chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacy technician refers to a 1-year-old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant medications were not reported. On 15-FEB-2018 the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry date: 23-AUG-2019) (dose, frequency and route were not reported) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1802USA001558.
Same day I received the shot, I experienced naseau, fever, and chills.   On Sunday (2 days later), I awoke covered in a raised, itchy rash all over my body.   It lasted until Tuesday.   On Wednesday, I had severe muscle tightening in both calves, originating in the muscle behind my knees.  It was so painful, I couldn?t stand in one spot for longer than 10-15 seconds.   I had to either sit or walk.  I finally have relief from that pain today (Friday).
now sick with some sort of flu; Initial information received on 25-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer.  This case involves a patient of unknown age and demographics who experienced now sick with some sort of flu after receiving vaccine influenza vaccine.  It is unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (strength, dose, formulation, frequency, lot number and expiry date: not reported) via unknown route in unknown administration site as prophylactic vaccination (Immunisation).  On an unknown date, the patient developed a non-serious event now sick with some sort of flu (influenza) (unknown latency) following the administration of influenza vaccine.  It is unknown if there were lab data/results available.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event (now sick with some sort of flu).  At time of reporting, the outcome was Unknown for the event now sick with some sort of flu.
Narrative:  Full body rash, pt went to ER and was instructed to take Benadryl. Appears like it helped symptoms based on some follow-up notes. Would not call this Severe.
Sweaty hand and feet; Sticky hands and feet; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweaty hand and feet) and STICKY SKIN (Sticky hands and feet) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (Sweaty hand and feet) and STICKY SKIN (Sticky hands and feet). At the time of the report, HYPERHIDROSIS (Sweaty hand and feet) and STICKY SKIN (Sticky hands and feet) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided  No treatment product information was provided
Got a coating on my tongue , the roof of my mouth ... Looked it up and looks like COVID tongue.. my is very raw feeling and sore
next morning couldn't wake daughter;was breathing okay;took 5min to wake;open eyes-seemed to be okay p/mom talked loudly to child;no fever, no other sx;
Less than 48 hours after vaccination, patient awoke to right eye swollen and red.  1 hour later, the other eye swelled up.  Over the next two hours - large, red, itchy welts appeared all over patient's face and neck.  Went to Urgent Care facility and was given prescription for Prednisone (20mg)- 2 tabs daily for 5 days; plus, advised to take 50 mg of Benadryl every 6 hours.  Welts continued to appear every day for the next five days.  As of today, 1/13/2020,  welts have decreased and patient went to PCP for follow-up.  Was taken off Prednisone and decreased the dosage of Benadryl (due to improvement and elevated blood pressure).
Patient admitted to hospital on 09/23/2021 with encephalopathy and was incidentally diagnosed with covid-19 on 9/13, but was asymptomatic.
Cold-like symptoms including stuffy nose, itchy eyes, severe malaise, sneezing, light coughing, and headache. Also minor involuntary muscle twitches and light spasms in the arm where the vaccine was administered.
Patient stated she experience heart flutters 3 hours after getting the vaccine which only lasted that evening. She woke up in the morning with no heart flutters but only nausea. She reported no other side effects since then.
10 AM: Vaccine administered. 1030 AM: Mom called office to report pt had begun to feel "itchy' on his face and scalp since vaccine. RN instructed to give 25 mg Benadryl. Mom administered. 1100 AM: Mom called back to report increased itching, redness, swelling of forehead. RN instructed to return to office immediately for evaluation. 1130 AM: Evaluation at office by ARNP. P: 96, RR; 16-18. Patient had hives and urticaria, alert, responsive, appropriate. No SOB, no hoarseness, no wheeze. Watched/monitored in office for about 20 minutes. 12 Noon: Vitals stable, itching, redness improved. Patient left office w/ mom and sister - instructed to continue Benadryl PRN for any urticaria, hives, Reassured. Patient reports that one week ago he was stung by yellow jackets x 6. (Had normal reaction of pain and swelling and redness at sites of stings, no signs of anaphylactic reaction). 230 PM: Mom called to report patient feels completely fine now and is no longer itchy.
