chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Given Gardasil (1st shot), Varicella booster, Meningococcal booster.  Not sure which order.  After second shot administered, son said he was feeling lightheaded.  I thought maybe he might faint so after his third shot, I held onto his head just in case he fainted and fell over.  He began to tighten all his muscles and tremor while I held him.  The nurse called for help and we laid him on the floor.  He stopped convulsing after about 15 seconds and he was given water and oxygen until he was able to get up on his own accord.  We were given a room with a place for him to lay down until he was steady enough to walk without help.  I am taking him to Doctor this afternoon.
Approx. 2 min. after receiving pneumococcal and inactivated influenza vaccines pt. stated he thought he would lay down and did so on the exam table on which he had been sitting while receiving the above vaccines. Approx. 2 min. later he was still supine, but quickly developed pallor and became unresponsive except to deep sternal rub; airway patent, breathing. Pupils were dilated, fixed at 5/5, 5/5. BP, right arm, large cuff: 128/ 84 mm Hg, HR 88, RR 16. I asked his wife to call 911, then to press the emergency alarm button in the exam room. She did so, the nurse practitioner (np) spoke with the 911 dispatcher and gave pertinent information to same. NP then asked pt.'s wife to go to the pharmacy and ask for the store manager to come to the clinic immediately. She did so, then returned to the exam room. The pt. became more responsive in the next 60 to 90 seconds, saying "please stop that" as np again performed sternal rub on him. The pt. then attempted to sit up; in doing so, he developed rubor then pallor, became unresponsive again and had generalized jerking and twitching lasting approx. 20 sec., airway patent throughout. He was eased back to supine position by np. Vital signs rechecked: BP, R arm, large cuff: 118/78 mm Hg, HR 90, RR 16. EMS arrived at 11:03 a.m., pt. remained drowsy but conscious, stating he stated a little blood in his mouth; speech clear. Pt. agreed to have EMS take him to Hospital for further evaluation. Pt. left with EMS at 11:08 a.m.
Following the injection I developed persistent shoulder pain consistent with SIRVA (Shoulder Injury Resulting from Vaccine Administration). That pain has continued for more than two months although it is diminishing. I did have a normal reaction to the vaccine the day following the injection. I wish to know whether the possible injection of the vaccine into the bursa rather than muscle has compromised the efficacy of the vaccine.
Thrombocytopenia (109,000); elevated D dimer (3960); fatigue; subjective fever; headache; sweats; injection site pain; paresthesias of hand on side of injection; This is a spontaneous report from a contactable physician (reporting for a patient). A 40-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were not reported), intramuscularly, administered in arm left on 15Mar2021 (at the age of 40-years-old) as single dose for COVID-19 immunization. Medical history included hypertension and COVID-19 prior to vaccination; patient had no known allergies. Concomitant medication included lisinopril. Patient had no other vaccine in four weeks and the COVID vaccine was received at a Public Health Clinic/Veterans Administration facility. On 15Mar2021, the patient experienced thrombocytopenia (109,000), elevated D dimer (3960), fatigue, subjective fever, headache, sweats, injection site pain and paresthesias of hand on side of injection. The adverse events resulted in emergency room/department or urgent care. The patient was tested for COVID post-vaccination through a nasal swab and Biofire PCR on 22Mar2021 which were both negative. Therapeutic measure taken as a result of the events included IV hydration. Outcome of the events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Based on the available information and close temporal association, a possible causal relationship cannot be excluded between the suspect product bnt162b2 and all reported events. The impact of this report on the benefit/risk profile of the Pfizer product 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.
