chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 7 year old female with allergic rhinitis and a history of "HAO" who on 16-JUL-2008 at 11:00 was vaccinated subcutaneously in right arm with the second dose of VARIVAX (Merck) (LOT # 659456/1912U).  There was no concomitant medication.  On 17-JUL-2008 the patient developed tender, papule, redness and swelling at the injection site.  Subsequently, the patient recovered from the symptoms.  Additional information is not expected.
Flushed face, head congestion, fatigue, injection site swollen (silver dollar), redness was put on antibiotic for 10 days. Duration highest intensity: 3 days.
More fluids under her right eyes; Knot under her right eyes; Swollen cheeks (more of the right than left); Cheeks are very tender; Swollen right eye; Sore to the touch right eye; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Swollen cheeks (more of the right than left)), TENDERNESS (Cheeks are very tender), EYE SWELLING (Swollen right eye), EYE PAIN (Sore to the touch right eye) and EYE SWELLING (More fluids under her right eyes) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for an unknown indication. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced SWELLING FACE (Swollen cheeks (more of the right than left)), TENDERNESS (Cheeks are very tender), EYE SWELLING (Swollen right eye) and EYE PAIN (Sore to the touch right eye). On 22-Mar-2021, the patient experienced EYE SWELLING (More fluids under her right eyes) and HORDEOLUM (Knot under her right eyes). At the time of the report, SWELLING FACE (Swollen cheeks (more of the right than left)), TENDERNESS (Cheeks are very tender), EYE SWELLING (Swollen right eye), EYE PAIN (Sore to the touch right eye), EYE SWELLING (More fluids under her right eyes) and HORDEOLUM (Knot under her right eyes) outcome was unknown. 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.   Treatment included Benadryl.
Information has been received from a physician concerning a 3-year-old male whose brother was vaccinated with a 0.5mL subcutaneous dose of varicella virus vaccine live (Oka/Merck) on 24-APR-2007. On 04-MAY-2007, this patient contracted full blown chickenpox. The sibling who received the vaccination did not experience an adverse event following vaccination with varicella virus vaccine live (Oka/Merck0. No additional information was provided. Unspecified medical attention was sought. No product quality complaint was involved. Follow-up information received from a Family Nurse Practitioner indicates that the physician who reported the event originally does not work at the clinic anymore and no other staff member is aware of the incident. Additional information is not available.
the patient has been administered dose of vaccine which was improperly stored.; This spontaneous report has been received from a vaccine coordinator who was also a medical assistant concerning a patient of unknown age and gender. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported.  On 11-JUN-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) with lot number R002510 and expiration date on 25-JAN-2020 (dose, dose number, route of administration and anatomical location were not provided), for prophylaxis.   It was reported that on 19-MAY-2019, 20-MAY-2019 and in 2020 (conflicting information), the vaccine was exposed to a temperature above 9 degrees Celsius: 16.4 degrees Celsius for 5 hours and 30 minutes, and below 2 degrees Celsius: 0 degrees Celsius for 9.8 hours. There was no previous temperature excursion. The call was placed because of a Digital Data logger report.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA004562:
Patient reported to clinic at work place 6/18/15, decreased range of motion, swelling, pain that has increased since day of injection (6/10/15), pain is constant/sharp/burning, pain moving down inner arm toward elbow.
T 97.1 right leg extreme swelling around site with hematoma plus swelling from femur to ankle. Lt leg only localizes redness and swelling at site, able to ambulate, advised to continue ice packs as needed and resume normal activity gradually.
Event occurred while exercising.  lightheaded, faint, jaw/neck/chest pain, loss of feeling in hands and feet.  Never had these symptoms before the vaccine.  I have a dilated cardiomyopathy and symptoms are that of myocarditis. Symptoms only occur while exercising: tachycardia, arrhythmia, palpitations.
2 hour post, pain in abdomen, 4 hours nausea and vomiting over the past 4 days. Pt has had dizziness, fuzzy feeling in his head.
