chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Deep vein thrombosis; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of DEEP VEIN THROMBOSIS (Deep vein thrombosis) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) tablet for CLL.    The patient's past medical history included Blood immunoglobulin G (low levels from past 20 years). Concurrent medical conditions included Chronic lymphocytic leukemia, Depression, Drug allergy (allergic reaction to Rituxan.) and Glaucoma. Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC) for an unknown indication.   In February 2020, the patient started IBRUTINIB (IMBRUVICA) (unknown route) 420 milligram once a day. On 20-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In January 2021, the patient experienced DEEP VEIN THROMBOSIS (Deep vein thrombosis) (seriousness criterion medically significant). At the time of the report, DEEP VEIN THROMBOSIS (Deep vein thrombosis) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 antibody test (610-1600): 347 (Negative) 347.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Other history included:no alcohol use, no drug abuse, non smoker Treatment information were not provided.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, the patient's past medical history of CLL and drug IBRUTINIB can contribute to this event. further information has been requested   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, the patient's past medical history of CLL and drug IBRUTINIB can contribute to this event. further information has been requested
Full body inflammation, significant pain muscle/joints, difficulty standing, walking, lots of popping/clicking in joints (knees, shoulders, ankles) Ibuprofen as OTC treatment prior to Doctor visit Doctor appointment and labs on 21May, continued with Ibuprofen OTC, labs all came back normal Unable to recall exact date of when pain muscle/joints was reduced enough to resume normal activity - used V-SAFE
Information has been received from a physician concerning a female (age not reported) who was vaccinated IM with a dose of Gardasil.  Subsequently the patient experienced vulvar pain.  The patient's outcome was not reported.  No further information is available.
7 days after 1st vaccine, experience full body breakout of hives.  After another week, went to doctor for treatment; received prednisone- 9 day dosage; after two weeks, hives faded, dried up, still itchy.   Self-medicated periodically with benadryl throughout the past 3-1/2 weeks.
Elevated Blood Pressure 168/84 ,Low Grade fever 99.3, Chills, and headache
The evening after 2nd dose I developed itching and  3 hives over my left eye.   I took Benadryl 25 mg at 6 pm and again at about 2 am as itching intense and disrupting sleep (as did chills and myalgia.)
client presents to Community Health office with complaints of a headache and very red blood shot eyes. (no pain, burning or itching associated with redness)
An intern had drawn up and injected 0.6 ml of the vaccine to the pt instead of 0.3 ml.  Per pt, they are feeling fine. Caregivers were given instructions on side effects to watch out for and when to alert doctor or go to ER. Pt was waiting for about 15 to 20 minutes after vaccinations and did not report any issues.
no adverse event; pneumococcal vaccine (unspecified) administered in 2018 and 2020; This spontaneous report has been received from a physician and a lawyer, via a medical records and fact sheet from a case in litigation for zoster vaccine live (ZOSTAVAX) (MARRS # 2103USA008101), concerning to an approximately 65 years old female patient. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication.   The patient was administered pneumococcal vaccine polyvalent (23-valent) (manufacturer unknown) (dose, route, strength, batch/lot # and expiration date were not reported) in 2018 (reported as onset: 2 years of office visit 22-OCT-2020) and pneumococcal vaccine polyvalent (23-valent) (manufacturer unknown) (dose, route, strength, batch/lot # and expiration date were not reported) in 2020 (Inappropriate Schedule of Vaccine administered). No adverse event was reported.  This is one of the two reports concerning the same patient.; Sender's Comments:  US-009507513-2103USA008101:
not feeling well; Lightheadedness; right arm where the injection site got swollen up to the top of her shoulder; Headache; problem in her sinuses; Hearing impaired; blurred vision; This spontaneous case was reported by a consumer and describes the occurrence of HYPOACUSIS (Hearing impaired), VISION BLURRED (blurred vision), MALAISE (not feeling well), SINUS DISORDER (problem in her sinuses) and DIZZINESS (Lightheadedness) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038C21A and 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Augmentin), Obesity, Hypertension, Thyroid gland swelling and Injury NOS since September 2008. Concomitant products included CHONDROITIN SULFATE, GLUCOSAMINE HYDROCHLORIDE, METHYLSULFONYLMETHANE (TRIFLEX SOFT CHEWS) for