chrisvoncsefalvay/vaers-outcomes huggingface dataset:
It's been 49 days since receiving the 1st dose of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (It's been 49 days since receiving the 1st dose of the vaccine) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and HYDROCHLOROTHIAZIDE, TELMISARTAN (MICARDIS HCT) for an unknown indication.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (It's been 49 days since receiving the 1st dose of the vaccine). On 18-Jan-2021, PRODUCT DOSE OMISSION ISSUE (It's been 49 days since receiving the 1st dose of the vaccine) had resolved.        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 details were not provided.
No adverse events. Given intranasal flu vaccine but was supposed to get IM vaccine.  1/6/2010 OB Consultation records received. Service date 12/11/09. Assessment: Anemia.
It was around December 16th when I went to (Privacy) for the holiday. I thought it was related to my sinus, but when the sinus cleared up, I still was unable to taste properly. My taste bud are elevated when tasting salty and sweet things. I saw an ENT and they concentrated on my ears and nose. The also believed it was sinus related. They prescribed that Flonase as its related to the sinus. There was no treatment provided. Occasionally I get my taste back. Most times its like I am eating fake foods. I am having a CT Scan and allergy test done.
First dose i had a reaction within 40mins. My face got extremely hot and red and blotchy and stayed like that for the day, 12hours or so.  didnt think much of it, waited for the flu like symptoms everyone else complained getting. Never got that, just a red hot face. Second dose within 5 mins of getting the shot, my face got extremely hot again and red. No one was around the mass vaccination where i was sitting didnt think to ask anyone. But this time it lasted a good 48 hrs and my face stayed red well into the next day when it started to subside my cheeks now were prickling.  Probably from being swollen. Afraid to get the Pfizer booster.
COVID Arm - Wide band of red, swollen, sore rash on vaccination site. Extremely sensitive to touch and extremely itchy. Not really responding to antihistamine. Some relief from itch by icing swollen site.
No adverse event.  a 5/8 needle was used instead of 1-11/2' needle based on gender, age and weight.
positive Covid pcr/Chills, fever; positive Covid pcr/Chills, fever; Dose Number: 3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administration date 07Dec2021 (Batch/Lot number: unknown) at the age of 51 years as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (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: IMMUNISATION (medically significant) with onset 07Dec2021, outcome "unknown", described as "Dose Number: 3"; DRUG INEFFECTIVE (medically significant) with onset 17Dec2021, outcome " recovered", COVID-19 (medically significant) with onset 17Dec2021, outcome "recovered" and all described as "positive Covid pcr/Chills, fever". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (17Dec2021) positive, notes: covid test type post vaccination=Nasal Swab. Therapeutic measures were not taken as a result of the events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
PATIENT STATED THAT SEVERAL DAYS AFTER 2ND COVID SHOT HE EXPERIENCED WHAT FELT LIKE A SUNBURN ON FACE AND NUMBNESS IN HANDS BILATERALLY LASTING AT LEAST 12 HOURS THAT WAS NOT RELIEVED WITH ICE AND ALOE VERA  HE WAS OUTDOORS AT THE TIME AND TAKING IBUPROFEN WHICH BOTH HE DOES ON A DAILY BASIS.  HE HAD PREVIOUSLY RECEIVED A STEROID INJECTION FOR HIS EAR. HE INFORMED ME OF THIS 7/21/21 AND STATED IT REOCCURED TO A MUCH LESSER EXTENT YESTERDAY AND WAS DOING FINE AND THE REDNESS HAD DIMINISHED  HE STATED HE CHECKED HIS TEMP THE FIRST OCCURENCE AND HAD A NORMAL TEMP
Autism; Dizzy spells at night; A bit anxious; This spontaneous case was reported by a consumer and describes the occurrence of AUTISM SPECTRUM DISORDER (Autism) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products TREPROSTINIL tablet, extended release for Primary pulmonary hypertension and TREPROSTINIL DIOLAMIN (ORENITRAM) tablet, extended release for Primary pulmonary hypertension.    Concurrent medical conditions included Pulmonary arterial hypertension. Concomitant products included AMBRISENTAN for an unknown indication.   On 19-Nov-2014, the patient started TREPROSTINIL (Oral) UNK mg. In February 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started TREPROSTINIL DIOLAMIN (ORENITRAM) (Oral) 5 mg. In 2021, the patient experienced AUTISM SPECTRUM DISORDER (Autism) (seriousness criterion medically significant), DIZZINESS (Dizzy spells at night) and ANXIETY (A bit anxious). At the time of the report, AUTISM SPECTRUM DISORDER (Autism), DIZZINESS (Dizzy spells at night) and ANXIETY (A bit anxious) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication has been reported.  