chrisvoncsefalvay/vaers-outcomes huggingface dataset:
stomach was upset; Rapid heart rate (160s bpm); nausea; Joint ache; fatigue; headache; dizzy; fluid retention; weakness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), FLUID RETENTION (fluid retention), ASTHENIA (weakness), ABDOMINAL DISCOMFORT (stomach was upset) and HEART RATE INCREASED (Rapid heart rate (160s bpm)) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Allergy to codeine.), Drug allergy (Allergy to morphine.) and Drug allergy (Allergy to pain pills.).    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced DIZZINESS (dizzy), FLUID RETENTION (fluid retention), ASTHENIA (weakness), HEART RATE INCREASED (Rapid heart rate (160s bpm)), NAUSEA (nausea), ARTHRALGIA (Joint ache), FATIGUE (fatigue) and HEADACHE (headache). On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (stomach was upset). On 06-Feb-2021, DIZZINESS (dizzy), NAUSEA (nausea), ARTHRALGIA (Joint ache), FATIGUE (fatigue) and HEADACHE (headache) had resolved with sequelae. On 10-Feb-2021, ASTHENIA (weakness) had resolved with sequelae. At the time of the report, FLUID RETENTION (fluid retention) and HEART RATE INCREASED (Rapid heart rate (160s bpm)) had not resolved and ABDOMINAL DISCOMFORT (stomach was upset) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, Heart rate: 160 bpm (High) 160 bpm.     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.   The patient was taking no concomitant medications.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Significant Follow; Additional adverse events (weakness, fluid retention) added, event outcome updated.; 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.
Child has hives from neck down 3 hrs after injections, no problems breathing. Treatment: none advised besides to call Dr. and see if they tell him to give child anything. Hives lasted about an hour and went away, child acted fine.
soreness in arm immediately after shot and progressing down arm for the next several hours | headache | severe body aches | fatigue | loss of appetite | chills | fever
Pfizer shot given.  Patient felt ok immediately after shot, but approximately 5 minutes later told his mom he felt weird.  He passed out and was helped to a sitting position.  When I was called out to the lobby patient was still feeling a little lightheaded but he was conscious and breathing normally.  He sustained a small cut on his hand which we cleaned up promptly.  Patient told mom he felt like his vision was  blurry.  Mom wanted him checked out so I called emergency help.
pt recv vax & stopped doing the things a child does @ this age; no long pulled up on feet or moved legs; showed weakness in lower extremities;encephalopathy, hypotonic, developmental delay in motor system, congenital myopathy, myasthenia
Right at 15 minutes as leaving the building incessant sneezing for 15 minutes, with strong sensation in right nostril, right eye turned bright red and was weepy.  Lasted for 15 minutes. Nose ran non stop for 3 hours.   Next day heart palpitations, HR up. Aware of pulse being elevated even at rest. Slowing returning to normal but tried to exercise and was nauseous after 20 min of exercise 5 days after vaccination.  Normally ride for 60 minutes with no problem.  Saw dr today. Will be seeing allergist soon. Will not take second vaccine.
Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th July 2021, the patient received the 1st dose of Shingrix. On 30th August 2021, 32 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that, the patient who had received the first dose of Shingrix , started experiencing shingles on 30th August 2021.  The reporter consented to follow up.
fever; headache; chills; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient's daughter)  A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Patient received the first dose on an unknown date. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced fever on Mar2021, headache on Mar2021, chills on Mar2021. The events outcome was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained
Afterwards, he had what sounds like typical flulike symptoms as well as fatigue which lasted about 3 days.  At the 3-day mark, he noticed neurological symptoms.  Specifically he noticed numbness and tingling on the medial side of his forearms and fourth and fifth digits bilaterally, on the right side more than the left.  He also noticed "slowness"  in his hands so that he had difficulty opening and closing, making a fist.  In his lower extremities, he became extremely uncoordinated.  He had difficulty with balance and walking.  He had difficulty going up and down stairs.  He noticed that when he would put his foot in a certain position, he would develop an involuntary rhythmic up-and-down movement of his leg.
Pt c/o low right back pain and right hip pain onset since day after receiving vaccine, has not resolved despite treatment with NSAIDs or  muscle relaxers. Denies prior injury, muscle strain/sprain, or known history or sciatica.
