chrisvoncsefalvay/vaers-outcomes huggingface dataset:
FEVER; This spontaneous report received from a patient concerned a 23 year old female. 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: 201A21A, expiry: 21-SEP-2021) dose was not reported, administered on 12-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-AUG-2021, the patient experienced fever. Laboratory data included: Body temperature (NR: not provided) 101.2 F. On 17-AUG-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever. This report was non-serious.
vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 28Jul2022; No adverse event; Administered the vaccine to 346 patients after the 30 day by used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 28Jul2022) and NO ADVERSE EVENT (No adverse event) in a 44-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 28-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 28Jul2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 28Jul2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 28Jul2022).    Concomitant medications were not reported.  They administered the vaccine to 346 patients after the 30 day by used and total Number of vials was 35. The vial did not undergo any temperature excursions. Treatment medications were not reported.
Information has been received from an RN concerning a 90 year-old male assisted living pt with Alzheimer'd disease, cardiac problems and no known allergies and a history of atrial fibrillation and dementia who on 7/16/01 was vaccinated IM on the right deltoid with a 0.5 ml dose of pneumococcal vaccine 23 polyvalent. On 7/17/01, the pt was found unresponsive and bradycardic on the bathroom floor at the assisted living facility. The pt was transferred to the ER. In the ER, it was noted that the pt's right arm was red, swollen and warm to touch. The pt was treated for cellulitis with IV amoxicillin trihydrate (+) clavulanate potassium (Augmentin). He was admitted to the hospital for his cardiac condition and was discharged from the hospital on 7/23/01 to a nursing home facility. The nurse reported that the pt's unresponsiveness was not related to the pneumococcal vaccine 23 polyvalent, it was related to his cardiac problems. The pt was discharged on PO amoxicillin trihydrate (+) clavulanate potassium (Augmentin) and it was noted that his arm swelling had greatly improved. The reporter expressed a concern with the lot. The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. It was reported that another pt (WAES 01072423) had a similar experience following exposure to pneumococcal vaccine 23 polyvalent (lot 637369/1187K). FOLLOW-UP information indicated that the pt was hospitalized for five days and subsequently, recovered. Upon internal medical review, the pt's cellulitis was considered to be another important medical event. Additional information has been requested.
Narrative: COVID infection with hospitalization after COVID vaccine series 02/17/21 COVID vaccine dose #1 03/15/21 COVID dose #2 12/29/21 COVID dose #3 01/27/22 COVID positive 01/28/22 Admitted to hospital d/t COVID + for quarantine and observation 02/03/22 Discharge from hospital remained asymptomatic.
pt recvd vax 15JUN95 & 18JUN95 pt exp a sore mouth & devel a low grade fever; 20JUN05 pt presented w/vesicles on the lt tonsillar area & petechiae;strep test on 20JUN95 was neg & dx w/herpangina;
Headache, Nausea, sore throat and cotton mouth within 5 mins of injection. EMT watch patient for half hour to make sure no major allergic reaction happens. Health Practioner and EMT suggested Benadryl and Tylenol and plenty of rest. If symptoms got worse to go into ER.   Symptoms subsided after 5 hours.
Information has been received from a physician concerning a child who was vaccinated with a dose of Rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human Bovine). It was reported that there was no other information. Unspecified medical attention was sought. No product quality complaint was involved. Follow up information from a health professional indicated that she had no idea about the cases of intussusception. She also indicated that no one else here would know about it. Intussusception was considered to be an other important medical event (OMIC). The physician also reported another case of intussusception following vaccination with Rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human Bovine) (WAES0607USA03708). Additional information has been requested.
