chrisvoncsefalvay/vaers-outcomes huggingface dataset:
is dizzy; don't fell well; without appetite; very "tired"; fever; body aches; fever did not drop below 100.4/100.2; headache; burning eyes; feel bad; This spontaneous case was reported by a consumer and describes the occurrence of EYE IRRITATION (burning eyes), FEELING ABNORMAL (feel bad), DIZZINESS (is dizzy), MALAISE (don't fell well) and DECREASED APPETITE (without appetite) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced EYE IRRITATION (burning eyes), FEELING ABNORMAL (feel bad), HEADACHE (headache), PYREXIA (fever), MYALGIA (body aches) and PYREXIA (fever did not drop below 100.4/100.2). On 22-Apr-2021, the patient experienced DIZZINESS (is dizzy), MALAISE (don't fell well), DECREASED APPETITE (without appetite) and FATIGUE (very "tired"). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, EYE IRRITATION (burning eyes), FEELING ABNORMAL (feel bad), DIZZINESS (is dizzy), MALAISE (don't fell well), DECREASED APPETITE (without appetite), HEADACHE (headache), FATIGUE (very "tired"), PYREXIA (fever), MYALGIA (body aches) and PYREXIA (fever did not drop below 100.4/100.2) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Apr-2021, Body temperature: 100.4.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported.
While grabbing Covid orange vial I opened commercial fridge. Bivalent and monovalent boxes were right next to each other. Bivalent box was open so assumed that was the monovalent. Put in the lot number in lot manager and did not notice it said "Booster" since I had other vaccines to administer as well. Tried to pre-chart for the patient and did not understant why I could not find the lot number that I had just applied in lot manger. I assumed I had made a mistake in lot manager and had not put it in correctly. I administered vaccine. I then called our Primary Care nuse, and she was the one that informed me I had accidentally grabbed the bivalent instead of the monovalent. Everyone was then informed.
Severe malaise for 5 days, fever with chills 48 hours, headache for 36 hours, shortness of breath 4 days, hard grapefruit size lump on injection site, generalized muscular pain x e days
Chest pressure  and night of vaccine. Intermittent until strong intensity on 25SEPT21. Labored breathing and shakiness additional symtom.
Daughter received an unknown flu vaccine and experienced arm pain; This spontaneous case was received on 26-Apr-2021 from other non-health professional via Communications (reference number: SEQW21-01228) and concerned a female patient of an unspecified age.  The patient's medical history and concomitant medications were not reported.   On an unspecified date, the patient was vaccinated with influenza virus vaccine polyvalent (brand not specified; dose, route of administration, anatomical location and indication: not reported). The batch number was not reported.  On an unspecified date, an unknown amount of time after receiving influenza virus vaccine polyvalent, the patient experienced arm pain.   The outcome of the event 'pain in arm' was not reported.   The patient did not provide a causality assessment.   This case is linked to case 202102297 and 202102299 (the same reporter).  Company comment: A female patient of an unspecified age developed pain in extremity after vaccination with the suspect product, influenza virus vaccine polyvalent. There is lack of information regarding the vaccination date and event onset date. Therefore, chronology is unassessable. Anatomical location of vaccination and event location was not clearly reported. Information regarding the underlying medical history, related diagnostic findings and concomitant medications has not been provided. Due to lack of information, causality for the reported event is unassessable.; Sender's Comments: A female patient of an unspecified age developed pain in extremity after vaccination with the suspect product, influenza virus vaccine polyvalent. There is lack of information regarding the vaccination date and event onset date. Therefore, chronology is unassessable. Anatomical location of vaccination and event location was not clearly reported. Information regarding the underlying medical history, related diagnostic findings and concomitant medications has not been provided. Due to lack of information, causality for the reported event is unassessable.
