chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Had her 1st dose injection 05Aug2021 and in between she is taking antibiotics; This is a spontaneous report received from a contactable consumer or other non-healthcare professional (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on 05Aug2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Caller was a consumer who had her 1st dose injection 05Aug2021 and in between she is taking antibiotics on Aug2021. She was asking if it is ok to get second dose, or should she wait. Caller stated she has not had any issues and before she schedules her 2nd injection she wanted to know if she took antibiotics it is ok to still get the 2nd dosage. Patient was received treatment for the event. The outcome of the event was reported as unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Pt vaccinated with Influenza developed nausea & vomiting for 3 days. Vaccine received on 14OCT pt seen in ER on 11OCT, sent home and admitted to hosp on 17OCT.
blood in the stool lasting from 2/03/22 through 3/17/22
Rash - Near Injection Site; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash - Near Injection Site) and NAUSEA (Nausea) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced VACCINATION SITE RASH (Rash - Near Injection Site) and NAUSEA (Nausea). At the time of the report, VACCINATION SITE RASH (Rash - Near Injection Site) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessment.  No concomitant medications were reported.  Treatment information was not provided.
Received vaccination on 3/31/2022, tested positive for COVID-19 on 06/29/2022 with a home test. Breakthrough.
pt called on 24JAN96 to report itching,redness & swelling & rash @ inj site;pt went to personal MD & treated w/steroid & DPH cream
SHE GOT DIZZY AND SPACED OUT FOR 5-10 MINTUTES. SHE HAD HER EYES OPEN.
Received immunizations of DTaP #4 and MMR #1 on 3/3/04. Pt's dad called on Sat 3/6/04 with cc: of rash and hardness around inj area. Pt was seen temp 97.8 deg ax with rash with lesions up and down RT leg site of DTaP also lite rxn on LT leg site of MMR.
Swelled immediately at injection site, about 1.5inx1.5in, about 1 inch rise. No other signs. Denied any symptoms.
Member received wrong vaccine due to missing question in 6 rights of administration. Patient came in for 'I'd during a flu clinic where all other patients were given the flu vaccine. Tech did not verify "right vaccine."
CHILLS; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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: Unknown) dose, start therapy date were not reported 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 chills. On 2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 2021. This report was non-serious.
2 months after receiving the vaccine I caught covid. I had a fever. I didn't have a sore throat, but I was hoarse. I was very tired. I was sweating at night because of my fever. I went to an urgent care. I was prescribed Paxloid. My covid symptoms lasted less than a week. The Paxlovid made me have a metallic taste in my mouth. I never lost my taste or smell while having covid, but after I finished taking the Paxlovid my sense of taste was slightly off. That lasted for about 2 weeks. After catching covid it took me a while to get back to my normal energy level.
Face became hot with facial swelling; hives. (+) cough, without shortness of breath.  Advised to report to ER, (7:20 PM), at which time symptoms had already begun to subside.  Took 1 dose of Benadryl after leaving ER (10:00 PM).  Shortly after, symptoms completely dissipated.  Next day, when seen in office, no residual effect.
Moderna COVID vaccine given 11/8/21, lot # 077C21B; 11/29/21 pt admitted to Hospital for altered mental state, weight loss, poor po intake, trouble swallowing and weakness x 1 wk; found to be positive for COVID; severe tremors and jerks - given carbidopa-levodopa; PEG tube placed; pt went into Hospice where he passed away
Severe vomiting nausea weight gain, no menstrual period, insomnia, chronic fatigue, hair loss, irritability, muscle aches and joint pain.
Severe stomach pain, prolonged nausea (greater than 24 hrs). Severe bone pain et "body shakes", severe pain at injection site (greater than 24 hrs).
Was notified by patient's wife this morning, that patient experienced tachycardia for a space of around 2 hours in the middle of the night with HR reporting around 150. Patient did not notify wife of reaction until this morning, where patient's wife checked HR again and it had normalized to the 80s. Patient did not experience any HA, nausea, sweating, chest pain, or any other negative symptoms aside from the elevated heart rate.
