chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report has been received from a registered nurse, via a field representative, concerning a 30 year old female patient. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported. On unknown dates, at age 27 years old, the patient received three doses of GARDASIL (concentration, dose, anatomical location, lot number and expiration date were not provided), administered intramuscularly for prophylaxis. On an unknown date, at age 30 years old, the patient was diagnosed with systemic lupus erythematosus. It was reported that the patient sought medical attention and an unspecified treatment was given for the event, however, it was unknown if lab diagnostics or studies were performed. At the time of reporting, the patient's outcome for systemic lupus erythematosus and the causal relationship between GARDASIL and the event were unknown. Upon internal review, systemic lupus erythematosus was determined to be medically significant.
Information has been received from a nurse referring to a patient of unknown age and gender. Patient's relevant medical history, concurrent conditions and drug reactions/allergies were not reported. On 15-JUL-2015, the patient was intended to be vaccinated with (Oka/Merck) VARIVAX, but was inadvertently administered with ZOSTAVAX (strength, dose, frequency, lot # unspecified). Concomitant medications were not reported. No adverse effects were reported. Additional information is not expected as the reporter did not wish further contact.
Joint pain in both arms; itching both arms intermittent till now; pain in hips; pain in knees; swelling in legs; swelling in right knee; This is a spontaneous report from a contactable consumer, the patient. A 78-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Enu20u) via an unspecified route of administration in the left arm on 17Mar2021 at 09:15 (at the age of 78-years-old) as a single dose for COVID-19 immunisation. Medical history included acid reflux (esophageal), cholesterol and blood pressure. The patient had known allergy to iodine, antibiotic, prednisone and sulphur. Concomitant medications included losartan (MANUFACTURER UNKNOWN), omeprazole (MANUFACTURER UNKNOWN), prednisone (MANUFACTURER UNKNOWN), simvastatin (MANUFACTURER UNKNOWN) and acetylsalicylic acid (ASPIRIN); all from unknown dates and for unknown indications. Prior to the 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 received any other vaccines within four weeks prior to the COVID vaccine. On 26Mar2021, the patient experienced joint pain in both arms, itching both arms intermittent till now, pain in hips, pain in knees, swelling in legs, more prominent swelling in right knee. The events resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the events. The clinical outcome of the event of joint pain in both arms, itching, pain in hip, pain in knees, swelling of legs and swelling in right knee was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
DEC98 approx 5mo p/2nd vax severe leg cramps devel;pt also devel joint & testicular pain;3rd dose not taken;
Experienced chill; Felt fast heartbeat; Headache; Muscle pain; Dizziness; Breathing difficulty; Felt exhausted; This is a spontaneous report from a non-contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number: Not reported, Expiration date: Not reported) as 1st dose, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021 the patient experienced chill, Felt fast heartbeat, Muscle pain, headache Dizziness, Breathing difficulty and Felt exhausted. The patient stated she received her pfizer covid vaccine on Friday afternoon and experienced chill, felt fast heartbeat, in the evening chills again and heart palpitation but the heart rate measure was normal, next morning a little better but had headache, muscle pain. dizziness a few times, breathing difficulty, felt exhausted. Then the next day felt little more batter, but out of breath when climbing stairs. Patient wanted to know how long the side effects lasted for the people into the clinical trials. The outcome of the events was unknown.  No follow-up attempts are possible; Information about batch/lot number cannot be obtained. No further information is expected.
Information has been received from a health professional and a physician concerning a 72-year-old female with hypothyroidism, hypertension, no known drug allergies and a history of endometrial and breast cancer and childhood chickenpox who on 30-OCT-2007 (also reported as 29-Oct-2007) was vaccinated subcutaneously in the right deltoid with a 0.5 milliliter dose of ZOSTAVAX (lot# 658395/0966U).  Concomitant therapy included LANOXIN, CARDIZEM, SYNTHROID, NEXIUM and EVISTA.  On 07-NOV-2007 the patient developed a vesicular rash with lesions too numerous to count scattered on the right side of her face, hairline and right eyelid and was diagnosed with shingles.  The patient had "stinging pain" that was rated a 4 on a scale of 1 to 10, 10 being the most painful.  There were no other systemic symptoms.  Medical attention was sought at the doctor's office and the patient was prescribed VALTREX and prednisone.  The maximum body temperature was 98.6.  Photos were taken.  The outcome was reported as not recovered.  The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present to identify if it associated with the wild-type VZV strain or with the OKA/MERCK vaccine VZV strain.  The sample of the lesion was collected on 09-Nov-2007.  The sample was taken from lesion fluid from the forehead.  The PCR results for the specimen from the lesion fluid from the forehead identified the presence of WT VZV.  Additional information has been requested. 03/26/2008 Additional follow-up indicates that the patient developed shingles on the right side of the face one week after vaccination. On an unspecified date the patient recovered. Additional information is not expected.
