chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recv vax 25JAN99 in AM & mom reported pt devel low grade fever 99-100 in evening of 25JAN99;c/o h/a;given APAP;26JAN99 early AM fainted in kitchen;father caught pt before hit the floor;did no LOC;taken to bedroom;MD not called;low fever;
1.Malaise and left arm pain after the vaccination from the day of administration till 2 months later 2.Palpitations and jitteriness from 2 months after the vaccine lasting for more than 4 months. Had to have tests carried out by cardiologist and was started on a beta blocker medication.
Headache the night of the shot - took Advil.    Awoke at 2 a.m. with body aches everywhere on my body.  Took Ibuprofen.   All day that day (which was the day after the shot)  had severe body aches and temperature was a high of 100.9.  Also very tired.    Took ibuprofen during the day.   Symptoms subsided somewhat by 7 p.m  Woke up the next day with just a slight headache and body aches are gone.
Systemic: felt like was about to pass out or faint, but didn't, tunnel vision-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Severe, Systemic: Visual Changes/Disturbances-Medium, Additional Details: at12:12pm pt felt dizzy and faint and was sweating, bp1:12:22pm 117/38 pulse 79, bp2:12:30pm 97/53 pulse 51, bp3: 12:39pm 95/61, bp4: 106/69 pulse 49 at 12:46pm. pt left at 12:50pm advised not to drive had daughter driv ehim home
Information has been received from a literature article concerning a 22 year old female patient developed uveitis and papilledema, following administration of GARDASIL. The patient had as a pre-existing conditions elevated free T3. A total of 24 cases of uveitis occurred following administration of GARDASIL; the gender in all cases was female. The median age was 17. The median time from vaccination to onset of ADRs was 30 days; time to onset was unknown in 1 case; the time to onset in this case was of 36z days from vaccination. There was one reported rechallenge of the GARDASIL vaccine. In 13 of the 24 cases other ocular side effects were noted including 3 case reports of papillitis, 2 case reports of retinitis and 1 case report of papilledema. Systemic side effects were noted in 9 of the 24 cases and included 3 cases of arthralgia. In 2 case reports multiple vaccines were administered simultaneously. The ocular findings of papilledema and papillitis may be confounded by pre-existing conditions (sarcoidosis, cat scratch disease and Behcet's disease) known to affect the optic nerve in 3 case reports. According to World Health Organization Causality Assessment Guide of Suspected Adverse Reactions, the relationship between human papilloma virus vaccination and uveitis was "possible". Causality assessments are based on the time relationship of drug administration, uveitis development and rechallenge data. This is one of several reports form the same literature source. Additional information has been requested.
Diagnosis with Pratatsisi,  Epididymitis -virus with bladder infection which was a new health condition after the vaccination. Urination of blood within a week or two post vaccination, other side effects included,
4 days following the booster, Patient woke up itching on his legs, arms, chest and back.  Upon looking in the mirror he saw hives / bumps on his skin.  He took an antihistamine which reduced the itching.  On January 2, he went to see a DR who prescribed a short regiment of antibiotics.  After 3 days no change and saw the doctor again and was given a longer- term antibiotic regiment.  Conditions improved but when the regiment was done, hives still appeared.  He had subsequent allergist appointments and was told to take a daily regiment of zertec.  He is still experiencing the hives.  They can appear suddenly on his face and disappear as quickly as they appeared.
felt the injection needle pinch his arm.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (felt the injection needle pinch his arm.) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Nov-2021, the patient experienced VACCINATION SITE PAIN (felt the injection needle pinch his arm.). At the time of the report, VACCINATION SITE PAIN (felt the injection needle pinch his arm.) outcome was unknown.            No Concomitant information was reported. No Treatment information was reported.   This case was linked to MOD-2022-509755, MOD-2022-509786 (Patient Link).
Day after vaccine given site was black and blue, next day red and swollen about 2 inches diameter, tender. Patient took Sudafed.
