chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 27-NOV-2007, the patient was inoculated with ZOSTAVAX vaccine (Dose, route of administration, site of administration, Lot number and expiration date were not provided), at a health department facility, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 21-JUN-2016, the patient was treated by a nurse practitioner, for the onset of a vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles.  As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. Additional information has been requested.
My vaccine was at 9am, after 1 hours I felt chills in all my body, I took Tylenol and during the day I was tired. When I went to bed, around 1 am I got high fever, my hands got paralyzed for 2 hours and I couldn't move. The next day I was on bed all day. I still have pain in my hands.
Acute RUQ  abdominal pain developed 12/4 after eating cheese. Patient has no prior history of gallstones or gallbladder disease.  Patient presented to ER 12/4 and ultrasound was initially read as negative. On 12/5 attending radiologist re-read ultrasound as consistent with cholecystitis with biliary sludging and pain persisted, patient returned to ER for surgical consultation. Laparoscopic cholecystectomy was performed 12/5 and the patient was hospitalized and observed overnight. Recovery was uneventful.
pt recvd MMR/OPV/DTP on 1MAR91 & devel a rash;
Information has been received from a nurse practitioner concerning a 20 weeks and 2 days old patient who on 06-DEC-2011 was vaccinated with the first dose of ROTATEQ, 2ml, orally (lot number not reported). The nurse reported, that it was off schedule. No adverse effects were reported. Additional information has been requested.
Delayed local reaction 9 days after injection: Wheel shaped redness approx 3inch, moderate itching at injection site, both increasingly worse each day. Began cetirizine with measurable improvement next day. I continue to take cetirizine daily with improvement. Initially, on day of injection, site became achy, mild redness and itching appeared 2nd or 3rd day, redness subsided, but itching continued, but decreased each day until 8-9 days later then reappeared.
The patient is a 76-year-old female. She was admitted because of shortness of breath, difficulty breathing, wheezing, and a lot of cough and yellow phlegm.  She was found to be COVID positive.  She was given Remdesivir, IV steroids, nebulizer treatment and oxygen.  She was seen by the lung specialist and the Pulmonary doctor. The acute respiratory infection of COVID got better, but she developed what appeared to be acute exacerbation of COPD and bronchitis for which she was given IV steroids, nebulizer, oxygen treatment, and bronchodilators by nebulizer machine, slowly improved with that regard.  Her BUN and creatinine went up.  She developed acute renal failure.  She was given hydration, sodium bicarbonate. For her diabetes and her cardiac problem, she was given Jardiance. She was slow to improve, but with physical therapy and occupational therapy and also the Physical Medicine and Rehab doctor felt that she was better suited for nursing home rather than inpatient rehab.  The patient did improve slowly gradually.  She was able to function somewhat.
non raised red rash on joints; itchy joints; This case was reported by a nurse via sales rep and described the occurrence of red rash in a 92-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced red rash and pruritus. On an unknown date, the outcome of the red rash and pruritus were recovered/resolved.   It was unknown if the reporter considered the red rash and pruritus to be related to Shingrix.  Additional information received were as follows: The patient experienced non raised red rash on joints that were itchy after receiving 1st dose of Shingrix, which lasted for 5 days. The reporter did not know if the reaction experienced was due to the vaccine or a surgery. The patient did not want to receive the 2nd dose of Shingrix.
Sore left arm, shooting pain in legs and arms, body aches, chills just for awhile, splitting headache, fever of 101 a little nauseated
Redness at injection site and move toward elbow and underneath arms (no pain, no fever, no numbness, no itching). Started 2 days post injection. Patient went to urgent care 9/26/18. She was prescribed prednisone 20mg (2 tablets daily with food) for 5 days. Pt has finished treatment and reaction has resolved. (Pt didn't get blood test to see what she had RXN to).
After 10 min pt turned red and listless and started with hives. Within 10 more minutes pt vomited. Pt was given Benadryl T2cc EPI 1:1000, Pt started with redness at 2:50 and given 2CC EPI 1:1000.
INJECT SITE RAISED UP, RED, AND ITCHING STARTED ON 10TH DAY OF VACCINATION, THEN RESOLVED 3 DAYS AFTERWARD.
Developed mild case of Shingles running down upper thigh on right leg - about 4 inches in length.
