chrisvoncsefalvay/vaers-outcomes huggingface dataset:
EMS called to pt who just received first dose of Moderna. 24/F with a PMH of anxiety and migraines. Allergies to Eggs and dairy Pt started feeling dizzy and nauseous right after administration of vaccine which pt states is normal for her every time she's near medical personnel and when she gets shots. Pt was taken into hallway where vitals were taken. BP 102/71, HR 90, RR 16, SPO2 98%  Vitals are within normal limits. Pt appears pale. She was given water and stated she was feeling better, skin color improved. Pt continued under observation for 30 minutes.  Observer helped registrer pt and she was showed the exit when her observation time was up.
Patient contracted COVID-19 after receiving two COVID-19 vaccine doses (Pfizer series completed on 3/20/21). Patient was admitted to the hospital for RLE cellulitis on 5/23/21 and started complaining of dry cough on 6/2/21. Patient tested positive for SARS-CoV-2 on 6/3/21 and was treated with monoclonal antibody therapy that same day.
Febrile 39C 26 hours after injections.  Uncontroled, unconsolable crying dring the night (11/13-11/14).  Tylenol 10mg/kg q6  alternating with Children's Motrin 5mg/kg q8.
Fever; Chills; Pain at injection site; Fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills), VACCINATION SITE PAIN (Pain at injection site), FATIGUE (Fatigue) and HEADACHE (Headache) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 010M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection site), FATIGUE (Fatigue) and HEADACHE (Headache). On 03-Mar-2021, the patient experienced PYREXIA (Fever) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 02-Mar-2021, VACCINATION SITE PAIN (Pain at injection site), FATIGUE (Fatigue) and HEADACHE (Headache) had resolved. On 03-Mar-2021, CHILLS (Chills) had resolved. On 03-Apr-2021, PYREXIA (Fever) had resolved.            No relevant concomitant medications were reported. Action taken with mRNA-1273 in response to the events were not applicable.     Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: No specific follow-up information recorded.
Sore muscles, joints; Feeling feverish; Sore muscles, joints; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Sore muscles, joints), PYREXIA (Feeling feverish) and MYALGIA (Sore muscles, joints) in a 62-year-old female patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received 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 ARTHRALGIA (Sore muscles, joints), PYREXIA (Feeling feverish) and MYALGIA (Sore muscles, joints). At the time of the report, ARTHRALGIA (Sore muscles, joints), PYREXIA (Feeling feverish) and MYALGIA (Sore muscles, joints) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.
Red rash swollen aprox 5 inches in diameter hot and itchy.  tx Benadryl, ibuprofen, cool compress.
Hair loss noticeable from head, eyebrows and body! It is not excessive but definitely noticeable and has never happened before.
12/16/09 11:00 am c/o feeling shivery and light headed provided with rest jacket and O.J. 11:10 am reports no shivering better and returned to class.
Moderate left arm pain throughout the whole arm, feeling cold in the arm. The patient has normal pulses, normal motor and sensory function.
PT CAME IN FOR COVID VACCINE, WAS PROCESS WITHOUT INSURANCE METHOD. AT ADMINISTRATION TIME, PT CONFIRMED THAT THIS IS FIRST COVID SHOT AND COUNSELED PT REGARDING POSSIBLE SIDE EFFECT. RIGHT AFTER MODERNA SHOT ADMINISTERED, PT CONFESSED THAT HE RECEIVED 2 DOSES OF PFIZER COVID VACCINE IN MARCH. HE ONLY GOT WANT TO ALSO GET MODERNA BECAUSE OF DELTA VARIANCE AND HE WANT TO BE EXTRA CAUTIOUS. TOLD PT THAT THERE IS NOT MUCH RESEARCH DONE REGARDING SIDE EFFECT OF GETTING 2 DIFFERENT COVID VACCINE, IT IS HARD TO KNOW WHAT TO EXPECT. HE CAN EXPERIENCE SAME SYMPTOMS LIKE BODY ACHE, FEVER, ETC. INFORMED HIM TO US IF HE IS EXPERICENCE ANY SIDE EFFECT AND WE WILL CONTRACT HIM NEXT FEW DAYS TO FOLLOW UP. NOTIFY IMMEDIATELY AND BC TO DO FOLLOW UP WITH HIM. HE SHOW NO IMMEDIATELY SIDE EFFECT AFTER THE SHOT. BECAUSE CLAIMS WAS NON-INSURANCE SO IT DIDNT FLAG AS RESOLUTION FOR DOUBLE COVID SHOT AND CHECKED STC LINK, NO COIVD VACCINE HISTORY.
