chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received the MCV4 Meningococcal and T-Dap vaccine at approximately 2:30 pm on October 22, 2007.  She awoke the next day with a rapid heartbeat, chest pain/tightness, sore throat and headache.  She was seen at her primary care physicians office on October 23, 2007.  He indicated that she possibly is having an adverse reaction to her vaccines.  He prescribed her Zithromax and is re-checking her heart rate in one week.  If it is still elevated, he will order an EKG.
6NOV98 chest hurts to breathe;gets fever on & off;achy all over;lower back hurts;
Pt received COVID injection at doctors office. Approximately 1 hour later while sitting in recliner,  wife noticed patient pale and unarousable. Paramedics were called and found patient with agonal respirations in asystole.  Pt was intubated, received epinephrine, amiodarone and atropine per ALS care. Pt  wife stated patient complained of dizziness and headache,  but no chest pain or shortness of breath. Pt transported to ER. Following testing and treatment in ER, pt transferred to ICU.
SUDDEN ONSET FEVER, RESULTING IN FEBRILE SEIZURE, LASTED ~ 40 MINUTES.
Patient stated having trouble breathing 3-5 minutes post vaccination. Pt was sat in a chair and was given a 0.3mg dose of epi-pen. EMS was called and the patient was taken to the hospital for observation. She called the store at approx 6:30pm on 09/12/23 to inform us she was home and doing well.
Constant burning, throbbing pain in R calf unrelieved by acetaminophen or naproxen; different from arthritis in her knee.
Patient describes pain, heaviness, numbness, tingling sensation for over a week after vaccination. Describes inability to use that arm for a good week after vaccination. States that currently the pain, numbness and tingling are intermittent and less intense.
mental fogginess; tiredness; stuffy nose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), on 05Nov2021 as dose 3 (booster), single (Lot number: FG3527) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, EN6201), administration date: 11Feb2021, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE, EN6200), administration date: 04Mar2021, for COVID-19 immunization. The following information was reported: FEELING ABNORMAL (non-serious) with onset 2022, outcome "unknown", described as "mental fogginess"; NASAL CONGESTION (non-serious) with onset 2022, outcome "unknown", described as "stuffy nose"; FATIGUE (non-serious) with onset 2022, outcome "unknown", described as "tiredness". Relevant laboratory tests and procedures are available in the appropriate section.  Clinical course: Patient's symptom started Wednesday night (24Aug2022) as a sore throat and progressed to a fever of 101F, stuffy nose, coughing, tiredness and mental fogginess. She received two Pfizer Covid-19 vaccines and booster.  No follow-up attempts are possible. No further information is expected.
cough; diarrhea; Feeling very, very weak; affecting throat; nausea; Bad headache; Fever of 103.4F; Feeling not good, feeling really sick; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling not good, feeling really sick), COUGH (cough), DIARRHOEA (diarrhea), ASTHENIA (Feeling very, very weak) and OROPHARYNGEAL DISCOMFORT (affecting throat) in a 65-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 was provided by the reporter.  Concomitant products included PANTOPRAZOLE, SERTRALINE, ROSUVASTATIN and LEVOTHYROXINE SODIUM (EUTHYROX) for an unknown indication.    On 23-Apr-2021 at 4:20 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, the patient experienced MALAISE (Feeling not good, feeling really sick). On 29-Apr-2021, the patient experienced COUGH (cough), DIARRHOEA (diarrhea), ASTHENIA (Feeling very, very weak), OROPHARYNGEAL DISCOMFORT (affecting throat), NAUSEA (nausea), HEADACHE (Bad headache) and PYREXIA (Fever of 103.4F). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. At the time of the report, MALAISE (Feeling not good, feeling really sick), COUGH (cough), DIARRHOEA (diarrhea), ASTHENIA (Feeling very, very weak), OROPHARYNGEAL DISCOMFORT (affecting throat), NAUSEA (nausea), HEADACHE (Bad headache) and PYREXIA (Fever of 103.4F) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment included  lots of fluids
very large red circle; warm; puffy; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (very large red circle), FEELING HOT (warm) and SKIN SWELLING (puffy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (very large red circle), FEELING HOT (warm) and SKIN SWELLING (puffy). At the time of the report, ERYTHEMA (very large red circle), FEELING HOT (warm) and SKIN SWELLING (puffy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment details were not provided.
