chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I did a rapid test but it also shows me like a positive line; I did a rapid test but it also shows me like a positive line; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; Lot number and expiration date was not reported), via an unspecified route of administration on an unknown date at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported that "I did a rapid test, but it also shows me like a positive line" on an unspecified date. The outcome of the event was reported as unknown.
From telephone correspondence received on 11/5/02, it was reported that a 31 year old male adult was vaccinated with TD ADS ADULT, lot # U0820AA, on 10/22/02. 24 hours post injection the patient developed a 2cm x 1cm area of ecchymosis and SC hematoma with arm soreness. Patient recovered. Per the physician, the patient has not had a tetanus vaccine for at least 10 years. The case is closed.
Red, hot, inflamed, crusted center in the postero-lateral fat of upper arm 10/24/2015 started KEFLEX 250mg cap.
shaking as if chilled or nervous; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 11Apr2021 at 11:00 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. Medical history included multiple sclerosis. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included glatiramer acetate (MANUFACTURER UNKNOWN), mirtazapine (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN) and fluoxetine hydrochloride (FLUOX); all from unknown date for unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Apr2021, the patient experienced shaking as if chilled or nervous. Therapeutic measures were not taken as a result of the event. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event shaking as if chilled or nervous was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a consumer refers to a unknown number of patients of unknown age and gender. The consumer reported that she had read reports on the internet of various unspecified patients. On an unknown date the patients were vaccinated with ZOSTAVAX (Lot#, dose/frequency, route and duration were unspecified). Subsequently the patients developed shingles (exact dates unspecified). The outcome of shingles was not reported. The relatedness between shingles and the vaccination with ZOSTAVAX was not reported. This is one of several reports from the same source. Additional information has been requested.
This spontaneous report as received from a certified medical assistant to an 12 year old patient of an unknown gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. Approximately in 2015 (reported as 27-AUG-2015 to 03-SEP-2015) the patient was vaccinated with improperly stored dose of GARDASIL lot # K010215 with expiration date 05-MAY-2017 or lot # K011562 with expiration date 08-APR-2017; dose and route of administration were not reported. No adverse experiences were reported. This is one of the several reports received from same reporter. Additional information has been requested.
Patient developed a rash in the left arm. This arm was opposite of the arm the vaccination was given into.
Covid19 infection with mild, cold-like symptoms; Covid19 infection with mild, cold-like symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 28-year-old male patient received BNT162b2 (BNT162B2), on 14Mar2021 as dose 1, single (Lot number: EN6199), on 05Apr2021 as dose 2, single (Lot number: EP7533) and on 15Dec2021 as dose 3 (booster), single (Lot number: FD7218) at the age of 28 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 21Aug2022 at 17:30, outcome "recovering" and all described as "Covid19 infection with mild, cold-like symptoms". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Covid19 infection with mild cold-like symptoms. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical course: Other vaccine in four weeks and other medications in two weeks was unknown. Covid prior vaccination and covid tested post vaccination was unknown
Patient describes mild blurred vision on right eye, numbness/tingling to right side of face. Denies any other symptoms
8 days later big red area; raised; warm to the touch; tender; COVID arm; only sore arm first; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (only sore arm first), INJECTION SITE ERYTHEMA (8 days later big red area), INJECTION SITE INFLAMMATION (raised), INJECTION SITE WARMTH (warm to the touch) and TENDERNESS (tender) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: ARTHRITIS BAYER TIMED RELEASE ASPIRIN and PROLIA. Concomitant products included SIMVASTATIN, CELECOXIB (CELEXA [CELECOXIB]) and DENOSUMAB (PROLIA) for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced PAIN IN EXTREMITY (only sore arm first). On 30-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (8 days later big red area), INJECTION SITE INFLAMMATION (raised), INJECTION SITE WARMTH (warm to the touch), TENDERNESS (tender) and DERMATITIS ALLERGIC (COVID arm). At the time of the report, PAIN IN EXTREMITY (only sore arm first), INJECTION SITE ERYTHEMA (8 days later big red area), INJECTION SITE INFLAMMATION (raised), INJECTION SITE WARMTH (warm to the touch), TENDERNESS (tender) and DERMATITIS ALLERGIC (COVID arm) outcome was unknown. Not Provided      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.
