chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fatigue; Dizziness; Nausea; slight headache; Dry heaves; broke out into a sweat; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 82 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Feb2021 09:30 (Lot number: EN6202) at the age of 82 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "motion sickness anyway" (unspecified if ongoing); "heart condition" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Fatigue"; DIZZINESS (non-serious), outcome "unknown", described as "Dizziness"; NAUSEA (non-serious), outcome "unknown", described as "Nausea"; HEADACHE (non-serious), outcome "unknown", described as "slight headache"; RETCHING (non-serious), outcome "unknown", described as "Dry heaves"; HYPERHIDROSIS (non-serious), outcome "unknown", described as "broke out into a sweat".   No follow-up attempts are possible . No further information is expected.
developed angioedema of lower lip more than one hour after injection continued to progress even at 12 hours after.  Had associated wheezing but no respiratory.
Patient received 1st COVID-19 vaccine on 6/24/21 and 2nd COVID-19 vaccine on 7/15/21. Both at same pharmacy. He had a well child check in July which showed elevated LFTS on baseline labs ( AST was 148, ALT is 161). He was seen by hepatology who obtained a liver ultrasound which demonstrated Echogenic liver, most commonly seen with fatty infiltration. He then presented to our hospital on 9/8/21 with 2 days of chest pain, feeling like pressure, was intermittent, and sometimes sharp. Labs demonstrated significantly elevated AST/ALT, CK, troponin, NT pro BNP, fibrinogen, d-dimer, and CRP. EKG showed ST segment elevation. ECHO showed normal heart structure with EF of 49%. A gated CT angiogram showed normal coronaries. A cardiac MRI showed diffuse inflammation. He was admitted due to concerns for myocarditis and started on ibuprofen on 9/9/21. EKG obtained later in the day on 9/9 was normal. The patient received 70 g (1 g/kg) IVIG on 9/10/21 PM. Hepatology, rheumatology, genetics, and infectious diseases were consulted and recommended a variety of tests. An ECHO on 9/13 demonstrated an EF improved to 52%. The patient remains admitted.
feeling unsteady; doesn't feel ok/had to go back to bed; he is shacking; chills; very tired; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (feeling unsteady), FEELING ABNORMAL (doesn't feel ok/had to go back to bed), TREMOR (he is shacking), CHILLS (chills) and FATIGUE (very tired) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 001A21A) for COVID-19 vaccination.     The patient's past medical history included Dementia. Concomitant products included ATORVASTATIN, AMLODIPINE, CLOPIDOGREL, DONEPEZIL HCL and MEMANTINE.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced GAIT DISTURBANCE (feeling unsteady), FEELING ABNORMAL (doesn't feel ok/had to go back to bed), TREMOR (he is shacking), CHILLS (chills) and FATIGUE (very tired). At the time of the report, GAIT DISTURBANCE (feeling unsteady), FEELING ABNORMAL (doesn't feel ok/had to go back to bed), TREMOR (he is shacking), CHILLS (chills) and FATIGUE (very tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Relevant medical history and concomitant medication were not provided. In June 2013, reported as about 8 months ago, the patient was vaccinated with GARDASIL dose 1, 0.5 ml, intramuscular. The patient was currently at an unspecified clinic to receive their second dose. No adverse effect was reported. Additional information has been requested.
Pt called back next day to say he did not have a wheal when he received his injection the day prior. Spoke with nurse who states patient did receive wheal initially but the wheal went away when she reacted the needle inside the patient's skin. Consulted with medical director who states patient received wheal initially and does need repeat dose. Medical director spoke with patient who insist that he never received when upon injection of 2nd Jynneos dose and insisted on getting 3rd dose at another agency.
Severe pain in armpits; Had soreness; Fatigue; Felt feverish; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY PAIN (Severe pain in armpits), PAIN (Had soreness), FATIGUE (Fatigue) and PYREXIA (Felt feverish) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 011M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Mar-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 23-Mar-2021, the patient experienced AXILLARY PAIN (Severe pain in armpits), PAIN (Had soreness), FATIGUE (Fatigue) and PYREXIA (Felt feverish). The patient was treated with PARACETAMOL (TYLENOL) at a dose of unknown and VITAMIN D NOS at a dose of unknown. At the time of the report, AXILLARY PAIN (Severe pain in armpits) and PYREXIA (Felt feverish) had not resolved and PAIN (Had soreness) and FATIGUE (Fatigue) was resolving.            No concomitant medications were reported.  Treatment of the events included, paracetamol, vitamin D and lots of water.  Action taken with mRNA-1273 in response to the events was not Applicable.