SHORTLY AFTER VACCINATION WITHIN MONITORING TIME, PATIENT ASKED IF IT WAS NORMAL "NOT TO FEEL WELL" POST VACCINATION.  PATIENT WAS LEANING ON A COUNTER AT THE TIME.  THEIR EYES ROLLED BACK, I BROKE THEIR FALL AND GRABBED THEM.  AFTER SITTING THE PATIENT CAME TO WITHIN A FEW SECONDS AND THE PATIENT HAD NO RECOLLECTION OF WHAT HAD HAPPENED DURING OR LEADING UP TO THEIR SYNCOPE.  I APPLIED A COLD COMPRESS ON THE BACK OF THE PATIENT'S NECK AND THEY QUICKLY RECOVERED.  THEY HAD NOT RECIEVED ANY RECENT VACCINATIONS BUT TO THEIR KNOWLEDGE NEVER EXPERIENCED SYNCOPE.
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 17FEB2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 17FEB2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 17FEB2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 17FEB2022) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2022 at 3:59 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 17-Feb-2022 at 3:59 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 17FEB2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 17FEB2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 17FEB2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 17FEB2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Patient ethnicity reported. The treatment information was not reported.
severe, unusual cramps and period starting significantly early - pain as severe as right after insertion of IUD - just started today so unsure of duration or outcome
0 symptoms on day 1-6. Day 7 I felt a little weak, thought it was due to lack of eating. Ate. Around 1pm, right arm started to get itchy. Around 3pm, arm started to hurt and began to get hot to touch as well as hurt. Around 4pm weakness increased, body went numb and it was hard to walk. The only way I can explain it is when your arm or leg falls asleep and it tingles and it's hard to move; that's what happened through my entire body. Only lasted 15min. Blood pressure increased (but may have been to the stress). After about 1.5-2 hours later, my body felt better, blood pressure was normal. I slept at my parents, as per the doctor's recommendation as a precaution. Two days after this event the slight tingling in my right leg and left hand is dissipating. Redness on my arm went from: Day 1-6, nothing. Day 7, small red spot at injection site. Day 8, a perfect circle on my arm. Day 9, gone as well as any pain or itchiness.  I am in the process of following up with my neurologist.
WARM TO THE TOUCH ON INJECTION SITE; PAIN ON INJECTION SITE; SWOLLEN INJECTION SITE; REDNESS ON INJECTION SITE; This spontaneous report received from a patient concerned a male 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, intramuscular, batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 12-APR-2021, the subject experienced warm to the touch on injection site. On 12-APR-2021, the subject experienced pain on injection site. On 12-APR-2021, the subject experienced swollen injection site. On 12-APR-2021, the subject experienced redness on injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain on injection site, warm to the touch on injection site, swollen injection site, and redness on injection site. This report was non-serious.
Covid vaccine on 1/11/2021. Tested positive for covid 1/13/2021. Developed lip swelling, hand/feet swelling and itching on 1/14/2021. Improved with benadryl.
Patient stated that the next day she noticed a lump on  her arm, The lump went  away and came back on 9/6/2021 about the size of a half dollar. The next day it was the size of a  lemon sized and hot to the touch. The next day it was the size of a half orange. Patient experienced a high level of fatigue
Patient received covid booster and flu vaccine on the same day.  Patient experiences mayalgias, general malaise, cough and congestion.  She thinks she has the flu.  Patient is treated with Norco 5, ketorolac, morphine, IV fluids and ondansetron with good results.
On 5/22/21 patient presented to  Emergency Room. Pt was diagnosed with the following: Syncope secondary to third-degree AV block, permanent atrial fibrillation, history of recurrent gastrointestinal bleed,  morbid obesity, type 2 diabeties mellitus with peripheral neuropathy, chronic ataxia, coronary artery disease, obstructive sleep apnea, gout, hypertension, multiple contusions of lower extremities, community aquired pneumonia (recovered) and, Anemia chronic but stable. Pt give pacemaker and dischared to nursing home for after care.
