chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient describes a bump and bruise at injection site. Describes bump as a large lump she can push around. It has not gotten better. Recommended seeking medical care.
Patient received Fluad Lot#312832 on 8/18/21 and received a second dose of Fluad on 9/29/2021.  Patient did not recall receiving prior dose of Fluad though it was documented as given.  He denies any adverse events.
I am really itchy and it is traveling around my body. There is no rash, hives, or swelling that I have noticed.
07/07/22 presents to ED for "abdominal pain". PMHx "paroxysmal SVT treated via ablation in 2016 and, more recently, multiple episodes of nausea, vomiting, right upper quadrant pain, and diarrhea"
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose Moderna,Lot#012L20A 2nd doseModerna,lot#012M20A Diagnosed covid positive:08/04/21 Symptom onset:08/04/21 Exposure:Home Symptoms:Fever, cough,sore throat,chills runny nose.
pt recvd vax;sxs began 4th day p/ vax; feeling like she was going to pass out;pounding all over body;"jumping muscles";heart palpitations;legs ache;difficulty swallowing;n & weakness;shortness of breath;
Information has been received from a 63 year old female with Osteopenia and drug allergies to penicillin and sulfonamide who in September 2007, was vaccinated with a dose of zoster vaccine live (Oka/Merck). Concomitant drug therapy included alendroanate sodium (MSD) and atorvastatin calcium (LIPITOR). On approximately 18-SEP-2007 the patient experienced nausea and vomiting. The patient stated the symptoms were noted to come and go and on 05-OCT-2007 the patient went to the emergency room. Blood tests and urine tests were performed and the results came back fine. The patient stated she went home the same day she went to the ER. The patient's outcome was not recovered. There was no product quality complaint. Additional information has been requested.
15 month old was given the 5-11 age group vaccine in July 2022.  Event was discovered today when pt. came for 3rd dose in primary series.  Patient did not experience any adverse effects from dose in July of 2022 and was given 2nd dose in primary series in August 2022.  No adverse effects were reported by caregiver.
Patient noted to have 20mm X 20mm erythemic area to right upper arm with itching.
Generalized urticaria-received diphenhydramine p.o. began at 9 pm on 6/28/05. Received vaccine at 2:55 pm 6/28/05. Patient stable at this date.
hot mouth; Everything tastes spicy; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ORAL DISCOMFORT (non-serious), outcome "unknown", described as "hot mouth"; TASTE DISORDER (non-serious), outcome "unknown", described as "Everything tastes spicy". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Approximately 3 min after administering Fluzone ID. The pt began to feel hot and light head. Pt sat on floor. Pt was unresponsive for approximately 30sec, pt continued breathing throughout.  EMS arrives pt still feels hot and nausea. She has EMS take her to the hospital.
CHILLS; 101 FEVER FOR A DAY & HALF; 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  (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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced chills, and 101 fever for a day & half. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine  was not applicable. The patient recovered from 101 fever for a day & half, and the outcome of chills was not reported. This report was non-serious.
Swelling and redness at the site. Positive induration noted centrally. Nontender to palpation.
Sense of taste returned after being fully vaccinated, It's a good one; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Sense of taste returned after being fully vaccinated, It's a good one) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (In november).   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Sense of taste returned after being fully vaccinated, It's a good one). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Sense of taste returned after being fully vaccinated, It's a good one) had resolved.            No concomitant medications were provided. Two weeks from the second dose, patient's sense of taste returned. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.
Lump; Redness; This is a spontaneous report from a contactable consumer, the patient. A 78-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6200) via unspecified route of administration in the left arm on 18Mar2021 at 10:00 (at the age of 78-years-old) as a single dose for Covid-19 immunisation. Medical history included controlled HBP (as reported), diabetes and cholesterol. The patient received other unspecified medications within 2 weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch Number: EL9262) via an unspecified route of administration in the left arm on 25Feb2021 at 10:00 (at the age of 78-years-old) as a single dose for COVID-19 immunisation. The patient previously received Rofecoxib (VIOXX) (no longer made) for unspecified indication and experienced drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not tested positive for COVID-19 since the vaccination. On 18Mar2021, the patient experienced redness and lump persisting for 5 days. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the redness and lump was not recovered.   No follow-up attempts are needed. No further information is expected.
