chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm is getting progressively redder at injection site and each day the red area is growing larger/spreading further; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15Sep2021 at 16:15 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 and birth control. The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included unspecified birth control medication from unknown date and unknown if ongoing and unspecified vitamins for unknown indications from unknown dates and unknown if ongoing. On 16Sep2021, the patient's arm was getting progressively redder at injection site and each day the red area was growing larger and spreading further. The patient was documenting it with pictures. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, on an unknown date, the patient underwent nasal swab test for COVID-19 and the result was negative. The clinical outcome of the event arm is getting progressively redder at injection site and each day the red area is growing larger/spreading further was not recovered at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
On 02/05/2021, My hands started to itch around 12:00 pm. after I had my hair colored.  At night I got home and I noticed I had hives, and I had them everywhere: neck, arm, stomach, sides, and my hands were all red. I took pictures and sent them to Dr. The doctor's colleague specifically asked  if I had the vaccine.  She  said not to worry because other people where having rashes. It started off with the hives. It dissipated to my hands, lower arms and face, as though I was flushed.  It lasted about a week to week 1/2.  I had an appointment with my allergist and he took an allergy test, on 02/16/2021, to see if I was allergic to  hair dye and dogs.  When I got the rash,  the blood work stated I had Hashimotos Syndrome, on 02/11/2021. I did not have Hashimoto Syndrome prior to the vaccine. I always had symptoms, of thyroid symptoms, like I was always cold, chills, dry skin, my hair sometimes falls out easily. I was born with thyroglossal cleft cyst.  It  was dormant. My thyroid test results were always negative before the vaccine. After the vaccine I had antithyroid peroxidase ab test and the result were high. (57.9-positive).  The vaccine brought out Hashimotos Syndrome.  I don't think it gave me Hashimoto. After I received the 2nd shot I got the rash, and was diagnosed with the Hashimoto.
Low white blood count and elevated D-dimer.  Leading up to the blood work was sever chest pain, ultimately diagnosed as acute gastritis (not typical for me at all). Other symptoms were general body aches and fever.  CT ruled out blood clot.
Experienced a first time episode of sustained Supraventricular Tachycardia (SVT) on 4/28/22, two weeks after the injection.  No history of this previously.  Heart rate was 240 and was treated with IV Adenosine in Emergency Room to convert rhythm after  over an hour of SVT causing shortness of breath and dizziness.
(11/14/2020) Patient is a 47 yo male, + chronic UC on Xeljanz since 2017 here with R sided rash. Clinical exam and history consistent with herpes zoster.   Differential diagnoses to include but not limited to:  Herpes zoster, dermatitis, tinea   Valtrex 1 g tid x 7 days, calamine lotion, tylenol or advil for pain control.  Herpes Zoster successfully resolved after 5 weeks
One day after vaccination, patient reported redness, pain and warmth at injection site that spread across upper arm over the course of 2nd and 3rd day after vaccination. Knot at injection site.
Woke up following morning after vaccine, felt very disoriented, confused, having hard time balancing and standing. Patient was unable to keep focus when looking something up on her phone and her eyes could not focus on the keyboard. Blood pressure came back 108/61. typically, this patient has high blood pressure even with medication. Felt very tired and fell back asleep for two additional hours. She woke up again trembling and freezing, but had a temperature of 102 degrees Fahrenheit. she covered herself in warm blankets, and took Tylenol. she slept again and woke up five hours later, took another Tylenol, then went to sleep again. Later that evening of the 19th, her fever broke.
Patient developed rash.  Went to Dr. After examination Dr. told patient she had shingles
Heart rate increase approx. 4 minutes after injection. Tongue became swollen and itchy on the side s of the tongue about 18 minutes after injection, with a difficulty in ability to swallow.  Extreme thirst for about 1.5 hours following the injection. No difficulty breathing, no throat swelling.
