chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sleeping over 8 hours a day ever since; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Sleeping over 8 hours a day ever since) in a 34-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2020, the patient experienced SOMNOLENCE (Sleeping over 8 hours a day ever since). At the time of the report, SOMNOLENCE (Sleeping over 8 hours a day ever since) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case concerns a 34-year-old of unknown gender who experienced nonserious unexpected event of somnolence.  Event onset occurred the same day as the first dose of mRNA-1273. Treatment not reported. Event resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Reporter's Comments: This case concerns a 34-year-old of unknown gender who experienced nonserious unexpected event of somnolence.  Event onset occurred the same day as the first dose of mRNA-1273. Treatment not reported. Event resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
NOT BE ABLE TO WALK FOR 7 WEEKS; COULD NOT BEND LEGS; ALL THE INFLAMMATION; 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 number. No concomitant medications were reported.  On an unspecified date, the patient experienced not be able to walk for 7 weeks, could not bend legs, and all the inflammation. Treatment medications (dates unspecified) included: cortisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from not be able to walk for 7 weeks, and the outcome of all the inflammation and could not bend legs was not reported. This report was non-serious.
multiple patients were vaccinated with improperly stored VAQTA on multiple dates; no adverse effect; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 13-FEB-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated(VAQTA) lot # R002086, expiry date 22-APR-2019 for prophylaxis.  No adverse event was reported. Previous temperature excursion was reported. Data logger was involved.
This medically confirmed health authority report (initial receipt 22-Feb-2016) concerns a 37 year old patient with unknown gender. On 30-Sep-2015, the nurse had re-used the syringe for multiple patients at an employee influenza vaccination clinic. The nurse brought three multiple dose vials of the vaccine that were intended for another event and were stored in her personal fridge without temperature monitoring. The nurse reported using two syringes she found in her supplies to administer vaccine to 67 patients. She reported wiping the syringes with alcohol and using a new needle for each patient. Only 2 multiple dose vials of vaccines (10 doses/vial) were used for 67 adult patients. This patient (one of the 67 patients) was administered intramuscular AFLURIA injection (batch number: 11049221A) in the arm. The patient was offered blood pathogen testing (hep B, hep C, HIV), hepatitis B vaccine and flu vaccine. On 05-Oct-2015, the patient underwent laboratory tests which showed positive results for Hepatitis B core antibody and was negative for hepatitis B surface antibody, hepatitis B surface antigen, HIV antibody, HIV antigen and hepatitis C antibody. The outcome was unknown.
Pt vaccinated with DTP developed fever to 103 & vomited during the night following immunization. Next day, fever 102.6, headache & five episodes of vomiting; no diarrhea.
Post vax, the pt developed a fever of 104.3 with generalized tonic/clonic seizure activity for approximately 10 minutes. Resolved spontaneously.
On 7th day my stomach started hurting and swelling. The pain was intense by the eleventh day including the left side. For the next week  the swelling and pain got worse and worse. I could not zip up my pants from the swelling. By the 14th day I had to leave work and go to the emergency room. I could not go to the bathroom because I was so swollen internally. I felt like I was going to throw up while I was in the waiting room. I couldn't stand up straight from the pain and also could taste everything starting to come up from my stomach and felt the burning in  my throat. I had cramping in my legs, feet and hands.
Sleeplessness. Have been awaking at 3:30 AM since first vaccine.; This is a spontaneous report from a contactable consumer, the patient. A 47-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 on an unspecified date in 2021 and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 19Apr2021 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy to penicillun (Penicillin allergy). Concomitant medications were not reported.  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. On an unknown date in 2021, the patient experienced sleeplessness and had been waking up at 03:30 since the first vaccine. The event did not result in doctor or other healthcare professional office/clinic visit/ emergency visit. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event sleeplessness was unknown at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous report has been received from a physician referring to a patient of unknown age and gender. No concurrent or historical condition was reported. On 07-JUL-2015 the patient was vaccinated with an improperly stored dose of VAQTA, dose, route, frequency, Lot number and anatomical location were unknown. No adverse event was reported. This is one of several cases received from the same source. Additional information has been requested.
Headache throughout day into next day (over 24-hours since injection.)  Took 2 Tylenol  after 24-hours from injection.  Chills started 12 hours after injection.   Lasted for 5 hours.    Others:  Joint paint. Fatigue.  Nausea.   All started 12+ hours after injection.
