chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of phlegm discolored in a 81-year-old male patient who received FLUARIX QUADRIVALENT. Concurrent medical conditions included pneumonia (since 2014). On 14th September 2015, the patient received FLUARIX QUADRIVALENT. On 20th September 2015, 6 days after receiving FLUARIX QUADRIVALENT, the patient experienced phlegm discolored, anxiety and cough. On an unknown date, the outcome of the phlegm discolored and cough were not recovered/not resolved and the outcome of the anxiety was unknown. The reporter considered the phlegm discolored to be unrelated to FLUARIX QUADRIVALENT. It was unknown if the reporter considered the anxiety and cough to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: This case was reported by patient's daughter. On 14th September 2015, about 6 days before the day of reporting, the patient received FLUARIX vaccine at local pharmacy. After vaccination, the patient started coughing up orange phlegm. The patient did not experience cough prior to the day before reporting. Therefore, the patient experienced anxiety and he thought to visit emergency room. Emergency room visit was avoided by the patient but the reporter was going to take the patient to see his pulmonary doctor later at the time of reporting.
patient felt light headed 8 minutes after vaccine, notified nurse and medic who was observing, nurse and medic had patient lay down supine and patient felt better immediately. Nurse and medic continued to monitor patient for 30 minutes. Patient felt well enough to leave on her own after event. Patient stated that, "this happens every few years after I get a vaccine.".  RN advised patient to make provider aware of this in the future.
SHE COMPLAINED OF BEING LIGHT HEADED AND DIZZY WITH NAUSEOUS AFTER RECEIVING THE VACCINE. ONSITE EMS RESPONDED BUT NO VITALS WERE TAKEN. SHE SAID SHE FELT BETTER, THE SYMPTOMS WENT AWAY AND SHE FELT WELL ENOUGH TO DRIVE.
This spontaneous report as received from a nurse refers to a 9 months 2 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) PEDVAXHIB injection, lot # K016965, exp. date: 20-JUL-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Patient had a patent stent in iliac veins for 8 years and after the second shot the left iliac vein stern thrombosed
approx 12 hrs after receiving the booster I developed what I expected to be normal side effects,  fever/chills/ injection site soreness/Headache; approx 16 hrs post booster I developed head to toe body aches, and the headed continued to increase in intensity;  I finally took Tylenol approx 20 hrs after receiving the booster,  it did alleviate the excruciating headache and body aches, but not the fever;  malaise set in approx 24 hrs after receiving the booster and still continues to today.   By the 4th day- I still had a fever  ranging from 99-102.7 despite 9,000mg of Ibuprofen and Tylenol.  My injection site was very sore/inflamed and red.  Telemedicine consult told me to report to the E.D. for labs.  There they were concerned about my arm.  They checked for cellulitis and an abscess.  They determined it to be an reaction to the booster.  My fever was 99.0 at the E.D.  They told me to cont with NSAIDs and to use warm compresses on my arm.  I followed up with my PCP 8 days post booster.  Labs were completed and I was shown to have elevated Eosinophils  (8.3%)    I am now 12 days post booster and I still feel very fatigued and a little bit of 'brain fog'
bleeding every day and losing a lot of blood; had some discharge/the discharge was first light and then got darker; got sick the next day; This spontaneous case was reported by a consumer and describes the occurrence of VAGINAL HAEMORRHAGE (bleeding every day and losing a lot of blood), VAGINAL DISCHARGE (had some discharge/the discharge was first light and then got darker) and ILLNESS (got sick the next day) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Menopausal.   On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ILLNESS (got sick the next day). On an unknown date, the patient experienced VAGINAL HAEMORRHAGE (bleeding every day and losing a lot of blood) and VAGINAL DISCHARGE (had some discharge/the discharge was first light and then got darker). At the time of the report, VAGINAL HAEMORRHAGE (bleeding every day and losing a lot of blood) and VAGINAL DISCHARGE (had some discharge/the discharge was first light and then got darker) had not resolved and ILLNESS (got sick the next day) outcome was unknown.            No Concomitant medications were provided by the reporter. No Treatment information was reported.
Red reashed hives on bilateral upper arms, stomach, and lower back about 30 min after vaccine.
Patient's mother states they had hives 3 weeks after the first shot on her face / body.
Patient return back to Flu Clinic and reported she started to itch and felt nausea. Starching herself on the chest, arms, and to chin area. NP quickly assess patient and patient given Benadryl 50 mg, PO. Observed patient and patient emesis approximately 20 ml with Benadryl noted. 13:48 patient given Benadryl 75mg, IM, Right Deltoid. Patient felt better after "throwing up." 13:49 airway patent. No stridor, no wheezing noted. Breath sounds are clear. 14:02 patient feeling better. Itching decrease and lip edema decrease. Airway Patent, no stridor, no wheezing noted. No rash noted. Patient escorted home with d/c instruction. Patient verbalized understanding to the instruction.
