chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse referring to a female patient of unknown age. Medical history and current condition of the patient was not reported. On an unknown date, the patient was administered improperly stored dose of GARDASIL (lot# K001631, expiry date: 06-NOV-2016) dose, route unspecified. Other suspect and concomitant therapies were not reported. No adverse events were reported. No further information was provided. The nurse provided that there have been no need for revaccination and provided patient names and dates of birth who had received the vaccination (other patients were captured in MARRS# 1412USA002140, 1502USA006587, 1502USA006588, 1502USA006589). This is one of several reports from the same source. Additional information has been requested.
pt was given flu vax & pneumovax on 15OCT92, both in same arm @ pt's request; subsequently had severe local reaction w/redness, swelling up into rt side of neck, & fever;
Bilateral ears because hot, red, swollen, blistered, and painful approximately 1 hour and 20 minutes after vaccine was administered.
Got the shot at 5pm on 4/28/21. Mild symptoms - the shot barely hurt and I felt fine. The arm hurt a lot for the first 2 days and then went away by day 3/4. Some nausea the next morning, April 29th, and a headache, but not bad. On May 5th, in the evening as I was going to bed my arm felt weird. Like the pain was coming back at the injection site. When I woke up the next morning, Thursday May 6th my arm definitely had that achey feeling again (but not as bad as the first 2 days). As the day progressed, by 3 pm, my left side muscle in my lower back (an area I have ongoing issues with, so it is a weak spot in my body) started to get really tight but it was weird bc I had not done anything to make it tight so it was just odd. Anyway, but 7pm on May 6th, I felt a lot of itching and went I looked at my arm it was a big red swollen circle at the injection site. Today is May 8th at 9pm and it is still there but is going away now, yay! Muscle tightness is also going away - not sure if they are related but they came and went at the same time.
11 yo male was given Pfizer Covid-19 vaccine dose 0.3 ml instead of 0.2 ml.  There have been no adverse effects per patient's father.
pt recvd Engerix-B on the following dates 20JUN91; 25JUL91; 19DEC91; pt had lack of seroconversion (low titers-less than therapeutic);
No adverse effects reported.; Patient received expired dose of ROTATEQ on 3/12/2019.; Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 12-MAR-2019, the patient received expired dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (lot#R000911, expiration date was auto-generated as 28-FEB-2019; orally; dose and frequency were unknown) for prophylaxis. No adverse effects reported.
Site reaction, redding of upper arm, that started that night and continued for roughly 5 days. Warm to touch, painful, and covered a large part of the upper arm. Patient took BENADRYL but did not improve the reaction "by much".
heart issues; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (heart issues) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CARDIAC DISORDER (heart issues). At the time of the report, CARDIAC DISORDER (heart issues) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided. No Treatment medications were not provided.
Burning sensation on injection. Chills headache fatigue muscle and body aches the day after injection.
pt recvd vax; pt exp blurred vision in left eye & saw spots in front of eye;
This spontaneous report as received from a female pharmacist of unknown age via company representative refers to herself who had unspecified drug reactions or allergy. Information regarding relevant medical history and concurrent condition were not reported. On an unspecified date in 2015 (reported as "this past week", which would be one day between and including 27-SEP-2015 and 01-OCT-2015), the patient was vaccinated with ZOSTAVAX (dose reported as "1 vial", route and lot # not reported). Information regarding concomitant medications was not reported. The day following the ZOSTAVAX vaccination, on an unknown date in 2015, she got a rash at the injection site. The pharmacist described the rash at the injection site as 3 inches in size and in oval shape. The patient did not seek medical attention. No treatment was given. No lab diagnostics studies were performed. The outcome of the event was unknown. This is one of several reports received from the same source. Additional information has been requested.
Associate tested positive for COVID 12/21.  Now reports symptoms of cough starting 12/18 not revealed at time of vaccine
Narrative: c/o lymph node swelling under left arm pit. Told to follow up with primary care physician if problem persists.
Pain at site of injection a few hours after; This is a spontaneous report from a non-contactable consumer, the patient. A 36-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the right arm on 16Apr2021 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included overweight, asthma, spring allergies and shrimp allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received phenobarbital (MANUFACTURER UNKNOWN), amoxicillin (MANUFACTURER UNKNOWN) and erythromycin (MANUFACTURER UNKNOWN), all on unknown dates for unknown indications and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included vitamin d nos (MANUFACTURER UNKNOWN), vitamin b nos (MANUFACTURER UNKNOWN) and iron supplements (MANUFACTURER UNKNOWN), all from unknown dates for unknown indications and unknown if ongoing. On 16Apr2021, a few hours after vaccination, the patient experienced pain at site of injection. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event pain at site of injection was recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.
