chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient had rash and swelling up and down her arm, as well as shortness of breath and malaise. It started about 4-6 hours after injection and lasted several hours.
This spontaneous case, initially received on 06-Dec-2016, was reported by a health professional and concerns an adult patient of unknown age and gender. Weight: not provided; Height: not provided. Concomitant medication: not reported. Administration of company suspect drug(s): On an unknown date, the patient received AFLURIA (pre-filled syringe). Dose regimen: Not reported, Route of administration: Not Reported. Batch number: WT52006 or WT56607. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date within a week of being dosed, the patient experienced fatigue (outcome: not reported), flu like symptoms (outcome: not reported), nausea (outcome: not reported), vomiting (outcome: not reported).
Patient states severe soreness and stiffness in the immunized arm. States she can not move her elbow more than 6 inches away from her body without severe pain in the upper arm
DIC, intracerebral hemorrhage, intubation, requiring plts transfusion, seizure
Moderna COVID-19 Vaccine EUA: patient brought in by ambulance to emergency department (ED) after reporting tongue and lip swelling  immediately after vaccination. Epinephrine (EpiPen) administered at vaccine clinic and diphenhydramine administered en route to ED. On arrival to ED patient denies headache, chest pain, blurred vision, shortness of breath, nausea, and vomiting.  Initial vital signs within normal ranges except for blood pressure 138/75 mmHg. Physical exam douments no acute distress and no rashes. Patient observed, repeat vital signs all within normal limits, symptoms improved, prescribed EpiPen and diphenhydramine, and discharged home stable with follow-up in place.
**Suspected** case of progressive vaccinia. Smallpox vaccine administered on 23 Jan 09, patient was diagnosed with AML/neutropenic fevers on 28 Jan 09, vaccine smallpox site has slowly enlarged (but not progressed over the last week).  7/14/09 Received hospital medical records of 1/28-5/28/2009. FINAL DX: Acute myeloid leukemia, type M0; neutropenic fever resolved; pseudamonal sepsis; MODS - AKI, shock liver, cardiomyopathy; lower extremity dry dangrene; perirectal phlegmon; progressive vaccinia; bilateral BKA w/refractory pain; platelet & Blood transfusion dependence. Extensive medical records reveal patient on 1/25/09 experienced HA, pancytopenia, febrile.  Admitted to outlying hospital where Tmax 104.2 & ANC 100.  Tx w/IV antibiotics & antiviral meds.  Bone marrow biopsy c/w ALL & transferred to higher level of care on 1/28.  Repeat bone marrow biopsy at hospital c/w AML, M0.  Very complicated hospital stay in ICU.  Initially tx w/chemotherapy then developed necrotic wound at smallpox vaccination site & dx w/progressive vaccinia.  Tx w/several meds including experimental meds.  ID, Heme/Onc, Gen Surgery, Vascular Surg, Colorectal Surg, Ortho consults done.  Became septic on 3/7 & placed on high dose pressor support & intubated.  Distal LEs became ischemic secondary to pressor support & sepsis.  Developed MODS (multi-organ dysfunction syndrome) w/liver, kidney & cardiac failure (EF 15-25%) as well as c.diff but recuperated (EF improved to 25-45%) & was extubated by 3/17.  Had bilateral BKA done 4/14 w/flap closure & great difficulty w/pain management post op on multiple meds.  Fitted w/prosthesis & received PT/OT.  Developed rectal incontinence secondary to perirectal infection & multiple pain meds.  Transferred to inpatient rehab facility while awaiting allogeneic stem cell transplant.
The day after the first injection, I had a severe reaction. Headache, nausea, fever, chills, body aches. on March 10th, ten days after the first injection, I was went to the emergency room for treatment of extensive rectal bleeding.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. Approximately on an unspecified dates since 07-JAN-2015, an unspecified number of patients was vaccinated with VARIVAX (Merck) (lot number, strength, dose, frequency and route was not reported) that had been exposed to a supported temperature excursion and additional doses of VARIVAX (Merck) that had been exposed to additional temperature outside of the recommended range. No adverse experiences had been reported. No product quality complaint (PQC) was involved. This is one of the several reports from the same reporter. Additional information has been requested.
Patient to ED 9/1 CC of Black stools x4-5 days. Patient COVID+ prior to admission 8/28. Patient with chills and appeared fatigue/weak, profusely sweating and was more confused. 9/2 Patient to OR for EGD, calmed down with the coughing, vitals remain stable. 9/3 Patient is A&Ox4 and showing no s/s of distress. 9/4 Patient reports some improvement in fatigue and states is no longer experiencing dizziness. 9/5 Patient AO x 4. No c/o pain, no respiratory distress. 9/6 Patient c/o headache. 9/7 Patient discharged in stable condition.