This spontaneous report as received from a registered nurse refers to unspecified number of patients. On unknown dates, the patients were vaccinated with M-M-R II (lot #, dose, route not reported), which were exposed to 31F over at least 10 days in a physician's office. The reporter stated that the physician's office has twice told her that no vaccines were administered, but then told her that there were, however, she had not specified patient information or dates of administration. No adverse effect was reported at the time of report. This is one of several reports received from the same source. Additional information has been requested.
Flu-like symptoms: achy, headache, chills, difficulty getting out of bed.
pt w/hx of varicella exposure recv w2 doses of vax 1APR97 & 21JAN98 pt lab results indicated a lack of seroconversion;
Patient presented to the ED on 4/23/21 and was subsequently hospitalized for Acute on chronic respiratory failure with hypoxia and hypercapnia. Patient presented to the ED on 5/5/21 and was subsequently hospitalized for hypertensive urgency and CVA. Patient died on 5/9/21.
Visual disturbance in lateral visual field of right eye.  Posterior vitreous detachment initially evaluated in the Emergency Room,  on April 12, 2021 and subsequently diagnosed by  Ophthalmology Department  on April 13, 2021.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 34.01 Years.   Concomitant products were not provided.   On 03-Apr-2021, Excursion time was 09:00 AM, temperature was 34,   total doses given for the day was 210, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 30-Mar-2021, vial was moved to clinic on 03-Apr-2021. 20 vials were sent to clinic. Vaccine BUD date was 29-Apr-2021.   On 03-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 38, 9 AM: 34, 10 AM: 38, 11 AM: 42, 12 AM: 41, 1PM: 41, 2 PM: 41, 3 PM: 40, 4 PM: 40 and 5 PM: 41.   The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.   Temperature recordings were taken using a traceable temperature monitor at every hour.   After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.   It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.   Treatment medications were not reported.
Seizures times 1 for 10 seconds. Fever for 2 hours; acetaminophen. Ceftriaxone 50np/kg, 295 mp IV 24 hours. CBC, blood c/s.
This spontaneous report was received from a physician regarding a 67 year old female patient. Previously patient had PNEUMOVAX23 vaccination with no reaction. Drug allergies and reactions were unknown. On 06-JUL-2016, the patient was vaccinated with PNEUMOVAX23 (lot # L035687/expiration date 16-FEB-2017, 0.5 ml/one time, intramuscular in the left arm (also reported-Pheunomia). Concomitant therapies included Lambisil AT, calcium, PREVENTOL G-D, levothyroxine sodium (manufacturer unknown) SINGULAIR, probiotics, albuterol and vitamin d. On an unknown date in JULY 2016, the patient experienced inflammation and swelling at injection site. Treatment was given for the adverse event. No laboratory diagnostic tests were performed. Patient sought medical attention. No PQC (product quality complaint) was involved. Action taken with PNEUMOVAX23 was reported as discontinued. The outcome of inflammation and swelling at injection site was reported as resolved. Additional information has been requested.
Chills, fever, headache, severe body aches. Onset of symptoms was 12 hours after receiving dose, lasting 24 hours from onset. Treated symptoms with Tylenol, ibuprofen and aspirin. Minimal response from medication.
Pt reported having seizures post vaccination & going to the ER. Admitted for observation 1 day in the hospital.
Information was received on 29-JUN-2017 from a pharmacist who reported that on 28-JUN-2017 an unspecified patient (age and gender not reported) was given an expired dose of VARIVAX (lot# L023587, expiration 26-JUN-2017) (dosage not reported). Pharmacist reported that sterile diluent (lot# M013638, expiration 19-NOV-2018) used to reconstitute the VARIVAX was not expired. No adverse effect reported. No additional information was provided. No contact information was provided for the reporter or patient. Additional information is not expected.
NAUSEA, HEADACHE, FEVER, CHILLS AND NECK PAIN.
Patient never tested for covid-19 prior to vaccination. Symptoms of stuffed and running nose and small rash may be related to covid-19, cold or flu, or the vaccine.  What affect the vaccination will have, if any, on the patient's condition is unknown.
