up in the AM. Suddenly felt dizzy and lightheaded. Sat down, had a few sips of juice and placed a cold rag on my neck. With assistance, agreed to move to the couch. Stood up and went limp. Guided down to the floor. Per report, body shuttered initially. +LOC for 5-10 seconds.
At around 3:03PM, patient came into the Pharmacy to request vaccination for flu. Paperwork was filled and at 3:14pm patient received Influenza vaccine (Fluzone HD) by Pharmacy Technician. After administration, the patient was walking with a relative and stated that she did not feel good, and was feeling faint. Family member was able to grab her and placed her on the ground in front of the Department. Health Ambassador came to the Pharmacy and notified that there was a person on the floor, she stated had received a vaccine. Pharmacist left the Pharmacy area to attend to the patient where the Store Co-Manager had already arrived at the scene and placed the patient on a chair. The patient was disoriented and stated she had chest pains and headache; Pharmacist felt for a radial pulse, and was able to feel it. Pharmacist instructed technicians to close the Pharmacy while calling 9-1-1 to request emergency personnel to come into the store. After that, pharmacist took oxygen tank and placed cannula in order to administer oxygen (at 3:26pm; 2L); meanwhile staff was helping with the code. Paramedic arrived at the scene at 3:32pm, and  instructed the Pharmacist to accompany him to the ambulance with the oxygen tank in order to load her into the ambulance. Paramedics took the patient to nearest hospital at around 3:37pm; they mentioned were taking her to Hospital.
pt recv vax 10APR97 & devel gen patchy, itchy dermatitis;pt family was also exp some kind of (unspecified) illness;ER or MD visit was required;the problem was reported to be cont on 11APR97;
Pt received Hep-B #3, IM, L thigh and developed a rash at administration site within 1 day. It lasted several days. Per pt's mom, had the same rash symptoms with 4 mo and 6 mo shots.
LOW GRADE FEVER; FATIGUE; HEADACHE; This case was reported by a consumer via call center representative and described the occurrence of low grade fever in a 18-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st April 2022, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 1st April 2022, less than a day after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced fatigue and headache. On 2nd April 2022, the patient experienced low grade fever. On an unknown date, the outcome of the low grade fever, fatigue and headache were unknown.   It was unknown if the reporter considered the low grade fever, fatigue and headache to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 04-Apr-2022 Reporter's comment: The case was reported by patient's parent. The patient received a dose of Bexsero and on same day experienced headache and fatigue and 1 day after vaccination on Saturday night (2nd April 2022) had a low grade fever and was unsure if the adverse events were still ongoing.  The reporter inquired if her son could receive the 2nd dose of the vaccine 7 weeks after 1st dose. Consent obtained to contact consumer and health care professional for follow-up but consumer did not want to prove health care professional contact information.
Seizures; She can't work.; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Seizures) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SEIZURE (Seizures) (seriousness criterion medically significant) and IMPAIRED WORK ABILITY (She can't work.). At the time of the report, SEIZURE (Seizures) and IMPAIRED WORK ABILITY (She can't work.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The Concomitant medications were not provided. They put her in 3 different medicines and they don't work, they're at a dead end. She can't work.  Company Comment: This case concerns a 41-year-old, female patient with no relevant medical history reported, who experienced the unexpected events of seizure. The events occurred 14 days (two weeks) after an unknown number of doses of mRNA-1273. The rechallenge was unknown since no information regarding the number of the doses was disclosed. The benefit-risk relationship of mRNA-1273 in not affected by this report. Further information was requested.; Sender's Comments: This case concerns a 41-year-old, female patient with no relevant medical history reported, who experienced the unexpected events of seizure. The events occurred 14 days (two weeks) after an unknown number of doses of mRNA-1273. The rechallenge was unknown since no information regarding the number of the doses was disclosed. The benefit-risk relationship of mRNA-1273 in not affected by this report. Further information was requested.
Patient states felt tingling and numbness in hands and arm after vaccination that resolved after about a month but returned after her RECLAST infusion.
Information has been received on 2/26/02 from a physician concerning a 70 year old female who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. Subsequently the pt developed a sore arm. The pt sought unspecified medical attention. Additional info has been requested.