face drooped; garbled speech; Initial information regarding an unsolicited valid serious case was received from a consumer/non-health care professional (patient's husband) via Medical Information (Reference number- 00806677) and transmitted to Sanofi on 11-Oct-2021.  This case involves a 79-year-old female patient who experienced face drooped (facial paralysis) and garbled speech (dysarthria) while receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Relevant medical history, medical treatment(s), vaccination(s) concomitant medication and family history were not provided.  On 08-Oct-2021, the patient received 0.7ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination.  On 08-Oct-2021 the patient developed a serious very-very, violent reaction as face drooped (facial paralysis) and garbled speech (dysarthria) same day (about an hour later) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  facial paralysis event was assessed as medically significant.  Additionally, it was reported that fearing a stroke her husband called ambulance, the admitted her into the hospital and after about 2 hours of observation her stroke signs disappeared and she was discharged, she was instructed to follow up with a neurologist.  No relevant laboratory data was provided.  It was not reported if the patient received a corrective treatment for the events.  Patient was recovered from both events on an unknown date.  There will be no information available on the batch number for this case.; Sender's Comments: This case concerns 79-year-old female patient who experienced facial paralysis and dysarthria after vaccination with FLUZONE HIGH-DOSE QUADRIVALENT. The time to onset is compatible with the role of the vaccine. Additional information regarding patient's past medical history, condition at the time of vaccination, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Patient felt like the right side of her face felt "weird" and tight. Received Benadryl 25mg po and symptoms improved.
After receiving my third Hep B ? I experienced flu-like symptoms, headache, chills, fever and overall fatigue and body aches.  It has persisted for two days.
Positional vertigo developed 4-5 days post second injection of Moderna vaccine.  Still continues at the time of this reporting.
I suffered a major Saddle Pulmonary Embolism (SPE) that left me needing to airlifted twice,; open heart surgery to remove the clot; needed to relearn walking, gaining all my balance, and all other body functions as well as regaining my strength.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2), on 28Apr2021 as dose 2, single (Lot number: EW0172) at the age of 62 years for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing), notes: Other medical history: COPD. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE (Lot No.: EN6027)), administration date: 05Apr2021, when the patient was 62-year-old, for COVID-19 Immunization. The following information was reported: PULMONARY EMBOLISM (hospitalization, disability, intervention required, medically significant, life threatening) with onset 25May2022, outcome "recovered with sequelae", described as "I suffered a major Saddle Pulmonary Embolism (SPE) that left me needing to airlifted twice,"; BALANCE DISORDER (hospitalization, disability, life threatening) with onset 25May2022, outcome "recovered with sequelae", described as "needed to relearn walking, gaining all my balance, and all other body functions as well as regaining my strength."; THROMBOSIS (hospitalization, disability, intervention required, medically significant, life threatening) with onset 25May2022, outcome "recovered with sequelae", described as "open heart surgery to remove the clot". The patient was hospitalized for pulmonary embolism, thrombosis, balance disorder (hospitalization duration: 60 day(s)). The events "i suffered a major saddle pulmonary embolism (spe) that left me needing to airlifted twice,", "open heart surgery to remove the clot" and "needed to relearn walking, gaining all my balance, and all other body functions as well as regaining my strength." required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative. Therapeutic measures were taken as a result of pulmonary embolism, thrombosis.  Clinical information: The patient suffered a major Saddle Pulmonary Embolism (SPE) that left the patient needing to airlifted twice, undergone open heart surgery to remove the clot, the patient was on full life support: a ventilator and ECMO machine for 30 days where the patient remained in the ICU. The patient spent another 30 days in the step down ICU before being transferred to a rehab facility for 3 weeks where the patient needed to relearn walking, gaining all the patient balance, and all other body functions as well as regarding the strength. There was No family history of blood clots. The patient recovered with lasting effects. The patient did not had covid prior vaccination. The patient was tested for covid post vaccination.
ongoing fatigue and exhaustion for more than 2 weeks. during the afternoon, relieved temporarily with sleep and rest.
Approximately 2 minutes after receiving vaccines, at 10:35am, while sitting in parent's lap, pt had what appeared to be a tonic seizure x 10 seconds.  Pt did not sustain any injuries before/during/after seizure.  Immediately following seizure, pt was able to state his name, squeeze his mother's hand when prompted, and nod in agreement to questions.  Pt was alert and oriented but fatigued, stated he didn't want to sit up because he was tired. Per parent, pt did eat breakfast that morning. Pt appeared pale and clammy.  Manual BP was taken (82/62 right arm, sitting) and temp (96.3 oral), slightly decreased. Snacks and juices given, which pt consumed readily. Pt complained of nausea for a few minutes and then resolved. Parent was given information for ED and nearby urgent cares, and offered to call EMS. Parent declined.  After about 40 minutes in observation pt was standing and walking around, color returned, speaking regularly. BP taken again, improved (96/70).  Parent called pediatrician and set up appt for 4pm same day.   Pt ambulated out of clinic with parent, alert, oriented, and steady on feet. Per parent, pt had appt with pediatrician same day as event at 4pm, physical exam was within normal limits. No testing was done.  Pt has appt scheduled with neurology in 2 weeks.
