chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient started feeling Light headed, nausea, sweating, knombness on both hands, feeling like she will pass out out 5 minutes after given the vaccination.  She was allert and oriented through out.  she refused Epi-Pen.  She was given Benadryl 50mg capsule.  EMS was activated after about 10 minutes of the vaccine.  The EMS took her vital signs and she was monitor her for a few minutes and was realeased without any medication.
Information regarding PREVNAR 13 was received from a consumer regarding a 2-year-old male patient who experienced trouble walking, fever, projectile vomiting and pain in right thigh. At 2 years of age, the patient received a dose on 24-May-2010. The patient experienced trouble walking, fever, projectile vomiting and pain in right thigh on 24-May-2010. The patient was taken to the emergency room; he was given ibuprofen and an unknown oral tablet for nausea and discharged to home. The event of projectile vomiting has resolved, fever is recovering, gait disturbance and right thigh pain continue. No additional information was available at the time of this report.
Booster dose not approved for patient less than 16 years of age.  Patient is 13y/o
01/04/2006 well child check received MMR vaccine, 01/05/2006 had seizure at day care seen in ED abnormal EEG admitted to hospital 01/06/2006. 01/07/2006 d/c'd on Depakote. Information received from ER summary states twitch as additional finding. msv
- 12h after injection and for 2 days: sore arm and flu-like symptoms (chills, fatigue, fever, loss of appetite, body ache, sweating, nose congestion, headache). - Day 4-10 post-injection: chest and left arm (from neck down to fingers) pain - Week 2 post-injection: constant migraine (night and day) for about a week - Week 2-3 post-injection: daily nose bleeding, every morning for about 10 days - Since the injection: disrupted menstrual cycles as follows: Cycle 1: periods arrived a week too early (on day 21) and were hemorrhagic Cycle 2: periods arrived too late (on day 40) and were hemorrhagic Cycle 3: periods arrived too early (on day 23) and were hemorrhagic
This spontaneous report was received on 02-MAR-2017 from a nurse and refers to multiple unknown patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided.  The nurse reported that multiple unknown patients were administered improperly stored vaccine of VAQTA (Lot number M0476587, expiration date 28-OCT-2017) on multiple unknown dates since 27-FEB-2017 for the indication of prophylaxis.  No adverse effects reported. Administered doses of VAQTA experienced temperature excursion from 0 to 2 degrees Celsius for 1 hour and 26 minutes. A digital data logger was involved. There were no previous temperature excursions. No further information was provided. his is one of several reports received from the same reporter.  Additional information has been requested.
Vaccine caused Optic Neuritis, blurry vision, faded color, pain with eye movement.  There is no treatment, visual disturbances will last weeks to months
Swollen upper left arm, sore, hard, reddened. (twice the size)  Had received pneumonia vaccine on 11/14/03-but did not remember it when screened on 11-14-05.
pain on both shoulders, the back of her neck; pain on both shoulders, the back of her neck; extremely tired; This is a spontaneous report from a contactable consumer (patient herself) via Pfizer sponsored program. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: unknown, expiry date: unknown) via unspecified route of administration on an unspecified date as dose 1, single for Covid-19 immunisation. Patients medical history and concomitant medications were not reported. The patient was done with the first dose 11 days ago and up until now she was experiencing pain on both shoulders, the back of her neck and feeling extremely tired, on an unspecified date. The outcome of events was unknown.   Follow-up attempts completed. No further information expected.
Flu; This case was reported by a consumer via interactive digital media and described the occurrence of influenza in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, 3 days after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced influenza. On an unknown date, the outcome of the influenza was unknown.   It was unknown if the reporter considered the influenza to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The reporter reported the case for their mother. The age at vaccination was not reported. The reporter's mother received flu shot and 3 days later, they got the flu.
Left arm became more and more numb, headache and warmth came over my body, fatigue and dizziness, heart palpitations and shortness of breath followed, diarrhea and vomiting then occurred. The following day, 5/16/2017, body stiffness, joint pain and stiffness occurred along with headache and malaise. Sore throat worsened and itching of the arms and head/neck occurred.
Rash after getting covid 19 vaccination on Friday 10/27/2023.  The next day woke up with terrible pruritus legs, arms, chest, back. Mild earlier in the day, then worse as the day progressed. Hard to sleep the first 3 nights.  Feet to chest, pruritic. No SOB. No local reaction over arm. Instructed to spot test ketoconazole before continuing over large area. Improving some. Started on oral steroid. OK to continue topical hydrocortisone short term.
