chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Bells Palsy; A spontaneous report was received from a consumer concerning a 65 year old male patient who experienced Bells Palsy/Facial Paralysis, Slurred speech/.Dysarthria, Facial droop/Facial droop,  Numbness on Facial right side/ Facial Paresthesia, Thumb numbness/ Thumb Paresthesia, Right paralysis/Right Paralysis, Right eye lid will not close/Right Eyelid Paralysis  The patient's medical history was not provided. Products known to have been used by the patient,  within in two weeks prior to the events, included Insulin Zinc Suspension, Insulin Aspart, Clopidogrel bisulfate, Gabapentin, Mesalamine, and Atorvastatin.  On 18-Jan-2021, prior to the onset of symptoms, the patient received the first of two planned doses of mRNA-1273 ( Batch number: 09L20A) intramuscularly into the right arm for prophylaxis of Covid-19 infection.  On 15-Feb-2021 the patient received the second of two planned doses of mRNA-1273 ( Batch number: 024M20A)  intramuscularly (site not provided) for prophylaxis of Covid-19 infection.  On 15 Feb-2021,  the patient left a voicemail message to safety and stated "got right paralysis, thought I had stroke, spent 4 days in the hospital and  diagnosed me with Bells Palsy".  Hospital admission, treatment information, and discharge dates were not provided.  On 16-Feb-2021 Safety agent reached the patient to clarify the information provided in his first report (15-Feb-2021).   The patient reported his symptoms began on 08-Feb-2021, 21 days following the first dose of mRNA-1273,  the patient experienced slurred speech, facial droop , numbness on facial right side, thumb numbness, right paralysis, right eye lid will not close and blurred vision of the right eye. He was hospitalized (date not provided).  Treatment information included a CT scan which was reported as normal . He reported seeing a speech therapist to help with his speech and improve swallowing. He reported no treatment was given to him. A physician diagnosed him with Bells Palsy on 10-Feb-2021.  Hospital discharge date was not provided.   The second dose of mRNA-1273 was temporarily withheld in response to the events rechallenge  date 15-Feb-2021 was reported as negative.  The outcome of the events,  Bells Palsy,slurred speech, facial droop , numbness on facial right side, thumb numbness, right paralysis, right eye lid will not close and blurred vision of the right eye were considered Not recovered/Not resolved.  Company Comment: the reported event Bells Palsy was considered possibly related to mRNA-1273.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
SHORTNESS OF BREATH ,PRESSURE IN CHH EST, NAUSEA, FEVER 101-102, SWOLLEN NECK GLANDS
Diagnosed with COVID-19 after vaccine Narrative:  Received 1st dose of Pfizer COVID Vaccine on 2/13/21 and second dose on 3/2/21. On 3/28/21 patient was admitted for psychiatry-related issue, exhibiting no symptoms of COVID-19. Routine testing for COVID-19 performed  prior to admission and found to be positive on 3/28/21. Patient asymptomatic.  Marked ADR as severe as the COVID positive test is delaying the patient's admission into rehab facility for continued treatment. Must remain in hospital until  cleared for discharge or able to be off isolation despite lack of symptoms.
Developed loud tinnitus after my first dose of the vaccine. Still have tinnitus after 3 months. It has significantly dropped in noise and annoyance
Coughing, non-stop; This spontaneous case from was received on 29-Nov-2022 from Novartis (reference number: NUS2022US263847), reported by other non-healthcare professional (consumer) and concerned a 44-year-old female patient.  The patient's medical history and concomitant medications were not reported.  On an unspecified date, the patient was vaccinated with influenza vaccine (brand not specified; dose, route of administration, anatomical location, and indication: not reported). The batch number was not reported.  On an unspecified date, an unknown amount of time after receiving influenza vaccine, the patient was really coughing, non-stop and cold weather change.  The outcome of the event was not reported.  The reporter did not provide causality assessment.  Company comment: A 44-year-old patient experienced cough an unknown amount of time after receiving the suspect product influenza vaccine. The patient's medical history, concomitant drugs, and diagnostic findings were not provided. Due to lack of information and unclear temporal relationship, causality for the reported event is unassessable.; Sender's Comments: A 44-year-old patient experienced cough an unknown amount of time after receiving the suspect product influenza vaccine. The patient's medical history, concomitant drugs, and diagnostic findings were not provided. Due to lack of information and unclear temporal relationship, causality for the reported event is unassessable.
Patient complained of pain in the area. Step father looked at area of injection, patients leg was swollen, bright red, and site was hot.
