chrisvoncsefalvay/vaers-outcomes huggingface dataset:
About thirty hours after receiving  first dose I started feeling waves of nausea, 2 days later it has improved but not completely gone.
Left and right side of neck up to the ear area was numb for several days. Developed a itchy rash on neck and notice skin peeling on ears.
light headedness; nausea; severe headache; muscle aches; This spontaneous case was reported by a nurse and describes the occurrence of DIZZINESS (light headedness), NAUSEA (nausea), HEADACHE (severe headache) and MYALGIA (muscle aches) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history provided.).    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced DIZZINESS (light headedness), NAUSEA (nausea), HEADACHE (severe headache) and MYALGIA (muscle aches). At the time of the report, DIZZINESS (light headedness), NAUSEA (nausea), HEADACHE (severe headache) and MYALGIA (muscle aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  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.; 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.
Vaccine administered to 17 years old patient; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to 17 years old patient) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A and 014C21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma since 04-Feb-2012.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to 17 years old patient). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to 17 years old patient) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication provided. No treatment medications were reported. Action taken with mRNA-1273 in response to the events were Not Applicable.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Follow up information received contains significant information. Added second dose information and his medical history.
Patient is a 77 y.o. female who presented with generalized weakness, cough, SOB, unable to make it to her hemodialysis.  Found to be COVID positive, requiring 2 L nasal cannula, was started on Decadron.  Patient was continued on hemodialysis during hospital course.  She was noted to have drop in hemoglobin as well as dark stools.  GI was consulted, she required 1 unit of packed red blood cell transfusion, H&H remained stable, recommended to have outpatient follow-up with Dr.  Patient was evaluated PT OT who recommended post acute, however patient refused and was discharged home with home health instead.
A rash appeared on neck, back, trunk, thighs, arms, palms and soles- maculopapular and spread to face, cheeks and forehead the next day). Child felt hot to warm for 5 days, getting Tylenol or Motrin for the ame once or twice a day, she was eating less than usual but drinking milk. On the 5th day of illness, she started spiking fevers regularly around the clock going up to 104.9 rectally on Day 6. Fever finally broke on day 9 of illness, the next morning she had a maculopapular rash from head to feet (not on palms and soles). The rash diappeared in 2-3 days. On day 17 of illness she started peeling around the fingernails which spread to the whole hand, after another week, she started peeling on the feet as well.
On 6/25/03 patient developed neurological symptoms of vertigo, syncope, and fatigue. She complains of dropping objects and has right hand weakness. These symptoms have continued for 3 months.
Patient presented himself as 18 and confirmed to staff that he was 18.  Staff realized pt. 17 after vaccine completed during documentation.
Headache, chills, fever, body aches, shooting pains in left arm and leg, loss of appetite
Started with ant bite feeling around injection site and arm. Spread to entire body. Then chest became so tight it felt like my ribs were being crushed. I called the nurse line and they sent me to the ER. At the ER I was treated with steroids and benadryl. The stinging Started to go away. They did an x-ray and said my lungs and heart looked OK. Since being discharged  I am still sick. Freezing then hot. Pain all over. My chest is till tight. Too dizzy to walk or drive. No energy.
Redness, swelling, itching. Erythema 5 cm x 5 cm. Hot to the touch.
Patient received 2nd Pfizer vaccine on 03/03/2021. Patient presented to the ED with symptoms of fever, cough, weakness, and body aches on 09/20/2021 and said these symptoms have been on going for 3 to 4 days. Positive Covid-19 results on 09/20/2021.
PATIENT CAME TO PHARMACY TO RECEIVE MODERNA VACCINATION. AFTER GIVING BOOSTER DOSE OF VACCINE, PATIENT THEN PRESENTS VACCINATION RECORD CARD TO REVEAL SHE NEEDED THE SECOND PRIMARY VACCINATION. ADDITIONAL 0.25mL WAS GIVEN TO THE PATIENT. NO ADVERSE EVENTS OR OTHER COMPLAINTS NOTED.