Aching joints, METOPROLOL and HYDROCHLOROTHIAZIDE for Hypertension, ASA for Prevention, MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced HYPOACUSIS (Hearing impaired), VISION BLURRED (blurred vision), SINUS DISORDER (problem in her sinuses), VACCINATION SITE SWELLING (right arm where the injection site got swollen up to the top of her shoulder) and HEADACHE (Headache). On an unknown date, the patient experienced MALAISE (not feeling well) and DIZZINESS (Lightheadedness). The patient was treated with DOXYCYCLINE HYDROCHLORIDE for Adverse event, at a dose of 100 mg; SALBUTAMOL (ALBUTEROL HFA) for Adverse event, at a dose of 90 mcg and METHYLPREDNISOLONE for Adverse event, at a dose of 1 dosage form. At the time of the report, HYPOACUSIS (Hearing impaired), VISION BLURRED (blurred vision), MALAISE (not feeling well), SINUS DISORDER (problem in her sinuses), DIZZINESS (Lightheadedness), VACCINATION SITE SWELLING (right arm where the injection site got swollen up to the top of her shoulder) and HEADACHE (Headache) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that patient's race information was black and patient had done CT scan. Also had a pending MRI of the head.  Patient was referred to ortho, endocrinology, neurology, ENT and gastroenterology departments. Imaging awaits- MRI brain, US, CT scan.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow up information received on 26-JUL-2021 contains patient medical historical, current conditions. Concomitant and treatment medications and new event updated, outcome of the events and also vaccination related information updated.
This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender with no pertinent medical history reported. The registered nurse reported that on 12-AUG-2013, one patient was vaccinated with an improperly stored dose of PEDVAX (lot # H022058 expiration date 10-OCT-2015) (dose and route not specified), that was exposed to 31F for 72 hours, which is an unsupported excursion noted by in-house stability data. No adverse symptoms reported. The nurse also reported that another patient was vaccinated with improperly stored VAQTA (MARRS 1308USA008790), another patient was vaccinated with improperly stored VAQTA (MARRS 1308USA009656), another patient was vaccinated with improperly stored ROTATEQ (MARRS 1308USA009659), and another one was vaccinated with improperly stored GARDASIL (Intramuscular injection) (MARRS1308USA009658). This is one of several reports from the same reporter. Additional information has been requested.
1 hr after vaccine - lightheaded & dizzy - lasted for 30 min.   3 hrs after shot, flushed all over and neck/face itchy - lasted for 5 hrs. Day 2 - Day 4 after shot, extreme fatigue. Week 3 after shot, 2 days of moderate fatigue. Week 4, stomach ache, nausea, diarrhea, ear canal fullness that made me extremely dizzy - lasted 4 days.
At the present the child s with her mother at the clinic for evaluation of her left thigh (ant) injection site. Complains of pain for 24 hours post-immunization, no redness noted by mother. Complained of pain this AM, "limping" slightly, "leg is red" per mom. Area of erythema and induration measuring 8 cm x 11 cm assessed; skin intact and non pruritic. Advised eval by Primary Physician, warm compresses, non-chafing clothing. PHN will F/O next week.
Mom reported to Emergency services that infant was sleeping in bed with her and when she awoke at 6:30AM on 5/21/05, infant was not breathing. Autopsy Report received stated patient experienced bronchitis.
I have a history of neuropathy that has been dormant most of the last year. I went in with no nueropathy occuring to get my vaccines. After the 1st Pfizer shot I had neuropathy starting the day after that went away in about  a week. After the 2nd about 3 days later it started with itching all over my body (neuropathic itch), and burning mostly in my feet, but random electrical shocks throughout my body 24/7 (while awake). It has not subsided and has actually gotten worse. There are at least a dozen people on the clinic message board saying the same thing happened to them, that the vaccine awakened or made worse their neuropathy exponentially. Here is the link to similar complaints.
9:30 started feeling more fever, chills, and very fatigue. Dr. and co- worker checked my vital signs and pressures were up from 170/90, 150/90, 140/90. At 1:30 went over to primary care doctor and was checked out by doctors MA checked BP and it was 150/90. PA checked BP and pressure came down to 118/80. PA prescribed 600mg of Ibuprofen.
Flu-like symptoms: shaking, chills, extremely sweaty, achy, and headache  Lasted for 24-36 hours
On 19 March 2023 he began to experience right-sided ear pain which progressed to numbness on the right side of his face on 21 March 2023.  By 23 March right-sided facial droop was evident and emergency room evaluation clinically diagnosed Bell's palsy.  right-sided facial weakness led to subsequent right-sided dry eye and difficulty chewing.
