chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dizziness; Stomach cramping; Soft stools; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), ABDOMINAL PAIN (Stomach cramping), FAECES SOFT (Soft stools) and HEADACHE (Headache) in a  patient of an unknown age and gender 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 DIZZINESS (Dizziness), ABDOMINAL PAIN (Stomach cramping), FAECES SOFT (Soft stools) and HEADACHE (Headache). At the time of the report, DIZZINESS (Dizziness), ABDOMINAL PAIN (Stomach cramping), FAECES SOFT (Soft stools) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was provided by the reporter.   No treatment medications were reported.
Administered Fluzone High Dose Quadrivalent to a 10 year old pediatric patient with no reported AE; Administered Fluzone High Dose Quadrivalent to a 10 year old pediatric patient with no reported AE; Initial information regarding an unsolicited valid non-serious case was received from a Pharmacist via a consumer/non-health care professional via Regulatory Agency (Reference number- 00837551) and transmitted to Sanofi on 02-Nov-2021.  This case involves a 10 year old male patient who was received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product administered to patient of inappropriate age and overdose).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient had no other vaccines.   On 01-Nov-2021, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (batch number and expiry not reported, formulation: prefilled syringe) via unknown route in unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to Inappropriate age at vaccine administration and overdose (latency same day).  It was reported "calling for a colleague in the retail setting who administered Fluzone High Dose Quadrivalent to a 10 year old pediatric patient. Is there any information or data of side effects FLUZONE HIGH DOSE QUADRIVALENT In a pediatric patient? The hospital pharmacist who called is aware of a retail pharmacy which gave a Fluzone High Dose Quadrivalent vaccine to a 10-year old immunocompetent patient today. The pharmacist caller was not given any information of what contributed to the dosing error. "   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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.  There will be no information available on the batch number for this case.
Symptoms: Headache: stabbing pain headache especially right temple Tinnitus: ringing in right ear Skin: rt ear red, swollen & bumpy. hair / scalp pain sensitivity Dizziness / Vertigo: Equilibrium and balance are off, walking like a drunk. Vision swims on head turn, phone appears to rotate in dark. Slight associated nausea. Occasional dry cough causing headache to explode.   Progression  SUNDAY 4/18/21 Second shot pfizer COVID-19 vaccine Gradual onset starting Thursday 4/22/21 (Day 4 since vax) or Friday (day 5 since vax.).  SATURDAY 4/24/21- day 6 (since vax) , 0 (since full onset) - sharp stabs of headache every once in a while, noticed at game & really set in in evening. Feverish at night. SUNDAY - day 7,1 - low energy, body aches, difficult to get out of bed, 3 hour nap, severe headache. MONDAY - day 8,3 - Dr   9:45. 185 lbs, 97.8. Flu, strep, COVID negative. 5 day course of steroids, Start Flonase, Still fairly dizzy TUESDAY - day 9,4: Significant headache still but manageable with acetaminophen. Balance issues, vertigo? WEDNESDAY day 10,5 - 5:30am - Awakened by splitting headache. feverish. 1 acetaminophen, 1 chlorphenirmine @ 6am.  By 10 AM, headache is back, high sensitivity to loud noise. Difficulty walking straight. THURSDAY day 11,6- 5:30am - awakened by splitting headache, 99.9 deg. 2 x acetaminophen. FRIDAY-    calls back, Will call in a prescription for anabiotic, meclizine.  SATURDAY 4:30am 2 x Acetaminophen 4am.  first antibiotic @ noon , Diarrhea & cramping 7pm.  Probiotic. 11 PM: 2X acetaminophen, anabiotic. SUNDAY- antibiotic 8, probiotic 10, Meclizine noon.  TUESDAY- day 11 - Didn?t sleep well; 1x acetaminophen @ 5am. Headache pulse WEDNESDAY- Day 12 - 1x acetaminophen @ 1am, Headache seems just enough to prevent sleeping well without meds. Dizziness continues at same level.  Meclizine doesn?t work. THURSDAY - Second visit with Dr  : might be shingles based on lesions on ear, will prescribe anti-viral. Less likely: Ménière?s, something else. Call on for MRI Monday if symptoms not resolved. SATURDAY 5/8/21 - Day 15-still on antibiotic and antiviral, neither seems to be doing anything.  Headache mostly gone, but dizziness /vertigo persist. Can not successfully walk heel to toe without falling over.
