chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician regarding a 12 year old female patient. The patient's medical history included that patient's father has an unusually large penis and scrotum. On an unknown date the patient was vaccinated with GARDASIL (lot # and expiration date unspecified), 0.5 ml, 3 doses, (route unspecified) for prevent Human papillomavirus (HPV). Patient's mother reported that she wanted to know if GARDASIL could have enlarged her daughter's labia, because the patient experienced this after having completed the GARDASIL series. In the message, the mother also wanted to let the doctor know that the patient's father has an unusually large penis and scrotum and she wanted to know if this is something that could be genetically related to the enlarged labia of her daughter. At the time of the report the outcome of the enlarged labia was unknown. It was reported that there was no hospitalization and no treatment given for the enlarged labia. Lab diagnostics studies were not performed. Patient sought medical attention. Additional information has been requested.
Fatigue, sore arm. rested (mostly in bed) all evening and all next day, now doing fine
Recurring vaccine side effects; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of VACCINATION COMPLICATION (Recurring vaccine side effects) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included no.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Recurring vaccine side effects). At the time of the report, VACCINATION COMPLICATION (Recurring vaccine side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were not provided.
violent chills; body rigidity spasms severe joint pain and muscle weakness rapid heart beat.  All lasting 9 to 12 hours onset 12 hours after injection. Injection site sore and red after 5 days
TINGLING; LIGHTHEADEDNESS; RANDOM SHARP PAINS AROUND CHEST ON BOTH SIDES PERSIST; NUMBNESS TO FACE; HEAVY FELLING; HEADACHE PERSISTS 2 WEEKS POST  VACCINE PULLING, ON LEFT AND  RIGHT SIDES; PAIN BEHIND LEFT THIGH; CHILLS ON HALF OF BODY; This spontaneous report received from a patient concerned a 27 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, non smoker, and penicillin allergy, and other pre-existing medical conditions included the patient had no known medical history. the patient did not have any history of drug abuse or illicit drug use. the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced pain behind left thigh. On APR-2021, the subject experienced chills on half of body. On 11-APR-2021, the subject experienced tingling. On 11-APR-2021, the subject experienced lightheadedness. On 11-APR-2021, the subject experienced random sharp pains around chest on both sides persist. On 11-APR-2021, the subject experienced numbness to face. On 11-APR-2021, the subject experienced heavy felling. On 11-APR-2021, the subject experienced headache persists 2 weeks post vaccine pulling, on left and right sides. Laboratory data included: Diagnostic ultrasound (NR: not provided) NEGATIVE. On 15-APR-2021, Laboratory data included: Blood pressure (NR: not provided) NOT REPORTED, and CT scan (NR: not provided) NEGATIVE. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache persists 2 weeks post vaccine pulling, on left and right sides, tingling, lightheadedness, random sharp pains around chest on both sides persist, numbness to face, and heavy felling, and the outcome of pain behind left thigh and chills on half of body was not reported. This report was non-serious.
Metallic taste, left side of neck pain-moderate, sore throat of left side-mild, left side of face and neck swellling, and mild headache-frontal
Flu Like Symptoms. Nausea, Weakness, Muscle Aches, Stomach Cramps.
upset stomach; This is a spontaneous report received from a Pfizer sponsored program. A contactable female consumer reported for her mother (patient) age 86 years that she received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine; Solution for Injection) via an unspecified route of administration as a SINGLE DOSE on unspecified date in 2021 (reported as a week ago) for COVID-19 immunization. Medical history included the first dose of BNT162B2 for COVID-19 immunization. The patient concomitant medications were not reported. Approximately on an unknown date in 2021, the patient, was having an upset stomach and wanted to know if this was caused by the vaccine. The outcome of the event upset stomach was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Red/welt at site of immunization (PROQUAD) (+) pain. Dx. with cellulitis. Rx: AUGMENTIN ES 600.
fatigue and headaches 2-3 days later.  15+ quarter-sized and itchy welts 12 days later, including at the injection site, but also all over legs, back, arms, and stomach. Welts are warm to the touch.
Two unknown patients >35 days from first vaccination without receiving the second dose; 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Two unknown patients >35 days from first vaccination without receiving the second dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Two unknown patients >35 days from first vaccination without receiving the second dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Two unknown patients >35 days from first vaccination without receiving the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.
