chrisvoncsefalvay/vaers-outcomes huggingface dataset:
focal seizure; feeling off; Hands were shaking; eyes fluttering; Blurry vision; headache for a few hours; Feeling tired; This is a spontaneous report received from a contactable Other Health Professional (patient). A 37-year-old female patient (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in left arm on 10Aug2021 16:45 (at the age of 37-year-old) (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  Medical history included Epilepsy and major depression, Grand mals. known allergies: No. Pregnant at the time of vaccination: No. Concomitant medications included lamotrigine; fluoxetine hydrochloride (PROZAC).  Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine: No. The patient experienced focal seizure, feeling off, Hands were shaking, eyes fluttering, blurry vision, headache for a few hours, all on 10Aug2021 22:00 with outcome of recovered on 11Aug2021, feeling tired on 10Aug2021 22:00 with outcome of recovering. Clinical course: Approx 5 hours after the shot the patient was awaken feeling off, the patient was an epileptic and the patient started experiencing the symptoms of a focal seizure, hands were shaking, eyes fluttering, blurry vision etc . The patient's seizures were well controlled and she had never experienced tremors with her focal seizures only when she had had grand mals which had been over 8 years ago. The patient experienced a headache for a few hours afterwards but issues have been resolved by morning except feeling tired which was common for her after her seizures. Adverse events were not resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Serious: No. Seriousness criteria-Results in death: No. Seriousness criteria-Life threatening: No. Seriousness criteria-Caused/prolonged hospitalization: No. Seriousness criteria-Disabling/Incapacitating: No. Seriousness criteria-Congenital anomaly/birth defect: No.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the available information in the case, the causal association between the event partial seizures and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  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.
Patient described "bubbling in chest" relative to her GERD experiences as well as some tingling in bilateral arms. No dyspnea, diaphoresis, dizziness or chest pain reported.
No additional AE's were reported; first dose on 24Sep202 l of his ROT ATEQ vaccine at six months old which was at 27weeks old; This spontaneous report as received from a consumer (patient's mother) and refers to a 6-month-old male patient. The patient's drug reactions, allergies and concomitant medication were not reported. His concurrent conditions included reflux.   On 24-SEP-2021, at 27-weeks-old, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), orally (exact dose, lot # and expiration date were not provided) for prophylaxis (product administered to patient of inappropriate age). It was stated that he did not get the vaccine at 2 and 4 month appointment because of reflux. The patient had not had any additional doses yet. It was also reported that the reporter was trying to get in touch with her pediatrician to see what they need to do. No adverse effects were reported.
teacher @ school noticed dazed look on face, face twisted, drooling, lethargic, lt arm rigid; sx lasted aprpox 15 mins; seen by MD then taken to hosp; neurologist said lab results neg;
Extreme pain at injection site, pain spread to shoulder, went to emergency at hospital. Administered pain medicines.
During the night after I received the first Moderna COVID injection, I woke up with a strong ringing in my left ear.  Over time the tinnitus has diminished a bit, but it is still not completely gone.
Redness around site, hot and hard.  Redness expanding down and partially around arm with vague borders-approx 16cm long 11cm wide with swelling.  Warm to touch.
L arm is warm to touch and has redness. Had fever for one night on 10/28. Itchiness in throat  Chest pain only when coughing. Headache, and sharp pain in head when coughing. sputum is yellow
Approximately 30 minutes after administration, patient reported coldness of hands and feet, light-headedness, and dizziness. Patient appeared pale. Patient moved to private area, laid flat, excess clothing removed, and offered juice and crackers. Patient reported a "strange feeling" in tongue and a "lump in throat", however voiced that she did not want epinephrine administration. Monitored closely for approximately 45 minutes. Vital signs remained stable and patient reported feeling in tongue/throat improving and returning to normal. Patient reported improved condition. Patient did not wish for ambulance transport to a health care facility. Patient discharged at approximately 10:45 am in company of a family member. Encouraged to seek medical advice from personal healthcare provider. Patient followed up with the next day via telephone, 1/22/21. Patient again reported improved condition and phone evaluation from her physician.