Mild  COVID-like symptoms after 2nd shot; Fever 102.8 F after 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (Mild  COVID-like symptoms after 2nd shot) and PYREXIA (Fever 102.8 F after 2nd shot) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in March 2021.   In August 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Sep-2021, the patient experienced SUSPECTED COVID-19 (Mild  COVID-like symptoms after 2nd shot) and PYREXIA (Fever 102.8 F after 2nd shot). On 12-Sep-2021, SUSPECTED COVID-19 (Mild  COVID-like symptoms after 2nd shot) and PYREXIA (Fever 102.8 F after 2nd shot) had resolved.            No relevant concomitant medications were reported.  No treatment information was provided.   Reporter did not allow further contact; Sender's Comments: This report concerns a 50 year old male patient with relevant past medical history of COVID-19 disease who experienced unexpected event of mild COVID like symptoms (coded as suspected COVID-19) and expected event of pyrexia. The events occurred on the same day following vaccination with second dose of mRNA-1273. The event pyrexia is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Case of a 65 years old female with past medical history of high blood pressure, HFrEF, COPD, CAD with CABG x 5 and hyperlipidemia presents to the ED due to complaints of shortness of breath,  On EMS arrival patient was found in the 70s O2 room air, given breathing treatments during route to the ED, she is vaccinated against covid. She has been exposed to family members at home. Denies any hx of diarrheas, abdominal pain, headache, fever or other associated symptoms.  Urine and bowel pattern within normal limits, patient is also aware that she has a mass in her lung and she has been unable to have a CT, since she has been denies twice by her insurance. Patient is independent ADLs and instrumental ADLs. Denies any toxic habits/ former smoker    On admission:   ProBNP is 29783.   Her creatinine is noted to be 5.2.  Previous creatinine from September of 2021 was 2.4.  EKG shows sinus rhythm at 73 beats per minute with incomplete right bundle-branch block.     XR Chest 1V 1. Focal masslike opacity in the left midlung. This may reflect a well-defined focus of consolidation or pneumonia however a mass is not ruled out. Further characterization with CT chest recommended.  2. Left basilar infiltrates and adjacent mild left-sided effusion.  3. Background of COPD and scattered fine reticular opacities suspected chronic. Tested + COVID 10/10/2021 1256
This spontaneous report as received from a pharmacist refers to an unspecified patient. On 20-FEB-2014 ("yesterday") the patient was vaccinated with an expired dose of ZOSTAVAX (lot # H019996, expiration date 02-FEB-2014) (dose and route unspecified). No adverse effects provided. Additional information has been requested.
On 10-25-18 around 2:30 pm I saw that patient had orders pending for a flu and Hep A vaccine. I looked at the orders and walked to the fridge to draw them up and mistakenly grabbed the HPV instead of Hep A, feeling rushed to help out the other MA's I rushed into the room and gave the vaccines before taking them out of the computer, which was my own mistake. I then caught my mistake after talking to the mom after giving the vaccines. I then stayed calm in the room even though I mentally was panicking, told the mom and patient I would be right back and rushed right to the nurse and shortly after explaining what had happened to the nurse, I explained the situation and mistake to Dr then went and explained what had happened to the patient and mom. I then after the doctor gave the Hep A and apologized to both the mom and patient. We checked in with the local health department to make sure there was no extra monitoring that needed to be done  for the patient.
Staff received 1st dose of Covid 19 vaccine. pt reports hx of allergy to shellfish. pt reports to observation RN that she is feeling nauseous, dizziness, and lethargic. VS taken at 1444 BP 120/64, RR 22, HR 85, SPO2 100%. pt reported that her "throat feels like tightening and closing" Called the on-call provider, MD, and 1 dose of epi pen was given at 1450 per providers order. immediately after, pt reports, "I feel a lot better; I felt a cool rush and I can breathe so much better." Called EMT 1452 per MD's advice for pt to be transported and observed in the ED. 1502 EMT arrived and pt BP 117/60 HR 93 RR 19 SPO2 100%. pt transported to ED.  Per ED report, pt was monitored, evaluated, and D/C home the next day. Pt received Benadryl x1 in the ED.
Nose Bleed/almost daily/same after second dose of shot. Both times acute reaction to shot; This is a spontaneous report from a contactable other health care professional (patient herself). A 49-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID -19 VACCINE, formulation: solution for injection and Lot Number: EL1283, expiry date: unknown) intramuscular, in Left Arm on 15Jan2021 as dose 1, single for COVID-19 immunization (Age at time of vaccination: 49 years-old). The patient had not received other vaccines prior to the vaccination. Medical history included asthma. Concomitant medications included salbutamol sulfate (ALBUTEROL SALBUTAMOL SULFATE]) and fluticasone propionate salmeterol (WIXELA INHUB) taken for asthma. Both were taken from an unspecified start date and ongoing. Patient took Hydrochlorothiazide 25mg Tab, and Diphenhydramine 25 mg as needed. On an unspecified date the patient experienced nosebleed/almost daily/same after second dose of shot. both times acute reaction to shot. On 11Mar2021 the patient underwent lab tests and procedures which included COVID-19 which was negative. The outcome of the event was recovering.  No follow-up attempts are possible. No further information is expected.