No additional adverse events; one patient received improperly stored vaccine on unspecified date since 1/8/2020 which was admmistered via unspecified route.; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.       On an unknown date in January 2020 (reported as since 08-JAN-2020), the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot# S013683, expiration date 05-MAY-2021; strength, vaccine dosage detail and route of administration were not reported) for prophylaxis (product storage error). The vaccine was reconstituted with properly sterile diluent (MERCK STERILE DILUENT). No additional adverse events. The storage temperatures were above 47 Fahrenheit degrees/9 Celsius degrees (9.1 Celsius degrees) for 45 minutes. Previous temperature excursion were -58 Fahrenheit degrees and +46 Fahrenheit degrees (from -50 Celsius degrees to +8 Celsius degrees) (-5.2 Celsius degrees) which were recommended storage temperatures range for 20 minutes. Data logger was involved.
-nausea/vomiting, wooziness(light headedness) -was evaluated -was given Zofran for nausea
Swollen lymph nodes in armpit on same side of injection site. Red blotchy patches around injection site. Swollen injection site.
PT STATES HER left calf started hurting enough to make her limp.  We elevated her leg for 15min and she said it felt better. advised guardian to watch and if worse see a DR
Urticaria (total body) erupted within 24 hours without other allergic manifestations. No other referable cause identified.
Moderna COVID-19 Vaccine Sore arm - lasted for about 3 days Slight fever the first night into the next day - ended in the evening of the 2nd day
This spontaneous report was received from a physician refers to a patient of age 6 (unspecified units) (unknown gender). No pertinent medical history was reported. On 04-SEP-2014, the patient was vaccinated with VARIVAX (Merck) (lot # K002920 and expiration date was 26-FEB-2016) dose 0.5 ml, subcutaneous injection. Concomitant medications was not reported. The physician reported that temperature excursions beginning 11-AUG-2014, with worst case exposure of -3.9C for 110 hours affecting VARIVAX (Merck) with lot # K002920 and expiration date 26-FEB-2016. Excursion supported for use within 3 months. No adverse effects reported. Patient did not sought medical attention. No Product Quality Complaint (PQC) was involved. This is one of the several patients from the same source. Additional information has been requested.
soreness in arm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness in arm at injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 039A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Feb-2021, the patient experienced VACCINATION SITE PAIN (soreness in arm at injection site). At the time of the report, VACCINATION SITE PAIN (soreness in arm at injection site) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication were reported.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-366413 (Patient Link).
Patient developed COVID symptoms despite 2 doses of vaccine.    Symptoms started on 4/7/2021 and included:  shortness of breath, headache, fatigue, and chills.  Tested positive for COVID.
Information has been received from a registered nurse concerning a 32 year old female pt who at a younger age was vaccinated with a dose of measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live (second generation). The pt was vaccinated post partum one year ago with a dose of rubella virus vaccine live (second generation). Subsequently on 05FEB2003 the pt had an antibody titer drawn that revealed that the pt failed to seroconvert to MUMPSVAX. Unspecified medical attention was sought. Additional information has been requested.
Onset Thurs evening with temperrature (102-103) through Friday. Achiness, sweats, dizziness and decrease in sleep. Monday night developed an itchy petechia rash on legs (bilaterally), lower shin area.
During shower the next morning after the shot, patient passed out 2 or three times. The first one falling to the ground, then got up, out of the bath and laid down on the floor then briefly passed out again. Rest of the day no other symptoms unknown to the ones common to the vaccine
My vision has been stable for 30+ years.  It had changed (for the better) in August with my left eye.  Starting around mid-September, the left eye seemed to change again.  I went to see the doctor and it had changed again (needing a weaker prescription) but could never be made sharp like previously.  I adjusted the glasses and it appears like my vision is changing again.  The ophthalmologist had no reason for the vision changing and changing rapidly or the lack of sharpness.  I started using lubricating eye drops and updated glasses.  Based on the continued poor vision in my left eye, will see the ophthalmologist again next week.    At this point, I don't know if this is related to the vaccine as I have had others with nothing like this before but it was recommended by the CDC call I got to report this.