The first two days I felt achy and ran a temperature of 101.3. I also had like my equilibrium was off a bit. On Monday morning around 8:00 am I realized I could no longer hear out of my right ear.  I made an appointment to see am ENT specialist on Wednesday April 21st. Through a series of audio tests it was confirmed that I had lost all sense of hearing in my right ear; left ear was 100% hearing. The doctor place me on a 10 day series of DEXAMETHASON 1.5MG. S So far I haven't regained any hearing in my left ear. I have an appointment May 6, 2012 to have a re-test for my hearing in the right ear.
The next morning I began to ache a lot so I took some Advil. Then I began to run a fever about  an hour later. 100 deg. I went home from work at lunchtime because I started to feel like I had the flu. Body aches, really tired and fever. I went to bed around 3pm and I?m still in bed today. 1/15/21 Severe body aches, very tired no energy, fever has gone, but massive headaches now.  I had an antibody blood test the week before and I still have them. I had Covid back in Feb/March 2020 and lost my smell and taste as a result.
Fever (101 F).  Treated with acetaminophen and resolved within 12 hours.  Epistaxis (first time in her life) on 11/28 at 3 pm, resolved within 15-30 minutes and did not recur.
Woke with visual distortions, elevated mood, whole body increased nerve sensations, impulsive thinking (symptoms akin to tripping on LSD). Symptoms had started in sleep state and invaded dream space and woke with them still active. Lasted about 4 hours after waking. Then fatigue and headache with no further of the symptoms that were awoken with.
On the night of the 2nd dose, 03/05/2021, my arm was, like a round baseball, flaming hot and it felt like it was on fire. About 1:30 AM I was shivering my temperature was 101 to 102. I had chills that went for around 2 hours. On 03/07/2021, I was back to being my normal self. On July 09, 2021, I  got stung bee on the upper back of my left leg. It created  great big patch of red and it was raised. It was about a 2 inch size patch. It stayed that same way after 4 or 5 days. On 07/15/2021 I went to see the doctor. He prescribed me some steroid lotion, triamcinolone acetonide cream .5% the doctor prescribed pills, but I never took the pills. I noticed it started going down with the cream after about 10 days it faded away. I have gotten stung by bees before, but I have never had a reaction to a bee sting like that before. I never had a bee sting were it didn't go away on it's own. I felt like my body's reaction changed after the vaccine. I felt the vaccine ramped up my defense system. When the bee stung me, if felt like whatever foreign body was in my system, my body just jumped right on it.
My eye became inflamed and was first misdiagnosed as conjunctivitis at Urgent Care. When condition worsened over the next week I went to my opthamologist who said I had inflammation in the eye and had me start on prednisolone and dorzolomide. It is over a year later and I am still fighting this condition. It will get better and then worse. After several months of iffy improvement Dr. put me on vanacyclovir which cleared it up for a while. But then it worsened. I was able to have the booster because Dr. put me on a prophatactic regimin  (4 weeks)which worked.
Developed spasmodic torticollis approximately 2 weeks after receiving Moderna booster
after vaccine on saturday, that night she felt dizzy sunday felt like she had the "flu" arm soreness, very tired, runny nose, bloody nose, headaches, rash with itchy red dots on her arms and legs, anxious and hyperactive for 5 days
Throat swelling, coughing for 4 hours, followed by high fever (102) and headache beginning at 5:00 PM. Went straight to bed. Took 2 aspirin. Still have some headache this morning.  Fever is down.
