chrisvoncsefalvay/vaers-outcomes huggingface dataset:
persons vaccinated with Moderna vaccine that was opened beyond 12 hours; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (persons vaccinated with Moderna vaccine that was opened beyond 12 hours) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (persons vaccinated with Moderna vaccine that was opened beyond 12 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (persons vaccinated with Moderna vaccine that was opened beyond 12 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.
Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (Fever). On 14-Feb-2021, PYREXIA (Fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-May-2021, SARS-CoV-2 antibody test: negative (Negative) Patient has undergone antibody test which was negative.         No relevant concomitant medications were reported.  No treatment information was provided.
Redness with swelling approximately 2 inches wide to left thigh. Warm to the touch. No treatment.
How long should a fever last after the Hep A vaccine; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Hepatitis A vaccine for prophylaxis.   On an unknown date, the patient received Hepatitis A vaccine. On an unknown date, unknown after receiving Hepatitis A vaccine, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Hepatitis A vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient questioned, how long should a fever last after the Hepatitis A vaccine. No other information was provided. The information regarding consent to follow up was not reported.
I just feel achy and tired like I am coming down with the flu. Sniffles and sore throat, no fever. Have felt progressively worse since my 2nd shot. The day after I was fine and then felt bad the 2nd and 3rd day, today.
hives across chest, both arms and upper back-hot flashes (not related to menopause)
On day 9, on left arm below the site of injection a skin reaction appeared. Skin appeared red, hard lump, warm to touch and very itchy. Took Tylenol and applied hydrocortisone cream.  On Day 10, the area enlarged (redness, hardness and itchy). Fingers were itchy as well. Took Tylenol and applied hydrocortisone cream. On Day 11, symptoms remained. Neck and mouth area are itchy as well. Took Benadryl with minimal  improvement. Experienced chills and swelling in the left arm pit area.
Swollen lymph node on injection arm (left side); This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 28Feb2021 at 09:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no allergies to medications, food, or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not received any other vaccines within four weeks prior to the vaccination. Concomitant medications included losartan (MANUFACTURER UNKNOWN) and water pill (unspecified); both for unknown indication from unknown date and unknown if ongoing. On 01Mar2021 at 07:00, the patient experienced swollen lymph node on injection arm (left side). The event 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 event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swollen lymph node on injection arm (left side) was not recovered at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
One hour post vaccination felt headache and pain in eyes. C/o ear pain and hot, face felt hot - c/o cramps in legs and hands. Took ADVIL. No other meds. Was not seen by physician.
lower back discomfort; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 68 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Mar2021 14:05 (Batch/Lot number: unknown) at the age of 68 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Tetanus, reaction(s): "no adverse effect". The following information was reported: MUSCULOSKELETAL DISCOMFORT (non-serious) with onset 14Mar2021, outcome "not recovered", described as "lower back discomfort".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
INCREASED BLOOD SUGARS; This spontaneous report received from a patient concerned a 34 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetic. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808609 expiry: 09-JUN-2021) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination on Left arm. No concomitant medications were reported. On 26-MAR-2021, the subject experienced increased blood sugars. Laboratory data (dates unspecified) included: Blood sugar abnormal (NR: not provided) fluctuating between 300 to 400 currently at 326. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from increased blood sugars. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210354739-Covid-19 vaccine ad26.cov2.s- increased blood sugars. This event(s) is considered not related. The event(s) 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(s) than the drug. Specifically: UNDERLYING DISEASE
Patients husband called about 4 hours after admin of vaccine; He said the patient's shoulder had a lump about the size of an egg and was painful. No redness, not hot to the touch (Left shoulder).
1/25- received vaccine at 11:45 am. Started round-the-clock extra strength Tylenol at 12:00pm. At 10:30pm began to feel chills and body aches. 11:00pm  got very hot and sweaty, hands began to tingle, vision became fuzzy around the edges, felt like I was going to pass out. Experienced tachycardia, tachypnea, and headache. 12:20am- vomited. Restless sleep through the night, chills, fever (100.6-99.6 on Tylenol), body aches, joint pain, stomach ache, woke at 5:00am.  1/26- spent all day vomiting. At least once every hour. Continued tachycardia, tachypnea, stomach ache,  fever, headache, body aches,  and joint pain. At 7:00pm took Zofran and I stopped vomiting. Still nauseous. Could not eat all day.  1/27- woke up with headache and slight body aches but otherwise felt okay during the day. Was hungry and able to eat. Starting at 10:00pm my stomach began to hurt again. Experienced bloating, sharp stabbing pain and nausea. Felt like I needed to vomit or pass a bowel movement but could not do either. Took Zofran at 11:00pm, did not help in relieving my GI symptoms. Still on round-the-clock extra strength Tylenol. Could not eat all night.   1/28- woke up still with headache, and mild-moderate stomach pain.  Able to eat a couple bites of food.