Myalgia, enlarged lymph node right clavicle area, chills Narrative: H/o double mastectomy in 2013 - right breast implant 10/6 received the flu vaccine 10/16- 10/17 - stretchy/achy pain right axilla and chest -she treated it warm compress; also body aches and chills. She took 200 mg advil twice on 10/17 and the same on 10/16. 10/18/2021 - swelling right clavicle are which is sensitive. The swelling is about the size of a golf ball. Body aches and chills have resolved. She still has aching in her right axilla. 10/19 -employee reports she still has swelling on her right neck and a little discomfort under her right arm pit. She is doing warm compresses She denies fever. 10/20 - employee reports she's feeling normal with only residual of slight swelling over the right clavicle. The discomfort under her right arm pit is also resolved.
According to mother, the patient developed "spots" on face & felt throat closing.  Child was advised to go to nearest ER.  Symptoms occurred ~45 mins after vaccines.
Patient had the Janssen vaccine as noted. He presented with significant superficial clot in the lower leg. Ultrasound read Mixed partially occlusive and occlusive superficial venous thrombosis in the right greater saphenous vein. This originates 2.2 cm from the junction with the right common femoral vein. He presented with 2 days of leg swelling without clear trigger such as travel, trauma etc.
fatigue; nausea; low grade fever; unbelievable chills; leftside pain in hip joints/razor sharp joint pains; injection site pain; leftside pain in fingers and toes; swollen tongue; rash; Wild Dizziness; Difficulty breathing; facial swelling; fast heart rate; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Wild Dizziness), DYSPNOEA (Difficulty breathing), SWELLING FACE (facial swelling), HEART RATE INCREASED (fast heart rate) and PAIN IN EXTREMITY (leftside pain in fingers and toes) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for covid-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (per patient she had undiagnosed covid-19 for three months in 2020 (from February through April). With it she had  super dry bronchial tubes, the doctor said she had asthma without examining her- over teleconference. She had respiratory and heart symptoms with covid-19. she was fuzzy headed with decreased mental sharpness with the covid-19.  It is better now.) from February 2020 to April 2020.    On 29-Jan-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021 at 4:00 PM, the patient experienced DIZZINESS (Wild Dizziness), DYSPNOEA (Difficulty breathing), SWELLING FACE (facial swelling), HEART RATE INCREASED (fast heart rate), SWOLLEN TONGUE (swollen tongue) and RASH (rash). On an unknown date, the patient experienced PAIN IN EXTREMITY (leftside pain in fingers and toes), FATIGUE (fatigue), NAUSEA (nausea), PYREXIA (low grade fever), CHILLS (unbelievable chills), ARTHRALGIA (leftside pain in hip joints/razor sharp joint pains) and INJECTION SITE PAIN (injection site pain). At the time of the report, DIZZINESS (Wild Dizziness), DYSPNOEA (Difficulty breathing), SWELLING FACE (facial swelling), HEART RATE INCREASED (fast heart rate), PAIN IN EXTREMITY (leftside pain in fingers and toes), SWOLLEN TONGUE (swollen tongue), RASH (rash), FATIGUE (fatigue), NAUSEA (nausea), PYREXIA (low grade fever), CHILLS (unbelievable chills), ARTHRALGIA (leftside pain in hip joints/razor sharp joint pains) and INJECTION SITE PAIN (injection site pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported Patient had no history of allergies. Patient took diphenhydramine to treat her symptoms.
pt recv vax 28DEC97 & pt devel cold sx for 10 days;24JAN98 pt recv 2nd dose of vax & devel upper resp sx for 10 days;
L Armpit lymph node swelling and tenderness; L Armpit lymph node swelling and tenderness; Left breast pain; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 29 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Aug2021 11:00 (Lot number: 0181) at the age of 29 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Anxiety" (unspecified if ongoing); "covid-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes. Concomitant medication(s) included: EFFEXOR taken for contraception. The following information was reported: LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset 08Aug2021 08:30, outcome "not recovered" and all described as "L Armpit lymph node swelling and tenderness"; BREAST PAIN (non-serious) with onset 08Aug2021 08:30, outcome "not recovered", described as "Left breast pain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of lymphadenopathy, lymph node pain, breast pain.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no known allergies. Patient had covid tested post vaccination Nasal Swab, which result as Negative on 11Dec2020.  No follow-up attempts are possible. No further information is expected.