blood clot; This is a spontaneous report from a contactable consumer. A 6-decade-old female patient (in her 50's) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at a single dose as vaccine. Medical history and concomitant medications were not reported. It was noted that one of the reporter's co-worker developed a blood clot after receiving the first dose of the Pfizer vaccine on an unspecified date. Any information or data on someone developing blood clots? The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Patient was vaccinated on June 5, 2021 , one week later she developed fever and myalgia and on June 27, she woke up with  bruising and petechia on the legs and arms. she also had hematomas over the oral mucosa and subconjunctival hemorrhage. On June 27, she was seen in the ER, platelet count was 1000. She received IVIG on June 28 and 29
severe flu symptons...extreme sore throat...weakness...no appetite...sleeping 15 hours a day...head aches...running nose...steady cough...ringing in ears
12/27/21: He presented with complaints of shortness of breath and cough for several days. He also endorses atypical chest pain which has been ongoing for years. He is unable to elaboarte on this more but notes it is not worse with exertion. Sometimes worse with laying supine or coughing. He does follow with a cardiologist but is unable to recall whom. Notes he did see them recently and has had full work up with NST and this was unremarkable.  Further work up on admission revealed BP of 200/73, EKG SR with LVH and RL pneumonia. COVId19 positive. He is fully vaccinated. BNP WNL. Troponin 54 and 51. Cr 1.51. Records indicate echo in 2020 EF 65% with no significant structural abnormalities. Patient received first dose J&J vaccine on 3/26/21/2021 Lot # 1808609 and the second dose on 10/26/2021 Lot # 1822811
developed cold 4 days after vaccine; cough lasting 5+ weeks (dry); headaches everyday; muscle aches and fatigue that resolved within two days of shot; muscle aches and fatigue that resolved within two days of shot; This is a spontaneous report from a contactable nurse (patient).  This 37-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL0140), via intramuscular on the left arm on 21Dec2020 (at 10:00) at a single dose for COVID-19 immunisation, administered at hospital. Relevant medical history included sulfa allergy. Past drug history included allergy to codeine. Relevant concomitant medications included fluoxetine and resveratrol. No other vaccine was received in four weeks. The patient developed cold 4 days after vaccine, cough lasting 5+ weeks (dry), headaches everyday, muscle aches and fatigue. Pre and post-vaccination COVID tests were not performed. Therapeutic measures taken as result of the events includes azithromycin (Z-PAK) and albuterol inhaler. Muscle aches and fatigue resolved within two days of shot while the remaining symptoms persisted.  The patient received then the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EK9231), via intramuscular on the left arm on 11Jan2021.
Five hours after the covid vaccine shot,  chills so bad my whole body was shaking, was running a temp , headache, aches all over.. these went away by the next morning but I continued to be very tired.   Day three I was still very tired and developed a cold sore on the left corner of my mouth and sores in my mouth.  Also had a left swollen gland near jaw line.   I just layed low and rested.  by March 23 the cold sore and sores in my mouth went away..
35 yo male, aprox 510 minutes post vaccintion pt feel to floor. Immediately had seizure activity. Impact was on l forehead area with a moderate size hemeatoma noted and abrasion. Pt is able to answer questions but not remember conversation prior to fall. VS initially were 99% o2 sat, hr-68, 82/43, hr 51. o2 via nc applied @ 2l per nc. o2 sat 99-100%. Skin cold, clammy, ashen, post seizure activity noted. EMS called. Father called was in car waiting and came into building. Pt transported to medical center via ambulance. Last VS 108/76, 100%, hr-87, r-20@1456. 1445 b/p 60/44, hr44, o2 sat-99%, r-18.
Pt recvd 3 doses of Engerix-B & was determiined to be a non-responde;r pt recvd dose of Engerix-B vax 8JAN92;
mom reports pt's bottom was shaking & tongue hanging out of mouth 1DEC94 date shot administered) went to Er where pt had another sz; ER MD dx fever seizure; No recommendations made from ER MD:
I had a total head cold, very congested, and cough with phlegm. I tested positive for COVID-19 at home.
Immunization given 4/15 w/out difficulty. Mom states pt developed flat red rash "measles like" over whole body and temperature 103.5, night of 4/19. Symptoms continued and saw MD 4/22. Tylenol/ Motrin and fluids. Also malaise and anorexia with above symptoms conditions and rash gone by 4/26-4/27
Insomnia, being "jolted" awake or just waking up at random times and unable to go back to sleep. Very tired and groggy most days. Hard to concentrate at work. Depression, excessive anxiety. Always worried about there not being a cute for this. Tingling, burning back, shoulder, and neck pain. Never too severe, but there a lot. Painful to sleep after a few hours. Nausea over half the time. Loss of appetite. Eating significantly less.  Lost 15 lbs in two months. Fatigue, brain fog, dizziness, lightheadedness.  Extremely tired. Originally neck pain in the front, now teeth/jaw hurt in the mornings. Random sensitivity to cold/hot foods. Unpredictable desire to have a bowel movement or to urinate. Usually unproductive. Sweaty hands/feet. Elevated heart rate randomly. Skin tingling/burning on the tops of arms and cheeks. Numbness in fingers. Originally ring/pinky, now thumb/index/middle finders. Mostly left side. Tinnitus, ear pain. Has gotten slightly louder and more noticeable.  Symptoms appeared starting a few days after vaccine #1 and are still ongoing as of date of VAERS report.