Officer was vaccinated around noon time, came back about 4 pm that his tongue was tingling he said he has slight pain to his legs. No difficulty breathing reported lungs clear, no wheezing. Increased BP VS 96 92, 24 110/80. His superior told me this morning 10/18/10 the officer went later last night to Emergency room, recd BENADRYL. He is back at work today.
left arm are sore; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer, the patient. A 46-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 11May2021 at 17:15, as a single dose for COVID-19 immunisation. Medical history included allergy to pineapples and some shellfish. The patient did not receive any other medications within 2 weeks of vaccination. Prior to the vaccination, the patient was not 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 4 weeks prior to the COVID vaccine. 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 27Apr2021 at 17:15, as a single dose for COVID-19 immunisation. On 14May2021, the muscles in the patient back that connect his left arm were sore almost every day. He worked in front of the computer. He did not notice it much when he was moving around. If he was stationary for more than an hour, he needed to do lots of stretching. The event did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. Therapeutic measures were taken as a result of left arm sore and included treatment with TYLENOL. The clinical outcome of the event left arm sore was not recovered at the time of this event.  The information on lot/batch number has been requested.
Pruritic, erythematous, papular rash on chest and abdomen started about 24 hours after the vaccine was given. Spread to arms and legs over the next week.  Persists 12 days later. She is afebrile and the rest of her exam is normal.
fever, nausea, severe headach, sore joints, vomiting, so far lasting since 3 am.
Information has been received from a physician concerning a female patient who in November 2007, was vaccinated with a first dose of GARDASIL (lot # not provided). Concomitant therapy included other unspecified vaccines administered on the same day. Post vaccination, the patient experienced hair loss. Subsequently, the patient recovered from the hair loss. The patient sought medical attention at the office. The patient refused to get the second dose. No product quality complaint was involved. Additional information has been requested.  10/08/08 This is in follow-up to report(s) previously submitted on 6/13/2008. Initial and follow up information has been received from a physician concerning a 13 year old female patient, with no medical history, no known drug allergies, no adverse events following prior vaccination and no illness at time of vaccination, who on 11-Aug-2007 (first reported as November 2007 and then as 01-Aug-2007), was vaccinated with a first IM dose of GARDASIL (lot # 655205/1426F). There were no other vaccines administered on this same day (previously reported that concomitant therapy included other unspecified vaccines administered on the same day). On 14-May-2008, the patient returned for her annual check-up and the doctor inquired about why the patient had not returned for her second vaccination. At that time, the patient's mother reported that the patient had experienced hair loss after receiving the first dose (followup information reported the onset date of 11-Oct-2007, 2 months after receiving the first dose). The hair loss lasted for two months (followup information reported duration of 10 to 12 weeks) and then she recovered all hair (followup information also reported date of recovery as May 2008). The patient sought medical attention at the office. The patient refused to get the second dose. No other information is expected.
Parent phoned - Approx 7:00pm blotchy skin noted around ears, throat; increase swelling approx 7:20pm. Taken to urgent care where BENADRYL was administered approx 20min hives and swelling disappeared.
Patient reported within minutes of having generalized, constant itching, mild erythema noted to patient's upper back, where she scratched repeatedly, no rash or respiratory distress noted
Shingles rash started  on 2/16/2021. T7, T8 right side from midline back to midline anterior torso. Treated with Valtrex 1 grm TID
Hot welt on the injection site that has been growing; Hot welt on the injection site that has been growing; Injection arm is heavy and hurts; Cannot focus in anything. "It's like having allergy"; Dizzy; Tired; Dizziness; Body aches; Nausea; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), PAIN (Body aches), INJECTION SITE WARMTH (Hot welt on the injection site that has been growing), INJECTION SITE MASS (Hot welt on the injection site that has been growing) and LIMB DISCOMFORT (Injection arm is heavy and hurts) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A2-A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced DIZZINESS (Dizziness), PAIN (Body aches), NAUSEA (Nausea) and FATIGUE (Fatigue). On 03-Apr-2021, the patient experienced INJECTION SITE WARMTH (Hot welt on the injection site that has been growing), INJECTION SITE MASS (Hot welt on the injection site that has been growing), LIMB DISCOMFORT (Injection arm is heavy and hurts), DISTURBANCE IN ATTENTION (Cannot focus in anything. "It's like having allergy"), DIZZINESS (Dizzy) and FATIGUE (Tired). On 29-Mar-2021, DIZZINESS (Dizziness), PAIN (Body aches), NAUSEA (Nausea) and FATIGUE (Fatigue) had resolved. At the time of the report, INJECTION SITE WARMTH (Hot welt on the injection site that has been growing), INJECTION SITE MASS (Hot welt on the injection site that has been growing), LIMB DISCOMFORT (Injection arm is heavy and hurts), DISTURBANCE IN ATTENTION (Cannot focus in anything. "It's like having allergy"), DIZZINESS (Dizzy) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment was provided for the events.