patient felt dizzy and pass out for few seconds ,  2  minute   after receiving  the vaccination . Patient felt hot and  then vomited .Patient said she felt better after vomited and drank water . No treatment  was given .Patient  stayed at pharmacy for 30  minute and deiced to  go home.
pharmacist mentioned receiving dose 1 of GARDASIL at age 19 and dose 2 at age 20 but never finished the series; No additional adverse events reported; This spontaneous report was received from a female pharmacist of unknown age referring to herself. There was no information about the patient's concurrent conditions, allergies, drug reactions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) at age 19 and was vaccinated with second dose at age 20 but never finished the series (exact dose, lot #, expiration date, route of administration and anatomical location of aforementioned vaccines were not reported), both of vaccines were used as prophylaxis. Dates of administration were unknown so could not confirm if the doses were administered within schedule from the prescribing information. No additional adverse events reported. No further information provided.
PATIENT RECEIVED THEIR FIRST COVID (MODERNA) ON 2/11/21 AND EXPERIENCED SWELLING OF THE ARM ON THE SAME DATE. PATIENT PRESENTED PERSISTING SWELLING TO THE PHARMACY ON 3/5/21.
Pt has red itchy and burning skin with peeling on abdomen and back. Stated headache, joint pain, and fatigue.
Pt developed fever and irritability immediately after vaccines. Rash developed 6 days later-consistent with roseola
CHILLS FOR COUPLE OF DAYS; This spontaneous report received from a patient via a company representative concerned an elderly of unspecified sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient never had covid-19 before. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 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 an unspecified date, the patient experienced chills for couple of days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills for couple of days. This report was non-serious.
Tested positive to COVID 19 on both an antigen and PCR test; Tested positive to COVID 19 on both an antigen and PCR test; This is a spontaneous report from a contactable consumer. A 13-year-old female patient received BNT162B2 (COMIRNATY; solution for injection), via an unspecified route of administration in Jun2021 (lot number was not reported) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 (COMIRNATY) on an unspecified date (lot number was not reported) as dose 1, single for COVID-19 immunization. The patient received her 2nd dose of BNT162B2 in mid Jun2021 and she tested positive on both an antigen and PCR test on 17Aug2021 while traveling in Ireland. The patient was asymptomatic. She had a previous PCR test in Jul2021 that was negative. The outcome of the event was unknown. Event occurred in a country different from that of the reporter. This may be a duplicate if the reporter also submitted directly to his/her local agency.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Some tenderness at vaccine site the day of  the vaccination and the next day; then no tenderness.  On 7th day there was a red, round lesion about 2 inches  in diameter around vaccination site; with some raised bumps and some itching.
Skin is falling off; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of skin peeling in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced skin peeling (Verbatim: Skin is falling off). The outcome of the skin peeling was not reported.   It was unknown if the reporter considered the skin peeling to be related to Shingles vaccine.     It was unknown if the company considered the skin peeling to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 19-JUN-2023 This case was reported by a patient via interactive digital media. Patient stated that the vac brought mine on so. Patient reported that she/he just had first dose and it was not fancy.  However patient kept on going and the skin was falling off and patient survived. The follow-up could not be possible as no contact details were available.
Pneumonitis and acute hypoxic respiratory failure  Patient was admitted to hospital on 12/5/21 with bilateral infiltrates on chest x-ray and severe hypoxia and confusion, kidney injury and liver injury as a result of hypoxia.  He was treated with oxygen, steroids, and made a full recovery
Within a week of receiving first vaccination, had long runs of skipped beats, went into a 30-40 second long continuous arrhythmia.   These continued for about a week and a half all day and night long.  These let up for a few days.  Had the second vaccine on 3/16 and having am having PVC's again.
