chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ALMOST PASSED OUT; LOW BLOOD SUGAR; A LOT OF GAS; VOMITED; PEED ON HERSELF; NAUSEATED; HALLUCINATION; FEVER; FELT COLD AND SAID SHE WAS FREEZING; PAIN IN LEFT KNEE; VERY WEAK, COULD HARDLY GET TO BED; EYES HURT WHEN TOUCHED; FELT MEDICATION GOING IN; SHALLOW BREATHING; HEADACHE; SHAKINESS; This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes and depression, and other pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, Laboratory data included: Body temperature (NR: not provided) 101.7 Degree. On 25-MAR-2021, the subject experienced shallow breathing. On 25-MAR-2021, the subject experienced eyes hurt when touched. On 25-MAR-2021, the subject experienced felt medication going in. On 25-MAR-2021, the subject experienced shakiness. On 25-MAR-2021, the subject experienced very weak, could hardly get to bed. On 25-MAR-2021, the subject experienced headache. On 25-MAR-2021 18:30, the subject experienced pain in left knee. On 25-MAR-2021 19:30, the subject experienced felt cold and said she was freezing. On 26-MAR-2021, the subject experienced hallucination. On 26-MAR-2021, the subject experienced low blood sugar. On 26-MAR-2021, the subject experienced vomited. On 26-MAR-2021, the subject experienced peed on herself. On 26-MAR-2021, the subject experienced a lot of gas. On 26-MAR-2021, the subject experienced nauseated. On 26-MAR-2021, the subject experienced fever. On 26-MAR-2021 01:00, the subject experienced almost passed out. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt medication going in, peed on herself, shakiness, a lot of gas, pain in left knee, and nauseated on 26-MAR-2021, was recovering from felt cold and said she was freezing, very weak, could hardly get to bed, almost passed out, and fever, had not recovered from headache, and eyes hurt when touched, and the outcome of vomited, shallow breathing, hallucination and low blood sugar was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210354256-JANSSEN COVID-19 VACCINE Ad26.COV2. S- Hallucination. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: Medical History of Depression.
Mild reaction; Not feeling that well overall; Mild flu like symptoms; Some fatigue for a couple of days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Mild reaction), MALAISE (Not feeling that well overall), INFLUENZA LIKE ILLNESS (Mild flu like symptoms) and FATIGUE (Some fatigue for a couple of days) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jul-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 COMPLICATION (Mild reaction), MALAISE (Not feeling that well overall), INFLUENZA LIKE ILLNESS (Mild flu like symptoms) and FATIGUE (Some fatigue for a couple of days). At the time of the report, VACCINATION COMPLICATION (Mild reaction), MALAISE (Not feeling that well overall), INFLUENZA LIKE ILLNESS (Mild flu like symptoms) and FATIGUE (Some fatigue for a couple of days) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient had no history of COVID-19. No concomitant product information was provided. Treatment information was not provided.      This case was linked to MOD-2021-313524 (Patient Link).
Maternal grandmother describes that skin overlying site of vaccination became red, warm to touch and tender.  After 2-3 days, the overlying 3-4 inch area of redness, warmth and tenderness improved and a knot was felt at the site of vaccination.  Size of knot was initially 2 to 2 1/2 inches but has improved to size of nickel.  Soreness is improving but not resolved completely.
Patient complained of light headedness, stated right arm cool, and bad taste in mouth. BP 123/80 initially. Pt stood up and became light headed BP 154/90 HR 76 SPO2 98%. RRT called. Pt transported to Emergency Department.
After Moderna injection (first dosage), I experienced chills, headache, and swollen stomach. Painful upper back and shoulder.
I had an itching throat and asthma breathing. For the first 20 mins I used my inhaler. For four days I was really tired. The next day after vaccine I experienced diarrhea.
