chrisvoncsefalvay/vaers-outcomes huggingface dataset:
intense joint/muscle pain in left leg and hips; intense joint/muscle pain in left leg and hips; Unable to use left leg for 3 days. Could walk days # 4-7 with canes,can walk without cane today; Still in pain but can walk without cane today; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EN6208 and expiration date: not reported), via an unspecified route of administration, in Left Arm, on 12Mar2021 at 08:45 (at the age of 64-year-old) as DOSE 2, SINGLE for covid-19 immunization in hospital.  Medical history included mast cell disorder, multiple sclerosis, gluten allergy, underlying autoimmune issues that were totally in remission before shots. Concomitant medications included cromoglicate sodium (CROMOLYN), topiramate (TOPAMAX), alfuzosin, levothyroxine sodium (SYNTHROID), methylphenidate hydrochloride (RITALIN).Historical vaccine included BNT162B2 (Pfizer BioNTech Covid 19 Vaccine; lot number EN6200 and expiration date: not reported), via an unspecified route of administration, in Left Arm, on 19Feb2021 (at the age of 64-year-old) as DOSE 1, SINGLE for covid-19 immunization and experienced Horrific joint pain and Couldn't lift arms, use wrists for 1 week. The patient was not pregnant at time of vaccination. The Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. On an unspecified date, after 2nd shot, patient experienced intense joint/muscle pain in left leg and hips. Unable to use left leg for 3 days. Could walk days 4-7 with canes. Still in pain but can walk without cane now. No treatment was received for the adverse events. The outcome of the event Walking difficulty was recovered while all other events was recovering at time of report.  No follow-up attempts are possible. No further information is expected.
Pt informed vaccinator that he received Moderna as first dose. Pt was given Pfizer as second dose. Pt aware of incident. no treatment needed
Unable to fall asleep half the night on 30Nov2021; had a booster shot; Could not concentrate; Fatigue; almost fell; Body aches that make him feel uncomfortable; Body aches that make him feel uncomfortable; Low fever; Dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (COMIRNATY), administration date 30Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, He is healthy and he did not feel this way with the first two doses), for COVID-19 Immunization, reaction(s): "He is healthy and he did not feel this way with the first two doses"; Bnt162b2 (Dose: 2, He is healthy and he did not feel this way with the first two doses), for COVID-19 Immunization, reaction(s): "He is healthy and he did not feel this way with the first two doses". The following information was reported: PAIN (non-serious), DISCOMFORT (non-serious) all with onset 2021, outcome "unknown" and all described as "Body aches that make him feel uncomfortable"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "Low fever"; DIZZINESS (non-serious) with onset 2021, outcome "unknown", described as "Dizziness"; INSOMNIA (non-serious) with onset 30Nov2021, outcome "unknown", described as "Unable to fall asleep half the night on 30Nov2021"; DISTURBANCE IN ATTENTION (non-serious) with onset 2021, outcome "unknown", described as "Could not concentrate"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "Fatigue"; FALL (non-serious) with onset 2021, outcome "unknown", described as "almost fell"; IMMUNISATION (non-serious) with onset 30Nov2021, outcome "unknown", described as "had a booster shot". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information:: wondering if he should take Tylenol. Stated that he tried to search online for PDF files and it did not mention any treatment. Wanted to know if these were side effects. Wanted to know if it was okay to travel. Clarified that it is for the Covid booster.
Developed diarrhea for 3 weeks, fever, speech and motor regression, has been evaluated for autism by specialist, results inconclusive.  MRI and EEG were normal.
Right shoulder with brisk response and robust take with approximately 5 inches of surrounding induration. No fluctuance noted. Associating itchiness, heavy feeling, +/- fever.
Woke up next morning with 11 red spots on right thigh. August 25. On Aug 27 3 more red spots appeared on the same area on right thigh. No other symptoms. Referred to her Dr.