This spontaneous report was received from a pharmacist referring to a patient of around 30 years old and of an unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not provided. On an unknown date, the patient was vaccinated with ZOSTAVAX (Lot number, expiration date, dose and route were unknown) for prophylaxis. The dose was administered for an unspecified physician. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
High Fever:  -Fever got up to 102.5 and would not come down below 100 even with medicine.  -Fever lasted about 18 hours  Chills: - so cold that teeth were chattering and body shaking  Sweats: -sweating throughout the night to point where sheets were wet  Headache: -Migraine headache throughout the night -mild headache the next AM
Shot given 6/5/08 by the evening area was the size of a golf ball.  By morning it grew larger, hot to touch, itchy.  By the evening of 6/6/08, it had blistered and burst with serious fluids.  Today, 6/7/08, she has a 4x4 cm wheal in the center of a 18x20cm.  Localized raised red area on back of left arm.
I am 22 weeks pregnant.  I have had no pregnancy issues.  But, I got Pfizer vaccine (first dose) on august 10th at 8 AM.  ON august 12th. My headache and body aches from the vaccine had went away, but my body now has ?tics? almost like someone with Tourette?s.  I have 2 kids to care for. Ages 2 and 8 months. Plus my body, being pregnant. Can?t handle it. It happens when I?m driving, sitting, laying down, in the shower, cleaning. Etc. my baby is healthy as of now. But, I?m having tic attacks. And the only thing that could?ve caused them is the vaccine.
This spontaneous report was received from a physician referring to 3-year-old male patient. Pertinent medical history or concurrent conditions were not reported. No information regarding the patient's pertinent medical history, concomitant medications or drug reactions or allergies was provided. On 24-MAY-2017, the patient was vaccinated with an improperly stored dose of VAQTA (lot # N005274 and expiration date 03-APR-2018; dose and route of administration were not reported) for prophylaxis. It was reported, that on several dates between 24-APR-2017 until 07-SEP-2017, the vaccine was exposed to various temperature excursions ranging from 32 degrees Fahrenheit (F) to 54F for the period of up to 70 hours at a time. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one case from several cases from the same reporter. Sender's Comments: US-009507513-1709USA007325.
Had a migraine for three days; headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Dec2021 (Lot number: 331308A, Expiration Date: 28Feb2022) at the age of 38 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Use to get migraines quite a bit" (unspecified if ongoing), notes: The caller use to get migraines quite a bit and received Botox for this.; "Allergic to Shellfish" (ongoing), notes: The caller had the reaction when was 14 or 15 years old.; "Allergic to Iodine" (unspecified if ongoing), notes: The caller had the reaction when was 14 or 15 years old. There were no concomitant medications. Past drug history included: Botox, start date: 2020, for Migraine, notes: The caller use to get migraines quite a bit and received Botox for this. The caller hasn't had a migraine since stopped getting Botox injections. The following information was reported: MIGRAINE (non-serious) with onset 22Dec2021, outcome "recovered" (25Dec2021), described as "Had a migraine for three days"; HEADACHE (non-serious) with onset 22Dec2021, outcome "recovered" (29Dec2021), described as "headache".  Additional information: The caller used to get migraines quite a bit and received Botox for this. The last time the caller received Botox was in 2020. The caller hasn't had a migraine since stopped getting Botox injections. Then the caller got a migraine after receiving the first dose Adult Pfizer Covid Vaccine. The migraine began, 22Dec2021. The caller had a headache that lasted for a week, but the migraine was three days. The caller was completely down, no light, no sound. nothing for three days during the migraine. Additional vaccines did not administer any other vaccine on same date of the Pfizer Suspect. AE(s) did not require a visit to an emergency room or physician office. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Relevant tests were none.  No follow-up attempts are possible. No further information is expected.
Starting  25-30 minutes after the first dose of the Pfizer-BioNTech Vaccine was administered, patient started to experience numbness in her face, chest pressure and gastrointestinal discomfort.
