chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Allergic reaction; Dizziness; Water blisters around injection site; No energy; Fingers were numb; Feeling like fainting; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERSENSITIVITY (Allergic reaction), DIZZINESS (Dizziness), VACCINATION SITE VESICLES (Water blisters around injection site), ASTHENIA (No energy) and HYPOAESTHESIA (Fingers were numb) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy NOS.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced HYPERSENSITIVITY (Allergic reaction), DIZZINESS (Dizziness), VACCINATION SITE VESICLES (Water blisters around injection site), ASTHENIA (No energy), HYPOAESTHESIA (Fingers were numb) and PRESYNCOPE (Feeling like fainting). At the time of the report, HYPERSENSITIVITY (Allergic reaction), DIZZINESS (Dizziness), VACCINATION SITE VESICLES (Water blisters around injection site), ASTHENIA (No energy), HYPOAESTHESIA (Fingers were numb) and PRESYNCOPE (Feeling like fainting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Apr-2021, Heart rate: (High) Fast.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.    Reporter did not allow further contact
Tinnitus within 10 minutes of vaccination in right ear.  Mild-moderate for 0-4 months.  Extreme to excruciating months 5 to ongoing.
Patient developed increased heart rate after vaccine and when to the emergency room where he was diagnosed with  hyperthyroidism. Patient is currently on Propranolol and Methimazole.
4/1/21: patient presented with chief compliant of left-sided epistaxis (nose bleeding).  Patient states she has had epistaxis on and off for the past 5 days. Stated she feels nauseas from the blood in the back of her throat. Significant active heavy bleeding from the left nare was confirmed.  Per the EUA, hospitalizations to be reported irrespective of attribution to vaccine
Pain in arm; Burning sensation; Skin warm; feeling kinda painful.; sleepy; itchy; developed a rash on the right arm; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm), BURNING SENSATION (Burning sensation), SKIN WARM (Skin warm), PAIN (feeling kinda painful.) and SOMNOLENCE (sleepy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY (Pain in arm), BURNING SENSATION (Burning sensation), SKIN WARM (Skin warm), PAIN (feeling kinda painful.), SOMNOLENCE (sleepy), PRURITUS (itchy), RASH (developed a rash on the right arm) and FATIGUE (tiredness). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Pain in arm), BURNING SENSATION (Burning sensation), SKIN WARM (Skin warm), PAIN (feeling kinda painful.), SOMNOLENCE (sleepy), PRURITUS (itchy), RASH (developed a rash on the right arm) and FATIGUE (tiredness) outcome was unknown.            No concomitant medication listed. Ice pack, Tylenol, and lotion after the second dose. The patient developed a rash on the right arm on the second day and was feeling tired, sleepy, and said that it was hot like the first one, the rash was hot too, still have it. It was itchy yesterday, and it was going away now, the whole rash.   This case was linked to MOD-2021-332471 (Patient Link).
Urticaria & red papular rash developed approx 5-10 mins. /p shots. Started resolving spontaneously /win 10 mins /p they developed
Sore Arm - lasted for 2 days Tinnitus in right ear - has been happening about 4 to 5 days after second shot, has not stopped yet. No treatment.
Patient had 2nd dose appointment for Pfizer vaccine, presented vaccine card revealing 1st dose Pfizer from Pharmacy on 5/19/21. Pharmacy assistant checked patient in, confirmed, and verified vaccine with customer. Pharmacist prepared Pfizer vaccine, reconfirmed vaccination card, and reconfirmed with patient, then administered Pfizer vaccine. When processing  administration paperwork,  insurance rejected that same manufacturer should be administed as 2nd dose. Upon investigation and due to same computer system, discovered that Moderna was administered as 1st dose. When other pharmacy was contacted, pharmacist said paperwork showed Moderna. When patient was contacted, patient states that originally he had asked for Moderna at other pharmacy, but they said due to "age restrictions," he had to get Pfizer vaccine. Other pharmacy gave him vaccination card with Pfizer information, and patient believed he received Pfizer as 1st dose, not Moderna. Consequently, he made appointment and received Pfizer at our pharmacy as 2nd dose.
