chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Very strong stomach pain; This case was reported by a consumer via interactive digital media and described the occurrence of stomach pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced stomach pain. On an unknown date, the outcome of the stomach pain was unknown.   It was unknown if the reporter considered the stomach pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 08 Jan 2023 Reporter's comment: This case was reported by a consumer via interactive digital media. The patient reported after the vaccination had very strong stomach pain.
(07/05/2021) Cold like symptoms, cough, dry throat, stuffy head, not allergy related. Still having a bad cough. (7/25/2021) ER visit after consultation over the phone with doctor. Albuterol every 4hrs. Tylenol or Advil every 6hrs.
Large red hives appeared on upper thighs and buttocks and they slightly burned and itched immensely and hurt. The rash would be present for days and go away.  This went on for two months.
Vaccine received by patient on July 17, 2015 he developed abdominal pain on July 24, 2015, went to the ER July 25, 2015, developed hand numbness and ptosis on July 26, 2015. He was admitted to the hospital July 26, 2015 and is now in rehab.
FEVER, DIZZINESS, HEADACHE, MYALGIA Narrative:  EMPLOYEE RECEIVED BOTH 1ST AND 2ND DOSES AT OUTSIDE FACILITY LOT # UNKNOWN. FEVER AND MYALGIA LASTED 1 DAY; HEADACHE AND DIZZINESS LASTED 3 DAYS  Other Relevant History:
MODERNA COVID-19 Vaccine EUA Over the first day after shot, arm became increasingly sore and swollen - like being punched or running into a doorframe and getting a bad bruise.  After a few days, symptoms went away.  However, on the 7th day after shot, the arm started hurting again and I developed a large swollen lump at the injection site - it is red, painful to touch, swollen and HOT (radiating heat) compared to other arm skin around it. Size currently (on night of day 8) is about 2x3 inches. It is consistently getting worse over the last 24+ hours, so not sure how symptoms will progress yet.  Continue to have ongoing prickly skin full-body hot flashes followed by all-over cold shakes with goose bumps - but no reported fever with thermometer.
Brain fog, dizziness, odd pressure sensation in small of back, tingling hands and feet, pressure headache, high blood pressure, difficulty concentrating or holding onto a thought,  typing words backwards, handwriting briefly with left hand, letter "E" written backwards. All lasted about 5 hours. The next morning, all  side effects subsided, with the exception of the brain fog, which lingered 3 days.
blood pressure spiked 165/115; 13 hour later could not move lower extremity without stabbing pains all over; Heart palpitations; Fever for 3-4 days of 103; about 9 days later noticed dizziness starting; Vestibular vertigo diagnosed, been for physical therapy; Other vaccine same date vaccine date 16Jan2021; Other vaccine same date vaccine date 16Jan2021; 10 weeks still unable to drive or work; This is a spontaneous report from a contactable healthcare professional (the patient). A 60-year-old non-pregnant female patient received, BNT162b2 (PFIZER- BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL3246) dose 1 intramuscular, administered in left arm on 16Jan2021 12:00 as a single dose, and dose 2 via an unspecified route of administration, administered in left arm on 16Jan2021 (Lot Number: EN5318) as a single dose for COVID-19 immunization. Medical history included Arthritis, hip replacement, pre diabetes. Concomitant medications taken within two weeks included Vitamin A, B12, C, D, One a day vitamin, esomeprazole sodium (NEXIUM [ESOMEPRAZOLE SODIUM]) and fish oil. The patient took no other vaccines within 4 weeks. The patient did not have COVID-19 prior to vaccination. It was unknown if the patient was tested for COVID-19 after vaccination.Within 30 minutes of vaccination left arm ran temperature. 13 hours later, the patient could not move lower extremity without stabbing pains all over which lasted 10 hours, blood pressure spiked to 165/115. She had heart palpitations, fever for 3-4 days of 103. This cleared up, about 9 days later she noticed dizziness starting. She contacted her doctor 4 days later. Vestibular vertigo diagnosed, she went for physical therapy, chiropractic, ultra sounds, Cat scans, MRI with/without contrast, VNG, 10 weeks still unable to drive or work. It had been over 70 days. The adverse event started on 06Feb2021 at 12:30. It resulted in a doctor or other healthcare professional office/clinic visit. Treatment was being given. The outcome of vestibular vertigo, could not move lower extremity without stabbing pains all over, blood pressure spiked, heart palpitations, fever, dizziness, unable to drive or work was not recovered  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on plausible dose- event relationship post-vaccination  and no alternate explanation the causal role of BNT162B2 vaccine cannot be excluded for the 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
Extreme Chills, body aches continuing from 12 hours after shot to 2/11/21...eye ache and fatigue.
