chrisvoncsefalvay/vaers-outcomes huggingface dataset:
22 y/o male who collapsed after a prolonged high intensity exercise run wearing about 30-40 lbs of gear on field run for > 1 hour; felt "unwell" at the end of 4 mile run; walked around about 1 1/2 laps and then collapsed. Does not recall any events following collapse until about 8 days later while hospitalized. Pt felt well prior to run - "near 100%". Reports he was well hydrated. When patient transported by ambulance, he experienced an altered mental status (initially unresponsive, then agitated, combative) and his temperature was 109 degrees F, rectally, which was confirmed at ER as >107 degrees F, rectally. Efforts to cool and sedate (received ATIVAN and HALDOL --> intubated). Temp down to 103 degrees F --> transferred to another Hospital. Temp down to 101 on admission; given additional fentanyl and versed for agitation. Hemodynamically stable with HRs 80-90 and SBP 100-20s; O2 stats > 97%. Loose green stools. HOSPITAL COURSE: Agitated, febrile to 102 rectally despite cooling blanket, fan and ice packs. Given Librium d/t concern for DTs with ETOH intake of about 30 beers/week (last ETOH intake around 3/14/2010); given VERSED as needed for agitation. Concern for cerebral edema (per CT with concern for herniation; episode in scanner where he was unresponsive, sluggish small pupils, heart rate in 30s, requiring resuscitation -->MICU). Given Mannitol with improvement. F/u MRI w/o evidence of elevated ICP. Received coverage for infections (doxy, vancomycin, ceftriaxzone, and acyclovir). After consultation with CDC and VHC, VIG (X1) administered IV (6000 units per kg) and pat also received IV methylprednisolone. Over hospital course, temperature returned to normal after several days, LFTS improved and mental status improved to near baseline. By 24 March, patient was extubated. He was following commands and answering questions, but no recall of previous 7 days. He was discharged on 28 March 2010. 13 April, Follow up visit, problems with motor skills (difficulty using fork and pen) and continues to report memory lapses ( -- > repair MRI and Neurology follow-up appt). 26 April, Follow Up, problems with mild memory lapses with forgetting what he is doing and at time how to do simple things such as tie his shoes. Problems falling asleep with sleep initiation taking anywhere from 2-3 hours. Also, admits to increased mood swings but he admits to being under some pressure from all this going on.
Arms face and back have severe acne that I've never had before. And a half dollar size rash in the Injection site
@ 1030 reported chest pain and difficulty breathing, gave 25mg Oral Benadryl, symptoms progressed to tightness in throat and dizziness.  Was transferred to ED after for evaluation.
On April 22, 2021, Pt had flu like symptoms.  On April 23, 2021 I received a text at work that pt was having chest pains.  I called his pediatrician.   We were thinking pt was still having flu like symptoms.  On Saturday, April 24, 2021, pt was still complaining about chest pains.   He was tired and not acting normal.   We took his blood pressure twice and his heart rate was 105 bpm..  Can not exactly remember blood pressure (seemed very off).  Took pt to the hospital where they measured his heart rate at 107 bpm.
Atrial Fibrillation, treated for 4 days with medicines then on 4th day ,... checked for blood clots (none fond) then shocked heart back in sinus rhythm
This spontaneous report as received from a physician refers to a 4 year old female patient. There was no information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies provided. On 17-JAN-2017, the patient was vaccinated with a properly stored dose of GARDASIL 9 (lot # M028323, expiration date 26-SEP-2018; dose, route of administration were not reported). No adverse effects were reported. Additional information is not expected because there was no consent to contact physician.
Sleepiness; Sore; This spontaneous case was reported by a patient and describes the occurrence of SOMNOLENCE (Sleepiness) and PAIN (Sore) 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 an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (Sleepiness) and PAIN (Sore). At the time of the report, SOMNOLENCE (Sleepiness) and PAIN (Sore) outcome was unknown.            No concomitant medication was reported.  Patient wanted to know which side effect patient might have if patient would receive the new Bivalent Omicron vaccine because patient only experienced sleepiness and sore with the 3 previous Moderna vaccines. No treatment information was reported.
Patient report generalized body aches, numbness, and tingling. Pt. reported feeling weak all over and states that her right leg is weaker than her left leg.  Pt. was brought to ER by her husband, because husband states that she was to weak to walk on her own to the bathroom. upon evaluation pt. appears tired and slightly drowsy but answers questions appropriately. The patient can state her name, where she is and the current month and year.
