chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PAXLOVID use for COVID-19 under Emergency Use Authorization (EUA): The patient presented to the his PCP on 12/16/2022 for severe headache. The headache had been mild for multiple weeks prior, and then became acutely worse after receiving his COVID-19 booster on 12/12/2022. He also had COVID-19 about six weeks prior and was treated with Paxlovid, which he took 10/24/2022 - 10/28/2022. He described the worst headache of his life (bandlike and frontal) with accompanying nausea. He was sent for a head CT which ultimately revealed bilateral subdural hematomas (right > left) with acute and subacute blood products. He was then referred to the ED and subsequently admitted to the ICU.
No adverse reaction noted at this time, however it was discovered after the shot was administered that there was inaccurate vaccine history given and patient had actually already received their 2nd dose (booster shot) of the Moderna vaccine.  The dose administered on 5/5/21 was the THIRD dose  the patient received.
Neck pain; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0198) via an unspecified route of administration in the left arm on 09Jul2021 at 11:00 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Concomitant medications included paracetamol (TYLENOL) and calcium/vitamin D 600 (MANUFACTURER UNKNOWN); both for unknown indication, from unknown date and unknown if ongoing. 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 COVID vaccine. On 11Jul2021 at 10:00, the patient experienced neck pain. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event neck pain was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Information has been received from a medical assistant referring to a 12 month old patient of unknown gender. On 20-MAY-2016 the patient was vaccinated with an expired dose of VARIVAX (first dose, lot # K006133, expiration date: 29-APR-2016, subcutaneous, dose was unknown) (expired product administered). No adverse effects were reported. This is one of several reports received from the same patient. Additional information has been requested.
Nausea, vomiting, dizziness, distorted  vision,  sore arm, fever, injection site swelling,  ambulatory deficiency.  Admitted to Hospital
Premature Ovarian Failure. On January of 2018 I began having irregular periods then in August of 2018 I stopped having periods altogether. I went through numerous tests and recieved the diagnosis of premature ovarian failure I have no familly history of anyone having early ovarian failure of fertility problems or any autoimmune disorders
A HAD KNOT DEVELOPED AT SITE OF INJECTION THAT REMAINED FOR WEEKS AND (AS PER PARENT) STILL LEFT A DARK DISCOLORATION ATTHE SITE TILL TODAY 03/04/2022. NO TREATMENT GIVEN TO MY KNOWLEDGE
Headache; Body Aches; Chills; Diarrhea; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ep7534) via an unspecified route of administration in the left arm on 25Mar2021 at 10:00 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medications were not reported. The patient had no known allergies to medications, food or other products. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En6204) via an unspecified route of administration in the left arm on 04Mar2021 at 10:00 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 25Mar2021 at 21:30, the patient experienced headache, body aches, chills, diarrhoea and nausea. Therapeutic measures were taken for the reported event and included treatment with pain pills. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events headache, body aches, chills, diarrhoea and nausea were recovered on unknown date.  No follow-up attempts are needed. No further information is expected.
pt recvd vax 930AM aked to wait @ least 10 mins a/leaving; p/one hr child c/o nausea, hot/cold & c/o tremors;
The day of the shot, we noticed significant swelling in my neck on the right of center.  The swelling has maintained its size for now six weeks and one day.  I have a dull numbness in my 2-3 smaller toes of my left foot.  Sometimes I feel this numbness in my right foot, but not always.  My left arm and two smallest fingers also feel funny.  There is a dull pain in my left arm and dull numbness in my left smaller fingers.  The outside of my left leg also at times shares this numb feeling.  On the day I got the shot I immediately felt like I had a dose of caffeine, though that feeling passed after a couple of hours.  It did not feel significant enough to keep me from driving or leaving the facility, but it was noticeable. I experienced diarrhea for about a week and a half. For the first week after the shot I alternated nights of not being able to stay still sleeping, keeping me awake almost the entire night, 3 of the first 6 nights.  I visited my family doctor within one week of the first shot.  He advised me not to get the second shot and made note of the swelling in my neck. I visited him at five weeks because the swelling in my neck and numb feeling has not changed.  He scheduled a CT Scan which has been scheduled.
