chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a consumer concerning his grandson of unknown age. On an unknown date, the patient was vaccinated with a dose of M-M-R II (lot number, expiry date, dose and route unspecified). No concomitant medications were reported. On an unknown date, the patient experienced ear infections and hearing loss. It was unspecified if the patient sought any medical attention. The outcome of hearing loss and ear infections was unknown. The consumer did not provide the name and demographics of the healthcare professional. Legal issue was involved. Adverse event was sent to legal department. The relatedness for ear infections and hearing loss was unknown for M-M-R II. Upon internal review, the event, hearing loss was considered as medically significant. This is one of the two reports from the same source. Additional information has been requested.
Patient complaint of dizziness and sweating10 minutes after vaccination. Loss of consciousness for 10 seconds. Patient placed on the gurney with elevated legs. Patient gained consciousness after 10 seconds. Patient was given juice  and discharged home  after 24 minutes observation .
Extremely sick for 5 days. Trimmers which I'm now taking Propanol for. Ankle swelling the size of grapefruits.
Infant became hypotonic, lethargic, had poor appetite and gagged constantly to the left starting 2 days after immunization. Periodic breathing at night also noted. Torticollis present on exam. Symptoms and signs have resolved. Breathing abnormality during sleep still present.
So after the second injection on the 27th of Jan. I started to have flu like symptoms, body aches and what not. The joint pain was minor. It was tolerable but as time went on it got worse. My medication that I was taking was not helping at all. It got to the point where I was walking, I had increased pain. When I was leaving work a couple days later I had trouble leaving work, I couldn't walk 25-40 feet to my vehicle after work. I had a severe spasm and my body was not functioning properly. I was finally able to make it to my vehicle. When I got to my vehicle I laid the seat back and laid there for about 15 minutes. I called a friend because I was really scared, I had never experienced that type of pain before. After about thirty minutes I was able to drive home. When I got home I had a lot of stiffness. When I took a step there were shooting pain in my left leg. I took ibuprofen 800mg and flexural. The next morning I was able to walk, I was still stiff but took a shower and went to work. At work someone saw me and got me a wheelchair at work, I am an RN. My husband took me to ortho on call. They did X-rays, they told me I needed to see an Orthopedic DR. On Feb 19th I started to see an orthopedic pain DR. On March 8th I started physical therapy, I did therapy 2x per week. They did an MRI, they determined I have a disc disease. On April 4th I had a steroid injection. I am scheduled to go back on June 9th for a possible another injection. I still cannot long distances but I know to take a break and it doesn't hurt as bad. I am constantly looking for a place to sit down. I am still being seen by an orthopedic DR.
Patient reports watery eyes and itchy throat following immunization with AVA # 1, Hep B 1, and typhoid # 3 on 3 Jun 08. He subsequently received Hep B # 2 in July without any problems. Patient reported that he has a history of latex allergy and felt that this reaction was due to latex. After a neg IgE Immune CAP, the patient was administered AVA #2 on 19 Aug, with premeditation of Claritin. He reported no problems with AVA # 2; Symptoms: Watery eyes, Pruritus.
Dizzy, lightheaded, tachycardia, intermittent tinnitus. Cramps not related to monthly cycle. Mood swings, abnormal pap smear.
This spontaneous report as received from a physician, through the patient's parent, via company representative refers to a 3 year old female patient. The patient's relevant medical history was not provided. On 06-JUN-2011, 08-AUG-2011 and 08-OCT-2011, the patient was vaccinated with ROTATEQ (lot number not reported) 2 ml, oral. No concomitant medications were reported. On 17-JAN-2015, the patient's parent called to state that the patient experienced diarrhea and vomiting (hospitalization) on 15-JAN-2015. Patient sought medical attention on 19-JAN-2015, the patient was hospitalized (length of stay unknown) and tested positive for rotavirus. Patient was treated with fluids and some other unspecified treatments. The outcome of the events diarrhea and vomiting was reported as recovered. The reporter's causality assessment was unknown. There was no product quality complaints (PQC) involved. No further information was provided. Additional information has been requested.
This spontaneous report was received from a certified medical assistant and refers to a 6 month old (at the time of the report the patient was 8 month old) male patient. Information on the patient's concurrent conditions, medical history or concomitant medications was not reported. On 02-MAY-2016 at 16:00, at the age of 6 month old, the patient was vaccinated with his first dose of ROTATEQ (lot# number reported as L033543, expiration date 30-MAY-2017, orally, dose was not reported). The temperature of excursion was 34F and the time frame was 65 hours. There was no previous temperature excursion and the call was not because of a data logger. No adverse events, signs or symptoms were reported. No product quality complaint (PQC) was involved. The patient had no illness at the time of vaccination. This is one of several reports received from the same source. Lot number L033543 has been verified to be valid lot number ROTATEQ. Additional information is not expected as all required correspondence has been received.
