chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Entire body morbilliform rash primarily on ribs and stomach, spreading slowly to upper arms. Not painful but mildly itchy; Entire body morbilliform rash primarily on ribs and stomach, spreading slowly to upper arms. Not painful but mildly itchy; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the right arm on 05Apr2021 at 11:45 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. On 06Apr2021, the patient experienced entire body morbilliform rash primarily on ribs and stomach, spreading slowly to upper arms. It was not painful but mildly itchy. It was reported that it had been 14 days now (at the time of this report) and spread had slowed but was not receding much, only a little bit around neck had gone away. Slightly lighter in color now all over. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events as the patient had been using over the counter 1 percent hydrocortisone creme twice a day for 4 days. On 08Apr2021, the patient underwent PCR test for COVID-19 via nasal swab and the result was negative. The clinical outcome of the events entire body morbilliform rash primarily on ribs and stomach, spreading slowly to upper arms. Not painful but mildly itchy was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Fifteen minutes post Pfizer vaccine booster administration patient reported feeling light headed, dizzy, and pressure/heaviness in chest. EMS was called and patient was transferred via chair to ambulance by EMS.
Starting the next day, 07/31/2021, patient experienced leg cramps, twitching in left eye, and bruise in left arm. A week later, Nose bleeds started to occur. Patient still experienced intermittent leg cramps, eye twitch and nose bleed for an additional 2-3 weeks. Although improved she is still experiencing some of the effects. She called her doctor and was observed by her son's eye doctor. Both did not believe cause for concern.
lack of efficacy; weird feeling; chills; fever; Vaccination site pain; runny nose; cough; dizziness; A spontaneous report was received from a consumer, concerning a male patient of 84 years age, who received Moderna's COVID-19 vaccine and experienced adverse events such as pain at injection, runny nose, weird feeling, chills, cough, fever, lack of efficacy and dizziness.   The patient's medical history was provided that seasonal allergies. Concomitant product use was provided by the reporter. Lab data was reported, on 2-MAR-2021, that the patient tested COVID positive.  On 27-FEB-2021, prior to the onset of events, the patient received the first of two planned doses of mRNA-1273 (lot number 031M20A) via IM route for COVID-19 infection prophylaxis.   On 2-MAR-2021, the patient tested positive for SARS-CoV-2.  Treatment medication was reported that diphenhydramine and Corcidin was taken.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the events, pain at injection, runny nose, weird feeling, chills, cough, fever, lack of efficacy and dizziness, were considered resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
reactive lymphadenitis; Naproxen 500mg twice daily for 5 days
Chronic Nosebleed R nostril beginning 3/20 early morning while shaving; no history of any NB. ENT cauterized R nostril area on 3 different times & packed it on 3/30; cardiologist discontinued Plavix for 7 days. No NB since then, rechecking on 4/8, resumed Plavix on 4/5/21.  No other symptoms during that 10 day period.
Extreme body pain, vomiting, chills, migraine.  Considered going to hospital as I could not keep any fluids down, including water.
Patient was given the J and J by mistake instead of an expected second dose of Moderna brand Covid-19 Vaccine. No immediate reaction was observed. Patient reported what could have been worse than expected vaccine related reactions including vomiting, aches, and fatigue over the next two days.
My menstruation was not regular. I have always had a very regular menstrual cycle. My menstruation has always been between 26-28 days. After the Moderna vaccine, the first month was 34 days and the second month was 36 days and third month was 21 days cycle. The fourth month after receiving my first vaccine was normal 28 days. This period started May 31st. In June, I became pregnant. I did not know I was pregnant until the beginning of July. My husband tested positive for Covid on June 26th.  Towards the end of our quarantining, I tested positive for Covid-19 on July 9th. I started bleeding this same day. I went to the doctor on July 13th after my quarantine was over. They confirmed the pregnancy and ultrasound detected a heartbeat. A month later I went back to the doctor, and they informed me that I had miscarried that baby less than a week after I went to the doctor in July.
The day after the shot, I was real tired. My arm was sore. I had the chills. My stomach was quezy . I had a slight headache .   The day after that I woke up with a slight headache but by the afternoon all symptoms had disappeared.
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; SORE ARM; This spontaneous report received from a consumer concerned a 73 year old male. The patient's height and weight were not reported. The patient's concurrent conditions included diabetes and difficulty hearing. Patient had no known allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number 1805018 and expiry: Unknown) dose was not reported, 1 total administered on 18-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 18-MAR-2021, the patient experienced sore arm. Patient had sore arm for a day. On an unspecified date (two weeks ago), doctor gave patient a blood test to determine if patient had antibodies. Patient had taken an antibody test and it was negative (confirmed immunological vaccine failure). Reporter did not know the type of antibody test that patient received, just knew it was a blood test. Patient had an upcoming appointment with physician in August and would discuss this with him. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm on 19-MAR-2021, and the outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint 90000186487.; Sender's Comments: V0: 20210739065-Covid-19 vaccine ad26.cov2.s-Confirmed immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
They morning after receiving the vaccine, patient noticed a rash just below the site of the administration. There was redness, arm soreness/pain, heat to touch but no fever. Patient came to the pharmacy to have it evaluated on Friday 10/24/20 by which time it had gotten better. When I contacted the patient on 10/25, patient reported marked improvement in symptoms, almost fully gone.