Tested positive for Covid on 3/20. Husband tested positive on 3/18 after spending several hours at a buffet on 3/15.  I always wear a mask and avoid gatherings so I am pretty sure I caught it from him.  We were both prescribed Paxlovid within a day of testing positive.  Initial symptoms were headache, chills, fever, nasal drainage, fatigue.  Within a day of starting Paxlovid, systems began to resolve.  Within 3 days we were getting back to normal activities with just continuous nasal drainage and some tiredness. My symptoms were done on 4/3.  Both of us tested negative on 4/09 morning in preparation for family event. I am sure this would have been much worse without the Paxlovid.
Enlarged lymph nodes; This is a spontaneous report received from a non-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, solution for injection), administered in arm left, administration date 01Mar2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: LYMPHADENOPATHY (non-serious) with onset 19Mar2021, outcome "unknown", described as "Enlarged lymph nodes". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
A little over a week after getting my first vaccine I started to develop a red hot spot on my right arm just under the injection site I thought nothing of it. 2 days later the redness as spread and the heat from the area got worse I went to urgent care and was give a shot of steroids and Benadryl and prescribed some antibiotics to protect from any cellulitis and some more allergy pills. That night the redness was gone and the heat gone. Today it?s back and bigger and worse then it was the day before
pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (pain). At the time of the report, PAIN (pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included Blood pressure medicine, Colestor,tablet for sugar on the dinner. No treatment medications provided.   This case was linked to MOD-2021-322419 (Patient Link).
Within 3 hours..very swollen..sore, red and hot to the touch.(for 5 days), shoulder socket extremely sore...spread across base of neck and into opposite shoulder socket.  Could not lift arms above my head for six days.  Very bad headache...Unable to carry on with normal activity for four days (in bed).  Overwhelming tiredness, teariness, loss of appetite, body aches, shivers...  NO FEVER.  Lost one week at work...  Used ibreprophen, tylenol, ice,         ********   I had a severe case of shingles at the age of four!!!!!  It doesn't ask this anywhere on the questionnaire but it is certainly worth noting.
ASYMPTOMATIC COVID-19 POSITIVE TEST ON SURVEILLANCE TESTING 3/15/22. NEGATIVE ON ADMISSION 3/8/22.
Patient woke up at 11:30 pm 11/08/2021 with fever of 101.9, headache and stomach ache. She threw up about 10 minutes later on the floor on her way to restroom; twice when she got to the toilet she threw up again. I gave children's Tylenol chewable to get the fever down. That worked. She went to sleep and woke up without fever. Stomach still ached but she ate normal. 11/09/2021 around 1:30 pm, I took her temperature since I had been monitoring it all day with it normal; however at 1:30 her temp read 100.4. I gave her children's Tylenol and she said she did not feel bad her stomach was fine. No headache. Fever went away by 2:30 pm.
This spontaneous report was received from a medical assistant and refers to a 12 month old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 07-JUN-2017, the patient was vaccinated with an expired dose of VARIVAX (dose and site of administration were not reported), lot # L017144, expiration date: 13-MAY-2017, subcutaneously for prophylaxis. Concomitant therapies included sterile diluent (STERILE DILUENT) (lot number was not reported). No adverse effects were reported. No further information was provided. Additional information has been requested.
Muscular pain in BOTH arms radiating from shoulders, down entire arm, into wrist, and palm of hands. Pain is constant, excruciating, lasting for 1-1/2 to 2 hours. Sometimes in morning and late evening, and bed time. Heat and cold make pain worse. Also have severe burning in lungs. Nothing seems to alleviate any of the symptoms. Just has to stop hurting on its own.  Muscle pain doesn't feel like just a sore or stiff muscle, more like nerve pain. All the above symptoms occur at same time (pain in arms and burning in lungs).  After Booster injection I slept for 2 days - nauseous - headache - chills - low fever - weak - no appetite - no energy. Site of injection red, swollen, hard, and hot. These symptoms lasted for 7 days.