Booster; pain in my arm and the armhole; pain in my arm and the armhole; feel nauseous; dizzy; fallen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from License Party. The reporter is the patient, Other Case identifier(s) 106960.  A female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included Bnt162b2 (Dose: 1), for COVID-19 immunization; Bnt162b2 (Dose: 2), for COVID-19 immunization. The following information was reported IMMUNISATION (non-serious), outcome unknown; PAIN IN EXTREMITY (non-serious), AXILLARY PAIN (non-serious), outcome not recovered; NAUSEA (non-serious), outcome not recovered; DIZZINESS (non-serious), outcome not recovered; FALL (non-serious), outcome not recovered.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Pt was given a booster shot from a multi-dose vial that had been opened 26 hours ago (exceeding the 12 hour time frame from first puncture). Pt has no adverse s/sx at time of call.
Started with a runny nose, headache, cough and fever reached 102.0. Then from there the cough worsen I couldn't breath and oxygen was at a 89. I did a phone visit with Doctor. Doctor prescribed benzonatate 200mg capsules 2 times a day as needed. I took the medication for about a week. It did help a little but I still have the cough and heaviness in my lungs.
Could not walk; Lost control of my urine; Fever; Rash; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient received bnt162b2 (BNT162B2), administration date 30Apr2021 (Batch/Lot number: unknown) at the age of 52 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "high cholesterol" (unspecified if ongoing); "high pulse rate" (unspecified if ongoing); "arthritis" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). Concomitant medication(s) included: VALSARTAN; MELOXICAM; CHOLECALCIFEROL; METOPROLOL; ATORVASTATIN; TRAMADOL; POTASSIUM; GABAPENTIN; LIDOCAINE; PREMARIN. The following information was reported: GAIT DISTURBANCE (non-serious) with onset 30Apr2021, outcome "recovered" (2021), described as "Could not walk"; URINARY INCONTINENCE (non-serious) with onset 30Apr2021, outcome "recovered" (2021), described as "Lost control of my urine"; PYREXIA (non-serious) with onset 30Apr2021, outcome "recovered" (2021), described as "Fever"; RASH (non-serious) with onset 30Apr2021, outcome "recovered" (2021), described as "Rash". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient's concomitant medication included: lidocaine patch, PREMARIN VAGINAL. On 30Apr2021, it was reported that patient experienced: relapse, could not walk, lost control of my urine, fever, rash.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Swelling of lymph nodes around the collarbone area; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration in the left arm on 05Feb2021 (at the age of 62-years-old) as a single dose for COVID-19 immunisation and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration in the left arm on 26Feb2021 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included heart disease, acid reflux (esophageal) and sulfonamide allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received unspecified medications within 2 weeks of vaccination. On an unknown date in Feb2021, the patient experienced swelling of lymph nodes around the collarbone area. The event 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 reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swelling of lymph nodes around the collarbone area was not recovered at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
pt recvd vax 30AUG93 & taken to hosp ER w/sudden onset of apneic; dx seizure disorder & static encephalopathy; peds ICU from 31AUG93 to 03SEP93;
VOMITING; DIZZINESS; NAUSEA; TIREDNESS; This spontaneous report received from a consumer concerned a female of unspecified age. 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: 1808978, expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination on left arm. No concomitant medications were reported. On APR-2021, the subject experienced nausea. On APR-2021, the subject experienced vomiting. On APR-2021, the subject experienced dizziness. On APR-2021, the subject experienced tiredness. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea, dizziness, tiredness and vomiting was not reported. This report was non-serious.
