chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received second Covid 19 shot  on 3/22/21. Severe chest pain while doing light yard work on 03/29/21.  Went to local Hospital that evening and received a stent on 03/30/21 on most severely restricted artery of three.  Blockages were reports as 90% and two at 60 - 70%
Received J&J on 4/8/21. Admitted 5/22/21 - 5/25/21 for hypokalemia and COVID pneumonia.
Congestion and cough with vomiting, rapid breathing that has lasted for 11 weeks (so far). Multiple trips to the doctor and ER in November and December. Have tried albuterol breathing treatments, prednisone, amoxicillin. Have had two chest Xrays and an EEG (after a strange episode of lethargy in December). Went to an ENT on December 26, who is guessing silent reflux may be a culprit (baby doesn't spit up). Currently on a daily dose of ZANTAC 2x a day (4mL). Symptoms persist. If no improvement by follow up appointment at the end of January, ENT will refer us to hospital.
Itching; Redness on the Arm; Breaking out with rash; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching), ERYTHEMA (Redness on the Arm) and RASH (Breaking out with rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itching), ERYTHEMA (Redness on the Arm) and RASH (Breaking out with rash). At the time of the report, PRURITUS (Itching), ERYTHEMA (Redness on the Arm) and RASH (Breaking out with rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant products were reported. No treatments were reported.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow-up received on 21-Jul-2021 contains significant information. The primary reporter contact details were updated. The start date of vaccination was added.
about 3min p/vax pt became very dizzy & blacked out;nurse caught pt before hitting head;cool cloth placed on forehead & neck was completely;recovered in five minutes;
Redness and itching at injection site about four hours after vaccine was administered. About 24 hours later the red area was about two inches in diameter, it became swollen, hot and tender and was itchy. I spoke with a nurse at my doctors office and she advised me to ice the area, and if painful to take Tylenol, she suggested taking Benadryl at night, and applying hydrocortisone cream. Area remained the same the third day and is improving today the fourth day: less swelling, tenderness and not as hot.
11/1/07 Flu vaccine, states eye drainage x 2 days; HA x 3 days, body aches.
This case was reported by a nurse and described the occurrence of a swollen leg in a 4 year old male patient who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed (Infanrix).  On 08/03/2004, the patient received the fifth dose of Infanrix in the left thigh (lot DTPA614B9).  At an unspecified time following the fifth administration of Infanrix, on 08/03/2004, the patient experienced a swollen left leg.  The nurse reported that the left leg was swollen, from the upper thigh to the knee area.  The patient was seen at a physician's office considered the swollen leg to possibly be related to vaccination with Infanrix.
Allergic-Dermatologic reaction after 10 to 12 days of getting the Moderna Vaccine or Booster; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Allergic-Dermatologic reaction after 10 to 12 days of getting the Moderna Vaccine or Booster) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Allergic-Dermatologic reaction after 10 to 12 days of getting the Moderna Vaccine or Booster). At the time of the report, URTICARIA (Allergic-Dermatologic reaction after 10 to 12 days of getting the Moderna Vaccine or Booster) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Caller mention that was in a social media group with around 37,000 members support group were member manifested getting this allergic-dermatologic reaction after 10 to 12 days of getting the moderna or booster,also states that were many other places in the internet social media and support group that works as a connector to patients that had similar reactions. No concomitant and treatment medications were reported.
Ulcerative colitis - diagnosed with severe pan-colitis that did not respond to any medication or biologics. Resolution was a total colectomy. Previously no digestive issues and no ulcerative colitis  diagnosis
7 days after receiving the initial vaccine in my left arm, I  was found to have 5 swollen subcutaneous lymph nodes ranging from 1-2cm  (ultra-sound results received 1.13.21 after referral from ENT).  At day 7 I also developed a hand-print sized swollen red patch on my arm around site of injection that has not gone away with Benadryl and cold compress.