At work-based community clinic, patient received two doses of vaccine on the same day (different brands). After receiving first dose, patient got back in line for a different dose. No adverse effects reported or noted during waiting period for either.  discovered during data entry after event completion
Donor states that right after getting in her POV that she felt short of breath. Donor left center at 13:35. Donor received immunization at 13:15.  Donor stated that she felt short of breath all day long. Didn't feel back to normal until the next morning. Donor denies taking any medicine to help with her symptoms. Donor states feeling tired and laid down once she got home.
My arm was raised, swollen and warm that went on for at least ten days. I also had lymph nodes swelling within the same time period, of the left arm pit area.
the patient received the adult version of the vaccine instead of the pediatric version.  Pt 's mom reported no adverse events, "they're fine."
Extreme headache, high fever, shortness of breath, fatigue, vomiting, wheezing after receiving second dose.
PATIENT COMPLAINTS OF SORENESS, SWELLING AND REDNESS THE DAY AFTER VACCINATION ON HER ARM.
The day following the shot, I was very tired and dizzy and thought that was just a side affect.  The tiredness/dizziness lasted for a couple weeks where I thought it was still a side affect.  By week three, my vision was getting bad and tiredness increased.  Also started getting thirsty and urinating more.  By August 10th I was admitted into the hospital with Ketoacidosis.  Then diagnosed with Type 1 Diabetes.
Patient verbalizes that when he arrived home after the administration of the COVID-19 vaccine he presented respiratory difficulty and epinephrine of his own was administered and he did not have to go to the hospital.
Neck stiffness; right side ear; mild headache; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Neck stiffness), EAR DISCOMFORT (right side ear) and HEADACHE (mild headache) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN for Cholesterol, PANTOPRAZOLE for GERD and Digestion impaired, LOSARTAN and METOPROLOL for Hypertension, CYANOCOBALAMIN, PYRIDOXINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE (VITAMIN B 1-6-12), MAGNESIUM ADVANCED and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for Supplementation therapy, ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Neck stiffness), EAR DISCOMFORT (right side ear) and HEADACHE (mild headache). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 30-Jan-2021, EAR DISCOMFORT (right side ear) had resolved. At the time of the report, MUSCULOSKELETAL STIFFNESS (Neck stiffness) had not resolved and HEADACHE (mild headache) outcome was unknown. Not Provided          Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Patient received 2nd dose on 20-Feb-2021, states that she experienced no new reactions but neckstiffness remained.
The next day I experienced tooth pain at the site of a previous root canal.; Fogginess; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 64-years-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0150) via an unspecified route of administration in the left arm on 15Apr2021 at 14:00 (at the age of 64-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient did not receive any concomitant medications. The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Apr2021 at 12:00, the patient experienced fogginess, fatigue. On 17Apr2021, the next day she experienced tooth pain at the site of a previous root canal. Therapeutic measures were not taken as a result of these events. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event fogginess, fatigue, tooth pain and pain was recovered on 19Apr2021.   No follow-up attempts are needed. No further information is expected.
pt recvd 2nd dose of Hep B vax on 25FEB92 & pt exp pain & swelling @ the inject site; @ the time of the report pt recovered;
On trip to see daughter. Experienced cardiac syncope after walking up five flights of stairs after dinner. First time - no history of problem. Do have a heart murmur since childhood but standard tests (EKG, echocardiograms, etc.) are all normal. Ambulance called and taken to local ER.
allergies/was pneumococcal vaccine; swelling; This is a spontaneous report from a contactable physician. An adult patient of an unspecified age and gender received pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) via an unspecified route of administration on an unspecified date at a single dose for immunization. Medical history and concomitant medications were not reported. The patient previously had reactions to hydrochlorothiazide w-triamterene noted on 19Sep2014 as palpitations and was noted as allergies as of 19Nov2020. It was noted that allergies as of 19Nov2020 was pneumococcal vaccine; noted on 19Sep2014 was reactions: swelling on unspecified dates. The outcome of the events was unknown.  No follow up attempts are needed. Information about lot/batch number cannot been obtained. No further information is expected.
After 30 minute wait time was over patient started to feel itchy around 1740, we gave the pt 25 mg Benadryl at that time. Pt HR 88 regular, oxygen 99%. Pt. reports tightness in chest around 1746. 1755 Pt. reports headache. 1800 itching is gone, chest tightness continues, pt. is now coughing.
