chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Ag test on 09Jan2022 at home is positive; Ag test on 09Jan2022 at home is positive; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 24Feb2021 (Lot number: EL3247) at the age of 40 years as dose 2, single and administration date 03Feb2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications.  The following information was reported: VACCINATION FAILURE (medically significant) with onset 08Jan2022, outcome "unknown", COVID-19 (medically significant) with onset 08Jan2022, outcome "recovering" and all described as "Ag test on 09Jan2022 at home is positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (09Jan2022) positive. It was unknown if therapeutic measures were taken as a result of covid-19. Reported Event: exposure 07Jan-08Jan overnight to COVID positive person then + symptoms 08Jan at 10:30pm ST and slight cough + Ag test on 09Jan2022 at home. It was unknown that the patient received any other vaccines within 4 weeks prior to the COVID vaccine, prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information provided, a causal association between reported events Vaccination failure, covid 19 with BNT162B2 is possible.
I had a very bad headache and nausea.  Threw up all day and couldn't eat or drink anything.  I even threw up the medicine.  It finally got better at approximately 7 PM.
Complained of muscle aches right arm, buttocks and right leg beginning around 8/5/07.  Today (8/21) muscle aches have resolved but complained of "swelling" lower right arm below elbow.  Advised to see TND.
This case was reported by a physician via sales rep and described the occurrence of shingles in an adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, 2 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported, but was selected as an adult as per vaccine indication. The patient developed shingles on leg 2 days after SHINGRIX administration. The reporter provided the consent for follow up.
Received flu vaccine on 10/14/03. Complained of chills/fever/lethargy approx 4-6 hours after receiving vaccine. Symptoms lasted 24-36 hours.
seizures/Convulsions; weird metal or acidic taste in my mouth; felt heavy; feel shaky; back spasms; blood pressure spiked to higher than normal levels; nauseous; weakness on my left side; pain at the injection site; pain at the injection site, my back, and neck; pain at the injection site, my back, and neck; feel super tired; This is a spontaneous report from a contactable consumer (patient). A 28-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 06Apr2021 11:15 (Batch/Lot Number: EP7533) as single dose for COVID-19 immunisation. Medical history included axenfeld reigers, bilateral congenital iris coloboma, bilateral glaucoma, hearing loss. Known allergies: peanut, albuterol, amoxicillin-pot clavulante, doxycycline, fentanyl, levosalbutamol (LEVALBUTEROL), oxycodone-acetaminophin, sedation. Concomitant medications in two weeks: cryofood (unspecific), folic acid, cyanocobalamin (B12), timolol and dorzolamide hydrochloride/timolol, all from unknown date for unknown indication. First, patient had a weird metal or acidic taste in mouth. Following that, patient felt heavy. Next, began to feel shaky having back spasms. His blood pressure spiked to higher than normal levels and started feeling shakey dropped. Patient was laid down by nursing staff and blood pressure dropped. After being laid down, patient started having seizures/convulsions, paramedics were called and patient was given midazolam hydrochloride (VERSED, anti-seizure meds) and was taken to the ER (emergency room). Once patient arrived at the ER, he felt nauseous and was given anti-nausea medication, after about 4 hours patient was released. But he was experiencing weakness on left side and pain at the injection site, back, and neck, and felt super tired. AEs onset at 11:30 of 06Apr2021. Outcome of the events was resolving. Patient had no COVID prior vaccination and had no COVID tested post vaccination.
Pt said she developed swelling and pain shortly after injection. Pain increased throughout the night and today. Pt presented with her upper arm swelled and red.; hot to the touch. She said she feels pain, but is able to move her arm and fingers.
round cyst like area sized shaped like a pea/ middle of the left armpit; under her left armpit started itching; sore left arm; feeling dizzy/ dizziness comes and goes/dizziness occurred while walking; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (feeling dizzy/ dizziness comes and goes/dizziness occurred while walking), CYST (round cyst like area sized shaped like a pea/ middle of the left armpit), PRURITUS (under her left armpit started itching) and VACCINATION SITE PAIN (sore left arm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033H21A, 014M20A and 046A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMINS NOS for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Nov-2021, the patient experienced DIZZINESS (feeling dizzy/ dizziness comes and goes/dizziness occurred while walking), PRURITUS (under her left armpit started itching) and VACCINATION SITE PAIN (sore left arm). On 23-Nov-2021, the patient experienced CYST (round cyst like area sized shaped like a pea/ middle of the left armpit). At the time of the report, DIZZINESS (feeling dizzy/ dizziness comes and goes/dizziness occurred while walking) had not resolved and CYST (round cyst like area sized shaped like a pea/ middle of the left armpit), PRURITUS (under her left armpit started itching) and VACCINATION SITE PAIN (sore left arm) outcome was unknown.            Treatment information was not provided.   This case was linked to MOD-2021-396228 (Patient Link).