Patient is a 63 y.o. male patient of CNP with history of CAD, essential tremor (status post brain stimulator), hypertension, DM type II presented with generalized weakness and found to have COVID-19.    Covid-19 Virus Infection Date of onset of symptoms: 07/05/22 Symptoms present on admission: Generalized weakness, fatigue, fevers Date of covid positive test: 07/05/22 Vaccination status: vaccinated, including booster Imaging: CTPA showing reticular opacities in lung bases, likely atelectasis. Oxygen requirements on admission: None Medical therapy: not indicated Consultants following: None Anticipate end of isolation: 7/15/2022   Generalized weakness Not associated with focal neurologic deficits (chronic essential tremors as well as delayed speech) -- on primidone  CT scan of brain w/o acute gross abnormalities. Likely multifactorial (COVID infection, dehydration) as other work up unremarkable PT/OT recommend upto 5, discharge to SNF   Strep viridans bacteremia 1/2 sets of Bcx +viridans strep Likely contaminant -- repeat Bcx no growth so far Hold on Abx   Hypokalemia - resolved K 3.2 (7/8) Replaced, replete 7/9   Elevated troponin due to demand ischemia CAD No chest pain or shortness of breath on presentation. Trop 30 -- > 48 -- > 53 EKG (reviewed) -- poor tremor artifact, NSR, no e/o acute ischemia CTPA without pulmonary embolism LHC (4/1/22) -- mild three vessel CAD, moderate RCA stenosis Restart home dose of beta-blocker and a statin. Aspirin was being held for TURP on 7/8 but resumed now as will push back procedure per Urology  Essential tremors Status post brain stimulator placement Continue home gabapentin, primidone   BPH Urinary retention Follows with Dr. and had TURP planned 7/8 Urology consulted -- rescheduled procedure Continue tamsulosin Required straight cath x1 for PVR >700cc Check PVR q8h with straight cath PRN -- > pt currently declining Foley and would prefer to monitor with straight caths for now PVRs have been 100-300s.   DM type II, controlled A1c 7.3 Holding oral hypoglycemics. Lantus, SSI   Hypertension Normotensive on admission. Continue home losartan, metoprolol
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Nausea-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Weakness-Mild, Additional Details: Benadryl 25mg given one dose bjd. temp checks done every 5 minutes. 30min overall event. Pt left with no issues with spouse. bjd
patient developed lower lip tingling and swelling and took Benadryl. Then progressed to have upper lip swelling. no other systemic symptoms for reaction. Symptoms did start 5.5 hrs after vaccine injection and 1 hr after eating dinner at a restaurant. No history of food allergy.
This male subject was enrolled in the prophylactic open study 110870 (MenACWY-TT-057).  On 4 April 2008, he received the 1st dose of HIB-MENCY-TT (IM L thigh) and of PEDIARIX (IM R thigh).  The subject received concomitantly PREVNAR (IM) and ROTATEQ vaccines (po).  Medical conditions at the time of the event included apnea and seizure.  Concomitant medications included PREVACID and KEPPRA.  On 02 July 2008, 89 days after the 1st dose of PEDIARIX, 89 days after the 1st dose of HIB-MENCY-TT, this five-month-old subject died.  The event was disabling, life-threatening, clinically significant (or requiring intervention).  The subject died on 02 July 2008, cause of death is unknown.  An autopsy was performed.  The investigator considered that there was a reasonable possibility that the death nos may have been caused by PEDIARIX and HIB-MENCY-TT.  Investigator Comments: Site was Notified of report of death on 07-03-2008, records have been requested.  All data pending.  07-07-2008.  After PI review, cannot completely rule out vaccine related causality, but not probable.  Subject on anticonvulsants and has underwent metabolic/neurologic work-up with no significant findings.  Possibility of Munchausen by Proxy, but waiting on pending results of physician and ER notes, apnea monitor results and autopsy and toxicology report.  8/22/08 Autopsy states COD as sudden unexpected infant death.  Report also states  Anatomical diagnosis: same as COD & aspiration of vomitus, terminal/subterminal focal bilateral.  Comments: infant had complicated history of seizures, aspiration & apnea which could not be substantiated during multiple hospitalizations & ER visits & Munchausen by proxy was questioned.  Autopsy showed only relatively mild terminal aspiration of vomitus. 8/5/08 Reviewed ER medical records of 7/2/2008 submitted by FDA from manufacturer.  Records reveal patient well known w/history of recurrent episodes of life-threatening events of possible apnea vs seizure over the prior 2 months w/cyanosis, choking & gagging.  Was on apnea/bradycardia monitor at home.  Found by parent vomiting & poorly responsive.  Started CPR & ACLS by EMS.  Arrived in ER in full arrest & unable to resuscitate.
feeling different; dizzy; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feeling different) and DIZZINESS (dizzy) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K202-A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced FEELING ABNORMAL (feeling different) and DIZZINESS (dizzy). At the time of the report, FEELING ABNORMAL (feeling different) and DIZZINESS (dizzy) 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.   Treatment information was not provided.  Concomitants were not provided.