pt recv vax OCT96 & 23DEC96 pt devel a fever over 100, chills, a cough, congestion,  nausea which lasted over 3wk;pt required a physician exam & was prescribed ATB;all of sx have resolved x/for cough;
approx 4hr p/vax got fever, swollen gland in throat, vomiting, upper resp congestion;h/a, fever seemed quite high;muscle contractions & aches;sx dissipated p/4hr;APAP;
Information has been received from a consumer concerning her 19 year old daughter with a history of acne and no known allergies who "about 4 months ago", in approximately September 2009, was vaccinated with the first 0.5 ml dose of GARDASIL. "About 2 months ago", in approximately November 2009, the patient was vaccinated with the second 0.5 ml dose of GARDASIL. There was no lot number reported. Concomitant therapy included birth control pill (unspecified). "About 2 weeks after the second dose", the patient began to experience hair loss and acne outbreaks on her face. The patient had a history of acne, but after treatment with ACCCUTANE (manufacturer unspecified) she had not had an outbreak in over 2 years until now. As of 27-Jan-2010 the hair loss has stopped and the patient is resuming therapy with ACCUTANE for the acne. Unspecified medical attention was sought. There were no lab studies performed. At the time of the report, the patient was recovering. No further information is available.
pt recvd vax mid morning as part of routine well check; pt very pale for last 1 1/2 hrs w/dec appetite & inc fussiness; called MD who said have family take pt to ER for shock;
This case was reported by a pharmacist via call center representative and described the occurrence of heart rate increased in a 74-year-old female patient who received SHINGRIX (batch number M77B4, expiry date 8th February 2021) for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced heart rate increased. On an unknown date, the outcome of the heart rate increased was unknown. The reporter considered the heart rate increased to be unrelated to SHINGRIX. Additional details reported as follows: The age at vaccination was not reported. The healthcare professional reported that her patient experienced an elevated heart rate after receiving SHINGRIX. It was lasted for around 24 hours. The healthcare professional did not believe it was related to vaccination. The reported batch number M7784 for SHINGRIX did not exist and was updated to M77B4 as per the sales database.
Remarkable Myalgia of extremities and back, interfering with rolling or sitting. Spasmodic twitching of upper extremities, These resulted in Hospitalization.
Persistent high fever for five to six days after vaccine with sever headache.  Fever required hospitalization to rule out meningitis
Runny nose, sore throat, red, itchy eyes with profuse mattering, couldn't catch his breath.  I called the drug store, talked to the pharmacist.  She recommended treatment at facility.  They saw him and called the ambulance to transport him to the ER.  They administered oxygen to the ambulance arrived.  His oxygen level there was 80.  He was going into anaphylactic shock.  I don't know which drugs they gave him at the hospital.  Call them. He was there until around 2:00 PM 10/17/2015.
pt was observed by mom & grandma to be pale & limp; 2 hrs p/receiving 1st DTP; sx lasted 1/2 hr;
Information has been received from a physician concerning a 4 week old patient who was vaccinated with pneumococcal 23v polysaccharide vaccine by mistake. No other information was available.
Left arm is swollen to about twice the normal size. Pain is a 2. Swelling is below elbow.
"Boil" formed with itching still on arm. Believes its at site - erupted done after.
received Janssen covid-19 vaccine on 6/18/21. Experienced myasthenia gravis exacerbation with significantly increased weakness for the next 4 weeks, then returned close to (but not quite at) baseline requiring escalation of MG therapy. AchR ab positive generalized myasthenia gravis onset age 20, s/p thymectomy age 28, off imunnosuppressants since 2014 due to breast cancer, with ongoing weakness managed only by mestinon up until now
vaccine given on 04/27/2023 pt waited in clinic for 15 min after vaccine was administered  by the CMA -Vaccine given was not the correct covid dose. 05/9/2023 T/C with mom and explained that patient was administered a lower Moderna dose than the CDC recommends. Recommendation is to have this dose re-peated. Mom reports no concerns after vaccine given. appt schedule for nurse visit on 05/18 for Covid Bivalent vaccine.
Pt presented for TB skin test reading Wed 3/15/06. Mother states she noticed swelling and rt deltoid redness 8:00 am 3/15/06 and thought child was bitten by ants. States cleaned arm with antimicrobial hand gel. Redness and swelling noted rt deltoid 50 mm + X 50 mm +. Hot to touch. Child able to use arm with no problem. Child running and playing. No c/o by child. Instructed mother to administer Benedryl oral topical and give tylenol prn for discomfort. Also instructed may apply cool compress. Advised if swelling worsens or child has any s/s of swelling or difficulty breathing take child to ER stat.
