chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PATIENT AWOKE THE DAY AFTER RECEIVING VACCINE, WITH NAUSEA, WORSENING OF RINGING IN THE EAR, VISUAL CHANGES AND A COLD SWEAT. HE ATTEMPTED TO GET OUT OF BED AND FELT LIKE HE WAS LOSING CONSCIOUSNESS  AND MUSCLE COORDINATION. HE REPORTED CALLING A FRIEND TO COME OVER TO HELP HIM. HE CALLED THE LOCAL MINOR EMERGENCY CENTER AND WAS REFFERED BACK TO WHERE HE WAS VACCINATED. I ASKED HIM TO PLEASE REPORT TO THE ER TO BE CHECKED BY A PHYSICIAN DUE TO PATIENT NOT HAVING A PRIMARY CARE DR. I REQUESTED THE PATIENT TO PLEASE REPORT BACK TO OUR PHARMACY AFTER BEING EVALUATED BY A DR.
This non-valid spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. The patient's concurrent condition, medical history, drug reactions and allergies were not reported. The patient's concomitant medication included sterile diluent (MRK INJ). On 29-MAR-2018, the patient was vaccinated with VARIVAX (dose, units and frequency not reported) (lot # N014368, expiration date: 09-MAY-2019), intramuscularly. No adverse events were reported. No product quality complaint was reported. This is a non-valid spontaneous report due to lack of patient identifiers. Follow up information has been received on 10-APR-2018 from an other reporter concerning the 36 year old male patient. The patient's concomitant therapy also included hepatitis B virus vaccine (unspecified). The patient had no pre-existing physician-diagnosed allergies, birth defects or medical history. On 39-MAR-2018, the patient was vaccinated with his second dose of VARIVAX (previous dose reported as 1)(right arm, lot# reported as NO14368 which was invalid) by intramuscular instead of subcutaneous. There was no treatment performed. There was no illness at time of vaccination.
Rash noted this morning by mother - first noted on left thigh spreading to trunk, forearms and head getting more spots as day goes on. Child fussy, with high temp. Per M.D. BENADRYL 2.5 mg/5 ml-3ml given. PRELONE 15 mg/5 ml-2 ml's given po.
SkinRash & CoughWheeze Narrative:  Patient with small rash on neck, Dr. in to evaluate, patient given 17:00 Benadryl 50mg PO , patient at 1730 having wheezing, congestion take to ER by nurse pules ox 97% breathing unlabored
Increasing resting heart rate over 4 month period.  2 months into this increase I went into atrial fibrillation on 7/5/21.   On 7/7/21, I reverted back into normal rhythm without external help.  Still feeling fatigue, slight dizziness, and increased heart rate as of today 10/8/21.
HYPOXEMIA 4/1/2023 ATRIAL FIBRILLATION, UNSPECIFIED
patient complained of itching and red rash on shoulder and ankle. The rash has gotten better however. Some is still lingering.
Redness and soreness at injection site and posterior aspect of left upper arm and occurring 24 hours after vaccine.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Apr2021 as dose 1, single (Lot number: ER8731) and on 14Nov2021 as dose 2, single (Lot number: FH8030) at the age of 49 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13May2022) Positive, notes: antigen test positive on day 5 and 6; (14May2022) Positive, notes: antigen test positive on day 5 and 6; (15May2022) Negative, notes: negative on day 7 and 8; (16May2022) Negative, notes: negative on day 7 and 8; (18May2022) Positive, notes: positive on day 10 and 11; (19May2022) Positive, notes: positive on day 10 and 11; (unspecified date) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course :Adverse event: After finishing 5 day Paxlovid, antigen test positive on day 5 and 6, negative on day 7 and 8. No test on day 9. Positive on day 10 and 11.
