chrisvoncsefalvay/vaers-outcomes huggingface dataset:
blood pressure fluctuation; severe headache; heart started racing; felt like my body was vibrating; flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart started racing), FEELING ABNORMAL (felt like my body was vibrating), BLOOD PRESSURE FLUCTUATION (blood pressure fluctuation), INFLUENZA LIKE ILLNESS (flu like symptoms) and HEADACHE (severe headache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product LEVOTHYROXINE SODIUM for Adverse event.    No Medical History information was reported.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started LEVOTHYROXINE SODIUM (Oral) 130 mcg once a day. On 28-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms). On 10-Feb-2021, the patient experienced PALPITATIONS (heart started racing) and FEELING ABNORMAL (felt like my body was vibrating). On 15-Feb-2021, the patient experienced HEADACHE (severe headache). On an unknown date, the patient experienced BLOOD PRESSURE FLUCTUATION (blood pressure fluctuation). On 31-Jan-2021, INFLUENZA LIKE ILLNESS (flu like symptoms) had resolved. At the time of the report, PALPITATIONS (heart started racing), FEELING ABNORMAL (felt like my body was vibrating), BLOOD PRESSURE FLUCTUATION (blood pressure fluctuation) and HEADACHE (severe headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement (120-80 mmHg): 163/100 mmHg (High) Increased and 101/80 mmHg (Low) Decreased.         No relevant concomitant medications were reported. No treatment information was reported. Patient initially administered 130 mcg of T 3, after taking it her heart started racing and her doctor suggested to drop the dose of drug to 5 mcg orally daily and then her blood pressure was dropped to 163/100 to 101/80 and later physician totally discontinued the T-3.; Sender's Comments: This report concerns a 61 year old female patient who experienced flu like symptoms (on the same day), palpitations, abnormal feeling (13 days), headache and blood pressure fluctuation (18 days) after vaccination with second dose of mRNA-1273. The patient was on concomitant daily oral levothyroxine therapy (T3) 130 mcg. In view of her symptoms, the physician decreased the dosage to 125 mcg daily, then to 110 mcg and finally discontinued the drug. The patient reported resolution of symptoms upon discontinuation of levothyroxine. Based on the available information, the concomitant therapy with levothyroxine remains a confounder for the reported events of palpitations, blood pressure fluctuation and abnormal feeling. The benefit-risk relationship of mRNA-1273 is not affected by this report.
30OCT97 5:30 pt noted numbness/tingling/pain in lt great toe-spread to foot & ankle;progressed to rt foot & ankle;move to lt hand-to forearm then rt hand;3 days later burning pain in lt face  & soreness on rt side of face;
felt bad; painful as hell in my shoulder/he couldn't lay on it; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt bad) and ARTHRALGIA (painful as hell in my shoulder/he couldn't lay on it) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2022, the patient experienced FEELING ABNORMAL (felt bad) and ARTHRALGIA (painful as hell in my shoulder/he couldn't lay on it). At the time of the report, FEELING ABNORMAL (felt bad) and ARTHRALGIA (painful as hell in my shoulder/he couldn't lay on it) outcome was unknown.            Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   Reporter did not allow further contact
her Atrial fibrillation (AF or afib) started again; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ATRIAL FIBRILLATION (her Atrial fibrillation (AF or afib) started again) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. V029A21A) for COVID-19 vaccination.     The patient's past medical history included Atrial fibrillation (Atrial fibrillation (AF or afib) started again, it was dormant for 5 or 6 years). Concomitant products included DRONEDARONE HYDROCHLORIDE (MULTAQ) for AFib, APIXABAN (ELIQUIS) for an unknown indication.   On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to dosage form. On 07-Mar-2021, the patient experienced ATRIAL FIBRILLATION (her Atrial fibrillation (AF or afib) started again) (seriousness criterion medically significant). At the time of the report, ATRIAL FIBRILLATION (her Atrial fibrillation (AF or afib) started again) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the event a causal relationship cannot be excluded.
Swelling and redness to injection site 30 minutes after injection. Refused to go to ER. Went home and took Benadryl. No other symptoms at that time. Area red, hard and swollen the next day.
