chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial Report. Adverse event: worsening dyspnea, Onset date: 10/1/2023, Subject enrolled in the Janssen study received study medication (Janssen ad26.CoV2. vaccine) administered on 10/17/2022. subject was recently discharged from the hospital on 9/28/2023 for shortness of breath (Dyspnea) and ongoing pleural effusion. Patient had fluid removed from left lung. Patient said he started to have issues breathing when lying flat the night of 9/30/2023. Patient felt pressure through his chest and abdomen. Patient denies any pain currently. He has been taking his lasix. His last dialysis was Friday 9/29/2023. He denies any cough or leg swelling. Assessment and Plan on 10/1/2023 shortness of breath. Vitals stable. Has diminished lung sounds to left lower lobe. Suspect reacccumulation of pleural fluid. Will obtain cardiac labs, basic labs. Will obtain CXR. Dispo pending results. 10/2/2023 pulmonary consulted patient has chronic recurrent left-sided pleural effusion, which has been tapped 4 times in the past, most recently end of September, analysis has been consistent with transudative pleural effusion, and cytology was negative for malignant cells, patient reports symptomatic improvement after drainage of fluid. Recommendations: -Discussed with patient potential benefits and risks of PleurX catheter insertion, and he is agreeable to proceed,Order has been placed for procedure, timing to be determined. -Discussed Lingular opacity with radiology team , likely related to rounded atelectasis related to nearby compressing left-sided pleural effusion, patient will need follow-up imaging with CT scan of the chest in 4 weeks after drainage of the effusion .
This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 06-JUN-2013 the patient was vaccinated with a partial first dose of GARDASIL (Lot#, dose and route not reported), due to syringe or needle leakage (the GARDASIL dose leaked where the needle and syringe connected). The GARDASIL dose was drawn into an unspecified administration syringe from a GARDASIL vial. Concomitant therapy was not reported. The patient received a second dose of GARDASIL on 12-SEP-2013. No adverse event reported. The follow up as received from a licensed practical nurse refers to 12 years old male. The patient did not think the patient received adequate first dose of GARDASIL due to leakage from syringe on 06-JUN-2013. Additional information is not expected.
Rash over leg abdomin and a little on face doesn't seem to bother him at all. He's not scratching or fuzzy, no fever, no redness or swelling at injection site. He also started vitamin D drops and oral Nystain for thrush at the same time.
Symptoms began approximately 7 hours after receiving the vaccine and continued throughout the following day.   The first symptoms were ear and sinus pressure.    Then malaise/fatigue, headache,  mild stomach upset.  Fever occurred in the middle of the night and got up to 101.1.  Also developed shakes/tremors and severe back and body aches.  My arm was sore at site of injection.
Redness appeared at injection site; This is a spontaneous report from a contactable 81-year-old non-pregnant female consumer reported for herself that she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EL0739), via an unspecified route of administration on 15Jan2021, 11:00 at single dose in left arm for covid-19 immunization. The patient's medical history included GERD, osteoporosis, high blood pressure, urticaria, osteoarthritis, high cholesterol. Known allergies: sulfa, known allergies: NSAIDS, known allergies: Tuna, salmon; known allergies: strawberries, corn, intolerant of seasonings, citrus, chocolate; known allergies: lactose intolerant and known allergies: caffeine. Concomitant medications included levothyroxine sodium (LEOXYL), atorvastatin calcium (LIPITOR), amlodipine besilate (NORVASC), pantoprazole sodium sesquihydrate (PROTONIX) and fexofenadine hydrochloride (ALLEGRA). Past drugs included Cipro with reaction known allergies: cipro; Vantin with reaction known allergies: vantin; Levaquin with reaction known allergies: Levaquin; Percocet with reaction known allergies: Percocet; Bactrim with reaction known allergies: Bactrim; Codeine with reaction known allergies: Codeine; Cleocin with reaction known allergies: Cleocin; Flomax with reaction known allergies: Flomax; Lexapro with reaction known allergies: Lexapro, Imodium with reaction known allergies: Imodium; Kaopectate with reaction known allergies: Kaopectate; and  PeptoBismol with reaction known allergies: PeptoBismol. On 17Jan2021, the patient experienced redness appeared at injection site (vaccinated 15Jan2021) about 3rd-4th day after injection, patch of redness 3 x 5 inches, remained red 2 weeks, began to pale in third week; was still mildly visible 05Feb2021, date of 2nd vaccine dose. The patient was allergic to long list of meds but doctor on 15Jan2021 reviewed her list and said ok to taking the first dose. The patient had not needed Epi-pen to cope with allergic reactions to medications but did carry one with her on each of the vaccination days. The patient had 2nd dose in unaffected arm and experienced no reaction or side effects to 2nd dose on 05Feb2021. The patient took Benadryl for 1-2 days for the event. The outcome of the event was recovered on an unknown date.   Information on the lot/batch number has been requested.