Every started with a sudden fainting on a normal day, later called syncope non known cause on 11/30/2021. After that. Numerous studies were done, turned out in January 2022 I was having a 50% lung capacity. Started on inhalers (never before had any breathing problems, neither had covid confirmed by antigen tests, neither family history). None life changes were made before,  eating clean, working out and walking at least 4 days a week, sleeping 8+ hrs daily, working, functional. None after 11/30/2021. No diagnosis yet. Started having heart palpitation in February 2022, really hard beats, was having extreme difficulties walking,  breathing, sleeping due to lack of air and weakness due to heart beats and horrible chest pain. Normal pressure, just 150+ heart beats per minutes. Severe emergency rooms visits. Left current location and moved as emergency to Homeland. A cardiologist finally sees me and after evaluations also with a electrofisologist, metoprolo succinate was the prescription given to me, currently taking 2x daily 25mg each pill (a person who was totally healthy before on a heart pill). This mix with inhalers -Flovent and Levalbuterol which my body does not tolerate either, probably because it wasn't made for my original body/cells affected now by the vaccines. I've lost over 20 pounds too, the doctors trying to fixed the chest pain prescribed me with Naproxen 1000mg daily which also caused gastritis and didn't resolved anything. All of a sudden also started having my feet numbs and eventually my hands, now diagnosed with Rheumatoid arthritis, yes a complete healthy person before the vaccine now has heart, lung, joint and mobility issues. The medication prescribed is methotrexate.
Subsequent to receiving one dose of varicella virus vaccine live the patient began to act peculiar. He experienced blank stares and tremors. It was reported that the pt may have experienced a seizure. The symptoms subsided and he appears to be back to normal. The pt sought unspecified medical attention. Follow up information reported that the pt also experienced decreased playfulness and activity, increased sleep, decreased appetite and no fever documented.
I did not have a reaction to the vaccine. I started feeling symptoms on 06/28/2022 with feeling very tired and achy. I tested positive for COVID-19 the second time on 06/29/2022.  I tested positive for COVID-19 the first time on 12/03/2021.  I never had a fever nor lost my sense of taste or smell with either infection. I have long COVID-19 and a terrible cough.
Initial report was received from a consumer, who was also the patient's parent, on 19 June 2013. A 15-year-old female patient received an intramuscular injection of MENACTRA (lot number and site not reported) on 18 June 2013 at 5:45 PM. At 11 PM, the patient got out of bed due to stomach pain and felt as if she needed to have a bowel movement. Once she returned from the bathroom, she began feeling dizzy and fainted. The reporter stated she lost consciousness for a little over one minute. After fainting spell, the patient had two more episodes of feeling faint and was listless. She fell asleep at 12:30 AM. The patient had no illness at the time of vaccination and a history of fainting and abdominal pain. Outcome was reported as recovered. Documents held by sender: None.
Little nausea; Fever; This is a spontaneous report received from a contactable consumer (caregiver) via a Pfizer-sponsored program.   An 80-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: unknown), via an unspecified route of administration on 31Mar2021 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included gastrointestinal disorder and hospitalization from an unknown date and unknown if ongoing (patient was in hospital for Gastrointestinal issues, non-related to vaccine). The patient's concomitant medications were not reported. The patient previously took historical vaccine BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: unknown),  dose 1 via an unspecified date for covid-19 immunisation. On an unspecified date in 2021, the patient experienced little nausea and fever. The patient did not feel this before after taking the first dose. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This case was reported by a physician via sales rep and described the occurrence of anaphylactic reaction in a male patient who received BEXSERO. Concomitant products included MENACTRA. On an unknown date, the patient received the 1st dose of BEXSERO. On an unknown date, unknown after receiving BEXSERO, the patient experienced anaphylactic reaction (serious criteria GSK medically significant), blackout (serious criteria GSK medically significant), difficulty breathing and dizziness. On an unknown date, the outcome of the anaphylactic reaction, blackout, difficulty breathing and dizziness were unknown. The reporter considered the anaphylactic reaction, blackout, difficulty breathing and dizziness to be almost certainly related to BEXSERO. Additional details were reported as follows: The age at vaccination was not reported. The patient previously had a dose of MENACTRA with no adverse reaction. A GlaxoSmithKline (GSK) sales representative called in to report an adverse event. The patient received a dose of BEXSERO and experienced an anaphylactic reaction, described as trouble breathing, felt dizzy, and blacked out. The patient was seen in the emergency room the same day. The sales representative was unsure if the patient was admitted. The GSK notified date was documented as 8th September 2017, but it was unclear when this adverse event was initially reported to the sales representative. The patient was not being seen by reporting health care professional. This adverse event was reported to the doctor by a friend and then relayed to the sales representative.
