chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she was late for her menstrual period; The office did a urine pregnancy test on fue patient, which was positive; titers negative for mumps; This spontaneous report was received from a nurse prescriber concerning a 39-year-old female patient.  The patient concurrent conditions included multiple sclerosis and diabetes mellitus. The patient's drug reactions included hydromorphone hydrochloride (DILAUDID) (got urticaria and palpitations), latex (got urticaria), kiwis (got urticaria), ondansetron hydrochloride (ZOFRAN) (got urticaria). Concomitant therapies included empagliflozin (JARDIANCE), metformin hydrochloride (GLUCOPHAGE), clonazepam (KLONOPIN), amphetamine aspartate (+) amphetamine sulfate (+) dextroamphetamine saccharate (+) dextroamphetamine sulfate (ADDERALL TABLETS), gabapentin, tramadol hydrochloride (ULTRAM), atorvastatin calcium (LIPITOR), and natalizumab (TYSABRI).   On an unknown date during the patient's childhood, she was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA (M-M-R II) (lot # and expiration date were not reported) 1 dose, subcutaneously, for prophylaxis.   On an unspecified date, the patient became pregnant with a date of last menstrual period (LMP) of December 2019.   On 08-JAN-2020, she had titers drawn for the measles, mumps, and rubella diseases, which were negative for mumps (results came back on 13-AN-020) (mumps antibody test negative). Therefore, the patient was administered a measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA (M-M-R II) booster, lot # S013719 and expiration date 05-MAY-2021, 1 dose, subcutaneously on 17-JAN-2020 (Gestation period at exposure: 1 trimester). Immediately after the patient was administered the vaccine, she stated that "she was late for her menstrual period" (menstruation delayed). Hence the office did an urine pregnancy test on then patient, which was positive. The patient also had blood drawn for a beta human chorionic gonadotropin (hCG) test (the result was not reported). The patient was referred to her obstetrician/gynecologist (OB/GYN) for follow-up. Te outcome of the events mumps antibody test negative and menstruation delayed was reported as not recovered.   The causal relationship between the events and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA (M-M-R II) was not reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2001USA007135:
Approximately 1 hour post administration employee became very light headed and began vomiting she then had a series of 3 seizures.
Administer Expired Vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired Vaccine) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired Vaccine). On 15-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired Vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  The pharmacist reported about the administration of expired Moderna vaccine that was given as booster shot to patient. The vaccines was stored in freezer, which was taken out one to two vials and place in fridge each day as needed.  No treatment was given on the patient.
Site: Redness at Injection Site-Mild, Additional Details: About 5 min. after immunization, pt fainted, pt had pulse and breathing but high BP 180/89; paramedic were called & pt was take to ER. Per pt wife, he had history of fainting with injwection & blood tests. Also he has cardiovaculary disease and pacemaker. I recieved all these info after pt. faining; if I was informed prior; I would have recommended pt to recieve vaccination at hospital location.
About 10 min after the shot Patient developed hives and complained about throat pain. BENADRYL given, vomited some and half given back. Hives got slightly better but he still got throat pain. EPI PEN Jr given. Hives disappeared in 5 min and throat pain is gone. Watched Patient for another 30 min and D/C home in stable condition. In the future, all flu shots in allergy clinic.
24 weeks pregnant on date of vaccine. Fever spiking at 101.4 for 48 hours after vaccine. Came down with combo of cold shower and tylenol every 6 hours.
Tinnitus (buzzing sound) in both ears starting within 1 week of vaccine administration and persisting ever since
rash got worse; rash covering her arm to her elbow and part of her shoulder; still itchy; rash at the injection site; itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash at the injection site), VACCINATION SITE PRURITUS (itchy), RASH (rash got worse), RASH (rash covering her arm to her elbow and part of her shoulder) and PRURITUS (still itchy) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE RASH (rash at the injection site) and VACCINATION SITE PRURITUS (itchy). On 13-Feb-2021, the patient experienced RASH (rash got worse), RASH (rash covering her arm to her elbow and part of her shoulder) and PRURITUS (still itchy). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE RASH (rash at the injection site), VACCINATION SITE PRURITUS (itchy), RASH (rash got worse), RASH (rash covering her arm to her elbow and part of her shoulder) and PRURITUS (still itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medications included unspecified medications for blood pressure and cholesterol.  On 12-Feb-2021 she experienced a rash at the injection site that was itchy and on 13-Feb-2021 got worse, covering her arm to her elbow and part of her shoulder. It had been getting better every day and now is just a little pink but still itchy.
Erythema on right shoulder at injection site, red, itchy, 4 inches height x 3 inches wide, 8 days after given
Shortly after the shot I noticed an itching on both forearms, above and below the elbow crease.  Around 3:00 PM it worsened to redness, small bumps and itching.