Patient received the three doses of ROTATEQ - #1 dose on 06/18/08, #2 dose on 08/22/08, # 3 dose on 10/24/08. Diagnosed on 01/27/09 with rotavirus antigen.  2/20/09 MR received for DOS 1/26-27/2009 with DX: Acute Gastroenteritis. Pt presented with multiple episodes of projectile vomiting and fatigue.  PE (+) for pallor, dry mucous membranes, hypoactive BS. Vomiting continued in ER. Tx with Zofran and IVF  which helped.
Severe face and throat swelling; difficulty swallowing; rash (shingles-like) across chest and back. Swelling subsided after 2 days; Rash is still present, though lessened in intensity
Fever up to 103.2, chills, muscle aches, diarrhea, nausea, vomiting, fatigue, night terrors, dizziness  All lasted over 72hrs
Shot site very red, swollen and painful. Became EXTREMELY fatigued within 2-2 1/2 hours; had to lay down for 3 hours. Woke up with fever and nausea and dizziness. Lightheaded. Ate dinner. Went to bed. Next morning (11/13/19) couldn?t get out of bed. Weakness in left side of body; body ache; low grade fever; extreme fatigue; very depressed. Next morning I woke up and had nearly no feeling in left side of body; arm, leg, foot, face. I tried to get up and dressed and noticed it was very difficult for me. My whole mouth and cheeks were droopy and my speech was very slurred. I couldn?t smile. My vision was blurry. I then realized these were all signs of a stroke. I called my doctor and she had me call 911 for possible stroke. Was in ER all day. Did 3 CT Scans. Can?t do mri due to metal hardware inside. After several hours of blood tests etc , my symptoms improved and they sent me home. After evaluating at home and recent symptoms since vaccine wondered if it was due to reaction to flu shot.
On 06/13/2022 received pain in back; 2 red dots on belly; developed into rash size of hand; nerve pain; constipation; and is still going on.
Pt awoke at 7AM on 3/12/2009 with fever of 101, pain and redness at the administration site, pain all over including jaw, joints and muscles.  Pt also complained of nausea and dizziness.  Pt went to the hospital at 1:50 PM that afternoon.  Pt was given Ibuprofen 600 mg to be taken every 6 hours and prochlorperazine for nausea. Pt was instructed by physician at the hospital not to have a tetanus containing vaccine again.  Pt's symptoms lasted until 3/16/2009.  Pt came to clinic today to report the above symptoms.  He reports that his arm is still sore and aches today.
25 year old male with a PMH of morbid obesity who is presenting with SOB and swollen legs.  He states that his symptoms began at the beginning of October with SOB and cough.  His symptoms have been constant, progressively worse and have been associated with swelling in his legs that is gradually increasing. He states that he went to the ED on 10/9/2021 and was diagnosed with a URI and discharged home.  Because his symptoms were persistent, he returned to the ED on 10/14/2021.  At that time he was having more SOB, accompanied by orthopnea and edema and was diagnosed with new onset heart failure.  Troponins were elevated at that time, and he was thought to have myocarditis from the moderna vaccine he received on 09/23/2021.  He was discharged with Toprol and Lasix, and instructed to follow up with cardiology and his PCP.  Since discharge home, he has been struggling with persistent orthopnea, DOE, and BLE edema.   The orthopnea prevents him from sleeping, because he is unable to lie flat. He states that he does not have chest pain, but his SOB is severe with exertion.  He has had some trouble getting outpatient follow up, so he returns to the ED for assistance.  Of note, he states that he got his first Moderna vaccine in June.  He felt ill after the vaccine for three days and subsequently developed some LE edema.  He states that he went to the doctor at that time and got a prescription for furosemide.  He took the furosemide for about a week, his leg swelling went away, and he stopped taking it.  The leg swelling did not come back until this month.  He put off getting the second dose of the Moderna vaccine for several months because of his reaction to the first dose.    In the ED he was noted to be tachycardic, but normotensive.  Laboratory workup demonstrated elevated BNP, and elevated transaminases.  Troponin was negative. CXR demonstrated fluid overload without effusion, and cardiomegaly.
uncontrollable screaming episodes lasting 15min occurring frequently (q 30min) beginning 10hr p/vax x 2 days;
morning after my skin felt achy i took advil and it was fine, that afternoon an injection site reaction started. i thought it was from where i  pulled the bandaid off bc it was pink but 24hrs later its bigger, more red and warm. I've iced it and it helped but as of this morning its still there, not any bigger or redder but its still warm. I am riding out bc its the only side effect I've had so far.