Site: Itching at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Patient stated that she got flu shot 10/20 and then the next day had a 99.8 degree (F) fever and then fever went away 10/22 but then she had worsening shortness of breath and increased sputum and coughing.  Patient was put on azithromycin course along with a 4-day steroid course and she got worse and then was put on doxycycline and another steroid course (this time prednisone 40 mg x 4 days, 30 mg x 4 days, 20 mg x 4 days, then 10 mg x 4 days). Patient stated she is currently feeling 75 to 80 percent better and is "not as short of breath as I was 2 weeks ago".
died in her sleep anaphylactic reaction; complete failure of the cardiovascular system; This is a spontaneous report from a contactable consumer (patient's friend). A female patient of unspecified age received the dose of BNT162B2 (COMIRNATY solution for injection; batch/lot number not reported), via an unspecified route of administration on an unspecified date (at an unspecified age) at dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, 7 hours after the vaccination (also reported as 10 hours after the vaccination), the patient died in her sleep due to anaphylactic reaction. It was determined as a complete failure of the cardiovascular system. The patient's husband tried to wake her up. The patient was put on life support but did not make it. The patient died on that night, on an unspecified date, on that bed. The patient's husband went to pick her up, but the patient was cold. It was unknown if autopsy was done. Outcome of the events was fatal.   No follow-up attempts are possible; Information about the batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: complete failure of the cardiovascular system; died in her sleep anaphylactic reaction
started getting headaches everyday; the injection site was hurting; Injection site swollen, about 3 inches long on the arm; Injection site red; Injection site warm; Injection site Itchy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (Injection site warm), VACCINATION SITE PRURITUS (Injection site Itchy), HEADACHE (started getting headaches everyday), VACCINATION SITE PAIN (the injection site was hurting) and VACCINATION SITE SWELLING (Injection site swollen, about 3 inches long on the arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Injection site warm), VACCINATION SITE PRURITUS (Injection site Itchy), VACCINATION SITE PAIN (the injection site was hurting), VACCINATION SITE SWELLING (Injection site swollen, about 3 inches long on the arm) and VACCINATION SITE ERYTHEMA (Injection site red). On an unknown date, the patient experienced HEADACHE (started getting headaches everyday). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Injection site warm), VACCINATION SITE PRURITUS (Injection site Itchy), VACCINATION SITE PAIN (the injection site was hurting) and VACCINATION SITE ERYTHEMA (Injection site red) had not resolved and HEADACHE (started getting headaches everyday) and VACCINATION SITE SWELLING (Injection site swollen, about 3 inches long on the arm) 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.   Treatment medication included Tylenol about 3 times a day. The patient put ice and warm compress on the injection site.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: follow up received on 28-Apr-2021 included No new information was received.
Patient went to the ER on 5/28/2021 after 2 weeks of calf pain, found t have DVT/PE
FEELING BAD; LAZY; SLEEPY; This spontaneous report received from a consumer concerned a 41 year old male. The patient's height, and weight were not reported.  The patient's past medical history included rheumatic fever, and concurrent conditions included non alcoholic, and non smoker, and other pre-existing medical conditions included patient have no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 13-APR-2021, the subject experienced lazy. On 13-APR-2021, the subject experienced sleepy. On an unspecified date, the subject experienced feeling bad. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lazy, and sleepy, and the outcome of feeling bad was not reported. This report was non-serious.
Moderna Covid 19 Bivalent 0.25mL, instead of 0.5mL to our adult patients.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Moderna Covid 19 Bivalent 0.25mL, instead of 0.5mL to our adult patients.) 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) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Moderna Covid 19 Bivalent 0.25mL, instead of 0.5mL to our adult patients.) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Moderna Covid 19 Bivalent 0.25mL, instead of 0.5mL to our adult patients.) 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 ACCIDENTAL UNDERDOSE (Moderna Covid 19 Bivalent 0.25mL, instead of 0.5mL to our adult patients.).    Concomitant medications were not provided. Treatment medications were not provided.  This case was for second patient of 9 patients reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-660845, US-MODERNATX, INC.-MOD-2022-666770, US-MODERNATX, INC.-MOD-2022-666771, US-MODERNATX, INC.-MOD-2022-666772, US-MODERNATX, INC.-MOD-2022-666773, US-MODERNATX, INC.-MOD-2022-666774 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-660845:Patient 1 US-MODERNATX, INC.-MOD-2022-666770:Patient 7 US-MODERNATX, INC.-MOD-2022-666771:Patient 4 US-MODERNATX, INC.-MOD-2022-666772:Patient 5 US-MODERNATX, INC.-MOD-2022-666773:Patient 6 US-MODERNATX, INC.-MOD-2022-666774:Patient 8
Arm was soar as expected. Armpit started getting tender half way through the day on the day after shot. Thought perhaps pulled muscle somehow even though I was testing the arm. Soreness continued to increase. Took Tylenol before bed. Woke up on day three to swollen armpit that is very tender when arm is jostled at all. It is still day three so I have not done anything about it. Will just continue to rest arm, ice occasionally, and take Tylenol.