received 0.5ml Moderna instead of 0.25ml booster dose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (received 0.5ml Moderna instead of 0.25ml booster dose) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012h21b) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 19-Nov-2021, the patient experienced ACCIDENTAL OVERDOSE (received 0.5ml Moderna instead of 0.25ml booster dose). On 19-Nov-2021, ACCIDENTAL OVERDOSE (received 0.5ml Moderna instead of 0.25ml booster dose) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown demographics. No concurrent conditions or medical history were provided. On an unknown date, those patients were vaccinated with single doses of ZOSTAVAX injection (strength, dose, route of administration, lot# and expiry date unspecified), post both supported and not supported temperature excursions. No concomitant medications were reported. No patient had reported experiencing an adverse effect due to receipt of vaccination post temperature excursion. This is one of several reports from the same source. Additional information has been requested.
Day after vaccination was administered, my brother developed upper and lower extremity pain and weakness, a full-body rash, and lethargy. His symptoms continued to progress; after 5 days with same symptoms he presented to the ED (Hospital on 12/3/21). He was diagnosed with Guillain Barre Syndrome and received 2 treatments of IViG. He continued with upper and lower extremity weakness and loss of bodily function. After 5 days at inpatient hospital, he was transferred to a rehabit facility to receive PT and OT.  He was progressing after day 3 in rehab facility, he developed bradycardia (40 bpm) and was then transferred to ICU.
Hives, rash, facial swelling, wrists swollen, mild anaphylaxis event with lips and eyes swelling on 12/27/21 ER visit, 2 epinephrine, 4 days of prednisone, claritin - 12/28/21 Foot swelling, continued facial swelling and intermittent hives on torso, back, wrists - 12/28/21 Urgent Care visit, tapering prednisone for 10 days - 12/29/21 Prednisone relieved swelling, still breakthrough rash from touching, food sensitivity Current dosing:  1 Claritin, 2 Pepcid daily, Tapered prednisone until further notice, 2 benadryl in evening
Myalgia, Arthralgia, Fever, Chills Narrative: Fever 102
Vaccine administered after temperature excursion; This spontaneous report was received from a medical assistant referring to a 12 year old patient, gender not reported. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (lot # S012037 has been verified to be a valid lot number varicella virus vaccine live (oka/merck), expiration date reported and establish as 17-APR-2021) (strength, dose, route of administration and anatomical location were not provided).  The temperature of storage and time frame of the excursion were 5° Celsius (C) for 12 hours respectively.  A digital data logger was involved, and there was previous temperature excursion of 8.4° Fahrenheit for 60 hours.
Pt received Adult Pfizer vaccine Dr notified, Mom notified by Clinic Administrator and doctor  Outcome: Pt still doing ok upon speaking with Mom on dates 2/15/22, 2/16/22 (Clinic Administrator), and 2/17/22 (doctor)
Shortness of Breath, vomiting x 1, body aches, headache, eyes were burning.   Stayed in bed x 3 days Did not take any medications or seek medical attention
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative via social media concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, 1 total, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 26-JUN-2021, the patient was diagnosed as COVID positive by positive COVID test (suspected clinical vaccination failure and suspected COVID-19 infection). Laboratory data included: COVID-19 virus test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected COVID-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210702601-Covid-19 vaccine ad26.cov2.s- Suspected clinical vaccination failure . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
I had stomach cramps and at first I thought it was just period cramps and it got so severe I went to Emergency room and my appendix was inflamed.