that bothered them was a sore arm; This is a spontaneous report from a Pfizer sponsored program. A female patient (reported herself) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient stated that both her husband and she have gotten the COVID doses and the only thing that bothered them was a sore arm. The patient had a 29-year-old son who won't get vaccinated because he says it's not FDA approved. She would really like Pfizer to push the FDA to get this COVID vaccine approved because she believes that a lot of people in the age range of 25-35 are waiting for the FDA to approve it. She wanted to know if someone from Pfizer would reach out to her in regard to the approval process and wanted to know what's taking so long, for the FDA to approve it. Since caller and her husband had a side effect.  Information on the lot/batch number has been requested.
Positive COVID-19 result; Positive COVID-19 result; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 24 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date Feb2021 (Lot number: EL3247) as dose 2, single and intramuscular, administered in arm left, administration date Jan2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: APRI. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 09Jan2022, outcome "unknown" and all described as "Positive COVID-19 result". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (09Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Dose 1 administration time: 10:45 AM. No other vaccine was administered in four weeks. No covid prior vaccination and post vaccination. No known allergies reported.  No follow-up attempts are possible. No further information is expected.
For the first 24 hours after vaccination I had low grade fever of about 100, joint and muscle aches, chills and severe fatigue.  Treated symptoms with tylenol and ADvil. Day two following the vaccination I experienced severe itching of my neck, chest, back and arms, palms of hands and soles of feet.  Slight rash visable to these areas.  Treatment included benadryl with some relief, but not total.  Day three following the vaccination still experiencing some itching, but much less severe and not needing treatment.
Vaccine administered to right deltoid at 10:35 am. Itchiness from waist up started at 1:30 pm. There was also facial and ear swelling. Pt was taken to ED by mother. ED prescribed Prednisone 20 mg - 2 tabs once daily x 4 days/BENADRYL 25 mg.
pt recvd vax 22MAY92 & w/in 72 hrs devel urticaria; treated unsucessfully w/steroids; also seen by dermatologist for yeast infect;
Facial numbness; tingling that ended up being all over my head; Severe headache; Fever; chills; body aches; sore arm; Other vaccine same date vaccine date 24Aug2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient A 50-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), administered in arm left, administration date 24Aug2021 12:15 (Lot number: FE3592) at the age of 50 years as unknown, single for covid-19 immunization. Relevant medical history included: "Pacemaker" (unspecified if ongoing). Concomitant medication(s) included: PANTOPRAZOLE; ARMOUR THYROID; ESTRACE; PROGESTERON. Past drug history included: Propylthiouracil, notes: PTU; Technetium tc 99m. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, LOT: FC3182, LOCATION: ARM LEFT), administration date: 24Aug2021.The following information was reported: HYPOAESTHESIA (non-serious) with onset 27Aug2021 17:00, outcome "not recovered", described as "Facial numbness"; PARAESTHESIA (non-serious) with onset 27Aug2021 17:00, outcome "not recovered", described as "tingling that ended up being all over my head"; HEADACHE (non-serious) with onset 27Aug2021 17:00, outcome "not recovered", described as "Severe headache"; PYREXIA (non-serious) with onset 27Aug2021 17:00, outcome "not recovered", described as "Fever"; CHILLS (non-serious) with onset 27Aug2021 17:00, outcome "not recovered", described as "chills"; PAIN (non-serious) with onset 27Aug2021 17:00, outcome "not recovered", described as "body aches"; PAIN IN EXTREMITY (non-serious) with onset 27Aug2021 17:00, outcome "not recovered", described as "sore arm"; PRODUCT USE ISSUE (non-serious) with onset 27Aug2021 17:00, outcome "not recovered", described as "Other vaccine same date vaccine date 24Aug2021". The events "facial numbness", "tingling that ended up being all over my head", "severe headache", "fever", "chills", "body aches", "sore arm" and "other vaccine same date vaccine date 24aug2021" none of the events started until day 3 after 2nd shot were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of hypoaesthesia, paraesthesia, headache, pyrexia, chills, pain, pain in extremity, product use issue.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 since prior to vaccination and tested positive for COVID-19 since the vaccination. Reported Event was patient reported this before she had to go to Emergency Room (ER) for the 1st and 2nd time. Her primary Doctor also wants a neurologist opinion. Facial numbness and tingling that ended up being all over her head, neck and top of shoulders. Severe headache that accompanied that. Fever, chills, body aches, sore arm. None of the events started until day 3 after 2nd shot.  Follow-Up (14Oct2021): Follow-up attempts are completed. No further information is expected.