immunocompromised; inadvertently given the Prevnar 13 again; This is a spontaneous report from a non-contactable pharmacist.   A 56-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for immunisation.  The patient's medical history and concomitant medications was not reported. The patient experienced immunocompromised on an unspecified date, received a Prevnar 13 last year and came in today to get her Pneumovax but was inadvertently given the Prevnar 13 again on an unspecified date. The outcome of events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: The association between the event "immunocompromised" with PREVENAR 13 use can not be fully excluded.  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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Information has been received from a physicians assistant concerning a 69 year old male who on Oct  13 2004 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 649076/0213P). On Oct 13 2004 the patient developed pain and edema at the injection site, high fever (as high as 101F), body aches and nausea. Unspecified medical attention was sought. The patients out come was not reported. There was no product quality complaint. It was noted that the patient had been vaccinated with pneumococcal 23v polysaccharide vaccine last in 1999. It was also reported that a female patient (WAES0410USA02401) and two unidentifiable patients (WAES0411USA01403) had similar experiences following vaccination with pneumococcal 23v polysaccharide vaccine. Additional information has been requested.
Patient given 1st dose covid-19 vaccine with FOC present. Had vasovagal respond few minutes after the vaccine was given in Nursing Station. Pt. Didn't completely passed out. Father had client on his arms when client felt weak, skin pale. Had patient lie down and lifted her legs up on the chair. Applied ice compression behind the neck. Given fluids-juice. Patient recovered after 3 minutes, ambulated to Observation area. Vital sign: BP 100/60, O2 Sat. 98%, HR 90.  Pt. Left walking with father, no injury reported.
back issues; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and administration date 10Apr2021 (Batch/Lot number: unknown) as single dose for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PREDNISONE. The following information was reported: BACK DISORDER (non-serious), outcome "unknown", described as "back issues". Therapeutic measures were taken as a result of back disorder.  Additional information: The patient got the first Pfizer COVID-19 shot and he was scheduled to take the second dose of the vaccine this Saturday (10Apr2021). His doctor has prescribed him prednisone for his back issues. He wanted to know if there would be interactions between the Pfizer COVID-19 shot and prednisone.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Vaccine was expired on 24-Oct-2021 and administered on 25-Oct-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 24-Oct-2021 and administered on 25-Oct-2021) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 24-Oct-2021 and administered on 25-Oct-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 24-Oct-2021 and administered on 25-Oct-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was reported.  Date the vial was initially stored in the refrigerator reported as unknown. Number of doses/vials was reported as 168 doses.  The vial did not undergo any temperature excursions.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Non Significant follow up received contains Primary Reporter address updated
Approximately 5 minutes after vaccine administration, patient fell and hit her head, had loss of consciousness for about 15 seconds.
pt developed a severe migraines and is still having them.  He vomits every time he eats.  He developed a rash on his chest, has shortness of breath, runny nose.  Some confusion and brain fog.  He went to  ER in  on 4/16/2021 for migraine headache and other symptoms.  He was given a CT and a shot of Demerol and sent home to FU w/ neurologist.  He continued having migraines so went back to  ER on 4/18/2021.  He had an EEG, ECG, and abnormal lab work.  He was given another shot of Demerol, Phenergan and IV fluids.  He was monitored for a few hours and released to FU w/ Neurologist.
Fever for 2-3 days (101.7*), fussiness - didn't sleep for more than 5 minute increments for 2 nights (fun), Poor appetite, vomit (once), non-stop crying for 3 hours from 7-11 pm and then broken sleep through the morning.
slight enlarged heart; went to ER for heart rate of over 180; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received bnt162b2, via an unspecified route of administration, administered in left arm on 26May2021 10:30 (Lot Number: Ew0177) as dose 2, single at the age of 55-year-old for covid-19 immunisation. The patient was not pregnant. The patient did not receive any other vaccines within 4 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. Medical history included high cholesterol from an unknown date, thyroid removal in 2011. The patient had no known allergies. Historic vaccine was bnt162b2, via an unspecified route of administration, administered in left arm on 06May2021 10:30 (Lot Number: Ew0167) as dose 1, single at the age of 55-year-old for covid-19 immunisation. Concomitant medications included atorvastatin calcium 10 mg, levothyroxine sodium 100, all taken for an unspecified indication, within 2 weeks of vaccination. 9 days after shot (04Jun2021) the patient went to ER for heart rate of over 180, sent home and had to go to ER 3 more than mrs within a 7 day period the last time they admitted her for 2 days. The patient did not have heart issues nor high blood pressure or any heart disease. She ran 110/55 normal pulse 50-60. The patient now had to see a cardiologist and he wanted to do a monitor. The patient had never had to go through this ever until this shot. They took X-rays and it showed an slight enlarged heart (06Jun2021 03:30 as reported). The patient was so upset the shot had done this to her. The patient underwent lab tests and procedures which included 9 days after shot (04Jun2021) heart rate of over 180; blood pressure: 110/55, normal pulse: 50-60 on an unknown date; x-ray: an slight enlarged heart on 06Jun2021. The adverse events resulted in emergency room/department or urgent care and physician office visit. The seriousness of events was hospitalization for 2 days from Jun2021. Therapeutic measures were taken as a result of events which included a pill to regulate to restart her heart. The outcome of events was unknown.
child began having intermittent breath holding episodes which started approx 1 month p/vax;later dx as atypical sz;
Patient was 17 years old at the time the vaccine was administered. Moderna is currently only authorized for individuals 18 years of age and older.