Positive COVID test; Positive COVID test; fatigue; nasal congestion; runny nose; headache; loss of sense of smell; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 35-year-old male patient received BNT162b2 (BNT162B2), on 06Apr2021 as dose 1, single (Lot number: ER8731), in left arm and on 27Apr2021 as dose 2, single (Lot number: EW0167) at the age of 34 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "diabetes" (unspecified if ongoing). Concomitant medication(s) included: TRULICITY; LEVOMIR; METFORMIN; JARDIANCE; ROSUVASTATIN; LOSARTAN. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 31May2022, outcome "recovering" and all described as "Positive COVID test"; FATIGUE (non-serious) with onset 31May2022, outcome "recovering"; HEADACHE (non-serious) with onset 31May2022, outcome "recovering"; ANOSMIA (non-serious) with onset 31May2022, outcome "recovering", described as "loss of sense of smell"; NASAL CONGESTION (non-serious) with onset 31May2022, outcome "recovering"; RHINORRHOEA (non-serious) with onset 31May2022, outcome "recovering", described as "runny nose". The events "positive covid test", "fatigue", "nasal congestion", "runny nose", "headache" and "loss of sense of smell" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31May2022) Positive, notes: covid test type post vaccination=Nasal Swab. Therapeutic measures were taken as a result of covid-19, vaccination failure, fatigue, nasal congestion, rhinorrhoea, headache, anosmia.
This patient had a rash, myalgias, fatigue, and paresthesia of the hands.
Runny nose; Sneezing; This is a spontaneous report from a contactable consumer, the patient. A 61-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unknown route of administration in right arm on 20Mar2021 at 12:30 (at age of 61-years-old) as single dose for COVID-19 immunisation. The patient had no medical history. The concomitant medications included multi-vitamins (MANUFACTURER UNKNOWN), calcium (MANUFACTURER UNKNOWN), vitamin d3 (MANUFACTURER UNKNOWN), biotin (MANUFACTURER UNKNOWN), vitamin b-complex (MANUFACTURER UNKNOWN) received within 2 weeks of vaccination. The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 21Mar2021 at 13:00, the patient experienced besides arm, had a runny nose and sneezing. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of runny nose and sneezing were not recovered at the time of this report.   Information about lot number cannot be obtained. No further information is expected.
3/23/21 started to have some left axillary discomfort on & off that feels like a pinching pain, 3 out of 10 pain. Continued intermittently still after changing clothing and after taking 200mg ibuprofen. When I palpated, there is no discrete masses or tenderness or redness, but there is some fullness specifically at the axillary tail end toward my left breast. Messaged PCP MD, advised to monitor and continue supportive care. Symptoms resolved on 3/26/2021.
fatigue intensified; I began having body aches; incessant itching on the right side of my body (head to toe); The most intense itching was at the injection site; Itching/hives spread to left side of face, arm and torso; I felt sudden extreme fatigue; mild chest pains; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 28Oct2021 10:30 (Lot number: FH8028) at the age of 41 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "hypertension" (unspecified if ongoing); "HSV2" (unspecified if ongoing), notes: other medical history: hypertension, HSV2, seasonal allergies/hayfever, lichen planus; "seasonal allergies" (unspecified if ongoing), notes: other medical history: hypertension, HSV2, seasonal allergies/hayfever, lichen planus; "Hay fever" (unspecified if ongoing); "lichen planus" (unspecified if ongoing). Concomitant medication(s) included: ALLEGRA 24 HOUR; FLONASE [FLUTICASONE PROPIONATE]; VALTREX. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6201, Location of injection: Left Arm , Route of Administration: Intramuscular), administration date: 23Feb2021, when the patient was 40 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL8982, Location of injection: Left Arm , Route of Administration: Intramuscular), administration date: 02Feb2021, when the patient was 40 years old, for Covid-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 28Oct2021 13:30, outcome "not recovered", described as "I felt sudden extreme fatigue"; CHEST PAIN (non-serious) with onset 28Oct2021 13:30, outcome "not recovered", described as "mild chest pains"; CONDITION AGGRAVATED (non-serious) with onset 28Oct2021 16:30, outcome "not recovered", described as "fatigue intensified"; PAIN (non-serious) with onset 28Oct2021 16:30, outcome "not recovered", described as "I began having body aches"; PRURITUS (non-serious) with onset 28Oct2021 16:30, outcome "not recovered", described as "incessant itching on the right side of my body (head to toe)"; VACCINATION SITE IRRITATION (non-serious) with onset 28Oct2021 16:30, outcome "not recovered", described as "The most intense itching was at the injection site"; URTICARIA (non-serious) with onset 28Oct2021 16:30, outcome "not recovered", described as "Itching/hives spread to left side of face, arm and torso". Therapeutic measures were not taken as a result of fatigue, chest pain, condition aggravated, pain, pruritus, vaccination site irritation, urticaria.  Follow-Up (04Nov2021): Follow-up attempts are completed. No further information is expected.