10/16/09 8:20am: Patient reports rapid heart rate, palpitations, severe dizziness since receiving H1N1 vaccination 10/15/09. Patient sent to ER for monitoring.  10/22/2009 records from ED visit 10/16/2009. Patient with c/o's dizziness, SOB, palpitations post vaccine. PE was normal, EKG noted NSR. Tx: none DC DX: none noted
Swelling, redness, and very hot where Pneumococcal Polysaccharide injection given (right shoulder). Fever, chills, headache that will not respond to medication. Whole body aches. Nausea, constipation.
the injection site is still hard, red, and hot (larger than a quarter) 9 days after injection. The arm is still tender to the touch (1 on a 1-10 pain scale). The inflamed area is slowly growing. No treatment applied.
No additional AE; Medical assistant called and reported that dose of M-M-R II expired on 29-JUL-2018 and was administered on 14-AUG-2018; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's medical history, historical drugs, allergies, concurrent conditions and concomitant therapies were not provided.   On 14-AUG-2018, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (rha), lot # M034856 and expiration date since it made matches with the autopopulated expiration date: 29-JUL-2018, (dose, frequency, route of administration and indication was not provided). No additional adverse event was reported.
Sore arm at injection site for a week. Softball size knot that has reduced to a nickel size after two weeks
This spontaneous report as received from a 71 years old female consumer refers on herself with hypertension and allergy to penicillin. In October 2012, the patient was vaccinated with 1 dose of ZOSTAVAX, subcutaneously (dose, anatomical location and lot number not provided). No concomitant therapy was reported. The patient stated that on 03-FEB-2013, she had shingles; however this had not been confirmed by physician. She described the pain as hives, one an inch in diameter on her left breast that had a yellow head. The patient would have appointment with her dermatologist. Lab diagnostics studies were not performed. The patient sought medical attention. The patient had not received treatment. The outcome of shingles and the pain as hives was unknown. The relatedness of shingles and the pain as hives was unknown for the therapy with ZOSTAVAX. Additional information is not expected.
Heart racing; trouble holding her urine; throbbing on the right side of her head; Nausea; elevated blood pressures of "240 and 190/92"; "sick" ever since after first dose; can't sleep; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (elevated blood pressures of "240 and 190/92") in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included DILTIAZEM, CILOSTAZOL (CLAUDINE), MONTELUKAST and SITAGLIPTIN PHOSPHATE (JANUVIA).    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced BLOOD PRESSURE INCREASED (elevated blood pressures of "240 and 190/92") (seriousness criterion medically significant), MALAISE ("sick" ever since after first dose), PALPITATIONS (Heart racing), URINARY INCONTINENCE (trouble holding her urine), HEADACHE (throbbing on the right side of her head) and NAUSEA (Nausea). On an unknown date, the patient experienced SLEEP DISORDER (can't sleep). At the time of the report, BLOOD PRESSURE INCREASED (elevated blood pressures of "240 and 190/92"), MALAISE ("sick" ever since after first dose), SLEEP DISORDER (can't sleep), PALPITATIONS (Heart racing), URINARY INCONTINENCE (trouble holding her urine), HEADACHE (throbbing on the right side of her head) and NAUSEA (Nausea) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient stated that she was likely to travel to the Emergency Room at the time of the call. Her second dose of the vaccine was scheduled to take place on 17May2021.  Company comment: Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded.  Event of blood pressure increased retained as serious (MS) due to readings provided being significantly high; Sender's Comments: Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded.  Event of blood pressure increased retained as serious (MS) due to readings provided being significantly high
Patient stated that she had severe stabbing pain over her entire body and paralysis of her arms and legs.  Around 2 AM on 9/17/09, she contacted the emergency room at Medical Center and talked to a nurse.  The patient decided to take 1 Benadry ODT tablet about 2:30 AM and another around 3 AM.  The patient stated that she felt much better the next morning upon awakening and the paralysis was gone.
A physician reported that a female received an injection of influenza virus vaccine (manufacturer unknown), 4 years ago and subsequently, developed "severe neurological problems". No further information was available at the date of this report.