Pt unable to be aroused on 21FEB92 approx 7AM; rescue squad called, CPR initiated & transported to hosp; unable to resuscitate; cause of death on certificate SIDS; no signs of illness prior to incident;
Reddened vax area, hard, swelling 3.5"x2.25", hot to touch with fever. Given Tylenol and Advil. Mom also gave Benadryl to help relieve swelling.
Impossible to know exact time of start! Silly to ask. Adverse event = headaches for weeks and then head tremors, no treatment until November, diagnosed as essential tremor but nothing showing on brain MRI and no meds are helping. No family history. They continue to this day.
couldn't sleep; severe arm pain; upper arm burning pain; collar bone pain; shoulder pain; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (couldn't sleep), PAIN IN EXTREMITY (severe arm pain), ARTHRALGIA (shoulder pain), PAIN (upper arm burning pain) and BONE PAIN (collar bone pain) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INSOMNIA (couldn't sleep), PAIN IN EXTREMITY (severe arm pain), ARTHRALGIA (shoulder pain), PAIN (upper arm burning pain) and BONE PAIN (collar bone pain). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, INSOMNIA (couldn't sleep), PAIN IN EXTREMITY (severe arm pain) and PAIN (upper arm burning pain) outcome was unknown, ARTHRALGIA (shoulder pain) was resolving and BONE PAIN (collar bone pain) had resolved.        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.   Concomitant product use was not provided by the reporter.; 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
This spontaneous report as received from a nurse regarding an unspecified number of patients of unknown age. There was no information about concurrent condition and historical medication. On 18-JUN-2015, the patients were vaccinated with improperly stored RECOMBIVAX HB lot # J013370, expiration date 03-FEB-2016 and lot number J0110613, expiration date 11-JUN-2015. No concomitant medication was reported. No adverse event was reported. No PQC (product quality complaint) was involved. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Initial effect was sore arm and very tired for the first 24 hours.  Flight at the end of December - I had significant trouble with ears taking off and landing.  That did seem to resolve itself once pressure was balanced.  Sometime over the next month or so my hearing became VERY poor in the right ear. Then the ringing whirring noises began in both the right and left ear.  I estimate this onset was February.  Initially, I thought it could be sinuses - but, it persisted.  Visited ENT and Audiologist in March.
Pt was administered a Gardasil 9 vaccine instead of a Pentacel vaccine.
Dizziness; Ringing in ears, both the ears; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 11Apr2021 (Lot number: EWU151) at the age of 59 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ESTRADIOL; TELMISARTAN; GLIPIZIDE; JARDIANCE; RABEPRAZOLE. Vaccination history included: Bnt162b2, for Covid-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset 13Apr2021, outcome "unknown", described as "Dizziness"; TINNITUS (non-serious) with onset 13Apr2021, outcome "unknown", described as "Ringing in ears, both the ears".  Additional information: The reporter wanted to report the side effect of her second vaccine. The reporter stated, Ringing in ears, both the ears and it started 2 days after vaccination which was 13Apr2021. It was also reported that the patient was been getting light headaches. On 07Apr2021, the patient took an ultrasound on the thyroid because after 1st vaccine it swelled up and a biopsy was scheduled for unspecified year of May 4th. The ultrasound results revealed nodules 4 mm on right side and a 2 mm and a 3 mm on the left side. Biopsy was scheduled for the right side. The patient said at the time of the report that she was experiencing the event for 3 days. Patient was also experiencing dizziness and was received some unspecified medicine along with Allegra and Meclizine 25 mg . It was also reported there is no expiration date on the vaccine.  No follow-up attempts are possible. No further information is expected.
Body aches and tiredness started around 10am on 2/5 Body aches, tired and feeling flu like continued throughout day by 5pm low grade fever and chills approx 98.6 fever and tired through the night most symptoms resolved by 24 hours left arm soreness as well starting 2/5 lasting 2 days
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021 at 11:37 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 04-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 04-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided. Treatment information was not provided.