Information has been received from a registered nurse concerning a 9 year old patient who in 2005 ("two years ago"); at seven years of age, was vaccinated with a first dose of MMR II. Subsequent to being vaccinated the patient developed an unspecified personality change, photosensitivity and a high pitched cry. The patient recovered from the reported events at an unspecified time. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
This report from study was received from a 34 year old female patient referring on herself with postural hypotension and no drug reactions/allergies. Approximately in 2001, the patient participated in a study that began in one place and ended in another, and was vaccinated with GARDASIL (Dose, route, and lot number were not reported). After the study, the patient learned she had been given the placebo and then later after her son was born, in approximately 2007, she received the actual GARDASIL (dose, route and lot number were not reported). No co-suspect therapies were reported. There was no concomitant medication. The patient stated that during the study she passed out after one of the GARDASIL doses but she does not know if it was a placebo dose or one of the doses related to the GARDASIL product dose. The patient also stated she often did not feel well after receiving the GARDASIL doses (again she did not know if they were the placebo or the actual product dose). The patient had questions about the efficacy of GARDASIL because she was recently, about six months ago (approximately in August 2013) diagnosed with HPV type 16 even though she was vaccinated against it. At the time of this report the outcome was unknown. No treatment was given for the adverse events. Papanicolaou (PAP) smear and colonoscopy was performed. The patient sought medical attention. Upon internal review the event passed out was considered as an other important medical event. The causality was not reported. Additional information has been requested.
skin reactions from the vaccine> This spontaneous case was reported by a consumer and describes the occurrence of SKIN REACTION (skin reactions from the vaccine>) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SKIN REACTION (skin reactions from the vaccine>). At the time of the report, SKIN REACTION (skin reactions from the vaccine>) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided by the reporter. Treatment information was not provided by the reporter.
Derm redness induration pain 4 cm with 10 cm rim of redness.
For 2 weeks have been feeling dizzy all day gets even worse at night to the point where I can?t sleep . Also get really bad dry mouth . Hasn?t gone away so just concerned
Patient complained of pain & diminished mobility of her arm ever since the flu shot was administered on Sept 15th, 2012.
Shock; This is a spontaneous report from a contactable consumer. A 17-year-old female patient received BNT162B2, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. Unknown if pregnant. The patient's medical history and concomitant medications were not reported. Unknown if received other vaccine in four weeks. Unknown if had COVID prior vaccination and if was COVID tested post vaccination. The patient experienced shock on an unspecified date. Adverse event resulted in Emergency room/department or urgent care and Hospitalization. Outcome of event was unknown.  The lot number for BNT162B2, was not provided and will be requested during follow up.
Headache all day; This is a spontaneous report from a non-contactable physician. A 38-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscularly in right arm on 19Dec2020 07:30 at single dose for COVID-19 immunization.  Medical history was none.  There was no other vaccine received in four weeks prior to the COVID vaccine, no other medications received in two weeks. The patient experienced headache all day on 19Dec2020 08:30 AM. No treatment received. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Facility type vaccine was hospital. The outcome of event was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Redness, slight swelling, tenderness 1.5 inch circular area with 3/4 surrounding swelling.
Came to office 10/30/03 AM. Left upper arm very red measuring 8 cm x 9 cm., hot to touch, swollen. Put on Zyrtec tsp per day and Keflex susp 1 tsp tid for 1 week. 10/31/03 Pt brought in, site started blistering all over last night, was still very red. According to mom much better this AM. Rx for Prelone syrup given.
This spontaneous prospective pregnancy report as received from the patient's friend refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with the second dose of GARDASIL (dose, route and lot number not provided) while being pregnant. The last menstrual period (LMP) and expected date of delivery (EDD) were not known. The pregnancy outcome was outcome pending. It could not be confirmed whether the product was GARDASIL or GARDASIL 9 used. Additional information is not expected as no contact information provided for the reporter, patient or physician.
Patient called having severe muscle pain describing it as feeling like all muscles in body spasming.  Said due to spasms it felt difficult to breathe. Patient was advised to get checked out at hospital.