Information has been received from a registered nurse concerning a multiple unspecified patients of unknown ages and gender. The patients' pertinent medical history, drug reactions/allergies and concurrent conditions were not informed. Concomitant therapies were not reported.  Since 28-NOV-2016, the patients had been administered improperly stored doses of LIQUID PEDVAXHIB lots # M032148 and M014926 with expiration dates 18-APR-2019 and 17-FEB-2019 respectively, (dosages and therapy routes were not provided), for prophylaxis. No adverse experiences had been reported. The doses of LIQUID PEDVAXHIB were exposed to a temperature >46°F but <77°F and were out of range for 21 hours. A data logger was used to track the temperature and there were no prior excursions. No product quality complaint (PQC) was involved. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1701USA003203: US-009507513-1701USA003710: US-009507513-1701USA003711: US-009507513-1701USA003712:
Dizzy; Blood pressure, was from 170/94 - 180/111; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy) and BLOOD PRESSURE INCREASED (Blood pressure, was from 170/94 - 180/111) in a 79-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced DIZZINESS (Dizzy) and BLOOD PRESSURE INCREASED (Blood pressure, was from 170/94 - 180/111). At the time of the report, DIZZINESS (Dizzy) and BLOOD PRESSURE INCREASED (Blood pressure, was from 170/94 - 180/111) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant Medications were not provided by the reporter. Treatment Medications were not provided by the reporter.
After receiving the MMR vaccine. patient felt dizzy and fainted for about 15 to 30  seconds on the chair. I was keeping him from sliding down and kept him on the chair. He came back to his senses after about 15 to 30 seconds. After he came back to his senses, he felt nauseous. He vomited 20 minutes later. I continued to monitor him for another 20 to 25 minutes while he was sitting down. He felt ok afterwards and had someone gave him a ride home. I told him to go to ER if any signs of trouble breathing. This does not seem like he is allergic to the vaccination.
Patient's eczema began one week after receiving a combination of the HIB1 and DTAP vaccines. Since then he has suffered from extreme eczema that prevents normal lifestyle and sleep. His eczema was formally diagnosed on May 18, 2004.
Pfizer Vaccine administered after being stored at regular freezer temps longer than recommended.  Dose determined invalid, client contacted, and recommended dose repeated.
chills; headache; fever; A spontaneous report was received from  a 74 year old male who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chills,pyrexia and head ache.  The patient's medical history was not provided. Concomitant medications include atorvastatin and atenolol.  On 11 jan 2021, the patient received first of two planned doses of mRNA-1273 (012L20A )for prophylaxis of COVID-19 infection.   On 8 feb2021, prior to the onset of events patient received second dose of mRNA-1273 (010M20A)for prophylaxis of COVID-19 infection.   ON 8 feb 2021 after the vaccination patient experienced chills,pyrexia and head ache.  outcome of the events are unknown.  Action taken with mRNA-1273 in response to the events was not applicable.
0938 Patient presented for first dose of Moderna vaccination. Patient provided a 30 min observation card due to history of Penicillin allergy. At 1011 Patient complained of her throat itching and swelling, tongue swelling and tingling and chest pain. EMS called by assisting staff member. Assessment of throat and oral mucosa were unremarkable. Lungs clear on auscultation. Pulses bilaterally strong and equal. Patient coughing continuously with increased respirations. Skin pink, no redness or rash present. BP 126/88, P106, R22, O2 98%RA. Administered 50mg IM Benadryl into right deltoid. Continued to observe patient. 1024 EMS arrived, patient reported feeling better. Respirations were easy and unlabored, P84, 02 99RA. Patient declined emergency transport, refer to EMS call number 21-803376. Advised patient to seek immediate medical attention if symptoms progressed after episode, patient verbalized understanding.
Hives on torso and extremity approximately 4 hours after receiving 1st Havrix. Called her doctor (was traveling Thursday) and took by mouth Benadryl. Symptoms lasted 2 days but rash was still noticeable for 10 days.
