chrisvoncsefalvay/vaers-outcomes huggingface dataset:
RIGHT ARM PAIN; DON'T FEEL WELL; CHILLS; FEVER; HEADACHE; SIDE-EFFECTS; SWEAT; FEELS WEAK, TOO ILL; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcoholic, smoker, depression, and anxiety, and other pre-existing medical conditions included no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: 1802068 expiry: UNKNOWN) dose was not reported, administered on 03-MAR-2021 14:30 for prophylactic vaccination. Concomitant medications included clonazepam for anxiety, escitalopram oxalate for depression, and gabapentin for sleep disorder. On 03-MAR-2021, the subject experienced side-effects. On 03-MAR-2021, the subject experienced sweat. On 03-MAR-2021, the subject experienced feels weak, too ill. On 03-MAR-2021, the subject experienced don't feel well. On 03-MAR-2021, the subject experienced chills. On 03-MAR-2021, the subject experienced fever. On 03-MAR-2021, the subject experienced headache. On 04-MAR-2021, the subject experienced right arm pain. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from side-effects, sweat, feels weak, too ill, right arm pain, don't feel well, chills, and fever on 05-MAR-2021, and headache on 04-MAR-2021. This report was non-serious.
Localized edema w/ erythema on pt's left deltoid area where vaccine was administered, since Monday rec. cold compress and MOTRIN prn pain.
no reported patient side effects; an expired dose of ROT ATEQ was administered; This spontaneous report as received from a nurse refers to a 4-month-old patient of an unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 18-MAY-2021, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1660992, expiration date 30-APR-2021, 2 ml, orally (also reported as by mouth) x1dose for prophylaxis. There was no adverse effects reported.
Received Pfizer Covid injection #1 on 11 April 2021.  Since then having blood in stool and abdominal soreness and diarrhea.  Blood in stool every other day, notices it when she wipes, clears after two wipes. first time noticed the blood in the toilet, didn't change the color of the water. Got better in between Had horrible stomach ache, mid-abdominal discomfort, after lunch, sudden onset, burning pain, sort of sharp, soreness, not dull, felt nauseous, no vomiting., next morning had "black, sticky" stool.  Feels weak.  Diarrhea 3-4 times every morning, first stool is large amount of unformed stool, then subsequent stools smaller Sometimes goes to urinate ends unexpectedly having loose stool  Feeling lack of energy
The child received an MMR vaccine. Two weeks after the vaccine, the child developed rash and fever. Mother brought the patient to the doctor's office and some lab tests were performed. Measles IgG was negative and IgM was positive, suggesting reaction to the vaccine.
Approximately 5 days after having the vaccine I started having terrible lower back pain. (4-13-2021)I had noticeable blood in my urine just a few days after receiving the vaccine. Each day the pain grew progressively worse. On 4-22-2021 I visited the OBGYN because I was having so much abdominal pain. They did some testing but before I got the results a day had passed and I was in worse pain. On 4-23-2021 I felt like I kept needing to urinate. I sat in bed that night and began feeling a contracting feeling and felt an urgency to push. I sat on the toilet and was in a lot of pain but I wanted to push. It felt like my bladder was contracting. When I was done there were approximately 3 clumps of blood in the stool with bloody red urine. I immediately went to the emergency room. In the emergency room over the course of a few hours I probably passed 15 to 20 additional clumps. The nurse collected the clumps which appeared to be blood clots. They were looked at under a microscope and determined they were NOT kidney stones but indeed just tissue and blood clots. It was very very painful. I was given a CAT scan to make sure I didn't have any kidney stones and the scan was negative. After receiving test results I was put on antibiotics and sent home. I felt bad for about 4 additional days and things started turning around.
This spontaneous report as received from a other health professional refers to a 37 year old female patient. On an unknown date the patient received two doses of M-M-R II (lot#, expiration date, dose, route, indication not reported) when the patient was a child. On an unknown date the physician had her titers checked and it was found that her titers were negative for MMR. The physician then decide to administer one dose of M-M-R II to the patient. In May 2014 ("one month ago") the patient was vaccinated with third dose of M-M-R II (lot#, expiration date, dose, route, indication not reported). The patient's titers had not been checked after it was administered. The outcome of the event was unknown. Additional information has been requested.
