chrisvoncsefalvay/vaers-outcomes huggingface dataset:
CONSTANT DRIP OF BLOOD DOWN THROAT; COUGHED UP BLOOD WITH SMALL BLOOD CLOTS PRESENT; BLOOD COME OUT OF LEFT NOSTRIL; FELT GUSH DOWN THROAT THAT FELT LIKE POST NASAL DRIP, POST NASAL DRIP SENSATION; TROUBLE SWALLOWING; REFLEX TO COUGH/COUGHING; SENSATION OF WARMTH AT THE BASE OF SKULL/NECK; FELT LIGHTHEADED; THROAT FEELING AS ITCHY; STRESS; This spontaneous report received from a patient concerned a 51 year old white and not Hispanic or Latino female. The patient's height, and weight were not reported.  The patient's past medical history included ovarian cancer, and congestive heart failure (CHF), and concurrent conditions included primary biliary cirrhosis, thyroid issues, and non smoker, and other pre-existing medical conditions included the patient had no known allergies. The patient was not pregnant at the time of report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042AZ1A, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 13-JUL-2021 to left arm for prophylactic vaccination. Concomitant medications included ursodeoxycholic acid for primary biliary cholangitis, and levothyroxine for thyroid disorder.  On 19-JUL-2021, the patient felt gush down throat that felt like post nasal drip and patient went back to work computer right after post nasal drip sensation and began coughing and coughed up blood with small blood clots present and had blood come out of left nostril. The patient had trouble swallowing and a reflex to cough and also had a sensation of warmth at the base of skull or neck that could have been related to stress and patient felt lightheaded and this symptom occurred around 15:30 and lasted for 20 to 30 minutes, but patient started to feel sensation again and coughed actively and coughed up a small blood clot. The patient was stated that they saved tissues with blood on them to show HCP and were tasting blood and continued to cough and patient's throat was bothersome and throat feeling as itchy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sensation of warmth at the base of skull, neck on 19-JUL-2021, had not recovered from coughed up blood with small blood clots present, blood come out of left nostril, constant drip of blood down throat, trouble swallowing, felt lightheaded, and throat feeling as itchy, and the outcome of felt gush down throat that felt like post nasal drip, post nasal drip sensation, stress and reflex to cough, coughing was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210741246- covid-19 vaccine ad26.cov2.s-CONSTANT DRIP OF BLOOD DOWN THROAT, COUGHED UP BLOOD WITH SMALL BLOOD CLOTS PRESENT .This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Temperature excursion with Moderna COVID-19 vaccine; No adverse event; The dose was administered to the patient post excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (The dose was administered to the patient post excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion with Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) in a 21-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 045H22A) for COVID-19 prophylaxis.     It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19.     On 07-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 07-Mar-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (The dose was administered to the patient post excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion with Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (The dose was administered to the patient post excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion with Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (The dose was administered to the patient post excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion with Moderna COVID-19 vaccine).    No concomitant medications were reported.  The temperature excursion occurred for both monovalent and bivalent. 9 doses of monovalent doses given. Multiple doses of 1st & 2nd doses administered. 27 total doses were administered post excursion.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-715674 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-715674:Master Case
redness & swelling rt arm & inject site in deltoid arm; t103 reported by mom pt irritable; taken by mom to MD 30JUL92 in PM t98.5; pain-swelling w/red streak rt upper arm; dx cellulitis rt upper arm;
Patient was given the adult Pfizer dose for booster (3rd vaccine) instead of the pediatric Pfizer dose.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 18-MAR-2013, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 10-MAR-2016, the patient was treated at a medical center for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of these malfunctions, 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. Additional information has been requested.
This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 20-OCT-2017, the patient was vaccinated with an improperly stored dose of ZOSTAVAX, lot # M039452, expiration date: 19-DEC-2017, for prophylaxis (dose # and route of administration were unknown). The dose of ZOSTAVAX was stored between 15 to 46 Fahrenheit (F) degrees for 7 hours and was detected by a data logger. There was no previous temperature excursion. The sterile diluent(manufacturer unknown) (lot # L029308 and expiration date: 31-MAR-2018) used for reconstitution did not undergo a temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1711USA006170.