The morning after I received the vaccine, I woke up and I had flu like symptoms. I had a low grade fever, some nausea, ringing in my ears and fatigue. By bedtime that night, I felt normal except for the tinnitus that stayed. I went to the doctor on 03/26, an audiologist, and she told me that it is tinnitus and she had another patient that got tinnitus after the vaccine also. I am having a lot of trouble hearing now. The doctor told me that the ringing that I hear is a short circuit in my brain. It's not so much in my ear, but from the processing of the brain. This is a habituation, which means I am listening to sounds through an app or web link to teach my brain how to ignore that sound. There is not any treatment for this condition. I will follow up with the doctor in a year.
Headache within a few hours that lasted for 3 days; Overall achy feeling within 12 hours and last for 2 days; Nausea within 12 hours and lasted for about 24 hours; Low grade fever about 8 hours (normal temperature is usually 97.8-98.6. temp was 99.8-100.5) Fever lasted for about 36 hours. Extremely itchy hives/rash began about 54 hours following the 2nd shot. Itching started on scalp and small patches on right arm and each leg. Itchy actually woke me up out of a deep sleep.  Today it has spread to  back of thighs, neck and several other smaller patches have popped up all over my body.  No breathing problems.
approx 10 days post vax w/OPV/Tripedia pt exp Bell's palsy; pt improved a/start of ATB; lab test revealed Lyme titre IGm titer pos;
lt thigh 2" larger than rt red, hot swollen hip to knee & posterior to leg; papular rash over body, itchy;
Information has been received through a voice mail from a physician concerning a 14 year old female who was vaccinated with VARIVAX (Merck).  Concomitant medication included montelukast sodium(MSD), PULMICORT and albuterol.  Subsequently the patient passed out after receiving VARIVAX and then they gave MENACTRA and hepatitis A virus vaccine (unspecified) after she passed out.  The patient was not hospitalized after the event.  The outcome was unknown at the time of report.  Additional information is not expected.
approx. 20 hrs. after receiving IM injection in left deltoid, her arm was red, swelled, and painful from injection site to elbow.  24 hrs. later these symptoms increased with painful swelling and redness from injection site to hand.  Went to dr., received PCN IM and placed on Augmentin.
Pt recv vax on 10/15/98; on 10/31/98 pt exp chicken pox x 1 wk
Vaccinator's notes: Pt was booked for a homebound vaccination with Moderna. When provider arrived the age was noted to be under 18. Other vaccines were offered, parents elected to continue with Moderna. Discussed risks and benefits and being outside the EUA for the age for Moderna. I did not have minor consent form, but details of the form were discussed and would be sent to parents. We also discussed that the second dose could be delayed until after august 26 and he would still be in the 42 day second were offered and strongly recommended, but after discussing his age and weight and wanting him to vaccinated before family members came to visit on his birthday week he was scheduled for before Turning 18. Minor consent form will need to be completed for the second dose.
Soreness at injection site (days 1~3), redness at injection site (Covid Arm) (starting 4/9)
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. No concurrent conditions, medical history and drug allergies were reported. On 18-JUN-2015, the patients were vaccinated with improperly stored doses of PROQUAD (Merck) (lot number L005295 and expiry date 17-AUG-2016) (dosing, regimen, route were unknown). No concomitant medications were reported. No adverse effects were reported. There was no product quality issue reported. Follow up information was received on 10-JUL-2015. It was reported that lot number L005295 with an expiry date of 17-AUG-2016 is a valid lot number for PROQUAD (Merck). On 03-AUG-2015, a phone call was made to the certified medical assistant. The phone call went directly to voice mail. A voice mail message was left requesting that the certified medical assistant return the phone call. Additionally, a request was made for patient identifiers, lot number, expiration date and date of vaccination. All telephone attempts to obtain follow up information have been unsuccessful. Follow up information has been received from the reporting Certified Medical Assistant (C.M.A.) during a phone call on 05-AUG-2015. The C.M.A. reported that she would have to research the request made for patient identifiers, lot number and expiration date and dates of vaccination. Follow-up information has been received from the medical assistant's clinic on 22-OCT-2015, regarding a 6-year-old patient of unknown gender. On 20-JUL-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) lot # L005295. This is one of several reports received from the same source. Additional information has been requested. Patient's details, product, event information and narrative were updated.