Modeema COVID-19 Vaccines EUA. I had a rash that started on my legs and within two days it was all over my body including my face.
respiratory type thing; dizziness; postpone second shot; fever; chills; A spontaneous report was received from a consumer concerning a 84-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chills, dizziness, fever, respiratory infection and had to postpone second shot schedule.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 15 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 024M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On an unknown date after first dose vaccination, the patient experienced  chills, dizziness, fever and respiratoryinfection for which she received antibiotics from ER visit. She had to postpone second  shot schedule.  Treatment information included as antibiotics.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of all events was not recovered and for missed dose recovered.; Reporter's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Severe pain in left hip and leg went to urgent care. DX sciatica prescribed Medrol dose pack- could not take allergic to prednisone. Follow up with (chiropractor)on 1-29 due to pain and problem walking. Received 2nd dose of COVID vaccine on 2/03. Tingling and burning started 2/12 on left side of neck and head. Pain in hip continued but not as severe. Had appt with dermatologist on 2-23 for yearly appointment. Rash had developed on left side of head and neck. Dx shingles. Acyclovir prescribed with some benefits but pain and rash continue. Reoccurrence of shingles 2015.
No adverse event; Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 12-Oct-2022, the patient experienced UNDERDOSE (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster).    Concomitant drugs were not reported. It was reported that patient received 0.25 mL of bivalent booster dose instead of 0.5 mL and stated that reporter called the CDC and were instructed to go ahead and administer the other half of the dose on the same day. Treatment medications were not provided. This case was reported for the adult patient 9.   This case was linked to US-MODERNATX, INC.-MOD-2022-658160 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-658160:Adult patient 9
My right arm was swollen with a large 6" red patch below the injection site. Below the injection site my arm was hard & swollen  and very sore. I couldn't lift my arm and had to take Ibuprofen (4 capsules @ 200 mg) to ease the pain & sleep with my arm on a pillow. The pain & swollenness lasted a few days.
This is a 94-year-old male who is brought in by ambulance after being found on the floor with unknown downtime.  He was in asystole upon EMS arrival.  He remains in asystole.  No advanced airway is in place.  The patient is getting compressions from Lucas device upon arrival.  It was reported that he was last talked to by family at 2 PM.  The patient got his SARS-CoV-2 vaccination this morning.  The patient is evaluated emergently.  CPR was ongoing with 3 rounds of epinephrine given.  The patient remains in asystole.  He has rigor mortis.  The patient's pupils are fixed and dilated.  The patient has compressions paused and ultrasound is used to evaluate for cardiac activity.  None is detected.  The patient has no electrical activity on monitor.  The patient's time of death is 2113.
Redness in the injection site; Tenderness in the injection site; Sore in the injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 31-Oct-2021 and was forwarded to Moderna on 01-Nov-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness in the injection site), VACCINATION SITE PAIN (Tenderness in the injection site) and VACCINATION SITE PAIN (Sore in the injection site) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     Concurrent medical conditions included Gastric disorder. Concomitant products included CIMETIDINE (TAGAMET [CIMETIDINE]) for Gastric disorder.    On 10-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced VACCINATION SITE PAIN (Tenderness in the injection site) and VACCINATION SITE PAIN (Sore in the injection site). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Redness in the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Redness in the injection site) had not resolved and VACCINATION SITE PAIN (Tenderness in the injection site) and VACCINATION SITE PAIN (Sore in the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.   Reporter did not allow further contact
No adverse effects; patient received one dose of improperly stored varivax; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, pertinent medical history, drug reactions/allergies and concomitant medications were provided. On 17-APR-2020, the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) (strength, schedule and dose # were unspecified) lot#S022756 expiration date reported as 22-JUL-2021 and lot#R020654 expiration date reported as 18-JUL-2020 via subcutaneous route for prophylaxis (product storage error). It was reported that, the sterile diluent used to reconstitute the vaccine was properly stored. No additional adverse effects reported. The temperature was reported as 5.7 Fahrenheit, previous temperature excursions were reported as -13.3 Celsius for 18 minutes and -13.2 Celsius for 18 minutes. The total time frame was reported as 18 minutes. There was an involvement of digital data logger. No product quality complaint involved.
Immediately after the shot on Friday Jan 22 I experienced a heavy leg feeling  lasting 4 hours. Saturday and Sunday, 1 and 2 days after the shot I experienced very extreme fatigue. Like I had no energy to even eat or drink water. I had light vertigo for 5 days after the shot. I had a sore arm til one week after the shot, nothing unusual or unusually painful. I had highly fluctuating heart rates. On Saturday and Sunday following Jan 22 as tracked by a blood-ox monitor: At the lowest I measured it in the upper 40s/low 50s. Generally it would race to 96, then drop to 76. Saturday night I experienced 8 hours of raspy, shallow breathing. All symptoms resolved by Wednesday the following week. Approximately three weeks after the shot around the late afternoon of Feb 7, I noted my heart felt like it was beginning to pound in my chest and beat fast. On a whim I checked my bp using a home bp monitor and noted it was elevated at around 141/not remembered diastolic. As the week progressed I had fluctuating blood pressure and heart beats where I could feel it rising and falling, but always trending higher than previous highs. On evening of Feb 11 I measured my bp at 192/unremembered diastolic and checked into an urgent care facility. My bp and heart palpitations continued to remain generally high with 2 other random and sudden spikes happening in April and June. Also by June I was experiencing sudden shortness of breath with physical activity and was diagnosed with pulmonary arterial hypertension. With medical treatment my symptoms feel like they resolved by late August/early September, but I will know for sure next year when the cardiologist does another echo gram of my heart.