Company Comment: This case concerns a 28-year-old male patient with medical history of pulmonary arterial hypertension. And on concomitant treatment Ambrisentan and Treprostinil who experienced an unexpected event of Autism. The event occurred after an unspecified dose of mRNA-1273 (Moderna COVID-19 Vaccine) administration. The rechallenge was unknown as details about the specific dose administered was not provided. Causality for the reported evens were not provided by the reporter. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report. Event is assessed as medically significant per Regulatory Authority reporting. Autism spectrum disorder is an important medical event.   Reporter did not allow further contact; Sender's Comments: This case concerns a 28-year-old male patient with medical history of pulmonary arterial hypertension. And on concomitant treatment Ambrisentan and Treprostinil who experienced an unexpected event of Autism. The event occurred after an unspecified dose of mRNA-1273 (Moderna COVID-19 Vaccine) administration. The rechallenge was unknown as details about the specific dose administered was not provided. Causality for the reported evens were not provided by the reporter. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report. Event is assessed as medically significant per Regulatory Authority reporting. Autism spectrum disorder is an important medical event.
shingles; Information has been received from a lawyer regarding a case in litigation concerning a male patient(pt) of unknown age.The pt's medical history, concurrent conditions and concomitant medications were not provided. In 2017, the pt was vaccinated with zoster vaccine live(ZOSTAVAX) (dose, route of administration, anatomical location, lot#, expiration date were unknown) by a pharmacist for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to zoster vaccine live(ZOSTAVAX) inoculation, pt was treated by a healthcare provider for shingles. As a direct and proximate result of zoster vaccine live(ZOSTAVAX), pt has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.
Initial report received from a healthcare professional on 08 January 2013. A 45-year-old female patient, with allergy to latex and codeine, who had no illness at the time of vaccination and whose concomitant medications were not reported, had received first dose of FLUZONE ID vaccine in left arm (Lot number: UT4470BA, route of vaccination ws not reported) on 05 January 2013. On 06 January 2013, the patient developed 4-incd red area, hot to touch. Corrective medications were not reported. No laboratory investigations were done. At the time of this report, the patient had not recovered from the events. Documents held by sender: none.
Patient given adult dose of HBV at 19 years and 7 months old, patient informed that he was given adult dose.
Left arm from shoulder to elbow and left part of left breast experienced a rushing sensation that lasted for several minutes; the left elbow hurt enough to wake me for the next few nights; the discomfort and pain waned; I reported the experience to my primary doctor on our next scheduled visit and he referred me to an orthopedist.  Three weeks of rehab resolved chronic discomfort.  The left breast had undergone surgery many years before.  Diagnosis of fibrocystic disease.
Patient said he was admitted to hospital with apparently a Guillain-Barre reaction told to him by a Physician.
lethargy; Joint pain/aches; muscle pain; headache/migraine; nausea; headache/migraine; persistent thirst; This is a spontaneous report from a contactable consumer (patient). A 31 years old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL3247), via an unspecified route of administration in Left Arm on 24Feb2021 at 13:15 as a Dose 2, single for COVID-19 immunization. The patient's medical history included Heart murmur, history of lyme disease, kenyan tick typhus, known allergies to Sulfa drugs, red dye. The patient's concomitant medication(s) included biotin supplement, melatonin, Multivitamin (unspecified) within two weeks after vaccination. Facility type vaccine was reported as Other. The patient had no Covid infection prior vaccination. The patient was not tested to Covid post vaccination. The patient had not received any other vaccine four weeks prior to Covid-19 vaccination. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3247) via an unspecified route of administration in Left arm on 04Feb2021 at 09:00 AM, as a Dose 1, Single for COVID-19 immunization. On 25Feb2021 at 11:00, the patient had experienced lethargy, joint pain/aches, muscle pain, headache/migraine, nausea, persistent thirst. No treatment received for resulted events. The outcome of the events was recovered on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
13 days post vax, the pt developed 20-30 lesions and no fever.  3 days post vax the pt was seen for a physical and blood draw. The pt fainted 2 times, was seen in the ER and diagnosed with dehydration. No fever, vomiting or diarrhea.
