chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt. presents today at 1347pm after receiving 1st dose of pfizer vaccine to left arm at 1230 pm on 2/26/2021. Pt. states that she started feeling dizzy and sleepy along with a feeling of not catching breath which started about 3 minutes after receiving the vaccine. Pt. states that she was instructed to come to health facility. Patient states that she developed a headache about five minutes after receiving the covid vaccine. Pt. denies treatment.
Starting in July, frequent pneumonia with multiple negative Covid tests and no indication of ever having Covid. Frequent low oxygen levels.
Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tiredness) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. In 2021, the patient experienced FATIGUE (Tiredness). At the time of the report, FATIGUE (Tiredness) outcome was unknown.            No concomitant medication information was provided. It was unknown if patient was enrolled in a Covid-19 vaccine trial. No treatment medication was provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
sore arm; This case was reported by a consumer and described the occurrence of pain in arm in a 82-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included hashimoto's disease.   In September 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter was patient's daughter. In September 2020, patient received 1st dose Shingrix and experienced sore arm. The patient had history of hashimoto. This case is linked to the case US2021003181.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021003181:same reporter
1 week after shot, I have a rash all over my body. It started in my left wrist 3/24 and when I woke up this morning, it is on both arms, left leg, upper back, & face.  The bumps are slightly red, raised, and itch a lot. I will take benadryl to see if it helps.
urticaria hives / localized hives; This spontaneous case was reported by a physician and describes the occurrence of URTICARIA (urticaria hives / localized hives) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second 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. On an unknown date, the patient experienced URTICARIA (urticaria hives / localized hives). At the time of the report, URTICARIA (urticaria hives / localized hives) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported   Treatment reported includes antihistamine and steroids.   This case was linked to MOD-2021-378187 (Patient Link).
Information and follow up information has been received for Pregnancy Registry for GARDASIL vaccine (yeast) from a 23 year old Caucasian female consumer with asthma and penicillin allergy who on 18-JUL-2007 was vaccinated IM with a first dose of GARDASIL vaccine (yeast) (Lot # 658100/0525U). Concomitant therapy included albuterol. The consumer reported that "I found out today (10-AUG-2007) that I am pregnant". No adverse reaction was reported. She had a "pregnancy test" done. The patient sought unspecified medical attention. The outcome was unknown. On 15-OCT-2007 the patient had a normal ultrasound. Additional information has been requested. Information was received on 07-APR-2008. A normal female infant was born on 21-MAR-2008 (weeks from LMP = 38 5/7). The baby weighed 6lbs. 11 oz. and had an Apgar score of 9/9. There were no congenital anomalies. The baby did develop some jaundice in the first few days of life. This resolved on it's own and was felt to be physiological. No other information was reported concerning this pregnancy. Follow-up information has been received in the form of medical records. On 23-MAR-2008, all state Department of Health tests screen-negative and no follow-up action was requested. On 24-MAR-2008, the newborn's total serum bilirubin test was 15.3 mg/mL (normal range 2.0 to 12.0). On 25-MAR-2008, the newborn's total serum bilirubin test was 18.4 mg/mL (normal range 2.0 to 12.0). On 26-MAR-2008, the newborn's total serum bilirubin test was 18.1 mg/mL (normal range 2.0 to 12.0). On 27-MAR-2008, the newborn's total serum bilirubin test was 16.3 mg/mL (normal range 2.0 to 12.0). On 10-APR-2008, the patient had a 2 week well child visit and all appeared normal. On 21-MAY-2008, the patient presented for a scheduled 2 months well child visit and baby's mother was concerned about the baby spitting up a lot. The baby "seems to be spitty". The physician found that the baby appeared healthy and gaining weight appropriately, so in that point he did not feel that the "spitting" was of any clinical significance. Physician noted will continue to monitor at future visits. Baby was given routine immunizations. On 21-JUL-2008, baby was at the physician's office for 4 month well child visit. It was noted the baby was still spitting up some, but now on formula  and spitting up less then was. Routine vaccinations were given. No additional information is expected. All medical records will be provided upon request.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 03-AUG-2015, the patient was vaccinated with 3rd dose of improperly stored GARDASIL with lot number: K016966, expiry date: 10-MAY-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
expired booster dose of Moderna vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired booster dose of Moderna vaccine) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired booster dose of Moderna vaccine). On 28-Oct-2021, EXPIRED PRODUCT ADMINISTERED (expired booster dose of Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The reporter was a practice manager of primary health clinic.  Concomitant medication of the patient was not reported. . The vial (lot #047B21A) was in the fridge on 14-Oct-2021 (expired on 09Oct2021). The reporter reported that the vial was in the refrigerator and it had not been compromised. There was no temperatures excursion. The vaccine was injected into the muscle.  No treatment information was provided by the reporter. Patient experienced no events after expired vaccine used   Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2021: Follow up received and updated with  HCP details , Patient race ,Patient experienced no events after expired vaccine used
Reported hives after he received the vaccine. Arm sore, achy, intermittent dizziness.