Brain confusion (1 hour), headache (3 days), body aches (3 days), vomiting (2 days). weakness & tiredness   (5 days).  No treatment for any of above.
Diagnosed with COVID; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Diagnosed with COVID) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Feb-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 COVID-19 (Diagnosed with COVID). At the time of the report, COVID-19 (Diagnosed with COVID) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter.  No treatment medication was provided.     Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: TCR-Follow up information received on 18-May-2021 contains no new information; Sender's Comments:
fever, (100.4) chills, fatigue, migraine starting 9 hours post injection of 2nd covid dose, lasting 18 hours
Redness at site and raised bumps at injection site. On had discomfort if area touched. Afebrile.
Patient was having pain in her left shoulder.  Patient had return to pharmacy at some point over the next week or so and asked if it could have been the vaccination.  She spoke with me, I told her I had not had anyone report any problems and told her to speak with her MD.  After approximately 2 months (11/20/09) the patient went to the physician and the physician diagnosed her with tendonitis.
1/8 TSP BLOOD AT INJECTION SITE; SMALL BRUISE; PERHAPS THE VACCINE WAS INADVERTENTLY ADMINISTERED SUBCUTANEOUSLY BECAUSE OF THE BLOOD STAINED COTTON; This spontaneous report received from a patient via a company representative concerned a 68 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) .5 ml, administered on 06-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included cyanocobalamin.  On 06-MAR-2021, the patient experienced 1/8 tsp blood at injection site, small bruise and perhaps the vaccine was inadvertently administered subcutaneously because of the blood stained cotton. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the 1/8 tsp blood at injection site, small bruise and perhaps the vaccine was inadvertently administered subcutaneously because of the blood stained cotton was not reported. This report was non-serious. This case, from the same reporter is linked to 20210323322.
As stated, had bad ache in arm the night of the injection of PREVNAR 13.  By the next morning was achey in all joints. Had some nausea, No vomiting. Headache was bad enough that was not able to go to work and layed on bed or couch all day.
The days after the shot the patient was sleeping 12-14 hours a day which was not normal. On 04/15 pt started to feel dizzy and signs of blurry vision began. They went their general physician ruled out stroke & clot, then recommended they see an eye dr since the vision was the worst symptom. By 04/21/2021 the pt lost 100% of their eye sight. They eye dr after doing a scan discovered the pt had temporal arteritis. They  believe the vaccine could had caused the body to lose the fight against the temporal arteritis and pt eyesight was lost.
Left arm pain and swelling extending to wrist/hand after 2nd  covid vaccine.  Swelling over shoulder and hand now resolved, though wrist  still swollen and  tendon.  Lateral forearm also stil significantly tender.Likely adverse reaction to vaccine.  Lower supspicion of  upper extermity  thrmbosis.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' pertinent medical history, concomitant medications and drug reactions or allergies reported. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II injection, lot # L009214, expiration date 17-MAR-2017 (dose, albumin status, anatomical location and route of administration were not specified). No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Started with cold like sx on 10/18, continued with febrile, cough, tachypnic went to Urgent care on 10/20, given amoxicillin phenergan and mucinex, continued with fever, tachepnea, tachycardic, went to ER.  Dx with Bi-Lateral Pneumonia and Hypokalemia.  Swabbed for H1N1, send out test only.  Given mulitple doses of IV Levaquin, IV and PO potassium, Tamiflu, other supportive medications.  Per ER Doc and Hospitalist, presumed H1N1 positive, from the H1N1 vaccine given 3 days prior to the onset of symptoms. 10/28/09:  Hospital Records and Discharge Summary received for Dates of Service 10/22/09 to 10/24/09.  Final DX:  Bilateral pneumonia with possible H1N1 influenza, GERD, Hypokalemia, improved. Assessment:  Admitted 2/2 cough and SOB, 1 week after receiving flu mist vaccine.    Experienced fever, cold, chills, body aches, wheezing, malaise and nausea.  She went to an Urgent Care Center and was given Amoxicillin, but sx. continued to worsen.  CXR with bilateral lung infiltrates.  Placed on Tamiflu and IV Levaquin.  Potassium supplementation given to correct hypokalemia.  Discharged to home.
Adverse events consisted of severe flu-like symptoms: Fever, chills, muscle aches, headache, nerve pain in arms, hands, back, and legs, extreme weakness and fatigue, and a rapid heart rate.  Treatment was with OTC pain medication:  1000 mg Tylenol and later 500 mg Ibuprofen  Outcome: started to alleviate after 24 hours
2 1/2-3 hrs p/vax pt awoke fram a nap had emesis, temp elevated & was trembling; brought back to the clinic, t100.5; APAP given; pt appears listless observed x 45 mins;
Chills fatigue sleeping 12 hours  10 days later complete loss of balance and severe dizziness