chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Opted to not get a second dose; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (Opted to not get a second dose) and NO ADVERSE EVENT (No adverse event) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Opted to not get a second dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, INTENTIONAL PRODUCT USE ISSUE (Opted to not get a second dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INTENTIONAL PRODUCT USE ISSUE (Opted to not get a second dose).    Concomitant medication was not reported. Treatment details were not reported.  After receiving first dose of Moderna vaccine patient opted to not get a second dose. The patient now presented and would like to receive his second dose but with the Pfizer BioNtech COVID 19.  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.
This spontaneous report was received from a Registered Nurse concerning a 15 year old female patient. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On 24-MAY-2017, the patient received the first dose of GARDASIL 9 intramuscularly (dose, lot number and expiration date were not reported) for immunization (prophylaxis). On 25-MAY-2017 at 07:30, the patient experienced severe pain in lower abdomen area that was described as stabbing and pressure. The patient did not received treatment for the event, and no laboratory diagnostics were performed. At the time of reporting, the outcome of the event was not recovered. The causal relationship between the event and GARDASIL 9 was not reported. Additional information has been requested.
tongue started to tingling; entire mouth got so dry; could not swallow; lips swelled; This spontaneous case was reported by a patient and describes the occurrence of PARAESTHESIA ORAL (tongue started to tingling), DRY MOUTH (entire mouth got so dry), DYSPHAGIA (could not swallow) and LIP SWELLING (lips swelled) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Johnson & Johnson vaccine. Past adverse reactions to the above products included No adverse event with Johnson & Johnson vaccine. Concurrent medical conditions included Allergy.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA ORAL (tongue started to tingling), DRY MOUTH (entire mouth got so dry), DYSPHAGIA (could not swallow) and LIP SWELLING (lips swelled). The patient was treated with TRIAMCINOLONE ACETONIDE (KENALOG [TRIAMCINOLONE ACETONIDE]) at an unspecified dose and frequency and PREDNISONE at an unspecified dose and frequency. At the time of the report, PARAESTHESIA ORAL (tongue started to tingling), DRY MOUTH (entire mouth got so dry), DYSPHAGIA (could not swallow) and LIP SWELLING (lips swelled) outcome was unknown.            No concomitant medications were provided by the reporter.  It was reported that on the 27th at 5:40 PM at a local vaccine facility, patient had the Moderna booster.   Patient had the Johnson & Johnson before because they do have allergies. It was reported that within 2 minutes of taking the shots, their tongue started to tingling, entire month got so dry and could not swallow.   Patient waited for 45 minutes and went home. 2 hours later, lips swelled. Patient had got a Tenalog shot from the doctor the next day and a Prednisone pill. The Tenalog helped with the dryness, the prednisone did not help stopping it.
Next day after the shot, I had nausea. The next day fatigue. By Friday 3AM I had widespread pain. I took Flexural pain in thighs and took Tylenol for left dorsal pain. It was painful all morning. I called in sick and slept all morning. I took shower at noon, my left dorsal was mottled with squiggly streaks. I had 101 temperatures. The mottling went away by evening. About a month later my hands started swelling, right was worse, and I couldn't see my knuckles. Monday the 12, the swelling went down. On Tuesday 13, the swelling came back. It took 9 months to get back to normal. I still have joint pains.
SHAKING; MUSCLE PAIN ON BOTH BICEPS, AND BOTH SHOULDERS, ON HIS NECK AND BACK; HEADACHE; ALL OVER SORENESS; COULD NOT SLEEP ALL NIGHT; FEVER; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018, and batch number: 1805018 expiry: 25/MAY/2021) .5 ml, administered on 09-MAR-2021 12:00 to Left Arm for covid-19 prevention. No concomitant medications were reported. On 09-MAR-2021, the subject experienced fever. On 09-MAR-2021, the subject experienced muscle pain on both biceps, and both shoulders, on his neck and back. On 09-MAR-2021, the subject experienced headache. On 09-MAR-2021, the subject experienced all over soreness. On 09-MAR-2021, the subject experienced could not sleep all night. Laboratory data included: Body temperature (NR: not provided) 98.7 F. On 10-MAR-2021, the subject experienced shaking. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, and shaking on 10-MAR-2021, was recovering from muscle pain on both biceps, and both shoulders, on his neck and back, had not recovered from headache, and all over soreness, and the outcome of could not sleep all night was not reported. This report was non-serious.