Imms give 8/2/12 in (L) mid. tricep. Pt come on 8/4/12 with c/o pain and swelling redness and warmth treatment ice & OTC medication check back as needed.
fever 9 days p/vax;sz lasting longer than 50min rx w/dilantin will cont taking dilantin x2yr @ least;
GAVE PATIENT 0.5MLS OF THE COVID 19 MODERNA BIVALENT BOOSTER INSTEAD OF THE PEDIATRIC DOSE OF 0.25MLS
Itchy, swollen eyes with clear drainage, blurred vision  at 630pm Eyes was swollen shut by 2am (still itching) I took some Claritin about 215am using ice packs to help with swelling Woke up with swollen eyes at 6am (still itching) Came to work with swollen eyes took Benadryl around 830am.  Eyes was still swollen but not as bad still draining and itching.  By noon I was having muscle aches and chills no fever. left work at 1215pm went home and increase fluids and took another 2 Benadryl and slept until the nest day.  Eyes was better still puffy and itchy with small amount of drainage.
Chills, sweats, ryalgia, headache, rash all started simultaneously although rash noted later at about 16:00 06/23/2003.
No additional AE information provided; Medical assistant calling to report that a 7-month old female patient was inadvertently administered VARIVAX today; This spontaneous report was received from a medical assistant referring to a 7-month-old female patient. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 04-FEB-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 milliliter, lot number T010315, expiration date 24-MAR-2022 for prophylaxis (route of administration not reported) (product administered to patient of inappropriate age). No adverse event was reported.
Fever of 102.9  Uncontrollable shaking  Terrible migraine  Numb arm on and off tingling N/V  extreme fatigue  Severe dizziness /vertigo  Excessive sweating  Blurry vision
Information has been received from a state health department concerning a pt who was vaccinated with varicella virus vaccine live. It was reported that a physician diagnosed a single case of chicken pox post vaccination with varicella virus vaccine live. No additional information is expected.
Entered atrial fibrillation during light exercise August 25, 2021.  Self-diagnosed using Kardia DTC EKG monitor.  Began anticoagulant therapy as per doctor's orders: rivaroxaban 20mg daily.  Outpatient DC cardioversion Sept. 1 was successful, and I remained in sinus rhythm.  Then I had a repeat episode of atrial fibrillation beginning the morning of December 4.  Successful cardioversion Dec. 8.  Both cardioversions performed by Dr.    Previous catheter ablation procedure was August 9, 2021 at hospital, requiring an overnight hospital stay.  Procedure successfully resolved premature ventricular contractions arising from two sites.
Pt recv vax on 11/14/98; on 11/16/98 pt exp erythematous of LA
After sitting for 10 minutes, I became very nauseated and lightheaded and walked self to gurney near by to lie down.  Medical attention was rapid and blood pressure was super low, 70/50 ish and returned to better number in Trendenlenberg position.  I was sent to ER for further monitoring and all is fine now-  Dx with near Syncope due to orthostatic hypotension.
HCP explained that 2 female colleagues who've previously had Moderna vaccine(s) had covid infection; Patient is greater than 30 weeks pregnant; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of COVID-19 (HCP explained that 2 female colleagues who've previously had Moderna vaccine(s) had covid infection) and MATERNAL EXPOSURE DURING PREGNANCY (Patient is greater than 30 weeks pregnant) in a 23-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced COVID-19 (HCP explained that 2 female colleagues who've previously had Moderna vaccine(s) had covid infection) and MATERNAL EXPOSURE DURING PREGNANCY (Patient is greater than 30 weeks pregnant). At the time of the report, COVID-19 (HCP explained that 2 female colleagues who've previously had Moderna vaccine(s) had covid infection) and MATERNAL EXPOSURE DURING PREGNANCY (Patient is greater than 30 weeks pregnant) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Reported that female patient who previously had Moderna vaccine(s) had covid infection. Reported that patient was greater than 30 weeks pregnant.  No treatment medications were reported.  Company Comment: This Spontaneous case describes the occurrence of maternal exposure during pregnancy in a 23-years-old female patient, with no medical history reported, who experienced the unexpected and non-serious event of COVID-19, which occurred on an unknown date after an unspecified dose of SPIKEVAX NOS, at greater than 30 weeks of gestation. No information disclosed about diagnostic tests performed, clinical course or treatments received. The benefit-risk relationship of SPIKEVAX NOS vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-749420 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-749420:same reporter/patient 2
Patient presented to emergency department on 12/9/2021 with sharp epigastric abdominal pain. Patient was admitted for necrotizing pancreatitis and was found to be COVID-19 positive during screening for admission. She was asymptomatic for infection during admission and did not require treatment. Patient left against medical advice on 12/18/2021.