Patient received her TDAP booster on Tuesday July 13th 2021. The next day she had a mild fever and didn't feel great, she had bad pain at injection site. We gave her Advil for the mild fever and arm pain.  Wednesday her fever was gone and pain at injection site was better. No Advil was administered. On Thursday July 15th at 1:30 pm. she started getting hives all over her face, neck and injection site of left arm 2. We gave her Benadryl as suggested by her pediatrician over the phone. Since then, the hives have been returning every day. It's now been 4 days. She's been continuasly getting hives since Thursday the 15th of July.  We've been treating her with over the counter Benadryl twice a day. They go away and return just as bad after medication wears off. She has no other symptoms aside from the hives.
Temperature high=104 decreasing  each hour over 8 hours Extreme coldness for an hour subsiding over 8 hours Muscle & joint ache Headache...at times like migraine with light sensitivity  VERY TIRED Loss of appetite  Disorientation  Off balance
2 raised bumps on her arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (2 raised bumps on her arm at the injection site) 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 14-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced VACCINATION SITE SWELLING (2 raised bumps on her arm at the injection site). At the time of the report, VACCINATION SITE SWELLING (2 raised bumps on her arm at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.      No relevant concomitant medications were reported.  No treatment information was provided.
Pt recvd vax 9JUL91 & exp chills, aches all over, nausea, felt like getting flu, shaking, pain, difficult breathing; MD called found cardiopulmonary collapse, unconscious & breathing to extreme difficulty, body shaking, 2-3 min violent shak
patient received dT vaccine on 9/3/03. on 9/5/03 developed severe diarrhea and erythema of vaccine site. on 9/6/03 vaccine site became quite edematous, skin taut, warm and red. redness extended to under her arm and almost encircled her entire upper arm. the size would be that of a grapefruit. the redness and swelling did subside by 9/8/03 but the site is still pink. only treatment was a couple doses of ibuprofen.
Swelling, redness, slight itch, mild warmth, approx. 3.0 x 7.0 cm.
Fever,Headache,Muscle Pain, Nausea, Chills 4 days after the vaccine.
Anaphylactic shock; pt recvd 1st dose of vax 26MAR92 & approx 30 minutes p/receiving 2nd dose on 27APR92 devel breathing difficulties & lost pulse;
she is running a slight fever, she is like 100.2; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), on 12Oct2022 as dose number unknown, 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: PYREXIA (non-serious) with onset 12Oct2022, outcome "not recovered", described as "she is running a slight fever, she is like 100.2". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: It was reported that, reporter stated,  need to know what to do with mother, she got the Pfizer COVID vaccination today and she was running a slight fever, she was like 100.2. Reporter was requested to contact nearest HCP in case of emergency.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Case number PHEH2016US023368 is an initial spontaneous report received from nurse on 13 Sep 2016. This case refers to a 51 year old patient of unknown gender. Past medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUVIRIN (batch number: 1515701, expiry date: not reported) at a dose of 0.5 ml intramuscular into right arm on 01 Dec 2015. It was reported that, the patient received FLUVIRIN MDV that had been exposed to 8 to 10 temperature excursion and it was administered to unknown number of patients. No adverse event was reported following this medication error (incorrect product storage).
2/26/21 1/2 moderate chest pains 2/27/21 heart pounding, pulse ** woke me up and lasted over 1/2hr 3/12/21 dizzy, fatigue, sweaty, Tachycardia, bradycardia 3/12-4/26/21 many symptoms that ebbed and flowed, really feeling bad. IE: incontinence of bowel and bladder, Tachy and Brady HEART beats, dizzy, sweaty, startle easily, can'T multi task, memory loss, confusion, extreme fatigue, short of breath, anxiety, poor sleep, neuropathy of feet and butt, low HRV run hot and cold, chest pain, headache, red face, muscle and joint pain  4/26/21 AID CAR TO HOSPITAL, STAYED 6 DAYS. Discharged May 1. Diagnosed with 7 TIAs put on clopidogrel 5/5/21 AID CAR TO HOSPITAL . Discharged May night of 6th. Diagnosed with seizures and put on Keppra. NOTE SYMPTOMS FOR BOTH HOSPITAL STAYS WERE EXACTLY THE SAME. I have yet to find a doctor to treat vaccine injury. neurologist helped with sleep, put me on 3mg Doxepin which works great. LDN 4mg  took care of dizziness and ringing in ear PT cured
Broke out into hives on legs, arms, stomach and back.  Lasted approximately 3 days.  Red, itchy, raised
pt was seen @ clinic 2AUG98;was seen in ER on 31JUL98 w/leg hematoma @ inj site;pt gradually inc in size w/some redness & warm to touch;pt exp inc swelling & pain;
consumer developed 5-8 lesions following the VARlVAX administration; This spontaneous report was received from a nurse prescriber and refers to a 12-month-old male patient. Information regarding the patient's drug reactions or allergies, concomitant therapies and his pertinent medical history was reported as none. On 03-FEB-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 ml, subcutaneously, as a first dose of immunization, lot # T022315, expiry date was reported as 30-JAN-2022, but upon internal validation was established as 30-JUN-2022 (formulation, concentration and frequency were not reported). The vaccine was reconstituted with sterile diluent 0.5 ml (formulation, concetration, dose number, frequency, indication, lot # and expiry date were not reported). On 03-FEB-2021 (following the varicella virus vaccine live (oka/merck) (VARIVAX) administration), the patient developed 5-8 lesions. It was reported the patient sought medical attention. The patient did not receive any treatment for adverse event. The outcome of the event was reported as not recovered. No product quality complaint (PQC) was involved. The causality assessment was not provided.