The patient received a COVID19 vaccine & was discharged.When he got to the car he felt dizzy & light headed. The patient returned to the building BP 168/108. P78. P.O. 99% - Rest & water 127/77, 118/180. The patient was discharged No Hx: Hypertension
Moderna vaccine stored beyond use by date; Vaccine administered to patient beyond use by date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered to patient beyond use by date.) and PRODUCT STORAGE ERROR (Moderna vaccine stored beyond use by date) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 068H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered to patient beyond use by date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna vaccine stored beyond use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered to patient beyond use by date.) and PRODUCT STORAGE ERROR (Moderna vaccine stored beyond use by date) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided by the reporter. Date the vial was stored in standard freezer was 04-Jan-2022 (2 degrees F high -1 degrees F low) Treatment information was not provided.
Headache; has a arm swollen; elevated temperature; Her hands and feet are cold.; This case was reported by a consumer via patient support programs and described the occurrence of headache in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th March 2020, the patient received the 1st dose of Shingrix. In March 2020, less than a week after receiving Shingrix, the patient experienced headache, swelling arm, body temperature increased and cold extremities. On an unknown date, the outcome of the headache, swelling arm, body temperature increased and cold extremities were unknown.   It was unknown if the reporter considered the headache, swelling arm, body temperature increased and cold extremities to be related to Shingrix.  Additional details were provided as follows: The patient reported that, after vaccination experienced swollen arm, headache and elevated temperature, hand and foot were cold. The reporter consented to follow up.
elevated heart rate; PVC's which lasted for three weeks.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Jul2021 12:30 (Lot number: EW0100) at the age of 48 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "tree nut allergy" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Note: Product=COVID 19, Brand=Pfizer,, Lot number=EW0100,, Lot unknown=False,, Administration date=10Jun2021,, Administration time=01:45 PM,, Dose number=1,, Vaccine location=Left arm), administration date: 10Jun2021, when the patient was 48 years old, for covid-19 Immunisation. The following information was reported: HEART RATE INCREASED (non-serious) with onset 03Jul2021 08:00, outcome "recovered" (2021), described as "elevated heart rate"; VENTRICULAR EXTRASYSTOLES (non-serious) with onset 03Jul2021 08:00, outcome "recovered" (2021), described as "PVC's which lasted for three weeks.". The events "elevated heart rate" and "pvc's which lasted for three weeks." were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of heart rate increased, ventricular extrasystoles.  Additional information:The patient AE treatment includes: Blood tests, EKG, Heart monitor.Patient had other vaccine in four weeks: No.  No follow-up attempts are possible. No further information is expected.
Patient presents with recent positive COVID-19 test, fatigue, cough, shortness of breath, admitted and managed with Regeneron on investigational study
Three days following the receipt of the Covid vaccine, I lost all hearing in my left ear.  I was diagnosed with  "sudden sensory nerve severe hearing loss" by an ENT
Narrative: PT RECEIVED 1ST DOSE PFIZER VACCINE. RECEIVED FLU VACCINE ON SAME DAY PRIOR TO PFIZER VACCINE. INSISTS ON GETTING PFIZER VACCINE IN SAME ARM AS FLU(LEFT DELTOID). PT STARTING COMPLAINING OF FEELING "FLUSHED & ITCHY THROAT" 5 MINS AFTER RECEIVING PFIZER VACCINE DURING THE 15 MINUTE OBSERVATION PERIOD ACCORDING TO MONITORS. PT WAS ESCORTED TO ER VIA WHEELCHAIR BY RN FOR FURTHER EVALUATION/TREATMENT.
Full dose of vaccine not administered due to suspected syringe malfunction.  Dose needed to be repeated.
Fatigue, chills, headache, severe body-ache/pain mainly on right side from shoulder to hand. Right leg/thigh (upper), calf (lower), shoulder and back pain and low to high grade fever (99.6-102.4). Mild body-ache/pain on left leg /thigh area and shot site.
patient developed redness, warmth, and tenderness 24 hours after injection at injection side.