I had a miscarriage at 9 weeks pregnant.  The fetus stopped growing at 6 weeks.
I positive for COVID-19 on 14FEB2023, I had a sore throat, coughing and a little vomiting. I was pretty fatigued. I contacted my doctor in telehealth and prescribed me paxlovid. I started feeling better after 1 day, now I am feeling very good.
date 04/07/2022 administered on 4/22/2022. Pfizer could not provide stability data beyond 04/09/2022 and recommended revaccination
muscle aches, joint aches, shoulder & upper back area 3 days post vax;
Pharmacist administered 1.0 mL instead of prescribed 0.5mL.
screamed constantly for 4hr, 1 1/2hr p/vax;high fever for 48hr;
This spontaneous report was received from a nurse referring to a 6 month old infant patient. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 08-MAR-2018, the patient was vaccinated with a dose of VAQTA lot # N026997 with expiration date 10-NOV-2018, for prophylaxis (route of administration was not reported). No adverse effects were reported.
flare up of SLE, swelling of joints of both upper & lower limbs, dec mobility of joints d/t pain;
pt wife called around 4:39pm stating that pt had received a 2nd booster for his pfizer. stated once he reached home he developed a watery nose bleed. bleed was somewhat managed by tilting his head and applying pressure on it with papertowel. pt's wife was questioning if the vaccine had anything to do with the nose bleed. upon checking in with pfizer prescriber info there was no mention of such side effect in the package insert. asked to pt to see medical attention via urgent care if the nose bleed dose not stop or he feels light headed. pt's wife states she will go to urgent care and keep us informed. pt's wife called back at 7:59pm with update. upon visit to urgent care. the pt bp was checked and it was hypertensive BP>200/100 mmHg. He was taken to ER by wife and being treated for high bloodpressure. pt will follow up with the cardiologist re: bp medications and get it re-evaluated.
Information has been received from a physician's office concerning a 7 year old male patient who on 01/11/00 was vaccinated with a 1st dose of Varicella virus vaccine live SC in the right arm. Subsequently, the patient developed "multiple lesions, some became red with green pus." The patient was placed on amoxicillin trihydrate (+) clavulanate potassium (Augmentin) chewable tablets for 10 days. Two weeks post-onset, the patient recovered from multiple skin lesions. The reporter felt that the patient experienced an Other Important Medical Event. Additional information has been requested.
My arm was sore for 3 or 4 days. I started getting chills and running a low-grade fever. At night I started to feel bad, and head became stuff. My fever kept getting worse. On the 11/3/2021 my fever became worse, and I couldn't stop coughing. I made appointment on 11/4/2021 to see a nurse. I was giving a COVID-19 test which I was tested negative. I was told I had sinus infections. The nurse gave doxycycline 100mg. Which I still coughing and have a fever.
Tongue felt ?tingly and weird?. Tongue was not swollen 25mg Benadryl po given. Pt left in private vehicle 98% o2 hr 72   Gait steady and without distress
13 y/o F with hx of exercise-induced asthma BIB mom for dizziness and chest pain s/p Pfizer COVID-19 vaccine received yesterday. Pt endorses nausea, HA, chest pain and SOB. No fever. Chest pain currently. Pt took albuterol 1.5 hours PTA. Pt usually only needs albuterol with physical activity. NO PMH/PSH. Vaccines UTD. NKDA.   Differential Diagnosis: vaccine reaction, myocarditis, pericarditis, costochondritis. After assessment and treatment, pt is well appearing, explained to mom on reassessment symptoms have resolved, no chest pain currently. Explained symptoms likely secondary to vaccine reaction, explained normal heart enzymes and normal EKG, strict return precautions given including chest pain and fever.