Case completed 2 dose MRNA vaccine in March 2021, and was hospitalized for Covid in January of 2022.  * Pneumonia due to COVID-19 virus Presented with COVD symptoms and positive test January 2. Had received Pfizer-BioNtech MRNA vaccine 2/14, 3/7/21. Admitted with COVID19 pneumonia 1/2/21 and treated with Remdesivir, Dexamethasone. Due to deterioration, Tocilizumab given January 4th. Patient improved since. Completed ten days of Dexamethasone on 1/12. Profoundly weak following COVID recovery. Continues to improve, albeit slowly.    Acute respiratory failure due to COVID-19   Patient with acute respiratory failure secondary to COVID19 pneumonia, has had high Oxygen requirements and was weaned down to 1-2L of O2. Needs have varied and small increase past few days, suspect from atelectasis and obesity hypoventilation. She is working with incentive spirometer and expect as she become more mobile she will continue to improve.
During  the night on 8/7/18, I experienced difficulty in maintaining my balance when getting out of bed and going to the bathroom. I had to be ready to grab an object as furniture to prevent falling while leaving the bed to the bathroom and  back to the bed. Yesterday, 8/8/18, I felt very agitated in general. I mentioned to my Wife that "I felt agitated and angry."  Today, 8/9/18 I feel somewhat spacey, but can functio w/o any problem.
1/2 hour after injection c/o arm sore tingly, hurts to move arm. Also recently had tattoo in same arm. Advised Ibuprofen, cool compresses, call if change/worse.
CONSUMER GIVEN EXPIRED VACCINE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. 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: 1805022, and expiry: 25-MAY-2021) dose was not reported, administered on 02-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 02-JUN-2021, the subject experienced consumer given expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of consumer given expired vaccine was not reported. This report was non-serious.
Blood pressure 155/95/  her blood pressure was going up; tachycardic; hot; dizzy; weak/ weakness; nauseated; This is a spontaneous report from a contactable nurse practitioner. A 38-year-old female patient (Weight: 68.04, Height: 165) received bnt162b2 (COMIRNATY Batch/Lot Number: FE3590; Expiration Date: 30Nov2021, NDC number: 59267100002) via an unspecified route of administration, administered in Arm on 04Nov2021 (at 38-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included Allergy, had allergies to soy and wheat. Concomitant medication included diphenhydramine. The patient previously took folic acid, Calamine, and calamine;zinc oxide (CALADRY) and experienced allergies. Caller clarifies that she is reporting on a patient, and she was the vaccinator of the patient, but is not a primary care provider for the patient. The patient was sent to the hospital in an ambulance, though it is not known if she was admitted to the hospital. The patient's reaction was that she was tachycardia, her blood pressure was going up, she was hot, dizzy, and weak. The patient was nauseated after two mins after she gave the injection, which was when she started having symptoms. At 4 minutes after injection she gave the patient 50mg of Benadryl PO, and maintained her vitals every few minutes until the ambulance arrived. The patient's blood pressure did come down some, but as far as the patient's dizziness and weakness, that was still the same before she left. Other Medical Conditions: Caller says the only difference for the two medications that patient is allergic to is that one is clear and one is not. On patient's questionnaire she did not report anything abnormal. The nurse considered the events as serious with Seriousness criteria-Other medically important condition. Results of tests and procedures for investigation of the patient included: the highest Blood pressure: 155/95 and Pulse rate: got up to 125 beats per minute, both on 04Nov2021 at 1444. Outcome of reaction/event at the time of last observation: Unknown.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.
Initial report was received from a health care professional on 28 November 2011. A 94-year-old male patient received an injection of FLUZONE HIGH DOSE (route, site of administration, date of administration and lot number not reported). On an unspecified date, the patient experienced choreoathetosis (reported as coreo antedosis) of the right arm. Medical history and concomitant medications were not reported. No further information was available at the time of the report. The patient outcome was not reported. Documents held by sender: none.
Vaccine expired on 8/31/22 and unknowingly gave vaccine 9/1/22. No adverse reaction noted.
5min post vax pt devel 7mm hive @ inj site w/no other hives noted;given DPH & watched x20min-@ 20min past hive dec to 2mm & red @ site no resp distress;