chrisvoncsefalvay/vaers-outcomes huggingface dataset:
severe flu like symptoms for 3 and 1/2 days; fever; chills; diarrhea; vomiting; aches; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number, time the vaccination was given, NDC number and Expiry Date are unknown), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. Patient's age at time of vaccination was unknown. The patient's medical history was none. There were no concomitant medications. Additional vaccines administered on same date of the Pfizer suspect were unknown. Prior Vaccinations within 4 weeks were unknown. AE(s) following prior vaccinations was unknown. Family medical history relevant to AE(s) was unknown. On an unspecified date, the patient experienced severe flu like symptoms for 3 and 1/2 days, fever, chills, diarrhea, vomiting, and aches. The clinical course was reported as follows: the reporter was reading on social media and saw her friend (patient) posted a whole bunch of side effects she had. She may have reported them, she was not sure. The reporter became aware of these side effects the previous day evening on 29Apr2021. She responded back and got a response this morning. With the first shot the patient had severe flu like symptoms for 3 and 1/2 days. She had fever, chills, diarrhea, vomiting, aches, etc. The reporter clarifies that the symptoms listed are the only symptoms she read. Her friend posted on a site called, Did you receive any side effects after receiving the COVID 19 vaccine? which is what caught the reporters attention. The reporter was sharing all of the information she has. She was looking to see how far back the post goes to see when she received the vaccine. She does not know when any of the symptoms started. She does not know on what dates the patient received the first or second dose. She does not have an NDC, lot, or expiration date available for either dose. She does not know where she received the vaccine. The reporter expects it was as far back as February, then 7 weeks. That was everything the reporter knows. It was unknown if AE(s) required a visit to Emergency Room or Physician Office. It was unknown If the patient was hospitalized. The patient underwent lab tests and procedures which included they checked her for blood clots (blood test): No blood clots on an unspecified date. Reporter seriousness for fever, chills, diarrhea, vomiting and aches was Unspecified. The outcome of event, severe flu like symptoms for 3 and 1/2 days was recovered on an unspecified date while other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report as received from a registered nurse refers to unspecified patients of unknown age and gender. No information about medical history, concurrent conditions were reported fort he patients. On an unknown date the patients were inadvertently administered with unknown number of doses of improperly stored ROTATEQ (dose strength unspecified). No adverse effects reported. The outcome of events reported is unknown. No product complaint was involved. This is one of the several reports from the same source. Additional infromation has been requested.
Mom reports child came home sick from school the day after receiving Tdap with 100 degrees F temp, chilling & body aches - also reported feeling winded when walking & hard to breath with fast heart rate & dizziness - also pale - fever gone today & went to school.
Had KINRIX and site of injection was swollen and red and painful. Child was given BENADRYL for the swelling & erythema.
On March 24th, I started menstruating with heavy bleeding and cramping. This continued until May 2nd. I bleed for approximately 39 days. I went to a gynecologist and they prescribed me progesterone to stop the bleeding. I had blood work that found my estrogen levels were very elevated. I received multiple ultrasounds which found ovarian cysts that I have never had before. I was going to gynecologist every 2-3 months for check ups on cysts. I started bleeding again from June 1st until June 19th. I had an ultrasound again and found more cysts which was more than the original cysts. For 4 months, I was at the gynecologist to get cysts checks on. This did coincide with trying to get pregnant. After months, I finally did get pregnant in early June. I had an miscarriage from a ectopic pregnancy which resulted in a removal of my fallopian tube and bleeding ovarian cysts were found. The fertility issues continued and I finally did have a pregnancy that resulted in a healthy child.
During administration patient took in the medication well, on the last little bit that was given to the patient, Patient started to gag and coughing. Patient continued to cough and then was looking like he could not catch his breathe. Patient became blue and Dr. was called in to the room,. As we tried to get patient to catch his breathe he continued to get blue and would gasp for air at one pint it seem like the patient was going to pass out. Dr. came in and baby seemed to be able to catch his breathe and baby looked more alert and stopped coughing and Dr listen to the patient and evaluated him.
Slight chills; Slight body aches; Sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16Mar2021 11:30 (Lot number: EL3247) at the age of 51 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Allergies to Sulfer" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1,  lot number=EL3247, Left Arm), administration date: 23Feb2021, when the patient was 51 years old, for COVID-19 immunisation. The following information was reported: CHILLS (non-serious) with onset 16Mar2021 22:30, outcome "recovered", described as "Slight chills"; PAIN (non-serious) with onset 16Mar2021 22:30, outcome "recovered", described as "Slight body aches"; PAIN IN EXTREMITY (non-serious) with onset 16Mar2021 22:30, outcome "recovered", described as "Sore arm". Therapeutic measures were not taken as a result of chills, pain, pain in extremity. No follow-up attempts are possible. No further information is expected.