Hospitalization for Sepsis due to UTI/Pneumonia, COVID positive on dates 7/28/2023-8/2/2023. Treated with dexamethasone, baricitinib, Remdesivir, vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
After 4 days arm is still swollen, red and painful.  She believes she had a reaction to vaccine.
The evening after having the vaccine she started having uncontrollable chills and a high fever. At the injection site she was having pains, she was having headaches and nausea also the feeling of being extremely tired. She slept for 2 days.
Associate received second dose of Pfizer on 2/11/2021.  On 4/21/2021 she started to have a cough, diarrhea, fatigue, nausea, runny nose, and a sore throat.  On 4/22/2021, she went to get tested and results came back covid positive.
The vaccine in question expired August 10, 2022 and was administered on Aug 13, 2022 by Rph.  Manufacturer was contaced and we were given this response: ?Analysis of the vials associated with your storage excursion is complete. The vaccine administered on August 13, 2022 from lot number AR4504B maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration.?
On 07/15/2004 the physician was contacted by the manufacturer after she left a voice mail regarding a possible adverse event with TD. A 28 year old female patient received a TD immunization in a local ER for having cut her foot on a piece of glass.  On 07/13 the patient described having had fever following the immunization starting the day of injection (max 101F) which was 100.2 in the office.  The patient complained of having a sore neck on the left side, low back pain and diarrhea the day before the visit.  On exam, the patient had one vesicle at the injection site and the arm had approximately a quarter size of warm, redness and swelling with tenderness.  Patient had full range of flexion and extension of her neck. Patient did not remember when she received a TD booster prior to the 07/10 dose. Follow up received by manufacturer on 07/19/2004: The patient was not ill at the time of the vaccination and has no previous allergies, birth defects or medical conditions apart from an allergy to Sulfa.  Patient was not taking any other medication apart from birth control and had no other vaccinations within 4 weeks prior to 07/10/2004.  Physician said that she contacted the patient on 07/15/2004 and the patient's arm was still a little sore and red.  The patient was scheduled for a follow up appointment. Follow up received by manufacturer on 08/12/2004: Physician said that the patient recovered.  The site of injection was still a little tender but was healing.  The patient also recovered from pain in lower back and neck.
I got my second Pfizer COVID vaccine on Friday February 26. On Saturday February 27 I started getting a droopy lip and a droopy eye lid on the ight side of my face.  I went to my doctor on Monday March 1 and after and examination and a CT scan (to eliminate other things), I was diagnosed with Bell?s Palsy. I am now on steroids and antiviral medication.  I still have Bell's Palsy at this time,
50 yo female with no medical history known to our system presents with Inferior STEMI with ventricular fibrillation cardiac arrest.  Unknown initial downtime without CPR. Arrived by rescue squad and taken emergently to Cardiac Catheterization Lab, required mid-LAD stenting.  Therapeutic temperature management (TTM), now rewarmed. Currently intubated on mechanical ventilation, on norepinephrine, poor neurological responses, consider neurology consult for brain evaluation/prognostic recommendations.  There is a progress note written by ED RN on 4/12/21 that states family reports she had "her 2nd COVID shot 1 week ago," but per Immunization Registry, only 1 COVID vaccine is recorded.
Patient reported some itching and discomfort in throat about 15 minutes after administration. Denied breathing or swallowing difficulty. Was given 25 mg of diphenhydramine by mouth and in 15 minutes patient reported feeling better
I developed a painless rash that followed a nerve path on Tuesday, September  27. It remained fairly painless with only mild itching. The next day, I became extremely fatigued and developed mild cold symptoms that lasted 7 days. We have a medically fragile daughter who cannot be vaccinated. She developed chicken pox on October 11,  she is homebound and has not left our house and limited people have entered. Her chicken pox case is lab confirmed. She was and still is very sick from this.