Patient reports rash on chest, stomach, back, both legs.  Rash was tender to touch, sensitive to heat and cold.  Intense itching continued to 2 post symptom arrival.
suspected vaccination failure; still got it; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient himself/ herself. The age at vaccination was not reported. The patient got the shingle shot and still got shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
This spontaneous report was received from currently 70-year-old, elderly, female patient who was reporting on herself. The patient did not have any pertinent medical history or any known drug reaction or allergies. On 05-JUN-2014, the patient was vaccinated with ZOSTAVAX, 1 dose in upper arm at pharmacy, lot # J014810 with an expiration date 21-FEB-2015, for shingles (route of administration was not reported). Concomitant therapies included MOTRIN, vitamins (MACULAR DEGENERATION VITAMIN'S) and AVASTIN injection. In approximately February 2018, reported as earlier this month, the patient was experiencing back pain. Subsequently, the patient was diagnosed with shingles and visited urgent care where she was prescribed valacyclovir and oxycodone (onset date in approximately February 2018, reported also as after receiving a ZOSTAVAX). There were no laboratory tests performed. Product quality complaint was not reported. The outcome of the events was not recovered. Causality assessment was not provided.
On 4/20/2021 my left arm in which I received the Moderna shot was very swollen  red and hot the redness and burning/pain shooting through hands and under arm have been there since than.  I saw my doctor today and she prescribed antibiotics for 10 days.
Patient has a red raised rash that was warm to the touch, probably infected, and was about 4 inches in diameter.
Patient reports waking up to severe pain Wednesday night (9/1/21). She describes the pain as, "pain that radiated all over my body. It felt like I was in labor. I was hot all over, but I did not have a fever." The pain lasted around 4 hours. The patient was unable to sleep or sit comfortably. She experienced severe nausea, headache, and weakness throughout Thursday (9/2/21). These symptoms were severe enough that she left work early. She had joint, bone (including jaw), and muscle pain that last from Wednesday night (9/1/21) to Friday (today, 9/3/21). She is also experiencing dull chest discomfort. This discomforted started today (Friday 9/3/21). Patient treated pain with Tylenol extra strength (OTC) 2 tablets in the morning and 2 tablets at night. She is still experiencing discomfort.
Patient received vaccine that was stored improperly. Vaccine was moved from ultra-cold freezer to freezer on 6/17/21. According to guidance from Pfizer, vaccine stored in the freezer after day 17 is considered improperly stored, and the patient will need to be re-vaccinated.
approx. 30 minutes post vaccine, c/o itching all over and became red from mid chest to mid face and upper back.  Epinephrine vial 1:1000 - 0.5 ml given rt arm.  EMS notified.  Transported to Hospital.
presented to ER 27DEC97 p/T103 the evening before temp was 102.6;physical WNL x/some scattered rhonchi otherwise clear & skin papular rash;discrete lesions w/erythematous on trunk & back some appear pustular or vesicular;
Inaccurately diagnosed with pneumonia; lung cancer in right lung that has spread; legs hurt; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Inaccurately diagnosed with pneumonia) and LUNG NEOPLASM MALIGNANT (lung cancer in right lung that has spread) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included AMLODIPINE BESILATE (AMLODIPINE BESYLATE), MELOXICAM, DEXAMETHASONE, CLONIDINE, FOLIC ACID, METOPROLOL, CETIRIZINE HYDROCHLORIDE (CETRIZINE), ROSUVASTATIN CALCIUM and ALBUTEROL [SALBUTAMOL] for an unknown indication.    On 17-Mar-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 PNEUMONIA (Inaccurately diagnosed with pneumonia) (seriousness criterion medically significant), LUNG NEOPLASM MALIGNANT (lung cancer in right lung that has spread) (seriousness criterion medically significant) and PAIN IN EXTREMITY (legs hurt). At the time of the report, PNEUMONIA (Inaccurately diagnosed with pneumonia), LUNG NEOPLASM MALIGNANT (lung cancer in right lung that has spread) and PAIN IN EXTREMITY (legs hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication also included Flonase.  Treatment medication included three antibiotics.  Laboratory details was mentioned as on an unknown date patient done scan which showed patent had lung cancer in right lung and it was now spreading.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Later in the same day:  Itching, some hives on shoulders and torso Evening at bed:  Shivering, cold Next morning:  Numbness on left side of mouth Treatment:  Went to Urgent Care next morning and took Claritin.   Symptoms went away and fully recovered within a day.