Pt recv vax on 12/15/98; on same day pt exp bruised vax site w/ redness, edema, hard, pain
16OCT98 hosp ;platelet count @ 2;dx w/ITP bruising heavily;
Pt "felt dizzy throat and tongue tingling" epinephrine per epipen (L) upper thigh - transported to ER via EMS in stable condition.
excess sweating; under left arm she has pain; swollen lymph nodes on her left side where she got vaccine/lymph nodes are swollen; pain is in lymph nodes,really hurts; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (excess sweating), PAIN IN EXTREMITY (under left arm she has pain), VACCINATION SITE LYMPHADENOPATHY (swollen lymph nodes on her left side where she got vaccine/lymph nodes are swollen) and LYMPH NODE PAIN (pain is in lymph nodes,really hurts) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Hormone replacement therapy since an unknown date. Concurrent medical conditions included Immunocompromised and Gene mutation.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (excess sweating), PAIN IN EXTREMITY (under left arm she has pain), VACCINATION SITE LYMPHADENOPATHY (swollen lymph nodes on her left side where she got vaccine/lymph nodes are swollen) and LYMPH NODE PAIN (pain is in lymph nodes,really hurts). At the time of the report, HYPERHIDROSIS (excess sweating), PAIN IN EXTREMITY (under left arm she has pain), VACCINATION SITE LYMPHADENOPATHY (swollen lymph nodes on her left side where she got vaccine/lymph nodes are swollen) and LYMPH NODE PAIN (pain is in lymph nodes,really hurts) outcome was unknown.            Treatment information was not provided
Patient received flu vaccine and passed out a few minutes later while still in the store. Patient complained of dizziness and slightly blurred vision after regaining consciousness moments later. Ambulance was called and patient was taken to emergency room.
Tendinitis [and bursitis] on her left shoulder; [Tendinitis and] bursitis on her left shoulder; This is a spontaneous case from, reported by physician to agency [reference number: SEQ19-04570] and initially received on 14-Oct-2019, concerning a 57-year-old, female patient.  The patient's medical history was not reported. The patient was taking concomitant medications, however, the reporter did not have a list of them.  On 08-Oct-2019, the patient was administered Flucelvax (QIV) [Influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, anatomical location: deltoid (left shoulder), route of administration: intramuscular, batch number: 259807 expiration date: 31-May-2020] for influenza prophylaxis.  On the same day, after vaccination, the patient developed tendinitis and bursitis on her left shoulder where the vaccine was administered. The patient was treated with unspecified anti-inflammatory and steroid medications.  At the time of initial reporting, the patient had not recovered from the events.   The case was assessed as non-serious.  The reporter did not provide a causality assessment.  Non-significant follow up received from a physician on 25-Oct-2019: Reference number (SEQ19-05493) added. No changes were made to the narrative.  Company comment: The patient developed rotator cuff syndrome and bursitis on the same day when Flucelvax QIV was administered. Chronology is plausible. More information regarding the patient's medical history and concomitant medication is needed. With information currently available, causal role of the suspect product is assessed as possibly related.
This spontaneous report was received from a medical assistant and refers to a 68-year-old non-pregnant female patient. The patient did not have any pertinent medical history, concomitant medications and drug reactions or allergies. On 29-NOV-2016, the patient was vaccinated with a dose of PNEUMOVAX23 (lot # M032635, expiration date: 20-MAY-2018, exact dose and route of administration were not reported). On 30-NOV-2016, the patient came to office and had redness, swelling and pain at injection site on the right arm. A physician assistant recommend acetaminophen (TYLENOL) or ibuprofen (MOTRIN) for the treatment of pain, diphenhydramine hydrochloride (BENADRYL) and steroids. It was not known if the patient had complied (also reported as there was no treatment for the adverse events given). There were no laboratory tests performed. The patient sought medical attention by visiting the physician's office. The outcome of injection site erythema, injection site pain and injection site swelling was reported as not recovered/not resolved. The relatedness between the events and PNEUMOVAX23 was not reported. Lot check requested. This is one of several reports concerning the same patient. Additional information has been requested.; Sender's Comments: US-009507513-1612USA000260:
9 hours after injection, woke up with chills, body aches, head ache, and extremely dizzy.  Lasted 8 hours then all symptoms were gone except the continued dizziness I still have whenever sitting up or rolling over when I'm laying down.  Been 7 days now and hasn't subsided.
Information has been received from a pharmacist concerning a female who on an unspecified date was vaccinated with the first dose of GARDASIL and was well tolerated. On an unspecified date was vaccinated with the second dose of GARDASIL. After receiving the second dose, the patient felt ill, pale, fever, felt faint and possibly vomited. Her symptoms began immediately after the second dose. Subsequently, within 48 hours the patient recovered from pale, fever, felt faint, possibly vomited and felt ill. No further information is available.