Left arm start swelling at the injection site and down to the elbow  around 5:30pm; This is a spontaneous report from a contactable consumer reporting for herself.     A 47-years-old female patient  received  bnt162b2 (BNT162B2; Lot #Eh9899) vaccine, via an unspecified route of administration in the left arm  on 20Dec2020 10:00 at single dose for covid-19 immunisation .  Medical history included hypertension from an unknown date , migraine from an unknown date , partial seizures from an unknown date , intracranial aneurysm from an unknown date. Concomitant medication included spironolactone (SPIRONOLACTONE), hydrochlorothiazide, triamterene (TRIAMTERENE & HCTZ), estradiol (ESTRADIOL).  The patient was allergic to lisinopril , amlodipine , gentamicin sulfate; methylmethacrylate;polymethylmethacrylate;zirconium dioxide , zonisamide .  The patient  left arm start swelling at the injection site and down to the elbow  around 5:30pm with outcome of recovering.
Covid-19 Bivalent booster given instead of Moderna Covid-19 for second dose of primary series.
2/5 0200 woke with significant joint pain in elbows/hips/knees and slight headache, this lasted on an off throughout the day 2/5 1300 fever/chill/fatigue, significant headache 6/10, arm pain at injection site - could not lift arm over head, fever/chills abated within 3-4 hours, all other symptoms lasted throughout the night, wheezing 2/6 - symptoms worsened, migraine headache 8/10, muscle pain, joint pain in knees/hips/hands, became "foggy" and clumsy - bumping into things, cutting my hands 3x with knives while attempting to fix food, then decreased appetite, very fatigued, fever/chills that last a few hours through the night, wheezing 2/7 - migraine headache 7/10, join pain ongoing, still foggy and clumsy - confused at times, very fatigued, muscle pain gone, still trying to lay down, no appetite, wheezing is gone 2/8 - called off work, still foggy (but no longer clumsy), headache 6/10, joint pain stopped mid-afternoon, still tired most of the day (likely my body trying to recover), appetite returned 2/9 - able to return to work and feeling almost back to normal
Information has been received from a Registered Nurse concerning an 87 year old male patient with no pertinent medical history or drug reactions/allergies, who "last week" (on approximately 01-FEB-2011) at "around 9:30 am", was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (Merck) (Lot # unspecified). Concomitant therapy included "an antibiotic". The nurse reported that "last week" (on approximately 01-FEB-2011), the same day he received ZOSTAVAX (Merck) by 5:00 pm, the patient reported "feeling weak and light on his feet" and that also had tachycardia. No lab diagnostic studies were performed. Subsequently, "the following day" (approximately on 02-Feb-2011), the patient recovered from "feeling weak and light on his feet" and from tachycardia. The patient sought unspecified medical attention. Additional information has been requested.
BLOOD CLOTTING; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced blood clotting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clotting was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211128043-Covid-19 vaccine ad26.cov2.s-Blood clotting. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Vomiting about 11 hours after injection; diarrhea for remaining of day after vomiting
Fever, migraine, anxiety, light headedness, anxiety attack led to fast heart rate, shaking legs, feeling faint, menstrual cycle either missed or late by 3-4 weeks (not pregnant)
Muscle weakness, Hypertension that is not controlled with his regular antihypertensive meds, and light headedness (comes and goes). States that he has an appt with his doctor on the 5th. Recommended: he needs to be evaluated by a health care provider today. Can not wait for the 5th. 4/27-4/28 unable to reach
6:00 headache, exhaustion  7:30 chills/hot, skin sensitivity, headache, exhaustion  Headache and exhaustion  have lasted 2 days. Chills/hot and skin sensitivity were only the night of the vaccine.
Rash on vaccine arm (left) and underarm - lasted ~5 days given antihistamine by RPh.
Patient developed a rash at injection site and got larger over time. Rash reached her elbow, was itchy and burned. Was a little hard and swollen.
Anaphylactic shock; Initial information was received on 30-Dec-2020 regarding an unsolicited valid serious case from a consumer/non-health care professional (patient).  This case involves a female patient (age unspecified) who had an anaphylactic shock, after she received INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date in 2011, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious anaphylactic shock (unknown latency), following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  As a result of this, she had been advised not to take the pneumonia shot, shingles shot, flu shots, in case they contain a common element that was present in the 2011 flu shot. Her question was simply due to the fact that she was afraid to take any further vaccines, especially the Coronavirus disease 2019 (COVID-19).  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 not reported.  Information on batch number was requested for this case.; Sender's Comments: This case concerns a female patient (age unspecified) who had an anaphylactic shock after vaccination with INFLUENZA VACCINE, produced by unknown manufacturer. The time to onset is unknown. Additional information regarding medical history, condition at the time of vaccination and lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
1st dose leaked on patients arm after administering; This spontaneous case was reported by a physician and describes the occurrence of INCORRECT DOSE ADMINISTERED (1st dose leaked on patients arm after administering) in a female patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (1st dose leaked on patients arm after administering). At the time of the report, INCORRECT DOSE ADMINISTERED (1st dose leaked on patients arm after administering) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
R upper arm + swelling + redness + pain + itching Prednisone taper, BENADRYL, DARVOCET N 100.