A nurse reported the occurrence of an injection site reaction in a 15 month old male who was vaccinated with Infanrix for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were unspecified. On 7/23/02, the subject received his fourth injection of Infanrix (556A2) into the right thigh. On the same date, he received an injection of IPOL at an unspecified site. He was seen by the physician on 7/25/02 with an injection site reaction characterized by redness at the site of Infanrix administration and swelling of the right leg. As of 7/31/02, the injection site reaction had resolved. The reporter stated that the injection site reaction was probably related to Infanrix administration.
I had symptoms of bad cold, post-nasal drip, coughing, sneezing, and tiredness. I consulted my doctor and because my symptoms was relatively minor she recommended over the counter medications. I took DAYQUIL for about a week.
No other AE/no PQC.; an expired dose of VAQTA was given to a patient.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported.  On 18-MAY-2022, the patient was vaccinated with an expired dose of hepatitis A vaccine, inactivated (VAQTA) intramuscular injection (1 ml/once, lot #T034003, expiration date: 28-MAR-2022; strength, and route of administration were not provided), administered for prophylaxis (Expired product administered). Vaccine had no history of temperature excursions. Patient had no adverse effects or symptoms following administration (no adverse event). Dose was supported by post-expiry memo. No further information was provided. No other adverse event (AE) or product quality complaint (PQC) was reported.
I have a strange pin prick feeling in the top of my head that only exhibits pain when my facial expressions or other movements cause my scalp to be moved or stretched. When I try to feel for something poking the top of my head, there is nothing there and touching the area does not cause pain. But then I may look to the right and frown, and suddenly there is a sharp needle feeling in the top of my head.
symptoms of the flu; Initial information was received on 07-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via social media.  This case is linked to cases 2020SA281563 and 2020SA317467 (same reporter).  This case involves a male patient (age unspecified) who had symptoms of flu (Influenza like illness), when he received INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient had symptoms of flu (influenza like illness) (unknown latency, non-serious event) following the administration of INFLUENZA VACCINE.  The reporter stated that a person can have a reaction to the flu shot. She did her son did and she spoke to several of her friends that have had the same thing happened to them. They had all the symptoms of the flu.  No laboratory data was provided.   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on the batch number for this case.
Flat red rash on chest and trunk. Developed 6 hours after vaccination. No fever, no other symptoms. Behavior and intake normal.
Information has been received from a healthcare worker concerning unspecified patient of unknown age and gender. On unknown dates, an unknown number of doses of improperly stored GARDASIL (lot# expiration date, strength, dose and route were not reported), RECOMBIVAX HB (lot# expiration date, strength, dose and route were not reported), PROQUAD (Merck) (lot# expiration date, strength, dose and route were not reported) and VARIVAX (Merck) (lot# expiration date, strength, dose and route were not reported) were inadvertently administered to unspecified patients. No adverse effects reported. It was unknown if the patient sought medical attention. Additional information has been requested.
shingles; Bell's palsy; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On approximately 11-NOV-2008, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not provided) for the prevention of shingles. On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine the patient developed Bell's palsy and shingles. As a direct and proximate result of Company's wrongdoings, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient had suffered and would continue to suffer significant medical expenses, pain and suffering, and other damages. As a direct and proximate result of Company's defective zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms resulted in physical limitations not presented prior to using Company's product. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of Company's wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The outcome of Bell's palsy and shingles was reported as not recovered/not resolved. The reporter considered the events to be related to Zoster Vaccine Live(ZOSTAVAX).  Bell's palsy and shingles were considered to be disabling. Upon internal review, the event of Bell's palsy was considered to be medically significant
Two weeks after receiving vaccination, severe dull ache began in right shoulder. Pain is sometimes in shoulder blade, shoulder (deltoid), right upper arm (bicep area). Pain is worse at night, enough to cause sleeplessness and inability to lie on right side. Pain somewhat eased by Tylenol or Tylenol/ Advil. Pain has not subsided or lessened since it began three weeks ago. I am an active healthy male in excellent health otherwise. I exercise regularly, maintain a healthy weight and have no chronic conditions.
lt arm was red & swollen, hot to touch started as bullseye around inj site, swelling & red extended to above shoulder & below elbow;swelling started 2MAY99, still swollen 4" around inj;
3 days fever, redness and swelling where shot was given, fussiness, very poor appetite, stuffy nose, on 5th day she got difficult breathing and symptoms similar to croup desease.
extreme pain in right hand. Unable to close or open pinky finger. Pain at base of finger.