After the second vaccine the ringing was louder; This is a spontaneous report from a contactable consumer (patient) and from a contactable Other Health Professional.   A 71-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: ER8727) via an unspecified route of administration, administered in right  arm on 23Mar2021 09:15 (at 71 years old) for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included duloxetine hydrochloride (CYMBALTA) taken for fibromyalgia; metoprolol taken for blood pressure measurement; atorvastatin calcium (LIPITOR ORIFARM) taken for blood cholesterol; vitamin D3 taken for vitamin d deficiency; colecalciferol, ubidecarenone (COQ10 + D3) taken for hypovitaminosis; acetylsalicylic acid (ASPIRIN (E.C.)) taken for an unspecified indication; calcium carbonate, colecalciferol, copper sulfate, magnesium carbonate, magnesium oxide, manganese sulfate, zinc oxide (CALTRATE + D PLUS) taken for an unspecified indication.  Previously the patient received the first dose of BNT162B2 (Lot: EN6205) on 02Mar2021 for COVID-19 immunisation and experienced tinnitus/ringing in the ear, like tinnitus; hearing loss/completely deaf in right ear.  The patient experienced after the second vaccine the ringing was louder on 24Mar2021 with outcome of not recovered. The patient underwent lab tests and procedures which included magnetic resonance imaging: abnormal on unknown date (Test results: Had MRI to make sure, there are 2 things in the brain that could cause loss of hearing.  1 is a tumor and one is something else. Don't have either). Therapeutic measures were taken as a result of the event included steroid.  Clinical course was described as follows: Patient stated right before second Pfizer COVID vaccine she lost her hearing and she has a severe case of tinnitus. She went to the doctor, ENT specialist, when she lost her hearing. The doctor still wanted her to get second vaccine, which she did. He needed to give her steroids for hearing loss. The type of hearing loss she has is called SSHL, sensory sudden hearing loss. He didn't want to give her oral steroids because he thought maybe it wouldn't be good to take with the vaccine. She received 3 injections of steroid (unknown name) into her ear. Patient stated she is two weeks post vaccination, and she is wondering at this point if she can take the steroids orally without interfering with vaccine as opposed to getting it injected in the ear? Patient stated she had hearing loss after the first vaccine and right before the second vaccine. After the second vaccine the ringing was louder. Patient stated that she still does not know if the ringing, tinnitus is from the vaccine or not. She stated that the ringing was still occurring on 23Mar2021 when she got the second dose of the vaccine. Patient stated that on 24Mar2021, the ringing had increased in volume, and it is now pretty loud and hasn't stopped.   No follow-up attempts are needed. No further information is expected.
Generally didn't feel this way; Nosebleeds; Headaches; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Generally didn't feel this way), EPISTAXIS (Nosebleeds), HEADACHE (Headaches) and FATIGUE (Fatigue) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 14-Jun-2021, the patient experienced HEADACHE (Headaches) and FATIGUE (Fatigue). On 15-Jun-2021, the patient experienced FEELING ABNORMAL (Generally didn't feel this way) and EPISTAXIS (Nosebleeds). At the time of the report, FEELING ABNORMAL (Generally didn't feel this way), EPISTAXIS (Nosebleeds), HEADACHE (Headaches) and FATIGUE (Fatigue) outcome was unknown.            Concomitant medication was not provided.  Treatment information was not provided.
MODERNA BOOSTER DOSE ADMINISTERED INADVERTENDLY BEFORE THE 6 MONTH WAITING PERIORD AFTER COMPLETED FIRST IMMUNIZATION CYCLE.  SPECIFICALLY, BOOSTER INJECTED 4 MONTHS AFTER COMPLETED FIRST VACCINATION CYCLE.
patient reported numbness in right side of face and tooth pain on the day after his covid-19 immunization. His prescriber evaluated him today and said he has a sinus infection with mild bells palsey.  Unsure if related to immunization.
Pt. came into pharmacy on 11/5/15 with large red rash on arm. She asked if she should see the doctor. I told her yes Large, red area on arm about the size of a cell-phime. Referred patient to physician.
Redness lower than in injection site inside arm to outer about 3 inches diameter. Advised to take Benadryl and call MD.
Case number PHEH2016US027671, is an initial spontaneous report received from a nurse on 24 Oct 2016. This report refers to a 50 years old female patient. Past vaccination history included influenza virus vaccine (manufacturer and batch number: not reported) and MMR vaccine received on an unknown date and she experienced cellulitis (see case: PHEH2016US027823). Concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number 1618701, Expiry: Apr 2017) at a dose of 0.5 ml intramuscularly on 18 Oct 2016. After vaccination, on 19 Oct 2016, she experienced cellulitis at injection site which started 24 hours later. Patient received treatment with KEFLEX and ice because the area was red and hot. It was reported that her mother also experienced the same reaction in the past to influenza vaccine (see case: PHEH2016US027672). The outcome of cellulitis at injection site was reported as condition improving; while it was not reported for other events. The event cellulitis at injection site was assessed as non serious by the nurse; while seriousness for other events was not reported. The seriousness of the events vaccination site cellulitis, vaccination site erythema and vaccination site warmth were upgraded (medically significant) based on the information available in the source document.