Please note above - I don't have my vaccine card on me at the moment, but can provide the lot numbers later if needed - feel free to contact me. It was a 3rd dose of the Pfizer vaccine. I did not receive any other vaccines on that date.  I received the shot on Tuesday evening.  The next morning after the shot, my upper arm at the shot site was very sore and I developed a large red welt. By the next day, the welt had swelled and spread to over 3 inches across. By that evening (Wednesday), my entire arm started to hurt, like I had overused the muscles. I figured it was just sore and went to bed. By Thursday morning, I was miserable. Never fully-sick, but I had a terrible headache, was nauseous and fatigued - I'd describe it as feeling like I was hit by a bus.   The WORST symptom was new this time - it never happed with the first or second shots. I had SEVERE swelling of the lymph nodes in my armpit (arm of the shot). It was so bad that it was causing nerve pain all the way down my arm, with zinging lightning pains and tingling in my fingers. It hurt to even touch the skin near my underarm, and just the weight of my arm at my side was hurting against it. I had trouble sleeping for days and could barely move my arm. This lasted an entire week, and seems to now have finally subsided (as of 12/8). I still have a huge welt/rash on my arm at the shot side, and the red tone of it is changing to more of a bruise. I had a similar (but smaller) reaction to the other shots, which left a welt and visible darkening of the skin for several months after the shots. So far, this one appears to be the same.   The lymph node swelling and pain were the most concerning. I've read that this is supposed to be a rare reaction, but of the two people I work with who told me they received the booster, one of them had the same reaction, so I'm doubting it's that rare. That was a very unpleasant experience and made my immunocompromised husband scared to get the booster. Thankfully he's getting his today - we will report if he has any reaction.
09:45 states is starting to itch on her right time  (leg , arm then Back)  no redness was noted at this time.  0950 itching now to chest and scalp , again no redness.  10:15  states her throat is feeling itchy   States  does have an epi pen at home be "just didn't think about bring it"  ER was notified that we were bring her for evaluation ; she was able to take few steps to the wheelchair , taken to our ER report given to the nurse.
Expiration date on Box is 5/2/2019..vaccine was administered on 5/5/2019..3 days after expiration date on box
Hearing loss  and tinnitus. Almost 3 weeks to return. Loss of low tones.
pt w/vomiting 24-48hr p/vax & projectile vomiting;
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 20-JUL-2016, the patient received an improperly stored dose of PROQUAD (lot # L040412, expiry date: 13-APR-2017) (incorrect product storage). No adverse effect reported. The outcome was unknown. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
SUFFERING SEVERE REACTIONS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced suffering severe reactions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suffering severe reactions was not reported. This report was non-serious.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2016, the patient was inoculated with ZOSTAVAX (dose, route of administration, site of administration and lot # were not provided) for routine health maintenance and for the prevention of shingles. The vaccine did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster including, but not limited to cellulitis.  Shortly after receiving ZOSTAVAX, the patient developed burning, itching, redness and warmth at the site of the injection. In response to these complaints, the patient presented to a physician and was diagnosed as suffering from cellulitis. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was considered to be not recovered. Causality assessment was considered to be related. Upon internal review, cellulitis was determined to be a medically significant event. Additional information has been requested.
Developed fever and chills, tmax 103.  near-syncope episode in office 12/22/16, admitted to Hospital for tachycardia and hypotension despite fluids administered.
Information has been received from a pharmacist referring to a 60 year old female patient. There was no information about pertinent medical history or drug reaction. On 20-MAY-2015 the patient was vaccinated with a dose of ZOSTAVAX (0.65 ml, lot # K021953, expiration date 10-FEB-2016) subcutaneously in the left deltoid region. No concomitant medication was reported. On 21-MAY-2015 the patient experienced swelling and tenderness at her injection site with the size of a golf-ball. The patient reported that the injection site was sore when she rubbed her hand over it. The pharmacist stated that she did not see any evidence of a rash, nor was the patient experiencing a fever or headache. The patient had not notified her nurse practitioner. The pharmacist stated that the patient was otherwise fine. No treatment was given to the patient. At the time of reporting, the patient was not recovered from the events. This is one of two reports received from the same reporter (1505USA015283). Additional information has been requested.
Patient experienced extreme muscle pain and loss of mobility in arm. She also felt lightheaded. She sought treatment at the hospital. She was treated with ibuprofen and cephalexin to avoid infection. I spoke to the patient this afternoon (8/3/18) and she said she has gained back some mobility but can still not lift arm above head. She is still experiencing pain.
Weakness, progressive.  Guillain Barre. Admitted to local hospital, treated with immune therapy.  Went to rehab then home.
