chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A 40-year-old female patient, with medical history of spondyloarthropathy and herpes zoster virus infection, had received an injection of influenza A/H1N1 vaccine, form unknown manufacturer (lot number, route and injection site unknown) on 23 April 2010. She was receiving methotrexate and indomethacin for spondyloarthropathy concomitantly. The day of vaccination, the patient presented with hardness and erythema at the injection site. Local hardness lasted one day and local erythema 2 days. On 25 April 2010, i.e. 2 days after vaccination, she experienced paresthesia on her right thumb that ceased on 07 April  2010. No therapy was prescribed.
pt recv vax & w/in 48hr p/vax exp blistering around the inj site;ER or MD visit was required;pt was treated w/Neosporin & an antihistamine;sx resolved w/in a few days;
Cellulitis at injection site Received IV antibiotics  and rx for oral antibiotics from another provider
Myocarditis; Chest Pain; a local reaction or blister on the vaccine site; This spontaneous report was received on 31MAY2019 from a physician via medical inquiry. A patient with unknown demographics experienced myocarditis, chest pain and blister on the vaccination site following the administration of ACAM2000 (Smallpox (Vaccinia) vaccine, Live).  Seven days ago (24MAY2019) the patient received smallpox vaccine (lot, dose and route unknown). Patient was hospitalized for myocarditis and presented with chest pain, local reaction or blister on the vaccine site but no fever. Outcome at the time of report was unknown.  The reporting physician was not involved in the care of the patient and was consulted by a provider from another healthcare facility to determine whether the patient needs any isolation precautions from infection control standpoint. The reporting physician did not have any other patient details.  Medical History/ Allergies: Not reported  Concomitant medication: Not reported.  Company Medical Assessment:  The Company considers that the diagnosis of myocarditis was possible related to ACAM2000. Despite the information is limited, it is assumed that the diagnosis made at the hospital is correct. In primary vaccinees, the onset of myocarditis associated with chest pain is within 4-15 days after vaccination, the patient was vaccinated seven days prior. The vaccination site reaction appears to be a satellite lesion, which is also a common complication of vaccination. More information has been requested.
LOCAL REACTION - HOT RED BRUISED AROUND AREA OF INJECTION. FLU LIKE SYMPTOMS.
This case was reported by a nurse via sales rep and described the occurrence of presyncope in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced presyncope and spasms. On an unknown date, the outcome of the presyncope and spasms were unknown. It was unknown if the reporter considered the presyncope and spasms to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected adult as per vaccine indication. The product was SHINGRIX and the reporter said the patient complained of spasms and had syncope like symptoms when driving.
Swollen left arm with stiffness, pain, and very high temperature in the arm. Treated with Medrol 4 MG Pak 21 Tab and Cephalexin 500mg, one capsule by mouth 3x daily for 7 days. Treatment began on 11-15-06, arm was better by 11-17-07. Completed med regimen as prescribed.
Recurrence of cancer (after being cancer free for almost  4 years) within 6 weeks of the second dose of Pfizer COVID vaccine.  My CA 125 had been less then 10.0 since 2017.  Three days after the first dose,  CA125 was 10.6.  Second dose was 1/30/21.  I opted to wait 6 weeks for my next set of labs out of concern for the "inflammation" causing a bump in my CA125, but now it was 31.7.  It continued to rise and a PET CT scan confirmed recurrence and extensive metastatic spread.
Felt bad; Body was Shaky; Fatigue; Chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt bad), TREMOR (Body was Shaky), FATIGUE (Fatigue) and CHILLS (Chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 039k20a) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced FEELING ABNORMAL (Felt bad), TREMOR (Body was Shaky), FATIGUE (Fatigue) and CHILLS (Chills). On 12-Mar-2021, FEELING ABNORMAL (Felt bad), TREMOR (Body was Shaky), FATIGUE (Fatigue) and CHILLS (Chills) had resolved.            No Concomitant medications was reported Treatment information was not provided
within 15 mins of vaccine administration pt reported she had numbness and tingling in her lips.  waited for 45 mins at vaccination site and then left.  around 9 pm on 4/9/21 stated she was lying in bed and heart started pounding so she called 911.  stated EMS took her BP and it was 165/? (cannot remember diastolic number) which is much higher than her "normal" BP which is "low to normal" numbers, usually running 111/80 or less.  Pt stated she did not allow EMS to take her to the hospital, then later decided she would drive herself to the ER.  Went to Hospital ER and waited a "long time" before deciding to leave without being seen.  Pt stated she then went to Urgent Care on Saturday to have her BP checked and after an hour of waiting decided to leave.  Pt reported she is going to be evaluated today.