Information has been received through the manufacturer pregnancy registry from a physician concerning a 16 year old female in good health with no drug or food allergies and no history or titer of chicken pox who on 8/5/03 was vaccinated in the left arm with a first dose of varicella virus vaccine live (lot # 64353/0599M). There was no concomitant medication. On 8/5/03 it was reported that the patient was pregnant when she received the vaccine. She was being seen in the physician's office for a routine appointment and reported that she was not sure but the thought that her LMP was a couple of weeks ago. Her estimated LMP was 7/24/03 with an EDD of 4/29/04. No treatment was required. The physician noted that he did not believe the patient would keep the pregnancy but the patient had not yet decided. No product quality complaint was involved. Follow up information from the physician indicated that the LMP was 7/24/03 with a EDD of 4/26/03. There were no previous pregnancies and the patient had an elective termination on an unknown date. It was reported that no prenatal testing or ultrasound was done and that there were no complications with her procedure. Additional information is not expected.
Information has been received from a nurse practitioner concerning an infant who in August 2007, was vaccinated PO with the first dose of Rotateq.  In August 2007, the patient experienced bloody stools.  The patient sought unspecified medical attention and was treated with Lactobacillus.  Subsequently, the patient recovered.  There was no product quality complaint.  Upon internal review, bloody stool(s) was determined to be an other important medical event.  This is one of several reports from the same source.
stiff neck; This is a spontaneous report from a contactable consumer (patient reported herself). A 54-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: unknown), dose 2 via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. patient had side effect of a stiff neck since 27Mar2021 and has been using a moist heating pad and a hot tub to manage her stiff neck. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous report as received from a pharmacy technician refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On 24-NOV-2015, the patient was vaccinated with an expired dose of PNEUMOVAX 23 (strength reported as 25/0.5 (units not provided), lot number K004483 and expiration date 16-AUG-2015, dose and route of administration were not reported). Concomitant therapy was not reported. No adverse effects were reported. Additional information has been requested.
Patient with history of chronic renal failure on dialysis. On 10/27 patient was brought to the ED by EMS after having 5-6 seizures over the span of approximately 12 hours. The patient does not have a history of seizures.  In the ED, patient found to be hypotensive with systolics in the 50s. Patient admitted 10/27-11/5 for septic shock, acute respiratory failure with hypoxia secondary to COVID pneumonia, and ventricular tachycardia. On admission, patient tested positive for COVID-19 by PCR. Patient has been vaccinated with COVID-19 primary series and one booster.
S/p administration of vaccine 24hr later pt developed erythema (blanching) itchy, and small area of induration at site.
On 11/5/2021, patient accidentally recieved children Pfizer shot but should have recevied adult Pfizer dose due to age (see report #709711). Safety Officer requested for patient to come back in next day to recieve correct dosage of vaccination. On 11/6/2021, patient came back to vaccination site and per Safety Officer direction, vaccinator gave child a second dose of Pfizer Children dose when should have recevied adult Pfizer.  Safety Officer informed of correct recommendations if patient were to need to come back for second shot due to incorrect first vaccination given.
Headache, Myalgia, Arthralgia, Diarrhea,  cold, "bone cold" shaking Narrative:
Within 30 seconds had metallic taste in my mouth. Approximately 1hr 15 minutes later I began to experience swelling of the tongue, scratchy throat, headache, heart palpitations and nausea, which progressed through the evening. Benedryl was taken PO at approximately 2005. At HS (approx. 2230) tongue was still swollen, though not grossly. In the morning my tongue was slightly swollen, but improved. All other symptoms persisted for 3-4 days.
Post one vaccination with Moderna if exposed to COVID; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE TO SARS-COV-2 (Post one vaccination with Moderna if exposed to COVID) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced EXPOSURE TO SARS-COV-2 (Post one vaccination with Moderna if exposed to COVID). At the time of the report, EXPOSURE TO SARS-COV-2 (Post one vaccination with Moderna if exposed to COVID) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment information not provided. List of concomitant medication were not given.