Pt. reported photosensitivity, headache, nausea, chills.  Pt. went to ER and was given ketorolac.
Sensitive skin, can break out even when putting sanitizer; Big red spot and the next day it was larger and it was hot; Red spot and the next day it was larger and it was hot; It was uncomfortable and very hot to the touch and it itched; Very uncomfortable; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Big red spot and the next day it was larger and it was hot), INJECTION SITE WARMTH (Red spot and the next day it was larger and it was hot), INJECTION SITE PRURITUS (It was uncomfortable and very hot to the touch and it itched), DISCOMFORT (Very uncomfortable) and SENSITIVE SKIN (Sensitive skin, can break out even when putting sanitizer) in a 66-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (Big red spot and the next day it was larger and it was hot), INJECTION SITE WARMTH (Red spot and the next day it was larger and it was hot), INJECTION SITE PRURITUS (It was uncomfortable and very hot to the touch and it itched) and DISCOMFORT (Very uncomfortable). On an unknown date, the patient experienced SENSITIVE SKIN (Sensitive skin, can break out even when putting sanitizer). At the time of the report, INJECTION SITE ERYTHEMA (Big red spot and the next day it was larger and it was hot), INJECTION SITE WARMTH (Red spot and the next day it was larger and it was hot), INJECTION SITE PRURITUS (It was uncomfortable and very hot to the touch and it itched) and DISCOMFORT (Very uncomfortable) had resolved and SENSITIVE SKIN (Sensitive skin, can break out even when putting sanitizer) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Softball size lump in armpit that moved to Brest area and later into throat and subsided after 7 days.; Softball size lump in armpit that moved to Brest area and later into throat and subsided after 7 days. Softball size lump in armpit that moved to Brest area and later into throat and subsided after 7 days.; I also have not had a return to my menstrual cycle; I also have not had a return to my menstrual cycle. I have had my monthly cycle consistently until the booster vaccine.; Dose received: 3; This is a spontaneous report from a contactable reporter (consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 23Dec2021 at 17:30 (Lot number: FD7218) at the age of 50 years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: EN6208, Anatomical location: Left arm, Administration time: 08:30), administration date: 18Mar2021, when the patient was 49 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot Number: EP7534, Anatomical location: Left arm, Administration time: 08:30), administration date: 06Apr2021, when the patient was 49 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 23Dec2021 at 17:30, outcome "unknown", described as "Dose received: 3"; AXILLARY MASS (non-serious), BREAST MASS (non-serious), PHARYNGEAL MASS (non-serious) all with onset 24Dec2021 at 04:30, outcome "recovered" (31Dec2021 at 04:30), and all described as "Softball size lump in armpit that moved to Brest area and later into throat and subsided after 7 days"; MENSTRUATION DELAYED (non-serious) with onset 24Dec2021 at 04:30, outcome "not recovered", described as "I also have not had a return to my menstrual cycle"; MENSTRUATION IRREGULAR (non-serious) with onset 24Dec2021 at 04:30, outcome "not recovered", described as "I also have not had a return to my menstrual cycle. I have had my monthly cycle consistently until the booster vaccine.". The events "Softball size lump in armpit that moved to Brest area and later into throat and subsided after 7 days.", "I also have not had a return to my menstrual cycle" and "I also have not had a return to my menstrual cycle. I have had my monthly cycle consistently until the booster vaccine." were evaluated at the physician office visit. Therapeutic measures were not taken as a result of axillary mass, breast mass, pharyngeal mass, menstruation delayed and menstruation irregular.  Additional information: The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
No adverse event; she inadvertently gave a 19 yr old patient a pediatric dose of 0.5mL instead of the 0.5 mL of the adult Moderna Bivalent dose; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (she inadvertently gave a 19 yr old patient a pediatric dose of 0.5mL instead of the 0.5 mL of the adult Moderna Bivalent dose) and NO ADVERSE EVENT (No adverse event) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1903B) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Dose 1, Lot EL3302) on 10-Mar-2021, PFIZER BIONTECH COVID-19 VACCINE (Dose 2 and Lot EP7533) on 07-Apr-2021. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 23-Mar-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 23-Mar-2023, the patient experienced WRONG PRODUCT ADMINISTERED (she inadvertently gave a 19 yr old patient a pediatric dose of 0.5mL instead of the 0.5 mL of the adult Moderna Bivalent dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (she inadvertently gave a 19 yr old patient a pediatric dose of 0.5mL instead of the 0.5 mL of the adult Moderna Bivalent dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (she inadvertently gave a 19 yr old patient a pediatric dose of 0.5mL instead of the 0.5 mL of the adult Moderna Bivalent dose).    It was reported that patient had received another dose of vaccine in past but was unsure of lot number. No concomitant medications were reported. No treatment details were reported.