Body aches, joint pain (especially neck and shoulders), TIRED, feeling warmer than usual, food tasting different (perhaps more intense), headache, tinnitus louder than ever, wounds very slow to heal.
Fatigue extreme , BBody/joint/lower back pain,  Day after vaccine : fever blister lower lip, burning mouth, itching ears and throat, headache
Day 2 ran high fever for 2 days, severe muscle weakness  Approximately 1 week after injection: Brought back my Covid symptoms (severe muscle weakness in legs, fatigue, brain fog) Increased my neuropathy pain in my feet 10 fold Increased migraines Increased depression  Overall it amped up my problems through the roof
Pt. received a second bivalent booster dose before it was authorized.  The dose given beyond its beyond use date.
Body Ache, Fatigue, Shortness of Breath, weakness, for more that 2 months. Injection site soreness.
COVID find was an incidental finding. 3/5/2022 "Chest x-ray today with pulmonary vascular prominence, bilateral perihilar airspace opacifications, likely bilateral small pleural effusions. X-ray right humerus shows fracture of mid to distal right humerus, associated with subtle lytic lesion.  Also seen is subtle sclerotic lesion (3.7 x 3.6 cm) in the in the neck/head of the humerus without fracture."
A parent reported that his 4 month old daughter received Rota Shield, Hib Titer, DTaP, Hepatitis B, and IPV. The pt subsequently developed constipation. Follow-up information received from the physician on 11/5/99 stated that the infant had a constipation problem that was documented several days after birth. The physician stated that the problem is not related to any vaccine.
Pt had large red swollen area at site of left deltoid, measureing 135mm x 80 mm. Pt had called the health center 9/23/04 but declined appointment until 9/24/04.
Information has been received from a registered nurse concerning a currently 2 year old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On an unknown date, the patient was vaccinated with VARIVAX (lot #: M033906 with expiration date: 28-JUL-2018) (dosage schedule, route of administration and anatomical location were not reported), for prophylaxis. The administered vaccine was improperly stored at temperature greater than 15°F but less than 46 °F  (15.5 °F) for 30 minutes and at temperature greater than 6 °F but less than 14 °F (10.1 °F) for 1.5 hours without any previous temperature excursion; this information was registered in a digital data logger. No adverse effects were reported.   This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA001065: US-009507513-1704USA001070: US-009507513-1704USA001067: US-009507513-1704USA001068: US-009507513-1704USA001069: US-009507513-1704USA001064: US-009507513-1703USA012554:
Seriousness criteria other medically significant (OMIC). Initial report received on 8/22/06 from a health care professional. A 21 year old female pt had received a left deltoid injection of Tripedia, (product not recommended for administration in this age group), lot number U1751CA, on 8/18/06. Within 24 hours post vaccination, the pt developed fever, aches and diarrhea. Four days post vaccination, the pt was experiencing shortness of breath. The event required examination by a physician. the pt had recovered by 8/22/06.
I got my vaccine about 10:30 AM. I had a slight headache (about 2 out of 10) but after the shot the headache went completely away. Several hours later I had muscle pain in my legs and upper back and a return of a quick jolting migraine ( about 5 out of 10 that quicky went to a level seven within 10 minutes). I spoke with (my roomate) and told her that I was going to the doctor for headache and muscle pain. I went to the ER. I was asked by the doctor about my symptoms and I told him that I had felt the headache and muscle pain after getting my shot earlier. I told hom that I had a very slight headache prior to the shot but shot took headache away. Dr asked me what was usually given for my headaches and I told him morphine. I had no nausea But I did have an unusal pain behind my right eye that I never had before. I went back out into the lobby and a nurse came out and asked me about my symptoms. I told her what I had told the doctor. I said that the muscle pain was probably due to the shot since I wasn't sore prior to that time. The nurse told me that it wasn't the vaccine but it was just a coincidence because i was having a migraine and was probably upset even though I was never upset. Another nurse gave me morphine, ativan, benadryl and phenergan for pain and then took my vital signs. After my pain had subsided I went home and went to sleep and felt fine the next morning.
Extremely sore in shot shoulder 2 days finally starting to ease.  Fever of 102.6 at highest for 14 hours now it is normal and moderate to severe body soreness muscle soreness body shivering and moderate headache side effects are almost completely gone now
vaccinated with Kinrix a 1.5 years old girl.; Inappropriate vaccination schedule; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a infant female patient who received DTPa-IPV (Kinrix) (batch number H9Y52, expiry date 31st January 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 10th December 2020, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter stated that they vaccinated with Kinrix a 1.5 years old girl, which led to inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. The nurse did not realize that the prescribing Information states that Kinrix is indicated for kids aged 4 through 6 years. This was the 3rd dose for DTaP and 3rd dose for IPV series. The reporter consented to follow up. No other information was available.