Vaccine frozen rather than refrigerated. Dose administered. Offered revaccination. Recently had new booster, no revax
The shot was not given in the muscle but higher in the shoulder joint.  It has caused and is still causing  pain in my shoulder as of today May 9th.
Patient stated after  15 minutes of getting vaccination and stated she felt like she felt light headed, felt like head and tongue were swollen, but they didn't appear to be swollen. Speech was clear. Treated with 25mg benadryl po and monitored for 45 minutes and patient stated symptoms resolved.
Awoke from sleep at 1am to uncharacteristic nausea and indigestion. Went back to sleep at 5am. Awoke at 9am and soon after began to have chills. Fever to 102F and severe body aches for the rest of the day until 2am the next morning.
p/vax pt c/o every ligament in legs & upper thighs felt like had been stretched out;also exp soreness, pain, stiffness in shoulders;pt sought unspecified med attention;
Low Grade Fever, Chills, Aches (concentrated in back, neck, shoulders), Headache, Congestion, Fatigue, Sore Arm  First Shot: generated sore arm, mild aches and then had inflammation 6 days later at injection site (redness, swelling, heat) got itchy and went away 5 days later
osteoporosis in both hips; Vaccination site swelling/ after taking Moderna booster shot for covid experienced some swelling; Vaccination site pain/ after taking Moderna booster shot for covid experienced some soreness; This spontaneous case was reported by a patient and describes the occurrence of OSTEOPOROSIS (osteoporosis in both hips), VACCINATION SITE SWELLING (Vaccination site swelling/ after taking Moderna booster shot for covid experienced some swelling) and VACCINATION SITE PAIN (Vaccination site pain/ after taking Moderna booster shot for covid experienced some soreness) in an 83-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 Rheumatoid arthritis.    No known allergies.  Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe). Concomitant products included METHOTREXATE from an unknown date to August 2021 for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Aug-2021, received third 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) Citrate Free. On 24-Aug-2021, the patient experienced VACCINATION SITE SWELLING (Vaccination site swelling/ after taking Moderna booster shot for covid experienced some swelling) and VACCINATION SITE PAIN (Vaccination site pain/ after taking Moderna booster shot for covid experienced some soreness). In October 2021, the patient experienced OSTEOPOROSIS (osteoporosis in both hips). The patient was treated with DENOSUMAB (PROLIA) at an unspecified dose and frequency. On 27-Aug-2021, VACCINATION SITE SWELLING (Vaccination site swelling/ after taking Moderna booster shot for covid experienced some swelling) and VACCINATION SITE PAIN (Vaccination site pain/ after taking Moderna booster shot for covid experienced some soreness) had resolved. At the time of the report, OSTEOPOROSIS (osteoporosis in both hips) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2021, Bone densitometry: Osteoporosis in both hips.         It was unknown if patient was enrolled in COVID-19 vaccine trial.  The reporter's causality for the events of after taking Moderna booster shot for covid experienced some swelling and soreness onset 24Aug2021 and osteoporosis in both hips was not provided with Humira(adalimumab).  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   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2022: Follow-up received, event added, lab data , co suspect information and treatment drug updated.
No additional adverse effects reported; A nurse states that on 04/21/2020 an improperly stored expired VARIVAX was administered to a patient; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications ere not reported.     On 21-APR-2020, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # S005077 with expiration date 21-FEB-2021, for prophylaxis (dose, route of administration and anatomical location were not reported). No adverse effects were reported. It was stated that the vaccine was exposed to a temperature excursion of 50 Fahrenheit degrees for 40 minutes. No previous expiration date was reported. A digital data logger was involved.