felt numb and emotionless; felt numb and emotionless; felt sick to my stomach; Food does not take good anymore and I have to force myself to eat; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 11May2021 16:30 (Batch/Lot Number: EW0173) (at the age of 27-year-old) as 2nd dose, single for covid-19 immunisation. Medical history included known allergies nickel. Concomitant medications included none (did not receive other medications the patient received within 2 weeks of vaccination). The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 administered in Arm Right on 20Apr2021 17:30 (Batch/Lot Number: EW0170) for covid-19 immunisation and had no adverse event. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 12May2021 09:30, the patient experienced felt numb and emotionless, felt sick to my stomach and food does not take good anymore and i have to force myself to eat. Seriousness criteria reported as non-serious. No treatment was given for the events. The outcome of the events was not recovered.
approx 5yrs p/vax pt devel pneumococcal pneumonia; hosp;pneumonia & sepsis due to streptococcus pneumoniae; renal failure.
Ache; Arthritis flare up; Numbness in Leg; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Ache), ARTHRITIS (Arthritis flare up) and HYPOAESTHESIA (Numbness in Leg) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ADALIMUMAB (HUMIRA) for Psoriatic arthritis.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (Ache), ARTHRITIS (Arthritis flare up) and HYPOAESTHESIA (Numbness in Leg). At the time of the report, PAIN (Ache) outcome was unknown and ARTHRITIS (Arthritis flare up) and HYPOAESTHESIA (Numbness in Leg) had not resolved.            Concomitant Drugs was not Reported. No medical history was provided by the reporter.
bell's palsy; stroke; diplopia; parethesias; Information has been received from a lawyer regarding a case in litigation and refers to a currently 60-year-old patient of unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 22-APR-2016, the patient was administered zoster vaccine live (ZOSTAVAX) (strength, dose, dose number, route, anatomical site of vaccination, lot number and expiration date were not provided) by a medical assitant for the long-term prevention of shingles and zoster-related conditions. On an unknown date (reported as subsequently), the patient was treated by providers for diplopia, paresthesia, Bell's palsy, and stroke. The patient claimed damages as a result of injuries to themselves, loss of consortium, loss of services, and economic losses. At the time of this report, the outcome of the events was unknown. The lawyer considered the events to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, stroke and Bell's palsy were considered medically significant events.
Patient was administered the 2nd dose of their vaccine series 14 days after the first dose, instead of 21 days
Information has been received from a medical assistant referring to a patient of unknown age and gender. No concurrent or historical conditions were reported. On 09-MAR-2015 the patient was vaccinated with a dose of improperly stored M-M-R II (dose unspecified in series) (lot # J008154, expiration date: 08-JUL-2015, subcutaneous, 0.5 ml, once). No adverse effects were reported. Additional information has been requested.
Approximately 15 minutes after the shot, I got lightheaded. A couple of hours later, my arm was sore and I started feeling tired. The next morning when I woke up, I felt like I had run a marathon and got hit by a semi-truck at the same time. My legs started having shooting pains. I could not walk normally. I ran marathons  before and I had the marathon walk. I could not walk for more than a couple of steps without having severe pain. It felt like all the nerves in my legs were on fire. It took approximately 4 or 5 days for the pain to stop and I could walk normally. I was in bed for 4 days. It took about 2 weeks to feel back normal. Then I started having spotting. I have not had a period or any break through bleeding in over 6 years. That lasted about 3 days. As of today, I am in a small flare. It is not a full flare but am having symptoms. If the symptoms do not improve in the next 2 weeks, I will be going to my GI doctor.
Vaccinated pt admitted with symptomatic covid infection. No information available about vaccine type, date, location, etc.
Patient received flu vaccine on 12/30/21 after already receiving on 11/19/21.
From 9:30-11am significant decline from minimal symptoms to headache, body ache, soreness at site of injection, fever (99.5°-100°). At 12pm took acetaminophen 325mg x2, reduced symptoms to manageable discomfort and no fever. Symptoms (incl fever) returned by 6pm, took another round of acetaminophen 325mg x2, which again helped through bedtime. Slept through the night, no fever next day.