SHINGRIX 50 MG INJ(IM)SNGL DSE 1 VL. Heart has become weak as to did all my muscles of my body. Blood pressure sky rocketed to 193/99. Doctors discovered as a result of this medicine that I now have A-Fib....As a result my heart had to shocked back into rhythm. From this medications I had fallen twice and medications cause my head to uncontrolled jerking motions. I felt as though I had a stroke with uncontrolled bowel and urination.
Normal injection type pain-within 1 hr difficulty raising arm- pain in shoulder. Within 2 hrs can't shift pain increases going down arm. TYLENOL-can't sleep-pain, numbness, tingling down to finger tips. Ice packs, pain pill at 2 am. Can't use arm-extreme shoulder pain. Ache all down arm. Started to get some use of arm back Day 4. Still pain and limited use. Sometimes burning pain-sometimes ache. 11/26 I got this shot on 11/15-It is 11/26. I am still having pain in my shoulder and elbow joints and upper arm muscle. I cannot sleep on my right side as it hurts too much. The pain isn't as severe but it is still painful. This is so not right-what has happened to my shoulder and arm?
Presented to ER 2 days after COVID vaccine - SOB, chest heavy, thought she was having COPD exacerbation, fever, cough, aches. EKG was normal, troponin was normal, CXR was normal/stable from past images. Patient took an extra dose of furosemide that day, and was on prednisone too.
The woman woke at 11:00 PM  feeling nauseated and the baby was kicking more than usual. The woman had lower back pain, she walked around and felt better.  At 0700 AM the next morning she woke with shortness of breath and dizziness.  The woman contacted her MD but did not receive a call back, she was referred by the H1N1 information line to go to the emergency room.   An hour later she had not heard back from her doctor and now complained of the back of her head hurting, she was again referred to the emergency room.  The woman did not go to the emergency room but spoke with her doctor.  The symptoms resolved on their own within an hour.  She does have occasional contractions and is in contact with her doctor.
Patient was fine after the vaccine, walked over to his chair where his dad was waiting. then a minute later noticed his head was down so went to assist. at that point he passed out but we caught him so he did not fall. He regained consciousness after about 10 seconds, we then laid him on the floor. he did not pass out again but was still very dizzy. 911 was called and paramedics showed up to assist. patient was not given water or food after vaccine. EMS determined his heart rate was running pretty low, father and patient and EMS agreed to take him to the hospital as patient was not fully improving.
None 12/07/09 Antenatal records received for DOS 07/21/09-11/23/09. G1 P0, EDD: 03/12/10
none of the patients responded to PPV23; This literature marketed report has been received from the authors of a published literature article, titled as stated below and refers to a 62 years old female patient with chronic lymphocytic leukaemia. She received 6 courses of antibiotics in the year before enrollment. Prior to ibrutinib, the patient was on therapy with rituximab.  Pre-vaccination, the number of Streptococcus pneumoniae serotypes with immunoglobulin G (IgG) titers greater than 1.3 microgram/milliliter was 11. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (lot #, expiration date, dose, route, and site of administration were not reported) for prophylaxis. Concomitant therapies included ibrutinib.  Post-vaccination, the number of Streptococcus pneumoniae serotypes with IgG titers greater than 1.3 microgram/milliliter was 11. The patient did not respond to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (vaccination failure). The outcome of event was unknown. The authors considered vaccination failure to be related to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown).  A copy of the published article is attached as further documentation of the patient's experience.  This is one of ten reports derived from the same literature article (cross referenced with MARRS# US-009507513-2103USA003406).  Sender's Comments:  US-009507513-2103USA003406:
Site of shot upper arm very sore, feverish, following day could barely lift arm. Two days later had a red rash over chest, back, neck and arm. Third day I began itching..Fourth day..rash gone but arm sore but usable. Monday symptoms lessens.