Quarter sized area of inflammation, RAT edematous and warm to touch. Encouraged use of warm compresses, Tylenol or Motrin as Rxed PRN, Neosporin ointment. Child ambulates well and apprears in no distress.
Pt recvd 3rd dose of Hep B vax & 20 min later exp rash on neck & face w/ itching of extremities.Tx w/ 25mg DPH.
Left thigh swollen, red, and hot at injection site. ER visit 2 days post immunization. Treated with Benedryl and Augmentin.
CELLULITIS DEVELOPED 8 DAYS POST VACCINATION.   PATIENT WAS PRESCRIBED ZITHROMAX Z-PAK AND ATARAX WITH NO SUCCESS.  PATIENT WENT TO ER 16 DAYS POST VACCINATION AND WAS GIVEN 4 DOSES OF KEFLEX.
body aches day after, vomiting beginning day of and continuing until 12/31, went to ER for fluids and zofran
Patient reported redness and pain at injection site and sought treatment at a Clinic location. Nurse Practitioner diagnosed the patient with a bacterial infection and prescribed clindamycin 300mg to be taken every 6 hrs for 10 days.
Patient felt a rapid heart rate and dizziness after sitting on a chair outside the pharmacy following his second shot. Patient laid down on the ground to prevent falling/passing out and notified staff that he didn't feel right. Patient stated that he has felt this way before after receiving previous immunizations, so he knew to get down on the ground before he were to pass out. Patient was given ice packs for his neck and arms to cool down and water. Patient stayed on the ground with staff for approximately 10 minutes, then got up with assistance to sit in a chair. He stayed in the chair for about another 15 minutes before stating that he felt fine and was released to go.
Enlarged dark blue veins in hands , legs arms. Bright red blotchy palms of handswith some yellow spots.  Skin colored lump on bottom of foot and joint of index finger
Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 3/7/2021 and 3/28/2021. Presented to the ED on 9/17/2021 with shortness of breath that started yesterday, as well as a 4 day history of nausea and vomiting. Patient was admitted 9/17/21 and initiated on bipap.  She was intubated 9/27/21.  She was on max mechanical ventilation and epoprostenol and despite proning her saturations were consistently in the 70s-80s. Patient treated with remdesivir, tocilizumab, and methylprednisolone.  Her husband elected to make her DNR and then comfort care.  Patient passed  away on 10/8/2021.
First dose of Moderna vaccine received on 1/11/21 Monday on my right arm. The following day 1/12/21 Tuesday I started having itchy rashes on my left ear, along with right arm soreness. The rash on my left ear gradually progressed and spread as days go by until 1/15/21 Friday. I woke up with swollen ears, hives on my face, neck, chest, and upper body. On Saturday morning 1/16/21, my symptoms worsen with more itchy red rashes. On top of the rashes, my lymph node on my left neck felt swollen and tender. Also, I had a weird sensation in my throat that was not going away like something was stuck. After a TeleVisit, I went to the ER that day and got medical treatment. I was given Benadryl, Pepcid, Dexamethasone and IV fluids. Then I was sent home with Cephalexin, Prednisone, Benadryl, and Epi Pen. Right now, I still have symptoms of rashes on my face, ears, and chest but they wax and wane. I can feel it itching beneath my skin even if they are not showing. With my ears, I can say that they are not swollen and are less red now. I have no other known exposure but the Moderna vaccine. I do not have any known allergy either but to bee stings.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's medical history and current conditions were not reported. On 06-APR-2015, the patient was vaccinated with an improperly stored dose of (Merck) VARIVAX (dose, frequency, route of administration, lot# and expiration date were not reported). No adverse effect was reported. Product quality complain (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
legs feel heavy; Pain at injection site; Body aches; Chills; Teeth hurt; Headache; Very tired; This is a spontaneous report received from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: unknown, Dose number: 1) via an unspecified route of administration in the left arm on 15Mar2021, 13:30 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. The patient medical history includes hereditary sensory neuropathy, Hashimotos thyroiditis. The patient concomitant medications include Levothyroxine, Bit D, Immunity vitamin. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not have any allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Mar2021, the patient experienced Headache, very tired, teeth hurt, legs feel heavy, body aches, chills, vaccination site pain. The patient was not treated for the adverse events. The clinical outcome of the events Headache, very tired, teeth hurt, legs feel heavy, body aches, chills, vaccination site pain was resolving at the time of the report. Information about lot/batch number cannot be obtained. No further information is expected.
soreness in left arm injection site.1st dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness in left arm injection site.1st dose) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029o20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 15-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced VACCINATION SITE PAIN (soreness in left arm injection site.1st dose). At the time of the report, VACCINATION SITE PAIN (soreness in left arm injection site.1st dose) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant product use was not provided by the reporter. Treatment information was not provided. Patient received vaccine in his shoulder deltoid muscle.   This case was linked to MOD-2022-465769, MOD-2022-465795, MOD-2022-465812 (Patient Link).