10 days after vaccination, "red raised are where I got the shot; it was more like a hive." She c/o itching and warm to touch. x 2 days on Benadryl and symptoms resolved. Called PCP; they stated to call Employee Health at vaccination site.
On 2/19/19, patient presented back to pediatrician's office with rash over bilat lower extremities, left ankle with larger erythematous raised patch, scattered rash on hand, toe, ear; Edema over the knee bilat, right greater than left; right knee painful to touch; irritability and excessive crying.
Information has been received from a nurse concerning patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On unknown dates, the patients were vaccinated with PNEUMOVAX 23 (lot # M022086 with expiration date 09-OCT-2017) (dose, strength, frequency, route of administration and anatomical location were not reported), for prophylaxis. The administered vaccines were improperly stored at temperature 47.1°F for 24 days without any previous temperature excursion; this information was not registered in a digital data logger. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA006677: US-009507513-1707USA006678: US-009507513-1707USA006679: US-009507513-1707USA006675: US-009507513-1707USA006507:
3-20-21: The day after the shot I had a miner swollen lymph node inner elbow area which went away.  4-18-21: Perfect health. No pain in left arm. 4-19-21 to 4-20-21 : Over 24 hours sudden increase of swollen lymph node of the inner elbow area of my left arm. Constant pain which increases sharply with arm movement. Unable to lift arm without high level pain. Can't put left arm through coat sleeve without assistance. No medical assistance yet, as this just occurred.  Waiting this week to see if it gets better.
Fever about an hour after injection then swelling headache and after a few weeks her periods became irregular and her started having insomnia. Then after two or three months her periods ceased all together.
This case was reported by a consumer via call center representative and described the occurrence of psa increased in a 71-year-old male patient who received SHINGRIX (batch number CH2X7, expiry date 25th April 2020) for prophylaxis. On 5th June 2018, the patient received SHINGRIX. On 5th June 2018, less than a day after receiving SHINGRIX, the patient experienced PSA increased. On an unknown date, the outcome of the PSA increased was unknown. It was unknown if the reporter considered the PSA increased to be related to SHINGRIX. Additional information was reported as follows: This case was previously not reported to anyone. The patient stated that he was on other medications at the time of vaccination with SHINGRIX, but the patient did not listed them. The patient showed his normal Prostatic specific antigen reading as 4.3 and 4.7. The patient received vaccination with SHINGRIX, and had his prostatic specific antigen was tested routinely the same day. After vaccination with SHINGRIX, when the patient's blood was withdrawn, the prostatic specific antigen lab test showed a level of 7.5. On 19th June 2018, the test was repeated for the patient and the prostatic specific antigen lab results showed as 8.0. The patient provided contact details of the physician. Follow-up information was received from physician on 3rd October 2018:  The batch number and expiry date for SHINGRIX was updated. The patient was vaccinated with the 1st dose of SHINGRIX intramuscularly. The VAERS details were updated. Lab Comments: On an unknown date the patient showed his normal Prostatic specific antigen reading as 4.3 and 4.7.
diarrhea and irritability developed 24 hours after immunizations;  no fever or vomiting or rash;  no weight loss; slowly improved over 7 days
Lose of taste, ended up in ED on 1/27 for COVID like symptoms, two negative tests.
Two days after vaccination pt presented with redness, swelling, warmth, and inflamed area. Seen by physician and diagnosed with cellulitis. Antibiotics were prescribed and pt is responding to treatment. Additional correspondence received on 04/06/2001, it was reported that the pt recovered from this experience.
Starting the night after the vaccination Jan. 7 the patient woke up with a fever of 100.2 and also arm soreness, body aches and headache. Patient temperature spiked to 101.2 at 9pm that evening.  Jan 9 patient temperature was 100.5 at 3pm and patient noticed some stuffiness in the nose. Jan 10 temperature 99.5. Jan 11 3am temperature of 101.3, stuffy nose, cough, body aches, headache, nausea. Jan 12 temperature of 102.8 with Rigors. Jan 13 still having headaches, on and off nausea, cough, low grade fever 99.2. Jan 14 Temperature 100.9. Jan 15 Temperature 101.8. Patient continues to have fever every evening.
Information has been received from a consumer via a website concerning a female patient of unknown age. On an unknown date, the patient was vaccinated with GARDASIL (lot#, dose, and route not provided). On unknown date, the patient died in her bath. The patient had been so healthy prior to the vaccination. The post mortem result stated a cause of death unknown. Additional information has been requested.