Started with some balance issues (walked into furniture), then arms started shaking, followed by full-body shaking and temporary blueish color on lips.
dizziness; little bit of diarrhea; increase fatigue; chills; throwing up; very nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (dizziness), DIARRHOEA (little bit of diarrhea), FATIGUE (increase fatigue), CHILLS (chills) and VOMITING (throwing up) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Nausea, Thyroid disorder NOS, Cholesterol blood excessive, Anxiety, Arthritis, Osteoporosis, Acid reflux (oesophageal), Pain and Allergy to antibiotic. Concomitant products included BIFIDOBACTERIUM INFANTIS (ALIGN JR) for Acid reflux (oesophageal), ESCITALOPRAM OXALATE (ESCITALOPRAM [ESCITALOPRAM OXALATE]) for Anxiety, MELOXICAM for Arthritis, ATORVASTATIN for Cholesterol blood excessive, ONDANSETRON for Nausea and Anxiety, ALENDRONATE SODIUM (FOSAMAX) for Osteoporosis, PARACETAMOL (TYLENOL) for Pain, CALCIUM CARBONATE, COLECALCIFEROL (CALCIUM + VITAMIN D [CALCIUM CARBONATE;COLECALCIFEROL]) and CENTRUM SILVER +50 for Supplementation therapy, LEVOTHYROXINE for Thyroid disorder NOS.   On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 25-Feb-2021, the patient experienced DIZZINESS (dizziness), DIARRHOEA (little bit of diarrhea), FATIGUE (increase fatigue), CHILLS (chills), VOMITING (throwing up) and NAUSEA (very nausea). The patient was treated with ONDANSETRON for Nausea, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIZZINESS (dizziness), DIARRHOEA (little bit of diarrhea), FATIGUE (increase fatigue), CHILLS (chills), VOMITING (throwing up) and NAUSEA (very nausea) outcome was unknown.            Action taken with mRNA-1273 in response to events was not applicable.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments   This case was linked to US-MODERNATX, INC.-MOD-2021-162252 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-162252:Same reporter
I have a lot of problems with my stomach and a lot of dairrhea. I barely I have an appetite. I went to my doctor and she think its from the vaccine because it all started after I received my vaccination.
(R) deltoid about 1 inch of erythema/swelling slight pain. (L) deltoid about 1/2 inch of erythema/swelling and pain.
About 6 hours after receiving vaccine, pt states she had a headache and fever to 102.  Felt achy and fatigued the entire next day and also developed slight swelling of upper lip.  On day of presentation to clinic (2 days after receiving vaccine) pt developed itchy rash/slight swelling of both hands.
This spontaneous report was received from a physician and refers to multiple unspecified patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (exact dose and route od administration were not reported, lot # L048237 with expiration date: 08-MAY_2017). The administered doses experienced a temperature excursion of 30 degrees Fahrenheit for 7 hours. No previous temperature excursion was reported. No adverse effect was reported. This is one of two reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a certified medical assistant refers to unspecified patients of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. Between 20-MAY-2016 and 31-MAY-2016, the patients were vaccinated with improperly stored VAQTA (lot # L043209, expiration date 17-SEP-2017; lot # L045713 expiration date 14-JAN-2017; route and dose were not reported). The vaccines were exposed to 8.9 Celsius degree for 44 minutes without previous excursion. The issue was due to data logger. No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Tenderness at the injection site.; This is a spontaneous report from a non-contactable consumer, the patient. A 27-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248) via an unspecified route of administration in the left arm on 03Mar2021 at 09:45 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food or other products. Concomitant medications included bupropion (MANUFACTURER UNKNOWN), spironolactone (MANUFACTURER UNKNOWN), cetirizine hydrochloride (ZYRTEC) and heights (MANUFACTURER UNKNOWN); all for unknown indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Mar2021 at 17:00, the patient experienced tenderness at the injection site. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event tenderness at the injection site was not recovered at the time of this report.   No follow-up attempts are possible. No further information is expected.
