chrisvoncsefalvay/vaers-outcomes huggingface dataset:
REACTIONS; SLEEPY; SLEPT A LOT; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced reactions, sleepy, and slept a lot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sleepy, reactions and slept a lot was not reported. This report was non-serious.
threw up; body aches; chills; high temp; Headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (threw up), MYALGIA (body aches), CHILLS (chills), PYREXIA (high temp) and HEADACHE (Headache) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 28-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VOMITING (threw up), MYALGIA (body aches), CHILLS (chills), PYREXIA (high temp) and HEADACHE (Headache). At the time of the report, VOMITING (threw up), MYALGIA (body aches), CHILLS (chills), PYREXIA (high temp) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-May-2021, Body temperature: 100.2 (High) now 100.2. On an unknown date, Body temperature: 103 (High) high temperature up to 103.         No concomitant medication was reported. No treatment was reported. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable
Pericarditis with large bloody pericardial effusion and tamponade  physiology.  A life threatening event.
UrticariaPruritus pinching in arm, hard/red at injection site Narrative:
Fainted. 10/7/2017 10:30 PM fell and cut nose open. 10/10/2017 6:00 AM fell and cut leg open. 10/16/2017 2:15 PM vertigo, fell and cut both arms open.
ringing in the left ear; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK5730) via an unspecified route of administration in the left arm on 23Dec2020 at 14:30 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and high cholesterol. The patient was allergic to intravenous pyelogram (IVP) dye. 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. Concomitant medications included cyanocobalamin (B-12), esomeprazole sodium (NEXUIM), losartan (MANUFACTURER UNKNOWN), hydrochlorothiazide (MANUFACTURER UNKNOWN) and rosuvastatin calcium (ROSUVAS); all taken from unknown dates for unknown indications and unknown if ongoing. On an unknown date in Jan2021, the patient experienced ringing in the left ear. The event 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. On an unknown date in 2021, the patient underwent hearing tests and the results were unknown. Therapeutic measures were taken as a result of the event and included treatment with hearing tests and changing of medications (unspecified). The clinical outcome of the event ringing in the left ear was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Chills, Headache around my temples and eyes, Joint Pains mostly in my ankles, Muscle/Body ache in my thighs, upper and lower back, and also my neck muscles, FatigueTiredness just sleep on and off during the 30 hours that I experienced these symptoms. I'm fully recovered. I did not seek medical attention.
Fever of 104-105 for 10 days. Had weakness, vomiting, diarrhea, wheezing, chest pains, asthma, loss of appetite, sore throat and fatigue. Lasted for about 3 weeks.
SUDDEN ONSET OF TINNITUS, BOTH EARS, L>R, WITHIN 60 MINUTES OF VACCINE ADMINISTRATION, LASTING ABOUT 4-8 HRS, THEN RESOLVING.  APPROXIMATELY 2 WEEKS POST-VACCINATION, ABRUPT ONSET OF MILD HEARING LOSS, LEFT EAR.  DIAGNOSED WITH 20 DB SENSORINEURAL HEARING LOSS IN 2 HIGH FREQUENCIES IN LEFT EAR AFTER AUDIOMETRY DONE ON 04/26/2021.
This spontaneous report received from a patient concerned a 76 year old female. 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 not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the subject experienced cramps. On 08-MAR-2021, the subject experienced aches. On 08-MAR-2021, the subject experienced dizzy. On 08-MAR-2021, the subject experienced sore arm. On 08-MAR-2021, the subject experienced headache. On 09-MAR-2021, the subject experienced diarrhea. On 09-MAR-2021, the subject experienced stomach cramps. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cramps, aches, dizzy, and headache on 09-MAR-2021, and sore arm on 12-MAR-2021, and had not recovered from diarrhea, and stomach cramps. This report was non-serious.
This spontaneous report as received from a Registered nurse refers to a 8 year old patient with no pertinent medical history and no drug reactions/allergies. On 04-JAN-2015 the patient was vaccinated with PNEUMOVAX 23 (dose unspecified) (lot # K007773 expiration date 01-MAY-2015), subcutaneous in the left arm. There were no concomitant medications. On 05-JAN-2015, therapy the patient experienced erythema, fever, swelling and pain, as well as a fever of 101F. The patient was seen an unspecified physician and was treated with MOTRIN. The outcome of injection site pain, injection site erythema, fever and injection site swelling was reported as recovering/resolving on an unknown date. No lab diagnostic studies were performed. Additional information has been requested.
10 hours after dose 2 of Moderna COVID-19 vaccine, experienced chills, fever, headache, vomiting, stomach pain, nausea, weakness and body aches. 36 hours later, headache, weakness, body ache, nausea, stomach pain, vomiting still present
sore arm for 3 days, tingly all over and tachycardic up to 130 bpm lasting for about 12 hours
I just started having migraines where nothing was working, it was lasting for days, I was missing kids events and leaving work early. None of my preventatives were working. I'm getting so many migraines I can't even function. I have been given extra meds for when I do get migraines, they are not working like they use to.  I'm on two prevetatives now with side effects.