This case was reported by a health professional and described the occurrence of muscular ache of the thigh in a 49 year old female patient who received hepatitis B vaccine recombinant (Engerix-B).  The patient's past medical history included adenotonsillectomy, appendectomy, arthritis, hypercholesterolemia, hysterectomy and ostepenia.  The patient also had family history of coronary heart disease and unspecified thyroid problems.  Concurrent medications included Multivitamin, Soy, Magnesium, Vitamin B, Fish Oil, Guggulipid, Baby aspirin, Actonel, Flax seed oil and calcium.  On 04/06/2004, the patient received the first dose of Engerix-B in her left arm.  At an unspecified time after the administration of Engerix-B on 04/06/2004, the patient experienced muscular aches in her thighs, joint aches, fatigue, muscle weakness, rash on her neck and forearms, and flu-like symptoms.  The events resolved on 04/08/2004.  The immunization series with Engerix-B was discontinued.  The health professional considered the events to possibly be related to vaccination with Engerix-B.
sore arm; like a cold coming on; congestion like a head cold and nose running and my throat is kind of flamed up a little bit; little runny nose; drainage in throat; Little aches and chills; It is hard for me to stay warm; Little aches and chills; It is hard for me to stay warm; fatigued, little tired; flu symptoms; little headache; itchy throat; This is a spontaneous report from a contactable consumer (patient, reported for self). A 75-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/lot number and Expiry date: unknown), via an unspecified route of administration, administered in arm right on 26Feb2021 12:30 (at the age of 75-year-old) as dose 1, single for COVID-19 immunisation at Pharmacy. Medical history included ongoing prostate problems, prostate cancer, allergic reaction to penicillin (He had an allergic reaction to penicillin. He had something they gave him penicillin for when he was around 14 years old. It made him pass out). Concomitant medications included dutasteride (AVODART) oral 0.5 mg gel cap one a day: morniflumate (FLOMAX) oral 0.4 mg capsule one a day both taken for prostate infection from unspecified date(s) and ongoing. No history of any previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. No vaccinations (within 4 weeks) prior to the first administration date of the suspect vaccine. No Adverse events following prior vaccinations. On 27Feb2021 the patient experienced congestion like a head cold and nose was running, and his throat was kind of flamed up a little bit. Little aches and chills. It was hard for him to stay warm, little tired. Patient was having flu symptoms. He got a little headache, little runny nose, and little symptoms in his glands in his throat, he clarified his glands did not feel swollen, he just had throat drainage. He had a sore arm for a day maybe a day and a half (unspecified date). He was also fatigued. His throat it itched (itchy throat), like a cold coming on or like the flu. Adverse event did not require a visit to Emergency Room/Physician Office. No investigation assessment. Therapeutic measures were taken as a result of the event(headache). Patient has been taking over the counter medicine and wants to know if its ok. He's been taking daytime and nighttime Nyquil and he took Aleve for his headache. Patient has been taking the recommended dosage for Nyquil because it comes with that little cup. He's taken Aleve when his headache gets kind of bad, he takes 1 pill, they are 220 milligrams. The events were non-serious. The outcome of the event sore arm was unknown and that of other events was reported as not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
took 1st shot in left arm and second in right. 4 days after 1st shot, went home sick from work because flushed on face, headache, and heart rate went up over 100 per minute when walking. Having pains in chest. Took ibuprofen and bed rest for day. Heart rate continued like this up to next injection. 2nd injection, fever, could not get out of bed because of vertigo for 3 days. Heart rate was still not normalized. Went to doctor 1st week of June complaining of pressure down my sternum area and heart rate issues.
102 degree fever, headache, dizziness, aches, and lethargy from +8hrs to +24hrs after vaccine administration.