Headache, Diarrhea & NauseaVomiting Narrative:  used Tylenol
headache; sleeping every day; start to lose appetite; he goes sleep with it and wakes up with it annoying for him it can't sleep in the middle of the night it bothers him; he cries for like hours; it's been really weird, like 6-7 months/ he's like in a fog; losing weight; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  An 18-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary series of immunization completed unknown manufacturer.), for covid-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "not recovered"; SOMNOLENCE (non-serious), outcome "unknown", described as "sleeping every day"; DECREASED APPETITE (non-serious), outcome "unknown", described as "start to lose appetite"; SLEEP DISORDER (non-serious), outcome "unknown", described as "he goes sleep with it and wakes up with it annoying for him it can't sleep in the middle of the night it bothers him"; CRYING (non-serious), outcome "unknown", described as "he cries for like hours"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "it's been really weird, like 6-7 months/ he's like in a fog"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "losing weight". The event "headache" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter reported that His son received the Pfizer covid-19 booster (not the new one bivalent/omicron, not verified if purple or gray) on June or May and experienced headache. He was sleeping every day, start to lose appetite, not eating. His headache continues as he goes sleep with it and wakes up with it annoying for him it can't sleep in the middle of the night it bothers him, he cries for like hours. it's been really weird, like 6-7 months, he's like in a fog (unverified, sounds like) you talked to him it's like he not even here. The headaches started after the vaccine, but they thought it would go away. Patient has been going to the doctors and he is still having it, the headaches have been going on for 6-7 months. He was crying every day.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Tested positive on 06/24 for COVID. Symptoms included Coughing, Nasal Discharge, Sneezing, Chills, Aches, Upset Stomach Nausea, Sharp shooting pain in feet.
12cm round red area to right deltoid (injection site) hot and tender to touch. Resp. even and unlabored. Lung field clear to auscultation. Patient alert and responsive, orientated x3. Treatment BENADRYL.
NAUSIA, FEVER, DIZZY, SHAKES, ACHEY, WEAK
Red injection site 2X2" after booster; Itchy Injection Site after booster; Red injection site 2X2" after booster; Very bad feeling after booster; Weak after booster; No appetite after booster; Muscle ache all over the body after booster; Chills after booster; A little Headache after booster; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Very bad feeling after booster), ASTHENIA (Weak after booster), DECREASED APPETITE (No appetite after booster), MYALGIA (Muscle ache all over the body after booster) and CHILLS (Chills after booster) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A, 026L20A and 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Dec-2021, the patient experienced FEELING ABNORMAL (Very bad feeling after booster), ASTHENIA (Weak after booster), DECREASED APPETITE (No appetite after booster), MYALGIA (Muscle ache all over the body after booster), CHILLS (Chills after booster) and HEADACHE (A little Headache after booster). On 08-Dec-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red injection site 2X2" after booster). On 09-Dec-2021, the patient experienced VACCINATION SITE PAIN (Red injection site 2X2" after booster) and VACCINATION SITE PRURITUS (Itchy Injection Site after booster). At the time of the report, FEELING ABNORMAL (Very bad feeling after booster), ASTHENIA (Weak after booster), DECREASED APPETITE (No appetite after booster), MYALGIA (Muscle ache all over the body after booster), CHILLS (Chills after booster) and HEADACHE (A little Headache after booster) was resolving and VACCINATION SITE ERYTHEMA (Red injection site 2X2" after booster), VACCINATION SITE PAIN (Red injection site 2X2" after booster) and VACCINATION SITE PRURITUS (Itchy Injection Site after booster) had not resolved.            No concomitant medications provided. On the 9-Dec-2021 the injection site was dark red with lighter red tong around it oval shape around 5. No treatment medications provided.   This case was linked to MOD-2021-406929 (Patient Link).
This non-serious spontaneous case, initially received from other non-health professional on 13-Nov-2018, concerns an 82-year-old, elderly patient of an unspecified gender. It was report that, the FLUAD TIV vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 22-Oct-2018, the patient was administered FLUAD (TIV) [batch number: 250802, route of administration, anatomical location, expiry date and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805536 was crossed linked to original case 201804863 due to same reporter.
pt recvd vax 1dec94 approx 11am & approx 8pm,pt's face swelled & broke out in petechiae type rash;rash on arms & face w/ itching;to clinic;atarax for itching;sxs lasted approx 2 days;5dec94 sxs resolved;
Pt developed throat tightness shortly after vaccination. Symptoms were mild. Pt was observed for over a half hour. No signs/symptoms to suggest anaphylaxis. HR 84, BP 110/82, SP02 97%. Pt elected to drive home and did not want to stay for further evaluation or possible treatment.