Information has been received from a registered nurse referring to a 41 year old patient of unknown gender. There was no pertinent medical history, concurrent condition or concomitant therapy reported. On 14-JUN-2016 the patient was vaccinated with PROQUAD (Drug Administered to Patient of Inappropriate Age), Lot # L016394 with expiration date of 08-NOV-2016 (strength, dose and route were not reported). No adverse reaction was reported. Additional information has been requested.
After 3 weeks of discomfort went to employee health - she sent me to orthopedic doctor, did x-rays, cortisone shot, did not help. Referred to physical therapy weekly; February 2018 MRI  approved.
Infant fell asleep p/immun. Awakened 2-3 hrs later & could not be comforted; Slept very intermittently for 24 hrs. Temp 102.8 while on tylenol. Infant seemed to be in acute generalized pain.
Four year old WF received DPT, IPV, MMR on 7/18/02, then developed generalized eruption no f/c, sob, lip swelling. Denies pruritus. Lesions not migrating. Mom and dad with pt. NO prior eruption with vaccination. PE: urticarial plagues trunk, face, generalized. Lips not swollen. Urticarial reaction 2 days immunization-no sign/symptoms of angioedema. Asymptomatic-may use po Benadryl prn itch wont' affect course of rash. May use OTC HC cream bid prn. Tz, sob, lip swelling occurs go to ER. Advised to get flu vaccination as scheduled. Risk of anaphalaxis/angioedema< risk of diseases that immunization protects against. Advised close observation at next immunization, if lip swelling or sob occurs need to get to ER immediately, risk of angioedema/death. Parents understood.
Dizziness (I passed out several hours after getting the shot); nausea; muscle aches; fatigue
mild pain on the injection site/my arm hurt just a little bit; This is a spontaneous report from a contactable consumer (patient). This consumer reported same event for herself and her husband. This is the first of the two reports. An elderly female patient above 75 years old received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in the arm, on an unspecified date at single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications were not reported. After the first vaccination, patient experienced very mild pain on the injection site that went away the next day, patient's arm hurt just a little bit, but by the next day was fine. Patient took an acetylsalicylic acid (BABY ASPIRIN) and did not experience hematoma/bleeding on the injection site. The patient has been told that some friends experienced a higher incidence/severity of adverse events after the 2nd dose (including pain on the injection site, fever, chills, vomiting) (AER#2021092618). Patient is about to receive their 2nd dose 21 days later (this Friday). She is wondering if the diphenhydramine hydrochloride/paracetamol (TYLENOL PM) and aspirin will affect the vaccine-induced antibody response and if it is true that patients get 'sicker' after the 2nd dose. (Is the incidence of AEs higher after the 2nd dose?). She is referring to the Pfizer-BioNTech COVID-19 vaccine. Outcome of the event was recovered.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021092617 same product/event, different patient.
arm sight redness; swelling; tenderness; tiredness; hotness/overall crappy feeling; This spontaneous case was reported by a patient and describes the occurrence of ERYTHEMA (arm sight redness), SWELLING (swelling), TENDERNESS (tenderness), FATIGUE (tiredness) and FEELING ABNORMAL (hotness/overall crappy feeling) in a 41-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. In 2023, the patient experienced FEELING ABNORMAL (hotness/overall crappy feeling). On 08-Nov-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced ERYTHEMA (arm sight redness), SWELLING (swelling), TENDERNESS (tenderness) and FATIGUE (tiredness). At the time of the report, ERYTHEMA (arm sight redness), SWELLING (swelling), TENDERNESS (tenderness) and FATIGUE (tiredness) had not resolved and FEELING ABNORMAL (hotness/overall crappy feeling) outcome was unknown.            Concomitant medication and treatment information were not provided.
Vis given to mom. Verify by employee. Pt had a reaction 3/25/2020.
(1) First one fever x 2 days 103. Body aches, fatigue. (2) 2nd; within one hour moderate fatigue, pale, weak, leg weakness, very sleepy, headache, nausea x 24 hours (bed rest).
Headache. Neck Pain. Drowsy. Fatigue. Lump under right arm pit. Consistent Coughing. Runny Nose. Sneezing.