Just siting and feel like she is going to pass out; "It's a riming in her right ear while she talks; A hoarseness in her throat; Diarrhea; Nausea feeling; Feeling squeamish; This is a spontaneous report from a contactable consumer or other non hcp. A 59-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: was not reported; Expiration Date: was not reported), via an unspecified route of administration, administered in Arm on 22Jun2021 (at the time of vaccination 59-years-old), as a single dose for COVID-19 immunization. The patient's medical history includes blood pressure. The patient's concomitant medications include blood pressure medication and has been taking Tylenol to keep a fever from coming, so takes 2 Tylenol every morning, every day of the week. Patient previously had first dose of BNT162B2 vaccine, on an unspecified date May2021 (at the time of vaccination 59-years-old), as a single dose for COVID-19 immunization. Caller reports that when she had the first shot, in the same arm, she had no symptoms. On around 27Jun2021 or 28Jun2021, the patient experienced Just siting and feel like she is going to pass out; "It's a riming in her right ear while she talks; Diarrhea; Nausea feeling; and Feeling squeamish. Caller declines to complete a safety report at this time. Caller states she wants to know if these symptoms are from the Covid vaccine, or from something else? Caller states after she speaks to Medical Information, she will speak to her primary doctor about what she should do. Caller began to verbalize her frustration with information being provided for transfer to hospital. The outcome for all the events was unknown.  Information about lot/batch number has been requested.
Lightheaded Vitals: B/P: 165/85 HR: 87 O2Sat: 98 Skin Signs: Cool and Dry Circulation: 5 Cap refill <2sec Resp: Wheezing (Chronic) Treatment: Supine position, water, 1 Nutter Butter  Repeat Assessment at 11:40 am Vitals: B/P: 150/90  HR: 91 Resp.: 30 O2Sat: 97 Skin Signs: Warm and dry Circulation: 5 Cap refill <2sec Resp.: Wheezing (chronic) Treatment: sitting up in wheelchair, continued water, 1 Nutter Butter  Disposition: Home at 11:57 am
Patient experienced scratchy throat 5 to 10 min after receiving the two vaccinations.  She came over to the pharmacy counter and I told her to sit down in front of me for a little bit.  After another 10 min she complained that her tongue and lips felt numb and tingled, and was having slight difficulty swallowing.  Her chest looked red.  At this point I called for EMS and continued to monitor.  She never had full blown anaphylactic symptoms, and an Epipen was never used.  After being evaluated by EMS in the ambulance she declined futher treatment and drove herself home.
Cold and shivering, headache, body ache, distant feeling in my head, weak, fatigued.
RECEIVED PFIZER-BIONTECH MONOVALENT (NDC 59267-1025-04) INSTEAD OF INTENDED BIVALENT (NDC 592-0304-02)
Full body hives/swelling onset hours after vaccine and fever 2 days after administration.  Treated with Prednisone and Vistaril with urgent referral to an Allergist.  Pt is stable.
Pt presented to hospital post fall with right hip fracture.  Pt also tested positive for covid. Required surgery for hip.  When stable pt discharged to SNF.
All per patient - Approximately 24 hours the symptoms started very quickly. Presented with "raspy non-productive cough". She described feeling cold and chills. She went to the ER within a few hours due to the symptoms on 10/13/19.  They did the tests below and then sent her home after about 6-7 hours. Clinic called back the next morning and told her to go back to the ER or they would call her an ambulance due to labs being high and likely/probable clot and likely an enlarged heart. At that visit she sat in the waiting room for several hours before getting to be seen. They did further blood work and a CT Scan. Patient unclear if she had pneumonia or bronchitis, enlarged heart, and fluid around her lungs and heart.
COVID-19 VIRUS TEST POSITIVE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not 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 covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced covid-19 virus test positive. Laboratory data (dates unspecified) included: COVID-19 antibody test Positive, Positive, and COVID-19 virus test Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 virus test positive was not reported. This report was non-serious.
On 3/31/21 patient was observed for 15 minutes following vaccination and reported no change to health status, so was cleared to leave the clinic area. Patient called the next day (4/1/21) to report that approximately 40 minutes following her vaccination, while driving home, she experienced sudden shortness of breath, muscle spasms, and increased heart rate. Patient reports that she pulled her car over to the side of the road, and then "blacked out". Pt does not know how long she was "out", but upon waking she vomited and called a family member for a ride home.  Patient reports that when she got home, she slept for 14 hours. Woke up the next day (4/1/21) and felt sore and exhausted. Vomited a few more times throughout the day, and was on the toilet and she "saw spots" and "blacked out" again. Patient say she did not fall over or collapse. Family member observed this "black out" to last about 30 seconds. As of 4pm that day, more than 24 hours post-vaccination, she was still feeling unwell and not able to keep food down.  Patient denies hives, itching, fever, congestion, swollen lips/face.  Patient was advised to drink water or electrolyte-drink, rest, and call 911 or her PCP if she experienced another episode of SOB, "black out" period, prolonged vomiting, or new symptoms. Patient agreed to suggested course. Patient has no health insurance, doesn't want to come to a medical clinic for evaluation.