The patient received covid vaccine and flu shot together at 0924 am. Around 0943 am patient complained of a tingling sensation around her mouth
Fatigue; Chills; An unusual headache with pressure "like something you would expect with the dengue fever"; Chills for three days; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of FATIGUE (Fatigue), CHILLS (Chills), HEADACHE (An unusual headache with pressure "like something you would expect with the dengue fever") and CHILLS (Chills for three days) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00J20A) for COVID-19 vaccination.     No Medical History information was reported.    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 FATIGUE (Fatigue), CHILLS (Chills), HEADACHE (An unusual headache with pressure "like something you would expect with the dengue fever") and CHILLS (Chills for three days). At the time of the report, FATIGUE (Fatigue), CHILLS (Chills), HEADACHE (An unusual headache with pressure "like something you would expect with the dengue fever") and CHILLS (Chills for three days) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment and concomitant medications were not provided by reporter.; Sender's Comments: Based on the current available information and temporal association between the 1st dose of mRNA-1273 (lot#00J20A) and  start date of the events of fatigue and chills, a causal relationship cannot be excluded.
flu; Initial information was received on 24-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional (patient) via social media.  This case is linked to cases 2020SA308167, 2020SA308168, 2020SA308169, 2020SA308170, 2020SA308163, 2020SA308172, 2020SA308173, 2020SA308174, 2020SA308175 and 2020SA308176 (same reporter).  This case involves patient (demographics unspecified) who had flu (influenza), while received INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination a few years ago.  On an unknown date, the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  No laboratory data was provided.  It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on the batch number for this case.
Unable to move arm; Body aches; Started feeling chills; Injection site pain; Headache; Feeling tired; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (Unable to move arm), PAIN (Body aches), CHILLS (Started feeling chills), INJECTION SITE PAIN (Injection site pain) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced MOBILITY DECREASED (Unable to move arm), PAIN (Body aches), CHILLS (Started feeling chills), INJECTION SITE PAIN (Injection site pain), HEADACHE (Headache) and FATIGUE (Feeling tired). At the time of the report, MOBILITY DECREASED (Unable to move arm), PAIN (Body aches), CHILLS (Started feeling chills), INJECTION SITE PAIN (Injection site pain), HEADACHE (Headache) and FATIGUE (Feeling tired) outcome was unknown.            Patient reported that on same day paitent  had unknown manufacturer fl u shot as well along with Moderna.  No Treatment medication reported.   Most recent FOLLOW-UP information incorporated above includes: On 31-Dec-2021: Follow Up received contain Additional information updated about Vaccine received.
knot in my right arm where I took my vaccine; tired; This spontaneous case was reported by a consumer and describes the occurrence of SKIN MASS (knot in my right arm where I took my vaccine) and FATIGUE (tired) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced SKIN MASS (knot in my right arm where I took my vaccine) and FATIGUE (tired). At the time of the report, SKIN MASS (knot in my right arm where I took my vaccine) and FATIGUE (tired) outcome was unknown.            Concomitant medications were not provided by reporter.  Treatment information was not provided by reporter.  Knot stayed there, never got bigger and never got smaller.
Cold tingling sensation around injection site that soon radiated down to forearm.  Currently that problem has passed but left a constant tingling sensation in tip of left index finger for over an hour now.
