chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Right sided facil droop / diagnosed with Bell's palsy; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a patient (pt) of unknown age and gender. The pt's pertinent medical history, concurrent conditions or concomitant medications were not reported. In or around 21-AUG-2017, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dosage and route of administration were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On 25-AUG-2017, four days after receiving zoster vaccine live (ZOSTAVAX), the pt suffered right-sided facial droop. Subsequently, on an unspecified date in August 2017, the pt was hospitalized and diagnosed with Bell's Palsy. It was also specified that the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The event was considered to be related to zoster vaccine live (ZOSTAVAX) vaccination.  Upon internal review, Bell's Palsy was considered medically significant.
Nausea, aches and fever started around 6:30pm and lasted throughout the night.  Symptoms continued with temperature around 100 through the following day until 5:30pm.  Tylenol taken 10/21 around 5pm (dose unknown).
Information has been received from a pharmacist concerning a 74 year old male patient with no pertinent medical history who on 29-SEP-2010 was vaccinated in right deltoid with a 0.5ml dose of PNEUMOVAX 23 (lot # 665904/0866Z). There was no concomitant medication. On 29-SEP-2010, the patient experienced redness in his right arm, flu-like symptoms and difficulty raisin his arm. On an unspecified date, the patient recovered. The pharmacist would like a lot check. The patient sought unspecified medical attention. This is one of several reports received from the same source. A standard lot check investigation has been finalized. All in-process quality checks for the lot number (lot # 665904/0866Z) in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center of Biologics Evaluation and Research and was released. No further information is available.
Pt. states that after receiving the 3rd dose of Phizer 12/08/2021, started experiencing symptoms 12/12/2021 of fever, chills, and swelling around the neck. Neck pain associated with swelling,  visit 12/13/2021 recommendation for Ultrasound follow-up with Primary. Pt. still experiencing symptoms, no noted Primary visit/communications.
Patient awoke approximately 7:15am-7:30am and started her usual morning routine.  At approximately 7:45am-7:50am she was sitting down having a cup coffee and suddenly became very dizzy.  She thought the symptoms would pass shortly but soon found herself "coming to" after her husband found her passed out for a short period of time.  Patient felt "off" the rest of the day, though reported feeling back to normal as of this morning.  Patient has a cardiac history (multiple stents placed) but denies any related symptoms or changes to medication.
A couple weeks after the 2nd shot  I had blurriness of vision and  had bouts of light headed dizziness . 4 weeks after the shot I began getting non-stop tinnitus in both ears. It is non-stop and cannot sleep
got a heart condition; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). A child patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (tris), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: CARDIAC DISORDER (non-serious), outcome "unknown", described as "got a heart condition".  Additional information: The report was not related to a study or programme. Consumer works in a hospital and majority 90 percent of patients took our covid vaccine. He had a friend's child took the vaccine and got a heart condition. Stated that we are hiding the side effects and it is a junk vaccine. Stated that we are saying the heart condition is from smoking weed and we are making excuses since we are making a junk vaccine. Investigation Assessment was not Provided.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Pain on the left side of chest when trying to get up from a sleeping position or when inhaling deeply.
EXCESSIVE SHAKING; WEIGHT LOSS; VOMITING; SEVERE MUSCLE PAIN; This spontaneous report received from a parent via a company representative concerned a 5 decade old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced excessive shaking, weight loss, vomiting, and severe muscle pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the excessive shaking, severe muscle pain, weight loss and vomiting was not reported. This report was non-serious.
Chills, body aches, fever, heart pain, blood vessels felt like they were burning, headache, sore arm, sweating, racing heart, fatigue.
valid birthdate upon  research in vaccine registry is (unlisted), all childhood immunizations are for the (unlisted) birthdate, form was filled out by recipient stating birthdate was (unlisted) therefore would be 18 years of age.
He had lost his taste & smell he also had a sore throat & he was congested so we waited a couple of days & took him to the pharmacy & got a covid test & it was positive & we did a telemedicine visit.
chills, fever (more than 24 hours, 100.5-101.5F, ) body pain, weakness, fast pulse Feel very sick. No treatment.