9/9/19 - pAiN iN lEft ARm, Achy joiNts 9/10/19 - HEADAchE @ 7pm, REDNEss At iNjEction site 9/11/19 sx iMpRovED some, hot not REsolvED 9/12/19 site RED swollen & wARm to thE touch
1/13  10:30am - 2:30pm   Extreme Chills 1/13   2:30pm - 1/14 5:00am   Fever (102.7 at the high point) Shortness of Breath, Increased Heart Rate, Lower Blood Oxygen Levels (down to 92%), Cough 1/14   5:00am - 7:00am  Chills 1/14   7:00am - 11:00am  Fever, Shortness of Breath, Increased Heart Rate, Lower Blood Oxygen Levels, Cough 1/14   2:00pm - 3:00pm  Chills 1/14   3:00pm - 5:00pm  Fever, Shortness of Breath, Increased Heart Rate, Lower Blood Oxygen Levels, Cough
Diagnosed at Hospital with Henoch-Schnlein purpura on 7/13/2008.  This is 3 days after vaccines were administered and also the day the patient became symptomatic. Patient awoke with a rash that her father thought was a heat rash.  When mother saw  the child it was "clearly not a heat rash" and swelling of the ankles had developed.
No adverse event. 62 year old client was given live H1N1 nasal instead of injectable H1N1 vaccine.
Swelling in feet and ankles , Spotting , Lower back pain , Headache.
pt recvd vax & devel what was dx as cellulitis characterized by redness & swelling in the arm of inject; pt was treated w/ATB & the react resolved; on f/u MD dx local erythematous react-felt pt did not have cellulitis
The immediate reaction was soreness but it escalated quickly to pain. By noon it was bad and I took a Tylenol. But by 4:00 in the afternoon it was extremely painful and my arm was stiff and my fingers felt stiff, too. The pain continued and  he fingers felt cold (the arm was very warm). By 8:30 that night I went to our town's ER as the pain level was 9. I could barely move my arm. I felt very cold in my fingers and even on the other hand. My blood pressure which is normally very good was 176 over 83 (not sure of the bottom number). They decided to x-ray to see if I had a hematoma. My arm shook like crazy when I got up and they asked me to move my left arm in a certain position. My arm shook so badly that it shook my my arm shook so badly that it shook my whole body. They gave me hydrocordone and it calmed down after a while. I left and took pain pills with me. I woke up at 2 am and took another pain pill. Today it is starting to move more and is less painful but still there is some soreness. and there is a baseball size red mark on my left arm 2-3 inches down from the injection site.
Mother noticed increased fussiness of her baby on 12/16/00 and felt a lump present on 12/19/00. Lump assessed by PHN at health dept. Lump of left thigh to about 2 1/2cm X 3cm in diameter with slight localized redness at site of lump. Mom denies that infant had not even developed a fever with this lump. Recommended warm wet packs to site and return if not resolved or call PMD.
Sjogren''s Flare: which includes dry eyes, eyes hurt, eyes red, and eyes puffy.; Fibromyalgia flare up: which includes whole body hurt more than usual, pain everywhere, more than usual, fatigue worse:; Fibromyalgia flare up: which includes whole body hurt more than usual, pain everywhere, more than usual, fatigue worse:; Digestive issues: which include cramping/Muscle Cramps; Digestive issues: which include loose bowel movement; Digestive issues: which include had to increase her GERD medicine for reflux.; This is a spontaneous report from a contactable consumer (patient) or other non-healthcare professional.   A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0173), dose 2 via an unspecified route of administration, administered in Arm Left on 19May2021 (age at vaccination: 57 year) as dose 2, single for covid-19 immunisation. Medical history included ongoing sjogren's syndrome, fibromyalgia and GERD. The patient concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) dose 1 via an unspecified route of administration, administered in Arm Left on 28Apr2021 (Batch/Lot Number: EW0164) as dose 1, single for covid-19 immunisation. Patient reported that the effects occurred after the second shot. Patient stated all the symptoms flared up at the same time. All symptoms probably appeared on 25May2021. On 25May2021, the patient experienced Sjogren's Flare: which includes dry eyes, eyes hurt, eyes red, eyes puffy and stated she had Sjogren's before the vaccine, she went to the doctor on 27May2021. Patient was going to an ophthalmologist. Fibromyalgia flare up: which includes whole body hurt more than usual, pain everywhere, more than usual, fatigue worse and she had fibromyalgia before the vaccine. Muscle cramps, muscle cramps was reported as worsened. Patient added later in report that digestive issues: which include cramping, loose bowel movement, had to increase her GERD medicine for reflux. Patient stated that when her GERD medicine was increased by her doctor, she had some improvement of her GERD. The clinical outcome of Sjogren's Flare: which includes dry eyes, eyes hurt, eyes red, eyes puffy and Digestive issues: which include cramping, loose bowel movement, had to increase her GERD medicine for reflux was recovering and Fibromyalgia flare up: which includes whole body hurt more than usual, pain everywhere, more than usual, fatigue worse, Muscle cramps was not recovered.  Follow-Up (03Nov2021): Follow-up attempts are completed. No further information is expected.