I received a call from the CDC saying that reports of Covid infections can be made using this form, although not an "adverse event". I am reporting two separate Covid infections, separated by 6 weeks. My first exposure was on 5/3. I began to have symptos on 5/5 and tested positive by antigen on 5/7. I completed a full course of Paxlovid, last dose on 5/12.   On June 19, I attended a large wedding. All guests had to show proof of vaccination and  booster. Several guests ended up  with Covid, as did I.  Yesterday, I completed another full course of Paxlovid.  Other information: both sets of symptoms were extremely mild and I only took the Paxlovid due to my age.  Also, although my 4th vaccine shot was Moderna; the previous 3 (3/5/2021, 3/28/2021 and 9/28/2021) were Pfizer.
This spontaneous report was received from a pharmacist referring to a female patient of unknown age who on 20-NOV-2013, was vaccinated with a dose of ZOSTAVAX (lot not reported). The pharmacist reported that a patient received ZOSTAVAX and developed a hard, red, painful knot at the injection site. The pharmacist stated that the patient tried to use an over the counter BENADRYL cream, but that it was ineffective for pain and redness. The patient consulted with a nurse "at her work", but no treatment was recommended. The pharmacist stated that she will be filing a VAERS report about this adverse reaction. Additional information has been requested.
Information has been received from the Pregnancy Registry for Gardasil from a physician concerning a female who was vaccinated with the first dose of Gardasil (lot # unknown) 0.5 mL. The physician recently found out the patient was pregnant. The physician did not know if the patient would terminate the pregnancy. No adverse experience was reported. Medical attention was sought. Follow-up information was received from the physician. The physician reported that the patient had an elective termination of her pregnancy not due to the use of Gardasil. Upon internal review elective abortion is considered to be an other medical event. Additional information has been requested.
tiredness in the arm, tingiling, reoccurring numbness (goes away and comes back)
Per patient she began to feel tired and out of breath, and as if something was stuck in her throat on 3/19/21. Patient states she went to Hospital freestanding emergency room around 4:30pm, she says she was given medication, but not sure what medication she was given and chest x-ray was taken due to chest pain. Patient was released on same day without any prescriptions and told to take Motrin or Tylenol for pain. Patient states she began having occasional mild itching to entire body on 3/31/21 and went to see Doctor and was not prescribed medication, states itching  has since increased in frequency and intensity. On 4/6/21 hives began to appear throughout body, went to see Doctor and was not prescribed anything. Patient denies change in dietary habits, detergents or household cleaning products, states she has a follow up appointment on 4/21/21 to discuss itching and hives. Patient states hives randomly appear and disappear, but itching is now constant. Patient in clinic to give report, she was noticed to be scratching most of the time she was with nurse
Redness around injection site, swollen, hardness at site, fatigue, hot/cold spells, chills.
Pain, hot, itchy rash at injection site. On-going, day 3 post injection
The patient fainted approximately 10 to 15 minutes after receiving the vaccine. She and her father walked to the front register and were waiting in line when she fell. We called 911 and monitored her closely until they came.  The patient was coherent and talking and said she was not in pain.  Paramedics came and took her to the hospital.
I was very fatigued with almost flu like symptoms. They lasted all day on 4/29/21.
patient stated that right arm near injection site increased in swelling over a couple of hours. became somewhat painful overnight in order to have a hard time sleeping. After waking up, the swelling decreased significantly. had flu-like symptoms overnight as well which has resolved.
Received vaccine, and hour later felt nauseous and dizzy, went home, laid down and had shallow breathing, next day(3/24/21) couldn't do much, fatigued, legs felt like giving out, midnight on 25th he jumped out of bed to check on animals before he made it to the door he felt really bad and had to sit down, wife checks him and speech was slurred, face was droopy, 40m later went to emergency room, emergency room said he was fine in grants. Hospital said he had a stroke possible bell's palsy. Still not doing well headaches, right side of body weak, blurry vision which is getting worse, one day doing well next moment he's not.