Patient report slight pain and rash at site. Then on 7/28 the same rash on legs., very itchy. Doctor told her it is "probably" the ZOSTAVAX. Rash described as "puffy, red and itchy".
Acute Pericarditis. Patient was admitted from 12/27-12/28/2020 at hospital by cardiology team who strongly felt the acute pericarditis was due to the Pfizer Vaccine (Dr. was senior cardiologist).
Red spots noted to right upper arm after receiving Hep A. Bled at site, informed would have bruise. Bandaid removed, redness noted under bandaid. Area warm to touch. No itching, swelling or SOB noted. Had appt with private MD after left facility.
Dizzy after shot.   rashes on face and numbness on the tip of the nose and tip of the tongue within 30 minutes.  Afterwards-  skin had burning sensation on face, neck,chest and arms.  swelling in feet .   headaches, nausea, light headedness
Information has been received from a physician concerning a 6 month old male who on 03-MAR-2008 was vaccinated PO with his third dose of Rotateq. On 05-MAR-2008 2 days after vaccination, the patient experienced blood in his stools. the physician was called for medical attention. Subsequently, the patient recovered. It was noted that the patient had no symptoms after the first and second doses of Rotateq. There was no product quality complaint. Upon internal review, blood in stool was determined to be an other important medical event. Additional information has been requested.
Complained of a mild stomach ache in the morning, but not bad enough to keep him home. Staff at summer care program noticed dizziness, extreme drowsiness, sudden extreme pallor, drop in oral temp to approx 95 degrees F., chills, weakness beginning at approx. 11:00 am. Parents were notified and ambulance called. ER physicians drew blood for electrolyte, blood sugar and blood count all of which came back normal. Was observed for several hours and given ibuprofen. Within about half an hour of taking the ibuprofen he was ambulatory.
The patient expired (likely as a natural consequence of disease progression) on Hospice about 2 weeks after a C19 vaccine dose on 09/30/2021.  Expired on 10/13/2021
Fingers become numb; Fingers become cold; Don't feel anything on his fingers can´t even put on the shirt button; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Fingers become numb), PERIPHERAL COLDNESS (Fingers become cold) and HYPOAESTHESIA (Don't feel anything on his fingers can´t even put on the shirt button) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced HYPOAESTHESIA (Fingers become numb), PERIPHERAL COLDNESS (Fingers become cold) and HYPOAESTHESIA (Don't feel anything on his fingers can´t even put on the shirt button). At the time of the report, HYPOAESTHESIA (Fingers become numb), PERIPHERAL COLDNESS (Fingers become cold) and HYPOAESTHESIA (Don't feel anything on his fingers can´t even put on the shirt button) outcome was unknown.            Products known to have been used by the patient, within two weeks prior to the event, included blood pressure medicine and diabetes medicine.  Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the event is not applicable.
Severe long lasting pain in arm,; difficult to move; This is a spontaneous report from a non-contactable consumer, the patient. A 50-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration on 11Mar2021 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Mar2021 the patient experienced severe long lasting pain in arm and difficult to move even after almost 3 days. Since the vaccination, the patient has not been tested for COVID-19. The clinical outcome of the events severe long lasting pain in arm and difficult to move was unknown at the time of report.  No follow-up attempts are possible. No further information is expected.
Evening day of injection: Fatigue, chills and muscle aches. Mild headache. Night: Muscle aches worse, very little sleep all night. Next day: Whole body aches, all muscles, bad headache, hot then cold chills off and on all day.  Spent the entire day in bed. Slept better at night finally. Second day a little less severe and mostly gone by the third day.
Narrative: muscles, aches, fatigue HA 1/5/21 Fatigue, HA rash/neck. 1/14/21 n/v HA 1/15/21 nausea.
Syncope approximately three minutes after injections.  Pt. placed supine with lower extremities elevated; instant return of skin color to pink and conscienceness.  BP - 98/70 pulse 78 O2 SaO2 - 95 %.  Vitals rechecked at five minutes.  BP - 104/68 pulse 86 SaO2 97%.