1)8/1999 Left elbow swelled up about the size of half an orange. Drained and injected 3X.Operated on 3/2000.  2)1/2000-2/2001 Left heel pain & numbness. Injected 2X. Comes and goes.  3)5/2001 Severe pain in left knee. Surgery performed on joint 2/28/2001. Problems with pain in the knee afer surgery for 5 months. Injected 3-4X.  4)5/2001 Pain in left hip. Sometimes it feels like it's out of joint. Pain goes away as fast as it comes, sometimes lasting 6-8 hours. Dr. prescribed muscle relaxers and anti-inflamatory medication.  Still happens.  5)6/2001 Developed dry eye problem. Herrick plugs were inserted into the drain ducts of my eyes to help retain moisture. Severity changes day to day.  6)11/29/2001 Sever pain in both shoulders. Surgery performed 2/2003 on right shoulder. Surgery performed on left shoulder 12/2004.  At present in therapy for left shoulder. Had to have it injected on 1/18/2005. Having problems with severe pain in right shoulder. Emergency room visit on 9/28/2004, felt like it was out of joint. Cleared up in 24 hrs. Reoccured on 1/19/2005, injected on 1/20/205 & 1/27/2005. These problems are ongoing.  7)11/20/2002 to present. Leaky bowels and severe rectum cramps that last up to 20-30 minutes. Received medication for the cramping, changed diet and do exercises to strengthen rectum muscle. Had colonoscopy on 9/203 to band the skin in my rectum ti help tighten it up. No change at present 2/1/2005 in the problem.  8) 5/2003 Emergency room visit for a lung problem. Shortness of breath, coughing,& wheezing. Developed same problem 12/2003 along with chest pain. Heart ruled out, put on Prednisone 2X. Lump removed from my lungs on 2/16/2004  9) 8/15/2003 to present. Developed ringing in my ears. Diagnosed with Tinnitus, told to live with it. Started getting worse 4/2005.  10) 4/12/2004 developed high blood pressure. Put on Micardis.  11) 10/2003 to present. Gland under my left jaw swollen. Told to keep an eye on it. Seems bigger today and a second smaller lump has appeared.  12) 5/2004 Both hands fall asleep (numb & tingle) with pain and have a hard time getting them to wake up. Carpal tunnel performed on left hand 7/26/2004. Left hand, meaning thumb & finger, doesn't fall asleep now and the right hand only does it occasionally. However, now the little fingers and the sides of my palms on both hands fall asleep all the time.  13) 9/23/2004 Pain right elbow. Injected.  14) on and off for 2-3 years I get pain on both sides of my back(kidney?) thatlast about 24hrs.  15)General: For four years I've had off and on night sweats. Concentration and memory are a problem. A good nights sleep is hard to comeby. Sex drive has dropped way off. Some problems seem to go away and then come back. 60 Day follow up: Still having problems with both shoulders pain both hands going numb, little fingers and side of palms, thumbs and fingers of right hand. Ears ringing bad. Slight numbness in both feet, left heel pain.  Per the follow up report-Still having operations. Problems with my nerves. After my sugeries I always have problem recurring. I require injections of Cortisone, Prednisone and anti-inflammatory. Hands shake and I can't write anymore.
I started getting chapped lips and the 13th and I applied Chapstick - within two days, they became water blisters (like what you get with a sunburn) on both top and bottom of lips. On inside of lips there were more blisters. It started affected eating. My mouth was on fire. I realized it was another shingles outbreak - I have a standing prescription for shingles since I've had shingles before  - Valacyclovir  HCL - 1 gram tablet  - I took two pills a day - 12 hours apart. Taking these: inflammation went down first and then blisters started going away - it took about two weeks. The herpes stays in my system but the outbreak is gone.
pt recvd vax & exp itchy blotching; pt was found to have erythema multiforme; condition cleared in approx 3 wks;
PATIENT REPORTED FEELING LIGHT-HEADED/FAINT  AND EXTREMELY HOT/SWEATY ABOUT 30 MINUTES AFTER RECEIVING VACCINATION.
8 days after vaccine developed swelling,redness and warmth at injection site Resolving with application of  heat.
Pt c/o "throat feeling tight". Epinephrine 0.3cc of 1:1000 sq left arm. 911 call for ER for evaluation, via ambulance. Released with meds.
Multiple vesicles at injection site, erythema with defined borders, warm to touch. Patient to use Benadryl and cool compress.
Pfizer Monovalent Covid vaccine given in error, should have been the Bivalent Booster. No adverse reaction
pt recvd vax & exp synovial fluid in rt midcarpal joint & rt hand;
pt stated that the same day after she got her vax she had typical symptoms like fatigue and soreness of the arm but she took a hot bath and developed itching on her right leg on the upper part of the calve. It was bright red and now it has turned into a purple raised area.  She has also has some spots developing  above the knee on the same leg.  She has used  Benadryl topical. She will see her PCP on 3/2/2021.
February 2020; I believe I had COVID-19 before they were able to diagnose it. I was diagnosed with bronchitis, pneumonia, and the flu. The placed me in complete isolation. It took months to recover. After effects from having COVID-19, I became allergic to avocados and I immediately had diarrhea and vomiting. This led me to going into anaphylactic shock and I had to reach out to emergency medical care for treatment. Allergies are continuing to be very deadly and extremely worrisome. For the second vaccination that I had I had extreme lethargy and I was out a day. I also had an extreme growth in my lymph node and it was then removed and it was reported I did not have cancer. Hyperthyroidism had intensified as well and I am unsure of when this began.
Symptoms started the next morning.  Body aches, fever (101.5), headache.   Symptoms subsided after 24 more hours.
Pt developed pain and swelling 1 day after vaccine in that arm which remains inflamed and may require I and D procedure.