This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 01-NOV-2012 08:19, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
pt states that they have phantom pain that radiates  down the arm to the wrist which is mild and transient
Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Systemic: Vomiting-Mild, Additional Details: PATIENT CALLED TO REPORT ABOUT 24 HOURS AFTER RECEIVING VACCINE THAT HE ATE LUNCH, THEN STARTED FEELING NAUSEOUS AND SWEATY, THEN HE VOMITTED X1 AND FAINTED, WAS OUT FOR ABOUT 1-2 MINS PER HIS WIFE. HE IS FEELING FINE NOW, DIDNT REPORT TO US UNTIL A WEEK AFTER HIS SHOT. PATIENT HAS HAD SYNCOPE PRIOR, BUT LAST TIME WAS ABOUT A YEAR AGO, SO HE IS ATTRIBUTING THIS TO HIS COVID VACCINE MODERNA BOOSTER SHOT
INFLAMATION, REDNESS AND ITCHING AROUND INJECTION SITE AND ABOUT TWO INCHES BELOW THE INJECTION SITE.  THE PATIENT INFORMED  HIS DOCTOR AND HIS DOCTOR ASKED HIM TO CONTACT ME.  PATIENT WAS ADVISED TO TAKE CETIRIZINE 10MG AT BEDTIME FOR THE ITCHING.
HEART WAS BEATING OUT OF MY CHEST; HOT FACE; ALMOST PASSED OUT; FULL BODY PAIN; CHILLS; FEVER OF 102.6; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced heart was beating out of my chest, hot face, almost passed out, full body pain, chills, and fever of 102.6. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102.6 (units unspecified). Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever of 102.6, hot face, almost passed out, chills, full body pain and heart was beating out of my chest was not reported. This report was non-serious.
developed hives.; This case was reported by a physician via call center representative and described the occurrence of hives in a 36-year-old female patient who received HBV (Engerix B) for prophylaxis.   In August 2020, the patient received the 1st dose of Engerix B (intramuscular). On an unknown date, less than a month after receiving Engerix B, the patient experienced hives. On an unknown date, the outcome of the hives was unknown.   It was unknown if the reporter considered the hives to be related to Engerix B.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Engerix-B vaccine 4 weeks ago and developed hives.  The reporter reported that the dose was given by the patient's primary care doctor and not by the caller. The reporter did not consent to follow up. The reporter had very limited information about the event and did not know the lot number or expiration date of the vaccine given.  The reporter was an allergist and said the patient was referred to him by the primary care physician who gave the first dose.  The patient did not give permission to follow up with HCP.
About 26 hours after receiving vaccine could not feel legs and arms - numbness and tingling, extremely weak. Progressed to torso and weaker the next several weeks. Started to get better after about four weeks to this day I still have weakness in the arms and legs.
"Covid Arm": 3" diameter red warm rash around injection site maybe slightly itchy. No big deal.
Area around injection was red swollen and tender 24 hours post injection.   48 hours post injuection swollen  area on R upper arm @ MMR injection site 6.5 X 5 cm. Area tender to the touch. No redness noted.