Severe vomiting off and on for 6 hours Accompanied by other normal side effects including chills, sweats, nausea
1st dose Moderna injection given on Dec. 29 2020.  Left arm at injection site became itchy (and left side of body random itchiness.) Spot itchy for 1.5 days and bump appeared (looked like ant bite, but did not hurt.) Resolved after 2 days with no medial intervention or drugs. Today is 01/08/2021 and bump appears to have resolved, no itchiness or redness. No headache no body ache. Possible joint achiness for the 1.5 days. All resolved
The Moderna vaccine was taken out of the freezer and placed in to the refrigerator on 9/8/2021. The vaccine was administered beyond the 30 days of which the vaccine is recommended to be kept in the refrigerator.  No adverse reaction occurred during the 15 minute waiting period or reported after the clinic date.  This participant is immunosuppressed and received 3rd dose.
Fever/chills, headache, nausea, light-headed, low blood pressure, weakness.  Lasted approx. 12?16 hours.
Tingling in hands and feet, sensation of goose bumps, numbness on tip of tongue, generalized body aches. Treatment with Benadryl seemed to reduce symptoms.
Was well at time of vaccination and had no immediate problems. The following day she developed nausea, vomiting and a headache. She reported a low grade temperature and body aches as if she had the flu. She stated there was no pattern with the migraines or any association with events. They would last a couple of hours and she would have some light sensitivity. Other than the occasional headache she denied any previous hx of headaches. She reported the headaches lasted approx 6 months and spontaneously resolved in May 2019. Did not seek formal evaluation other than a pcm visit and never received a diagnosis of migraines.   Symptoms: HEADACHE(R51).
Information has been received from a physician concerning a 10 week old female who on 04-JUN-2010 was vaccinated with the first 2ml dose of ROTATEQ (oral, lot # 664876/1470Y). On 05-JUN-2010 at 2:00 am the patient was vomiting. The patient was treated with PEDIALYTE SOLUTION and then clear fluids for 6-8 hours. Symptoms subsided in a a few hours. The patient received unspecified medical attention. On an unspecified date, the patient recovered from vomiting. Additional information has been requested.
Headache, stomach ache, injection site ache, swollen and painful lymph nodes, and mild fever next day, dizziness and nausea started 3 days later
Pfizer on 6/4, 6/25, and 10/8, Positive on 12/7
11/12 Sat evening rash on buttocks, 11/13 Sunday rash on legs and ankles, 11/14 Monday ankles very swollen and behind knees, 11/14 Wed face rash, swollen lips, plus itching x 5 days. Call to RHHD then TO Dr. family has no insurance, was given order to place client in bath tub with baking soda and use Benadryl as needed.
Patient reports delayed s/s patient reports SOB, mild fever, dizziness, cough, inflammation and redness to right deltoid. Patient was seen by PCP. Apply ice to upper extremity, BACTRIM PO x 2 daily, for 10 days, BENADRYL gel OTC daily, cetirizine 10 mg PO daily. Ret to pulmon.
Pain at the time of the flu injection. Soreness for two days. After two days, the pain progressed and I was losing my range of motion, and wasn't able to move my right arm/shoulder without excrutiating pain. Numbness in right arm with mottling noticed. Not able to sleep due to the excrutiating pain keeping me up all night. Ice, heat and NSAIDS not helping at all with the discomfort. The injection was injected too high above my deltoid resulting in the pain and has not yet gotten better. Gets worse as the days go on.
Employee became dyspneic and complained of chest pain about 10 minutes after vaccination.  Stated she needed aerosol treatment and was having difficulty with taking deep breath.  Wheezing noted in ED.
Headache behind the eyes started at 11:01 am, nausea started at 11:10am. Fever 101.8 degrees F started after 12:00pm. Following day 04/18/2021 fever reached 200.1 degrees F.  Fever broke early morning Monday 04/19/2021 Nausea and headache stopped. Diminished sense of smell and taste and lack of appetite persist.