27MAR morning pt c/o pain in neck, shoulder & arm pit, swelling & hard lump red & warm to touch;
Dizziness, rash, hives, trouble breathing. Treatment - Benadryl, Pepcid, and steroids.
mild reactions (unspecified) after all 4 Moderna shots during 48 hours; This spontaneous case was reported by a patient family member or friend and describes the occurrence of IMMUNISATION REACTION (mild reactions (unspecified) after all 4 Moderna shots during 48 hours) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in April 2020. Concurrent medical conditions included High density lipoprotein increased (taking Praluent for HDL cholesterol adjustments). Concomitant products included ALIROCUMAB (PRALUENT) for High density lipoprotein increased.   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 and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (mild reactions (unspecified) after all 4 Moderna shots during 48 hours). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; IBUPROFEN at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, IMMUNISATION REACTION (mild reactions (unspecified) after all 4 Moderna shots during 48 hours) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2020, SARS-CoV-2 test: Positive.   The reporter stated that he did not remember if his wife (patient) started taking Praluent before or after any Moderna COVID-19 vaccination. The reporter did not remember the dates for the previous vaccinations but stated that her wife had already received 4 Moderna shots (included first and second booster doses).  The patient experienced mild reactions (unspecified) after each injection but it was resolved within 48 hours and the patient might have took Tylenol, Ibuprofen or Advil to treat symptoms.   This case was linked to MOD-2022-681969 (Patient Link).
This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). A 13 year-old male patient received bnt162b2 (BNT162B2), administration date 28May2021 (Lot number: EWO177) as dose 1, single and administration date 18Jun2021 (Lot number: EWO180) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANXIETY (non-serious) with onset 2021, outcome "unknown", described as "Extreme anxiety". Additional information: Event took place after use of product. No follow-up attempts are possible. No further information is expected.
"Pt received first dose of Pfizer on 6/12/2021 @12:06pm. While sitting under observation @12:16 pm, pt c/o dizziness and had an episode of syncope.Pt had an assisted fall w/ observation RN.  Pt was A/OX4 right after. Pt was ambulated to triage area via wheelchair . No c/o of SOB, nausea, chest pain but c/o tingling in all extremities Charge RN/onsite provider/ANM notified.   VS @12:18 - 86/43, 58, 100%spo2 RA, 20 (RR), @12:23pm: 92/53, 69, 98% spo2 (RA), 20 @12:32pm: 83/55, 65, 20, 100%spo2 (RA), @ 12:45pm (sitting): 89/55, 99%, 60, @12:45pm (standing): 90/57, 61, 100%.   Pt was able to swallow and was given juice and saltine crackers. No prior hx of syncope. Onsite provider advised for extended observation for 15 mins. As per pt last meal was eaten around 8:00am in the morning. Pt notified her mom and as per pt, mom asked pt to drive back home. Pt was advised to seek ER services if symptoms worsen. At 12:45pm, pt was d/c home. Pt ambulated w/stable and steady gait.  Pt stable and released from vaccination site."
11/19/2021 - Left ear started ringing loudly. 11/24/2021 - Woke up from a nap with blurred vision and both ears ringing very loudly. Went to Urgent Care. They determined I wasn't having a stroke, didn't see anything unusual with the ears, suspected maybe a t-shirt touching my face affected the vision, and I was sent home. The vision gradually improved but the loud ringing continued. 11/27/2021 - The left ear sounded muffled and developed an echo. The loud tinnitus continued. 11/29/2021 - Developed muscle and joint pain in my neck, jaw, fingers, thumb joints, wrists, as well as my right shoulder and right knee. 12/2/2021 - Negative Covid test  12/7/2021 - Woke up in the middle of the night with a buzzing sensation in my body, loud tinnitus, swollen joints, and stiff fingers. I saw the doctor at the clinic who ordered labs to check inflammatory markers, diabetes, and thyroid. He prescribed Voltaren gel.   12/16/2021 - Negative Covid test  12/22/21 - The pain and fatigue continued with only slight improvement. Met with a doctor, an immunologist, to go over the labs and discuss possible causes. She considered an adverse reaction to the Moderna booster, a breakthrough covid infection, and a Parvo infection. I tested negative for Covid twice and also tested negative for Parvo, Rheumatoid arthritis, lupus, multiple myloma, MS, diabetes, and thyroid problems.   1/1/2022 - I still have tinnitus, reactive arthritis, and fatigue. I'm unable to engage in previous activities like working out or walking my dog.
headache after the second vaccine; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache after the second vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache after the second vaccine). At the time of the report, HEADACHE (headache after the second vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Medical History information was reported.  No concomitant medication were reported.   No information on treatment is provided by the reporter.
After getting the vaccine had uncontrollable shaking, headache, fever, but felt very cold This is the 2 Nd time with the same reaction... had same complications when the first dose was administered
Three days after taking my second dose of Pfizer COVID 19 vaccine, I experienced a transient ischemic attack (TIA), with a temporary loss of control of my left arm and weakness in my left leg.  Following an emergency room visit and related testing it was determined that I had a 65% blockage of my right carotid artery.  I was given blood thinner and was hospitalized for three days.