HARDER ERECTIONS/SEX LIFE HAS IMPROVED  DRAMATICALLY/SEX LIFE HAS IMPROVED  DRAMATICALLY; This spontaneous report received from a patient via a company representative from social media concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced harder erections/sex life has improved dramatically/sex life has improved dramatically. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of harder erections/sex life has improved dramatically/sex life has improved dramatically was not reported. This report was non-serious.
12 hours after the dose the patient exhibit signs of dizziness and described the room was spinning. I monitored patient her blood pressure was slightly low with a normal pulse, SpO2, and RR. I re-evaluated her every 15 minutes for an hour. Her stats returned to normal. I am a licensed EMT and as of the Government Amendment EMT's are classified as healthcare professionals.
This spontaneous report as received from Nurse practitioner regarding a 60 years old male patient with no pertinent medical history and no drug reactions or allergies. On 15-MAR-2013 the patient was vaccinated with ZOSTAVAX 19400 PFU (lot number and expiration date not reported) (dose, route and anatomical site not reported). Other suspect medications included TWINRIX (dose and route not reported). Concomitant therapies included amlodipine besylate, LOTREL. On March 2013 (reported as"this past weekend") the patient came down with rash on his abdomen and on his upper back. Rash was scattered and patient complained of some itching. The Nurse practitioner believed that it was a mild case of Chickenpox. The outcome for the chickenpox was not reported. The reporter stated that no treatment was given for the chickenpox. The patient sought medical attention by going to an office visit. The reporter did not assess the causality between chickenpox and ZOSTAVAX. Additional information has been requested.
11/5/21:  present to ER c/o body aches, general weakness, SOB, cough for 5-7 days.  COVID positive test.  Afebrile, CRP 5.1, d-dimer 280, lipase 678, NA 131, WBC 4.7, HH 18/55, troponin negative.  CT of chest shows ground glass parenchymal opacitize L>R with bullous emphasema, negative for PE.  Given IV decadron and mAb Regeneron.  Sat 90% on RA RR 26 HR 90s.  Patient refused admission and demanded discharge.  DC home with Hospital Care at Home program. 11/6/21:  AM HCaH program follow up with patient.  Sat 88% on RA with desat to 85% with activity.  Refusing to go to ER or PCP.  Home oxygen delivered to patient. 11/6/21:  PM HCaH follow up.  On 4L NC sat 88% with SOB at rest.  Patient agreeable to going to ER 11/6/21 @ 2300 in ER:  Patient arrived SOB, fatigue, afebrile, RR 28-30 sat 90-94% on 5L NC. Glucose 493, WBC 6.9, CRP 5.7, NA 134, EGFR 54.  Admitted to telemetry unit.  Started on baricitinib, dexamethasone, Lovenox, vitamin cocktail, IV Ceftriaxone, IV doxycycline. 11/8/21:  Increase need for 6L NC sat >88&.  crackles throughout and moist non-productive cough.  Afebrile.  SOB with any activity. 11/9/21:  SOB and desat to 80% with movement.  ABG on 10L NC 7.43/30.8/53/20.5 BE -2 sat 86%.  Placed on 15L HFNC. 11/11/21:  BiPaP added at night 10/5 FiO2 100%. 11/13/21:  C/O abdmonimal pain with palpable mass.  CT of abdomen shows new rectus sheath hematoma.  All anticoagulation discontinued.  On 20L HFNC with NRBM to maintain sat >88% 11/15/21:  Down to 15L HFNC with intermittent use of NRBM.  Desat to 65% with ambulation to bathroom.  D-dimer 1078 CRP 2.6 11/17/21:  ABG 7.45/36.7/49/25.6/BE 1.7 sat 86% on 13L HFNC 11/18/21:  Weaned down to 6L NC at rest, 10 L NC with activity sat 90% at rest and 85% with activity.  CXR shows new small left effusion 11/20/21:  Patient leaving AMA despite conversation with pulmonologist and hospitalist.  DC on 6L NC, two week steroid taper, and COVID HCaH program. 11/21/21:  HCaH program follow up to patient home.  Weaned self down to 4L NC sat 85%.  Denies any need for further follow up by program 11/30/21:  Follow up with PCP.  Denies issues.  Still requiring 3L via NC to keep sat > 90% with activity but tolerates RA at rest at times.
doses administered after 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered after 30-day use by date) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Feb-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered after 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses administered after 30-day use by date) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications and treatment information were not provided by reporter.  The Moderna vaccine BUD was 16-Jan-2022.  Reporter confirmed that 23 patients received shots after the 30-day use by date. Dose administered after 30-day Use By Date or after manufacturer date of expiry. Number of doses/vials: 23 doses. On 17-Dec-2021, the vial was initially stored in the refrigerator. The vial didn't undergo any temperature excursions.