Increase of blood sugar by at least 6; ketosis; This spontaneous case was reported by a consumer and describes the occurrence of KETOSIS (ketosis) and BLOOD GLUCOSE INCREASED (Increase of blood sugar by at least 6) in a 78-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-May-2023, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 30-May-2023, the patient experienced KETOSIS (ketosis). On an unknown date, the patient experienced BLOOD GLUCOSE INCREASED (Increase of blood sugar by at least 6). On 02-Jun-2023, KETOSIS (ketosis) had resolved with sequelae. At the time of the report, BLOOD GLUCOSE INCREASED (Increase of blood sugar by at least 6) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: Increased.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that patient had Increase of blood sugar by at least 6, end of ketosis. It was unknown if the patient experienced any additional symptoms/events.   No treatment medications were reported.
Pfizer COVID vaccine vial was punctured at 8:40 am  on 9/13/21 and last dose from vial was administered to patient at 3:06 pm on 9/13/21, 26 minutes after expiration time. Patient was monitored for 1 hour. No adverse signs or symptoms occurred.
62 year old male with hx ESRD, s/p renal transplant 2017, CKD, baseline cr 1.8-2 per mother, lifetime deafness, hypertensive nephrosclerosis due to HTN, has not been on HD on over 4 years,, CVA, juvinille infartcts leading to deafness, very independant, Heart failure, VHD, hx endocarditis, right upper extremity dvt on eliquis, extended to right IJ, DVT right leg, PDA, was in ususal state of health and developed cough and fever and chills and tested positive COVID 19on 12/30/21. He presented to ED for increasing cough and shortness of breath and dehydration due to poor dietary intake. He is alert and oriented and understands, mom at bedside who helps him and translates for him. In the ED he had a chest xray which showed bilat infiltrates, He got a fluid bolus of 2.5 liters, was 90% room air and now 98% on 2-4 liters. He also has new onset PAF flutter, controlled rate, denies hx of , already on eliquis. He has elevated inflammatory markers, and first troponin is positive, lactic slightly elevated at 2.1, and Cr is at 3.9 way above his baseline. He denies chest pain or nausea or vomiting but poor po intake
Did not feel good all day/ felt like staying in bed; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Did not feel good all day/ felt like staying in bed) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039F21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PREDNISOLONE, TIMOLOL, ASPIRIN [ACETYLSALICYLIC ACID], BILBERRY [VACCINIUM MYRTILLUS], DILTIAZEM, GINKGO BILOBA (GINGKO BILOBA), GLUCOSAMINE, HYDRALAZINE, LOSARTAN, METOPROLOL, MULTIVITAMIN [VITAMINS NOS], FISH OIL (OMEGA 3 [FISH OIL]) and VITAMIN C [ASCORBIC ACID] for an unknown indication.   On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. 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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Nov-2021, the patient experienced VACCINATION COMPLICATION (Did not feel good all day/ felt like staying in bed). At the time of the report, VACCINATION COMPLICATION (Did not feel good all day/ felt like staying in bed) outcome was unknown.            Patient stated that he did not have any other symptoms aside from that.  No treatment information was provided.
Infanrix was administered by mistake to a 13-year-old patient; Infanrix was administered by mistake to a 13-year-old patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 13-year-old female patient who received DTPa (Infanrix) (batch number HH443) for prophylaxis.   On 10-NOV-2022, the patient received Infanrix. On 10-NOV-2022, an unknown time after receiving Infanrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Infanrix was administered by mistake to a 13-year-old patient) and wrong vaccine administered (Verbatim: Infanrix was administered by mistake to a 13-year-old patient).  The outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date 2 Oct 2023: Nurse reported that in 2022 a dose of Infanrix was administered by mistake to a 13-year-old patient who was supposed to receive Tdap, which led to inappropriate age at vaccine administration and wrong vaccine administered. The reporter consented to follow up via email agreed.
Starting at approximately 3:30 on March 12, 2021 after the vaccine was administered I had a swollen left arm that was red hot and painful.  By that night and for the next 2 days my fever ranged from 101 to 103.  I had muscle and body aches and flu symptoms.  By Monday at around 6:00 the fever broke and I felt better.