Area left thigh encompassing shot site: area about 6x6 inches. Warm, red, swollen but not tender.
insomnia/has not been able to sleep past an hour or two at a time since 12Feb2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 87 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Feb2021 (Batch/Lot number: unknown) at the age of 87 years as dose number unknown single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications.  The following information was reported: INSOMNIA (non-serious) with onset 13Feb2021, outcome "not recovered", described as "insomnia/has not been able to sleep past an hour or two at a time since 12Feb2021".  Additional information: Caller was caring for 87 year old mother. Her mother received the Pfizer COVID-19 vaccine on 12Feb2021. She stated shortly after her mom developed insomnia and has not been able to sleep past an hour or two at a time since 12Feb2021. Caller wanted to know if this was a side effect of the vaccine and long can she expect it to last. Time of Onset (24 hour clock): Began night of the 13Feb2021 at bedtime.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
COVID-19; COVID-19; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 34 year-old female patient received bnt162b2 (BNT162B2), administration date 05Oct2021 (Lot number: EW0196) at the age of 34 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE: 1, Lot Number: EL3248, MANUFACTUERER UNKNOWN), administration date: 02Mar2021, when the patient was 33 years old, for COVID-19 immunization; Covid-19 vaccine (DOSE: 2, Lot Number: EL3248, MANUFACTUERER UNKNOWN), administration date: 23Mar2021, when the patient was 33 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 05Oct2021, outcome unknown; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 22Dec2021, outcome unknown.  Clinical course: Says she is fully vaccinated and has had the booster shot of the Covid Vaccine and now has Covid 19. The patient verifies that her first and second doses of the vaccine have the same Lot Number. The patient had not required to visit to emergency room/physician office. The patient description of complaint was Tested positive for Covid 19 after three doses of the Covid 19 Vaccine.
PERICARDITIS; PAINS AND NEEDLES ON LEGS AND FEET; This spontaneous report received from a patient concerned a 28 year old male. The patient's weight was 165 pounds, and height was 73 inches. The patient's concurrent conditions included: alcohol use in moderation as there was no time to drink, and other pre-existing medical conditions included: The patient had no medical history, had no family history of heart issues, no medication and had no known allergies. The patient participated in activities related to martial arts, rugby. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809, and expiry: UNKNOWN) dose was not reported, 1 total administered on 02-OCT-2021 at around 09:00 for prophylactic vaccination (dose number in series 1) on right arm. No concomitant medications were reported.  On 02-OCT-2021, the patient experienced symptoms 8 hours post vaccination. The patient stayed at vaccination place for 10-15 minutes and biked back home and had dinner at a restaurant near house, while walking back to apartment the patient started to had extremely high heart rate. The patient went to apartment and then to hospital. At hospital the patient was diagnosed with pericarditis and was admitted there. The patient had complaints of pains and needles on legs and feet, palpitations with extraneous exercise, specifically cardio. As per consumer, the patient's resting heart rate was around 55 beats per minutes (bpm), and sometimes even in 40s, and in between 40s and 50s bpm, but post vaccination the heart rate was over 130 bpm and stayed over 100 bpm until 09:00-10:00, the day after vaccination, on 03-OCT-2021. The patient was being in follow up with cardiologist as the heart issues were not resolved. The patient was hospitalized for 2 days and was discharged on 03-OCT-2021. The patient had an emergency room visit for extremely high heart rate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pericarditis, and the outcome of pains and needles on legs and feet was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20211219890-covid-19 vaccine ad26.cov2.s-pericarditis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).  20211219890-covid-19 vaccine ad26.cov2.s- pains and needles on legs and feet. This event(s) is labeled per RSI and is therefore considered potentially related.