HEART WEAK; REAL SICK; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total, administered on 09-APR-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 24-APR-2021, the patient experienced weak heart, was really sick, and hospitalized on unspecified date. The patient was on pacemaker. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from heart weak, and the outcome of real sick was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210725335-Covid-19 vaccine ad26.cov2.s- Heart weak, Real sick . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Client very nervous with International Travel Vaccinations; received 4 immunizations and was about to receive one more, when she slumped over in the chair.  The nurse held her up in the chair around the waist and called out for help.  An administrative employee came quickly and assisted the nurse to lowering the client to the floor. She began to respond as she was gently laid on the floor.  She was pale and anxious and described the incident as "like a dream".  A covered ice pack was placed on her forehead and she took a couple sips of water. She refused a Capri Sun drink ("I don't drink sugary things"), but had a cup of pure apple juice a bit later. Refused the 5th shot at that time.
Headache doesn't go away; Diarrhea; Joint pain; Muscle pain; I am tired and sleeping a lot; I am tired and sleeping a lot; I can't bent, I hardly get back up and if I stand over the floor it hurt so bad down in my joint area; Dizzy; My arm injection site got itching;  going get sick or my body is rejecting vaccine; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date: Unknown), via an unspecified route of administration, administered in arm on 07Aug2021 as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Addition context stated that the patient took the first dose of vaccine on 07Aug2021 and was having a lot of headache, diarrhoea, joint pain, muscle pain. The patient was tired and was sleeping a lot, headache didn't go away. Also reported that if the patient bent over it was like the patient couldn't, the patient hardly could get back up and if the patient stood over the floor it hurt so bad down in the joint area. The patient felt tired and dizzy. The reporter stated that when the pharmacist gave first shot, the patient's arm (injection) site got itching right away, so the pharmacist gave one allergy pills (unspecified) and it went right away. The patient questioned if going to get sick or the body is rejecting vaccine. Therapeutic measure included unspecified allergy pill for arm (injection) site itching. The outcome of the event headache was not recovered while other events was unknown.  New follow-up is being submitted to notify that the batch/lot number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Allergic reaction, itchy throat and mouth with trouble breathing  within thirty minutes. Went to ER within the hour afterwards and was given epinephrine. Symptoms subsides ten minutes after being given medication.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Oct2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 49 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hyperlipidemia" (unspecified if ongoing); "anxiety" (unspecified if ongoing). Concomitant medication(s) included: CRESTOR; ZOLOFT; VITAMIN D3; VIT E [TOCOPHEROL]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Jun2022) Negative; (10Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: The patient was reported about adverse events and other medications received in 2 weeks. The anti viral details product COVID 19 treatment. The treatment start date 29May2022 and Stop date 03Jun2022 and lot number threw out. The indication treatment of COVID-19 reported. The vaccine location right arm was administered. The other medication details other medication in 2 weeks product Crestor other medication in 2weeks and brand Unsure, Zoloft, Vitamin D3 and Vit E. The adverse event Rebound COVID. Negative test and better 06Jun. Symptoms back and positive again 10Jun. The adverse event start date 10Jun2022. The patient recovered Recovering and treatment for adverse event was reported as No and patient had no known allergies.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective (LOE) cannot be ruled out.
1DEC91 h/a, photophobia; 7DEC91 paralysis of rt pupil, adie's pupil; pt seen in ER for unequal pupils to r/o aneurysm; inc chemosis; 20DEC91 impaired central vision, bilat, retinas showed mutiple serous detachments, bilat opic disc edema;
I normally don't have headaches or blurred vision, but these symptoms came on the day after my vaccination. My headaches concentrated on the front and the lower back of my head. As I was getting ready, started having confusion, lightheadedness and dizziness which lasted the whole day. My body was sore and aching on my arms, hips, knees and my back. This aching lasted for about 3-4 days. My skin started to be discolored in appearance kind of greyish. This lasted about 2-3 days.