2/13/2021-intense pain in left back under shoulder going around to front rib 2/26/2021-large itchy red patch at injection site
soreness immed p/inject mostly next Am; nausea next Am this Am pain worst in arm & into back; pt's arms red, arms & hand are swollen & painful;
pt recv vax 23SEP98 3PM limp, pupils dilated p/vomited (projectile);cont vomiting all of formula & then green bile;skin was clammy & pale had dark circles under eyes;lasted 2hr no fever;unresponsive for 2hr;
Back pain 9/10, nausea, dizziness and fever 101 ~14 hours after dose administered
Narrartive: COVID infection following COVID vaccine series 12/21/, Pfizer, dose #1 01/12/2021 Pfizer, dose #2 08/13 pt cc: No symptoms exposure: unknown 08/16 COVID swab, result: detected
Rash near injection site. Rash size of apple. 2-3inch in Diameter; Soreness from initial injection on day 1; A spontaneous case report from united states from  an Other Health Professional on 26-JAN-2021 , which refers to a Female aged 25 Years.  On 16JAN2021  the patient received Moderna COVID-19 Vaccine for COVID-19 vaccination.   the patient developed Rash near injection site. Rash size of apple. 2-3inch in Diamete, .after receiving first dose of Moderna Vaccine. 1st dose was on 16JAN2021(Batch Number 042L20A) intramuscular route. Symptoms started 2 day later on Monday 18JAN2021. Rash right near injection site. Rash size of an apple. 2-3inch in diameter. Had soreness from initial injection on day 1. The soreness went away on the same day. :. The eventual diagnosis made on was Vaccination site rash . Not taking any medications to treat symptoms.  Currently on no medications. Second dose on 13FEb2021. Laboratory details were not provided.  Action taken with mRNA-1273 in response to the events was not reported.      The outcome of reported events fever was recovering and outcome of Rash near injection site  was unknown and soreness of injection site was recovered.  The reporter assessment for the event(s) were not provided.     Terse Narrative (for PSUR narratives and signal review) Brief 3 line summary of above for CIOMS listing: Report Source- Other Health Professional,  Age- 25 Years,  Sex- Female,  Suspect Drug- Moderna COVID-19 Vaccine,  Treatment-    Diagnosis\Outcome- Rash near injection site. Rash size of apple. 2-3inch in Diameter - Unknown,Soreness from initial injection on day 1 - Recovered/Resolved.
The patient´s arm then became swollen for the last few days; received PNEUMOVAX 23 simultaneously with an unspeciffied "flu" vaccine in the same arm; This spontaneous report was received from a consumer referring to his uncle, a male patient of unknown age. The patient's concurrent conditions, past medical history and concomitant medications were not reported.  On an unknown date (reported as few days ago), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (dose, frequency, route, lot/batch # and expiration date were not provided) for prophylaxis; simultaneously he was vaccinated with an unspecified flu vaccine in the same arm (dose, frequency, route, lot/batch # and expiration date were not provided) (product administered at inappropriate site). Then, the patient's arm became swollen for the last few days (peripheral swelling).  The outcome of peripheral swelling was unknown  The causality assessment between the event and Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23) was not reported.
Chronic hives, excessive itching, swelling of lymph nodes, skin rashes, extremely dry skin, constant muscle spasms.
Per parent request and gave the pediatric dose to 12 YO. No adverse events ahve been reported as of  12-12-21.
PT. DEVELOPED A FEVER UP TO 103 DEGREES ON THE NIGHT THAT VACCINES WERE ADMINISTRED. ALSO NOTICES WAS RED, RAISED BUMPS ON PATIENT'S ARMS AND TORSO. PT. MOM GAVE PATIENT TYLENOL AND FEVER WAS WELL CONTROLLED. PMD'S OFFICE NOTIFIED BY MOM THE DAY AFTER VACCINES ADMINISTERED. PT. AFEBRILE ON THE DAY AFTER BUT STILL HAS THE RASH. PATIENT'S MOM INSTRUCTED TO CONTINUE TYLENOL AS NEEDED FOR FEVER AND MONITOR CLOSELY. INSTRUCTED TO CALL BACK IF FEVER PERSISTS, RASH PERSISTS OR WORSENS OR ANY OTHER CONCERNING SYMPTOMS ARISE. PATIENT'S MOM WAS REASSURED.
patient received first injection on 3/16/21. Contacted pharmacy on 3/25/21 to report injection site swelling, redness, and hot to touch. Patient said it showed up night of injection but she did not contact us right away. Told patient to apply cool compress to the area and also to take antihistamine. Patient called back and said it was doing better. Advised patient to contact doctor in case of cellulitis if antibiotic needed.
chest pain; chest pain, feels tight when breathing in and out; This is a spontaneous report from a contactable consumer or other non health care professional (patient). A 17-year-old non pregnant female patient received BNT162B2 (Solution for injection; Batch/Lot Number: FD8448, Expiry date: Unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 17Aug2021 11:00 as DOSE 1, SINGLE for covid-19 immunization (at the age of 17-year-old). The patient had no known allergies and other medical history. The patient had not received any other vaccine within 4 weeks. Concomitant medication included paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported (Other medications in two weeks). The patient was not pregnant at time of vaccination. The patient had not been diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID post vaccination. On 17Aug2021 16:30 the patient experienced chest pain, feels tight when breathing in and out. The patient received no treatment for the events. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
The patient was given expired vaccine on 4-20-22.  the patient is scheduled to revaccinate
Numbness in the hands and legs; High heart rate; This is a spontaneous report from a contactable consumer. This male consumer (patient) reported for himself.  A male patient of unspecified age received a dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on an unspecified date as DOSE NUMBER UNKOWN, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, after the vaccination, the patient experienced numbness in the hands and legs and High heart rate. The events assessed as non-serious. The outcome of the events was unknown.  No follow-up attempts possible. No further information expected.