Fever: I had a temperature around 100 degrees (and higher maybe) for at least 4 hours (1AM to 5 AM). It may have lasted longer but I was sleeping. I was better when I woke up. I took Ibuprofen at around 4 AM. Joint aches periodically that same night and through the day after.
ACUTE RESPIRATORY FAILURE ACUTE HYPERCAPNIC RESPIRATORY FAILURE CHRONIC RESPIRATORY FAILURE CHRONIC HYPERCAPNIC RESPIRATORY FAILURE ACUTE ON CHRONIC RESPIRATORY FAILURE ACUTE ON CHRONIC HYPERCAPNIC RESPIRATORY FAILURE HYPOXIA
sore arm at injection site for the first 24 hours, next ten hours: fever, chills, aches in arm muscles. ended abruptly as it started.
I developed chicken pox two months after the second shot.  I was not exposed to chicken pox at all.  When I went to my doctor to get treatment for the chicken pox, they said that many of their patients had developed chicken pox or shingles after getting the covid-19 vaccine and that was possible in my case as well.
FLU SYMPTOMS; LEG CRAMPS; COLD SYMPTOMS; FEVER; HEADACHE; EXTREME TIREDNESS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included lab test were done for other reason and the doctor added clotting test.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On APR-2021, the subject experienced flu symptoms. On APR-2021, the subject experienced leg cramps. On APR-2021, the subject experienced cold symptoms. On APR-2021, the subject experienced fever. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced extreme tiredness. Laboratory data included: Antibody test (NR: not provided) Negative, and COVID-19 rapid POC test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, headache, extreme tiredness, flu symptoms, leg cramps and cold symptoms was not reported. This report was non-serious.
Patient presented to emergency room on 2/1/2021 with a chief complaint of having a chronic headache  and fatigue following receipt of the Moderna vaccine 10 days prior.  Following examination by the physician, the patient was diagnosed with an acute subdural hematoma. The patient subsequently underwent decompressive surgery, however demonstrated worsening neurologic status over the next several days and ultimately expired on 2/4/2021.
pt recvd vax around 1PM a/arrived home tinglingly all over similar to allergic reaction; lt arm dull, ache of entire arm for 2 days; difficulty moving arm for 3 wks; no redness or swelling;
left leg injection site  with erythema 4 x 2.5 cm, no edema, no calor, no tenderness to touch, no masses palpated. no sign of infection and anaphylaxis reaction
She got her vaccine, had the normal reactions, sinus and things right away.  She had a headache and thought that was unusual as it is rare for her to get a headache.  On Sunday 10/29/23 it started all up again, has had a fever, as well as really bad headache since Sunday.  She is hot/cold because she is running a temperature, sweaty/clamy.  She has no sinus issues, no congestion, none of that really, she just feels awful.  She has loss of appetite and has not eaten in the last few days or so.  She has been taking vitamin D3, as well as Oscillocoecinum a homeopathic remedy, which she just started taking it on Tuesday and she does not see any help from it yet.  She has a Telehealth APT tomorrow.
Soreness at injection site. Increased redness, tenderness going down my arm, with slight swelling to just below elbow area
First 32 hours: Swollen tongue, hives around left eye, fever, joint pain At the 6th day: SHINGLES, joint pain, fever
Pt described Itching around injection site and "Hot Flashes" similar to Menopause for 1 week slowly waning
Pt was seen on 5/24/10 for physical given DTaP and HEP A in R arm. Started with a swelling yesterday and looks blistery in R arm today.
Face was very red like a sunburn.  Then pimple like rash appeared on face and extended down entire body. The rash is still present today (6-21-13).  Mother took child to the doctor yesterday and was told it was a reaction to her MMR vaccine and that rash should go away.  Mother was concerned because rash has been present for over a week and does not look any better.
death SHORTNESS OF BREATH U07.1, J12.82 - Pneumonia due to COVID-19 virus
Pt received Pentacel but should have been given Tdap due to her age. MA discussed with HD and they stated the dose does NOT need to be repeated because it was high enough. Pt did not have any physical reaction to injection.
No additional AE; an expired dose of ROTATEQ was administered; This spontaneous report was received from a medical assistant referring to a 7-week-old patient of unknown gender. Concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 20-JAN-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot #U007860, expiration date 14-JAN-2022; dose and route of administration were not provided) for prophylaxis (expired product administered). No additional adverse event. The outcome of expired product administered was unknown.