Experienced sore throat  several after injection.; Experienced ear pain several after injection.; This is a spontaneous report from a contactable consumer. A 56 year old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch Number: EN6199), via unspecified route of administration on the left arm on 09Mar2021 at 02:00 PM (at the age of 56-years-old) as a single second dose for COVID-19 immunisation. Medical history included allergic to raw apple, almond, peach, nectarine and lactose intolerance from an unknown start date. Past drug history included a first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch Number: UNKNOWN), via unspecified route of administration in the left arm on 16Feb2021 at 01:30 PM as a single first dose for COVID-19 immunisation. Concomitant medications included lipitor (MANUFACTURE UNKNOWN) and advair (MANUFACTURE UNKNOWN) from unknown dates for unknown indications and unknown if ongoing. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The patient had not tested positive prior or since the vaccination. On 11Mar2021 at 03:30 PM, the patient experienced events sore throat and ear pain after the injection. The Clinical outcomes of events sore throat and ear pain were recovered at the time of reporting.   No follow-up attempts are possible. No further information is expected.
pt recvd vax; mom states episodes of prolonged screaming beginning approx 4 hrs p/ vax;cont for several hrs; mom states did not give acetaminophen;reports pt ok next day;did not seek med attention;
I normally exercise by walking indoors, ususally 5000 steps a day, with two canes.  On the day following the vaccination, I had reached 1500 steps but was finding the effort unexpectedly difficult, and was feeling warm.  I used the EKG function on my Samsung Watch and it read Atrial Fibulation detected,  This has never happened before (or since) under normal exercise circumstances.
Local title: Physician, Clinic note date of note: FEB 01, 2012 at 10:43 02/01/2012 Addendum Status: Complete. Patient return stating the arm where she had the pneumonia shot this morning is swollen. Patient said the swelling has stopped worsening the last 1-2 hrs. Slightly red and warm. No fever, no shortness of breath or wheezing. No swelling of her lips. PE: Lt deltoid area slightly swollen and warm to touch. No erythema. No limitation of movement. MEDROL dose pack ordered. BENADRL qid prn (patient has at home). Return if symptom worsens, arm turns red, sob, wheezing or swelling starts. Patient acknowledged understanding. Local title: Nursing Primary Care Note Date of Note: FEB 01, 2012 at 08:55 This is the patient's initial visit to establish care and receive medication. The following screening options were offered: *PNEUMOVAX: Patient received 0.5ml of pneumococcal vaccine IM at this encounter. Site: Lt deltoid. Manufacturer: Merck Lot #: 0895AA Exp. date: 11/12/2012
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Headache-Medium, Systemic: Seizure-Mild, Systemic: Shakiness-Mild, Systemic: Weakness-Mild, Additional Details: Caregiver went limp following the vaccine and fainted, for report 10 seconds. Patient was clenching hand and looked to be having a mild seizure. No history of seizure or adverse effects of to any vaccines Patient did not fall or hit head. Patient states felt disease and began to black out. After 10mins patinet reported felt shaky and had a small headache
This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient. A 48-year-old male patient received BNT162b2 (BNT162B2), on 06Jan2022 as dose 3 (booster), single (Lot number: 3209) at the age of 48 years, in left arm for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Apr2022, outcome "unknown", COVID-19 (medically significant) with onset Apr2022, outcome "recovered" (2022) and all described as "Treatment of COVID-19"; PRODUCTIVE COUGH (non-serious) with onset 10May2022, outcome "not recovered", described as "Cough has become more productive"; FATIGUE (non-serious) with onset 10May2022, outcome "unknown"; OROPHARYNGEAL PAIN (non-serious) with onset 10May2022, outcome "unknown", described as "sore throat". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11May2022) Negative. Therapeutic measures were taken as a result of Covid-19, productive cough. Other medication in 2weeks was no, Anti-viral details: product was COVID-19 Treatment, brand=Pfizer, treatment start date was 28Apr2022, treatment stop date was 03May2022, indication was Treatment of COVID-19. Were you/Was the patient taking any other medications/products within 2 weeks of starting COVID-19 treatment was no. Did you/the patient previously receive a COVID-19 Vaccine was yes. Symptoms of cough, fatigue, and sore throat returned significantly on 10May2022.  Rapid at home antigen COVID test was negative 11May2022. Cough has become more productive and remains in 13May2022. What treatment received for the adverse event was  Medication for cough. Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events. The case will be reassessed once new information is available.