Information has been received from a medical assistant concerning a 19 year old female with penicillin allergy and a history of pseudomotor cerebri who on 10-JUL-2007 at 11:00 was vaccinated intramuscularly with a 0.5 mL first dose of Gardasil.  On 04-SEP-2007, the patient was vaccinated intramuscularly with a 0.5 mL second dose of Gardasil (lot 658556/1060U).  Concomitant therapy included EFFEXOR, TOPAMAX and ALLEGRA-D.  On 04-SEP-2007, at approximately 4:15 pm, the patient called the office to report that she had hives on her face.  The patient described the hives as "coming and going".  On 04-SEP-2007, the patient recovered.  Additional information has been requested.
PAIN INTHE LEFT ARMS ,TICKLES AND I HAVE 2 DODULES ONE 5 MM AND ANOTHER 6 MM VERY SWALOW AND THE ARMA AND LEFT HAND IS VERY WEAK
Patient vaccinated 6/7/17 with TDaP (R delt.), Hep B (Left delt.). RTC to HU 6/13/17, stated had reaction to vaccine given in (R) arm. C/O of pain, swelling, and vomiting fizzy substance after injection.
1355: pt received Tdap, Flu, Hep B vaccine and PPD per HM2. Patient was getting her coat and then told HM2 that she didn't feel well. HM2 helped her to chair, her eyes deviated to left side, and she became unresponsive. No head trauma noted. HM2 held pt and called for help. RN and myself arrived to find patient gray, unresponsive and unable to find pulse. We both attempted sternal rub, decorticate posturing noted to left arm and then patient had urinary incontinence. Pt woke up quickly and was quite alert and able to answer questions and transferred to gurney with minimal help. See vitals section. 1405-patient oriented x 3 and able to tell us her husband's contact information and called her mother on her cell phone. Pt was in good spirits. No hx of past seizures or pertinent medical hx. Accucheck glucose level=91. 1420-IV started in right AC w/ 20 gauge per RN x 1 attempt with good blood return. NS 1000cc hung open. 1430-helped pt get into clean xray shorts and she continued to be in good humor and asking questions. Report called the MC per Dr. to Dr. 1435-911 called for transport and SBAR given. Patient advised that she must receive any future vaccines in a hospital setting and to follow up with us next week after evaluation in ER. Pt verbalized understanding and was very appreciative of care.
12/22/21: This is a 91-year-old female with a PMHx of congestive heart failure and questionable dementia (HPI limited due to patient being poor historian) presents with a chief complaint of generalized illness.  Patient reports generalized weakness, shortness of breath, and cough for 3 days.  Per ED note patient evaluated by EMS 3 days ago after being called secondary to a cough, however patient refused at that time.  Today patient's daughter called EMS again for persistent dry cough and blood noted on her shoulder (source unknown).  Patient denies any known head trauma, chest pain, abdominal pain, N/V/D, hemoptysis, or any other symptoms. Patient received first dose Moderna vaccine on 2/15/2021 Lot # 007M20A, the second dose on 3/15/2021 Lot # 010A21A and the booster on 11/18/2021 Lot # 065F21A
8/1/2013 started with a severe sinus cold treated at home with OTC Sinus meds lasted 2 weeks. Cough never went away. 10/23-11/3 flu like symptoms went to Urgent Care on 11/3/13 diagnosed and tx for pneumonia. 12/6/13 prescribed inhaler lungs cleared up on x-ray. 12/16/13 x-ray 12/23/13 Levaquin lungs still hurt 12/26/13 Pulmonary Specialist diagnosed me with COPD prescribed Advair, doxycycline, predisone, and inhaler.