When shot was given had an electric shock run down from top of left arm to bottom of left toes. After shot first day sore arm, second  and third day extremely sore and swollen and red arm can hardly move it. With using ice and alternating Tylenol and Motrin ATC. Headaches and mild temp. Within 15 min of getting shot heart rate shot up to 130.
Left arm is red; Arm was sore the next day, and seems to be getting worse which describes it as red and swelling; Left arm is swollen; Arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Left arm is red), CONDITION AGGRAVATED (Arm was sore the next day, and seems to be getting worse which describes it as red and swelling), VACCINATION SITE SWELLING (Left arm is swollen) and VACCINATION SITE PAIN (Arm was sore) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071F21A, 013M20A and 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, the patient experienced VACCINATION SITE ERYTHEMA (Left arm is red), CONDITION AGGRAVATED (Arm was sore the next day, and seems to be getting worse which describes it as red and swelling), VACCINATION SITE SWELLING (Left arm is swollen) and VACCINATION SITE PAIN (Arm was sore). At the time of the report, VACCINATION SITE ERYTHEMA (Left arm is red), CONDITION AGGRAVATED (Arm was sore the next day, and seems to be getting worse which describes it as red and swelling), VACCINATION SITE SWELLING (Left arm is swollen) and VACCINATION SITE PAIN (Arm was sore) outcome was unknown.            No concomitant product use was provided by the reporter. No treatment medication was provided.  The patient asked if she can take Benadryl or not.
My lips had been chipped and now they are kind of bloody; My lips had been chipped and now they are kind of bloody; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunisation. Medical history included blindness. The patient's concomitant medications were not reported. The patient was trying to find out some side effects for the Covid19 Shot. It has been couple of months since the patient had last one. It has been a few weeks patient's lips had been chipped and now they are kind of bloody. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
THE PATIENT INDICATED THAT HE EXPERIENCED SWELLING AND REDNESS IN THE LEFT ARM.  THIS WAS THE ARM THE HE RECEIVED THE PNEUMOVAX 23 INJECTION.  HE ALSO EXPERIENCED FEVER AND FATIGUE.
This is a spontaneous report from a contactable consumer, the patient. A 54-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01Sep2021 at 12:00 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included gout, hay fever and known allergies to dust, but nothing specific. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Concomitant medications were not reported. On 01Sep2021 at 13:00, the patient experienced left arm pain, extreme sinus and allergies issue, gout and inflammation issues greatly increased, lack of energy and body pain. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On 18Sep2021, the patient underwent SARS-CoV-2 test via nasal swab and the result was negative. The clinical outcome of the events left arm pain, extreme sinus and allergies issue, gout and inflammation issues greatly increased, lack of energy and body pain was not resolved at the time of this report. The patient also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8839) via an unspecified route of administration in the left arm on 21Sep2021 at 14:00 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. The lot number for BNT162b2 was not provided and will be requested during follow up.
Expired vaccine is stored and then administered; Doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date) and PRODUCT STORAGE ERROR (Expired vaccine is stored and then administered) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vaccine is stored and then administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date) and PRODUCT STORAGE ERROR (Expired vaccine is stored and then administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.  HCP said that 606 doses were given after expiration date. HCP said that there was a confusion between the expiration date printed in the carton and the expiration date when the QR code was scanned.  On 29-Oct-2021, vaccine was placed in refrigerator. Vaccine did not undergo any temperature excursion. No adverse events were reported.
rash on hands and feet.  OTC medications including Zyrtec, diphenhydramine and hydrocortisone cream
On 06/14/2022   I was positive for COVID-19. I was really tired and chilled. I didn't feel good at all. After few minutes my throat was  sore up extremely that I just went to bed. On 06/15/2022 the next morning I went to the urgent care I was given anti viral . i got the anti viral shot around 11:00AM . After about 15 hours at 3:00AM I was able to swallow. I started feeling better slowly by slowly. On 06/27/2022 or 06/28/2022 I was negative. My tease bud is still recovering.
1st dose 2 and 1/2 years ago. 2nd dose not yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (the patient received first dose 2 and half years ago from reporting).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 17-AUG-2022 Reporter's Comments: The patient had not yet received 2nd dose of Shingrix. The reporter gave consent to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose which led to incomplete course of vaccination.
Cellulitis of skin/arm erythema/swelling AUGMENTIN/ice.