Patient was fully vaccinated, no booster. Patient developed COVID19 on 11/30/2021, spent time in the hospital from 11/29/2021 to 12/23/2021, went to hospice on discharge from the hospital, and died on 12/31/2021. Patients death is being examined by the mortality review team to determine if it was COVID19 related.
Pt receive the ROT5 (Rotavirus live, pentavalent)  on  12/13/2006 and 02/14/2007. Almost immediately after the 2nd dose, pt's appetite began to decrease, and he stopped feeding completely on 2/16. Had a fever of 99.8 axillary on 2/16. Also had 2 loose stools within 1 hr in the late afternoon of 2/16. No vomiting. Was taken to the ER due to his complete refusal of breast or bottle feeding. Had a negative sepsis screen. Later on that day, resumed breast-feeding and all symptoms resolved.
I contracted COVID.  Strong, lingering cough, lingering fatigue, loss of appetite, aches, sinus congestion
Reported to pharmacy 11/29/2014.  Described fever, redness and itching at the sight and below sight of the injection, and lethargy.
Starting 10 hours after the injection at 2AM Local ET on Thursday, June 24th,  I began feeling a severe headache, feverish, and fatigue.  I was working a midnight shift so I was awake the whole time.  At about 4AM local (12 hours after injection), I began feeling severe stomach and groin cramps as well. All of these symptoms got worse of the next 24 hours. the fever, headaches, and cramps were at their worse about 18-30 hours after the injection. I took Tylenol and tried to sleep but did not sleep long as the fever was very high in this period. I nearly went into the Emergency room on 25 June.  At this time, I felt a little better, but still very fatigued and having some stomach/groin cramps still at 9PM on Saturday, June 26th.
gout/symptoms started a week ago; This spontaneous case was reported by a consumer and describes the occurrence of GOUT (gout/symptoms started a week ago) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMIN D NOS for an unknown indication.   On 22-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced GOUT (gout/symptoms started a week ago). At the time of the report, GOUT (gout/symptoms started a week ago) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable  Other Concomitant medications included blood pressure medicine, high sugar medications. No treatment medications were reported.
Stumbled, had a controlled fall to the ground,  NO LOC,  no change in LOC  had metallic taste in mouth and pain in abdomen  vitals were stable,  improved on O2.  transported to local er via EMS
Identified tumor on right side of head . Tingling facial sensations . Anemia as well
Febrile illness without ill contacts, GI symptoms.  3 cm circular erythematous patch with slight papulovesicular surface at/near varucekka vaccune sight.  No other rash or lesions.
Started itching a week after shot, swelled up a good amount and is hot to the touch, and bright red patch maybe 5×5 inches
Patient experienced bright red rashes (non-blistering) all across body 3-4 days after vaccine administered.  Patient has followed up with a physician within several days of their reaction, who is currently managing their condition.
From initial information received on 19/mar/2004 from a registered nurse regarding an adverse event occurring in the U.S.A., it was reported that a 43-year-old female patient received a dose of TD ADS ADULT, lot number U1022AA, administered in the left deltoid on 12/mar/2004. An unspecified time later, the patient developed pain in her left deltoid and could not lay on the arm. The patient was seen by a physician on17/Mar/2004 and 18/Mar/2004. She was not sure whether the arm was red, warm or swollen. The patient also developed a lump on her neck. Reportedly, some information will be available at future date in approximately one week. It is unknown when the patient received her last Td booster. The patient's recovery status was not reported. From additional information received from a health care professional,it was reported that the patient fully recovered from these events. No other new medical information was provided. Further information is not anticipated, this case is considered closed. The reporter of this case is the same reporter of case 200401155.
Dull ache at injection site, began 3  to 4 days at after injection. Now still dull ache.
Patient received the vaccine in left arm by Pharmacist. Patient stated a phobia of needles. Shot administration was normal. Patient walked out of the vaccine room and told his mom he felt light headed and dizzy. She had him sit down to which he fainted and was unresponsive for 45 seconds or so. Mother was present and got pharmacy attention. The  reaction was at 10:39 am and by 10:43am patient was talking and answering questions but was still very pale. EMS 911 was called and patient was given water. EMS arrived on seen and patients blood pressure was 83/49 and oxygen was 97. EMS decided to transport patient to emergency services.
Her skin was burning hot, she was sweating, and had a 104 temperature. She was also very fussy nonstop and didn't nap much.