Pt had her first Shot of Moderna on 1/21/2021 and her second shot on 2/18/2021- Lot # 024M20A.  She also had a Td on 4/12/2021 Lot # A132A1.  She is unsure exactly when her first symptoms started but around July she had a tight circumferential feeling around chest. Symptoms progressed through August and she developed numbness in toes that worked it's way up to her chest. She went in for an Emergency MRI and was diagnosed with Transverse Myelitis and also Multiple Sclerosis.  She had 3 lesions total and was told this was caught early. This may or not be related to a vaccine but since transverse myelitis can develop after a vaccine I am reporting it.
Pt noted rash 2 days after immunization received. Rash began along armpit & across chest. Pt will take ZYRTEC but declined steroid trial of triamcinolone. Pt will follow up as needed.
No additional AE; A patient received an expired dose of the VARIVAX vaccine; This spontaneous report has been received from a medical assitant, concerning a patient of unknown age and gender.  The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On 13-JUL-2023, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, (lot number U020244 was verified to be valid, expiration date reported and confirmed as 28-JUN-2023), administered as prophylaxis (exact dose, route of administration, and anatomical location were not provided) (Expired product administered). No additional adverse event (AE) nor product quality complaint (PQC) were reported.
Grandmother called at 8:30 am complaining of swelling and redness in patient left thigh grandmother stated that the area involved was bigger than 50 cent piece, advised grandmother to bring child in and let nurse look at area. Told grandmother to put a cold compress on area. Patient's grandmother stated that she was taking child to health department due to it being closer to HD. Called patient 4/19/04 ,no response, left message. To contact health department. Pt 4/20/04 called second time, no response. Left message.
Patient received first dose Pfizer vaccine at 2:13pm and began having difficulty swallowing around 2:25pm.  Oxygen 100% on room air., Heart Rate  111, Blood Pressure 136/84, Respirations 20, Epi pen administered at 2:32pm in right thigh. At  2:45pm telemetry place and was found in sinus rhythm. No chest pain, palpitations, pressure, shortness of breath noted. Patient continues to report difficulty swallowing. IV placed by EMS at 14:51 .20 right arm. 10mg Dexamethasone given via intravenous. Also 50mg Diphenhydramine given intravenous. Pt transfered to Hospital via ambulance.
First shot was ok no major side affects, second shot not feeling well for the first week, did not feel normal until 3 weeks.  the 3 rd shot, did not feel well at all the first week, started to develop heart pain on the 3rd day. After 4 weeks it was time to go to the doctor and find out what is wrong.
103 degree temp at approximately 6:30 PM. Seizure around 7 PM which prompted call to 911. Second seizure in squad en route to local hospital. After stabilized in ER, transported via ground squad to another hospital (35 miles away). Tested for meningitis and other neurologic problems - all within normal range. Discharged today on 5/2/11 at 5 PM.
This case was reported by a consumer via call center representative and described the occurrence of localized erythema in a female patient who received SHINGRIX for prophylaxis. On 23rd September 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 24th September 2018, 1 days after receiving SHINGRIX, the patient experienced localized erythema and injection site pain. On an unknown date, the outcome of the localized erythema and injection site pain were recovered/resolved. It was unknown if the reporter considered the localized erythema and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. The patient experienced redness right below the injection site. The patient stated that it was red for a long time, however, she was not sure how long the redness lasted. Pain lasted for 1 to 2 weeks before subsiding. The patient required Emergency room visit. The reporter did not consent to follow up. The patient did not wish to provide any contact information or health care professional information.
Child was vac. on 07/30/08. Has developed case of chickenpox. (noticed 12/1/08 by mom)
Patient was given 1 dose of HPV 9 (mistakenly for his sister). He is doing fine - no reaction at all.
Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 30-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (One drink a week prior to pregnancy). Concomitant products included SPIRONOLACTONE from 25-Mar-2019 to 04-Mar-2021 for Acne, CETIRIZINE HYDROCHLORIDE (CETRIZINE) from 25-Mar-2020 to 04-Oct-2020 for Allergy, DOCUSATE from 15-Feb-2021 to an unknown date for Constipation, FAMOTIDINE for Heartburn, PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for Pregnant, TRIVITE from 04-Nov-2020 to an unknown date for Vitamin supplementation.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 05-Sep-2020 and the estimated date of delivery was 12-Jun-2021. On 31-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  sixteenth week of the pregnancy. The vaginal delivery occurred on 20-Apr-2021, which was reported as Full-term. For neonate 1, the birth weight was 1501 grams (3lbs 5oz) with an APGAR score of 8 and 9 at (1, 5 minutes). The outcome was reported as Term Birth w/o Complications. Female fetus was delivered at 41+2 weeks of gestation with 53.3 cm length and 34 cm head circumference. There was no fetal abnormalities on delivery and no infant abnormalities at 1 month post partum. On 31-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Oct-2020, Pregnancy test: positive (Positive) Positive. On 05-Nov-2020, Ultrasound foetal: normal (normal) Normal. On 03-Dec-2020, Blood test: normal (normal) Normal. On 03-Dec-2020, Ultrasound foetal: normal (normal) Normal. On 22-Apr-2021, Ultrasound foetal: normal (normal) normal. On 03-Nov-2021, Blood glucose: normal (Negative) Normal-negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.   Most recent FOLLOW-UP information incorporated above includes: On 08-Aug-2021: Follow-up received on 08-aug-2021 and contains delivery information and concomitant medication information.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
5 days post injection and ongoing: strong pain in the chest area and thus inhibited from doing any strenuous exercises/workouts. Lifting  >20 lbs from the ground is strenuous activity for me now. 1-2 days post injection: fever, chills, elevated bpm, abdominal pain, join pain, muscle aches.
This spontaneous report has been received from a female patient of unknown age, who was reporting on herself. No information regarding the patient's pertinent medical history, concurrent conditions or concomitant medication was provided. On 28-MAY-2015 (reported as "a week ago today"), the patient was vaccinated with the first dose of ZOSTAVAX dose reported as "one time vaccine", lot#, expiry date, route of administration and injection anatomical location were unspecified. On 30-MMAY-2015, 48 hours after the vaccination, the patient experienced soreness, redness the size of a quarter or 50 cent piece. The patient's pharmacist recommended her to use BENADRYL 4 times a day. The soreness and redness started to get smaller and at the time of this report, it was 4 times a size. The patient sought medical attention. The relatedness between ZOSTAVAX and the events was unknown. Additional information is not expected as no contact details are available for the reporter.
Pt called pharmacy to inquire about fever after SHINGRIX shot--she started running the fever almost exactly 24 hours after her 2nd shot--Her fever is measuring at 103 degrees Fahrenheit.
pt recv vax & devel an exaggerated inj site rxn, described as cellulitis;
Stabbing pains in my head , arms, and torso.  Nausea.   Lasting two days.
PROQUAD instead of Varivax given to pt. along with the MMR and other above listed vaccines.
I have been on Junel 1/20 birth control for 5+ years and usually bleed extremely lightly and do not deal with cramping. Within a couple weeks after getting the first dose of Pfizer, I had the worst most painful and heavy period of my life, at a time when I do not usually get my period (two weeks into my birth control monthly pack). I experienced clots, back pain, extreme bloating, and severe bleeding for 9 or so days (my period usually lasts 3-5 days maximum). Once that ended, I dealt with bleeding after sex, and intermittent spotting for two months straight, for all of July and August. Then, I did not get my period AT ALL for September, October, and November during the placebo weeks of my birth control. Then in December 2021, I had again an extremely painful and heavy period with lots of bloating and breast tenderness during the placebo week when it normally should come. Now I am bleeding AGAIN only 2 weeks into my cycle, the bloating is OUTRAGEOUS (my entire uterus and lower belly feels inflamed and under pressure) and the flow is extremely heavy. I never had irregularity issues before the vaccine and now it has been six months and I am still dealing with the side effects. I have been taking my birth control at the exact same time every day as prescribed, have not missed doses, and have not had any other major life events since getting the vaccine. I have never tested positive for COVID-19 or believed that I contracted it.
Patient states after receiving flu shot, later that evening  her left hand (left arm is site of flu shot) began to tingle as if it were falling asleep, she states that during the day when she is using her hands its fine but when she about to go to sleep/evening times is when it really bothers her. It tingles and burns.
Pt was due for a bivalent booster. The medical assistant inadvertently administered the Moderna monovalent dose meant for 6-11 year olds (also labeled "booster doses only").