Tingling in lips and tongue. Raspy voice. Some shortness of breath and chest pain. Pt reported hx of asthma and pt took a breathing treatment of albuterol.  No tongue swelling, rash, or airway closure reported.
died yesterday due to blood clots; This is a spontaneous report from a contactable consumer.   A 55-year-old female patient (mother) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 28Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient medical history and the patient's concomitant medications were not reported.  The patient experienced blood clots and died due to the event. It was not reported if an autopsy was performed.   Information on the lot/batch number has been requested. ; Reported Cause(s) of Death: died yesterday due to blood clots
By 3:30p his ears, throat and lips were red, facial swelling, BP 144/100, HR 110-115. Some shortness of breath. Symptoms resolved by 5:30p after 50mg PO Benadryl. Taken to ER by EMs at 6pm where no further treatment was required.
The pt complained of pain at the injection site down to the elbow. Pain also experienced in left side of back. Describes pain as muscle ache. Denies fever and redness at site of injection. The pt states "just don't feel well". The pt was better on 3/15/01.
Dose 1: Moderna 10/26/2021 Dose 2: Moderna 11/26/2021
medication error due to administration of vaccine that was reconstituted with wrong diluent, with no reported adverse event; Initial information received on 08-Dec-2022 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 11 years old female patient who had medication error due to administration of vaccine that was reconstituted with wrong diluent, with no reported adverse event while receiving vaccine YELLOW FEVER VACCINE - [YF-VAX].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included TYPHOID VACCINE (TYPHOID VACCINE) for Immunisation; and RABIES VACCINE (RABIES VACCINE) for Immunisation.  On 18-Nov-2022, the patient received a 1 dose of suspect YELLOW FEVER VACCINE at a dose of 0.5 ml (lot no. UJ412AB and expiry date: 22 Nov-2025) via subcutaneous route in the right arm for immunisation.  On 18-Nov-2022 the patient had a non-serious event of medication error due to administration of vaccine that was reconstituted with wrong diluent, with no reported adverse event (product preparation error)(latency: 1 day) following the administration of YELLOW FEVER VACCINE.  Action taken: not applicable.  Outcome: Unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Patient awoke with chest pain, dyspnea, and distended neck veins.  Admitted to hospital (see diagnostic test below).  Symptoms resolved without intervention.  Nurse follow up on 05/27/04 states: "Per review of hospital d/c summary, please add to Box 7: Low blood pressure (TACHYCARDIA), hypotension (HYPOTENS), effusion on echocardiogram (EFFUS PERICARD), dry cough (COUGH INC), and perimyocarditis (MYOCARDITIS - the term PERICARDITIS is already in Box 12). Please also change FLATUL to VASC DIS in Box 7 (for distended neck veins)."
shot area is painful; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingles vaccine.  Additional details were provided are as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient received a shot and had painful shot area for days after. The follow-up could not be possible as no contact details were available.
pt recv vax;exp lt leg pain, limping; to hosp w/ elev WBC; dx tentatively JRA; tx w/ motrin;
To my knowledge, the patient/client did not suffer a physical adverse reaction to this vaccine.  The "J&J" vaccine appears to have been given to a 17 year-old.  The administration of this particular vaccine to a 17 year-old client being the primary adverse event.  The 17 year age and birthdate are those reported by the client.
Patient describes local site pain/redness/irritation that has lingered on for a longer duration of time than typical. He still complains of injection site pain and irritation (it has been 7 days since the injection).
pt recv vax 13SEP97 & & approx 3wk post vax pt devel partial hearing loss in the lt ear described as high frequency, sensory neural hearing loss;pt dx w/lt sensorineural hearing loss p/vax;
This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On an unspecified dates, an unspecified number of patients were vaccinated with 57 doses of improperly stored GARDASIL 9 injection lot # L045711 (expiry date: 08-MAY-2017) (dosage not reported). The vaccine was stored at temperature 53.2F for 6 hours and no previous excursion was reported. No adverse symptoms reported. No Product quality complaint (PQC) was involved. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
Flushed, sore throat, itching, throat wheeze at 1835 25 mg diphenhydramine po given at 1837 Symptoms relieved at 1846
This case was reported by a healthcare professional and described the occurrence of multiple sclerosis flare in a subject of unspecified age and gender who was vaccinated with hepatitis B vaccine (manufacturer unspecified). The subject's medical history included multiple sclerosis. On unspecified dates the subject received 1st and 2nd doses of Hepatitis B vaccine (unknown). At an unspecified time after the 2nd vaccination with Hepatitis B vaccine, the subject experienced multiple sclerosis flare. This case was assessed as medically serious by GSK. At the time of reporting the event was unresolved.
tingling at tongue, cheeks and lips; numbness at tongue, cheeks and lips; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (tingling at tongue, cheeks and lips) and HYPOAESTHESIA (numbness at tongue, cheeks and lips) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jun-2021, the patient experienced PARAESTHESIA ORAL (tingling at tongue, cheeks and lips) and HYPOAESTHESIA (numbness at tongue, cheeks and lips). At the time of the report, PARAESTHESIA ORAL (tingling at tongue, cheeks and lips) and HYPOAESTHESIA (numbness at tongue, cheeks and lips) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   2nd dose taken on 07-Jul-2021 (Lot: 011D21A) No concomitant medication was reported.  No treatment medication use was reported.   This case was linked to MOD-2021-405936 (Patient Link).