1/12 vaccination 1/13  I woke up, fatigue. Went to work. I could feel my HR increase. Pressure on my chest, upper right side. It progressed to neck and shoulder, pressure and sharp stabbing pain. Went to lay down in dark room. Vitals stable except pulse. ER; could not keep eyes open I was so fatigued.  Fever; 100.4. BP 131/85. Tachycardia, body aches, extreme fatigue, dizzy.  Tylenol, COVID test, blood work, chest xray, EKG; short of Toradol.  EKG looked normal. Advised to come back if worsened after 48 hours.
Headache is really bother her; Head is hurting pretty bad; Nausea little bit; Fever; This is a spontaneous report from a contactable consumer (grandparent). A 15-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number:EW0169, and expiration date was not reported), via an unspecified route of administration on 23Jun2021, as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), DOSE 1, SINGLE for covid-19 immunization. On 23Jun2021, the patient started feeling some side effects, she had a headache, little bit of nausea, and fever. At the morning of report, the patient still had a headache and it really bother her and her head was hurting pretty bad. The reporter would like to know what patient can take for her headache. The outcome of the event Headache was not recovered and of Nausea and pyrexia was unknown at the time of report.
swelling to throat, lips, & tongue w/moderate dyspnea lasting approx 24hr p/vax;did not seek treatment;
he collapsed after the 15-minute waiting period post vaccine and got rushed into the ER. His heart almost stopped from his BP dropping so low and he had convulsions for about an hour. Stabilized in the ER after 3 hours and was sent home.
Shortly after second shot I noticed my sex drive go to almost zero. I have never had a problem before. I had my testosterone checked and I was 450 which was in range. I went on testosterone therapy for 5 weeks and went up to 750 with no change in sex drive. I stopped takes testosterone because it did not give me  the desired affect of helping my sex drive. My sex drive is at a zero. My organisms are no existent. All started with the shot.
Treatment of COVID-19; Treatment of COVID-19; 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 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 as dose 5 (booster), single (Lot number: Gj2524) at the age of 68 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Cancer" (unspecified if ongoing); "Amoxicillin allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures (Paxlovid) were taken as a result of drug ineffective, covid-19.
Within week of the dose the partial vision loss happened again in my left eye (which happened within a week after in my left eye the 1st dose but this was temporary and only lasted for a few hours) and did not clear up, it stayed. I called and saw my eye surgeon doctor. I saw him on April 7th and he found the occlusion which is like the burst vessel in my retina and he referred me to the doctor. The doctor determined it was an arterial occlusion not a a venous occlusion. Now I have a little area of permanent vision loss in my left eye. The doctor suggested I started taking low dose aspirin to prevent another occurrence.  He checked for any other risk factors and found none.
Droopy left cheek.; This is a spontaneous report from a contactable nurse. A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EJ1685), intramuscularly in the left arm, on 17Dec2020 at 14:30 (at the age of 52-years-old) at a single dose for COVID-19 immunization. The patient had no medical history or concomitant medications. The patient had no other medications within two weeks of vaccination. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously took sulfamethoxazole, trimethoprim (SEPTRA) and experienced allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced droopy left cheek on 21Dec2020. No therapeutic measures were taken as a result of the event. The clinical outcome of droopy left cheek was recovered in Dec2020. It was also reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of droopy left cheek might not be excluded considering the plausible temporal relationship.  The patient had previous allergy reaction to antibiotic (sulfamethoxazole, trimethoprim) use.  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.
elevated tropinin critical 30, hypercalcemia, critical, lymphadenopathy requiring resection
Student received vaccination in school-based vaccination clinic setting. Upon returning to classroom, student had syncopal episode, was excused from class, and presented to school R.N. for evaluation. Vital signs reported as stable by school R.N., student noted to be slightly pale. Student was provided water and laid down in treatment room for 10 minutes. After rest period, color improved and student reported feeling less faint. Parent notified and advised regarding post vaccination monitoring. Student was dismissed to home.