T/C from pt c/o of muscle and joint pain all over had Td 2-4/03 8:45am. Aching by 4pm same day. No redness on swelling at site. Wonders if a reaction to Td states over 10 yrs since last Td. Was handling a horse when had was jammed against trailer hitch/skin on top of hand broken. Pt cleared wound-no signs of infection today: States she did cal PMD post injury and was referred for Tx. Hx of fibromyalgia and also had lung tumor removed 6/99. Never on chemo or medications, missed work lat night do to feeling ill.
Bexsero administered to patient who previously had Trumenba.; This case was reported by a other health professional via call center representative and described the occurrence of interchange of vaccine products in a 17-year-old male patient who received Men B NVS (Bexsero) (batch number ABXC05AA, expiry date 31st March 2023) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis and MENINGOCOCCAL B VACCINE (TRUMENBA) for prophylaxis.   On 8th June 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, the patient received TRUMENBA. On 8th June 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced interchange of vaccine products. On an unknown date, the outcome of the interchange of vaccine products was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 08-JUN-2022 Reporter's comment: The reporter stated that Bexsero was administered to a patient who previously had Trumenba. The reporter consented to follow up via postal. Additional Supportive Information: The patient was administered with Bexsero who previously had Trumenba which led to interchange of vaccine products.
The administering nurse, received a phone call on 10/10/2018 at approximately 9:30 p.m. from the child's father. He reported the child felt feverish and seizing. Nurse advised them to take the child to the ER immediately. Upon arrival at ER, he was reported with a temparature of 104 degrees (F) and following administration of antipyretics, the temperature went down 102 degrees (F). Client was sent home with a diagnosis of febrile seizures and oral thrush. Family was advised to alternate between Tylenol and Motrin every 6 hours. The morning of 10/11/2018, the father called nurse again and reported that the child had no further seizures and remains afebrile.
None known. FU: Per telephone f/u with nurse reporter, the preliminary COD is SIDS. This was confirmed by telephone f/u with the coroner. He related that the baby was found by in home caregiver swaddled in a blanket in the center of an adult bed and not breathing. She called 911 and EMTs transported infant to hospital where he was pronounced dead. An autopsy was done. Per telephone f/u with PCP vaccine provider he related the following: it was thought likely that the baby had arrested quite soem time before the caregiver found him. There were no apparent signs of trauma reported. The infant had appeared well at the time of his well baby check on 8/13/04. He had some previous problems with diarrhea and gad probably due to cow's milk, but this was apparently resolved or at least decreased with formula change On 8/23/04, the baby was brought in with what was later determined to be a viral illness. He'd reportedly had a recent truncal rash that had resolved prior to the actual appointment and also had fever up to 102 degrees. Blood cultures were negative after 5 days and more immediate blood work was such that antibiotics were not indicated. The child appeared alert and in no acute distress.  Nurse follow up on 11/16/04 states: "baby was more tired, had fever, and had decreased appetite on 8/23/04. Diagnosed with viral illness." - 11/16/04 Medical records reviewed. Pt had history of neonatal pneumonia and cellulitis at circumcision site. Later c/o mild regurgitation and gagging without vomiting, abdominal gas and loose stools. At time of AE the baby seemed more tired than usual and had decreased appetite. Blood culture was found to be negative for growth 5 days later. Diagnosis was viral illness. 12/1/04 Autopsy report confirms COD as SIDS.
little pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (little pain) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (little pain). At the time of the report, PAIN (little pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant drug was not reported. Treatment medication was not reported.  It was reported that patient had no event with Dose 2 and he was due for shingles, flu shot, and also interested in taking the booster shot.