A few minutes after receiving the covid vaccine my whole body got hot, red and splotchy, and my throat was burning. The pharmacist on site gave me Benadryl and a couple minutes later I started to feel better. A couple hours later my face started to itch. My face and neck were itchy for 12 hours.
nerve sensations/She is having sensations at her ankle then it will travel to her knee, then it might travel to her breast area. It may travel to the lower part of her stomach.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12May2021 15:15 (Lot number: EW0150) at the age of 62 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: BURNING SENSATION (non-serious) with onset 17May2021, outcome "not recovered", described as "nerve sensations/She is having sensations at her ankle then it will travel to her knee, then it might travel to her breast area. It may travel to the lower part of her stomach.".  Additional information:She is having sensations at her ankle then it will travel to her knee, then it might travel to her breast area. It may travel to the lower part of her stomach. It's like a mild nerve type of pull sensations that she is having. It travels to her hips and travels to her hand and most of the time she feels at night because she's lying down. It's mild but it's there and she can feel it. And it travels. It moves. It could be her elbow, her wrist.   Follow-up (01Jul2021): Follow-up attempts completed. No further information expected.
8/7/09. c/o redness. Swelling and sore are left lower arm 8/8/09. Area on left lower arm red and raised 3 inches in length and 1 1/2 inches wide. Called family physician and instructed to give TYLENOL and contact HCHD. 8/9/09, Area remains the same. TYLENOL continued. 8/10/09, Redness and swelling resolving still c/o soreness. Health department contacted.
Hands and feet began itching day after the vaccination. On 09/21/2009, four days after vaccination, top lip of mouth started to swell. Began taking Benadryl.
by noon achy-not feeling well throat closing up, coughing, above breast ached like filling up w/fluid; pt took allergy pills; that eve severe chills so cold feet were ice, teeth chattering; 10NOV sweaty, clammy, t101; 9NOV eyes burned;
Called on 5/25 to report severe muscle pain in left arm with limited ROM. Pain started after 2nd dose of Twinrix 5/4/09 but became worse after 3rd dose and was still severe one week after receving er doses. States pain and movemnet improved after OTC Motrin and Benadryl
Information has been received from a registered nurse concerning an 18 year old female with asthma and no known drug allergies who on 27-JUN-2008, 26-NOV-2008 and 13-APR-2009 was vaccinated with first dose (dose, route and lot number not reported), second dose (dose, route and lot number not reported) and third 0.5mL dose (route intramuscular, lot number 661531/1311X), respectively of GARDASIL.  Concomitant therapy included "birth
Information has been received from a physician concerning an approximately 8 month old female with no pertinent medical history who on 19-JUN-2007 was vaccinated PO with a 2.0 ml dose of Rotateq. On 20-JUN-2007 the next day, the patient experienced blood spots in her diaper. On approximately 20-NOV-2007 the patient also experienced watery stools (about 10 to 15 of them) for 6 to 7 weeks." It was unknown whether medical attention was sought. In June 2007, a stool specimen was performed and confirmed it was rotavirus. There was no product quality complaint. Upon internal review blood spots were determined to be an other important medical event. Additional information has been requested.
THIS REPORT IS FOR AN ADMINISTRATION ERROR.. PT RECEIVED A LOWER DOSEAGE OF VACCINE DUE TO ERROR IN DILUENT ADDITION..  NO ADVERSE EFFECTES NOTES DURING OBSERVATION PERIOD..  FOLLOW UP TODAY SHOWS NO ADVERSE EFFECTS PER MOTHER
Patient had already received flu shot on 09/12/22 and another dose was administered on 05/13/23
That evening I began to get tired, could not complete work, and went to bed around 8 pm.  I was tired all week and could barely get out of bed until today, Sunday, 6 days later. Mostly just overwhelming fatigue, few aches, little fever or chills, just really, really tired for days.  I missed work the whole week including Saturday.
2 days after my second injection I woke to an incessant ache in my right pinky finger.  Another 1-2 days later, tightness in both my knees began to the point where I could only bend them back about halfway without pain and discomfort.  By 5/12, my right knee became increasingly uncomfortable and I started getting sharp pains and my knee would give way.  By Saturday, my right knee was visibly swollen.  Mind you I played tennis 4 times this week up to that Friday when I realized I was having some extreme problems.   On Monday I saw the Orthopedic who diagnosed me with "moderate" arthritis in both knees.  No doubt the arthritis was already there BUT the sudden onset of inflammation was in conjunction with the second vaccine.
Patient came this morning complaining of pain in left arm, shoulder, neck & jaw. Passed out in exam room 3 times BP 129/80, called EMS to transport patient to ER. Patient currently on pain & nerve pills from Dr's office.