Fever of 101 degree Fahrenheit; Headache; Nausea; Chills; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09May2021 at 16:15 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Medical history included none. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medication included vitamin d nos (MANUFACTURER UNKNOWN) from an unknown date for an unspecified indication. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 18Apr2021 at 16:30 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. On 09May2021 at 20:30, the patient experienced fever of 101degF, headache, nausea, chills and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. On 09May2021, the patient underwent body temperature and the result was 101degF. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever of 101degF, headache, nausea, chills and fatigue was recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Pain in the joints, chills, headaches for two weeks. Then started morning stiffness and trigger finger that didn't go away. I went to see a Dr., and she sent me X Rays and blood tests. XRays showed inflammatory arthritis. She referred me to the Rheumatologist. Blood tests showed an increase of the C-Reactive proteint. I was diagnosed with zeronegative Rheumatoid Arthritis.  The first medication (hydroxychloroquine) was improving the pain. I had to stopped it due to a bad tinnitus it was causing me. I'm waiting to get a new medication, but the morning stiffness and trigger finger is coming back. Also having pain in the knees that I didn't have before.
Nausea and weakness. Lightheadedness, resolves w/ lying down. No trouble swallowing, talking or breathing. Ondansetron 4mg for nausea.
Around 10 minutes after receiving vaccination, patient noticed warmth and itching. There were no changes in ability to breath. Discussed treatment options, such as applying cold compress, taking diphenhydramine orally or topically, or applying topical hydrocortisone cream. Instructed patient on when to contact primary care doctor or seek emergency medical care. Information was discussed with patient through virtual interpreter. Patient felt well enough to go home, and information was written down for future use
Information has been received from a physician concerning a 9 month old male with no pertinent medical history or drug allergies who on 06-SEP-2007, 13-NOV-2007 and 15-JAN-2008 was vaccinated with his first, second and third doses of ROTATEQ (lot# 657660/0972U, "0672U", 657785/1244U). Suspect vaccination administered on 15-JAN-2008 included PEDVAXHIB. Concomitant vaccinations administered on that day included a dose of diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid, a dose of poliovirus vaccine inactivated (unspecified) and a dose of PREVNAR. On 15-APR-2008 the patient experienced diarrhea, vomiting and was diagnosed with rotavirus. The patient was hospitalized for 24 hours to an emergency care facility and had to be "rehydrated." On 15-JAN-2008 therapy with ROTATEQ was discontinued. The patient recovered 24 hours later. There was no product quality complaint. Additional information has been requested.
**Please note that this form continues the story of diarrhea after my first Covid shot (1/11/2021). See earlier VAERS form for the first incidence.**  I had my second Covid-19 shot on 2/1/2021. The following morning, I awoke with diarrhea, and this continued for nearly three months, with a brief gap from 2/11 to 2/14.  At first, my stool was lumpy, with mucus, but it gradually turned quite watery. It was also clear by eye that I was having trouble digesting higher fiber foods (salads, fruit & vegetable skins, et al.), so I worked to keep to a lower fiber, bland diet. Episodes of diarrhea varied with the day, but they usually occurred first thing in the morning, with some additional episodes during the day or in the middle of the night. By the end of this period, I had lost about eight pounds.
About 3-5 days after injection, 2 cm firm tender, non-erythematous soft tissue mass appeared appeared at injection site.  Lump enlarged and developed two prominent areas that look like they may evolve into vesicles.  Child has mild flu like symptoms a the same time and is cranky.
Only half of dose was injected.; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the right arm on 30Mar2021 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medications received within 2 weeks of vaccination included cetirizine hydrochloride (ZYRTEC) and multivitamin (MANUFACTURER UNKNOWN) both taken from an unknown date. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021, at the time of vaccine administration, the patient noticed that only half of dose was injected, when the patient arrived, they had 3 doses left and threw two away, when attempted to administer it would not go in, the needle was replaced and attempted again but only about half went in. The clinical outcome of the event vaccine under dose was unknown.  No follow-up attempts are needed. No further information is expected.
severe headaches; Face was hot; vision issues; a screen/wire appears over eyes; Vomiting, difficulty to keep food down; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (Face was hot), VISUAL IMPAIRMENT (vision issues; a screen/wire appears over eyes), VOMITING (Vomiting, difficulty to keep food down) and HEADACHE (severe headaches) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced FLUSHING (Face was hot), VISUAL IMPAIRMENT (vision issues; a screen/wire appears over eyes), VOMITING (Vomiting, difficulty to keep food down) and HEADACHE (severe headaches). At the time of the report, FLUSHING (Face was hot), VISUAL IMPAIRMENT (vision issues; a screen/wire appears over eyes), VOMITING (Vomiting, difficulty to keep food down) and HEADACHE (severe headaches) 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.   Concomitant medication were blood thinner, thyroid medication and baby aspirin. Treatment details included Tylenol and Ondansetron HCL 4 mg tablets.