9:45  Pale, eased to floor/mat  BP 102/60  Pulse 64 9:55  BP 104/58  Pulse 60 10:00  Left ambulatory with Dad.  Color pink, skin warm an dry.  Has routine Dr appointment shortly and will talk to her about her episode
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose 01/06/2021 pfizer,Lot#EL3246 2nd dose: 01/27/2021Pfizer,Lot# EL8982 Diagnosed covid positive:07/02/2021 Exposure:Community Symptoms:Cough, diarrhea,HA,Abd pain.
Extreme right arm pain still occurring three days later, inability to lift arm over 45°. Shirt material touching arm is painful. White oval area at site of injection still remaining to date. Fever- like symptoms for 2 days following injection, body aches, medicine head feeling.
Headache, Myalgia, muscle soreness on left side and back from arm to waist. Narrative:  Other Relevant History:
This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 66-year-old female patient who received SHINGRIX for prophylaxis. On 21st January 2019, the patient received the 2nd dose of SHINGRIX. On 21st January 2019, several hours after receiving SHINGRIX, the patient experienced muscle pain, influenza-like symptoms, joint pain, headache, foggy feeling in head and injection site pain. On an unknown date, the outcome of the muscle pain, influenza-like symptoms, joint pain, headache and foggy feeling in head were recovering/resolving and the outcome of the injection site pain was not recovered/not resolved. It was unknown if the reporter considered the muscle pain, influenza-like symptoms, joint pain, headache, foggy feeling in head and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose of SHINGRIX injection in left deltoid at the pharmacy on 21st January 2019, around 12 noon. Within a couple of hours, they started having miserable side effects further described as terrible muscle aches, like the worst case of flu ever; joint aches; headache; felt in a fog; and soreness at the injection site. On 23rd January 2019, she finally feels better but still had soreness at the left deltoid at the injection site. The reporter did not know lot or expiration date. The reporter gave consent to follow up. This case has been linked with case US2019012770, reported by the same reporter.
This spontaneous report was received from a consumer's wife refers to a 74 year old male patient. The patient's medical history included hardening of the arteries (2 stents put in). Drug reactions or allergies was reported as none. Approximately on an unknown date in 2007 (also reported as 7 years ago) the patient was vaccinated with ZOSTAVAX dose 1, one time vaccine. Concomitant therapies included statin for cholesterol, Metoprolol (for blood pressure). On 25-AUG-2014 the patient experienced shingles with very little pain. The primary reporter was a consumer. She stated that she and her husband (patient) both got the vaccine 7 years ago, but the husband developed Shingles last week which was very mild with very little pain. Patient was prescribed anti virus medicine, and oral tablet for reduction of inflammation. A month ago blood test for cholesterol and liver enzymes was done (details unspecified). Patient sought medical attention. There was no product quality complaint (PQC) involved. The outcome of shingles with very little pain was unknown. Causality assessment was not provided. Additional information has been requested.
6 Month to 5-year-old vial presentation utilized for first dose in patients 6 to 11-year-old; This spontaneous case was reported by an other health care professional and describes the occurrence of OFF LABEL USE (6 Month to 5-year-old vial presentation utilized for first dose in patients 6 to 11-year-old) in a 6-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1416B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Jul-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jul-2022, the patient experienced OFF LABEL USE (6 Month to 5-year-old vial presentation utilized for first dose in patients 6 to 11-year-old). At the time of the report, OFF LABEL USE (6 Month to 5-year-old vial presentation utilized for first dose in patients 6 to 11-year-old) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided. No treatment medication information provided.
body ache; I got very high fever; headache; This is a spontaneous report from a contactable consumer (patient). A 40-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 15Apr2021 07:30 (lot number: EP6955; expiry date: unknown) at the age of 40-years-old, as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EP6955; expiry date: unknown) in the right arm, as dose 1 single, at 12:30 PM, for COVID-19 immunisation. Patient is a vegan. The patient was not diagnosed with COVID prior vaccination. Facility type vaccine was reported as "Other". The patient did not receive other vaccines in four weeks; and did not receive other medications in two weeks. On 15Apr2021, after getting second dose of Pfizer, immediately after 15 minutes (07:45), patient experienced headache. After 12 hours of vaccine (at 19:30), the patient got a very high fever and body ache which remained for 4-5 days. After that, fever and body pain were gone but headache remained after 3 months. The patient did not receive treatment for the events. Outcome of the events body ache and fever was recovered on unspecified date in Apr2021. Outcome of the event headache was not recovered. The patient has not been tested for COVID-19 since vaccination.