THE RESIDENT WAS ROUTINELY TESTED FOR COVID ON 1/29/21 AND POSITIVE RESULTS RETURNED ON 1/30/21; WAS ASYMPTOMATIC AT FIRST, BUT DEVELOPED SYMPTOMS ON 1/31/21 THAT PROGRESSED AND THE RESIDENT DIED ON 2/7/21
Migraine; This is a spontaneous report from a contactable healthcare professional, the patient. A 74-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration and unspecified anatomical site on 01Mar2021 at 02:15 (at the age of 74-years-old) as a single dose for COVID-19 immunisation. Medical history included migraines, sleep apnea. Prior to vaccination, the patient was not diagnosed with COVID-19. Since vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. On 02Mar2021, the patient experienced migraine for 4 days. It was reported that the migraines was severe for first 2-3 days. Patient also stated that she was a migraine sufferer but these were severe. So went to doctor, but doctor said really nothing to do. Patient stated that she wishes not to have same migraines with 2nd shot on March 28. The patient did not receive any treatment for the event. The clinical outcome of migraine was recovered on an unknown date at the time of report. Information about lot number cannot be obtained. No further information is expected.
Pt was vaxed w/measles vax on 7FEB91 & subsequently exp occipital & bitemporal h/a whic remitted spontaneously in a day or two;
I received my second shot on March 28 I had typical flu like symptoms fever 104.3°, body aches, chills, shortness of breath,  by Wednesday March 31 my over all symptoms had resolved. On Thursday I had an intense calf pain that would not go away,  seen primary care provider on 4/5/21, had ultrasound done DVT was ruled out. On Tuesday 4/6/21 I had left sided chest pain with residual left sided arm pain, and shortness of breath. Went to the ER, where they had done labs and ruled out heart attack. They had me follow up with PCP, whom referred me to cardiologist. Cardiologist was seen tests have been ordered but not completed yet. Feelings of shortness of breath have been on going since I had completed the second shot.
Information has been received from a physician concerning her child who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). subsequently the patient experienced shingles. It was unknown if medical attention was sought. No product quality complaint was involved. No additional information was available. Additional information has been requested.
This study case was received from the investigator on 27 August 2012. A male subject with a past medical history of allergy, smokeless tobacco use and a former smoker had received ACAM2000 (lot number, route, site and date of administration not reported) and an unspecified amount of time later was found to have on 04 August an elevated Troponin, central laboratory level of 0.13 ng/ml (Draw date 02 August 2010). The subject had a rapid Troponin I level on 02 August 2010 that was within normal limits (negative). A repeat Troponin on 10 August 2010 was 0.12 ng/mL. The subject was asymptomatic according to the investigator. No ECG was performed. No additional cardiac-related medical encounters, labs or radiology information was available. The subject had no concomitant medications. No further information was available at the time of the report. The subject's outcome was ongoing (not recovered). According to the investigator, the event of elevated Troponin was considered an other important event and possibly related to vaccination. Per the Investigator, this represents a case of potential myopericarditis and was referred to the study's adjudication committee for assessment. Documents held by sender: none.