Chills; Body aches; A spontaneous reportwas received from a Consumer for a 50-year-old, female patient who received Moderna's COVID-19 vaccine and developed chills and body aches.  The patient's medical history, as provided by the reporter, included fibromyalgia. Concomitant medications was not provided.  On 30 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.     On 31 Dec 2020, the patient awoke with chills and body aches. Treatment for the events included acetaminophen, quetiapine and gabapentin.  Action taken with the second dose of mRNA-1273 in response to the events was not reported.  The outcome of the event(s) chills and body aches were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded. However, patient's significant medical history of fibromyalgia may have been contributory.
103 fever starting 8 hours after shot and last 36 hours, continued 99 fever.; Terrible exhaustion; lack of appetite; uncontrollable sweating; This is a spontaneous report from a contactable consumer. A 40-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Unknown), via an unspecified route of administration, administered in Arm Left on 27Feb2021 09:15 as DOSE 2, SINGLE (at the age of 40-years-old) for covid-19 immunisation. The patient's medical history included hypothyroidism. The patient's concomitant medications included levothyroxine sodium (SYNTHROID); ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 27Feb2021 at 17:00, the patient experienced 103 fever starting 8 hours after shot and last 36 hours, continued 99 fever, terrible exhaustion, lack of appetite and uncontrollable sweating. The patient did not received the treatment. The outcome of the event was recovering.    No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Patient with fibromyalgia experienced a flare-up of her symptoms 48 hours post-immunization. Described as neck and all-body pain -> took approximately 2 weeks to resolve.
Syncope times 2. MR received for ER visit for syncope x2 one day after flu, Menactra (verified), and Tdap vax.  PMH: 12 yr. with ADD.  PE WNL.   HPI: Child fainted morning after vax. while going to the BR, then fainted again on her way to tell mom.  Taken by ambulance to hosp.  Assessment: Vasogenic syncope, dehydration, muscular disorder
Patient presents to the emergency department with complaints of shortness of breath and associated weakness. He was subsequently admitted for management of pneumonia and COPD exacerbation. Patient was discharged home 4 days later in stable condition.
Client received flu vaccine April 9, cleared by medical to proceed with COVID vaccine . Client met with medical, was advised, but opted to proceed. Vaccine given.
mom reported pt woke up w/screaming > 3hr, t103, held head & screamed, opened & closed hands & looked @ them;couldn't stand or crawl, fell over from sitting position;lt side of face swollen ;ear & eye infect;cellulitis;angioneurotic edema
Patient presents to office for follow up vaccine reaction. SHINGRIX 2/22/19. She experienced a sore arm over the next 3 days. She then developed a scattered "rash" she describes as "chicken pox" like.   A few scattered pox marks on right upper leg, right hand. Blistered pox mark left temple which resolved with hydrocortisone. Malaise. Significant LUE pain radiating down left arm. Applying pressure along lateral epicondyle resulted in numbness of lateral 5th digit. Burning sensation. No rash. She presented to UC and was diagnosed with shingles. Valcyclovir ordered. Symptoms have largely resolved.
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of covid-19. She was treated with paxlovid (start date- 16May2022 and stop date- 20May2022) for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. On 30-JUN-2015, the patient was vaccinated with improperly stored dose (Oka/Merck) VARIVAX (lot number, dose and route were unknown). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Swelling and redness in right eye started about 32 hours after second dose of Pfizer COVID19 vaccine; eyelid was swollen almost shut; eyeball was swollen; pressure sensation from behind eyeball
Strong torso and back muscle aches, cold and shivering.  Strong symptoms began 12 hours after vaccination.  Symptoms lessened substantially about 15 hours after the vaccination, but continued at much lower levels for 24 hours after that.   Please note: I didn't know I needed prior vaccine information when I went for the Covid19 vaccine.  I thought it was 14+ days since my dose 2 pneumonia vaccine, but I later looked it up and found it had been 10 days.
High blood pressure for 24 hours.  Blood pressure readings with medication  stay in the 130/82 range, but all day after covid vaccine was administered blood pressure reading remained 167/91. Call to advice nurse was made and advice nurse instructed patient to monitor blood pressure, if it reached over 180/101, to seem immediate medical assistance.