Sore arm, dyrea, increase blood pressure,  extreme joint an muscle pain, cough, fatigue,  got better after 20 days
EXTREME SWELLING AT LEFT DELTOID AT INJECTION SITE ALONG WITH EXTREMELY SWOLLEN LYMPHNODES UNDER LEFT ARM. BECAME VERY UNCOMFORTABLE EARLY IN THE MORNING ON 01/08; CALLED clinic NURSE AND WAS ADVISED TO COME TO THE EMERGENCY ROOM 08:30, 0/09 TO VARY THE CAUSE OF THE SWELLING.  DR. CONFIRMED ADVERSE REACTION TO THE PFIZER BOOSTER VACCINE BECAUSE OF ME BEING GIVEN MODERNA VACCINE INITIALLY EVEN THOUGH RECOMMENDED BY CDC THE TWO INTERACTED ADVERSELY. GIVEN A STEROID SHOT FOR THE SWELLING AND HAD LINGERING PAIN AND SWELLING UNTIL 01/11.
received a single dose of Moderna Covid vaccine in March, but was unable to receive the second; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (received a single dose of Moderna Covid vaccine in March, but was unable to receive the second) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (received a single dose of Moderna Covid vaccine in March, but was unable to receive the second). At the time of the report, PRODUCT DOSE OMISSION ISSUE (received a single dose of Moderna Covid vaccine in March, but was unable to receive the second) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported by the reporter.
Rash onset 10 days post vaccination. Rash on hands, dorsal and palmar surfaces, bil elbows, and knees. Concentric targetoid macules and papules associated with itching and discomfort. No other symptoms. Rash consistent with EM-Minor.
Onset fever: 10/19/06 5:30am 103F; duration: 3hours. By 10/20 6:30am; 99F. Left arm pain at 9:15pm on 10/19/06, warmth, inflammation, lump at site.
This spontaneous report as received from a physician via company representative refers to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions and concomitant drugs were not known. On an unknown date, the patient was vaccinated with GARDASIL 9 (dosage regimen were unknown by reporter), intramuscularly. On an unknown date, the patient "passed out" at the office front desk after administration of GARDASIL 9. Paramedics were called to the office but the patient recovered without requiring treatment. no hospitalization was required. Causality assessment was not provided. Additional information has been requested.
Chest pain began on 3/22 around 2 pm with what initially felt like allergies--chest congestion and heaviness in chest. As the day progressed, pain set in to the degree that sleeping was uncomfortable both because of challenges breathing and because finding a spot that wasn't painful was challenging. Upon waking on 3/23, the pain was significant and continued to worsen between waking at 7 am with trouble breathing and being in a high level of pain along with disorientation by 9 am. I went to the emergency room at this time, where they performed a series of lab tests, imaging tests, cardiac monitoring, EKG 12 lead, and administered medications. No cause was found and I was sent home with prescriptions for an NSAID and an inhaler. The chest pain persisted off and on for two weeks prior to the emergency room visit.
About 6 weeks after the 3rd dose, I contracted COVID-19. On roughly day 5 or 6, I started having significant chest pressure, heart fluttering, and left arm tingling. About a week later, I also started having occasional dizziness.
Altered taste and smelling things not present such as smoke. My taste and smell have been "off" since the evening or receiving the vaccine. Things don't taste right. I keep smelling things that are not present, and my normally sensitive smell is off. Sensory issues: Feelings of poky/stinging sensations in my arms, hands, shoulder, legs, and feet. Ears plugged up the day I received the shot. Now diagnosed with an ear infection. Winded and out of breath. Daily headaches General feeling of being unwell. Lethargy and fatigue.