DOB REPORTED ON CONSENT IS NOT ACCURATE ACCORDING TO DATABASE. CHILD IS UNDERAGED.
Patient reported fever of 103 the night that she received COVID vaccine dose. Fever was associated with body aches, dizziness, nausea and headache. Episodes of nausea, dizziness, and lightheadedness have been intermittent now since 12/29/2020.  Episodic dizziness and nausea has affected ability to perform daily functions of job. Patient also reports pain and weakness of right arm.
had all signs of a stroke (could have had a stroke); migraine headache; incoherent speech; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (had all signs of a stroke (could have had a stroke)) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No relevant medical history was reported.  Concomitant products included ATORVASTATIN for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (had all signs of a stroke (could have had a stroke)) (seriousness criterion medically significant), MIGRAINE (migraine headache) and DISORGANISED SPEECH (incoherent speech). At the time of the report, CEREBROVASCULAR ACCIDENT (had all signs of a stroke (could have had a stroke)), MIGRAINE (migraine headache) and DISORGANISED SPEECH (incoherent speech) outcome was unknown.            Additional concomitant medication included an unspecified blood pressure medication.  Treatment information was not provided.  Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Further information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Follow up/additional information included the reporters contact information (address) and the mention of had all signs of a stroke / could have had a stroke.; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Further information has been requested.
c/o t014; extremely painful lt thigh-no redness or swelling; limping gait; 23NOV94 6 hrs later better on APAP & Advil walking better-told to call if new sx;
Kind of like a welt; Rash on parts of her body on her back; red spot at injection site, 3-4 inches in diameter; Headache; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Kind of like a welt), RASH (Rash on parts of her body on her back), VACCINATION SITE ERYTHEMA (red spot at injection site, 3-4 inches in diameter) and HEADACHE (Headache) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 091F21A, 02AL20A and 013L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN, SERTRALINE, CLONAZEPAM, COLECALCIFEROL (VITAMIN D3) and VITAMIN B12 [VITAMIN B12 NOS] for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, the patient experienced URTICARIA (Kind of like a welt), RASH (Rash on parts of her body on her back), VACCINATION SITE ERYTHEMA (red spot at injection site, 3-4 inches in diameter) and HEADACHE (Headache). The patient was treated with XYLOMETAZOLINE HYDROCHLORIDE (SUDAFED [XYLOMETAZOLINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. On 27-Oct-2021, HEADACHE (Headache) had resolved. At the time of the report, URTICARIA (Kind of like a welt), RASH (Rash on parts of her body on her back) and VACCINATION SITE ERYTHEMA (red spot at injection site, 3-4 inches in diameter) had not resolved.            This case was linked to MOD-2021-367396, MOD-2021-367552.
I had a really bad, difficulty breathing, and wheezing. I had to use my general inhaler and nebulizer every four hours. My doctor gave me steroids. I had a CAT scan on my lungs, and it showed pneumonia. I also had fluid in my lungs.
Pt. received vaccine, MENVEO on 1/17/14. She states next day she had rash on her right side of the body, has been vomiting, developed a fever and has stomach pains. Also has feeling of anxiety and "freaks out" about every little thing and she's never had a history of anxiety. No treatment yet but plans on seeing a doctor.
Child came to clinic to have Tb test red, noticed left arm, red, tender and warm. NO Tx administered. Advised mother to watch arm for increased redness and tenderness. To contact pediatrician if arm became worse.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 21-APR-2016, the patient was vaccinated with an improperly stored does of M-M-R II injection, 0.5 ml lot # L026553, expiration date 16-JUL-2017 (route and site of administration were not reported). According to the reporter, the vaccine was stored at a temperature of 11.1 degrees Celsius for 1 hour and 36 minutes and also at a temperature of -12.3 degrees Celsius for 1 hour and 33 minutes (excursion dates were not reported). Digital logger was involved. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Immediately "did not feel right", progressive.  "Few days" later developed cold, sinusitis, fell several times.  Went to Dr. with leg weakness, tingling of toes.  Now chokes on saliva.
Got the new HPV vaccination in 2006 at the age of 21. In 2011, I began having issues with my hands and now can't even stand or walk. Issues with bladder and bowel movements.