I had a fever of 102.3 degrees with chills/shaking/malaise/headache that lasted for 18 hours after the symptoms started. I was unable to go to work/care for my children secondary to my reaction. I have completely recovered now and have no lasting effects.
This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: Unknown. The reporter is the patient. A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Positive for COVID-19 / did not test positive for COVID-19"; THROMBOSIS (medically significant), outcome "unknown", described as "Clot in my leg"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "Leg swollen up"; MALAISE (non-serious), outcome "unknown", described as "Fell ill"; CHILLS (non-serious), outcome "recovered"; COUGH (non-serious), outcome "recovered"; PYREXIA (non-serious), outcome "recovered", described as "Fever"; PAIN (non-serious), outcome "recovered", described as "Soreness on the right side"; GAIT INABILITY (non-serious), outcome "unknown", described as "Could not walk". The events "positive for Covid-19 / did not test positive for Covid-19", "clot in my leg", "leg swollen up" and "could not walk" required emergency room visit. The patient underwent the following laboratory tests and procedures: Chest X-ray: Unknown; SARS-CoV-2 test: Negative, notes: Around the holidays the family gathered after being tested and we all tested negative; Scan: clot, notes: The doctor came and did a scan and they found a clot in my leg. Therapeutic measures were taken as a result of thrombosis. Clinical information: Patient was fully vaccinated. 2 doses and then one booster. Everything was fine after the booster. Just a little sore. Around the holidays the family gathered after being tested and they all tested negative. However, her grandson fell sick. He had a fever, cough, congestion. He was taken to the doctor and the fever went down. A day after fell ill. By the third day, at home, felt chills, cough, fever, soreness on the right side. The next day it was gone. The next 3 or 4 days it was fine. Then, on 18Jan to 19Jan2022 ended up in the ER with leg swollen up. The doctor came and did a scan and they found a clot in leg. Patient was administered heparin and all that kind of stuff. He was sent to be taken an X-ray and the hematologist put on blood thinners for a minimum of three months. For 2 weeks straight patient couldn't walk. The doctor said that, according to the timeframe, most probably patient got the clot from a mild case of COVID-19. So now patient on a blood thinner. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
NauseaVomiting, HYPERtension, Tachycardia, NONE Narrative:  SENT TO EMERGENCY ROOM, PT OBSERVED FOR 30 MINUTES, VS ASSESSSED  Other Relevant History:
Passed out; Things were going downhill; Dizzy; Injection site was painful; Fatigued; Muscle pain; Joint pain; Nausea without vomiting; Low grade fever; A bit of an ache in injection arm; A spontaneous report was received from a consumer concerning a 79-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the following:  things were going downhill, injection site was painful, fatigued, muscle pain, joint pain, nausea without vomiting, low grade fever, dizzy,  passed out, and a bit of an ache in her injection arm.  The patient's medical history was not provided. No concomitant medications were reported.    On 19-Feb-2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (lot/batch: 032L20a) intramuscularly for prophylaxis of COVID-19 infection.  On 19-Feb-2021, the patient received the vaccine around noon and by the evening she could tell things were going downhill. She went to bed early, and throughout the night the injection site was painful, she was fatigued, she had muscle pain, joint pain, nausea without vomiting, and a low grade fever. The patient got up at night to go to the bathroom and got dizzy and passed out. She said she was passed our for barely a minute and when she came too she laid there for a bit before she went back to bed with her husband's help. All day on Saturday 20-Feb-2021 the patient was in bed but by that evening she was able to get up and walk out of the bedroom. On Sunday night 21-Feb-2021, she was able walk up stairs without huffing and puffing and felt much better. The patient states they have recovered from it all except sometimes when doing yoga, they can feel a bit of an ache in the injection arm.  No treatment information was provided.   The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable.  The outcome of the events things were going downhill, injection site was painful, fatigued, muscle pain, joint pain, nausea without vomiting, low grade fever, dizzy, and passed out, were considered recovered/resolved.    The outcome of the event, ache in injection arm, was unknown.; Reporter's Comments: This case concerns a 79 Y/O F with a serious unexpected event of loss of consciousness along with NS unexpected dizziness, feeling abnormal, pain in extremity, and NS expected fever, fatigue, myalgia, arthralgia, nausea, vaccination site pain. Event onset the same day as second dose mRNA-1273. Events resolved except arm pain. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.