Fever 101.4.  Body aches; chills; extreme weakness. No appetitive.   Severe headache with second dose.
Extreme headache from temples all the way down to base of skull Muscle soreness in back and neck
I have a rash on my arm and all over my chest and stomach; This is a spontaneous report from a contactable consumer or other non hcp (patient).   A patient of unspecified age and gender received bnt162b2 (BNT162B2, solution for injection), dose 2 via an unspecified route of administration on 02Aug2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (BNT162B2) via unspecified route of administration on 12Jul2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient experienced i have a rash on my arm and all over my chest and stomach on an unspecified date. The clinical course was reported as follows consumer started, "I got the second Pfizer shot yesterday and I have a rash on my arm and all over my chest and stomach. I just wanted to report that and I don't know if that is common or what's the 'deal with that', what's with the rash?". Consumer stated, "I did it exactly the way they told me. My second shot was on 02Aug and my first shot was 3 weeks before that. The first one was 12Jul (Confirmed as 12Jul2021)." The outcome of event was unknown  Information on the lot/batch number has been requested.
I had fever; shakes; fatigue; body aches; headaches; sore throat and nasal dripping which are still and I was treat with IV   monoclonal antibodies.
Hypotensive.  Dizzy and sweating.  pulse 52 hr @ 12:46, BP 110/40.  12:51 BP 90/50.  12:54 BP 96/60.  1:00pm BP 108/68.
Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 19-MAR-2022 14:17; Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 19-MAR-2022 14:17; This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 19-MAR-2022 14:17) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 19-MAR-2022 14:17) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2022 at 2:17 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 19-Mar-2022 at 2:17 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 19-MAR-2022 14:17). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 19-MAR-2022 14:17). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 19-MAR-2022 14:17) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 19-MAR-2022 14:17) outcome was unknown.        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. Vaccine administration time was reported as 14:17:37. Patient received booster dose. The patient received moderna vaccine past its 30 day of expiry date. Vaccine went into 2 to 8 degree Celsius thaw state on or about 24-Dec-2021. This vaccine was administered up until its manufacturing expiry date of 04-Apr-2022. We no longer possess this lot number. No treatment information was provided.
Fever > 101, irritability, generalized muscle soreness, crying, stating  "I feel so bad", sore throat.
Very sore arm with puffiness and rash. Injection area was warm and throbbing. Second day- leg, back and muscle ache. Stomach ache and feeling very tired with loss of appetite.
8/15 by evening left upper arm was swollen and extremely painful. Took 1000mg acetaminophen and applied ice. Kept ice on all night. 8/16 general malaise, headache, queasy stomach. Took 2 more acetaminophen. Kept ice on all day. 8/16 decided to try B-12 complex sublingual liquid, 1 ml, at lunch time to try to feel better. It seemed to help. (Would have gone to doctor if it had not!). 8/17 repeated B-12, 1 ml at noon. 8/17 feeling a little better less soreness in arm. Began to feel tender skin spots on head; also had mild stiff neck. 8/18 headache and tender skin on head. 8/18 headache. Tender skin spots gone. 8/19 symptoms gone. Note: I only had mild soreness in upper arm when I had first shot, that is normal for me. I decided to report it because it was unusual for me to have that much pain after a shot. It had me concerned enough that I never even thought to take my temperature. If B-12 hadn't helped, I would have gone to E.R.
another GARD A SIL 9 was given at another pediatric office on 28 FEB 2020/third dose today 17 SEP 2020.; third dose today 17 SEP 2020/another GARD A SIL 9 was given at another pediatric office on 28 FEB 2020; This spontaneous report was received from a medical assistant referring to a 13 years old male patient. The patient's pertinent medical history, concomitant therapy and concurrent condition were not provided.  On 25-OCT-2018 and 19-SEP-2019, the patient was respectively vaccinated with the first and second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose detail, strength, route, lot# and expiration date were not provided) for prophylaxis. On 28-FEB-2020, the patient received another dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose detail, strength, route, lot# and expiration date were not provided) at another pediatric office (inappropriate schedule of product administration). On 17-SEP-2020, the patient was accidentally vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (1 time vaccine dose in a 3 dose regiment, lot# 1637642, expiration date 28-MAY-2022; route and strength were not provided) (extra dose administered). The outcome of inappropriate schedule of product administration and extra dose administered was unknown.   combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: 1637642; expirationdate: 28-MAY-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Pt unknowingly pregnant at time of vaccination - estimated date of conception 13 Feb 2015 per ultrasound from 30 Mar 2015.