Vaccine expired on 01-Apr-2022 and stored in the refrigerator on 20-Apr-2022; Received vaccine expired on 01-Apr-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received vaccine expired on 01-Apr-2022) and PRODUCT STORAGE ERROR (Vaccine expired on 01-Apr-2022 and stored in the refrigerator on 20-Apr-2022) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     It was unknown if the patient ever had COVID positive test or diagnosis.  Concurrent medical conditions included Penicillin allergy and Blood pressure high. Concomitant products included AMLODIPINE BESILATE (NORVASC) and HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL AND HYDROCHLOROTHIAZIDE) for Blood pressure high.   On 16-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 21-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 21-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received vaccine expired on 01-Apr-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 01-Apr-2022 and stored in the refrigerator on 20-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received vaccine expired on 01-Apr-2022) and PRODUCT STORAGE ERROR (Vaccine expired on 01-Apr-2022 and stored in the refrigerator on 20-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that patient was not given any other vaccines within 1 month prior to Moderna COVID-19 vaccine. Patient did not seek for medical care, and it was unknown whether patient experienced a similar event in the past. It was reported that the vial was initially stored in the refrigerator on 20-Apr-2022 at 06:44 PM. The vial did not undergo any temperature excursion. No treatment medications were reported.
Patient was found slumped over in wheelchair, drooling and unable to respond/follow simple instructions; sent to ED for evaluation. CT scans and MRI NEGATIVE for new/recent stroke; resident slurred speech likely due to hypertensive urgency
2 days after vaccination; arm red, itchy at injection site. Patient states throat tight. Prednisone ordered, triamcinolone cream, as well as BENADRYL.
First shot- sore arm at injection site. For about 48 hours.   Second shot- extreme arm pain at injection site for 48 hours almost immediately.   6 hours after shot administered: Body/muscle aches general ill feeling, low grade fever 100.5  12 hours after shot administered: persistent fever, 101, more severe body aches, chills, (flu like symptoms), headache, groggy, fatigue, general ill feeling. Ibuprofen administered, brought fever down.  48 hours after shot administered:  fever is on and off, 100-101. Body aches, chills, headache and grogginess have subsided.   48 hours after shot administered: Red sore in the roof of mouth.
Joint pain; Sickness; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint pain) and ILLNESS (Sickness) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced ARTHRALGIA (Joint pain) and ILLNESS (Sickness). At the time of the report, ARTHRALGIA (Joint pain) had not resolved and ILLNESS (Sickness) had resolved.            No concomitant medications were reported. Adult male patient reported that his Joints had been hurting knees/hurting while going up and down stairs and feeling Sick with skyrizi (risankizumab) and might be due to cold weather. Patient was sick for 2 days after second dose of Covid-19 vaccine. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   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. No treatment information was reported.
At time of flu administration, patient states she felt a burning sensation going down her arm. 5 hours after getting the flu shot, she experienced a sudden onset of vomiti (1 episode) followed by lightheadedness, diaphoretic and low grade fever. She states she developed pain & a lump (size of half dollar) at the injection site. The pain radiated up & down her arm and was constant. She took Ibuprofen 6oomg BID with minimal result. She notified NP 11/04/14. She was advised to take Ibuprofen 800mg TID and call if no improvment. Patient was evaluated 11/14/14 after no improvement. Ultrasound was completed and results were no abnormalities. Recommend that she uses warm compresses to the area.
pt recv vax in AM & 3PM c/o chills, muscle aches, n;came to ER 930PM t102.7, chills, joint pain, n/v x 5;pain & swelling @ inj sit lt deltoid;recv IV fluids, compazine, Toradol, zantac;d/c from ED much improved;dx w/febrile synd post
36 hours of body aches, fever, headache.  48 hours of fatigue.
Had Fluzone Oct 6, next day had a headache and started with hematachezia (has Ulcerative Colitis), Hemaglobin dropped 2.4 after immunization from 14.4 to 12. He later needed iron infusion X2.
Started sneezing with watery itchy eyes 4 days after injection. On day 4 woke up with hives on back that has spread to right arm. Rash is small and not raised, but is quite itchy.
Jerking movements of rt leg progressing to entire body lasting 5 min, no cyanosis, t98.5 ax, eyes remained open whole time, stopped spontaneously was drowsy afterwards; PE-nl x/rhinorrhea;
No signs of anything other than a large, warm, red patch surrounding the site of injection. It started as a solid red patch 7 days after the injection and is now just a ring on day 8.