10-6-10 Red area on Lt arm 1 1/2 x 1 inches at flu vaccine injection site. BENADRY PRN.
approx 10 mins p/inj pt c/o feeling hot & itchy over most of body; pt was given DPH;
On 11/13/15, 65 yo F was seen in clinic for nurse only visit for immunizations. During this visit, pt received Flu vaccine, age 3yo, preservative free, IM (QUADRIVALENT) 0.5 mL in left deltoid (NDC #49281-415-50, Lot #UI493AB, exp: 6/30/2016). On 11/16, pt called clinic and reported that on 11/15, she developed redness and mild swelling to left deltoid area, accompanied by mild fatigue, malaise, nausea and low grade fever. Pt had self-treated with acetaminophen and ibuprofen. Pt was offered office visit, but initially declined this due to travel. Pt was advised to apply intermittent ice to area and continue to monitor reaction. On 11/17, with symptoms unchanged, the pt returned to clinic for evaluation. MD exam found "On the left arm, extending from the deltoid inferiorly, there is erythema and warmth. Mild tenderness at the injection site." A CBC and comprehensive metabolic panel was ordered to evaluate for infection given left lower quadrant tenderness. Pt was advised to seek emergency care for any worsening symptoms. Pt told to monitor border of area of erythema and call for any enlargement. On 11/19, pt was called and pt reported "left deltoid side is slightly less red, slightly less warm and has better mobility of her arm today". WBC resulted were elevated at 15.3. Pt continues to monitor site and again agreed to seek care if elevation in fever or any new or concerning symptoms.
Infection in left leg, approximately 3" x  6". Lumps in groin area, very painful.
20 MINUTES AFTER INJECTION CLIENT COMPLAINED OF VISUAL DISTURBANCES.  HE STATES THE WHITE TRUCK PARKED NEXT TO HIM APPEARED PINK FOR A SPLIT SECOND THEN RETURNED BACK TO LOOKING WHITE.  CALLED EMS PER PROTOCOL  MANUAL B/P 220/90, PATIENT THEN ALSO COMPLAINED OF CHEST PAIN/TIGHTNESS. ASA 325MG WAS GIVEN TO PATIENT PER PROTOCOL AND 4 L OXYGEN VIA NC. PATIENT WAS TRANSPORTED VIA EMS TO HOSPITAL.
Fever (101.8 - 102.3) and chills Fatigue Headache/stiff neck and pain Lasting 24 hours
Arthralgia Narrative: Mild hip and pelvis ache, still lingers  Other Relevant History:
Information has been received from a registered nurse concerning a 30 day old infant patient who on 09-DEC-2011 was vaccinated with the first dose of ROTATEQ (lot number not provided). The infant also receive PENTACEL and PREVNAR at an alternate schedule and the pharmaceutical companies were notified. No adverse symptoms noted. Follow-up information has been received from a licensed practical nurse who reported that the female patient was vaccinated with a first dose of ROTATEQ, oral (lot number 1393AA, Expiry date 03-DEC-2011) (dose not reported) on 08-DEC-2011 (previously reported as 09-DEC-2011) at 08:15. No adverse reactions were reported. No further information is available.