Muscle soreness/pain on the arm received the vaccine, started soon after the jab, lasted for two days Rash on the arm received the vaccine, 2'x1' started a week after the jab, lasted for a week
1st shot March, second in April - my May I had a nodule, which I did not know was Dupuytrens Disease. I got booster in November and within 2 weeks had 6 more nodules on my hand. Cytokines  are involved in Dupuytrens - I have no family history and nothing before any vaccination. Took off aggressively after booster which is atypical for this diseases. There are so many women in chat rooms about this disease and recent occurrences. Generally men are more prone to DD. On top of that, no research on this rather common, debilitating disease. I am very pro vaccine but will not be getting another booster as I am convinced it kicked this disease off.
Tachycardia on 24Apr2021; Had breakthrough covid infection documented 17Apr2021; Had breakthrough covid infection documented 17Apr2021; This is a spontaneous report from a contactable consumer or other non healthcare professional (patient). A 60-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EL9261), dose 2 via an unspecified route of administration, administered in Arm Left on 05Feb2021 (Age at vaccination 60 years) as dose 2, single, and received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EL3248), dose 1 via an unspecified route of administration, administered in Arm Left on 14Jan2021 (Age at vaccination 60 years) as dose 1, single for covid-19 immunisation. Medical history included Known allergies: Sulfa. Concomitant medication(s) included lubiprostone (AMITIZA); estradiol (IMVEXXY); vitamin d3 (VITAMIN D3); fish oil (FISH OIL) and multivitamins. The patient previously took reglan [metoclopramide] and experienced drug hypersensitivity (Known allergies: Regian). Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been tested for COVID-19. On 14Apr2021, the patient experienced had breakthrough covid infection documented 17apr2021 and experienced tachycardia on 24apr2021. It was reported that patient had to go to emergency room for tachycardia on 24Apr2021. Tachycardia persisted for 2 months. Patient was not received treatment for events. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 19Apr2021 COVID test type: Nasal Swab. Facility where the most recent COVID-19 vaccine was administered at hospital. Patient was visited to emergency room and physician office. The outcome of event Tachycardia was recovered on unspecified date in 2021. The outcome of other events were recovering.  No follow-up attempts are possible. No further information is expected.
Information has been received from a physician concerning a 60 year old pt who was vaccinated with pneumococcal vaccine 23 polyvalent. Concomitant therapy included tetanus toxoid in the same arm. Subsequently, the pt experienced redness and swelling. The physician questioned whether it could be related to the pneumococcal vaccine 23 polyvalent. Additional information has been requested.
Doctor ordered PCV 20 and by error Tdap was administered, no reaction to vaccine. Patient was contacted and notified of error, he scheduled for 06/22 at 9:45am to administer the correct vaccine (PCV 20).
Symptoms from virus; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Symptoms from virus) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Symptoms from virus). At the time of the report, VACCINATION COMPLICATION (Symptoms from virus) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment information was provided.
local rxn-red & warm didn't come in for over 1 wk-got bad hole in arm-size of an eraser;skin brown & discolored;
Patient was fine until later that night of imz. She came to pharmacy next day with arm swollen and hot. Told her to try BENADRYL and if no resolution then call her doctor.
At 1425, patient was in the observation area and complained of "being hot and dizzy." Patient reported that "I feel like I was blacked out for a second and then I see you." Escorted patient to EMS room. BP: 120/62, P:80, O2 SAT= 98% on RA. Patient reported that she had panic attack sometimes, and she took Lorazepam 1 mg at 1320 at home. RN offered snack and water to patient. Applied cold compress to her neck.  After 20 minutes visiting with patient in the EMS room, patient reported she was feeling much better. RN escorted patient to the car at 1445.
A report has been received from a Pharmacist concerning a female patient, who had been receiving FLUMIST Quadrivalent. FLUMIST Quadrivalent started on an unknown date. The reporter stated that, the patient experienced administration to patients over 49 years old. The outcome of the event of administration to patients over 49  years old is unknown. The report was considered to be non-serious by the reporter.
Immediately following vaccination, pt had pallor, c/o dizziness, and "lights seeming too bright".
Patient went to Dr. because he developed a rash on his face near and in his righ eye. His Dr. said that he had shingles.