Information has been received from a nurse concerning a 5 year old female who 4 years ago, in 2003, was vaccinated with a 0.5mL subcutaneous dose of varicella virus vaccine live (Oka/Merck). About 4 years ago, in approximately 2003, the patient developed vesicular lesions at the injection site. No other symptoms were noted. Subsequently, the patient fully recovered. No product quality complaint was involved. Additional information has been requested.
Headache, Myalgia, UrticariaPruritus, HARD KNOW AT INJECTION SITE Narrative:
dizzyness for 4 days.  Was seen by the paramedic on Sunday 2/28/21  at the immunization site and they checked all my vital signs and said nothing was overly concerning they made we wait a bit and then released me. Monday night I felt poorly and went to bed early. Tuesday I went to work, still feeling bad and then the dizziness seemed to worsen. I'm a teacher, the school called the paramedic, they came checked my vital signs again and said it was clearly a reaction to the vaccine, and sent me home. I subsequently slept for two days, and the symptoms are mostly gone. I little foggy still, and infrequent bouts of dizziness when I move my head to quickly. I am concerned about taking the second shot.
Diaphoretic, tachypnic, pale face, hypotensive. Given 20 ounces water and juice. BPs 97/67 (pulse 86), 107/75 (pulse 86). 98% O2 sat.
Choking sensation in my throat that lasted for about 2 hours, pain at the injection site, inflammation, and rash all over arm, blood vessels burst underneath the skin of my arm (there is currently bruising), body aches, lack of energy, fever symptoms.
Chills and sweats, hydrated and rest.  Symptoms subsided around 1530 12-21-20.
Sudden onset of dizziness, lightheadedness, and the sensation that my eyes wouldn?t focus on anything. After about an hour of this, severe projectile vomiting occurred multiple times throughout the next two hours. Paramedics came, vitals were normal. Ended up going to sleep, but woke up with a headache.
VACCINE WAS STORED IN FREEZER AND NOT IN FRIDGE. NO TREATMENT.
Have a painful pus pocket on tongue  headache for two days and tired for 2 days
Mom states hives developed today on back, abd and arm. Pt does have URI. No other sxs. Received shot on 6/28/04. Given Benadryl.
Patient had 5 minute tonic clonic seizure with temp 101 on evening shots were given.  Patient had a history of prior febrile seizures.  Seen at Hospital and also had an otitis media which was diagnosed at the time of the immunizations.
This spontaneous report has been received from an office manager and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 26-JUN-2017, the patient was vaccinated with expired dose of GARDASIL lot # K010215, expiration date 05-MAY-2017 (dose and route of administration were not reported). No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Patient bled from vaccination site, then a small whelt appeared at the vaccination site, then he lost consciousness for approximately a minute.
Eye swelling; Profuse rhinorrhea; Sneezing; Coughing.
bells palsy; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 70 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 29-JUL-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced bells palsy. On an unspecified date, the patient was treated by a physician for bells palsy. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Upon internal review, the event bells palsy was determined to be medically significant.  Additional information has been requested.
Fatigue; General aches and pains; This case was reported by a other health professional via sales rep and described the occurrence of fatigue in a patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced fatigue and general body pain. On an unknown date, the outcome of the fatigue and general body pain were unknown.   It was unknown if the reporter considered the fatigue and general body pain to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Bexsero vaccine and experienced fatigue, general aches and pains.
I started feeling ?off? a few hours after vaccine. I had pains traveling throughout my body and was worried it was a blood clot. Later that night, I began feeling pins and needles in my arms, legs, hands and feet which lead to numbness. I continue to have these same symptoms 2 weeks later. They have been getting worse as my whole body is now experiencing numbness (including torso, tongue, gums, face, etc). The tingling and numbness was so bad that i had to pull over when driving. I cannot sleep at night because of how painful and uncomfortable I am. I have been to 2 doctors (PCP and neurologist) and have to undergo further testing. I also developed a large rash on the inside of both legs, both elbows and on my stomach.