Rash, itching, redness, hot in the area where the vaccine was administered.  These symptoms started one week after the inoculation.
either the first or second dose of the Covid vaccine she had chills; Was achy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 05Feb2021 (Lot number: EN5318) at the age of 73 years as dose 1, single and administration date 03Mar2021 (Lot number: TN6201) as dose 2, single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (ongoing); "high cholesterol" (ongoing). Concomitant medication(s) included: AMLODIPINE taken for hypertension; OLMESARTAN taken for hypertension; ATORVASTATIN taken for blood cholesterol increased. The following information was reported: CHILLS (non-serious), outcome "recovered", described as "either the first or second dose of the Covid vaccine she had chills"; PAIN (non-serious), outcome "recovered", described as "Was achy".  Additional info:Patient received Booster Dose on 27Oct2021 and experienced vomiting and diarrhoea but she noticed her pulse has been very high all day. Caller states she didn't realize it if it was elevated yesterday.  No follow-up attempts are possible. No further information is expected.  Follow-up (08Nov2021): Follow-up attempts are completed. No further information is expected.
Patient received adult dose of Hepatitis A vaccine before age 19 years. No adverse reaction noted.
First, I started with a cough, and then pain in my knees and hands. It developed into rheumatoid arthritis and lymphedema. It is still going on at this time.
Sustained, rapid heart rate; This is spontaneous report from a contactable consumer (patient) . A 59-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 23Mar2021 (Lot Number: ER8727) as single dose , dose 2 via an unspecified route of administration, administered in right arm on 13Apr2021 14:00 (Lot Number: EW0151) as SINGLE dose for covid-19 immunisation.   Medical history included high blood pressure from an unknown date and unknown if ongoing, arrhythmia many years ago from an unknown date and unknown if ongoing.  The patient's concomitant medications were unspecified. The patient did not receive any other vaccine within 4 weeks prior to the vaccine.  Prior to the vaccination, the patient was not diagnosed with COVID-19. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The patient sustained, rapid heart rate in Apr2021 "02:00 PM". The event occurred after dose one and dose two. The event after dose one required treatment by Urgent Care Clinic, EMS, and hospital emergency department. Treatment included adenosine in hospital. Outcome of the event sustained, rapid heart rate was recovering.  No follow-up attempts are needed. No further information is expected.
On 7/20/01, 9 days after MMR, Varicella, IPV and Hep-B vaccines were given, pt had (+) erythematous multiple macular papules with some confluent all over the body with fever for 5 days. Fever went up to 102F and pt was fussy. Measles-like reaction.
Information has been received from a RN concerning an 11 year old white male with cystitis and no allergies who on 05May05, at 4:30PM, was vaccinated SC in the right arm with a 0.5mL first dose of varicella virus vaccine live (lot548316/0583P). Concomitant therapy included amoxicillin (+) clavulanate potassium (Augmentin) for cystitis. It was noted that the pt had otitis media at the time of vaccination. The RN reported that in 24May05, the pt developed a rash and itchy lesions on the chin, neck, back and thighs. On 25May05, the pt was seen in the office. At that time it was unsure if the rash was due to varicella virus vaccine live or an amoxicillin (+) clavulanate potassium reaction. The pt was again seen on 26May05 and at that time a diagnosis of chickenpox was made. On that same day, therapy with cetirizine HC1 (Zyrtec) was started. It was unk if the pt had a fever and no lab/diagnostic tests were performed. At the time of this report, the pt's chickenpox persisted. Follow up information from a health professional indicated that the pt was seen on 24May05 for WTI with amoxicillin (+) clavulanate potassium (Augmentin) ABO and on the same day developed a pruritic rash that began on his chin and progressed to his neck, chest, back and thighs. The pt was treated with cetirizine HC1 (Zyrtec). It was noted that it  was a typical vesicular rash of varicella viremia. It was reported that the pt's rash was resolving on 31May05, and that the pt recovered. Additional information is not expected.
Woke up with global speech aphasia and left sided weakness at 5:45 am the morning after injection. Saw primary care provider with also high blood pressure (145/104 ). Referred to ER for possible stroke and had CT, CTA, MRI, and echocardiogram performed. All had negative findings. Transferred to another hospital for observation and follow up MRI same night with contrast- negative findings. Hospitalist prescribed aspirin 81 mg for 30 days with discharge diagnosis of possible flu vaccine reaction and TIA.