This spontaneous report as received from a health worker refers to a 12 months old male patient. The patient was inadvertently vaccinated with ZOSTAVAX (lot#: 0422AE, expiration date: 27-MAR-2013, 0.65 ml, subcutaneous, left leg) instead of VARIVAX (Merck) today(on 28-AUG-2012). No adverse effects reported at this time. No other co-suspects were reported. No concomitant medications were reported. At the report time the outcome of event was unknown. It was unknown if the patient sought medical attention. Additional information has been requested.
Headache - shooting pain in the back of head; Feeling unwell; This is a spontaneous report from a non-contactable consumer (patient). A 52-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not reported), via an unspecified route of administration, administered in Arm Right on 04Mar2021 at 08:45 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. The patient's medical history included had issue with knee pain in both knees. Patient's concomitant medications included meloxicam at 7.5 mg once daily and gabapentin; both were taken for an unspecified indication, start and stop dates were not reported. On 04Mar2021 at 09:00, the patient experienced headache - shooting pain in the back of head and was feeling unwell. It was reported that no other vaccine taken in four weeks of vaccination. Patient not had COVID-19 prior vaccination; not tested for COVID-19 post vaccination. Patient was not received treatment for the events. The outcome of events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Less than 48 hours of having the vaccine, I noticed a large lump in my left armpit. It is significantly swollen, approximately the size of a peach, and very sore.  I went back to pharmacy and discussed it with the pharmacist. After looking at it, she told me she had not seen this reaction and suggested I take something for pain and swelling and for me to report my reaction to the CDC. She said if the condition persist, I needed to notify them again.
This spontaneous report was received from a nurse referring to an unspecified amount of patients with ages and gender unknown. Patient's medical history, current conditions and concomitant medications were not reported. On unspecified dates the patients were administered improperly stored doses of VARIVAX (strength, route of administration and dose were not provided) Lot # N017399, expiration date 07-JUN-2019; Lot # N010108, expiration date 28-MAR-2019; Lot # N012488, expiration date 20-APR-2019; reconstituted with properly stored sterile diluent (unknown lot and expiration date) indicated for prophylaxis. The time frame was 6 hours with temperature of 6 Fahrenheit degrees to 14 Fahrenheit degrees. Digital Data Logger was involved. No adverse event was reported.
Approx 9PM day following vax child began high pitched screaming, "not unusual cry" lasting approx 1 hr became limp w/shallow breathing, hard to rouse & cyanotic immediately p/ the crying episode. p/4hrs observation in ER was fine, no fever.
sl swelling & red blotches noted @ site of DTAP; red blotches also noted @ bilat upper arms & posterior legs; blotching began w/in 2-5 mins & was resolved when ice was applied to site of DTAP; blotches also @ LUA site of MMR;
Child developed red tender swelling left thigh which required hospitalization 04/21/04/23/04 at medical center . He did not have fever. Child was treated with IV antibiotic and discharged on oral Abx, Benadryl.
Fever, extreme body aches, fatigue, rash on chest and sore arm. Took day off work 01/27/21 hoping to get over the affects.
Son states patient has had a cough for 6 weeks. He was placed on antibiotics a z-pak the other week. It is described as diffuse patchy opacities concerning for covid.
Immediately could taste the vaccine in the middle of my tongue, started to feel jittery, hands grew cold after 4 minutes, felt spacey, felt numbness in the tips of middle fingers of right hand, face started to feel slightly numb from right to left, tongue started to swell on the left side, lips felt thick. This was a progression of 15 minutes. Vitals taken by EMT  - all in normal range. I could walk cautiously. It was a matter of drinking water, eating oyster crackers without salt, and waiting. Left the facility about 11:30am and went for Benadryl. Benadryl helped some (taken about 11:45am) This also affects my serotonin levels making me sad and edgy. Restless afternoon, initial event subsided. Right arm hurt. Needed more Benadryl (1 tablet again) the next day. Added 2 ibuprofen in evening. Spacey, unsettled, fatigued. No fever. Monday: Brain fog most of day. Tuesday: brain fog lifting, but pain occurring in left hand in knuckles and fingers.
Immediate muscular pain in the left arm; low-grade headache began about an hour following the vaccine, followed by mild nausea, stomach pains, fatigue, and general muscular aches.
L shoulder began swelling 1 day after administration.  Pt. c/o pain, swelling, itching, redness & heat.