Info has been received from a CMA concerning a 17 month old white female with no medical history or allergies, who on 8/30/05 was vaccinated, SC, into the right thigh with a dose of MMRII (lot 647652/0579R). There was no illness at the time of vaccination. There was no concomitant medication. On 8/30/05, 5 minutes after vaccination, the pt developed 1 cm sized hives under her right eye. The pt also developed a 7 cm blotch at the injection site with redness and swelling. The pt was treated with Benadryl and all events improved. It was noted that the pt was referred to an allergist. There were no lab/diagnostic studies performed. Subsequently, the pt recovered. No product quality complaint was involved. Additional info is not expected.
swelling in the scrotum and testicle area; This spontaneous case was reported by a consumer and describes the occurrence of SCROTAL SWELLING (swelling in the scrotum and testicle area) in a 46-year-old male patient 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 SCROTAL SWELLING (swelling in the scrotum and testicle area). At the time of the report, SCROTAL SWELLING (swelling in the scrotum and testicle area) had not resolved.            No Concomitant medications were provided. Treatment medication included antibiotics for epididymitis.   This case was linked to MOD-2021-369164 (Patient Link).
Became extremely dizzy with a high heart rate. 5 minutes after vaccination.  This continued for  an hour and I called the paramedics. My blood pressure was high and heart rate was high. This same thing happened about 2 weeks after I got my second shot  as well.  (February 13 2021) Continue to experience  intermittent high blood pressure, high heart rate and tingling pressure in feet.  All tests of heart have come back normal.
I had a sore arm for about a day after receiving the vaccine.  I had a fever and I felt exhausted prior to testing positive for COVID-19 in 02/2023.  I contacted my doctor and got a prescription (unknown) to help with the symptoms. I tolerated the medication without any complications.
lip swelling; rash; itchy; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of LIP SWELLING (lip swelling), RASH (rash) and PRURITUS (itchy) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for Covid-19 Vaccination.     The patient's past medical history included No adverse reaction (no medical history reported). Concomitant products included ATORVASTATIN for an unknown indication.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2021, the patient experienced LIP SWELLING (lip swelling), RASH (rash) and PRURITUS (itchy). At the time of the report, LIP SWELLING (lip swelling), RASH (rash) and PRURITUS (itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medications were not provided by reporter.   Reporter did not allow further contact
allergy to spicy food after the third dose of Moderna vaccine.; skin rashes; Itchiness; This spontaneous case was reported by a non-health professional and describes the occurrence of FOOD ALLERGY (allergy to spicy food after the third dose of Moderna vaccine.), RASH (skin rashes) and PRURITUS (Itchiness) in a 30-year-old male patient 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and 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 FOOD ALLERGY (allergy to spicy food after the third dose of Moderna vaccine.), RASH (skin rashes) and PRURITUS (Itchiness). At the time of the report, FOOD ALLERGY (allergy to spicy food after the third dose of Moderna vaccine.), RASH (skin rashes) and PRURITUS (Itchiness) outcome was unknown.            No concomitant medication reported. No treatment information was provided. It was reported that patient does not had underlying disease.
12 year old was given Moderna as first and second dose of COVID vaccine. Child had no symptoms after first vaccine. Child had no symptoms as of 4 hours after second vaccine was given.
This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. The nurse reported that, on an unknown date, an unspecified amount of doses of VARIVAX (Merck) 0.5 ml, subcutaneous (lot # and expiration date were not reported) that underwent a temperature excursion was administered to an unspecified amount of patients. No adverse effect was reported. Follow up information has been received from a licensed practical nurse on 23-JAN-2015. It was reported that there was no lot numbers, expiration dates and patient data readily available. Nurse reported that no adverse event had been reported following administration of vaccinations. Follow up information has been received from a licensed practical nurse on 23-JAN-2015. The nurse stated that 9 doses of VARIVAX (Merck) with lot number K006137 were administered since fridge incident (since 09-DEC-2014). Follow up information has been received from a licensed practical nurse on 18-MAR-2015. On 04-OCT-2013, the patient of unknown age and gender was vaccinated with a dose of VARIVAX (Merck) that underwent a temperature excursion. This is one of several reports received from the same reporter. Additional information is not expected, all available information has been received.