Headache, dizziness, chills, body aches, diarrhea, nausea, tiredness. Tylenol every 4-6 hours
ears started to ring; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 86 year-old female patient received bnt162b2 (BNT162B2), administration date 19Mar2021 (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: TINNITUS (non-serious) with onset Mar2021, outcome "not recovered", described as "ears started to ring".  Additional information: It was reported that the event was experienced within 3 to 4 days after receiving the dose. Event was still continuing and has not resolved. She wanted to know if this could be a side effect of the vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Approx 2 days after receiving vaccine, client began to experience "strange" feelings, "being in a fog", not able to take a deep breath.  I advised today(10/22) that he seek urgent care
Cellulitis; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6199; Expiration Date: 20Jun2021) on 09Mar2021 as a single dose, with route of administration unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. In Mar2021, after the first dose of vaccination, the patient had cellulitis. The event was assessed as serious (medically significant). The patient was on an unspecified antibiotic as treatment for the event. The outcome of the event, cellulitis, was unknown. The patient was scheduled to return for the second dose on 30Mar2021.  Information on lot/batch number was available. Additional information has been requested.
12 yo female here for follow up on "seizure-like" activity last week. States that after HPV on 9/1 she did well however went to school and started feeling weird during PE. She states that she was not in full control of her body and that she felt dizzy. Then she started feeling weak and by the time mom picked her up from school she was slurring her words and did not recognize her brother. She took her home and rested but then one hour later she fainted and was shaking. Mom took her to the ER where an extensive work up including blood work, EKG, EEG, CT, UA were all negative. Since that time she has felt foggy, fatigued, and just not herself. She has had retro amnesia and could not do tasks that she normally would. States that she has been sleeping ok, going down about 10pm and waking up normally but then feeling tired throughout the day. No more dizziness, HA, blurry vision, loss of motor function, seizure activity, or other symptoms. Eating and drinking ok, normal output. No fever. No meds at this time. Does state that her right arm has also been hurting since the immunization and then IV placement in the same arm. Hurts when she is writing for a long time or using it for a long time. Denies any numbness, tingling or loss of function.
Developed gradual aches over the course of the following two days, until I was in severe pain by the morning of 6 Oct. Went to urgent care for help on 6 Oct, followed by ER on 7 Oct and was treated for possible kidney stone. Developed rash on left trunk area and was diagnosed with shingles on 8 October.
13 X 10 cm.  Red warm raised area around DTAP administration site right thigh.
Approximately two to three weeks following my 3rd dose of Moderna, I contracted COVID-19. Shortly after that, I began to have irregular cycles. They were 10-15 days late in January and February and completely absent in March. I have begun a treatment prescribed by my doctor and am waiting on results.
Extreme fatigue lasting more than 3 months, extreme joint pain so severe every joint in my body throbbed.  I could hardly walk some days as my feet hurt so much.  I would have to soak in a hot tub of water many nights to get any relief.  After about 8 weeks of this I started taking a Collagen supplement which has helped immensely, as long as I take it daily. In July 2021 I had a CT scan because of abdominal bloating and a ultrasound in November 2021 and found out I have an enlarged spleen and liver, with a 1/2 inch tumor on my liver.  There is no medical reason for this as I am a non drinker and not overweight.  No history of liver or spleen problems are in my family.  I attribute this to the vaccine as there is no other explanation.
Recurrence on 19 April 2021 (the first since November 2015) of tinnitus in Left ear. It is much louder this time, and accompanied by fullness in the ear and tenderness around the ear.  A few days later -- 26 April 2021 -- I developed tinnitus in my Right ear as well; this is new.  Very loud, debilitating, leading to poor sleep quality and duration.  Overall, I just don't feel like myself.  I had a mildly sore arm after the first vaccine (no redness or swelling) and a moderately sore arm after the second shot (swelling, no redness).  All resolved within 2 - 3 days.
PT EXP PAIN AND STINGING AT SITE OF INJECTION OF ENERGIX-B.  TREATMENT:  PT COUNSELING.  DOSE #2 09Jan90 PT EXP SIMILAR PAIN AT SOI.
Patient received the vaccination and was still sitting in the chair. I had returned to the pharmacy and the wife was standing next to the patient. Patient fainted in the chair, I rushed over to help and we called the paramedics. The wife and I moved the patient to the floor. He was shaking for a few seconds then regained consciousness quickly. We lifted legs to help improve circulation. Paramedics came and evaluated the patient, patient had no further symptoms.
Erythema & swelling around injection site of varicella at L upper arm ~3-4 cm.