Approximately two weeks (05/12/2021) after receiving the vaccine, I started to experience tightening in my legs all around. It felt like every time I would massage the cramps out of my legs, an hour later the muscle tightness/pain would come back. It was interrupting my sleep. I also experienced knee and hip pain along with the tightness in my legs. I also experienced some brain fog on and off for about 3 weeks. I visited my PCP on 05/19, but by 05/17 my symptoms had improved. On 05/18 my pain/tightness had gone away completely. I had to do vigorous stretches and I took 4 tablets of 200mg per day for a couple days.
Fever 102.5 F 12 hours, nausea 8-9 hours, lethargy 8-9 hours.
The next morning after I received my vaccine 02/12/2021, I woke up and I could not turn my head and the entire left side of my body was stiff. I had mild fever, 99.5. I was more concerned because I could not move my head and the entire side of my body was stiff. The same side I got my injection on. That lasted about 24 hours and then I was fine. I contacted the clinic, telephone conference, and they told me to stay home then went over my signs and symptoms.
SPONTANEOUS CORONARY ARTERY DISSECTION; SEVERE ADVERSE REACTION TO JANSSEN COVID-19; This spontaneous report received from a patient concerned a 66 year old female of unspecified race and ethnic origin. The patient's height, and weight were not reported. Apart from her age, the patient was otherwise healthy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 01 total administered on OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 03-OCT-2021, the patient experienced severe adverse reaction to Janssen COVID-19. Eight hours after, the patient had increased heart rate (HR) of 130-150 bpm; and 911 was called and the patient was taken to hospital and got admitted. Magnetic resonance imaging (MRI) showed Septal myocardial infarction (MI). The patient was diagnosed with spontaneous coronary artery dissection. The patient was hospitalized for two days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the spontaneous coronary artery dissection and severe adverse reaction to janssen covid-19 was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20220609922-Covid-19 vaccine ad26.cov2.s-spontaneous coronary artery dissection, severe adverse reaction to Janssen covid-19. 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). Therefore, this event(s) is considered unassessable.
On 4/17/10 patient fell 5-6 feet, landed on right shoulder and taken to ER for eval. In ER it was noted that right arm was erythematous, swollen and warm to touch. Determined it was probably related to the vaccines he received 4/16/10. Admitted and started on IV antibiotics. it was unclear if this was a cellulitis or just an inflammatory reaction-no cultures were obtained. Mom states daughter reacted similarly to her final round of vaccines.
About 3:30 pm on 12/28/2017 began to have loose, watery stools with stomach cramps. This continued to occur every 1-2 hours with episodes of intense vertigo, nausea and headache.
Patient is an 18 yo, F, who received her first series of Covid -19 vaccine today of Pfizer 0.3 mls Lot # FJ 6369 with Mfg date of 09/2021 on her left deltoid by MA at 18:15, tolerated the procedure well.  She was asked to wait 15 minutes for observation, and was asymptomatic.  At 18:30, she approached the Provider's table and complained of feeling dizzy, and passed out. She was laid in yoga mat and head was supported. VS checked. Pulses and breathing present throughout and were adequate. B/L hands cool to touch. She would sit up at times and pass out again.  Appeared like eyes rolled but no seizure activity noted. HR between 48-54, Sats 87-99%. RR 12-14/min. BP=140/62 mmHg.At 18:32- In-house ED team activated by MA At 18:35-Epipen 0.15 mg given IM to right VL. 18:36-ED team arrived and updated. Patient awake, tried to call sister on cellphone, hands still shaking. Brought to ED with patient permission via WC accompanied by ED team.