This spontaneous report was received from a pharmacist refers to a 87 year old female patient. On 17-OCT-2014, the patient was vaccinated with second dose of PNEUMOVAX 23, 0.5 ml, intramuscular, approximately one year after patient had received the first dose of PNEUMOVAX 23 (in 2013). No adverse effect was reported. The outcome of patient received a second dose of PNEUMOVAX 23, approximately one year after patient had received the first dose of PNEUMOVAX 23 was unknown. Additional information has been requested.
Approximately 10 minutes after vaccination, patient has difficulty breathing and begins to hyperventilate.  She complains that she cannot breathe and hives erupt around the injection site on the left arm.  911 is called.  Blood pressure is normal at 135/85.  Subsequent pressure drops to 118/77.  Pharmacist administers 0.3mg epinephrine IM to left thigh followed by diphenhydramine 50mg IM to left arm.  Patient is moved to supine position and continues to have difficulty breathing.  She is wheezing, squeak noises indicated possible narrowing of airways and she cannot talk.  A second dose of epinephrine is administered approximately 2:35PM.  Paramedics arrive and patient is transported to hospital.
Headache, Sedation, Fever, Chills, Neck pain Narrative:
Body chills and violent vomiting for 4 hours; Body chills and violent vomiting for 4 hours; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 12Apr2021 at 14:15 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. The patient had no other medical history and no known allergies to medications, food, or other products. Concomitant medication taken within two weeks of vaccination included prenatal vitamins for unknown indication from unknown date. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 22Mar2021 at 14:15 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Apr2021 at 02:00, the patient experienced body chills and violent vomiting for four hours. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events body chills and violent vomiting for four hours was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Vaccinee rec'd a series of 3 Engerix-B injects (deltoid) according to 0, 1, 6 mo schedule. About 1 mo following the 3rd dose, results of testing for Hepatitis B surface antibody indicated she had a low titer;
Dizziness, fever, tinnitus, chills nauseas, fatigue, redness at injection site. 2 days later - arm red, swollen, warm, itchy and hard.
chills body aches headache dizziness nausea stomach cramps / bowel issues red rash appeared a few days later on chest and arms
A spontaneous non-serious report of administration to a pregnant female was received from a physician concerning a 26 year old female patient. On 19-Dec-2008, FLUMIST was unknowingly administered to a woman that was two weeks pregnant. Past obstetrical history included: Para 1, Gravida 1, Premature 0, Spontaneous Abortion:0, Elective termination:0. The patient's last menstrual period was 19-Nov-2008. The estimated date of delivery was 26-Aug-2009. The pregnancy was ongoing. There was no adverse event associated with this pregnancy at the time of the report. Treatment and reporter/sponsor causality assessments are not applicable. The reporter was asked to report when the pregnancy ended and if the patient experienced any adverse events during pregnancy.
Syncope. pt lost consciousness briefly (under 1 mintue) pt was alert and oriented by the time I saw him. pt has hx of same for every vaccination.
Rec'd vaccine yest around 4pm - reports body aches, fatigue and headache began this morning.  States she has been sleeping most of the day and just recently checked her temp and has a fever of 101.8F.
was administered a dose of ROTATEQ and vomited once after administration; vomited once after administration resulting in a possible incomplete dose; This spontaneous report was received from a nurse practitioner referring to a 2-month-old infant patient. Information on patient's medical history, concurrent conditions and concomitant therapies was not reported. On 09-MAY-2019 the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength, dose, frequency were not reported, lot # R033253 and expiration date 19-JUL-2019) via unknown route for prophylaxis. On 09-MAY-2019 the patient vomited (vomiting) once after administration of the vaccine resulting in a possible incomplete dose (accidental underdose). The outcome of vomiting was unknown.   Action taken with the suspect therapy was not applicable. Causality assessment was not reported. There was no involvement of product quality complaint (PQC).  Lot number R033253 has been verified to be a valid lot number for rotavirus vaccine, live, oral, pentavalent.