The date of first puncture of the vial used for this patient was on 05/17/2021.  When trying to place an order for the 2nd doses, we were informed about the 12 hour expiration after first puncture rule, which was not expressed to us when the vaccine was picked up.  This office called Moderna to report an issue and were told that this form needed to be filled out  and also that the reason behind the 12 hour expiration after first puncture is due to the fact that there is no preservative in the vial and the chance for infection inccreases after 12 hours.  We were also told not to restart, to proceed with the 2nd dose.  There was no adverse reaction to this patient whatsoever.
Headache after the first Moderna Covid-19 vaccine.; Sore left arm after the first Moderna Covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache after the first Moderna Covid-19 vaccine.) and VACCINATION SITE PAIN (Sore left arm after the first Moderna Covid-19 vaccine) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In December 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache after the first Moderna Covid-19 vaccine.) and VACCINATION SITE PAIN (Sore left arm after the first Moderna Covid-19 vaccine). At the time of the report, HEADACHE (Headache after the first Moderna Covid-19 vaccine.) and VACCINATION SITE PAIN (Sore left arm after the first Moderna Covid-19 vaccine) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication was reported. No treatment medication was reported.   This case was linked to MOD-2022-482652 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Feb-2022: Follow-up document received contains no new information
Patient reported pain, numbness, and swelling in left arm. Also reported swelling of throat which caused difficulty swallowing. Treated with prednisone.
On Sunday, January 24th, I woke in the morning (6 days after vaccination) with a 3x2 flat red ring around injection site. The following morning, Monday, January 25th I woke with extreme red inflammation of my left eye. An opthamologist diagnosed the condition as nodular scleritis. My infectious disease doctor reported a component in the Moderna vaccine to have molecular mimicry to shellfish, to which I am extremely allergic. The nodular scleritis was treated with a course of Prednisone at 40mg tapered over 10 days, which lessened the redness and swelling gradually. My infectious disease doctor advised that I should not receive the second dose of Moderna.
Post vax, the pt experienced chest tightness, dyspnea, productive cough with low grade fever correlated to increased smoke in the area from massive forest fires. Pt felt it was due to her vaccine.
VACCINE GIVEN WITH INSULIN SYRINGE NOT SURE IF GOT THROUGH THE MUSCLE; This spontaneous report received from a patient via a company representative 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: Unknown) dose, start therapy date were not reported 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 vaccine given with insulin syringe not sure if got through the muscle. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine given with insulin syringe not sure if got through the muscle was not reported. This report was non-serious.
Sever muscle pain in both arms and hips that radiates throughout my legs, fingers and wrists . Tinnitus and vertigo. This has been ongoing since 5/4/21. Advil helps relieve symptoms but does not cure it.
Pt came in to get a flu vaccine. I asked if she had any allergies.  I gave fluzone in RD. After giving I noticed pt looked to be possibly pregnant. She did not tell me she was pregnant until I started out of the room and turned and asked if she was pregnant. Then she told me "yes, I am 28 weeks". I immediately called representative at the Imunnization office.  I went back to the room and told pt what had been given and advised her to let her OB provider know at next appt. Discussed that there had been no trials with pregnancy and flu vaccine with preservatives.  She verbalized understanding and had no further questions.
Received Rabies Vaccine #2 in AM of 5/4/10. That evening she developed flu like symptoms. Nausea, abd pain cramping, frequent B.M. At night she was clammy, chilling, alternating with perfuse sweating. Had been working out a lot. Instructed to take Ibuprofen and fluids.
congestive heart failure, left bundle branch blockage, left ventricle wont dialate, EF of 20%.  water pills 160mg a day, beta blocker, 1/2 a day. muscle twitch while sleeping or rest.
01May97 Pt recv 1st dose vax. 21Jan98 Pt devel rash that started on trunk. 1 fluid filled pimple on back & low grade fever. 22Jan98 "p.c. rash gone except face, pin head size blister on back; denies illness; afebrile; probably not c-pox".
104.2 temp, chills, head to toe body ache, headache, sensitivity to light, felt nauseous, excessive arm or injection site pain. A couple of days later cause this lasted for almost a week, I got diarrhea.