1ST VAX GIVEN ON 4-12-90. WITHIN HOURS DEVELOPED HIVES ON BOTH SHOULDERS AND THE TOP 1/4 OF BACK. AROUND 7PM HIVES TURNED RED. THROAT FELT DRY AND CLOSING. 4-13-90 PT WAS FINE
TWO DIFFERENT AUTOIMMUNE DISORDERS; LOST ALL HAIR ON THE BODY; ADVERSE EVENTS; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no family history of either autoimmune disease. The patient work in military and have regular exercises. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, almost immediately after vaccination the patient began to have problems. The patient was diagnosed with two different autoimmune disorders and the patient was now taking medication daily and told for rest of his life. Additionally the patient had lost all hair on the body and paying to have treatments to hopefully bring it back but it was expensive for him. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the two different autoimmune disorders, lost all hair on the body and adverse events was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220362785-COVID-19 VACCINE AD26.COV2.S- Two different autoimmune disorders The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Immediate malaise, arthralgias, chills, injections site soreness 12 hours: Swelling and redness at injection site, light headedness, disoriented, dysphoria 24 hours: Global body rash (maculopapular) Severe headache, left calf and leg swelling and pain 72 hours: fever to 101.0, chills, worsened arthralgias, upper extremity swelling 5 days: Urticaria, chills, continued fever, malaise, worsened left clf swelling - pt sought care at urgent treatment clinic 4/24/2021: continued fever, extremities very painful, rash persisted - pt sought care at ED 2 weeks: patient sought care at Rheumatologist's office for rheumatic symptoms and above 4 weeks - present: menorrhagia, malaise, exacerbated rash with exertion 8 weeks: patient sought care at Ob/Gyn: given OC's without relief of menstrual disorder The patient's symptoms have impaired her daily function and ability to exercise
Approximately 12 hours after receiving the first vaccine I experienced a headache and congestion in my face and especially my ears.  The ear pressure was very uncomfortable and I had noise like wind in both ears. Sounded like I was shouting and echoing when speaking.  Took allergy meds and Tylenol.  No relief.  Finally Sudafed provided some relief from the pressure.  Felt like I needed to pop my ears.  Definitely worse on the left side.  This has continued for a week. This morning I was so unbalanced I had to hold on to the wall to get to the bathroom.  Had sweats and chills for a few hours.  Also quite fatigued which is very rare for me.  Very concerned about hearing loss if this does not resolve soon,
Upon immediate injection. I started to shudder, tremble and was freezing cold and my BP spiked to 177/104 at highest. Took a full 12 hours to normalize BP. HR was totally normal. But BP was still in 160?s after 2 hours.
1st dose June 16 2021/ 2nd dose 13August 2021; Hot flushes; felt like his arm was gonna fall out; Headache; This spontaneous case was reported by a patient and describes the occurrence of HOT FLUSH (Hot flushes), LIMB DISCOMFORT (felt like his arm was gonna fall out), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose June 16 2021/ 2nd dose 13August 2021) and HEADACHE (Headache) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039C21A and 039C21A) for COVID-19 vaccination.     Concomitant products included CLONIDINE and LORAZEPAM (ATIVAN) for an unknown indication.   On 16-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Aug-2021, the patient experienced HOT FLUSH (Hot flushes), LIMB DISCOMFORT (felt like his arm was gonna fall out) and HEADACHE (Headache). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose June 16 2021/ 2nd dose 13August 2021). At the time of the report, HOT FLUSH (Hot flushes), LIMB DISCOMFORT (felt like his arm was gonna fall out) and HEADACHE (Headache) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose June 16 2021/ 2nd dose 13August 2021) had resolved.            No treatment information was provided.
A FOURTH DOSE WAS ADMINISTERED 12/31/2021 AT A VACCINE CLINIC
I am a registered nurse. I received the 2015 Influenza Vaccine through my employer at approximately 4:30 PM, Tuesday, October 21, 2014. Lot# UI198AA, exp: 30JUN15. At approximately 10:PM, October 21, 2014, I began to have rigors, severe headache and neck ache, and strong urge to vomit, weakness. These symptoms lasted about 3 hours. The next day I experienced weakness, fatigue, runny nose, sore throat and slept until 3 pm next day. I called service that administered the vaccine on both 10/22 and 10/23/2014-no reply to date and time. I called my attending physcian and received a callback. Today I remain weak, runny nose, sore throat, and fatgue.
passed out; This spontaneous report has been received from a medical assistant via a company representative referring to a healthy 11-year-old male patient. The patient's concurrent condition, medical history and concomitant therapy information was not provided.     On approximately 09-AUG-2019 (reported as about two weeks ago), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, frequency, route, lot # and expiration date were not reported) as prevention of human papillomavirus vaccine (HPV). Other suspect therapy included unspecified pertussis vaccine and unspecified meningitis vaccine at the same visit (strength, dose, frequency, route, lot #, expiration date and indication were not reported).        On approximately 09-AUG-2019 (also reported as about two weeks ago), the patient experienced passed out for less than a minute. The outcome of passed out was reported as recovered. The patient did not seek any medical attention. No treatment was given to the patient. No lab diagnostics/studies were performed.  The causality between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.  Upon internal review, the event passed out was determined to be medically significant.