Patient said his left arm swelled up, was hot to the touch, was red in color. He also had a fever for 3 days and felt aching in his legs. After 3 days he was beginning to feel better but his arm was still swollen, hot to the touch, and red in color.
rash on right leg/patient described the rash as itchy; Patient described the rash as itchy and looked like little pimples; This spontaneous report was received from a physician and refers to a 27 year old female patient. The patient's concurrent conditions included allergy to ciprofloxacin (CIPRO). Her medical history and concomitant medications were not reported.  On 14-JUN-2023, the patient was vaccinated with the fist dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # U029496, expiration date not provided but upon internal review stablished as 21-SEP-2023) administered intramuscular (IM) in the left upper arm as routine vaccination.  On 18-JUN-2023 (also reported as 3 - 4 days after receiving vaccine), the patient experienced several lesions of rash on her right leg which were itchy and looked like little pimples (rash pruritic, dermatitis acneiform). No treatment was given for these events, and on 02-JUL-2023, the patient recovered from the events (also reported as lasted for about 2 weeks). On 21-AUG-2023, the patient was vaccinated with the second dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # W089697, expiration date not provided but upon internal review stablished as 13-DEC-2024) administered in the left upper arm (route of administration not provided) as routine vaccination.  Causality assessment between the events and varicella virus vaccine live (oka/merck)(VARIVAX) was not provided.
Patient had dog bite.  Last Td 8yrs ago.  Reported arm hurt for 3-4 days and mild aches. After admin of vaccine patient report feeling achy 3-4 hour afterwards, felt like "hit ground with parachute." Unable to sleep, "weird nightmares".  Temp 101 at 24 hrs past admin.  Exam at 48 hours past vaccine T 98.6-small local reaction at site, lungs clear.
The next, the area where the shot was given was so red, swollen, and painful. I had a low-grade fever. These symptoms last for about a week now. The area is green looking down and the pain is less now.
Could not hold bowel for 2 weeks. Fatigue, eyes felt like sand and very sore then eyes stinging. Eyes water for about 4 hours.
Large and painful lump under my right arm (armpit); swollen, hot, extremely painful and brown coloring (like a bruise);  Upper neck on right side: swollen Both ankles swelled and turned bright red - especially the right one  Flash pains in both knees all night long  (continues)  Right rib cage extremely painful when leaning over and/or taking a deep breath (subsiding now: 4.28.21)
Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Additional Details: Pt DID NOT recieve Covid-19 vaccine at Pharmacy but inquired about side effects and what to do.  Pt states they had 1st dose of moderna Covid vaccine 2 weeks ago. Pt states they have had severe itching at injetion ever since injection and now the site is \"bumpy\" is as well.  Advised pt to take diphenhydramine for itching and swelling and to follow up with primary care dr in the am.
Patient was given full 0.5ml dose of vaccine instead of the 0.25ml dose for the booster
Headache, Myalgia, Arthralgia, Fever, inj site pain, aches, body aches, joint pain, shills, fatigue Narrative:
About 6 PM the evening of vaccination, the employee reports developing aches and pain in joints, then chills and fever.  In approximately 2 hours developed diarrhea which continued throughout the night.  The following day felt very tired and slept all day.
This case was reported by a physician to a sales representative and described a child of unspecified gender who did not respond to immunization with Havrix, for prophylaxis. On an unspecified date in 2005, the subject received 2nd dose of Havrix "according to schedule." On an unspecified date in 2006 before 12 April 2006, less than one year vaccination with Havrix, a hepatitis A antibody titer was negative.
after 4 hrs after the 1st shot of Moderna, patient had swelling of tongue for about 48 hrs. After the swelling disappeared, patient started to have ulcers on her tongue, and they lasted for about 4-5 days. patient did not take any medication at the time to help with the adverse reactions. patient did not have any trouble breathing.
Head pressure, runny nose, congestion. Tylenol with head pressure resolving. Referred for flu and COVID testing
Patient's employer - HR Department states that on the day of receiving the shot his wife told the HR department that he didn?t feel right. For the next two days, Wednesday and Thursday, October 30 and 31 patient called out sick. He reported back to work the following week, but went home early due to not feeling well. He complained of numb legs and toes. To current, patient is on life support (critical condition).