Four hours after receiving second Pfizer COVID vaccine, patient experienced redness and hot flushing to tops of feet that lasted four days.  MD approved booster.  20 minutes after receiving the Moderna booster, patient experienced throat swelling described as "difficulty swallowing" and about one hour later, "hard to breathe".  She was taken by ambulance to the hospital.
pt recv vax & site was red & swollen 3 days post vax;no tx was required;pt discharged w/sx;
Inflammation on the site of injection, Nausea, Fever, generalized itching,  erythema and headache. Patient felt better on the third day after injection.
Large swelling of arm and shoulder, redness > 2" and fever. Seen at ER. Given antibiotic and diagnosed with cellulitis. Currently on Keflex at office follow up 12/4/03. To finish Abx and call office if worsens or not improved.
pt recv vax & devel pain & GBS;hosp is presumed, although not documented;this is a serious, labelled event;
Fatigue; 1/24 pm-redness/itching Narrative: Fatigue (1/22pm); redness and itching at injection site (1/24/21pm); took benadryl, feels it is improving
Pt work with chills and pain at injection site and suffered a vasovagal syncopal episode while attempting to get Advil from bathroom, she fell and hit her head, suffering a contusion.  At time of office visit the following morning, she does not appear to have signs of concussion or more serious head or neck injury.
Shingles rash on underarm/chest of left arm. Seen in urgent care. Treated with valtrex.
Information has been received from a physician concerning a female who was vaccinated with zoster vaccine live (Oka/Merck). The physician reported that the vaccination was a while ago and that there still was a round circle at the site of the injection. It was unspecified if the patient sought medical attention. Current patient status was not reported. A product quality complaint was not reported. Additional information has been requested.
Sudden and unexplained dizziness when moving.  Can be explained as a sort of "floaty" feeling.
Complaints of swelling and pain at injection site then began having nausea from increased pain. Had night sweats. Continues to have pain - no redness.
Pt experienced severe pain and throbbing at site of injection. Have seen orthopedists, neurologists, had MRI done, x-rays, and neurological testing of nerves. Sustained damage in radial nerve. Pt is currently taking Neurentin.
Around injection site is red; Around injection site is puffy; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Around injection site is red) and VACCINATION SITE SWELLING (Around injection site is puffy) in a patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Around injection site is red) and VACCINATION SITE SWELLING (Around injection site is puffy). At the time of the report, VACCINATION SITE ERYTHEMA (Around injection site is red) and VACCINATION SITE SWELLING (Around injection site is puffy) outcome was unknown.            Concomitant medication list was not provided. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.
Patient stated her tongue, lips and eye lids were swelling.  Patient had children's liquid Benadryl with her and immediate started drinking the Benadryl.  Patient was assessed by the NP and also by her PCP while in the office.  Patient was advised that she needed to go to the ER via ambulance, she refused. She was observed for an additional 30 min. with no further symptoms. Vitals were taken again before she left the office.  Patient was contacted again via phone at 3:00 pm to check on her, she stated she was home and doing well. She contacted the after hours service at 6:37pm stating she was continuing to have swelling when the Benadryl wears off.  Patient was advised by the after hours provider to go directly to the ER and explained the risk of airway swelling during the night. Pt. verbalized understanding.  Pt. was seen in the ER on 3/26/21 in the ER for allergic reaction was discharged the same day with instructions to follow up with her PCP.
This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Medical history was not reported. The nurse informed that on 13-MAY-2014 the patient was vaccinated with MMR II (strength, dosage and route were not reported) lot number: J006955, expiration date: 07-JUN-2015. That may had been improperly stored since February 2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to be confirmed to be within recommended storage temperature since then. The highest temperature the MMR II could had been exposed was 70F. Also stated that was no way to determine what the exact temperature was at any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
extreme erythema approx 3" diameter-acute tenderness, warmth @ inject site lt deltoid; unable to move arm w/o pain, numbness to fingertips; pt consulted w/MD 13AUG93 prescribed Zithromax; seen by MD 11AUG93;
Child recd 1st immun in clinic @ Hlth Dept; Mom phoned 230PM stating child awoke @ 145PM screaming & was still screaming; Seen by MD felt it was rxn to DPT; Given DPH;