This case was reported by a consumer via call center representative and described the occurrence of nerve pain in a female patient who received FLUARIX QUADRIVALENT 2017-2018 season for prophylaxis. On an unknown date, the patient received FLUARIX QUADRIVALENT 2017-2018 season (intramuscular). On an unknown date, unknown after receiving FLUARIX QUADRIVALENT 2017-2018 season, the patient experienced nerve pain and injection site pain. On an unknown date, the outcome of the nerve pain and injection site pain were unknown. It was unknown if the reporter considered the nerve pain and injection site pain to be related to FLUARIX QUADRIVALENT 2017-2018 season. Additional details were provided as follows: The age at vaccination was not reported. The reporter was husband of patient during call it was mentioned that, the patient had a flu shot years ago and experienced nerve pain in the shoulder where it was given. The reporter was unable to verify name or formulation of the flu shot. The reporter did not consent to follow-up.
proportion of the dose administered could be estimated as about half; vaccine flowed 3 or 4 inches quickly down my arm and the over the finger holding my clothing; This spontaneous case was reported by a consumer and describes the occurrence of UNDERDOSE (proportion of the dose administered could be estimated as about half) and DEVICE CONNECTION ISSUE (vaccine flowed 3 or 4 inches quickly down my arm and the over the finger holding my clothing) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 030L30A) for COVID-19 vaccination.     Concurrent medical conditions included GERD (No Historical Condition reported) since 01-Jan-2016. Concomitant products included OMEPRAZOLE from 01-Jan-2016 to an unknown date for GERD.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced UNDERDOSE (proportion of the dose administered could be estimated as about half) and DEVICE CONNECTION ISSUE (vaccine flowed 3 or 4 inches quickly down my arm and the over the finger holding my clothing). On 17-Mar-2021, UNDERDOSE (proportion of the dose administered could be estimated as about half) and DEVICE CONNECTION ISSUE (vaccine flowed 3 or 4 inches quickly down my arm and the over the finger holding my clothing) had resolved.            Patient stated she was 70 years old with no comorbidities.  Patient reported no allergies.  Patient stated the second vaccination dose was administered by a non-medical staff (office manager).  There was no physician at the vaccination site; however, a nurse practitioner who was in charge "did not know if it was a problem or not but, either way, another shot was impossible because I would go into shock."    Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Follow up included patient age, weight, height, medical history and  concomitant medication information added.
This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 76-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site warmth (1st dose received on 10th July 2018, please refer the case US2018164362).  On an unknown date, the patient received the 2nd dose of SHRINGRIX On an unknown date, less than a year after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, erythema, skin warm and itchy. On an unknown date, the outcome of the extensive swelling of vaccinated limb, erythema, skin warm and itchy were recovered/resolved. It was unknown if the reporter considered the extensive swelling of vaccinated limb, erythema, skin warm and itchy to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient did not see her physician and called the physician and that was forwarded to the pharmacist where the vaccine got. Basically both shots made her arm below injection site by 3 to 4 inches swell up and red, hot, itchy and it was healing the diameter of the spot was 4 inches in diameter. The patient wanted to know at the time, the patient was concerned about having the second injection. This case has been linked with case US2018164362 reported by the same reporter for the same patient.
Having a lot of disorientation and confusion; Having a lot of disorientation and confusion; Trouble speaking; putting words in sentences together; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 11Mar2021 (Batch/Lot number: unknown) as unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CONFUSIONAL STATE (non-serious), DISORIENTATION (non-serious) all with onset Mar2021, outcome "unknown" and all described as "Having a lot of disorientation and confusion"; SPEECH DISORDER (non-serious) with onset Mar2021, outcome "unknown", described as "Trouble speaking; putting words in sentences together".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.