crohn's flare up; temperature between ninety nine point one and ninety nine point seven; bruising on top of thighs; nausea; back pain; This is a solicited report from a Study (Marketing Program Name Not Available) received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4340356-00 (AbbVie).  A 29 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Lot number: 1159670) till Nov2021 at unk (citrate free) for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: CROHN'S DISEASE (medically significant) with onset Mar2022, outcome "not recovered", described as "crohn's flare up"; BODY TEMPERATURE ABNORMAL (non-serious) with onset Mar2022, outcome "unknown", described as "temperature between ninety nine point one and ninety nine point seven"; CONTUSION (non-serious) with onset Mar2022, outcome "unknown", described as "bruising on top of thighs"; NAUSEA (non-serious) with onset Mar2022, outcome "unknown", described as "nausea"; BACK PAIN (non-serious) with onset Mar2022, outcome "unknown", described as "back pain". The patient underwent the following laboratory tests and procedures: body temperature: (Mar2022) between 99.1 and 99.7; weight: (Mar2022) loss of 3 lbs. The action taken for adalimumab was dosage permanently withdrawn on Nov2021 and dechallenge was negative. The reporter's causality for the events of temperature between ninety nine point one and ninety nine point seven, bruising on top of thighs, nausea and back pain was not provided while event of crohn's flare up was a reasonable possibility with Humira (adalimumab). The reporter considered "crohn's flare up", "temperature between ninety nine point one and ninety nine point seven", "bruising on top of thighs", "nausea" and "back pain" related to bnt162b2.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided there is a reasonable possibility of causal association between the events with the suspect product bnt162b2.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Patient presented to Health Department with his mother, for influenza vaccine administration. RN instructed patient's mother to hold him in her lap and hug him in order to keep his arms/hands restrained to prevent him from grabbing at syringe. RN present to help hold patient's legs in place. RN attempted to administer vaccine in patient's Right thigh, his left arm/hand wriggled loose from his mother's grasp and he grabbed at the syringe, and was poked by the needle on his left hand which instantly started bleeding. No vaccine was administered with this specific syringe. RN held pressure to Left hand site for 5 minutes, bandaid was applied and reinforced with coban. At this time, RN was called in to assist with flu shot administration. New vaccine was prepared and with patient's mother, RN and RN helping to hold patient in place, Flulaval vaccine was administered in Left vastus lateralis. RN checked on patient 15 minutes later while in waiting room and bandaid remained in place with no bleeding evident.
Vaccination date for 2-year-old was 06JUL2022 and 18AUG2022.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccination date for 2-year-old was 06JUL2022 and 18AUG2022.) and NO ADVERSE EVENT (No adverse event) in a 2-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AS1414B and AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 06-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Aug-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccination date for 2-year-old was 06JUL2022 and 18AUG2022.) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccination date for 2-year-old was 06JUL2022 and 18AUG2022.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccination date for 2-year-old was 06JUL2022 and 18AUG2022.).    No concomitant medication was reported. No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-689229 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-689229:Original case
Had Vaccine on 9-20-03Developed. Chest pain on 9-22-03 - sharp in nature. Went to ER. Found to have rash over ant chest wall. Diagnosed As Shingles. Rxed with antiviral ? Acyclovir. Today I added Elavil 10mg qhs for pain.
Consistent Diarrhea for 8 weeks, none stop Thyroid tests showed extreme elevated count, like never before & still dealing with that. Vaginal yeast Severe weakness, sleeplessness, body flushes, hair loss, weight gain, head fog & heaviness
Anaphylaxis (hives, low perfusion) . Treatment given: > Epinephrine 1:1000 SQ 0.2ml. > Supplemental O2.
Employee received .2 cc of Pfizer instead of .3 cc which was inadvertently administrated by vaccine nurse.   NO ADVERSE REACTION, just reporting medication error.   Our Vaccine Task Force, after speaking with CDC and DOH, decided to offer the employee an additional COVID-19 vaccine dose. Thanks.
RINGING IN THE EAR; ANXIETY; SORE ARM; This spontaneous report received from a patient concerned a 56 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: 1808980 expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 on right arm for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced ringing in the ear. On 01-APR-2021, the subject experienced anxiety. On 01-APR-2021, the subject experienced sore arm. Treatment medications included: ibuprofen. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sore arm, and had not recovered from ringing in the ear, and anxiety. This report was non-serious.
Enlarged red circle around site of injection. Patient states area is very warm, and the area is also painful. Patient stated she did not feel any systemic effects and did not have a fever.
Information has been received from a physician concerning a 17 year old female patient, who one week ago (approximately 02-SEP-2008) was vaccinated with the second dose of 0.5 mL GARDASIL (Lot # not reported). One week ago (approximately 02-SEP-2008), the patient experienced urinary tract infection after receiving the second dose of GARDASIL. The patient sought medical attention, seen by the physician. There was no product quality complaint. Additional information is expected.