Collapsed; difficulty breathing; weakness; Pain in chest; tingling all over body.; This is a spontaneous report from a contactable consumer (parent).  A 28-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 10Mar2021 at 12:15 (Lot Number: EN6206) (at the age of 28-year-old) as single dose for COVID-19 immunisation.  Medical history included bipolar from an unknown date and unknown if ongoing. Concomitant medications included lamotrigine (LAMICTAL); amphetamine aspartate/ amphetamine sulfate/dexamphetamine saccharate/dexamphetamine sulfate (ADDERALL) and alprazolam (XANAX); all taken for an unspecified indication, start and stop date were not reported. On 10Mar2021 at 12:15, the patient collapsed and experienced difficulty breathing, weakness, pain in chest and tingling all over body. The events resulted in physician office visit. No therapeutic measures were taken as a result of the events.  The patient outcome of the events was not recovered.
A report has been received from a Health Professional concerning an 8 year old, Female subject, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. The patient experienced patient received a full dose of FLUMIST in one nostril which started on 08-Oct-2012. The outcome of the event of patient received a full dose of FLUMIST in one nostril is unknown. The report was considered to be non-serious.
I had a runny nose and congestion. I also experienced lightheadedness and fatigue. I took a COVID-19 home test for 3 days and they were negative.  My symptoms continued and I had a slight headache and sore throat. I tested for COVID-19 once more and it was positive. I contacted my doctor, and he said not to take Paxlovid. I took Nyquil and Dayquil to treat my symptoms. I got worse. I was getting more and more tired.  I went to the doctor on March 04, 2023, and received a breathing treatment. I was really fatigued. I tested negative on March 05, 2023. My symptoms lingered after I was negative. On Wednesday March 08, 2023, I flew out of the country, so I was unsure if the symptoms were from that or the COVID-19 symptoms. I was tired for another week.
Large red swollen area around vaccine admin site, spreading length of arm from elbow to shoulder. Red, warm.
My big toes began hurting really bad. They got hot and reddish. They hurt for about an entire day. I put fungi with extra tea tree oil. That calmed it down. The right foot pain and discoloration completely stopped. On the left foot went to a reddish purple to an opal color. It then varied to a reddish purple again. It is discolored in my toenail. It lightens and gets darker. The pain and discoloration went on for about a week. The pain is gone but the discoloration is still present. The Tuesday after mother's day I cut my finger and received stitches. Along with the stiches I also received a tetanus shot. I received the tetanus shot in my right arm but I developed a painful knot in both my COVID arm and my tetanus arm. I put neosporin and a bandaid and massaged them which helped. The knots are going away but they haven't completely disappeared.
arm was red and warm below injection site; arm was red and warm below injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (arm was red and warm below injection site) and INJECTION SITE ERYTHEMA (arm was red and warm below injection site) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 030L2A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension (High blood pressure) since 1978. Concomitant products included FISH OIL for Cholesterol, HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN/HIDROCLOROTIAZIDA) for Hypertension, ASPIRIN [ACETYLSALICYLIC ACID] and VITAMIN D3 for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced VACCINATION SITE WARMTH (arm was red and warm below injection site) and INJECTION SITE ERYTHEMA (arm was red and warm below injection site). On 22-Feb-2021, VACCINATION SITE WARMTH (arm was red and warm below injection site) and INJECTION SITE ERYTHEMA (arm was red and warm below injection site) had resolved.            No treatment information provided by Reporter.   This case was linked to MOD-2021-094031, MOD-2021-094031 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Follow-up received. Patient details,Medical history, concomitant medications added
pain and swelling at injection site, fever and body aches,  joint pain, nausea, fatigue
This case was reported by a healthcare professional and described the occurrence of limb swelling in a child (15 months to 5 years) subject of unspecified gender who was vaccinated with INFANRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of INFANRIX at 0.5 ml. Within two days of vaccination with INFANRIX, the subject experienced limb swelling described as doubling or tripling in size. A product complaint was indicated. At the time of reporting the outcome of the events was unspecified. This event occurred in 7 patients. Linked cases include A0746417A, A0746425A, A0746426, A0746427A, A0746428A and A0746430A. Follow-up identified a product complaint number. It was additionally reported that the field rep stated that a nurse reporting the adverse event believed that a quality assurance problem caused the adverse drug effect. No details on the reported event. A quality statement received on 27 November 2008 from GSK Biologicals Quality Assurance and Quality Control stated that, "No deviation that could be linked to the complaint has been highlighted. No incident during distribution and no cold chain deviation that can be linked to the adverse were recorded."
arm is really sore; This is a spontaneous report from a Pfizer-sponsored program Pfizer first connect. A non-contactable female consumer reported for herself.  An unspecified age female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number and expiration date were not reported), dose 2 via an unspecified route of administration, on 01Feb2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 02Feb2021, the patient experienced arm is sore. The outcome of event is unknown.  Reporter have some correction with the date event instead of 03Feb2021 it should be 02Feb2021.  No follow-up attempts are possible; Information about batch/lot number cannot be obtained. No further information is expected.
