chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Itching and rash-like all around injection site (white bumps w/red rash). Noticed 1-2 days after shot. Went to DR, he said "looked like she was allergic to something in shot". Called a few days later, and patient was better.
felt heavy; HEADACHE; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt heavy) and HEADACHE (HEADACHE) in an 80-year-old female 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, the patient experienced FEELING ABNORMAL (felt heavy) and HEADACHE (HEADACHE). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (felt heavy) and HEADACHE (HEADACHE) had resolved.            No concomitant medication information was provided   This case was linked to US-MODERNATX, INC.-MOD-2021-062842 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-062842:First dose case
chills; Nausea; Extreme body pain; Fever; This is a spontaneous case from a contactable consumer, the patient. A 50-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: EL9266) as a first dose in the left arm on 15Feb2021 at 10:30 am and (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: EN6206) as a second dose in the right arm on 08Mar2021 at 13:30 pm via an unspecified route of administration for COVID-19 immunization(age at the vaccination: 50 years). Medical history and concomitant medications are not reported. Prior to the vaccination the patient was not diagnosed with COVOD-19. Since the vaccination, the patient had not been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The facility where the most recent COVID-19 vaccine was administered was at a  Clinic. On 15Feb2021, the patient experienced Fever, chills, extreme body aches, nausea for first dose and no side effects for second dose. No therapeutic measures were taken for the events fever, chills, extreme body aches and nausea. The clinical outcome for the events fever, chills, extreme body aches, nausea are recovered on an unknown date. The patient feels like he didn't get a second dose or something was wrong with the second dose as he did not experience with any events. No follow-up attempts are needed. No further information is expected.
Patient received improperly stored vaccine; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug allergy/reaction and concomitant medications were not reported. On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) one dose (strength, frequency, route were unknown) lot # S003865, expiry date: 08-AUG-2020 for prophylaxis. On an unknown date, the patient recived improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live(PROQUAD) vaccine (product storage error). The outcome of product storage error was unknown.
numbness and tingling in mouth and cheek on left side/a little spot on the lip of numbness; numbness and tingling in mouth and cheek on left side; numbness and tingling in mouth and cheek on left side; This is a spontaneous report from contactable nurses.  A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318), via an unspecified route of administration on the left deltoid on 27Jan2021 16:30 at a single dose for COVID-19 immunization. Medical history included type 2 diabetes mellitus, hypothyroidism, and hypertension. There were no concomitant medications.  Patient previously took lisinopril. On 27Jan2021, two minutes after receiving the vaccine, the patient experienced numbness and tingling in mouth and cheek on left side on the same side that she got the vaccine on, so she took 50mg diphenhydramine (BENADRYL), it went away and she slept all night. She then woke up and felt fine, with the exception of a little spot on the lip of numbness on 28Jan2021, so then she took 25mg Benadryl at 11:00 and it was gone all day. In the last 15 minutes her numbness was back and so she took another 25mg Benadryl at 17:00. Patient stated that she knows if this kept continuing she will have to go to the emergency room. In detail, patient had tingling on lips and mouth. The tingling traveled up her left side of the face to the bottom of her nose. Took 50mg of diphenhydramine after she got home. Woke up morning of 28Jan2021 with tingling on her lip, so she took 25 mg at that time. The tingling came back the afternoon and she took another 25mg and another dose before bed. She reports a small area of tingling on her lip remains as of 29Jan2021. She has not take any more diphenhydramine. She does not think it was Bell's Palsy.The reporter considered the event medically significant. Patient inquired if she can take the second dose of the vaccine and that she has done that before with lisinopril (not further clarified). Patient was to receive the second dose on 18Fe2021 or later. Patient did not have anything just right before the vaccine, has had no positive Covid or antibody test prior to the vaccine and no issues with vaccines in the past. The patient has recovered from the events, numbness and tingling in mouth and cheek on 28Jan2021 and outcome of the event, little spot on the lip of numbness was not recovered.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Nausea, vomiting, lethargy,  headache, fever of 101.7, loss of appetite, bodyaches,chills
This spontaneous report as received from a consumer regarding her daughter refers to a female patient of unknown age. No information about medical history, concurrent conditions and concomitant medications were reported. The reporter stated that on 22-JUL-2014 the patient was vaccinated with MMR II and (Oka/Merck) VARIVAX (strength, route were not reported) at her well baby visit. The reporter also mentioned that the vaccines administered were well with in expiry. On 30-JUL-2014 evening, the patient felt warm and temperature rectally was measured with a result of 104.1 F. The patient was given with a dose of MOTRIN to bring it down. The reporter stated that fever had decreased to around 100F next day morning and was given additional MOTRIN dose the same morning. The outcome of high fever was reported as Recovering/Resolving. No product quality complaint was involved. Additional information has been requested.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's pertinent medical history and concurrent condition were not reported. On 14-AUG-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (lot # K021548, expiration date 06-MAY-2016, dose, frequency and route were unknown). No concomitant medication was reported. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Suffered an anaphylactic reaction and I was taken by ambulance to the Emergency Room; Diarrhea; Nausea; Headache; Myalgia; Fever; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANAPHYLACTIC REACTION (Suffered an anaphylactic reaction and I was taken by ambulance to the Emergency Room) in a 67-year-old male patient who received mRNA-1273 (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Was hospitalized with Covid in February 2021) on 01-Feb-2021, Deep venous thrombosis NOS (Ended up with Deep Venous Thrombosis in the hospital) and Thrombophlebitis.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced HEADACHE (Headache), MYALGIA (Myalgia), PYREXIA (Fever) and FATIGUE (Fatigue). On 07-Apr-2021, the patient experienced DIARRHOEA (Diarrhea) and NAUSEA (Nausea). On 13-Apr-2021, the patient experienced ANAPHYLACTIC REACTION (Suffered an anaphylactic reaction and I was taken by ambulance to the Emergency Room) (seriousness criteria medically significant and life threatening). On 01-Apr-2021, PYREXIA (Fever) had resolved. On 12-Apr-2021, NAUSEA (Nausea) had resolved. At the time of the report, ANAPHYLACTIC REACTION (Suffered an anaphylactic reaction and I was taken by ambulance to the Emergency Room), DIARRHOEA (Diarrhea), HEADACHE (Headache), MYALGIA (Myalgia) and FATIGUE (Fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  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 these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
lump under my chin below my left ear which is very sore to the touch after my 2nd dose.