Extreme fussiness, not sleeping longer then 2 hrs at a time. No drinking more then 2 oz at time. Slight fever 100.3.
patient presents from home with stroke like symptoms on 10/22/2021. admitted for 14 days (10/22/2021 - 11/5/2021). discharged to rehab facility with diagnosis of pontine stroke.
No additional AE reported.; vaccine administered after temperature excursion; This spontaneous report was received from a nurse, concerning a 3-year-old patient of unknown gender. Information regarding the patients' medical history, concurrent conditions, drug reactions or allergies, and concomitant therapies was not provided.  On an unknown date, there was a temperature excursion registered for varicella virus vaccine live (oka/merck) (VARIVAX) of -11.8 Celsius degrees for 1 hour 45 minutes and 0 seconds. It was reported that there was no previous temperature excursion reported (conflicting information, also reported previous temperature excursion as "yes").  On 30-SEP-2022, the patient was vaccinated with the improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot # U039726, expiration date 15-DEC-2023, (dose, route of administration, and anatomical location were not provided) administered for prophylaxis (product storage error).   No additional adverse event was reported.
Bone Pain; Weakness; Itchiness at injection Site; Chills; Fever; Muscle pain; Headache; Tired; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Bone Pain), ASTHENIA (Weakness), CHILLS (Chills), PYREXIA (Fever) and MYALGIA (Muscle pain) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Apr-2021 at 10:00 AM, 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 20-Apr-2021, the patient experienced BONE PAIN (Bone Pain), ASTHENIA (Weakness), CHILLS (Chills), PYREXIA (Fever), MYALGIA (Muscle pain), HEADACHE (Headache), FATIGUE (Tired) and VACCINATION SITE PRURITUS (Itchiness at injection Site). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and NAPROXEN SODIUM (ALEVE) for Adverse event, at an unspecified dose and frequency. At the time of the report, BONE PAIN (Bone Pain), ASTHENIA (Weakness), CHILLS (Chills), PYREXIA (Fever), MYALGIA (Muscle pain), HEADACHE (Headache), FATIGUE (Tired) and VACCINATION SITE PRURITUS (Itchiness at injection Site) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: TCR-NNI On 29-Jun-2021: TCR : AE outcome
about 24hr p/vax pt devel h/a, chills, fever (T101, 102 oral), muscle & body aches, fatigue, gen malaise lasting 2 days;also devel 2 1/2inch area of induration, redness & tenderness @ vax site lasting 5 days;
Hypotonia, Developmental Delay, Speech Delay, Sensory Integration Dysfunction, Allergies, GI Reflux.
Information has been received from a registered nurse for GARDASIL, a Pregnancy Registry product, concerning a 17 year old female patient who on 09-JUL-2010 was vaccinated with the first dose of GARDASIL (Lot # 663559/1178Y) (route and dose not reported). The nurse reported that the patient became pregnant after receiving the first and only dose of GARDASIL. No adverse event was reported. The patient's last menstrual period and estimated delivery date were unknown. Follow up information has been received from the registered nurse who reported that on 08-APR-2011 the patient delivered a viable healthy female neonate via caesarean section. Gestational age of neonate was unknown. Weight of the neonate was 8 pounds, 7 ounces. American Pediatric Gross Assessment Record (APGAR) scores were 9/9. The registered nurse reported that there were no congenital anomalies noted on the OB/delivery report. The patient would be followed by her OB/gynecologist for routine care. Upon internal review, caesarean section was determined to be an other important medical event. Additional information is not expected.
Heart racing/Palpitations; Hot and flush feeling; Hot and flush feeling; Weakness; Dizzy; This is a spontaneous report from a contactable nurse (patient). A 38-year-old female patient received BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: EL3248), intramuscular in the right arm on 15Jan2021 at 12:30 PM as a single dose for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient was not pregnant, did not receive any other vaccine within four weeks, did not have any other medications in two weeks, had no known allergies, and did not have COVID prior to the vaccination. The patient experienced heart racing, palpitations, hot and flush feeling, weakness, and was dizzy on an unspecified date. Therapeutic measures were taken as a result of the events which included Benadryl. The patient was not COVID tested post-vaccination. Outcome of the events was recovered.
At 12:57 am on 10/6/21 I woke up with pain in my legs. My limbs felt heavy and my chest had pressure. I was shivering profusely at room temperature. At 2:00 am I woke again with sweats and sharp pain in my chest. The chest pains have been on and off since. I had a terrible headache ranging from 12:57 am-2:30 pm.