Sore arm during the day of and following day. Fever and chills began the evening of the vaccine about 14 hours after the injection. All-day, mild headache the day following the injection. Treatment consisted solely of rest. No medication was taken. Second day following injection no symptoms.
Significant local reaction involving swelling and erythema of upper arm from shoulder to elbow. No treatment required.
Initial information received on 30-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked to cases 2018SA331166, 2018SA331477 and 2018SA331478. This case involves a five-years old patient of an unknown gender who had received vaccine FLUZONE HIGH DOSE (lot number, expiry date, dose, dose in series, route, site of administration were not reported) on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided. This was a case of actual medication error due to Inappropriate age at vaccine administration and overdose. It was not reported if any adverse event occurred or not following the vaccination. 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 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. Documents held by sender: none.
Mild case of varicella with skin and oral lesions 10/24/2001.
Felt generally unwell 12 hours after the vaccination: onset of headache and body aches. During the night, fever spiked to 103 degrees, had uncontrollable shakes, chills, cold sweats, dizziness, and mild nausea. This lasted roughly 48 hours. After 48 hours, fever was reduced, body aches remained, but other symptoms subsided. I continue to feel generally unwell with body aches and a slight fever. In retrospect, I should have gone to the hospital.
Site: Pain at Injection Site-Medium, Additional Details: moderate pain/tingling sensation on the injection site/arm
Joint pain on arm where I received the vaccine from the shoulder to the wrist started 2 days after the vaccine.  Then 4 days after the vaccine, I had headaches from the back of my head/neck up to my eyes..  Took Ibuprofen for the joint pain and extra strength Tylenol, fir the headaches, which lessened the pain.
Patient received Heplisav vaccine on 06/06/22 @ 6:25 pm. After leaving the clinic, the patient called back at approximately 7pm and c/o itching and having welts all over his body after getting the vaccine. Patient was instructed to report to the ER which he later did. He informed staff that he was given Benadryl. Also stated he longer is itching or has welts.
Pt states day after vaccine injection noticed redness, soreness, swelling, pain and warmth at injection site.
Patient has swelling, redness, pain and itching approximately 5 cm by 4 cm area.
tested positive for COVID; tested positive for COVID; This is a spontaneous report from a contactable nurse reporting for the mother. A 92-years-old female patient received the first dose of bnt162b2 (BNT162B2) vaccine , via an unspecified route of administration on 12Jan2021 at single dose for Covid-19 immunisation .  Medical history included dementia.   The patient's concomitant medications were not reported. In Oct2020, the patient received the flu vaccine. The patient was tested positive for covid  on 27Jan2021 with outcome of unknown. The patient was hospitalised because of the event on 29Jan2021. The patient got her first vaccine on 12Jan2021, she tested negative for COVID on 19Jan2021 but on 27Jan2021 she tested positive. The patient has been retested on 29Jan2021 and is still positive.   Information of lot/batch number has been requested.; Sender's Comments: The association between the event lack of effect (tested positive for COVID after 15 days) with BNT162b2 can not be completely excluded.
pt recvd vax & thigh is red & swollen; doesn't want to walk; mom applied warm compress;
Information has been received from a registered nurse concerning a female nurse who received a Hep B series 15 to 20 years ago and now her hepatitis B titer was less than 0.1. The nurse did not know the manufacturer or lot number nor did she have any documentation of the hepatitis B series being given other than the patient's word. It was unknown if the patient sought any medical attention. At the time of reporting outcome was unknown. This is one of several reports concerning same patient. Additional information has been requested.