Began itching on legs during night, awoke in am to find red rash on ankles, chest, abd, arms, legs, wrists. Rash worsened the next day 10/26/11, subsided on 10/27 but not completely gone, not itching bad, no other new foods/meds/topical/lotions/etc added during this time.
suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 11 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles. The patient stated that, the shingles were very contagious. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization and laboratory confirmation were not provided.
pt recvd vax; approx 30 mins later, returned to clinic w/ swelling of rt eye lid;no SOB,rash or fever noted;dph given; had hives & inc edema at this time;probable MMR allergic rxn;
Fever as high as 103.1 (after Motrin) Injection site pain Joint pain Headache  Chills Skin sensitivity  All over feeling unwell Increased heart rate (as high as 135)
first pain at injection site, several hours after the vaccination, pain started to spread. skin and joints, and muscles achey, tired, couldnt sleep at night. next day, very tired. pain gone except at injection site
vaso-vagal spasm type movements; eye fluttering; child turned very pale; change in appetite; Initial information received on 14-Apr-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 months old and unknown gender patient who experienced vaso-vagal spasm type movements, eye fluttering, child turned very pale and change in appetite while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunization; and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Immunization.  On 12-Apr-2022, the patient received a  dose of 0.5 ml of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (formulation, strength: unknown)  lot UJ592AAA via intramuscular route in unknown administration site.  On 12-APR-2022 the patient developed a non-serious events vaso-vagal spasm type movements (vasospasm) eye fluttering (blepharospasm) child turned very pale (pallor) change in appetite (appetite disorder) same day following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the all the events.  At time of reporting, the outcome was Recovered / Resolved in 2022 for all.
This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act concerning a male patient who received MMR II (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3) (HSA) (Lot # 640912/1521L).  It was reported that the patient has a very high level of mercury.  The water and paint in the patient's home was checked and no mercury was found.  This was originally reported by "parents of the patient".  A lot check has been requested.  Lot check result for (lot # 640912/1521L): A standard lot check investigation was performed.  All in-process quality checks for the lot number in question were satisfactory.  The lot met the requirements of the center and was released.  Additional information has been requested.
Patient is a 27-year-old male with PMH of HTN, HLD, DM type II, CKD, dwarfism, severe phimosis s/p circumcision on July 2023 presented to Facility with cough fever, malaise chills.  He was found to be COVID-positive with signs of sepsis, CXR showed possible pneumonia versus atelectasis.  Patient had high fever secondary.  Currently on room air.   Pt doing well. Wants to go. Willing to leave AMA. PE unremarkable. D/w Dr., leukocytosis likely reactive. F/u with PCP and Nephrology as OP.     Acute Renal Failure with Hyperkalemia CKD stage IIIb Non Anion Gap Metabolic Acidosis History of severe phimosis s/p circumcision on July 2023 Creatinine on admission 7.28, was 2.4 on 8/2 UA is negative for infection Ultrasound and renal showed left kidney is obscured by bowel gas, no hydronephrosis or nephrolithiasis Serum immunofixation is negative, C3, C4, ANA and ANCA are negative. HIV antibody nonreactive September 5. 9/27 status post kidney biopsy?per nephrology show complement of ATN however there is also chronic damage from DM nephropathy.   Covid-19 Virus Infection Possible sepsis Pneumonia ruled out Covid-19 Virus Infection Date of onset of symptoms: 9/23 Symptoms present on admission: Yes Date of covid positive test: 9/23 Vaccination status: vaccinated Imaging: Chest x-ray Oxygen requirements on admission: Yes Current oxygen requirements: Room air Medical therapy: not indicated Consultants following: ID Anticipated special isolation end date: 10/3 Admitted with subjective fever chills shortness of breath  COVID-positive CXR atelectasis versus developing pneumonia and left lung Currently on room air  Leukocytosis Elevated WBCs, tachycardic on 10/3 D/w ID - CT CAP ordered and negative for acute inflammation OK for discharge per ID   Anemia Check stool for heme occult Transfuse for hb <7 No obvious bleeding Hemoglobin 6.8 on 9/28 Transfuse 1 unit Hemoglobin stable D/w Nephrology who thinks this is all CKD and hydration dilution of Hb.   Occult blood negative Hematology consulted for Retacrit   Learning disability MRDD Depends on aunt for decision making Lives alone since mom died recently CM working on safe discharge plan and helping him with services Discussed with his aunt today they are working on getting some help at home.  We will try to optimize services at home   Insulin Dependent DM Type II HgA1c 4/28/23: 9.4 Hold metformin Continue home lispro and lantus. Accuchecks AC/HS with ISS coverage Endocrinology consulted   Essential Hypertension Hold lisinopril Start patient on hydralazine 50 mg tid   Dyslipidemia Continue atorvastatin
PATIENT CALLED THE PHARMACY ON 02/09/2022, SHE WAS ASKING WHAT MEDICATION SHOULD SHE TAKE FOR THE CLOT. I ASKED WHY IS SHE SUSPECTING OF A CLOT. SHE SAID THAT SHE GOT HER BOOSTER ON 01/28/2022 AT OUR PHARMACY AND AFTER 2 DAYS SHE CANNOT WALK AND HAVE SEVERE HIP PAIN. SHE ALSO COMPLAINED ABOUT HAVING BRAIN FOG AND DOING UNUSUAL THINGS AND CANNOT PERFORM USUAL TASK.  I ADVISED HER TO GO SEE A DOCTOR SO HER SYMPTOMS COULD BE ASSESSED BETTER OR A LAB WORK COULD BE DONE. AND IF HER SYMPTOMS WORSEN, GO TO URGENT CARE.