Pt called pharmacy on 9/19 stating that injection site was swollen, felt warm and was firm. Symptoms started that evening and had progressed since.
10/20/05 11:30am Mother called re: L leg; red at site, size of quarter, entire thigh swollen; advised to contact doctor. 10/21/05 11:15am Recall to mother, did not take to dr. until 10pm on 10/20/05, swelling at site and upper thigh had continued to increase; seen at ER; dr. stated rxn. due to MMR immunization; given Benadryl & IM steroid; swelling & redness decreased today. In reviewing allergy hx today, mother states "sensitive" to red & purple gelatin; on 10/19/05 when asked if allergic to gelatin, mother stated "no".
hospitalized 9/22/21 - generalized fatigue, body aches, cough, and fever that has been present for approximately 7 days.  Patient states that she is getting short of breath with ambulation at home.  SARS-CoV-2 positive 9/22/21.
Nausea, syncope episode, evaualed by EMS-refused transport. Cleared.
Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Dizziness / Lightheadness-Mild
Patient was supposed to get 1 flu vaccine in left arm and 1 Hep A vaccine in right arm. However, by error the patient recieved 2 flu vaccine instead in right and left arms. The patient still recieved Hep A vaccine in right arm thereafter.
12/2003 Flu like symptoms. Chest congestion. Self medicated with over the counter cold medicine. 1/2003 Symptoms became worse. Primary Doctor began treatment for Bronchitis. 3/2003 suspected Asthma. Treated with numerous inhalers. 8/2003 referred to Pulmonologist. Have been under his care to date. All test are negative. Symptoms persist.
Four hours after receiving my 2nd vaccine, I fainted while standing in my kitchen. Bystanders said I was out cold for about 1 minute, and was flailing my arms and legs, but did not appear to be a full on seizure.
PT RECEIVED ROUTINE 6MO VACCINES IN OFFICE AROUND 2:20PM ON 11/25/19. MOM AND DAD PRESENTED TO ER AROUND 8PM REPORTING THAT PT WAS HAVING POOR RESPOSIVENESS, HYPOTONIA, AND ALTERED BREATHING PATTERN THAT STARTED AROUND 630PM. PT WAS TRANSFERRED FROM LOCAL ER TO ANOTHER HOSPITAL. PT IS STILL THERE AT THIS TIME.
A report was received from a health professional on 30 October 2001, concerning a 78 year old male patient who experienced chills, a light head, dilated pupils, raised blood pressure and raised pulse, 45 minutes after receiving an Influenza vaccine on 17 October 2001. On 17 October 2001, the patient experienced a cold clamy feeling, a distant feeling, a lump in throat, dilated pupils, and a raised blood pressure and pulse, 45 minutes after receiving an Influenza vaccine.  The patient recovered 2 hours later. There was insufficient information to determine the reporter's causality assessment.
Rash on Achilles heel which became swollen and painful. I had this same effect after taking Levaquin several years ago. The day after having the second vaccination on March 3, the rash became much redder and the Achilles heel much more painful. The rash, swelling and pain lessened after several days. Tendon is still slightly swollen.
At 9:45 Patient complained of nausea after smelling Lysol being sprayed. Patient stepped outside to get fresh air and I stepped out also to observe her. V/SBP 153/89, 98 % O2 and HR 74. Gave patient water and had her sit for additional 30 minutes. Patient said no signs of difficulty breathing ans she felt better after breathing fresh air.
my right shoulder is extremely sore and unable to work Narrative: r shoulder / arm pain 2/6-date