she got some reactions to the first vaccine/ she had to be tested for PG ingredients as an allergy test; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number and Expiration Date: not reported), via an unspecified route of administration on an unspecified date (at the age of 55 years old) as first dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient got some reactions to the first vaccine and ended with cardiologist due to that who indicated that the patient had to be tested for PG ingredients (as reported) as an allergy test. The patient mentioned that she had has not been able to get the test done and had has an appointment to get the second dose this next Wednesday (as reported). The patient would like to know if she can delay the vaccine to a 7th week after the first dose since she has already waited for 6 weeks. The patient had has contacted 2 physicians and the CDC and nobody could give her an answer to this question. Outcome of the event was unknown.  Information about batch/ lot number has been requested.
Diarrhea  within 6 hours,  severe headache top and back of head following  2 1/2 days.
The unusual and unexpected issues is mouth sores, lasting several days. Actually, still healing, but not getting worse after 5 days. Also the expected  significant  headache for 24-36 hrs. Typical body aches, but not severe.
My upper arm started to get really red/ red/ it almost went down to my elbow; Hard; Swelling; It looked discolored; It still hurts periodically; there is a little nodule below  the injection site now; Covid arm; Allergic reaction; Where  I got the shot, it got red around and also red in the center; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (My upper arm started to get really red/ red/ it almost went down to my elbow), INDURATION (Hard), SWELLING (Swelling), SKIN DISCOLOURATION (It looked discolored) and PAIN (It still hurts periodically) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (My upper arm started to get really red/ red/ it almost went down to my elbow), INDURATION (Hard), SWELLING (Swelling), SKIN DISCOLOURATION (It looked discolored), PAIN (It still hurts periodically), VACCINATION SITE NODULE (there is a little nodule below  the injection site now), VACCINATION SITE REACTION (Covid arm), HYPERSENSITIVITY (Allergic reaction) and VACCINATION SITE ERYTHEMA (Where  I got the shot, it got red around and also red in the center). At the time of the report, ERYTHEMA (My upper arm started to get really red/ red/ it almost went down to my elbow), SWELLING (Swelling) and VACCINATION SITE ERYTHEMA (Where  I got the shot, it got red around and also red in the center) had resolved, INDURATION (Hard), SKIN DISCOLOURATION (It looked discolored), VACCINATION SITE NODULE (there is a little nodule below  the injection site now), VACCINATION SITE REACTION (Covid arm) and HYPERSENSITIVITY (Allergic reaction) outcome was unknown and PAIN (It still hurts periodically) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter. No treatment information was provided by the reporter.
Facial Redness beginning on Sunday, the morning after the first dose of the vaccine.  The following day (Monday), his face started to swell as well and he couldn't open his right eye upon waking.  We went to the doctor who said it was just a side effect of the vaccine and time would heal it. By Tuesday his face was extremely puffy, and the skin especially on his forehead and around his eyes was red, bumpy, and dry and felt hot to the touch although he did not have a fever at any time.  On Wednesday he was starting to have reduced redness and puffiness.  It continued decreasing until the following Sunday, when he wasn't puffy at all, though the skin is starting to peel now.
Hives, sneezing, anaphylaxis, wheezing, itchy throat, stuffy, started in evening, hives first then itchy throat, probably about an hour, as that got worse throat started swelling. Took 50mg prednisone 2 benadryl and albuterol inhaler.  Breathing got better and hives went away but still had swollen throat and took pepcid. Headache afterwards but that's typical of an allergic reaction.  I can't be sure it was from the vaccine or not but nothing I did yesterday would normally trigger that reaction
This spontaneous report as received from a registered pharmacist refers to a 67 year old female patient with no pertinent medical history and no drug reactions or allergies. On 11-MAR-2014, the patient was vaccinated with a single dose of ZOSTAVAX (Lot # reported as J013133, expiration date 17-JAN-2015) subcutaneously in the left arm. There was no concomitant medication. The pharmacist reported that on an unknown date in March 2014, the patient developed a 2-3 inch round area of warmth and itchiness at the injection site after administration of ZOSTAVAX. The patient did not received treatment for the adverse events. There were no Lab diagnosis or studies performed. The outcome of 2-3 inch round area of warmth and itchiness at the injection site was reported as recovering/resolving. Additional information is not expected.