Fever, fatigue, body aches, chills, headache which started approximately 5 hours after vaccine. Symptoms cleared after approximately 24 hours. 3 days after vaccine period came 2 weeks early. My period are always regular and on time.  My period is extremely heavy.  At the same time my skin became very dry. The skin on my face is peeling.
Patient went to hair salon after event.  Patients father thought she had a seizure, but It sounded to me like she passed out.  We gave her a cold compress.  I stayed with until the ambulance was ready to leave, and she was awake and filling better.  She did not hit her head.  Her father caught her.  and laid her down.
Pt states, post vax, he started feeling light-headed, dizziness and nausea. The symptoms started after a couple of months. Also, noticed loss of weight. (loss 20 lbs). No active duty.
Headache, Myalgia, NauseaVomiting, Chills, Fatigue Narrative:
No additional adverse effect reported; A patient received improperly stored VARIVAX; This spontaneous report was received from a nurse concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history and historical drug were not provided. Concomitant therapies included sterile diluent(STERILE DILUENT).  On 16-JUN-2020, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) improperly stored for prophylaxis, lot number reported as R0277989, expiration date 01-OCT-2020. Strength, dose, frequency and route of administration were not provided.   The temperatures involved were: below -14 to -10 degrees celsius (-11.8 degrees Celsius) in a timeframe of 2 months. It was not reported a previous temperature excursion and a data logger was involved.   Lot number R0277989 is an invalid lot number for varicella virus vaccine live (Oka/Merck) (VARIVAX)
Chills, fever, dizziness, soreness, headache, extreme fatigue, nausea.
Shingles in the groin area; pain; glucose has been running high; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 80-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles at age of 26). Concurrent medical conditions included insulin dependent diabetic and diabetic neuropathy.   In October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced shingles, pain and glucose increased. On an unknown date, the outcome of the shingles, pain and glucose increased were unknown.   It was unknown if the reporter considered the shingles, pain and glucose increased to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient had Shingrix and glucose has been running high ever since and had a severe case in the groin area and was extremely painful. The patient had steroid type reaction and patient asked how prevalent is this type reaction. The monograph did not list as an avr. The patient was glad that had diabetic neuropathy to deaden the pain.      Lab Comments: The patient had diabetic neuropathy to deaden the pain
4:00PM-Patient given Hep A. Shortly after receiving stated "My ears are ringing and I have tingling around the mouth". When questioned if had previous history of complications with vaccine stated "no, but in the past have had a reaction to shellfish". Pt.was given 20cc of liquid benadryl and vital signs were taken. VS were stable. Alerted facility physician and monitored pt. for 1 hour. Notified patients physician of incident and private physician  ordered solumedrol for patient.VS were taken and stable before leaving clinic. Followed-up with patient following day and pt denied any further complications.
Pt reported ear pain, nausea, and dizziness, along with chest congestion ("inflamed" per pt) feeling and cough. Pt stated she "feels like her wind pipe is inflamed." Feels SOB, eases some when she coughs. Pt was instructed to go to the ED on 5/5, where she was found to have oxygen saturations in the mid 80% range. Pt was diagnosed with "pneumonia due to COVID-19 virus" and admitted.
Temperature that product was out of range: 27.5 F; Initial information received on 13-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 12 months old male patient who received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE and it was reported temperature that product was out of range: 27.5 f (Product storage error).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 13-Nov-2019, the patient received a 0.5ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE Suspension for injection in pre-filled syringe (batch number UT6656NA; expiration date 30-JUN-2020) via intramuscular route in the left vastus lateralis for prophylactic vaccination. Time Exposed: at least 7 hours below 32 F.   It was reported the patient received an invalid Fluzone Quadrivalent. Inactivated vaccines should be repeated as soon as possible.  It was a case of actual medication error due to incorrect product storage.   It was unknown if the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  No other information was reported.