Arm was swollen and sore; Arm was swollen and sore; Felt under the weather/Did not feel well; Fever; Felt achy; Headache; This is a spontaneous report from a contactable nurse (patient). A 69-year-old female patient received bnt162b2, via an unspecified route of administration, administered in Arm Left on 19Apr2021 11:00 (Lot Number: ER8731) as 1st dose, single for covid-19 immunisation. Medical history included Chronic pain, covid-19 from Jan2021, Aneurysm on an artery to her spleen, Multiple back and hip surgeries, 8 Surgeries, Cholesterol, Osteoporosis, Nerve pain, pain, Multiple failed fusions. Concomitant medications included atorvastatin taken for cholesterol; colecalciferol (VITAMIN D) taken for osteoporosis; gabapentin taken for Nerve pain; marijuana taken for pain; calcium. The patient previous received the Trumemba meningococcal vaccine in 2017 for immunization and experienced Seizures; Meningococcal vaccine for immunization and experienced felt under the weather; Pneumococcal vaccine for immunization. She did not feel well after vaccine. She stated her temperature never got above 99 after the first dose. Arm was swollen and sore, felt under the weather, fever, felt achy, headache; they were occurred maybe 20 to 21 hours after vaccine (20Apr2021). Her arm was swollen and sore. She felt under theadds that this was for about 5 days, her temperature was 99 and that was as high as it got. She felt achy and her arm was sore. She had a headache. She added that this went into the second day and she started feeling worse. She had COVID in January, which is probably why she reacted to the first shot. She stated that is what she has heard. She started to feel better until she got the second shot. The causality as yes. She received a chest xray at the end of Feb2021 and she just saw pulmonologist and has to go back for a pulmonary function test. She confirmed this was from before the vaccine and to follow up after she has had Covid. The patient reported the events as serious as medically significant. The outcome of the events was recovering.; Sender's Comments: Based on the available information, a possible contribution of the drug to the events Arm was swollen and sore, Felt under the weather/Did not feel well, Fever, Felt achy and Headache cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
pt recvd vax & became very rigid w/clinched teeth & was involuntary of urine, spastic movements of both arms occurred for approx 20 sec; c/o nausea w/dizziness; pt was very pale;
no additional adverse event; temperature excursion for GARDASIL 9 that was administered; This spontaneous report was received from a registered nurse referring to a 18 year old patient of an unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.    On 06-AUG-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # S020254 expiration date 09-DEC-2021, 0.5 milliliter for prophylaxis.  The vaccine was out range for accumulative time frame of 75 hours and 17 minutes at 11.2 Celsius degrees. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S020254; expirationdate: 09-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Vomiting, dry heaves, lethargic.  This continued all day on 5/1/2010.  He was seemingly better on 5/2/2010.  On 5/3/2010 he started vomiting again.  He also had dry heaves, no appetite/ nausea, slight fever, lethargic, and very restless.
Over the last 9 months since I received one Moderna Vaccine shot.  I have had months of sleepless night including hot flashes.  Inability to fall asleep and stay asleep.  I have also experienced muscle cramps and head aches.
hot, swollen, red rash that grew from the size of a penny into that of a softball. Happened with both dose #1 & #2
a slight headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (159558). The reporter is the patient.  An 85-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Nov2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 85 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number: 1st booster), for COVID-19 immunization; Covid-19 vaccine (Primary Immunization series complete, Manufacturer: Unknown), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 14Nov2022, outcome "unknown", described as "a slight headache".  Additional information: she took her Second booster dose today at noon and she got a slight headache.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
55 year old female who has completed a 30-minute observation period with the following signs and symptoms of an adverse reaction: other - reports dizziness,facial tingling,ha,throat tightness, rapid respiration. Pfizer-BioNTech COVID-19 vaccine # 1 in series administered.  o Action(s) taken: Epinephrine administered AT 1304, transferred to higher level of care o Allergy to COVID-19 vaccine documented in Aller
1.5 in spot around injection site that is itchy, red, swollen. Pt told to take benadryl, use compress and topical antihistamine as needed.
No additional AE/No PQC; HCP reported a pregnant woman was given MMR II and VARIVAX.; This spontaneous report has been received from a medical assistant and refers to a 41-year-old pregnant female patient.  The patient's pertinent medical history, other drug reactions or allergies, concurrent conditions and concomitant therapies were not reported.  On 14-AUG-2023, the pregnant patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection (lot number w031812 has been determined to be valid for varicella virus vaccine live (oka/merck) (VARIVAX), with an expiration date established as 05-OCT-2024) (strength was not provided); and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection (lot number w036931 has been determined to be an invalid lot number for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), expiration date has been reported as 19-MAY-2023) (maternal exposure during pregnancy) (strength, and indication were not provided); both vaccines were administered intramuscularly for immunization. No adverse events were reported.