The late afternoon/evening on the day of the shot, my right side of my face, head, and neck felt sore. The next morning when I woke up, my right jaw joint was extremely inflamed and so much so that I could not bite down and my teeth did not touch or fit together. The pain was so bad and I had such limited movement of that area that I couldn't even move my tongue out to lick my lips. Then on Sunday, the pain was even worse and I could still not touch any teeth together and my bite was so off that my lower teeth did protrude out beyond my upper teeth. I went to the doctor the next day (Monday) in which he gave me a prescription for Meloxicam to reduce the inflammation. I had taken ibuprofen the days prior with no effect at all. Meloxicam did not work that much better but did reduce the inflammation a little bit. It was not until Thursday of that week (6 days after vaccine) that the inflammation was reduced enough to actually chew. MY front teeth touched together first and then the other teeth over the next couple of days.
Headache, lasted 27 hours.  starting 15 hours after injection Fatigue starting 10 hours after injection lasting 40 hours
On 04/15/2021 I got a cramp/charlie horse for 2 days on my left thigh, which I have never had before and I have been actively been playing pickleball for 1.5 years straight about 6 days a week for few hours every time I play, also been lifting at gym 2-3 times a week. Then my left calf got stiff the next day, then the next day my left thigh, left calf and behind the left knee all stiff and behind left knee felt it was hyper extended for several days and I was limping.  I am right handed and only use my right arm to play pickleball, my left arm got sore more like sore muscles but with aches that don't go away.  Then my shoulders and next got achy sore, then my right leg right side on the side of calfs got tight, then both the cushion part of both bottom of my feet near the toes sore, feilt sort of bruised with no bruise, felt tender and sore it is still that way today.  I also notice when I lift or play pickleball after rest at night I am super sore and tight and difficulty to sleep at night as I can't move much and morning wake up very sore muscles with aches.  This is not typical muscle soreness, more like an ache feeling soreness.  Also my right arm got tennis elbow, but the pain went to non tennis elbow area more to the left forearm area, which is also very unusual.  Then my left arm, I got tennis elbow and I don't use my left arm when playing pickleball.  Sore aches are in muscles I don't use or sore in places I have never been sore before.  I have ran marathons, lift weight extensively, played pickleball for 5 hrs straight, I rarely get sore and it only lasts 1-3days at the most, now just simple game for short time and I am extremely sore all over in various random places as the soreness areas move.  I need an antidote for this, this is clearly not normal as this all happen after the Janseen shot.  I also end up getting TMJ on my left mouth near the left ear been this way for over 2 weeks.
09/03/22 presents to ED for "hypoxia and increased respiratory secretions". PMHx of "PE, recent hospitalization for multidrug-resistant pseudomonal pneumonia, history of stroke, trach dependent"
Itching, red, swollen, hard center, warm to touch, sensitive to touch. TYLENOL and ice.
redness; sensitive; swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (redness), SENSITIVE SKIN (sensitive) and VACCINATION SITE SWELLING (swelling) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), NORTRIPTYLINE and LORAZEPAM (ATIVAN) for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness), SENSITIVE SKIN (sensitive) and VACCINATION SITE SWELLING (swelling). At the time of the report, VACCINATION SITE ERYTHEMA (redness), SENSITIVE SKIN (sensitive) and VACCINATION SITE SWELLING (swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included None.
red, hot, itchy, and swollen 4in.x4in. on right deltoid
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 28-JUN-2016, the patient inadvertently received an expired dose of ROTATEQ oral liquid, orally lot # K023537, expiration date: 22-JUN-2016 (exact dose and dose number were not provided). There were no adverse effects reported. Additional information has been requested.
Information has been received from a nurse concerning her daughter, a 19 year old female patient with no past medical history or allergies who on 06-SEP-2006 was vaccinated with the first dose of GARDASIL (lot number, route and site not reported). The patient was not taking any medications prior to GARDASIL. The patient received the remaining two doses "at the appropriate scheduled times." About one month after receiving the first dose of GARDASIL, the patient developed pain in her ankle and had difficulty ambulating up and down stairs. She was seen by the family physician who diagnosed her with tendonitis. One month and a half after the first dose, the patient was seen by an orthopedic surgeon and underwent blood tests and a MRI. The nurse stated that the "blood work was erratic for a healthy teenager" and the ANA results were positive. The patient was then referred to rheumatologist, which she was still seeing. The patient was diagnosed with an autoimmune disease and reactive arthritis in her hip, knee and ankle. She was placed on therapies with PLAQUENIL, Vitamins, Fish oil, tramadol, and ibuprofen. The nurse reported that the patient was also seen by a urologist since "she was spilling protein in her urine due to the ibuprofen". The ibuprofen was discontinued. The patient saw an eye specialist every three months to evaluate for possible visual side effects that may occur with the PLAQUENIL and tramadol (no visual side effects reported at this time). The nurse reported that the patient did not require any hospitalization or life saving measures due to this reaction. This reaction was not related to a cancer or an overdose. The nurse stated "This is something that she is going to have for the rest of her life." At the time of the report, the patient did not recover. The health care professional contacted during telephone follow-up could not supply the following information: date of birth, dates of vaccination/therapy, dose number (if applicable), lot number (if applicable), date of event, recovery status, hospital name (if applicable), healthcare provider contact information. Follow up information has been received from a receptionist of a doctor's office who reported that the patient is an 18 year old female (previously reported as 19 year old). Additional information has been requested.