A report has been received from a Health Professional concerning a male patient who had been receiving FLUMIST quadrivalent (intranasal) 0.2 milliliters, once/single administration. FLUMIST quadrivalent started on an unknown date. It was reported that patient number eleven received the FLUMIST, 0.2ml dose, one time intranasally, date of vaccination not provided. It was unknown if the dose of 0.1ml was given in each nostril. The office refrigerator had a temperature excursion of 1.5 degrees C for a total of 17.5 hours. The temperature would be at recommended temperature range and then dip to 1.5 degrees C, then go back to original range. FLUMIST quadrivalent was continued. The outcome of the event of patient number eleven given FLUMIST that underwent a temperature excursion and it is unknown if the dose of 0.1ml was given in each nostril is unknown. The report was considered to be non-serious.
May 6 my left upper leg was 5x the size as my left leg, I called and took a picture and my orthopedists said come tomorrow I want to make sure you do not have an infection, I went and didn't not, he was unsure what what was going on.. I have been to the orthopedist, physical medicine and rehab dr, rhuematologist, immunologist , and pain management doctor
Fever of 101.  Body and head aches.  Lasted for about 24 hours.  Woke up on the 28th feeling fine. Tylenol seemed to work better for pain as opposed to Advil and Aleve.
It has been 8 days since my 2nd Moderna shot and I still have dizziness.  I had slight dizziness during the first shot, but only within the 15 minutes I was required to stay after the vaccine, however it did not last long and did not have any dizziness until after the 2nd shot.  I almost passed on on 3/27 (2 days after), have not but continue to have intermittent bouts of dizziness that I had not had before.  Fatigue also continues to be a problem.
weak; Tired; Sore throat; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (weak), FATIGUE (Tired) and OROPHARYNGEAL PAIN (Sore throat) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) 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 ASTHENIA (weak), FATIGUE (Tired) and OROPHARYNGEAL PAIN (Sore throat). At the time of the report, ASTHENIA (weak), FATIGUE (Tired) and OROPHARYNGEAL PAIN (Sore throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment and concomitant medications were reported.   Reporter did not allow further contact
11/8/2021   Chief Complaint:  Altered mental status   Source of Information:  Patient   History of Present Illness:  This is a 73y.o. female with past medical history of HTN, HLD, DM2, schizophrenia who presented to the local ED on 11/8/21 who presented for altered mental status from a HCF.  Patient was recently hospitalized for UTI and TME at another HCF from 10/14-10/25.  She was since discharged to another facility.  There she was noted to only be alert and oriented to self.  Her baseline is reported to be alert and oriented x4.     Upon my exam, patient lethargic; difficult to arouse, but when she arounses will answer her name.     In the ED, patient was placed on 3L NC.  Labs were significant for WBC 16.7, lactic acid 2.8, which has now normalized, sodium 155, creatinine 2.68, glucose 282. She was started on rocephin for UTI. Covid swab was postive, and was started on decadron.
COVID-19; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (COVID-19) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Company comment: Very limited information regarding this event has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
pt recvd vax 27OCT92 & devel itching, hives 12 hrs later then lips swelled pt seen 28OCT92 had urticaria over amrs, buttocks & foot w/angiodema of lips;
Patient reports suddenly feeling light headed and "numb from ears up". Symptoms occurred approximately 10 minutes post vaccination.  Upon standing, patient's legs were too weak to walk. BP and glucose checked, all within normal limits. EMS called and patient taken to hospital.