Maternal exposure during pregnancy; Never received a second dose; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) and PRODUCT DOSE OMISSION ISSUE (Never received a second dose) 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.    In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) and PRODUCT DOSE OMISSION ISSUE (Never received a second dose). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved and PRODUCT DOSE OMISSION ISSUE (Never received a second dose) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided. The patient and her husband took the dose back in May, but never received second dose. She was found pregnant about a week ago prior to this report. Company Comment: This is a case of product exposure during pregnancy with no associated AEs and missed dose for this female patient of an unknown age. Patient will continue to be contacted for further monitoring of AEs during the pregnancy. Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs and missed dose for this female patient of an unknown age. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
1:15pm 112/77, 97, 22. Presented w/ s H/A in frontal occipital, skin w/d, resp even and regular.
Immediately while getting the vaccines, the patient felt sick and started having swelling and applied ice. She has pain and swelling in the left deltoid and it radiates to the collarbone and left side of the neck. The area is hot to the touch.
on 1/13/20 (a week and a day after receiving my first moderna COVID19 vaccination), I developed a swollen, red, hard mass on my left arm around the site of injection on my left arm.  It was itchy and warm.  I proceeded to take 2 tablets of benadryl and applied ice.  I went to the  emergency room for an evaluation.  They recommended anti-itch topical ointment and to monitor symptoms.  We discussed having the second vaccination and the risks/benefits.
Woke with massive congestion , not much of a voice, slight difficulty breathing and general malaise. Test for COVID was negative. (We brought home tests with us.) I felt well enough to resume activities and thought I had a bad cold. On the third day in the evening, I developed a bad cough. Test for COVID was positive. Since I was on a cruise, notified the sick bay. They retested with the same positive result.  Since I didn't have a fever and I was already starting to feel better, they gave me Corocidin and cough drops and told me to isolate. After taking the Corocidin and a good nights sleep the cough was gone and I felt much better. I still had a lot of congestion and no energy. This continued for another 3 weeks or so when I finally started to feel like myself again. I only took the Corocidin for a week. Interestingly, my partner was tested repeatedly after I developed COVID and never developed it.
4/24/2013 High school nurse called to report that yesterday patient had (R) arm swelling, redness and hard 4cm area. Mom took child to get checked at Doctor's office. Not sure of outcome.
2 weeks after receiving Covid 19 vaccine my knees rather quickly became very tight and very sore making it difficult to get up from a chair.  This condition has persisted with varying degrees of pain, discomfort, and impaired mobility.  Since 1/25/21, my osteo arthritis is exacerbated.
Patient received Pfizer COVID vaccine in our facility on 6/9/21 and 6/30/21. As dose #2 is documented in the vaccine card, patient inadvertently pulled out 2 vaccine cards. One of them is documented with Pfizer dose #1 given on 6/9/21, still needing 2nd dose to be documented. While the other card showed that patient has received Pfizer COVID vaccine on 2/24/21 and 3/18/21 from another facility. Patient was apprehensive when asked about the other vaccine card. Information System also showed that patient did receive Pfizer COVID vaccine on 2/24/21, 3/18/21, and 6/9/21, making 6/30/21 as a 4th dose. There was no adverse reaction in this case. Event is reported due to administration error.
Patient's entire arm and hand were painful for the first 5 days and is still experiencing constant aching from the elbow up which increases w/ movement.
This spontaneous report was received from a licensed practical nurse and refers to a 14 year old patient of an unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 16-AUG-2016, the patient was vaccinated with an improperly stored dose of VAQTA injection, lot # M021124, expiration date 02-FEB-2018 (dose, route and site of administration were not reported) for prophylaxis. No symptoms were reported. Product quality complaint was not involved. The administered dose of VAQTA was stored in the temperature of 32 degrees Fahrenheit for 15 minutes and in the temperature of 31 degrees Fahrenheit for 15 minutes. The reporter did not know why the temperature excursions occurred. There were no previous and no further excursions. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1608USA012794: US-009507513-1608USA012916: US-009507513-1608USA012908: Original Case : 1608USA012908.
FEVER OF 101 AXILLARY AT HOME. NOT CONTROLLED WITH TYLENOL. 102.5 RECTAL IN OFFICE. CONTINUE SUPPORTIVE CARE.