Information has been received from a medical assistant referring to a 9 years old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy were not reported. On 11-JUL-2017, the patient was vaccinated with the third dose of GARDASIL 9 (lot # N002720, expiration date 12-MAY-2019)  (dose, route of administration and anatomical location were not reported) for prophylaxis. The administered doses of vaccine was exposed to a temperature excursion between 46.8 degrees Fahrenheit (F) which lasted for a 18 hours and 59 degrees Fahrenheit (F) which lasted for 65 hours on 13-JUN-2017. There was 59F previous temperature excursion for 4 hours. Data logger was used to track the temperature. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA005381: US-009507513-1707USA010591: US-009507513-1709USA012722: US-009507513-1709USA012723: US-009507513-1709USA012724: US-009507513-1709USA012726: US-009507513-1709USA012727: US-009507513-1709USA012728: US-009507513-1709USA012729: US-009507513-1709USA012730: US-009507513-1709USA012731: US-009507513-1709USA012732: US-009507513-1709USA012733: US-009507513-1709USA010537: US-009507513-1709USA012774: US-009507513-1709USA012777: US-009507513-1709USA012776:
Left deltoid area with redness and warmth from shoulder area down to 2" above elbow. None painful.
Dysphora lose of appetite unable to preform routine work tasks unstable on feet unable to drive safely removed from work position
Pt recvd 1 dose of Engerix-B & exp inc numbness in hands; pt is being screened for MS;
Client vaccinated with Moderna Covid 19 vaccines on January 15 and February 12, 2021.  Tested PCR positive for Covid with symptoms (runny nose, cough) on 7/7/2021.  Symptoms started on 7/6/2021.  Reported because client was vaccinated and tested positive for Covid more than 2 weeks post vaccination.
Patient received HPV dose 1, left deltoid, IM. After receiving the vaccine the patient had a syncope episode.
Breast pain; underarm pain; This spontaneous case was reported by a consumer and describes the occurrence of BREAST PAIN (Breast pain) and AXILLARY PAIN (underarm pain) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid nodule (Graves with thyroid Nodules) since 1999, Graves' disease (Graves with thyroid Nodules) since 1999 and Varicose veins since 2019. Concomitant products included VIT D [VITAMIN D NOS], MULTIVITAMINS [VITAMINS NOS], FEXOFENADINE HYDROCHLORIDE (ALLEGRA) and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.   On 04-Feb-2021 at 3:40 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021 at 10:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced BREAST PAIN (Breast pain). 05-Mar-2021, the patient experienced AXILLARY PAIN (underarm pain). In 2021, BREAST PAIN (Breast pain) and AXILLARY PAIN (underarm pain) had resolved.            No treatment medications were reported.   This case was linked to MOD-2021-039741 (Patient Link).
This spontaneous report as received from a female doctor of pharmacy of unknown age reporting on herself. On an unknown date, the pharmacist while attempting to withdrawal reconstituted ZOSTAVAX (dose, route, lot number not reported) the vial leaked and product got on her hands. No adverse effect reported. PQC filled. Additional information is not expected.
Chills! I believe I may of had a 24 hr flu of some sort and talked to the health nurse about this.
Pt with pmh shown below presents with a left nosebleed on and off since yesterday. Pt has a perforated septum and low platelets at baseline and reports chronic nose bleeding. No other symptoms reported. ED visit within 6 weeks of receiving the COVID vaccine.