Patient exhibited a seizure like episode that lasted approximately 15 seconds.; feel dizzy; pale and clammy skin; pale and clammy skin; This is a spontaneous report from a contactable other hcp (nurse). An adolescent non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0162 and expiry date: unknown), dose 1 via intramuscular on 08Jun2021 as dose 1, single for covid-19 immunisation. The patient's medical history included syncope when patient was younger (had syncopal episode after a vaccination). The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no allergies. On 08Jun2021 the patient experienced exhibited a seizure like episode that lasted approximately 15 seconds. Patient was placed on the ground in a supine position where she regained consciousness. Patient with clammy and pale skin. Attempted to put patient in chair, once in chair she began to feel dizzy and was placed back on the ground in a supine position. Patient was able to sit up on the ground and was given juice and crackers. Patient continued to have pale and clammy skin. Alert and oriented x 3. EMS arrived and patient transported to hospital. The patient underwent lab tests and procedures which included Blood sugar at 14:13 was 92, at 14:05 BP was 122/69, at 14:10 BP was 122/58, at 14:05 heart rate was 100, at 14:05 respiratory rate was 18 on 08Jun2021. The outcome of all the events was unknown.; Sender's Comments: Based on the information available and temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events. . The case will be reassessed once new information is available  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.
Positive pregnancy test on 1/15, received covid booster 1/8 and confirmed missed miscarriage on 2/22/2020. No previous history/family history of miscarriage
Body aches and chills around 24 hours after. 103-degree fever for 24 hours and the body aches and chills didn't get any better through that whole time. I was really, tired. My arm was super sore and red. I went and got tested for COVID-19 yesterday afternoon - I had to do it for work. I had a fever yesterday all day. I don't have a fever today. My body aches are gone. My arm is still super sore and a little itchy, but I feel way better now, though.
Itchy; Hot to the touch; Pain in my upper arm; Red raised skin/  It was 3.5 inches at the longest point and 2.5 inches at the next biggest point, and at the thinnest point it was 1 inch and 5/8ths; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy), FEELING HOT (Hot to the touch), PAIN IN EXTREMITY (Pain in my upper arm) and ERYTHEMA (Red raised skin/  It was 3.5 inches at the longest point and 2.5 inches at the next biggest point, and at the thinnest point it was 1 inch and 5/8ths) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced PRURITUS (Itchy), FEELING HOT (Hot to the touch), PAIN IN EXTREMITY (Pain in my upper arm) and ERYTHEMA (Red raised skin/  It was 3.5 inches at the longest point and 2.5 inches at the next biggest point, and at the thinnest point it was 1 inch and 5/8ths). The patient was treated with HYDROCORTISONE for Adverse event, at a dose of topical cream; IBUPROFEN for Adverse event, at an unspecified dose and frequency and CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) at an unspecified dose and frequency. At the time of the report, PRURITUS (Itchy), FEELING HOT (Hot to the touch), PAIN IN EXTREMITY (Pain in my upper arm) and ERYTHEMA (Red raised skin/  It was 3.5 inches at the longest point and 2.5 inches at the next biggest point, and at the thinnest point it was 1 inch and 5/8ths) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
9/30/04: right upper arm red, hot, tender, swollen. Told mother to administer Tylenol every four hours and follow up monday if no relief.
Body aches started around 8pm Chills began and Temperature of 99.7 recorded around 10pm. Treated with ibuprofen Temperature of 100.4 recorded at 10:30pm  Temperature of 99.9 recorded the following day (5/6/2021) at 11am, along with continued body aches and fatigue. Took additional ibuprofen Symptoms subsided around 7pm on 5/6/2021
Left arm soreness lasted several days Flush feeling, chills, temp of 99.5-100.5, headache, left armpit itching, weakness when standing, soreness in upper thighs.
Left shoulder very painful first night, could barely take off shirt at night. It has been nearly 3 weeks and shoulder is still sore. Can hardly lift arm up.
This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 14-APR-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) lot # K025766, expiry date 08-JUN-2015. This is one of the several reports received from the same reporter. Additional information has been requested.
14 hours following injection, severe pain at injection site, radiating through arm, neck and shoulder. Inability to move shoulder and upper arm independently for 2-3 hours.
BLOOD CLOT; TISSUES NECROSIS; UNABLE TO WALK; CAPILLARIES EXPLODED; This spontaneous report received from a 35 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN)  frequency one total, dose was not reported, administered on 07-APR-2021  in left arm for prophylactic vaccination. No concomitant medications were reported.  The patient reported about 3 weeks after vaccination his health problems started. He had been to numerous ERs, to primary neurologist, finally at 3rd hospital visit he was admitted and was in the ICU for 5 days. On 07-JUN-2021, they concluded a blood clot had formed in leg and traveled down to feet in toes where all capillaries exploded and tissues in toes necroded and died. The patient was unable to walk by self. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clot, tissue necrosis, unable to walk and capillaries exploded was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210648314-covid-19 vaccine ad26.cov2.s-blood clot, tissue necrosis, unable to walk, capillaries exploded. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Bad Headache and body aches the night of vaccine. Felt a bit better the next day but still lingering headache.