Information has been received from a physician concerning a 19 week old male with a history of reflux and no drug reactions/allergies, who on 29-AUG-2007 was vaccinated po with a first dose of Rotateq (lot number: 657511/0553U). On 09-NOV-2007 the patient was vaccinated with a second dose of Rotateq (lot number: 657667/1392U). Concomitant vaccinations that day included PEDIARIX, Hib conj vaccine, PREVNAR. Concomitant therapy included ZANTAC. On 11-NOV-2007 the patient experienced vomiting, diarrhea and refused to eat. On 12-NOV-2007 the physician examined the patient. The child was eating but his other symptoms had not resolved. On 13-NOV-2007 the patient was examined in the emergency room and diagnosed with hemolytic anemia. The patient was admitted and transferred to the Intensive Care Unit. Lab diagnostics studies were performed and included: hemoglobin 6 g/L and creatinine 3 mg/dL: 13-NOV-2007. The outcome was reported as not recovered. No further information was available. There was no product quality complaint. The adverse events were considered to be an other medical event, disabling and immediately life-threatening by the reporter. Additional information has been requested.  11/26/2007 MR received. Child presented to local ER with 3 day hx of vomiting and diarrhea.  Decreased oral intake x 3 days.  No urine output since prior pm. Puffiness of hands and feet beginning day before admission, and maked pallor.  Child was transfered directly to PICU of local Hospital for eval.  Pt noted to have dry mucus membranes, delayed cap refill, hypertension 160's/100's, and a faint erytematous macular rash. Admission PE (+) for moderate respiratory distress, tachypnea and grunting respirations, marked pallor, edema of hands and feet, scrotal edema, abdominal distention, tachycardia, irritability and tea-colored urine.  Admitted with Hemolytic Uremic Syndrome requiring dialysis.  Peritoneal dialysis catheter inserted on 11/13/07 and returned to OR x2 for catheter malfunctions.  PICU note on day #14 shows current problem list:  Acute renal failure 2' hemolytic uremic syndrome.  Hypertension. Serratia marcescens bacteremia.  Acute upper GI bleeding. Nutritional deficiencies on TPN. Electrolyte abnormalities.  Anemia requiring intermittant transfusion. Thrombocytopenia requiring platelet transfusions.  Hypogammaglobulinemia.  Narcotic Abstinance syndrome.  Wolff-Parkinson-White pre-excitation syndrome.  Acute respiratory failure requiring mechanical ventilation-now resolved. Massive anasarca-now resolved.  Hypoalbuminemia and hypo proteinemia now resolved.  12/27/2007 D/C Summary received for DOS 11/13-12/18/2007 with Final DX:  Acute Renal Failure.  Probable hemolytic uremic syndrome.  Hypertension.  Anemai.  GI bleeding 2' to irritation from NG tube. Pt on dialysis 11/14-12/07/2007 with reduction in creatinine. Pt remained somewhat hypertensive during admission. D/C on Enalapril and Norvasc. otherwise as above.
2 days after vaccine, right arm broke out in hives forming large plaque, itchy, hot to touch , about 4 inches by 3 inches right now, and spreading on arm,
12 hours later the patient experienced a fever of 101.3 F and headache; 12 hours later the patient experienced a fever of 101.3 F and headache; This spontaneous report was received from a consumer, via a company representative, and refers to a 13 year old male patient. The patient had no pertinent medical history or allergies. No information was provided regarding the patient's concurrent conditions and concomitant medications.  On 25-JUN-2019, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) intramuscular (strength, dose, anatomical location, lot number and expiration date were not reported) for prophylaxis.  On an unspecified date in June 2019, reported as "12 hours later", the patient experienced a fever of 101.3 degree Fahrenheit (°F) (pyrexia) and headache. Fever decreased to 99 °F at an unspecified time.  At the reporting time, the patient had not recovered from his pyrexia and headache. The reporter did not provided the causality assessment between the aforementioned events and therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).
I had been vaccinated and boosted a total of four times as of January. Then, on May 1st I was symptomatic and tested positive (PCR) for Covid-19.