Patient called today on 12/23/20 reporting that after her first dose, she broke out in full body hives 3 days later. She contacted her doctor who told her to take OTC bendaryl tablet and topical cream to apply. These treatments resolved the hives after 2 days she reported.
Patient received tdap to left deltoid and mcv4 to right deltoid. Patient had no reaction after immunizations with no s/sx of distress or allergic reaction prior to leaving clinic after admin. Patients mother was talking to another mother in the lobby so they had stayed for a few minutes after.  About an hour after immunization admin, patient and his mother returned to clinic. Patients right upper arm was visibly red, hot to touch and was firm around needle insertion site with edema present. Patients face was also visibly red and hot to touch. Patients color was otherwise normal in all other areas of the body, no cyanosis noted. Patient has no signs of shortness of breath or problems breathing, patient states he ?feels fine?. No swelling noted in mouth or opening of throat.  Patient and his mother instructed to go to the nearest ER immediately for patient treatment. Patients mother stated she was taking patient to ?one of the hospitals?. At 1545 hospital contacted mother who was still at hospital with patient and he was receiving treatment for allergic reaction.
ACUTE PERICARDITIS  - HOSPITALIZED 12/1/21 TO 12/5/21 .  12/1 HAD SUDDEN ONSET CHEST PRESSURE, SOB.  TAKEN BY AMBULANCE TO ER.  TOOK FEW DAYS TO GET CORRECT DIAGNOSIS, PAIN UNDER CONTROL
few minutes after adminstering the 2 shots, pt  passed out in the font of the pharmacy counter. (OTC isle)  I did not see him. the cashier associate quickly notified me. We called 911 and code white. He was on the floor, but he didn't drop or hit his head or back. He wasn't responsive. I quickly started CPR. He gained his conscious immediately, but was very dizzy / disoriented. I asked him if he is DM or if he has heart condition. He informed me that he is a cardiac pt and takes heard Meds. I asked him about NTG he said he left them at home. I had staff looked up his file and yes, there was an old/ expired rx for NTG i gave him one under his tongue. then, EMT came and picked him up
Patient presents today fussy with red papules all over the body, 1/2 mm to 3 mm in size no pustules and vesicles. Not concentrated on hands and feet.
Hives around the injection site began today, 8 days after injection. Treating currently with over-the-counter antihistamine. Not yet resolved.
Information has been received from a RN concerning a 5 yr old white male who on 18Mar03 was vaccinated in the right deltoid with the first dose of varicella virus vaccine live (lot 643821/0865M).  On 26May04 the pt presented at the physician's office with a fever and a papular rash with vesicles on his trunk and legs. The pt was reported as having breakthrough. The pt was treated with acetaminophen (Tylenol), ibuprofen (Motrin) and increased fluids. No product quality complaint was involved. Follow up information indicated that the pt was afebrile.  It was also reported that pt's two brothers  were vaccinated with a dose of varicella virus vaccine live and developed breakthrough  (WAES0406USA02067 and 0406USA02726). Additional information has been requested.
Prickly red rash developed about 4-6 hours after the inection. mild rash on neck, chest and back
Extreme alertness, inability to sleep at night, for 2 weeks solid, and now intermittently, for another week.  Waking in middle of night with extreme anxiety running through my body (never experienced in my life before, i calmed it down myself, 4 nights this week);  Extreme fatigue.
CLOT BLOOD; This spontaneous report received from a consumer via a (other manufacturer Pfizer) 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, and batch number were not reported) 1 total, 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 clot blood. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of clot blood was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210713681-COVID-19 VACCINE AD26.COV2.S-Clot blood . 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).
Patient came to pharmacy showing arm with redness and swelling starting just below injection site involving all tissue down to elbow and patient feeling like it was feverish and maybe swelling redness was continuing to worsen. Two injection site barrier bandages were used about 1-2 inches apart for the vaccines, removed by patient the next morning, showing partial redness "rings" from where the two bandages were placed before the injection also.
I had a ruptured ovarian cyst and an inflamed appendix. I have been taking over the counter medication. I went to the ER where they did an ultrasound and CT scan. I have some follow up appointments with a PCP, OB/GYN and a general surgeon as well as some imaging scheduled.
Pt reported flushing/sweating. Vitals: 115/59, 72, 20 -- > 113/63 Pt given a cold compress.  Pt stable and released from the vaccination site