COVID-19; Rebound COVID symptoms 4 days after completion of the course; This spontaneous case was reported by a nurse and describes the occurrence of SYMPTOM RECURRENCE (Rebound COVID symptoms 4 days after completion of the course) and COVID-19 (COVID-19) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    The patient had no allergy.  Concurrent medical conditions included Asthma.   On 14-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) 1 dosage form. On 12-May-2022, the patient experienced SYMPTOM RECURRENCE (Rebound COVID symptoms 4 days after completion of the course). On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, SYMPTOM RECURRENCE (Rebound COVID symptoms 4 days after completion of the course) and COVID-19 (COVID-19) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. The patient was not taking any other medications within 2 weeks of starting COVID-19 treatment.  No treatment information were provided.  Company comment: This spontaneous case concerns a 33-year-old female patient with no relevant medical history who experienced the unexpected non serious AESI of COVID 19 unknown days after the administration of third dose of mRNA-1273 vaccine. Patient took NIRMATRELVIR, RITONAVIR (Paxlovid) for 5 days as treatment for COVID 19. Then patient experienced Rebound COVID symptoms 4 days after completion of the course of Paxlovid. Details regarding primary doses of vaccination, concomitant medications, other investigations are not available. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 33-year-old female patient with no relevant medical history who experienced the unexpected non serious AESI of COVID 19 unknown days after the administration of third dose of mRNA-1273 vaccine. Patient took NIRMATRELVIR, RITONAVIR (Paxlovid) for 5 days as treatment for COVID 19. Then patient experienced Rebound COVID symptoms 4 days after completion of the course of Paxlovid. Details regarding primary doses of vaccination, concomitant medications, other investigations are not available. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Woke up with chest  pain at 2:32 a.m. and at 9am on 06/01/22 More severe chest pain (throbbing and squeezing of chest) at 3:44am on 06/02/2022. Was diagnosed with a heart attack.
pt recvd vax; redness, swelling, itching at site p/ dose 1 & 2; ha & n p/ dose 2 lasting 2 hrs;
Stop sleeping nights, fever, irritability, very fussy. Sleepy but would not sleep but 4 a min his cry changed. Seizures (But we did not realize what they were).  03-09-09 Vaccine records received.  10/23/09 Discharge summary received for DOS 3/24-4/20.  FINAL DX: Subdural bleed status post craniotomy, bilateral retinal hemorrhages, shaken baby syndrome.  Infant brought to ER for unresponsiveness and respiratory failure. Apparent  seizure. Suspected non-accidental head trauma. Intubated. Large subdural bleed. Subsequently evacuated.  Bilateral retinal hemorrhages noted per ophthalmology consult. C/W shaken baby syndrome. Significant neurological deficits including not following light with eyes, pupils nonreactive to light, flaccid left side, negative grasp reflex L side. Reduced tactile stimulus response L side. Moving all limbs spontaneously. Discharged to long term care.
Following the shot I felt a bit ill and some arm soreness, but understood that was expected. The arm pain has persisted and is considreable, intermittent pain with occassional loss of strength. It is so sudden and can take my breath away. It is sometimes accompanied by a popping feeling and sound. Prior to the shot my arm was 100% in good shape and I have had no injuries or exceptional use of it.
Bodyache; Tiredness; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Bodyache), FATIGUE (Tiredness) and HEADACHE (Headache) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PAIN (Bodyache), FATIGUE (Tiredness) and HEADACHE (Headache). At the time of the report, PAIN (Bodyache), FATIGUE (Tiredness) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitants was reported. No treatments was reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: TCR received on 28-05-2021 contains no new information.
Pain and decreased ROM, unable to lift arm higher than shoulder height or towards the mid line started on 11/1/2018. Around 1 week slight improvement to ROM, can lift arm higher than shoulder, but decreased strength noted. Using Ibuprofen and Tylenol daily. Around 11/19 started taking Ibuprofen 800 mg every 6 hours and applying heat to arm for short intervals. Some improvement noted. 12/3 Pain extending to bicep and difficulty dressing and undressing. Decreased strength continues.