This is a spontaneous report obtained from a contactable nurse. A 17 year old male patient (ethnicity: other) received, on 08Nov2016, the first dose of TRUMENBA; (Lot. R65027, Expiration date: 30Sep2017, NDC number: 00050100-01) at 10:21 AM, intramuscularly, in the left deltoid, at 0.5 ml, single dose and the fifth dose of FLUZONE, (Lot. UT5598JA, Expiration date: 30Jun2017, NDC number: 49281-416-88) intramuscularly, in the right deltoid, at 0.5 ml, single dose, both for immunization. Relevant medical history includes seasonal allergy. The patient had previously received multiple flu shots and two doses of FLUMIST with no reaction. Family history included high cholesterol (father). Concomitant medications were unknown. On 08Nov2016, mother noticed notable swelling to both eyes, particularly the right eye. The patient also experienced high fever for 3 days accompanied by fatigue for 4 days with chills. Mother assumed it was an allergy and gave patient Claritin and treated fever with OTC medication, Tylenol. Nurse reported a possible allergic reaction to TRUMENBA. The patient recovered from the adverse events on an unspecified date, in Nov2016.
Sharp and constant chest pain on upper left side, shortness of breath, extreme fatigue. Symptoms began about 30 hours after second vaccine and lasted 5 days.
A couple of day later I started to have crohn's symptoms, going to the bathroom a lot and was one of them. I had an MRI and the doctor says it was clear. After 10 days I had a stomach ache I went to the hospital they did multiple CD scans and found out that I had a obstruction in my belly so I had small intestinal disease. I was hospitalized for 6 days and prescribed me steroids.
Marked swelling, redness and pain in both upper fingers.  Developed 6 hours after first set of immunization.  Patient received DTAP/IPV/HIB/PREVNAR/HEP B.  Swelling was over DTAP/PREVNAR.  Treated with cold pack/Tylenol
Swelling under arm (armpit) - 2 weeks; pain and discomfort; Headache- 1 week; Severe 1 day and mild for 6 days; Nausea - 1 week; unable to eat loss of 4 pounds; Heart pounding 1 night, shaking, cold chills
COUNSEL PATIENT. HE WAS GETTING IMMUNIZATIONS TO REGISTER FOR SCHOOL. HE GOT MMR AND VARIVAX. IT WAS THE SECOND DOSE FOR BOTH. MY TECH INPUTTED EVERYTHING CORRECTED. I PULLED AND MIXED ZOSTAVAX INSTEAD. I CHECKED THE BOTTLE LOTS AND EXP DATE BUT DID NOT REALIZE UNTIL I WAS FILLING OUT THE FORM THAT I ADMINISTERED THE WRONG VACCINE.
pt recvd vax;1 mo p/ dose 3, exp an elevated white blood cell count, abdo pain & fever
8cm x 8cm red raised area @ inj site lt deltoid;tender & warm-body aches-chills;
second dose scheduled 25 days after first dose; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (second dose scheduled 25 days after first dose) in a 23-year-old female patient 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) at an unspecified dose. On an unknown date, the patient experienced OFF LABEL USE (second dose scheduled 25 days after first dose). At the time of the report, OFF LABEL USE (second dose scheduled 25 days after first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product information reported.  No treatment medication information given.   Reporter did not allow further contact
Patient stopped by today as a walk in c/o developed rash and swelling over left arm after getting pneumonia shot yesterday. Denies any difficulty breathing or sob. No itchiness over the rash, but feeling burns. O/E: Alert and oriented, not in distress. VS: stable. Lungs: Clear CVS: S1 S2 regular, Abdomen: benign. CNS: no focal deficit: Skin: erythematous rash noted over left arm. A/P: rash left arm, due to reaction to PNEUMOVAX. Will put on MEDROL dose pack and BENADRYL prn. Outpatient Pneumococcal vaccine ordered. Patient received 0.5ml of pneumococcal vaccine IM at this encounter. Site: Lt. deltoid. Manufacturer: Merck Lot #: 1427Y Exp. date: 7/3/11. Symptoms: Symptoms: 1. Angioedema, 3. Paresthesia. Treatment Drugs Used: 1 - Methylprednisolone Dose: ud Units: Tab Freq: Every day Route: PO.
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    This case contains information for the 79th of 190 adult patients described by the reporter.  Concomitant Medication use information was not provided by reporter.  It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Treatment Medication use information was not provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:Master case