LITTLE SORENESS OF THE ARM/ LITTLE TENDERNESS; This spontaneous report received from a patient concerned a 73 year old of unspecified 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 not reported, batch number: 0432A21A, expiry: UNKNOWN) dose was not reported, administered on 07-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 07-JUN-2021, the subject experienced little soreness of the arm/ little tenderness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from little soreness of the arm/ little tenderness on 07-JUN-2021. This report was non-serious.
At 1100, pt complained of headache and dizziness.  Pt began shaking in her extremities.  Upon RN exam, pt had ataxia in bilateral upper extremities.  MD examined pt, pt appeared to be hypoglycemic.  Pt continud to snack on foods from RN team, appeared to decrease shaking.  Pt continued to complain of headache.  Pt sat for 30 more minutes of observation.  Pt left with brother and sister in law.  Advised pt and family to seek medical treatment at emergency room if symptoms persist.
Started with  low grade fevers with headache late in the afternoon, almost daily. On 09/08/2021 around 1:00 pm I started getting the chills, headache increased, sore throat, body aches started and fever increased. 09/09/2021: I had 104 degree fever and it stayed around 101 through Saturday night. Chills, severe sore throat, extremely difficult to swallow, body aches and headache. By Sunday, 09/12/2021, my symptoms improved but had a serious non productive cough. Had to reach out to doctor to get prescription cough syrup because Cepacol and Robitussin were not helping.
blood in my stool; I coughed up a minor amount of blood; slept all day/difficult to stay awake; very fatigued/still experiencing the fatigue; chills/still experiencing the fever/chills; dizziness; on and off cold; slight discomfort; mild fever/overnight fever/still experiencing the fever; sleeping about 2-4 hours a day; I'be been waking up every hour since the booster shot; This spontaneous case was reported by a non-health professional and describes the occurrence of HAEMATOCHEZIA (blood in my stool), HAEMOPTYSIS (I coughed up a minor amount of blood), DISCOMFORT (slight discomfort), DIZZINESS (dizziness) and NASOPHARYNGITIS (on and off cold) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high and Tobacco user (currently rotate a vape and a regular tobacco product.).    On 27-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced INSOMNIA (sleeping about 2-4 hours a day) and SLEEP DISORDER (I'be been waking up every hour since the booster shot). On 27-Nov-2021, the patient experienced DISCOMFORT (slight discomfort) and PYREXIA (mild fever/overnight fever/still experiencing the fever). On 28-Nov-2021, the patient experienced DIZZINESS (dizziness), NASOPHARYNGITIS (on and off cold) and CHILLS (chills/still experiencing the fever/chills). On 30-Nov-2021, the patient experienced FATIGUE (very fatigued/still experiencing the fatigue). On 01-Dec-2021, the patient experienced HAEMATOCHEZIA (blood in my stool), HAEMOPTYSIS (I coughed up a minor amount of blood) and SOMNOLENCE (slept all day/difficult to stay awake). On 01-Dec-2021, SOMNOLENCE (slept all day/difficult to stay awake) had resolved. At the time of the report, HAEMATOCHEZIA (blood in my stool), HAEMOPTYSIS (I coughed up a minor amount of blood), DISCOMFORT (slight discomfort), DIZZINESS (dizziness), INSOMNIA (sleeping about 2-4 hours a day) and SLEEP DISORDER (I'be been waking up every hour since the booster shot) outcome was unknown and NASOPHARYNGITIS (on and off cold), FATIGUE (very fatigued/still experiencing the fatigue), CHILLS (chills/still experiencing the fever/chills) and PYREXIA (mild fever/overnight fever/still experiencing the fever) had not resolved.            No concomitant drug details were reported. No treatment details were reported.
C/o tingling around vaccine site and distal posteriorly from vaccine site. He is able to work without weakness or pain.
Swelling under my left armpit that looks like a sack of skin hanging off my body. The swelling started that evening and I when I told the pharmacist about it they said it would probably go away in its own. It has not.
This is STUPID b/c Noone even reads pays atten to these.Ive been EXTREMELY Sick Since My 2nd vaccine. I've been to the hospital 3/4 times, primary care, neurologist and even a specialist who deals with movement disorders and no one can tell me what's wrong. My hands would  shake and wouldn't stop.It was completely constant and I couldn't even hold a bowl or silverware because they shook so much. Now it is so much a constant during the day but still at night. I also get muscle spasms all the time just out of the blue. Still No One can tell me what's wrong and I am convinced it's from the vaccine because nothing had changed for years before that as far as meds and allergies.
ARM WAS LITTLE SORE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced arm sore. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of arm sore was not reported. This report was non-serious.