After administration of HPV in left arm patient just looked straight ahead. I asked patient if she felt light headed and she said yes. I had her lay down. She did not have any loss of consciousness. Upon laying down she stared straight ahead. Her Uncle was asked to come back to the room and Dr. was brought into the room to exam patient. I asked her to tell me her name, where she was, why she was here. She slowly answered all questions appropriately. At that time she had left arm twitching that lasted about 6-7 minutes. All vitals with in normal limits. 911 was called due to starring, delayed speech and left arm twitching that did not stop. Once ambulance arrived patient's arm twitching had stopped, she was sitting up and able to answer all questions appropriately with out and any delay. Escorted to hospital by ambulance. Called to see patient about 5 mins after HPV injection. When I entered room, patient was supine on the bed, staring with LUE shaking. She responded in a slurred voice to questions but answered correctly. No eye deviation, but appeared to be staring, ? left mouth drooling. She was able to squeeze right UE but left was weaker. Uncle in the room had never seen this prior. No recent illnesses per uncle. On phone conversation her aunt denies any previous seizure history or pseudoseizure. No new medications. Complex psych history and social situation. Reviewed last WCC. VSS as below (HR 76, O2 96%, BP as below) entire event were stable. LUE twitching continued > 6 minutes. Due to decreased LOC and continued shaking, EMS was called. On their arrival she was alert and shaking had stopped. She stated "what happened?" but then could relay events. No weakness and normal neuro exam otherwise she was tearful. Reviewed events with aunt, via phone and also EMS. DDX - pseudoseizure vs partial seizure vs stress event. Referred to ED for further care given change in LOC, via ambulance.
SKIN SLIGHTLY TENDER TO TOUCH; SWELLING IN THE LEFT ARMPIT AROUND LYMPH NODE AREA; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's past medical history included gallbladder removal, and ovary removal, and concurrent conditions included allergy to dust mites, consumes alcohol- couple of glasses of wine per week, and non-smoker, and other pre-existing medical conditions included the patient had no history of drug abuse/ illicit drug use.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 around 13:30 to left arm for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced swelling in the left armpit around lymph node area. On an unspecified date, the subject experienced skin slightly tender to touch. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling in the left armpit around lymph node area, and the outcome of skin slightly tender to touch was not reported. This report was non-serious.
This spontaneous report as received from a medical assistant refers to a 21 year old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a pediatric dose of VAQTA, 0.5 ml (frequency, route of administration and anatomical location of administration were not reported) lot # M039202, expiration date 11-MAR-2018, for prophylaxis. No adverse effects were reported. Product quality complaint was not involved. Additional information has been requested.
Erythema multifore, diffuse erthematic pinpoint papular rash on hands, arms, legs, thighs, trunk, back. Erythematic plaques bilateral cheeks, right ear lobe. 8 cm circular erythematic wheal with central clearing on left deltoid at site of injection. Erythematic plaque on left elbow.
11:30am pt passes out immediately after injection. Required consciousness within 30 secs. Ice pack paled on his neck and given water to drink, sat for 10 minutes. Pt returned to work.
Patient reports that about a week receiving the two vaccines in the same day she started experiencing a loss in upper arm strength and upper leg strength.  It has not recovered and it has been six weeks.
I was diagnosed with Shingles - sores on head and face moving towards my eye. Doctor is hoping that it doesn't move into my eye and start causing issues there. Headache behind right eye and extreme fatigue. Taking Valtrex and tylenol/ibuprofen for pain management.
Received Yellow Fever Vaccine (Lot UF 583 AA EXP 15 APR 10) around 4:15 pm on Monday August 24, 2009.  Around 8:45 pm that evening my throat started closing up (reaction level about a 7 on a 10 scale of severity) --- in a manner similar to past experiences with food allergies.  Food intake prior to reaction was entirely normal.  I took 1 Benadryl 25mg tablet and when my throat failed to respond I took a second Benadryl and received relief.  The next morning I could feel a slight continuing throat closure sensation --- but not enough to justify further Benadryl intake.
rash like hives white w/red surrounding-area itches-relieved w/topical lotion; no fever,  muscle tenderness, swelling; denies contact w/irritant; BY 16MAY94 was drying w/tiny scabs present
19 y/o wm ADSM presents as a referral from WAMC ED for skin rash after multiple vaccinations, including primary SPV.  Symptoms: rash, diffuse, pruritus, lesions, patch.  11/09/09:  Medical record received for date of service 10/26/09.  Vaccination record also received.  Dx:  Skin disorder exanthem. Assessment:  Presents with c/o rash.  Pt. has several small acne-like pimples scattered about on the forearms, calves, thighs and back.  The left elbow is significant for hypertrophied.  Scaly area of skin with associated macerated areas and signs of superficial, secondary infection.  The removed bandage was noted to have darkish, purulent material adhering to it.