Reported hives beginning 24 hours post vaccination.Starting on forehead and spreading gradually over entire face and under her chin. Reported mild itching. The hives gradually faded after three days. Denied SOB, trouble swallowing, horseness or wheezing, paleness, weakness fast hertbeat, or dizziness.
blood clot on right leg (she is now on blood thinners); swelling in face and tongue; swelling in face and tongue; This is a spontaneous report received from a contactable reporter (Consumer or other non- HCP) from medical information team. An 85-year-old female patient received bnt162b2 (COMIRNATY), administration date Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROMBOSIS (medically significant) with onset 2021, outcome "unknown", described as "blood clot on right leg (she is now on blood thinners)"; SWELLING FACE (non-serious), SWOLLEN TONGUE (non-serious) all with onset 2021, outcome "unknown" and all described as "swelling in face and tongue". The events "blood clot on right leg (she is now on blood thinners)", "swelling in face and tongue" and "swelling in face and tongue" were evaluated at the physician office visit (consulted primary care physician, her thyroid specialist and two other doctors). Therapeutic measures were taken as a result of thrombosis included blood thinners.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient experienced tingling in her fingers and numbness of the vaccinated arm. Tingling stopped after 24 hours and numbness lasted for 2 days.
since Friday morning has had an elevated heart rate; This is a spontaneous report from a non-contactable consumer reported for an adult female patient (lady friend). An unspecified age adult female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection Lot number was not reported) via an unspecified route of administration on 11Mar2021 as dose 1, single for COVID-19 immunisation. The patient medical history included breast cancer survivor from an unknown date and unknown if ongoing he is a breast cancer survivor, has numerous allergies and perhaps also an autoimmune disease, numerous allergies from an unknown date and unknown if ongoing he is a breast cancer survivor, has numerous allergies and perhaps also an autoimmune disease, autoimmune disease from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. On an unspecified date in Mar2021, the patient experienced since Friday morning has had an elevated heart rate. The patient underwent lab tests and procedures which included heart rate resulted as elevated heart rate on an unknown date Mar2021 since Friday morning has had an elevated heart rate. The clinical outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Fever to 104 from day 5 to day 14 and continuing after vaccination.  No other symptoms other than mild fatigue
Rash warm to the touch; Had a rash; Felt a bump; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Felt a bump), VACCINATION SITE WARMTH (Rash warm to the touch) and VACCINATION SITE RASH (Had a rash) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036a21a) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced VACCINATION SITE MASS (Felt a bump). On 15-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Rash warm to the touch) and VACCINATION SITE RASH (Had a rash). At the time of the report, VACCINATION SITE MASS (Felt a bump), VACCINATION SITE WARMTH (Rash warm to the touch) and VACCINATION SITE RASH (Had a rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product included blood pressure medications and diuretic medications. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Contact information of reporter was updated.
Administer expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) in a 62-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine). On 29-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product information was not provided. Reporter stated that no treatment was given to patients.  Reporter also stated that the vaccines were stored in freezer and they took out one to two vials and placed in fridge each day as needed.
whose disease have flared; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (whose disease have flared) in a female patient of an unknown age 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) 1 dosage form. On an unknown date, the patient experienced CONDITION AGGRAVATED (whose disease have flared). At the time of the report, CONDITION AGGRAVATED (whose disease have flared) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were not reported. No treatment medications were not provided.
Site of injection was red, hot and inflamed. Also patient said it was painful to the touch and broke in hives.
Patient received first dose of COVID vaccine.  She stated she was feeling nauseated.  She then was lightheaded and lost consciousness and slid out of her chair and hit her head on the floor.  She was arousable immediately after.  Her VSS.  She was able to ambulate to our gurney and tolerate water.  She was transferred to the ED for further observation.
Moderna COVID-19 Vaccine EUA On Saturday, Feb. 20, 2021 I woke around 4:00 a.m. cold and shivering, my neck and head hurt. I took my temperature orally (the only thermometer I had at home), it was 101.9.  I took Tylenol, it helped a little. I was lethargic throughout the day. My head and neck hurt all day and into Sunday, even with Tylenol. I did not sleep well Saturday to Sunday, started coughing, but only when laying down, (maybe allergy related?) so I sat up and slept in a chair. I woke up Sunday without a fever, no Tylenol, but still had achy neck and a slight headache. I did continue to take Tylenol because my neck and head still hurt.  But I was able to move around, a little, if I overdid it, I had to sit.