1. Patient reports frequent dry eyes with associated headaches; onset in March 2021. Patient states that her headache worsened and was experiencing daily headaches; onset in July 2021. Patient denies head injury. Patient describes headaches band like across forehead with associated dizziness.  2. Patient reports prior history of bleeding gums but states that it has worsened during this deployment. Patient noticed bleeding gums when brushing or flossing everyday; onset June 2021. 3. Patient reports frequent headaches with associated pressure in ear drums, sensitivity to noises, dizziness, and eye pressure; onset April 2021. 4. Patient reports joint pain in shoulders and elbows after working out in gym; onset in April 2021. Patient was evaluated by medic; self-care with rest and OTC pain reliever. Patient states that her symptoms worsened in SEP 2021. Patient states symptoms improved with rest but flares up when she performs physical fitness training.  5. Patient reports left sided low back pain after working out in the gym; onset July 2021. Patient was evaluated by medic; self-care with rest and OTC pain reliever. Symptoms improved with rest but flares up when she performs physical fitness training. 6. Patient reports fingers joints sensitive to temperature; onset July 2021. Patient states that she would notice numbness/tingling in cool air condition room; joint pain in hands/fingers worsened in warm/hot temperature. Describes tingling and burning sensation in joints in bilateral hands/fingers in warm/hot temperature. Patient reports symptoms improved but not resolved.  7. Patient reports that her knees feels unstable when lifting weights; onset April 2021. Patient denies direct trauma or injury to affected areas. Self-care with rest and OTC pain reliever. Patient reports symptoms improved with rest but not resolved. 8. Patient reports weight gain, ~ 30 lbs, in the last 4 months despite changes in diet or exercise. Patient reports acne worsened as well. 9. Patient reports frequent trouble sleeping during this deployment. Patient states that she had trouble falling asleep and staying asleep; racing thoughts and thinking about work and assignment deadlines; and felt tired and sluggish during the day.
Glucose dropped to 40 . Dizzy and light headed . Lasted about 20 mins
Over 2 days had severe joint and muscle aches in knees and back. Fatigue. Slight fever and chills.
Vasovagal syncope- felt lightheaded, almost passed out twice, and vomited.
Two weeks after my 3rd dose, I was getting bumps on my back. My daughter was massaging me and I was burning. I broke out in hives and I couldn't go to the dermatologist for three months, so I went to the emergency room and they gave me creams. After that, they sent me home with 5 steroids. It made it better, but after the steroids were done it came back even worse on back, arms, legs chest. In April, I saw a dermatologist. They did a biopsy and found that I have a skin disease. They gave me 70 steroid pills. I will go back June 1. The steroids are still in my system and the hives have subsided.
Pain in the chest, on the left side. For a few seconds, a few sensations; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 29Sep2023 at 14:45 as dose 1, single (Lot number: HO9835) at the age of 39 years, in left arm for covid-19 immunisation; influenza vaccine inact sag 4v (FLUCELVAX QUADRIVALENT), on 29Sep2023 as dose 1, single (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history included: "Subclinical hypothyroidism" (unspecified if ongoing), notes: Over the last few years. I do not take any medications associated with it. Concomitant medication(s) included: B12 [CYANOCOBALAMIN]; D3. The following information was reported: CHEST PAIN (non-serious) with onset 29Sep2023 at 21:30, outcome "recovered" (Sep2023), described as "Pain in the chest, on the left side. For a few seconds, a few sensations". Therapeutic measures were not taken as a result of chest pain.  Additional information: Patient reported pain in the chest on the left side for a few seconds and a few sensations. It was unusual and unexpected. He had to stop other activities, sat on the sofa and waited till it went away and then he went to sleep. Patient had no COVID prior to vaccination and was not COVID tested post vaccination. He had no known allergies.
Erythema, edema, hives, lymphadenopathy, treated with prednisone
Severe mono like muscle aches lasting 14 days and eczema flare up on ears, neck, and feet requiring 10mg prednisone tablet step therapy
sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (sick). At the time of the report, ILLNESS (sick) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. Patient got the 1st Moderna Covid-19 vaccine and it was the worst decision they made because they were sick for 2 months and was still experiencing lingering effects close to 2 years now.  No treatment medication was provided.   Reporter did not allow further contact
7 days after the vaccination developed a large rash which burned, hot to the touch, and itched for 7 days. The lymph nodes in the left armpit became swollen and painful. After 7 days the rash dissipated, but there is a persistent pain deep inside the arm and in the shoulder joint.
pt recv vax; inconsolable crying; swelling at inject site; inc amount of analgesia required;
Nausea, chills, body aches, low grade fever. 3 hours, Fine for 5 hours, then sick for 8 hours
Per NP at pediatricians office, Mom brought child in to office today for worsening rash.  Per report child broke out in  red flat rash starting at bilateral upper arm injection sites.  Rash continued to get worse.  Per provider it is a "very red, angry rash"   No additional symptoms per mom or provider.   Mom gave child benedryl with no improvement.   No ill contacts.  Provider treating with prednisone X7 days.