got the flu shot 4 years ago and I was sick for 10 days; Initial information received on 22-Oct-2021 regarding an unsolicited valid  non-serious case received from a consumer non health care professional under reference number: US-SA-SAC20211027000289. This case involves an unknown age and unknown gender patient who was administered the flu shot 4 years ago and i was sick for 10 days (Illness) while receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatments, vaccinations, concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number and expiry date not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious event got the flu shot 4 years ago and i was sick for 10 days (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  No laboratory data reported.  It was not reported if the patient received a corrective treatment for the event.   At time of reporting, the patient was recovered from the event.  There was be no information on the batch number for this case.
Patient ID: Patient 94 y.o.    Admit Date:  7/19/2022   Discharge Date:   7/25/2022   Discharge Diagnosis:  Principal Problem:   Subcapital fracture of femur, right, closed, initial encounter Active Problems:   Late onset Alzheimer's disease with behavioral disturbance   Acute renal failure with acute tubular necrosis superimposed on stage 3a chronic kidney disease   History of deep venous thrombosis (DVT) of distal vein of left lower extremity   Bladder mass   COVID-19 virus infection   Pelvic lymphadenopathy   Invasive carcinoma of urinary bladder     Hospital Course:  94 year old male resident of a nursing home was admitted for right hip fracture which was surgically repaired. He also ha Covid-19 infection and advancing bladder cancer. Family decided not to pursue further with treatment of the cancer. He also has acute renal failure. Family made him DNR and later comfort care after hip fracture was surgically repaired. He is lethargic and not in distress. He will be transferred back to the NH today in comfort care status.     Physical Exam on the day of discharge: Last Recorded Vital Signs: Temp: 99.5 °F (37.5 °C) Heart Rate (Monitor): 65 Pulse: 72 BP: 137/90 Respirations: 16 SpO2: 96 % O2 Flow Rate (l/min): 2 l/min General Appearance: lethargic  Eyes: PERRLA ENT: moist mucus membranes, no adenopathy Lungs: clear to auscultation bilaterally  Heart: irregular rate and rhythm Abdomen: soft, non-tender Skin: No rashes or lesions  Extremities: no edema Neuro: disoriented   Consults:  IP CONSULT TO ORTHOPEDIC IP CONSULT TO UROLOGY IP CONSULT TO NEPHROLOGY IP CONSULT TO SOCIAL WORK IP CONSULT TO SUPPORTIVE CARE SERVICES IP CONSULT TO SOCIAL WORK IP CONSULT TO SUPPORTIVE CARE SERVICES IP CONSULT TO SUPPORTIVE CARE SERVICES   Significant Diagnostic Studies:   CT head, BLE venous US, VQ scan   Operations: Right hip hemiarthroplasty   Disposition:  SNF   Discharge Condition:  Poor
On the 2nd shot 2/25/2021, arm swelled, sore, big red circle. Headache, extreme chills, diarrhea, throwing up, extreme fatigue, dizziness, body aches, no appetite, severe pains in feet, developed a lump on top of left foot that felt hard but went away after 2 months. Change in temperament, crying, angry, yelling and screaming all the time. So tired I cannot perform daily duties still to this day. I was extremely sick for six (6) days. Neighbors had to take care of me & my dog. I was afraid to go to the hospital or doctor. I will NEVER TAKE ANOTHER VACCINATION AS LONG AS I AM ALIVE. I believe this shot has impaired me. Keep getting extreme hot flashes but mostly on the left side.