Felt like heart racing, POx & VS stable. Patient had cortisone shot 2 days prior with rash
Persistent encephalopathy beginning 2 days after vaccine, with multiple hospital admissions, some clinical improvement after CSF drainage from VP shunt, then recurrence of encephalopathy with falls, lethargy. Treatment included intubation, CSF neg for infection, clinically diagnosed with autoimmune encephalitis, brisk response to steroids.
pain; redness; This non-serious case was reported by a consumer and described the occurrence of pain in a 69-year-old male patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Concomitant products included rosuvastatin calcium (Crestor).   On 20-OCT-2023, the patient received RSV vaccine. On 23-OCT-2023, 3 days after receiving RSV vaccine, the patient experienced pain (Verbatim: pain) and erythema (Verbatim: redness). The outcome of the pain and erythema were not resolved.   It was unknown if the reporter considered the pain and erythema to be related to RSV vaccine.     It was unknown if the company considered the pain and erythema to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 23-OCT-2023 The patient self-reported this case, and this report was submitted via the online direct entry reporting system.  The patient received concomitant product Crestor, was ongoing till the time of reporting. The patient received RSV vaccine and experienced pain and redness which was ongoing. The symptoms were not treated. The reporter gave permission to contact GlaxoSmithKline.
Pt received flu vaccine 9/29/11 fever that evening 105 ax. Fever continuing with TYLENOL.
Became highly anxious after vaccines given.  Reported tingling in mouth, numbness in feet, and diff. breathing. States couldn't move legs.  Epinephrine inj. given verbalizes relief after 20 min, left area after 30 min.
At 18:00, pt had large red welt noted with pain on movement. Md notified and was given Benadryl PO X1 and ice applied. Seen by MD, 24 hours, post vax, with increased edema, erythema and pain. Prescribed Augmentin X 10 days and edema, erythema had resolved after 72 hours.
This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 16-NOV-2018, the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # R001084, expiration date 07-NOV-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). On 17-DEC-2018, the patient was vaccinated with improperly stored ROTATEQ (lot # R015435, expiration date 17-APR-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccines were exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1901USA001125:
TINGLING, NUMBNESS IN FACE AND THROAT. TINGLING AND HEAVINESS IN ARMS AND LEGS. FAST HEARTBEAT. TOOK STEROID WHEN I GOT HOME. ALL STARTED AFTER 35 MINUTES AFTER INJECTION. NOTIFIED PHARMACIST THEY HAD ME SIT FOR ADDITIONAL TIME.
HIGH FEVER (104 DEGREES ONE HOUR AFTER TYLENOL WAS ADMINISTERED,) LARGE RED RASH AT INJECTION SITE, HARD SWELLING OF INJECTION AREA, PERSISTANT CRYING, PERMANENT SETBACK OF DEVELOPMENTAL SKILLS.
This report was received from the vaccinee and from the vaccinee's mother and has not been verified by a physician or other healthcare professional. His medical history included mononucleosis, "recent" conjunctivitis, chondromalacia and 2 episodes of Lyme disease. He had Lyme arthritis at the age of 11, with hospitalization and treatment with Rocephin. He again had Lyme disease in high school. The vaccinee did not have gout, psoriasis or Crohn's disease. There was no family history of rheumatoid arthritis or lupus. The pt admitted "heavy" involvement in contact sports, including football, wrestling and track. There was no illness at the time of vaccination. On 02/16/2000 and 03/22/20000, the pt received his 1st dose of Lymerix. On approx. 5/22/00, the pt began to experience right knee pain. There was no swelling; there was pain with walking and running and with getting out of bed in the morning. X-rays and MRI revealed a "spot/cyst" on the right femur. A bone scan was performed on 5/20/01; results were not known to the pt. The 2nd and 3rd doses of Lymerix were administered on approx. 10/2/00 and approx. 4/2/01, respectively. As of 5/22/01, the event was resolved. On follow-up received on 06/15/2001, the physician indicated that "no adverse reactions were reported to me."