After receiving the vaccine, the patient developed redness and swelling at injection site. The patient was seen by their PCP who prescribed a MEDROL dose pack and hydroxyzine.
Patient was given his vaccine from a  full vial prior to reconstituted with Normal Saline. Treatment: Patient was observed at the clinic for one hour after vaccination. Patient had no complaints prior to leaving the clinic. Dr placed a Follow up call to patient two hours after he was released from the clinic. Pfizer was consulted. Pfizer reported the patient may experience increased arm pain. Pfizer approved patient to receive second vaccine on his due date. Follow up instructions given to the pt per Dr. Pt advised of date for second vaccine. Patient contacted again 1/20/21 per Dr. Patient doing well and voiced no complains
Extreme pain at injection site, cannot raise arm more than 1 inch and pain in the shoulder and neck area and do not get any relief from the Tylenol or ice packs.
Post vax, the pt developed joint and skin inflammation, rapid heartbeat, swelling of legs, hives for 3 years, positive ANA (lupus), diarrhea, vomiting, skin rash, depression, and breathing problems.
Patient is a 4 years 1 month old male who presents for: Immunization reaction. He was given MMR, varicella, DTaP and polio on 1-9. Red urticaria like reaction in first 12 hours, has waxed and waned since then. No frank fever at home, has been active. Mom has used a few doses of BENADRYL. Temperature: 99.4 F. Alert and well appearing. In no distress. 6cm area of erythema, induration at site of varicella vaccine. lacy erythematous macular rash on right thigh. Cool packs to legs. BENADRYL q 4 hrs. Discussed warning signs of worsening for which to call or go to ER. These would include: increasing fever or worsening redness and induration. Follow-up if not improving or problems worsening.
Information has been received from a nurse referring to a 20 year old female patient. The patient's medical history included gallbladder removal and headache. Drug reactions/allergies was reported as none. Concomitant therapy included oral contraceptive. The patient was vaccinated with three doses of RECOMBIVAX HB (dose, router, lot # and expiration date were unknown) one dose on 16-JAN-1997, one dose on 14-MAY-1997, and one dose on 10-SEP-1997. A hepatitis B titer was drawn on 12-AUG-2017 and the results showed there was no immunity to hepatitis B. One booster dose of RECOMBIVAX HB (lot# N006321, expiration date 08-NOV-2019) was administered to patient on 18-AUG-2017. No treatment was given. The outcome of the event was reported as not recovered. The patient visit physician to seek medical attention. The causality assessment was not provided. This is one of two reports regarding to the same patient. Sender's Comments: US-009507513-1708USA011342.
The patient received a third shot because "just thought it would be safe"; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTRATION ERROR (The patient received a third shot because "just thought it would be safe") in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 010A21A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) injection for COVID-19 vaccination.    The patient's past medical history included Hepatitis. Concurrent medical conditions included COPD and Hypertension.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Aug-2021, the patient started TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 03-Aug-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (The patient received a third shot because "just thought it would be safe"). On 03-Aug-2021, PRODUCT ADMINISTRATION ERROR (The patient received a third shot because "just thought it would be safe") had resolved.            Concomitant product use was not provided by the reporter.    Reporter did not allow further contact
The area on my arm where the shot was given has gotten more swollen and has started to spread a little down my arm.  It has also become itchy.  I also have swelling of my lymph nodes in my armpit and neck--it is painful to touch on my neck and has a constant pain in my armpit.  It has given me a very uncomfortable feeling on the left side of my body.
Vaccination site pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Shingles and Diabetes. Concomitant products included GABAPENTIN and PARACETAMOL (TYLENOL) for an unknown indication.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, VACCINATION SITE PAIN (Vaccination site pain) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Dr misinformed us that the HPV vaccine is required for school. High fever between 102 to 105 F over two days. Vomit few times.  We took him to ER on 16th. Confusion occurred in the morning of 17th, and we called an ambulance.
Had moderna covid vaccinations on 2/11/2021 and 3/11/2021.  Had a breakthrough diagnosis of covid on 12/6/2021.
Information has been received from a licensed practical nurse concerning 2 girls who on an unspecified dates were vaccinated with an unspecified dose of GARDASIL. A patient's mother heard that they have had hair loss and hair brittleness after vaccination with GARDASIL. These 2 girls are athletes and wash their hair several times each day. Additional information is available.