Am experiencing heavy vertigo/dizziness 6 days later. has been happening for over 24 hours.; Am experiencing heavy vertigo/dizziness 6 days later. has been happening for over 24 hours.; Normal arm soreness the day after. severe pain in same arm 5 days later, for roughly 6 hours; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the right arm on 15Apr2021 at 17:00 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included bupropion (MANUFACTURER UNKNOWN), gabapentin (MANUFACTURER UNKNOWN), trazodone hydrochloride (DEPRAX) and duloxetine hydrochloride (CYMBALTA); all for unknown indication on unknown date and unknown if ongoing. The patient previously took buspirone (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced normal arm soreness the day after on 16Apr2021, and severe pain in same arm 5 days later, for roughly 6 hours. The patient also experienced heavy vertigo and dizziness 6 days later on 21Apr2021 and it had been happening for over 24 hours. The events 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 events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events normal arm soreness the day after, severe pain in same arm 5 days later, for roughly 6 hours; experienced heavy vertigo and dizziness 6 days later and it had been happening for over 24 hours was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Congestion; Vaccination site inflammation; Cough; Exposure to COVID-19; headache; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (Congestion), VACCINATION SITE INFLAMMATION (Vaccination site inflammation ), COUGH (Cough), EXPOSURE TO SARS-COV-2 (Exposure to COVID-19) and HEADACHE (headache) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NASAL CONGESTION (Congestion), VACCINATION SITE INFLAMMATION (Vaccination site inflammation ), COUGH (Cough), EXPOSURE TO SARS-COV-2 (Exposure to COVID-19) and HEADACHE (headache). The patient was treated with IBUPROFEN for Vaccination site inflammation, at an unspecified dose and frequency. At the time of the report, NASAL CONGESTION (Congestion), VACCINATION SITE INFLAMMATION (Vaccination site inflammation ), COUGH (Cough), EXPOSURE TO SARS-COV-2 (Exposure to COVID-19) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Aug-2021, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  The patient stated that he  had 15 COVID tests in the last 2 years and there were no positive results. The patient also stated that these symptoms will affect his cardiovascular capacity which will affect his job.
Information has been received on 02-MAR-2017 from a licensed practical nurse regarding a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On an unknown date the patient was vaccinated with a dose of RECOMBIVAX HB lot # M026309 expiration 11-NOV-2018, 10/1.0 mcrg/ml intramuscular for prophylaxis which was improperly stored. The vaccine was stored at a temperature >46 degrees F but < 76 degrees F for 66 hours. There was no previous temperature excursion. The call was made due to a data logger. No adverse effects were reported. No further information was reported.  Additional information has been requested.
pulled a muscle under her left breast; This is a spontaneous report from a contactable consumer (patient).   A 61-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE  (at the age of 61 years old) for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported.  The consumer received the first dose of the Covid vaccine and is scheduled to receive the second dose today at 1 p.m.  On unspecified date, the patient pulled a muscle under her left breast.  Outcome of the event was unknown.  No follow-up attempts were needed. Information on Lot/batch number cannot be obtained.
Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with a dose of GARDASIL (route and lot # unknown). Subsequently, the patient developed vaginal palsey (spasms of the vagina). The patient sought unspecified medical attention. It was unspecified if lab studies were performed. At the time of this report the patient's status was unknown. Additional information has been requested.