Itchy skin developed at 1 am on 5/21/2021 (11 hours after vaccine dosage). Took 1 Benadryl 25mg tablet. Itchy throat developed at 4 am. Took another Benadryl 25mg tablet, symptoms improved and I fell asleep. In the morning, around 9 am, my throat and back of mouth still felt weird to swallow. Took 1 Benadryl at 10 am.
when vaccine was administered, an artery was hit; heart was affected; severe allergic reaction; This is a spontaneous report received from a contactable reporter consumer or other non HCP.  A 60 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administration date Mar2021 (batch/lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (unspecified if ongoing); "diabetes" (unspecified if ongoing). The patient had no covid prior vaccination. The patient's concomitant medications were not reported. It was unknown whether the patient had other vaccine in four weeks.  The following information was reported: WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (hospitalization) with onset Mar2021, outcome "unknown", described as "when vaccine was administered, an artery was hit"; CARDIAC DISORDER (hospitalization) with onset Mar2021, outcome "recovered" (2021), described as "heart was affected"; HYPERSENSITIVITY (hospitalization) with onset Mar2021, outcome "recovered" (2021), described as "severe allergic reaction". The events "heart was affected" and "severe allergic reaction" were evaluated at the emergency room visit. It was unknown if patient was covid tested post vaccination. Therapeutic measures were taken as a result of cardiac disorder, hypersensitivity. The AE treatment was unsure.  Additional information: The reporter informed that when vaccine was administered, an artery was hit and the patient's heart was affected. A severe allergic reaction was reported as well.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Greater than 35 days between Moderna Covid-19  vaccinations; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Greater than 35 days between Moderna Covid-19  vaccinations) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Greater than 35 days between Moderna Covid-19  vaccinations). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Greater than 35 days between Moderna Covid-19  vaccinations) outcome was unknown.        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.   The patient was questioning if it is too late to receive the second dose, since the period is greater than 35 days between doses.; Sender's Comments: This report refers to a case of inappropriate schedule of product administration for mRNA-1273, batch no. 027C21A with no associated AEs.
Pt states about 3 days post vaccination, noticed shaking in right leg and hand. Unable to grip things as well as before and a little weakness in right leg.
Delayed rash on upper arm below vaccination point.  Itchy and hot to the touch.  Lasted for 10 days before going away.
Pneumonia; This is a spontaneous report from a contactable consumer (patient) Pfizer-sponsored program. A male consumer of unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 09Feb2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. It was reported that on 02Mar2021 patient was scheduled for second shot and he will also receive Novocaine for pneumonia. The outcome of the event was unknown. Information on the lot/batch number has been requested.
Information has been received from a physician assistance concerning a 12 month old male patient who on an unspecified date was vaccinated with a dose of MMR II (lot number not provided). It was reported that within the last month, in January 2011, the patient was given the vaccine and developed what the provider thought was measles. Patient went to the ER for treatment. It was unspecified if lab diagnostic studies were performed. At the time of the report the patient's outcome was unknown. Additional information has been requested.
Patient is an 83-year-old male with a history of hypertension, diabetes, hyperlipidemia admitted with hypoxemic respiratory failure secondary to Covid 19 pneumonia with evidence of superimposed CAP.  Also evidence of right lower lobe pneumonia on imaging.  Given increased oxygen requirements he will be brought into the hospital for further management.  COVID (+) 11/17/21.
48hr p/vax severe myalgias, rigors,chills & h/a;
Swelling right upper arm around injection site. Swelling lasted 3-4 days. Ice packs applied locally. Temp. normal.
I caught Covid-19 after the 3rd dose. I had to go to the Dr. because the vertigo was so bad. I was not getting better with my PCP protocol and had to go see another Dr. I continued to have vertigo for about 2 weeks after testing positive. I was not able to work and I was sent by ambulance to the E.R.