Starting 06/28/2022, I had a sore throat, and developed a fever of 100.5, body aches, headache, cough, congestion and a little diarrhea.  I tested myself that day with an at-home test which was positive.  I called my physician that afternoon and the next day she called in Paxlovid which I started on 06/30/2022. After 4-5 days in, I no longer had a fever, but still congested and coughing. However, I felt better. I was still slightly short of breath if I walked fast. I didn't come back to work until 10 days out due to coughing quite a bit. At day 14, I felt perfectly fine. I lost my sense of taste and smell, and it returned about 72 hours after stopping Paxlovid,
massive hair loss; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (massive hair loss) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced ALOPECIA (massive hair loss). The patient was treated with ZINC for Adverse event, at an unspecified dose and frequency and BIOTIN for Adverse event, at an unspecified dose and frequency. At the time of the report, ALOPECIA (massive hair loss) outcome was unknown. Not Provided          This case was linked to MOD21-080638 (E2B Linked Report).; Sender's Comments:  MOD21-080638:
3inch red inflamed rash at injection site Treated with hydrocortisone cream and ice Went away after 7 days
No adverse event; administered with expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine).    No concomitant medication information was provided.  The dates of administration of the vaccines was reported as 1 Apr 2022, 5 Apr 2022, 6 Apr 2022, 8 Apr 2022, 11 Apr 2022, 12 Apr 2022, 13 Apr 2022, 14 Apr 2022, 22 Apr 2022, 9 Jun 2022, 10 Jun 2022, 13 Jun 2022, 18 Jun 2022 and 22 Jun 2022. It was unknown whether patient took first, second or first and or second booster doses.   The vial was initially stored in refrigerator on 7-Jun-2022. The vial did not undergo any temperature excursions.  No treatment medication information was provided.
Heart rate was elevated but subsided during the first 15 mins. about 30 min. later pain in the lower  right arm between wrist and elbow.
PATIENT'S MOM INFORMED US THAT PATIENT WAS "SCARED OF NEEDLES". PATIENT APPEARED CALM IN VACCINATION OFFICE AND DID WELL WHILE VACCINE WAS BEING ADMINISTERED. PATIENT SAID HE FELT GOOD, STOOD UP WITH NO ISSUES, AND WALKED TO OBSERVATION AREA TO TAKE A SEAT. FIVE OR SIX MINUTES ELAPSED AND I WAS CALLED OVER WHEN PATIENT WAS "GOING DOWN".   I RAN OVER AND NOTICED THE PATIENT PALE, COLD,  WITH CLAMMY SKIN. HIS EYES WERE ROLLING INTO THE BACK OF HIS HEAD AND HE WAS BARELY RESPONDING TO HIS NAME. PATIENT'S MOM WAS CALLING HIS NAME AND I RAN TO GET THE BP CUFF.  COULD NOT GET A PULSE OR BP ON PATIENT, CALLED 911. PATIENT WAS RESPONSIVE BUT BARELY. PATIENT RESTED, SITTING, WITH ARMS ON TOP OF A GARBAGE PAIL BECAUSE THE THOUGHT HE WAS GOING TO VOMIT. MOM TOLD US THIS HAS HAPPENED TO HIM IN THE PAST WITH OTHER VACCINES. HE HAS "VACCINE ANXIETY". THE PATIENT WAS TAKEN ON A GURNEY BY EMS, WAS AWAKE AND RESPONSIVE. EMS TOOK CARE OF HIM IN PARKING LOT IN AMBULANCE AND WE SAW PATIENT HEAD HOME IN CAR WITH MOM.
I experienced nausea, cough, fever, acute unspecified headaches and syncope. They performed a COVID-19 test, BMP, CBC, Magnesium, chest x-ray and cardiac monitoring. I was given Tylenol and Zofran. As of now, except for the floaters in my eye, I feel pretty good. I went to my optometrist, back in August, and he said that they were fine.
exacerbation of the herpes simplex; localized injection site pain; localized injection site pain and swelling; low-grade fever / chills/ headache; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of HERPES SIMPLEX (exacerbation of the herpes simplex), VACCINATION SITE PAIN (localized injection site pain), VACCINATION SITE SWELLING (localized injection site pain and swelling), PYREXIA (low-grade fever / chills/ headache) and CHILLS (chills) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Herpes simplex.   On 04-Feb-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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HERPES SIMPLEX (exacerbation of the herpes simplex), VACCINATION SITE PAIN (localized injection site pain), VACCINATION SITE SWELLING (localized injection site pain and swelling), PYREXIA (low-grade fever / chills/ headache), CHILLS (chills) and HEADACHE (headache). At the time of the report, HERPES SIMPLEX (exacerbation of the herpes simplex), VACCINATION SITE PAIN (localized injection site pain), VACCINATION SITE SWELLING (localized injection site pain and swelling), PYREXIA (low-grade fever / chills/ headache), CHILLS (chills) and HEADACHE (headache) outcome was unknown.            No Concomitant medications were provided No Treatment information provided   Reporter did not allow further contact
9 days post MMR developed testicular pain, swelling and had Orchitis and Epididymitis on exam and ultrasound.
Joint pain over entire body. Swollen painful finger. Stabbing head pain in right temple. Stomach and lower abdominal pain. Loss of consciousness due to abdominal pain.