Joints could not keep up; Muscle/joint fatigue; Side effects with COVID vaccination/lost taste; This spontaneous case was reported by a patient and describes the occurrence of ARTHROPATHY (Joints could not keep up), MUSCLE FATIGUE (Muscle/joint fatigue) and AGEUSIA (Side effects with COVID vaccination/lost taste) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included METHOTREXATE for an unknown indication.   In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) CF. On an unknown date, the patient experienced ARTHROPATHY (Joints could not keep up), MUSCLE FATIGUE (Muscle/joint fatigue) and AGEUSIA (Side effects with COVID vaccination/lost taste). At the time of the report, ARTHROPATHY (Joints could not keep up) and MUSCLE FATIGUE (Muscle/joint fatigue) outcome was unknown and AGEUSIA (Side effects with COVID vaccination/lost taste) was resolving.            No treatment information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Information has been received from a medical assistant referring to a 67 year old female patient with hypertension and osteoporosis. Concomitant therapies included FOSAMAX, calcium (unspecified) and lisinopril. The patient was allergic to adhesive tape. On 04-OCT-2018 the patient was administered an improperly stored dose of PNEUMOVAX 23 (lot # R009162 and expiration date 06-JAN-2020, intramuscular, strength, dose and frequency were not reported) for prophylaxis. On the same date hours after receiving the PNEUMOVAX 23, the patient experienced an unspecified injection site reaction that lasted for an unspecified amount of time. No treatment was given to the patient. No lab diagnostics/studies were performed. The patient did not seek medical attention. The patient recovered from the injection site reaction on an unknown date in October 2018. The causality was not provided. The temperature excursion was 32 Fahrenheit to 35 Fahrenheit for 10 hours. There was no previous excursion. The call was because of a data logger.
1st fever noted eve of 3/16/04 the next day noted redness & warmth at site of injection right arm not deltoid. Following day area of redness was larger and fever come & go- chills & sweating, feels achy- headache. Taking Tylenol.
ill; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "ill".  Additional information: consumer needs to cancel apt for husband for the second dose of the covid vaccine, unable to make the second apt. husband was ill, and the doctor recommending he doesn't get the second dose while ill, consumer didn't state if he got ill from the first dose of the vaccine or not. Reporter called her vaccination site or local health dept. to get the number for local rescheduling, also explained the vaccine timeline of 21days. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The vaccines experienced multiple excursions, vaccine stored at temperature outside the recommended range, no adverse event; patient received IPOl vaccine that was expired, no aderse event; Initial information received on 02-May-2019 regarding an unsolicited valid non-serious case received from a Nurse by phone.  This case is linked to cases 2019SA125054, 2019SA125072, 2019SA125008, 2019SA125094, 2019SA125047, 2019SA125041, 2019SA125033, 2019SA125087 and 2019SA125087 (same reporter).  This case involves a four years old female patient who was vaccinated with a 0.5 ml once dose of IPV (VERO) [IPOL] (Batch number: N1K931M and expiry date: 19-Nov-2018, intramuscularly in deltoid NOS) and DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] on 05-Mar-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR VACCIN); VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) and TUBERCULIN PPD (TUBERCULIN PPD) for Tuberculin test on same visit (05-Mar-2019).  It was a case of actual medication error due to incorrect product storage and expired vaccine used.  Case details: The vaccines experienced multiple excursions.  1st excursion excursion: 13Feb2019-14Feb2019 was out of range for 8 hours and 45 mins was at 1.56 degrees C. for the Fluzone Quad, Daptacel and ActHIB. 2nd excursion: 13Feb2019 9 hours 15 mins 1.56 degrees C. 3rd Excursion: 15Feb2019-22Feb2019 was out of range for 9 hours 30 mins at 1.56 degrees C. 4th excursion: 13Feb2019-22Feb2019 was out of range for 13 hours at a temperature of 1.18 degrees C for the Daptacel, Menactra and Adacel 5th excursion 13Feb2019-25Feb2019 were out of range for 24 hours and 15 mins at a temperature of 1.18 degrees C. Fluzone Quad and Pentacel 6th excursion 22Feb2019-26Feb2019 out of range for 23 hours 45 mins at 1.18 degrees C. Fluzone Quad, Pentacel and Daptacel 7th excursion: 13Feb2019-26feb2019 out of range for 33 hours and 4 mins at 1.18 degrees C for Adacel, Menactra, Ipol, ActHIB, Dapatacel, Pentacel and Fluzone Quadrivalent.  No adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   Information on the batch number was requested for Daptacel.  Documents held by the sender: none.
site of injection-red, round bump/blotch, 2inx2in, tender, sore, raised, itchy, 3 days, painful to touch