pt recv vax 28AUG96 & no rxn/problems until 7SEP96 when awakened w/t100, joint pains, body aches, cervical lymphadenopathy & rash (maculopapular)8SEP96 inj site became red,swollen & painful;
MOTHER PHONED ACDOH TO REPORT THAT RASH DEVELOPED THE NIGHT OF THE VACCINE AND HAS PROGRESSED TO ENTIRE FACE (HAS ALSO HAD DIARRHEA OVER THE WEEKEND)STILL HAS RASH
My husband had tested positive for COVID-19 two days before I did. I awoke on 03/06/2023 with the worse runny that I could not get to stop for a bit. I took a home COVID-19 test that came back positive, I called the COVID-19 hotline was prescribe Paxlovid. Started taking it that after, in five days I was testing negative. By day three I had a sore throat, took a home COVID-19 test and was positive again, I also had a temperature of 101F. I quarantined for a week, took another home COVID-19 test, this test came back negative. I had lost my sense of taste and smell. I am getting both sense of taste and smell back.
Mother reported symptoms of headache; sore throat; rash to face, stomach, and both legs; redness to white part of both eyes; and swollen eyes on 4/10/2018. Presented to Public Health Department on 4/18/2018 with red raised rash to medial chin, and one raised white spot to medial upper sternal area near neck. Generalized examination performed and no evidence of any additional rash; no redness to throat; no redness to bilateral sclera; no edema bilateral periorbital. Denied complaint of Headache. Referred to Health Center or local ER for further evaluation and assessment.
p/vax pt had stiff neck & on 8/25 pt eyes felt like had pressure behind them; told to go to eye MD
Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 04-SEP-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally as prophylaxis (lot # 1660991 with expiration date 27-APR-2021) (strength, dose and frequency were not reported).  The improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without previous temperature excursions. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2009USA006106:
I felt like I was stung by something on the far back part of my tongue. I then felt like my throat a dry, scratchy and tingled. This continued for several hours. I took benadryl at 230 and after 45 minutes it subsided a bit. Still there but not as strong.  I also got a headache on the left side of my head.
23 year old patient who took Johnson and Johnson COVID-19 vaccination on Friday 10/1/21 because of school requirements for vaccination. Subsequent day on Saturday, he developed muscle aches of the extremities from the site of injection to other extremities. On Sunday, he began to have dark color urine. Admission into hospital, baseline CK over 300,000 on 10/7/21, - Admission ALT 538, AST 2012. Abdomen ultrasound "Unremarkable right upper quadrant ultrasound." Patient only reported 2 acetaminophens at home since Johnson and Johnson vaccine - 10/13/21: Patient continues to be on IV fluids. The creatinine kinase is 13,691 and AST/ALT 397/335 which are both substantial improvements from admission labs - Discharged 10/14
Patient said that she felt a sharp pain in her back and could not move. I called 911 and by the time they arrived she was feeling better. The EMTs later released her to go home. An hour later we called to follow up and she said she was doing fine
Approximately 2 hours after receiving vaccine patient  described delayed urticaria occurred on numerous areas on the body. Including stomach, hands , feet, arms, legs, and thighs.
Arm gradually became more painful. Difficulty driving with left arm at 8 p.m. Got into bed with chills. Around 3 a.m. woke with a massive headache, chills and sweats, joint and muscle pain. Went to the kitchen for a glass of water and to take Ibuprofen but almost blacked out. Sat on the floor and placed forehead on cold tiles because of sweats and nausea. Crawled to the couch and remained there until 8 a.m. Moved to bed. In and out of sleep with mild chills and sweats the rest of the day.
Swelling and warmth on right deltoid; area of 2 cm induration-4 x 6 cm in diameter.
Covid arm: large swollen lump on my arm at the injection site. It is red, itchy, sore and warm to the touch
10PM p/inject p/7 wouldn't eat or take bottle; fever 103 did not respond to APAP or baths; up all noc hollering; cried rigorously during sleep; exam - neg; fontanelle is bulging; poss CNS problem; 37MAR92 pt acting nl-did not take to ER;
Patient came in on 4/14/2021 to get her first dose of the Pfizer vaccine.  The RN went over prevaccine questions  which patient did not answer truthfully. Patient is allergic to eggs and also had a reacation to the the flu vaccine in 2020 in which she was diagnosed with Guillain Barre and also takes Vit B12 injections that she has a reacation to, throat tightness when doing the medication she pre medicates with Benadryl. Today she pre medicated with Benadryl and got her vaccine at 0916 and started felling tingling in hands and feet and had throat tightness.  She was sent to the Emergency Room.