Around 05 pm the pain and fever slowly started and by around 10 pm i started to have cold and hot fever, joint pain, lower back pain and followed by cramping and stomach uncomfortably and a serious pain. Medicine used for treatment: stomach such as omeprazole and anti acids, nausea tabs and pain and fever relievers but really nothing worked because of the nuasea
TOOK TWO UNREFRIGERATED DOSES; A spontaneous case report was received from a pharmacist on 01-Apr-2019 for two consumers.  Based on the information obtained from the pharmacist, two individual case safety reports PVX201904-000254 (PVX2019-780; female) and PVX201904-000255 (PVX2019-781, male) were created and cross-linked in the database.  This case report describes a male consumer who "took two unrefrigerated doses", while being on oral Vivotif (one dose every other day) for typhoid fever prophylaxis.   Case report: The consumer took two doses of Vivotif, which was unrefrigerated for 48 to 72 hours at 68-degree Fahrenheit.  Action taken with Vivotif was not applicable.   The clinical outcome of the event "took two unrefrigerated doses" was unknown.  Company's Comment: The causality of the event "took two unrefrigerated doses" was considered as not applicable. ; Sender's Comments: Company's Comment: The causality of the event "took two unrefrigerated doses" was considered as not applicable. US-PaxVax Berna GmbH-PVX201904-000254:
SHOULDER PAIN THAT AFFECTED ACTIVITIES OF DAILY LIVING THAT IS RESOLVING PER PATIENT
felt drunk or high; he felt drunk; felt dizzy; thought he might fall; head spinning; This non-serious case was reported by a consumer via call center representative and described the occurrence of feeling high in a 74-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number y2j2b, expiry date 29-JAN-2025) for prophylaxis.   On 19-SEP-2023, the patient received the 1st dose of Arexvy (left arm). On 19-SEP-2023, 30 min after receiving Arexvy, the patient experienced feeling high (Verbatim: felt drunk or high), feeling drunk (Verbatim: he felt drunk), dizziness (Verbatim: felt dizzy), feeling abnormal (Verbatim: thought he might fall) and head spinning (Verbatim: head spinning). The outcome of the feeling high, feeling drunk, dizziness, feeling abnormal and head spinning were resolved (duration 2 hrs).   It was unknown if the reporter considered the feeling high, feeling drunk, dizziness, feeling abnormal and head spinning to be related to Arexvy.     It was unknown if the company considered the feeling high, feeling drunk, dizziness, feeling abnormal and head spinning to be related to Arexvy.  Additional Information: GSK Receipt Date: 06-OCT-2023 The patient received a dose of Arexvy and approximately 30 minutes after the injection he felt drunk or high, dizzy and thought he might fall, and his head was spinning. This lasted for about 2 hours and then all symptoms resolved. The reporter consented to follow up.
Pt recvd 3 doses of Engerix-B vax & 29OCT91 it was determined that pt did not respond to the vax series;
Patient became lethargic, diaphoretic, complained of dizziness and eyes dilated bilaterally 15 minutes after injection was given.  Patient was assisted to the floor.  Legs were elevated.  Vital signs were taken at 0635.  BP 135/70, HR 75, Resp 16, O2 sat 98% on room air.  Patient denied shortness of breath, throating swelling or pain.  EMS was called at 0634.  Epi Pen 0.3 mg  was administered at 0638 in the left deltoid.  Vital signs were taken again at 0642, BP 138/72, HR 106, Resp 20, Temp 99.3, O2 Sat 99% on room air.  Patient verbalized that he was feeling better after epi was administered.  Patient ate last at 0430.  Interpreter was used to communicate with the patient.  Interpreter contacted the patient's emergency contact.  EMS arrived at 0644, patient was assessed and taken via ambulance.  Epi pen was sent with EMS.
recvd vax, develop fine red irregular rash, blotchiness & a "hive" several inches below inj site, pain & achiness down to wrist & night sweats 11/18/98,  appears to be resolving
Lethargy, vomiting, diarrhea, fever, loss of appetite, unusual rash at injection site measuring approx 8inches by 4 inch.  Symptoms have not resolved.