Post vax, the pt cried substantially and became hypotonic/hyporesponsive/dusky in color which lasted 1-5 minutes. He was brought to the hospital by EMS. Symptoms resolved spontaneously.
pt brought to ED with hypoxia; positive for COVID; admitted; given dexamethasone, remdesivir; respiratory status worsened requiring intubation and deep sedation to maintain O2 sats in the 80s; AKI; pt's respiratory status continued to deteriorate; DNR and transitioned to comfort measures; pt was extubated and passed away in the hospital
2nd dose lot #042L20A.  Had not reaction the 1st shot.  2nd shot (Tuesday) within few hours was cold and tired.  Next morning (Wednesday) temp which is normally 96.9 was 100 in am and 102 in pm.  Was extremely exhausted.  Oxygen sat which is normally 99 was running around 92.  Next morning (Thursday) temp 99.9 and was exhausted all day.  I can not say if aches was from COVID as I am always somewhat achy.  Friday woke up feeling great but with a few hours started to feel strange - took blood pressure and was 102/56 in am.  Later in afternoon was at 136/90. Oxygen sat back to 99 all day.   Blood pressure been running high since.
Site: Pain at Injection Site-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Chills-Mild, Systemic: Nausea-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild
Patient received FluBlok which is indicated for 18 and older, unless in clinical setting or rx for FluBlok written by doctor, given to the pharmacy
About 2:06pm, 90 years old female was found on the floor on her right side in front of the exit door of College Vaccination site.  Patient was awake and alert in minimal distress. Patient reported that she felt dizzy while walking towards the exit door to the car and fell on the floor.  Ambulance was called at 2:09pm. Patient sustained deep abrasion on the right side of her forehead, laceration on the tongue, right side of the upper and lower lip with minimal bleeding.  At 2:19pm, patient oxygen saturation was 92%room air. Patient was given oxygen 2 litres via nasal cannula, tolerated well. Laceration and abrasion areas cleaned with normal saline and patient was made comfortable awaiting for the ambulance.  The fire truck and supervisor #407 arrived at the scene at 2:20pm and the ambulance with paramedics arrived at the scene at 2:27pm. About 3:32pm, patient was transported via ambulance to Hospital for further evaluation and treatment. Prior to patient transported to the hospital, her oxygen saturation was 96% room air and heart rate 67. Patient has history of seizure disorder and stroke with left sided weakness, and she uses cane for ambulation. For fall and safety precaution, upon patient arrival to the vaccination site, patient was offered wheelchair and was transported with wheelchair to the vaccination area to get the vaccine and was monitored for 15 minutes. Patient was also offered a wheelchair and transported with wheelchair from the vaccination area, however patient refused to be wheeled to her car. Patient requested to sit at the waiting area to wait for her daughter to assist her in the car. The fall occurred when patient daughter came to get her at the waiting area without asking for assistance for the patient to be wheeled to the car, and the patient was ambulating with a cane with the daughter to the car.
Day after suffered low grade temperature, chills, nausea, vomiting, aches & pains, sore throat, headache, diarrhea. Duration of 3 days. Due to Covid protocol at healthcare facility where I work at I was taken off work until no fever was present without taking medication.
Experienced SOB, irregular heart beat in April.  After 1-2 weeks, saw Dr. on 3/9/21.  Prescribed Metoprolol.  He performed an EKG, Chest x-ray, Pulmonary Perfusion Scan to rule out PE.  3/11/21, a ZIO monitor was applied and I wore it for 14 days.  3/29/21 an echocardiography was performed.  6/3/21 I saw cardiologist.  6/29/21 Cardiac Stress Test indicated abnormal results with an intermediate risk of cardiac event.  7/8/21 Heat Cath performed showing mild-moderate heart disease.  No repairs were needed.  Upcoming appointment with Dr. 2/23/22.
Subsequent to receiving vax, the pt presented to a physician's office with shingles described as at least 100 lesions on the right side of his waist above the waist line. They were very painful. The pt was prescribed Vicodin for pain which was 8/10 on a pain scale of 1 - 10. The pt was also prescribed elavil 25 mg at night for 3 months to protect against postherpetic neuralgia. On an unspecified date the patient fully recovered without any problems. No further information is expected.
Information has been received from a medical assistant referring to multiple patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant medications were unknown. On multiple unspecified dates, the patients were administered improperly stored VARIVAX (dose and route unknown, lot #M010485, expiration date: 01-MAR-2018). The vaccines were exposed to 7.5 Fahrenheit degree for 15 hours. No previous excursions. There were no data logger. There was no adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.