Information has been received from a medical assistant referring to a 18 years old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy were not reported. On 11-JUL-2017, the patient was vaccinated with the third dose of GARDASIL 9 (lot # N002720, expiration date 12-MAY-2019)  (dose, route of administration and anatomical location were not reported) for prophylaxis. The administered doses of vaccine was exposed to a temperature excursion between 46.8 degrees Fahrenheit (F) which lasted for a 18 hours and 59 degrees Fahrenheit (F) which lasted for 65 hours on 13-JUN-2017. There was 59F previous temperature excursion for 4 hours. Data logger was used to track the temperature. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA005381: US-009507513-1707USA010591: US-009507513-1709USA012722: US-009507513-1709USA012723: US-009507513-1709USA012724: US-009507513-1709USA012725: US-009507513-1709USA012730: US-009507513-1709USA012727: US-009507513-1709USA012728: US-009507513-1709USA012729: US-009507513-1709USA012731: US-009507513-1709USA012732: US-009507513-1709USA012733: US-009507513-1709USA010537: US-009507513-1709USA012777: US-009507513-1709USA012776: US-009507513-1709USA012774:
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. On 07-AUG-2015, the patient was inadvertently vaccinated with a dose of ZOSTAVAX, subcutaneously, expiration date 20-AUG-2016 (strength, dose, lot # were not provided) which was inadvertently reconstituted with sterile diluent (Merck), lot H021469, expiration date 31-MAY-2015. No adverse effect reported. Additional information has been requested.
Fatigue; Not Hungry; Lethargic; Flu-like; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles and breast cancer.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 2 hrs after receiving Shingrix, the patient experienced fatigue, appetite absent, lethargy and influenza like illness. On an unknown date, the outcome of the fatigue, appetite absent, lethargy and influenza like illness were recovered/resolved.   It was unknown if the reporter considered the fatigue, appetite absent, lethargy and influenza like illness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose approximately 3 months ago and within 2 hours after the patient felt fatigues like she was ready to take a nap.  The patient experienced not hungry and was similar to flu but not as serious. Lastly the patient felt a little lethargic and that she only wanted to watch TV. The next morning caller's mother felt better and by the afternoon back to normal. The reporter did not consent to follow up. The reporter declined to provide demographics including last name and address.  The patient would receive 2nd dose from a pharmacy in the town. and if her mother experiences side effects that she would call back and possibly provide follow up contact information.
Bad headache for 24 hours, lethargic for 3 days, red welt at injection site for 2 weeks, continuing dizziness off and on
Pt states he has had pain in vaccination arm consistently since two days after receiving his first Shingrix dose.
Follow-up information was received that provided office phone number, date of vaccination, recovery status, illness at the time of vaccination, birth weight and laboratory test. Information regarding PREVNAR was received from a nurse regarding a 12-month-old patient who received a dose on 10-Apr-2007 and experienced fever of 103 degrees Fahrenheit, severe diarrhea, strange rash, possible hives and vomiting. Relevant medical history was not provided. Product was administered on 10-Apr-2007. Dose regimen was 1 dose 1 time per day. Concomitant medication were not reported. In Apr-2007, the patient received a dose of PREVNAR. Within 24 hours, on 10-Apr-2007, the patient experienced fever of 103 degrees Fahrenheit, severe diarrhea, strange rash that could be possible hives, and vomiting. On an unspecified date, the patient recovered from the events. Body temperature (results: 103 deg. F.) was done on 10-Apr-2007. Rotavirus test (results: positive) was done on 17-Apr-2007. See related case(s): HQWYE721920APR07 (adverse event, non-expedited). No additional information was available at the time of this report.
I started experiencing pain in my calf on 4/21 that same night of the vaccination.  There was a tight feeling in my knee and every time I took a step with my right leg  there was pain that radiated down my calf. It almost felt like a  muscle pain so I ignored it for a few days. By 4/24 the pain had gotten so bad that I didn't want to walk anywhere and cried when I walked. My mom came and picked me up and took me to the  urgent care center. They asked me a few questions and told me that I needed to go to the ER to get checked for a blood clot. I went to hospital on 4/24, and an ultrasound of my knee was done. The doctor diagnosed me with a blood clot and told me to stop taking the Xulane which was my birth control at the time. They told me to follow up with my OBGYN and a hematologist. (I had been on my birth control for about 6 months and  I have never had any issues with blood clots and they do not run in my family. The NP is who told me to report my blood clot to the CDC because she is a little suspicious that the shot is where it come from.)
First dose in Left arm, but then sore shoulder on right arm. Second dose, week after dose diarrhea and vomiting, then pain in both shoulders after a few days, it is now five days after the second shot and I still have PAIN in both shoulders
time 1:30.  Symptoms include heart racing, feeling shaky. Treatment, 50 milligrams Benadryl PO time 135. Epinephrine injection. Emergency services called time 155. Vitals. Time 1:30 BP:120/90 Pulse: 135 respiratory rate: 24  Vitals. Time 1:35 BP:124/88 Pulse: 106 respiratory rate: 12  Vitals. Time 1:45 BP: Pulse: 127 respiratory rate: 30