Facial swelling. Patient has known dental problems and is being  followed for this. Upper lip swelling x 2 day duration. Bilateral periorbital edema, left side much worse than right side. There is obvious fluid trapped in the lower lid. No discharge is noted. Veteran denies visual changes or eye pain, but state that his upper lip is tender to palpation. No obvious trauma is noted to the face. Veteran denies any new medications, is not taking an ACE inhibitor, and denies any recent chemical or environmental exposures. Veteran denies any neck or throat swelling, itching, or respiratory difficulties. No hives or urticaria are noted.
Consumer's husband, an army inductee was administered influenza virus vaccine (MFR unknown) during winter 1972-1973. Within 1 mo, pt condition dx as GBS. Hospitalized for 6 months. Pt currently under care of neurologist.
76-year-old female presents to the emergency department complaints of a rash.  The rash is red, seems to be worsening daily, very painful, constant.  She has been taking prednisone, that does not seem to help.  She developed a rash after the initial  Moderna COVID immunization, and then it went away.  When she got her she 2nd immunization on 03/27, a couple days later she developed the same type of rash, only significantly worse.  She denies any difficulty with breathing, swelling of the tongue.  There is no rash throughout the rest the body, she did get the shot in the left shoulder.  She has not had any fevers.  No difficulty breathing.     this rash is consistent with that of shingles.  It occurred on the left shoulder, where the COVID vaccine was given.  She initially developed a rash after the 1st 1, then again after the 2nd shot.  This has pain consistent with that of shingles.  Unlikely allergic reaction, but possible.  She is currently on prednisone she will continue that.  She was given acyclovir and gabapentin.  One dose was given here in the ER.  No swelling of the tongue, no evidence of anaphylaxis.  The rash does not go beyond the left shoulder region.  Patient appears otherwise stable, normal vital signs besides hypertension.   The primary encounter diagnosis was Herpes zoster without complication. A diagnosis of Rash was also pertinent to this visit.
devel  rash/hives, congestion & bronchial spasms;rx w/Epi inhaler, steroids & DPH in ER
This spontaneous report as received from a physician assistant refers to a 33 year old female patient. The patient's pertinent medical history and concomitant medications were not reported. On unknown dates, the patient was vaccinated with three doses of GARDASIL (lot #, expiry date, dose, frequency, route of administration and anatomical location were not reported. On an unknown date, the patient had a test for an unspecified reason which showed that the patient was positive for herpes simplex virus 2. The outcome of the adverse event was unknown. The relatedness between the adverse event and GARDASIL was not provided. Additional information has been requested.
POSITIVE TO COVID; SICK; This spontaneous report received from a patient concerned a female of unspecified age. 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: Unk) dose was not reported, administered on 27-MAR-2021 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 2021, the subject experienced sick. On 09-APR-2021, the subject experienced positive to covid. Laboratory data included: COVID-19 virus test (NR: not provided) POSITIVE TO COVID. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sick and positive to covid was not reported. This report was non-serious.
approx 30 minutes after vaccine - runny nose, sneezing, water eyes approx 1 hour after vaccine - generalized itchiness, redness, flush approx 1 hour 30 mins - 2 hours after vaccine - rash around insertion site, rash on right arm, swelling in throat/mouth, difficulty swallowing took Benadryl over the counter called 24 hour nurse hotline, recommended ER visit ER visit given Benadryl, Epinephrine, Pepcid, Steroids Prescribed Benadryl, Pepcid and Steroids
From the injection sight down to almost elbow and going side to side a solid red rash; solid red rash that was hot to the touch; This is a spontaneous report from a contactable consumer, the patient. A 61-years-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 28Mar2021 at 08:45 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes, blood pressure high and overweight from an unspecified date. The patient was allergic to soy. The patient received other medications (unspecified) within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 28Mar2021 at 20:00, the patient reported that from the injection sight down to almost elbow and going side to side a solid red rash, that was hot to the touch and the area covered was size of her hand. The patient did not receive any treatment for the event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of from the injection sight down to almost elbow and going side to side a solid red rash and solid red rash that was hot to the touch was not resolved at the time of reporting.  No follow-up attempts are needed. No further information is expected.
Cyst-like lump  about the size of a grape on left collar bone day after injection; fever, chills, back ache, headache about 14 hours post injection.
Patient died due to COVID-19 illness after being fully vaccinated. no one believes the death to be related to the vaccine.