Large rash at injection site (covering entire upper arm). Fever on day 2 of 100.3. Fever on day 3 of 99.6. Severe muscle aches. Fatigue.
This spontaneous report was received from a registered nurse and refers to a currently 50-year-old female patient. The patient's drug reactions and allergies included allergy for FLAGYL, Sulfa and unspecified plant extracts. The patient's pertinent medical history and concomitant therapies was not provided. On an unknown date in 1983 (reported as 35 years ago), the patient was vaccinated with PNEUMOVAX 23 (dose, frequency, route of administration, lot # and expiration date were not reported) for prophylaxis. On an unknown date in 1983, after receiving vaccination, the patient vomited, had throat tightening and due to that she received an epinephrine (manufacturer unknown) injection, administered after an unspecified amount of time after the previously reported events. On unknown dates, the patient had newly diagnosed diabetes and heart disease. The outcome of diabetes and heart disease was unknown. The outcome of vomiting and throat tightening was reported as recovered. The relatedness between the events and vaccination with PNEUMOVAX 23 was not reported. Upon internal review, the events of diabetes, throat tightening and vomiting were determined to be medically significant.
9 days p/vax devel measles red dots which quickly spread & formed red patches,started w/ears & face then all over;also has fever 102 & diarrhea;
Patient got his vaccine on 5/29/21 and then received his normal chemotherapy treatment a few days after receiving the vaccine. He had red blotches all over his body and his left leg swelled. He didn't have any problems with his first vaccine. He was and is currently taking a prednisone taper. He's still experiencing these blotches and it doesn't seem to be getting better so he wanted to make sure the pharmacy was aware.
onset date is approximate; girlfriend hospitalized with severe perineal cellulitis; viral culture grew vaccinia confirmed by state public health laboratory
Tingling sensation; 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 PARAESTHESIA (Tingling sensation) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (Tingling sensation). At the time of the report, PARAESTHESIA (Tingling sensation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. No treatment information was provided by the reporter.
fever, nausea, hives, swollen lip -Provided ibuprofen, and antihistamines over the counter
arm was a little ache, sore; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received the first dose and 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), route and dates were unknown, both at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient mentioned receiving both doses of the COVID-19 vaccine and feeling fine except that his arm was a little ache and sore on an unspecified date. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
This spontaneous report as received from a female patient of unknown age concerning herself. On an unknown date in January 2013 the patient was vaccinated with ZOSTAVAX (lot number, dose, route and injection site were not reported) for the prevention of shingles. Sometime in April 2013 the patient got a case of the shingles. The outcome of shingles was unknown. The action taken and causality were not reported. It was unspecified if the patient sought any medical attention. Additional information is not expected.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 15-MAY-2017, the patient was vaccinated with PROQUAD lot # M044018, expiration date: 01-MAY-2018 that might have underwent temperature excursions of -14 to -10 degrees Celsius for 1 hour and -9 to 8 degrees Celsius for 2 hours reconstituted in sterile diluent. No adverse experience was reported. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA008370.
Dizziness cough (allergies, per Pt.) noted; appeared anxious Narrative:  c/o dizziness. given juice. HX. HTN. @0945 BP 170/81, P. 93, R 18, O2 96%; @ 0955 BP 143/76, P. 89, R 18, O2 97%; @ 1005, BP 175/82, P. 87, R. 18, O2sat 97%. Sent to ED for further evaluation. Given IV fluids for dehydration. resolved.
chills, fever, headache, cough, runny nose. starting 1/18/2022
Employee states his right eye became irritated - twitching and around nose. Initially thought it was his contact lenses and a new cleaner he started using. His face became numb from his forehead, cheek and mouth, upper teeth. He sought medical attention at local emergency department Hospital. Then went to his family physician. Vaccine was given at work Medical Department. Substitute nurse gave injection. Department under renovations. Unable to locate Vaccine consent form that has date and location vaccine was given. Will send information when record located.
pt rec'd grey cap pfizer vaccine after it was stored in freezer for 22 days- pt rec'd replacement dose on 6/2/22