4am - muscle aches, dehydration and extreme thirst 8am - severe muscle aches, weakness, dehydration, nausea, fever, hallucinations, chills, cold sweat, too weak to stand up, migraine and severe light sensitivity, sinus pressure and pain.
A day getting the vaccine, started feeling extreme itchy all over body; Have continued experiencing itching after all the vaccines; Took Benadryl and was prescribed a topical cream, doesn't remember name; The cream seemed to help temporarily; Going back to the Doctor for a follow up in November 2022.
bump at site of injection, inflammation and small bruising at site. patient advised to take tylenol for inflammation
Dec 30 2:30 AM - body aches, chest pain, difficulty breathing Dec 30 4:00 AM - chest pain, difficulty breathing Dec 30 6:30 AM - chest pain, difficulty breathing Jan 3 4:00 PM-9:00 PM - difficulty breathing, headaches, dry cough Jan 5 4:00 PM - 6:00 PM - difficulty breathing, sore throat, dry cough Jan 6 2:30 PM - 3:30 PM - chest pain, difficulty breathing, increasing heart rate for 1 hour (greater than 117 bpm) Jan 6 4:30 PM - 6:00 PM - chest pain, difficulty breathing, intense wheezing
redness at the injection site; warm at injection site; muscle pain; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th May 2019, the patient received the 1st dose of Shingrix. On 9th May 2019, less than a day after receiving Shingrix, the patient experienced injection site erythema, injection site warmth and muscle pain. The patient was treated with acetylsalicylic acid (Aspirin). On an unknown date, the outcome of the injection site erythema, injection site warmth and muscle pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site warmth and muscle pain to be related to Shingrix.  Additional details were reported as follows: Late into the night of vaccination, the patient started having the following symptoms as red at the injection site, she said that the redness was 3 inches long by 1.5 inches wide, injection site was warm to the touch, pain in her muscles. She had taken an aspirin the day of reporting.  She had the injection at her physician's office. The outcome reported for all AES in the structured field of database is RECOVERING/RESOLVING instead of not resolved (outcome uploaded in database)
1/19/21 at 3:20 pm client's wife or partner,  came to POD concerned about client who was unable to get up from toilet on 1/18  at 10p and fell.  911 was called and he was evaluated and remained at home.  Today he is unable to get out of bed.  She has to feed him in bed and he is using a urinal in bed.  (POD Mgr.), and I, CA-L, RN, were present and advised to contact client's PCP and have client evaluated by 911 because change in status. voiced understanding.  Later called and spoke to  who stated she is awaiting a call from Dr.
Information has been received from a nurse practitioner concerning a female who was vaccinated with a three dose series of Recombivax HB in 1998 and a titer in 2007 is negative.  No additional information is available.  Unspecified medical attention was sought in the office.  There was no product quality complaint.  Additional information has been requested.
patient called on 11/08/2019 saying that the day after he took the shot he felt pain in his left arm and become more painful when he try to raise his arm up and still the pain is there. when asked if there is any tingling sensation he answered no, and when he asked if he think that the pain is coming more likely from the bone or the muscle, he answered from the muscle.
I felt extreme dizziness after getting Pfizer shot #1, I had to sit down at the pharmacy I got it at, because I had overheated after getting the shot. The next two days, managers were helping me, because I was starting to go blank and forget what I was saying or focusing on far more than usual. On June 30, after dose #2, I suddenly started feeling extreme weakness in the left arm, and the weakness traveled to my right arm. I was at work and sitting down on a comfy seat. I felt nerve pain shooting up the back of my arms, through my shoulder and head, up and down my legs, and my vision went blank, and I kept blinking so I could see again. Once I got home from work, I lost feeling in my hands for roughly 30 minutes.
Hours after the vaccine was administered the patient complained of redness at injection site and pain. The next day she had a fever of 101 F and worsening pain and redness. The next day the patient went to the ER and was diagnosed with cellulitis on left arm extending to upper left chest.
Swollen tender lymphadenopathy in axilla; confirmed major reaction; treated with antiinflammatory; continue to f/u daily until resolved & to determine course of treatment.
Fluzone HD shot.  Extreme pain in left shoulder (where shot was given).  Unable to move arm for 2 days.  Still painful to raise arm from shoulder.  Took Tylenol for the pain.  Moving arm at all was excruciating all night after injection.