Extreme fatigue, aching, chills, headache, cheeks flushed. No fever.
Pt developed headache and sore throat and pain at the site of the injection but pt states that eventually, had a very mild sore throat before the vaccine was given.
Patient was administered a 3rd dose of the primary series instead of the Pfizer Bivalent booster
Extreme weakness and very tired, pain at injection site.  Felt like I got hit by a truck.  Today is 3rd day after injection and symptoms have lessened, but still sluggish.  Right elbow below injection site warm to touch with slight swelling today.
Information has been received from a certified medical assistant, concerning her 25 year old daughter, with a sulfonamide allergy, who on 30-AUG-2007 was vaccinated IM, with the first dose, 0.5 ml, of HPV vaccine (lot 3658558/1061U), and on 27-NOV-2007, was vaccinated IM, with the second dose, 0.5 ml, of HPV vaccine (lot #659435/1265U).  Concomitant therapy included hormonal contraceptives (unspecified).  In November 2007, following the second vaccination, her daughter developed an itchy rash to her torso and the back of her arm.  Treatment included diphenhydramine (Benadryl) and hydrocortisone cream (manufacturer unspecified).  At the time of this report, the outcome of the event was not recovered.  Additional information has been requested.
On the day of vaccination (1/6/2021), I had arm pain and chills which continued into the next day. I felt fine on 1/8/2021. On 1/13/2021 I began to have arm pain and shoulder weakness. The arm pain has resolved but I have transient numbness and the shoulder weakness is getting more and more painful.
Patient presented 01/24/2006 with 10 umbilicated lesions in varying stages, from papules vessicles crusts, which began 3 days prior (01/27/2006).  Treated with Aveeno baths, Benadryl elx, Calamine Lotion, monitor symptoms.
Mom was present but left to look at some products in a nearby aisle while patient sat quietly after getting her vaccine. Pharmacist and Mom heard her phone drop and mom started talking to her daughter to get her attention.  Daughters eyes wanted to roll back in her head and her color was very pale.  Patient could speak but took awhile for her thoughts to form and answer questions. She was able to answer simple questions correctly. Mom and Pharmacist removed patient's jacket and lowered her safely to the floor as she was very clammy.  911 was called.  Kept patient's head upright as she had a hard time not slumping over.  Patient was evaluated at the hospital and sent home the same night.  Pharmacist followed up the next day and patient said they told her to follow up with a neurologist.
This spontaneous report as received from a registered nurse refers to an unknown number of patients (gender and age not reported). Since October 2014, improperly stored VARIVAX (Merck) (dose, lot number and route not provided) were administered to patients. No adverse effects were noted. This is one of several reports received from the same source. Additional information has been requested.
Patchy red histamine reaction type rash over cheeks, forehead, bilateral arms and bilateral legs, also on R chest wall, otherwise sparing torso.  Rash responded to benadryl, has not occurred before or since.
First evening of the J&J vaccine (4/1/2021) I had a fever, chills, headache, and was lethargic.  This lasted for 2 nights.  These symptoms I anticipated.   What I didn?t anticipate was my abdominal pain.  I still feel as of today (4/14), pain in my abdomen.  The areas of the discomfort are all over my mid-section.  I was so worried that I went to ?Urgency Care? doctor on 4/5/2021 and the nurse had me go for a ?CT Scan?.  I also went to my Primary care physician on 4/13/2021 and described my concern and abdominal pain but didn?t get a diagnosis.
Pediatric 5 - 11 year old dose given in error.  Pt had no significant reactions
patient received the vaccine 13 days ago but now suddenly has injection site swelling that is painful and red. Advised patient to have her doctor look at it to make sure it was not skin infection since it has been so long since the injection. Patient stated that she is also still having headaches, fever and cough which she has been experiencing since the injection.
EXTREMELY PAINFULMUSCLE ACHS first night. fevers ranging from 102+ to 101 for 3 days still get mild body aches in evening.  Lack of energy
Body aches; Exhaustion/fatigue; Low grade fever; Headache; Foggy; This is a spontaneous report from a contactable Nurse (patient) reported for herself. A 39-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL0142) intramuscular in Left arm on 12Jan2021 08:30 at single dose for COVID-19 immunisation. She received the first dose (lot number=EJ1685) intramuscular in left arm on 22Dec2020 08:30 AM at age of 38 years old for COVID-19 immunisation. The patient medical history was not reported. There was no known allergies. Concomitant medication included phentermine. On 12Jan2021 21:30, the patient experienced body aches, exhaustion/fatigue, low grade fever, headache, foggy. No treatment received for events. The patient was not pregnant. Events outcome was recovering.
Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose).    No concomitant product reported by reporter.  It was reported that the nurses had no standing order other than what they had for second booster, when first administering bivalent boosters. So they assumed the same dose as the second booster and administered 0.25 ml instead of 0.5 ml to uncompromised adults. The HCP had asked if the patients need an additional 0.25ml dose now. It was reported that CDC had recommended to re-vaccinate the patient with full dose of 0.5mL.  No adverse events were reported.  No treatment medication reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-646512 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-646512:same reporter
Erythema from elbow up to shoulder - pruritic - went to E.R. - also up to another hospital.
Technician vaccinated 11yo patient with the adult Pfizer COVID vaccine dose instead of the Pfizer COVID pediatric dose.  Patients was observed for 30 minutes to gauge for fever, dizziness, fatigue.  Patients experienced slight dizziness, but improved with water intake.
Information has been received from a physician, concerning a 17 year old female patient who on 12-AUG-2008 was vaccinated with her first dose of GARDASIL from her school. Lot number not available at this time. A few days ago, she experienced symptoms of Bell's palsy with paralysis of her face. She phoned the doctor and will be seen in the office this week. As of 22-SEP-2008, the patient had not recovered. There was no product quality complaint. Additional information is expected.
Pt received redness and swelling at injection site.  Instructed to use cold compress and f/u w/ doctor if worsens.
No additional AE information reported; GARDASIL 9 was out of refrigeration for 24 hours before administration; This spontaneous report was received from a consumer referring to his daughter, an adult female patient who was 26 years old at the time of the report. The patient's pertinent medical history, concomitant medications, concurrent conditions and previous drug reactions or allergies were not reported.   On an unspecified date in January 2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 injection (exact dose, anatomical site of vaccination, route of administration, lot number and expiration date were not reported) as prophylaxis.   The vaccine was out of refrigeration (room temperature) for 24 hours before administration (product storage error). It was reported that the patient did not receive the second and third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). In addition, the reporter stated that the patient did not have a primary care provider. No additional adverse event information was reported (no adverse event).
Menstrual cycle started 2 days late. It ended after 6 days which is normal.; Then it started again 2 days later. It is very weird. I bleed from around 2pm until 7pm, then stop. I wake up the next morning thinking my cycle is over, but it starts again later inthe day; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730, also reported as EN6205) via an unspecified route of administration in the left arm on 30Mar2021 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported for the patient. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Concomitant medication was reported as not applicable. On 10May2021, the patient's menstrual cycle started 2 days late. It ended after 6 days which was normal. Then it started again 2 days later which was very weird. The patient bleeding from around 14:00 until 19:00, then it stopped. The patient woke up the next morning thinking cycle was over, but it started again later in the day. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events menstrual cycle started 2 days late, started again 2 days later which was very weird, bleeding from around 14:00 until 19:00, then it stopped was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a pharmacy technician refers to a 12-year-old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant medications were not reported. On 13-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.
Blood clots in his left leg; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clots in his left leg) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No relevant medical history was reported.  Concomitant products included APIXABAN and ENOXAPARIN for an unknown indication.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced THROMBOSIS (Blood clots in his left leg) (seriousness criterion medically significant). The patient was treated with APIXABAN (ELIQUIS) for Clot blood, at an unspecified dose and frequency. At the time of the report, THROMBOSIS (Blood clots in his left leg) 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.   Company Comment   Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.   This case was linked to MOD-2021-220804 (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 event, a causal relationship cannot be excluded. Further information has been requested.
Patient developed tightness in ears, neck, and throat after the shot. The next day she had fever to 104 degrees 5:40 PM, red eyes, skin sensitivity, hallucinations, and became distraught. Symptoms resolved by 8/8/13.
Hives and itching about the face.  Denied any other symptoms including chest pain, SOB or difficulty swallowing.  Pt was given oral Benadryl and observed.  Epi was available but not given.  Sxs resolved over time.
5/15 I began experiencing hives, now I'm diagnosed with Chronic Hives.
está muy angustiada / is very distressed; se colocó la primera dosis de la vacuna Moderna el 04Feb2021 y no consigue cita para la; This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSED MOOD (está muy angustiada / is very distressed) and PRODUCT DOSE OMISSION ISSUE (se colocó la primera dosis de la vacuna Moderna el 04Feb2021 y no consigue cita para la) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported. ).    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced DEPRESSED MOOD (está muy angustiada / is very distressed) and PRODUCT DOSE OMISSION ISSUE (se colocó la primera dosis de la vacuna Moderna el 04Feb2021 y no consigue cita para la). On 17-Mar-2021, PRODUCT DOSE OMISSION ISSUE (se colocó la primera dosis de la vacuna Moderna el 04Feb2021 y no consigue cita para la) had resolved. At the time of the report, DEPRESSED MOOD (está muy angustiada / is very distressed) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Coronavirus test: negative (Negative) three tests were negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.