This spontaneous report as received from a healthcare worker refers to a patient of unknown age. The patient's medical history was not reported. On an unknown date the patient was vaccinated with (Oka/Merck) VARIVAX. Concomitant medications were not reported. ON an unknown date the patient was vaccinated with (Oka/Merck) VARIVAX stored at temperatures between -12 Celsius (C) to -10C. No adverse effect reported. The outcome of vaccinated with (Oka/Merck) VARIVAX stored at temperatures between -12C to -10C was unknown. This case is linked to case # 1406USA013699 (same reporter link). Additional information is requested.
On 6/26/15 at injection site-redness, swelling, tenderness, pain, rash. Started on 6/25/15 with dime sized redness c/o tiredness, nausea, vomiting, fever, tingling in fingers both hands on 6/26/15.
58 y/o male seen 5/3/10 received polio and THYPHIM VI on 5/3/10 - (-) titer to MMR -> give MMR 5/18/10 - Approx 13 days after MMR both knees stiff, unable to walk, and swelling in joints worsened over week and include (R) wrist pain and stiffness. Required removal of synovial fluid on (L) knee for relief and steroid injection - Also had elbow pain and stiffness - Flex 30 degrees both knees severe pain - Symptoms resolved 6/6/10.
Chest covered in red itchy spots, red eruptions over chest onto shoulders, Itchy slight burning - treated with topical hydrocortisone 1% and oral Benadryl.  11/14/2019 Re eruption same pattern only very itchy and increase in burning and hurting.  Overall skin feels like tiny pin pricks.  Sought medical treatment by dermatologist who prescribed oral prednisone for 10 days, tapering dose along with prescription topical hydrocortisone cream twice a day.
After returning home from my 2nd Pfizer shot, I felt woozy and disoriented (as I did the first time). I had not eaten anything only had a cp of coffee that morning and water.  Then about an hour or so later, my lips started to tingle/burn and then my tongue was swelling just a bit and starting hurting. The tongue pain is still there a day later but much improved. I was also very fatigued and had to take Tylenol and Advil to help.
Severe chills at night for over 2 to 3 hours. High fever. Woke up next morning and went to get a glass of water, felt dizzy and could not walk. Then vomited water out. Severe congestion.
Patient developed a short lived near syncope spell x 30 mins after receiving Pfizer vaccine while getting up from exam bed no injury to report  he reported feeling warm and appeared pale and clampy and diaphoretic vitals: B/P 126/90 pulse 77 oxy 99%. He showed no symptoms of allergic reaction no rash no angioedema, lungs were clear with obstruction reporting no tingling or swelling of the tongue he was observed for 30 mins walking around normally before being transitioned back to his guardian he did not lose conscience discharge vitals B/P 123/85 sat 100% pulse 82.
Sore arm and felt lethargic for a couple of days but never really felt sick, 2 days of tiredness. Lower back pain, hips hurt and I feel my feet very sore and heavy.
Large inflamed lymph node in front of neck starting 8 days after vaccine.; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 26Feb2021 at 09:30 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. Medical history included dermatomyositis, migraine and allergy to sulfa. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included naltrexone (MANUFACTURER UNKNOWN), estradiol (MINIVELLE) and sumatriptan (MANUFACTURER UNKNOWN), all from an unknown date for an unknown indication. On 06Mar2021 at 10:00, the patient experienced large inflamed lymph node in front of neck starting 8 days after vaccine. The event resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event large inflamed lymph node in front of neck was not resolved at the time of report.  No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a physician via an unspecified reporter referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 05-NOV-2015, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10PK 0.5mL SD-PFS LLokwTip 10PK" and  lot # L014876 with expiration date 13-JAN-2017 (route of administration and anatomical location were not reported), which was stored at a lowest recorded temperature of 27F (2.7 Celsius) for 72hours. The vaccine status was reported as excursion and the storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No concomitant therapies nor adverse effect were reported. No product quality complaint was involved.  This is one of several cases from the same reporter. Additional information has been requested.