Approximately 24 post Kinrix vaccination patient had marked non-pitting edema to his right upper leg with redness that extended from his right greater trochanter to his right knee.  Patient complaint of pain rated 2 on a scale of 1-10.  Afebrile.  Patient given prescription for Prednisone and Keflex.  Patient was unable to tolerate Prednisone per telephone follow up, but is taking the Keflex.  After 2 days on Keflex, the edema and redness resolved and patient no longer complaining of pain.
On 4/7/00, received vaccine. On 4/13/00 broke out in morbilliform rash on legs and arms with 103 degree fever. Rash persisted. Temp remained to 103 on 4/18/00. Rash remained 12 days post vax. Pt had an ER visit on 4/13/00.
site sorness (lasting 48 hours) Headache (began 12 hours after injection and continues to present) body ache(began 12 hours after injection and continues to present) fever(began 12 hours after injection and continues to present) weakness(began 12 hours after injection and continues to present)
Went to ER on 4/27 with c/o chest pain (~3 day history), resolved. Returned to ER on 4/30 for chest pain- diagnosed with a small LEFT lower lobe segmental and subsegmental pulmonary embolus on CT 4/30/2021,  hospitalized until 5/2/21, discharged on Eliquis, metoprolol, pantoprazole, keflex (for sore throat, negative throat cultures), metoprolol, atorvastatin, amlodipine.
24 hours after administration of Varivax #09924 Date on VIS 3-13-08 and Hep A # AHAV327AA Date on VIS 3-21-08 on her left upper arm, developed a hard, erythematous induration painful and itching. 3cm initially, 7cm today.
disoriented; flu-like symptoms; Tired; weak; achey; Low-grade fever; This is a spontaneous report from a contactable consumer (patient).  A 77-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 20Feb2021 at 10:15 (at the age of 77-years-old) as dose 2, single for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD) and psoriasis. Patient had no known allergies. The patient received no other vaccine in four weeks. Concomitant medication included fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (TRELEGY ELLIPTA).  Historical vaccine included bnt162b2 (Batch/Lot Number: not reported) on 30Jan2021 at 12:00 pm as dose 1 in Left arm for covid-19 immunisation. On 21Feb2021, the patient experienced disoriented, flu-like symptoms, tired, weak, achey and low-grade fever. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative on 26Feb2021. Facility type vaccine was a school or Health Clinic. Treatment was given for the events. The patient was not covid prior vaccination. The patient tested for covid post vaccination. Outcome of the events were not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pt was given PENTACEL and PEDIARIX.  No adverse effects as of 12/15. No adverse effect on 12/31.
Swelling, soreness, redness at injection site. Progressed to pain and difficulty raising arm. Spiked fevers in excess of 101 degrees within 24 hours. Symptoms progressed to swollen painful lymph nodes throughout the body, swollen hands, increased erythema at injection site 6"x8", raised, hot to touch, painful, stiffness of shoulder and elbow joints on side of injection. Was seen by primary physician, prescribed Prednisone and antibiotics.
12 hours post vaccine, fever chills.  15 hours post vaccine vomiting for 10 hours Nausea for four days (as of time completing this form)  No treatment; let run course
15 minutes after receiving vaccine started to "hum" fell over backwards hit head on floor, unconscious approx 10 seconds -> head twitching
same night she had chills; fever of 103degF; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (same night she had chills) and PYREXIA (fever of 103degF) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced CHILLS (same night she had chills) and PYREXIA (fever of 103degF). At the time of the report, CHILLS (same night she had chills) and PYREXIA (fever of 103degF) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia (99.5-100.9 °F): 103 °F High.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment information was provided.
pt was given Engerix-B in JUL & AUG92 & exp rash, hives, malaise & aches;
Pain and swelling at injection site x 1 month. Pain at shoulder with flexion and abduction above 90 degrees.
Since having the vaccination I have experienced strange progressive changes to my menstrual cycle which was up until the second vaccination a predictable 28 day cycle!! I am now experiencing a 21 day cycle. A month prior to the vaccine my hormones were checked via blood test and were perfect 'no perimenupause ' symptoms or signs.  I have also suffered a slowing of my bowel to the point of relying on laxative and fibre supplements otherwise the chronic constipation almost shuts the bowel down. I am seeing a gastroenterologist tomorrow! These symptoms are slow progressing and I am not alone 3 other women between 35-52 are experiencing similar menstrual and bowel changes since their pfizer!! This needs more research....