My underarm swelled up and it was sore for seven days. I had a headache, I felt like I had body aches all through my body, extreme fatigue. I slept for almost 24 hours. I felt very achy for all of May. In June, the swelling finally went down but then I was getting constant headaches. I went to the ER on the 23rd and I had a swelling  by the nape of my hairline, near my ear. It was soft and it hurt a lot, anytime it was touched, it caused my head to hurt more. The doctor gave me antibiotics and said it was lymphnode-itis.
soreness; itching rash at the injection site; itching rash at the injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (soreness), VACCINATION SITE PRURITUS (itching rash at the injection site) and INJECTION SITE RASH (itching rash at the injection site) 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.     On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (soreness), VACCINATION SITE PRURITUS (itching rash at the injection site) and INJECTION SITE RASH (itching rash at the injection site). At the time of the report, VACCINATION SITE PAIN (soreness), VACCINATION SITE PRURITUS (itching rash at the injection site) and INJECTION SITE RASH (itching rash at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported No treatment medications were reported for mRNA-1273 (Moderna COVID-19 Vaccine) (unknown), the reporter did not provide any causality assessment.    Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Non significant follow up
ADMINISTRATION OF THE JNJ COVID 19 VACCINE, 24 HOURS TO 5 DAYS AFTER VIAL BEING PUNCTURED; INCORRECT PRODUCT STORAGE; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. The drug was associated with Medication error. No concomitant medications were reported. On an unspecified date, the patient experienced administration of the JNJ covid 19 vaccine, 24 hours to 5 days after vial being punctured, and incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of the JNJ covid 19 vaccine, 24 hours to 5 days after vial being punctured and incorrect product storage was not reported. This report was non-serious.
After receiving her vaccine client stated that she felt light headed, has tingling in both hands and feet.
Pt fainted after vaccination. Pt was nervous and does not like needles. Pt's eyes rolled and awake but not aware; laid pt on floor spoke to patient and responded to external chest rub. EMS responded. BP 110/80, glucose okay. Pt refused transport to hospital. Pt was awake and aware and father drove home.
pt exp vesicular & papular lesions on thighs, chest, increasing in number each day
From beginning my left arm hurt and got to point over a couple weeks where i couldn't lift it,  i ended up having to do physical therapy for several months, and still have a full pain in my left arm.
Systemic: Body Aches Generalized-Medium, Systemic: Hyperventilation-Medium, Systemic: Joint Pain-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Pt began to display symptoms related to anxiety that progressed to hyperventilation/nausea/full on body aches/ pt states she was then unable to move her arms/legs/hands due to body aches.  Pt reported that her body was aching and that she was feeling nauseated.  Pt's fingers were turning blue due to intense clenching.  Paramedics/Ambulance called for so pt can be further evaluated.
Intermittent Chest pains.  Emergency Room visit on 4/23/21, stayed overnight for observation.  EKG, echocardiogram and chest x-ray completed.  All tests did not reveal source of chest pain, however one EKG report did show abnormal when taken during the occurrence of chest pain.  Discharged with no further treatment.
Severe headache, lasting for 2 full days.  Intermittent numbness in left thumb.  Muscle aches, fatigue.
Fever for 48 hours, headache for 5 days straight,  body aches for 5 days and counting,  fatigue and nausea for 5 days and counting.
Case-patient had first Pfizer COVID-19 vaccine on 12/18/2021 and illness onset for MIS-C was on the same day. Case had COVID-19 with mild symptoms approximately 4 weeks before MIS-C onset. Case-patient met case definition for MIS-C with evidence of clinically severe illness requiring hospitalization, fever, multisystem organ involvement (cardiac, hematologic, & GI). The case-patient experienced cardiac shock, chest pain, abdominal pain, vomiting, diarrhea, conjunctival injection, and various elevated inflammatory markers (see box 19 below). Case-patient was treated with IVIG, ASA, steroids, and epinephrine and survived after a 4 day hospitalization (1 day in PICU).
Patient c/o slight dizziness while in mother's vehicle.  Patient c/o headache pain scale 7/10.
Case number PHEH2014US003647 is an initial spontaneous report from the pharmacist received on 21 FEB 2014 with a follow-up received on 25 MAR 2014. This report refers to a 12-year-old female patient who was accidentally vaccinated with FLUCELVAX 2013/2014 (batch number: 003031A, expiry date; JUN 2014) at a dose of 0.5 ml intramuscularly on 01 JAN 2014. No adverse event reported following this medication error (inappropriate age of vaccine administration).  Follow-up from pharmacist received on 25 MAR 2014: Batch number amended.  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 25 MAR 2014. The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".