pt recv vax 14FEB97 & 18FEB97 pt exp fever, cardiomegaly, tachypnea, tachycardia & grunting resp;dx cardiomyopathy & hosp same day;diagnostic test revealed initial ejection fraction of 7" & on 25JUN97 echocardiogram revealed eject fraction
No adverse event. Noticed that wrong vaccine given within ten minutes, informed physician, patient's guardian, and Health Department. Per CDC guidelines, ZOSTAVAX counts as a valid dose toward Varicella immunity.
Rash began on elbows one week after the vaccine, the pimples went away and then flatten out so now they look like little red spots on her arm . they began on her arm and her leg like it broke out in those spots. Went to the doctor  office on 4/29/21  and couldn't determine the cause.  Patient doesn't recall if she mention the vaccine to the doctor.
Swollen tongue and face Rapid heartrate Trouble breathing Dizziness  Weakness Nausea and vomiting  Chest pain
Suspected myocarditis. Chest pain with multiple intermittent dysrhythmias including complete heart block, junctional, PVCs. Trop leak. Elevated NT-proBNP. Planning for IVIG.
ARM PAIN LAST FOR 7 DAYS, GENERAL MALAISE AND SLEEPLESSNESS FOR 7 DAYS.
Went to the hospital because my legs swelled up and I was in pain. Things got worse less then 24hrs after the second shoot.  Now I feel tired/ dizzy/ drunk all the time. Almost 24/7. It?s making life really hard for me.
My joints specifically my wrists and ankles started swelling within 2 weeks. I had a great amount of swelling in my knees, upper spine along shoulders, hips, hands swelled to having no grip. My doctor referred me to a rheumatologist. The Rheumatologist diagnosed Rheumatoid arthritis and prescribed methotrexate, prednisone. In January, the 17th I had a ganglion cyst appear and was removed Feb 9th. During this period I have had unpredictable episodes of very strong hand shaking.
Having suffered all the common side effects of this vaccine between date of receiving it, April 7th, 2021, to this time of writing, evening of April 11th, 2021, I began to suffer from bladder pain and burning during urination on the morning of April 11th, 2021.  I've had no treatment for this as of the time of reporting .  I plan to contact my doctor's office Monday morning, April 12th, 2021.
passed out; body temperature rose fast; sweating; blood pressure and ECG went low; blood pressure and ECG went low; This is a spontaneous report received via COVAES from a non-contactable consumer (patient). A 43-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, first dose via an unspecified route of administration, administered in right arm on 01Apr2021 10:00 (Lot Number: EP7534) as single dose for covid-19 immunisation. Medical history included allergies to penicillin. Concomitant medication(s) included diphenhydramine hcl. Side effects started about 4 minutes after getting the shot. At first, the body temperature rose fast, and patient started sweating. Then, patient passed out, and both blood pressure and ECG went low. Patient was sent to the emergency room and released a few hours later. AE resulted in Emergency room/department or urgent care. Treatment included fluids. No Covid prior vaccination. No Covid tested post vaccination. The event outcome for events was recovered.  No follow-up attempts are possible. No further information is expected.
ITCHING ; REDNESS ; SWELLING " LIKE A WATER BUBBLE", WARM TO THE TOUCH . SYMPTOMS LASTED X 1 WK. PT WAS NOT SEEN IN CLINIC NOR ER. PT DENIES PAIN. PT SHOWED ME APPROXIMATE SIZE OF SWELLING AND MEASURED 9CX K12  CM INNER ARM. 10/14/2021 PT SEEN IN CLINIC FOR HER REGULAR FOLLOW UP AND VACCINE ADVERSE EVENT REPORTING FORM FILLED OUT.