I woke up on 6/25 with a scratchy throat. A few hours later I was feeling worse. I slept 6/25 all day. I felt bad with a scratchy throat and tightness in chest. I was very thirsty and drank lots of water. I slept until about 2 pm on 6/26 and felt much better. I have felt better every day since. By 6/27 I was mostly back to normal.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant therapies and drug reaction or allergies was provided. On 01-NOV-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # R016127, expiration date: 22-MAR-2018, (exact dose was not provided) intramuscularly for prophylaxis. There was no adverse effect reported. Administered dose of vaccine experienced temperatures of 32 Fahrenheit degrees (F) up to 35 F (32.5F) for 82 hours and 47 F to 77 F (55.6 F) for 6 hours. Data logger was involved. There were no previous excursions reported.
Within hours of receiving vaccine had headache, took Ibuprofen and went to bed early. When woke up still had headache, as the morning went on developed muscle aches, chills, nausea, fatigue and aching joints. These symptoms lasted for 48 hours, and were debilitating. Took Tylenol q6 hours.
Patient has hx of hypertension and Stage 3 kidney disease, obstructive sleep apnea with c/o palpitations, productive cough, congestion, fatigue, and weakness. Patient's HR was up and EKG revealed atrial fib with RVR.  He was given antibiotics and steroids He was discharged on 8/22 and was readmitted on 8/25 with worsening of symptoms  patient developed sepsis and returned with afib with RVR again. Patient's oxygen demand increased and worsening resp. failure patient was intubated and placed on a ventilator. Patient also had a NSTEMI Patient was terminally extubated and expired on 8/28.
Got second dose of vaccine the morning of March 10th.  Had the "expected" symptoms of fatigue, headache, and chills the evening of March 10th. Woke up on March 11th around 6:50am and felt the same symptoms as the night before but also really hot and nauseous, stood up and began to slowly lose vision. Went to parents for help and they saw me pass out and collapse. Went to  Emergency Room and they found I had a really high heart rate and I received an IV to help with rehydration. Was released after that and have continued to have the same symptoms plus muscle soreness but no longer feel as dizzy and haven't had any issues with vision or consciousness since.
Patient states with first vaccine red spots appeared on feet with some discomfort. When they got the second shot, the discomfort increased to pain and  shoots up to knees.
Shooting lights in left eye; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: er8727) via an unspecified route of administration in the left arm on 04Apr2021 at 15:30 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not have allergies to medications, food, or other products. The patient received unspecified concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 05Apr2021, on the second day, the patient experienced shooting lights in the left eye. The patient reported that he had no issues on the day of the shot. The events did not result in a doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care visit. The patient did not receive any treatment for the event. The clinical outcome of the event shooting lights in left eye was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
dizziness after 15 minutes sitting down post vaccination. Recommended pt to sit another 10 minutes to sip on water, snack and relax.  after which pt stated she felt better. no more dizzines
She had heavy bleeding from her vagina; This is a spontaneous report received from a contactable consumer. This consumer reported for female patient (wife) that: A 63-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  Patient had first shot of vaccine and had heavy bleeding from her vagina. So don't know if this had something to do with it, also patient is 63 years old and highly unlikely that she is having periods. Reporter concern "I don't know about it and I want to know if there are people who have experienced similar situations or did anyone report to you about the similar condition. Also, I want to know, is there any solution to the problem?". The outcome of the vent was unknown.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
Fluid buildup under arm after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE OEDEMA (Fluid buildup under arm after 1st dose) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010a21a) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-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 VACCINATION SITE OEDEMA (Fluid buildup under arm after 1st dose). At the time of the report, VACCINATION SITE OEDEMA (Fluid buildup under arm after 1st dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided No treatment information provided
Initial case received from health care professional on 06 February 2012. A male patient received an injection (route and site not reported) of ADACEL, sanofi pasteur Ltd. lot number not reported, three to four years ago (date of vaccination not provided). The patient's medical history, any concomitant medications, and any illnesses at the time of vaccination were not reported. Three to four years post-vaccination with ADACEL, the patient tested positive for Pertussis. The outcome was not reported. Documents held by sender: none.