A Case of Post-Vaccine Myocarditis Mimicking Long Covid; This is a literature report for the following literature source(s): A 59-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "mild COVID infection" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for Covid-19 immunisation, reaction(s): "intermittent chest discomfort several days after receiving her first dose of the Pfizer-BioNTech COVID-19 vaccine", "diminished exercise capacity", "unexplained fatigue", "found to have dynamic troponin elevation peaking at 177 ng/L". The following information was reported: MYOCARDITIS (hospitalization, medically significant, life threatening), outcome "recovered", described as "A Case of Post-Vaccine Myocarditis Mimicking Long Covid". The patient underwent the following laboratory tests and procedures: Cardiac stress test: failed to demonstrate an etiology, notes: after dose 1; Computerised tomogram thorax: failed to demonstrate an etiology, notes: after dose 1; ambulatory cardiac monitoring: failed to demonstrate an etiology, notes: after dose 1; Magnetic resonance imaging heart: revealing edema in the basal lateral, notes: wall and late gadolinium enhancement in a subepicardial distribution, suggestive of myocardial inflammation; performed two weeks later, notes: showed complete resolution of myocardial edema with residual subepicardial LGE in the basal lateral wall consistent with prior myocarditis; Specialist consultation: results unknown; Troponin: 177 ng/L, notes: dynamic troponin elevation peaking. Therapeutic measures were taken as a result of myocarditis.  Clinical course: Patient subsequently received second dose of the COVID-19 vaccine which resulted in worsening cardiopulmonary symptoms that persisted over the next several months. Her symptoms were initially attributed to long COVID, and she was provided supportive care and  for anxiety. After reevaluation in the Cardiology clinic, the patient underwent cardiac MRI revealing edema in the basal lateral wall and late gadolinium enhancement in a subepicardial distribution, suggestive of myocardial inflammation. She was treated with prednisone 50 mg daily and colchicine 0.6 mg twice daily resulting in resolution of chest pain. A repeat MRI was performed two weeks later showed complete resolution of myocardial edema.; Sender's Comments: Based on available information and the temporal association, a possible contributory role of Comirnaty vaccine cannot be excluded for the reported event  of "MYOCARDITIS". The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a 71-years-old female patient received PREVNAR 13, via an unspecified route of administration on left arm on 26Sep2017 10:00 at single dose for prevention of pneumonia at Physician Office. Medical history included breathing problems and cholesterol condition from an unknown date and unknown if ongoing. Concomitant medication included ongoing LIPITOR for probably almost 20 years, COMBIVENT started 2 months ago to help with breathing problems. The patient experienced arm was still sore, huge lump on arm, very warm to touch all on early morning 05Oct2017. On 06OCT2017, she went back to the doctor's office, in which she was told this was normal. On 25Oct2017 she went back to the doctor's office and was told the office was having problems with prolonged soreness with the injection, as they had other reports of this complaint. The outcome was not recovered.
UTI; POTS; heart was not behaving properly; could not walk; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received BNT162b2 (BNT162B2), as dose 1, 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: URINARY TRACT INFECTION (non-serious), 14 days after the suspect product(s) administration, outcome "unknown", described as "UTI"; POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (non-serious), outcome "unknown", described as "POTS"; CARDIAC DISORDER (non-serious), outcome "recovered", described as "heart was not behaving properly"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "could not walk". Therapeutic measures were taken as a result of cardiac disorder.  Additional information: The reporter's sister was in withheld and the caller has a daughter in another city a few hours away from the caller and they all including the caller herself, received the Pfizer Covid vaccine 1st dose on the same day and 14 days later they all had UTIs. Stated they each had a different lot of the Pfizer Covid vaccine that day. She, her sister, and her daughter all had the UTI 14 days after the 1st dose of their Pfizer Covid vaccine. Stated she had no information on her daughter or her sister to provide and no lots, expiry dates, NDC numbers or dates of their Pfizer Covid vaccines to provide. She, her sister, and her daughter all had the UTI 14 days after the 1st dose of their Pfizer Covid vaccine. Her daughter now has POTS and her sister and daughter had to wear heart monitors for six weeks after because their hearts were not behaving properly and that issue with the sister and daughter's hearts seems to have rectified and that has resolved for them. Her daughter ended up in the hospital for five days and could not walk.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
pt recv vax;tested pos for hep B surface antigen;MD felt perhaps Hep B may have been the cause;
Two 10 second convulsions followed by paleness and sweating. Patient was anxious prior to shot and was not responsive during convulsions. Wife stated that he "always has this reaction". Nurse Practioner that administered the vaccine stated that it was congruent with classic vasovagal symptoms after immunization. EMS arrived but patient did not want to go with them.