I received my booster 12/29/21 and 13 days later I developed hives and rashes on my body; I received my booster 12/29/21 and 13 days later I developed hives and rashes on my body.This spontaneous case was reported by a nurse and describes the occurrence of URTICARIA (I received my booster 12/29/21 and 13 days later I developed hives and rashes on my body) and RASH (I received my booster 12/29/21 and 13 days later I developed hives and rashes on my body.) 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 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced URTICARIA (I received my booster 12/29/21 and 13 days later I developed hives and rashes on my body) and RASH (I received my booster 12/29/21 and 13 days later I developed hives and rashes on my body.). At the time of the report, URTICARIA (I received my booster 12/29/21 and 13 days later I developed hives and rashes on my body) and RASH (I received my booster 12/29/21 and 13 days later I developed hives and rashes on my body.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Breakthrough case admission after three vaccines Pfizer 2/24/21 Lot# EN6202;  Pfizer 3/17/21 Lot# EN6204;  Pfizer 10/4/21 Lot# FF2589
Fever of 101; Headache; Chills; Extreme body aches; This is a spontaneous report from a contactable consumer or other non hcp. A 51-years-old female patient received 2nd dose of bnt162b2 (COMIRNATY,Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 24Feb2021 13:30,at the age of 51 years old,as Dose 2,single for covid-19 immunization.Medical history included thyroid cancer from an unknown date and unknown if ongoing in 2008, hypertension, migraine,seasonal allergy and obesity from an unknown date and unknown if ongoing. Concomitant medication(s) included levothyroxine sodium , metoprolol, cetirizine hydrochloride (Zyrtec) and vitamin d [vitamin d nos] taken for an unspecified indication, start and stop date were not reported.The patient experienced fever of 101, headache, chills and extreme body aches on 25Feb2021 06:00. The patient underwent lab tests and procedures which included body temperature: 101 on  unknown date.The patient historical vaccine included 1st dose of Pfizer vaccine on 04Feb2021 01:30 pm on left arm.The patient was not pregnant at the time of vaccination.The patient had not received any vaccine within 4 weeks.The patient was not diagnosed with covid19 prior vaccination and not tested for covid post vaccination.The patient reported no allergies.The outcome of the events was recovered.  No follow-up attempts are possible; information about lot/batch number cannot been obtained
normal reactions like sore arm; on the 6th day after the first shot I developed a terrible sore throat which lasted for 5 days; This is a spontaneous report from a contactable consumer or other non hcp.   A 62-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 15Feb2021 12:00 (Batch/Lot Number: EN6208) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included methimazole (METHIMAZOLE) taken for an unspecified indication, start and stop date were not reported; propranolol (PROPRANOLOL) taken for an unspecified indication, start and stop date were not reported; pantoprazole (PANTOPRAZOLE) taken for an unspecified indication, start and stop date were not reported; famotidine (FAMOTIDINE) taken for an unspecified indication, start and stop date were not reported.  On 21Feb2021 (6th day) after the first dose, the patient experienced normal reactions like sore arm on the 6th day after the first shot she developed a terrible sore throat which lasted for 5 days. The PCP sent for a Covid test. On 26Feb2021, sars-cov-2 test: negative was negative. The sore throat disappeared as abruptly as it started while the outcome of the event localised infection was unknown. The action taken in response to the event(s) for bnt162b2 was not applicable.  No follow-up attempts are possible. No further information is expected.
Information has been received from a physician concerning a female (age not reported) who in September 2007 (exact date unknown), was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast).  The doctor sated that the patient reported extreme pain in her arm since the vaccination 1 month ago.  The patient received unspecified medical attention.  The patient's outcome was not reported.  Additional information has been requested.
RHEUMATOID ARTHRITIS; SUN BLISTER DUE TO OUT IN SUN A LOT; COVID-19 VIRUS TEST POSITIVE; This spontaneous report received from a patient concerned a 72 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, intramuscular, batch number was not reported, expiry: unknown) dose was not reported, 1 total (dose 1) (1 in 1 Once) administered on 09-APR-2021 for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. Age at time of vaccination 71 years old. Concomitant medications included hydroxychloroquine and prednisone for drug used for unknown indication. On OCT-2021, the patient experienced covid-19 virus test positive (drug start period: 06 months) (Dose number in series 1). Laboratory data included: COVID-19 virus test Positive. On an unspecified date, the patient experienced rheumatoid arthritis and sun blister due to being out in sun a lot (Dose number in series 1). The patient received additional two doses of non-company suspect vaccine of tozinameran (Pfizer) (Dose number in series 2) (form of admin not reported, intramuscular, batch number: unknown, expiry: unknown) dose was not reported administered on 01-APR-2022 (second dose) and 02-MAY-2022 (booster dose) (1 in 1 Once) for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with two doses of tozinameran (Pfizer vaccine) (Dose number in series 2).  The patient had Non-company suspect drugs included: adalimumab (Humira) (solution for injection in pre-filled pen, citrate free, subcutaneous, batch number was not reported, expiry: unknown) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran was not applicable; and action taken with adalimumab was not reported. The patient recovered from covid-19 virus test positive, and had not recovered from sun blister due to out in sun a lot, and rheumatoid arthritis. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220737512 -Covid-19 vaccine ad26.cov2.s -Rheumatoid Arthritis. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY(rheumatoid arthritis). Therefore, this event(s) is considered not related.