This spontaneous report as received from a Registered Nurse refers a patient of unknown age with no pertinent medical history/drug allergies or drug reactions reported. On 20-MAY-2015, the patient was vaccinated with an unspecified dose of improperly stored (Oka-Merck) PROQUAD (route and anatomical location were not reported), lot # K022448 expiration date 13-MAY-2016. There was no concomitant therapy reported. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
4 hours after taking first dose patient developed a rash.  Patient took diphenhydramine and called Dr.  Rash has since subsided and pt was advised by doctor to discontinue use.  Patient was advised by pharmacist that he would be high risk for getting IM immunization due to suspected allergic reaction to oral vaccine.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm, I had that with the first 2 doses) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.  The patient's past medical history included Pain in thigh (in September or October), Surgery in November 2019 and Surgery ((right Leg) product of a clot for the previous surgery.) in January 2020.Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] and IBUPROFEN (EXCEDRIN IB) for Anticoagulant therapy. On 05-Mar-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 VACCINATION SITE PAIN (sore arm, I had that with the first 2 doses). At the time of the report, VACCINATION SITE PAIN (sore arm, I had that with the first 2 doses) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.No Treatment informations were reported.Patient stated that since the surgery she takes a full aspirin and Excedrin to make the blood thinner.This case was linked to MOD-2021-395886 (Patient Link).
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, previous drug reactions or concomitant medications. On 31-AUG-2018, the patient was inadvertently vaccinated with (rHA) (M-M-R II) lot number M034857 with expiration date on 27-JUL-2018 with sterile diluent (MERCK) lot number M031575 with expiration date on 26-MAR-2019 (strength, dose, route of administration, anatomical location, lot number and expiration date were not reported) for prophylaxis. No adverse effects were reported.
When I received my vaccine when I was waiting the 15 minute period. My right for arm hurts really bad. It started going down my right leg. After I few weeks it went away. Than a few weeks ago it started hurting intensely again. I had a dr. Appointment for a normal visit. I mentioned my arm and elbow hurting bad.  I never mentioned getting the shot in that arm or what had happened to me. I did not think about the relation to the shot until after the visit because he kept saying you had to do simmering to make this happen but I can not recall anything except the shot.
p/vax pt felt faint;then pt briefly passed out then pt vomited;MD felt pt episode sz secondary to vasovagal response;
Began with deep itching feeling in feet. Loss of balance. Foot drop. Bilateral polyneuropathy in feet and hands. Loss of weight, extreme fatigue, dizziness, difficulty swallowing even liquid. Crossed vision.
Immediately after receiving 1-2 drops of the ROTATEQ vaccine, the infant's face turned red and had projectile vomitus.  Second attempt a few minutes later (1-2 drops) the same outcome.  ROTATEQ stopped.  Referred to hospital today.
Heart palpitations to the point where I could not sleep; Heart palpitations to the point where I could not sleep; Extreme fatigue; Slight headache; sore arm; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received first dose of BNT162B2 (brand=PFIZER), via an unspecified route of administration (vaccine location=right arm) on 28Jan2021 15:45 at a single dose for COVID-19 immunization. Medical history included breast cancer and mitral valve prolapse. She had no known allergies. Concomitant medications included celecoxib (CELEBREX). No other vaccine in four weeks. No covid prior vaccination. The patient experienced heart palpitations on 28Jan2021 10:00 PM to the point where she could not sleep - started 6-8 hours after receiving vaccine. Some better the next day but still having palpitations. Day 2 after vaccine about the same. Extreme fatigue, slight headache & sore arm but not too bad on an unspecified date in 2021. No treatment received for the events. No covid test post vaccination. The patient was recovering from heart palpitations to the point where I could not sleep while outcome of other events was unknown.  Information on the lot/batch number has been requested.
Pain and swelling both arms, redness at sites of inj., pains all joints inch. Fingers. Admin ADVIL (3x200mg) every 4 hrs; awoke at 630 AM with shaking chills; took 2 TYLENOL (500mg) every 4 hrs., forced fluids, lasted 2 days w/severe aches and pains; then began to subside; 4th day normal, but sore left shoulder for 8 week.
pt recvd vax; lab eval showed that pt did not seroconvert due to no titer;
Information has been received from a physician concerning a 19 week old female who on 27-NOV-2007 was vaccinated with a 0.5 ml second dose of PEDVAXHIB (OMPC) (Lot #"1164U").  Concomitant vaccination on the same day included PEDIARIX and PREVNAR.  On 01-DEC-2007 the patient developed a rash on her face and backside of her neck.  There was no laboratory or diagnostic tests performed.  Unspecified medical attention was sought.  At the time of the report the patient had not recovered.  The patient did not have any AE with the first dose of PEDVAXHIB (OMPC).  Additional information has been requested.
Severe pain that woke me up in the middle of the night and could not move arm.  The next day I had a large red rash on the arm bicep area.