neuropathy/my arm having severe pain then my hands; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), on 03Feb2021 as dose 2, single (Lot number: EN6198, Expiration Date: Jun2021) at the age of 67 years, in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Vaccine: 1st Dose COVID-19, Product name/manufacturer: Pfizer, Lot number: EL3249, Date: 10Jan2021), administration date: 10Jan2021, when the patient was 67-year-old, for Covid-19 Immunization.  The following information was reported: NEUROPATHY PERIPHERAL (medically significant) with onset Feb2021, outcome "unknown", described as "neuropathy/my arm having severe pain then my hands". The event "neuropathy/my arm having severe pain then my hands" required physician office visit. Therapeutic measures were taken as a result of neuropathy peripheral.  Clinical course: The reporter stated that they owned a construction business for 25 years. They worked as a team just the (2) two (she and her husband) neither one of us have taken any prescription drug ever. The report stated how to move forward to COVID. Everyone was going to die if we don't take the vaccine. So, they did, twenty days after the 2nd dose. She noticed both her arms having severe pain them my hands. I received a shot in each arm as did her husband. Her husband's hands and feet severe pain. They went to the doctor at urgent care. She told me she sees patients like every day all day. The patient was diagnosed with neuropathy. Prescribed gabapentin. This was the first prescription drug she had taken, and she was 70 years old not a diabetic and no other problems. The reporter's husband had the same, not a diabetic or any other problems. She went to a hand specialist, thinking I have arthritis nope no arthritis he also prescribed gabapentin. The patient never dreamed that when she turned 70 years old, she would be in severe pain all day and night and constantly be applying whatever, shale oil is recommended, my husband refuses to take any medication or "Shale oil". The reporter stated that she truly thinks Pfizer was responsible for our misery and should be held accountable.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300109696 same reporter/drug/AE., different patients.;
Severe tinnitus/Terrible tinnitus; horrible brain fog; dizziness; vertigo; short term memory loss; shortness of breathe even when laying down; shortness of breathe even when laying down; exhaustion; This is a spontaneous report from a contactable consumer (patient). A 33-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 10Jul2021 at 15:30 (at the age of 33-year-old) as dose 1, single for COVID-19 immunization. Medical history included known allergies to Penicillin. There were no concomitant medications. Patient received no other vaccine in four weeks and did not receive any other medications in two weeks. Patient was not pregnant at the time of vaccination. The patient experienced severe tinnitus, horrible brain fog, dizziness, vertigo, short term memory loss, shortness of breath even when laying down, exhaustion on 10Jul2021. 8 days later patient was still experiencing symptoms and terrible tinnitus. The patient underwent lab tests and procedures which included Blood test IgM (sars-cov-2 antibody test): negative on 15Jul2021, Blood test IgG (sars-cov-2 antibody test): negative on 15Jul2021. Patient did not have covid prior vaccination and was covid tested post vaccination. Therapeutic measures were taken as result of events as Xanax, cat scan, x ray, bloodworm. Adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The outcome for all events severe tinnitus, horrible brain fog, dizziness, vertigo, short term memory loss, shortness of breath even when laying down, exhaustion was not recovered.  Information about lot/batch number has been requested.
Rash. Onset 3 days after administration. Sounds to be resolving (9 days after onset).
Myocarditis; This is a spontaneous report from a contactable consumer (parent). A 24-year-old male patient received the second dose of bnt162b2 (BNT162B2, batch/lot number was not reported), via an unspecified route of administration, administered in Arm Left on 2021 (in May2021 or beginning of Jun2021, administered around 17: 00 or 18:00) (at the age of 24-years-old) as DOSE 2, SINGLE for COVID-19 immunisation. The vaccine was administered at a hospital. The patient did not receive any vaccine within four weeks prior to receiving bnt162b2. There patient had no relevant medical history or concomitant medications to report. The reporter stated that the patient has been a healthy kid. The patient previously received the first dose of bnt162b2 (BNT162B2), on May2021 (administered around 17: 00 or 18:00) (at the age of 24-years-old) as DOSE 1, SINGLE for COVID-19 immunisation; he had no reaction to first dose aside from sore arm. The reporter stated that her son had the second vaccine in May2021 or beginning of Jun2021 and experienced myocarditis after the second vaccine dose. He was in the hospital and he is fine for right now. The reporter stated that the patient is stuck with a (currency amount) bill. The reporter was asking about compensation. Two days after his second dose of the vaccine is when he was diagnosed with myocarditis on an unspecified date in 2021. When querying treatment, she reported that he went to the doctor that morning since he was having chest pain, shortness of breath, and dizziness and the doctor gave him a nitro spray in his mouth and sent him off by ambulance. He was given something in the hospital to relax the heart muscle and he was monitored closely. She does not think he was given a lot of medications in the hospital. The patient had EKG (electrocardiogram), echo, and blood draws. The doctors were watching levels in the blood draws, and knows one blood level was high, she is not sure what the name of the blood level for the heart that was high. She stated that the patient had an unusual spike in EKG. The adverse events required a visit to the emergency room and physician office. The patient was followed-up with regular GP (general practitioner) and he had a few follow-ups with the cardiologist. The patient was also hospitalized for 2 days. Outcome of the event myocarditis was recovered on an unspecified date in 2021.   The lot number for BNT162B2, was not provided and will be requested during follow up.