Information has been received from a physician concerning an 2 month old patient who was vaccinated with the first dose of Rotateq. The patient developed nasopharyngitis. The patient sought medical attention via ER visit and was treated with a dose of penicillin (unspecified). Subsequently, the patient recovered and was noted to be fine. There was no product quality complaint. Additional information has been requested.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 04-JAN-2018 and 23-APR-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ (strength were unknown) (lot# N004815 and expiration date 07-OCT-2018; lot# N024295 and expiration date 24-MAR-2019) orally for prophylaxis, respectively. The sterile diluent (MERCK) (lot# and expiration date were unknown) was properly stored. No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001958.
Low grade temp. 100.2 All over body aches tired/no energy I took 1250mg. Tylenol, 2x's on 2/5/2021 and slept most of the day. Today, 2/6/2021 I feel fine. No further symptoms and no further need for Tylenol.
Patient received Moderna COVID vaccine IM to left arm. Patient reports tingling sensation to left arm radiating to the back of neck. Patient stated she waited the 30 minutes and began to feel like her throat was itchy. Patient denies SOB, dizziness, chest pain or severe headache. Vital signs taken BP 186/91 P 79 o2 sat 97% on room air. Retook patient VS BP 177/82 P 82 o2 sat 98% on room air. Patient transported via wheelchair to Walkin Clinic for further evaluation. Patient transported via wheelchair to Walkin Clinic for further evaluation. Report given to healthcare worker, ARNP, advised patient to be  evaluated for further treatment.
Mouth and tongue (top and bottom) numb and stinging, facial swelling and red rash - 5 days Fever 101 - 2 days headache - 5 days nausea - still have diarrhea - 6 days Sore and stinging left arm (received vaccine), sore upper and lower back and neck. Felt like I was kicked in those areas - still have Fatigue - 6 days, lessening Toes bright red at the top and are painful, areas on bottom of toe as well - still have
STIFFNESS; PAIN; This spontaneous report received from a patient concerned a 54 year old male of unknown race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis, moderate to severe chronic plaque psoriasis, and moderate to severe ulcerative colitis, and other pre-existing medical conditions included: No known allergies and no relevant medical history. The patient previously received 2 doses of covid-19 vaccine ad26. cov2.s (dose 1 of dose number in series 1) (dose 2 of dose number in series 1) (suspension for injection, intramuscular, batch number and expiry were not reported) dose was not reported, 1 total, administered on an unspecified date for prophylactic vaccination which was an off label use and inappropriate schedule of vaccine administration (dose 2 of dose number in series 1). The patient experienced covid-19 (dose number in series 1) when treated with covid-19 vaccine ad26. cov2. s for prophylactic vaccination. The outcome of the events covid-19, inappropriate schedule of vaccine administration and off label use was unknown. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, intramuscular, batch number and expiry was not reported) dose was not reported, 1 total administered on 30-DEC-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: upadacitinib (form of admin unknown, oral, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe chronic plaque psoriasis, moderate to severe ulcerative colitis, and moderate to severe rheumatoid arthritis. 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 unknown date in 2022, the patient experienced stiffness, and pain (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with upadacitinib was not reported. The patient recovered from stiffness, and pain. This report was non-serious. This case, involving the same patient is linked to 20220349210.
pt reported feeling weird and after injefction face was pale. Delay answers,  pt was given water & blood pressure  was taken 3 time. Doc checked on pt.
Large persistent  rash over torso, upper legs, and buttock region; This is a spontaneous report from a non-contactable consumer, the patient. A 29-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: Ew0175) via an unspecified route of administration in the right arm on 28Apr2021 at 00:00 (at the age of 29-year-old) as a single dose for COVID-19 immunisation. The medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medication within two weeks of vaccination. On 01May2021 at 00:00, the patient experienced large persistent rash over torso, upper legs and buttock region. Therapeutic measures were taken as a result of reported event which included treatment with Benadryl or used calamine lotion. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event large persistent rash over torso, upper legs and buttock region was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Temperature Excursion issue; Patient received expired Moderna Covid-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature Excursion issue) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A, 036C21A, 036A21A and 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature Excursion issue). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature Excursion issue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The patient received their first primary series dose of the Moderna vaccine on 10-Feb-2021 and had no adverse Reactions to their first dose of the Moderna Covid-19 vaccine. The patient received the second primary series dose of the Moderna vaccine on 10-Mar-2021 and had no adverse Reactions to their second dose of the Moderna vaccine. It was reported that the Immunocompromised patient did not receive 3 full primary series doses. The patient received the first Booster Dose on 11-Nov-2021 and reported no other adverse events to their booster dose. The patient received expired Moderna Covid-19 vaccine as their Second Booster dose on 18-Apr-2022. Reportedly, the patient reported no other adverse reactions.  The dose was administered after 30-day Use by Date or after manufacturer date of expiry. The date the vial initially stored in the refrigerator was 21-Mar-2022 and it was also reported that the vial did undergo the temperature excursions.  The patient's weight was unknown.  No treatment information was provided.   This case was linked to MOD-2022-545321 (Patient Link).