Patient developed rash 01/24/2019 13 post vaccines for MMR/ Var unknown which is causing, no treatment at this time.
3 x 4 in. area on left tricep from MMR vaccine given 7/10/15 red, slightly swollen, tender and itchy.
I was diagnosed with Thyroid Eye Disease; I had been having bulging eyes; I had been having dryness; I had been having pain; I had a sore arm; This spontaneous case was reported by an other health care professional and describes the occurrence of ENDOCRINE OPHTHALMOPATHY (I was diagnosed with Thyroid Eye Disease) and EXOPHTHALMOS (I had been having bulging eyes) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Graves' disease since 2019. Concomitant products included LEVOTHYROXINE for Graves' disease.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 11-Feb-2021, the patient experienced VACCINATION SITE PAIN (I had a sore arm). On 17-May-2021, the patient experienced ENDOCRINE OPHTHALMOPATHY (I was diagnosed with Thyroid Eye Disease) (seriousness criterion medically significant), EXOPHTHALMOS (I had been having bulging eyes) (seriousness criterion medically significant), DRY EYE (I had been having dryness) and EYE PAIN (I had been having pain). At the time of the report, ENDOCRINE OPHTHALMOPATHY (I was diagnosed with Thyroid Eye Disease), EXOPHTHALMOS (I had been having bulging eyes), DRY EYE (I had been having dryness), EYE PAIN (I had been having pain) and VACCINATION SITE PAIN (I had a sore arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient reported that she experienced Thyroid Eye Disease.she'd been experiencing eye dryness, pain, & bulging.  She reports that she'd been using over the counter eye drops On 20-May-2021 she saw an ophthalmologist and On 10-Jun-2021 saw an eye surgeon. "My Dr recently told me I need to have a hysterectomy." Treatment information was not provided.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, patient´s history of Grave´s disease could be a confounding factor for the event Endocrine ophthalmopathy.   This case was linked to MOD-2021-290469 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, patient´s history of Grave´s disease could be a confounding factor for the event Endocrine ophthalmopathy.
Age 2 began staring, getting flushed, giggling, not responsive to calling name.  Took for EEG was abnormal
New onset sinus venous thrombosis 15 days after 2nd dose of COVID19 vaccine. Patient did had other predisposing factors that include use of OCP, sinus issues since she is a swimmer, and dehydration at admission.
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 PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021 at 9:29 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Jan-2021 at 9:29 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), 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, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of the patient was 23.63.  Concomitant product use was not provider by the reporter.  Excursion time was 09 AM, temperature was 34 and on 10 AM temperature was 34, total doses given for the day was 96, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 05-Jan-2021, vial was moved to clinic on 07-Jan-2021. 6 vials were sent to clinic. Beyond use date was reported as 27-Jan-2021.   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 brand 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.
45 Minutes after the shot, my head got light, stomach upset, I vomited twice, and was sweating. I ate 30 minutes before taking the shot. I felt bad all day, could not eat again until the next day.
The patient recently saw the nurse practitioner and told her he thought the injection was high, close to the joint. Practitioner didn't think there was any nerve damage but that patient did complain of pain with motion.
This spontaneous report was received from a nurse, via company representative, refers to an 18 year old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 12-APR-2016, the patient was vaccinated with a dose of GARDASIL lot # K010215, intramuscularly, (dose and expiry date not provided). Subsequently, on the same day, the patient experienced throat closed and she could not breathe. The patient did not go to emergency room that day. Then the next day, on 13-APR-2016, the patient family sought medical attention and took her to urgent care (facility unknown), where she was treated with unspecified steroid pack. The patient's parent strongly thought that physician may have given the patient something other than GARDASIL. The outcome of the throat tightness and dyspnoea was reported as recovered in approximately 2016. Causality assessment was not provided. Additional information has been requested.
Fever, chills, muscle aches, cough, wheezing, shortness of breath, headache, fatigue, loss of taste and smell
Patient's left arm was sore and had a blotchy red rash.  Patient was instructed to continue Benadryl 25 mg every 8 hours for the next 2 days. Use cool pack 3 times daily for the next 2 days.
Extreme untreatable Headaches, burning sensation left side of body, backache left side, Eye Pain and sudden onset of shingles.