Blurry vision, racing heart, dizziness, hot/clammy, chills after being really hot, anxiety all within 20 mins from injections. At 7:30 when home, cold, dull ache at base of skull.
Metallic Mint Taste, canker sore on tongue, dizziness/faint, increased bpm (beats per minute), face was hot and burning after working out (1 day and ongoing after), can't quench my thirst, and throat felt tight.
Post menopausal spotting. so far twice resulting in a biopsy - negative 6/22, Urinary Tract Infection (in which I haven't had one in several years), 8/22 Nitrofurantoin prescribed on the 5th day still having symptoms. Floaters in right eye, onset 8/27/22, still ongoing - haven't seen eye doctor.
Patient was put to bed at 10pm in his usual state of health.  Parents found him unresponsive at 1am when they went to check on him per family routine. EMS was called.   He was brought to the ER and was pronounced dead.
Pt had a febrile seizure. 8/8/18 2317-Patient is a 12 m.o. female. 12-month old female with no chronic medical conditions brought in by family this evening for evaluation following first-time seizure. Patient had routine 1 year checkup at pediatrician's office yesterday and received both MMR and varicella vaccines. Had been well prior. No cough nasal drainage vomiting. This evening around 10 PM, 2 hours prior to arrival, patient cried out during sleep. Mother found her with rhythmic jerking of upper and lower extremities and upward eye deviation and drooling. The episode lasted 2-3 minutes. She was post ictal for 10 - 15 minutes after the event. Now back to baseline. On arrival to the ED noted to have fever to 103.3. Mother was unaware that she had fever until temperature was taken this evening. No prior history of seizures. No family history of seizures or febrile seizures. Her vaccines are up-to-date. No recent antibiotics. No history of urinary tract infections. Mother does report she developed new onset watery diarrhea today. No blood in stools. No vomiting. No sick contacts and does not attend daycare. The history provided by the mother and a relative. History reviewed. No pertinent past medical history. There are no active problems to display for this patient. History reviewed. No pertinent surgical history.
Headache reported x 12d. Cl attended school and sports without interruption. No meds administered.
12/30/20  Tingling and numbness in feet especially when arising in the morning-would initially clear up. 1/21  Pain in feet.  Examined by Dr., podiatrist who recommended an exam by a neurologist or to try a chiropractor, but the neurology appointments were out to 6 weeks delay or so. 2-1-21 to 3-3-21  Treated by Dr. a chiropractor.  Condition worsened and he recommended going to a neurologist. 3/8/21  Dr. a neurologist examined Patient and ordered extensive blood testing. 3/12/21  Dr. tentative diagnosis Guillain Barre Syndrome and he sent us directly to Hospital to begin IV immunoglobulin therapy.  We were admitted through the ER under the supervision of Dr., radiographed by Dr., CT scan of head and brain by Dr., and had an ECG by Dr. 5 treatments of IVig begun that night, 4 more doses of IVig were added later. 03/16/21  MRI of brain by Dr.  3/17/21  Second confirmatory opinion on GB diagnosis by Dr. MRI of upper spine by Dr.  3/20/21-3/26/21  Plasmapheresis by Dr.  03/25/21  Endoscopic exam of larynx showing unilateral paralysis by Dr.  4/1/21  Exam by Dr who ordered discharge from hospital and transfer to Rehab Hospital. 4/2/21  Discharged from Hospital and transported to Rehabilitation Hospital under the care there of Dr., Dr., & Dr.  4/22/21 -5/2/21  Neuromuscular evaluations by Dr.  5/2/21  Discharged from Rehab Hospital for continuing physical and occupational rehab at home. 5/6/21  Recheck by Dr.
Bleed like your on your cycle; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VAGINAL HAEMORRHAGE (Bleed like your on your cycle) 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 VAGINAL HAEMORRHAGE (Bleed like your on your cycle). At the time of the report, VAGINAL HAEMORRHAGE (Bleed like your on your cycle) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided No treatment medication information was provided
profuse and constant post nasal drip, which led to a sore throat . throat sore for about 5 d with fatigue and continued post nasal drip
Case number PHEH2016US023420 is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 29 year old patient whose gender was not specified. The patient's medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515701) at a dose of 0.5 ml intramuscularly in the right arm on 18 Mar 2016. It was reported that the patient received FLUVIRIN multi dose vial (MDV) that had been exposed to 8 to 10 temperature excursion. The patient did not experience any adverse events following vaccination.