Sudden onset dizziness. Continued light headedness through 11/6/21 - now resolved
101 fever for 36 hrs, joints pain, head aches, nausea, severe body aches, constipation, cough, disorientation.
Fever, chills, nausea, headache, soreness of arm/injection site x2+ days
Initial misuse report received from a healthcare professional on 19 April 2013. ACTHIB reconstituted with sterile water was administered to a patient (no information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
anxiety; scratched; She felt tired; she got a hive on her breast and the next day on her arms/hives on left breast; redness; This is a spontaneous report from a contactable consumer (patient). A 63-years-old female patient received bnt162b2 (BNT162B2,Solution for injection,Batch/Lot Number: EN6198,Expiry date was not reported), dose 1 via an unspecified route of administration, administered in Arm Right on 02Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included breast cancer from 2011 to an unknown date Verbatim: Breast cancer, blood pressure abnormal, lymphadenopathy,mastectomy from an unknown date and unknown if ongoing. On 16Mar2021 the patient experienced she got a hive on her breast and the next day on her arms/hives on left breast, redness, and on an unspecified date anxiety, scratched, felt tired. Patient stated that she had the first dose of the pfizer covid 19 vaccine on 02Mar2021. She stated that on Tuesday she got a hive on her breast and the next day on her arms. Shewanted to know if she should take benadryl. On Monday or Tuesday she had hives on her left breast. Later in the night it was not all over but it was on her breast.  She has had hives before and it scared her. It was gone the next morning but she had redness. She did some gardening yesterday and was scratched and had some redness. She is a breast cancer survivor. Her sister said she may have had a reaction to the vaccine. She can't use the left arm because she has no lymph nodes and has had a mastectomy. She was told she might have to use a leg to get the vaccine. She did call Pfizer to confirm the site that could be used. She has anxiety because she has to go Tuesday to get the second shot. The hives are gone. She does not have any itching. She used calamine lotion on it. Yesterday she had an area on her arm. It was definitely hives. She takes a medication for her blood pressure. She does not know what the name is. It starts with the letter C. Is that the same as a blood thinner. She can go to the see her doctor tomorrow if there is an issue. Therapeutic measures were taken as a result of she got a hive on her breast and the next day on her arms/hives on left breast (urticaria).The clinical outcome of the event urticaria was recovered with sequelae, redness with recovering and rest of all event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Five to ten minutes after Typhoid shot in left arm got numb, burning sensation and numbness went down to outer two fingers. Left eye and sinuses felt dried out with pressure. Left side of neck and upper back felt tight and painful. Left hip down to ankle had pain.
A non-serious spontaneous report of stomach ache and decreased appetite has been received from a consumer, patient's father, concerning a 42-month-old female subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The patient's past medical history and concomitant medications were not reported. The patient received FLUMIST on 16-Dec-2009. On 17-Dec-2009, the patient experienced stomach ache and decreased appetite. As of 19-Dec-2009, these events were still occurring.
swelling developed, looked like a chipmunk; swelling developed that got worse; tightness to lips; sensitivity; This spontaneous case was reported by a physician and describes the occurrence of SWELLING (swelling developed, looked like a chipmunk), CONDITION AGGRAVATED (swelling developed that got worse), LIP DISORDER (tightness to lips) and HYPERSENSITIVITY (sensitivity) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Skin cosmetic procedure (Filler injection with Restylane in "smoker's lines") on 01-Jun-2021.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWELLING (swelling developed, looked like a chipmunk), CONDITION AGGRAVATED (swelling developed that got worse), LIP DISORDER (tightness to lips) and HYPERSENSITIVITY (sensitivity). At the time of the report, SWELLING (swelling developed, looked like a chipmunk), CONDITION AGGRAVATED (swelling developed that got worse), LIP DISORDER (tightness to lips) and HYPERSENSITIVITY (sensitivity) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication use was not reported.
patient was given a duplicate vaccine of prevnar 20. pateint received. prevnar 20 ion 1/5/23 and 3/6/23
Patient with history of COVID vaccines who admitted to hospital with COVID detected PCR.  Provider d/c note:  "86 YO female with past medical history significant for CAD s/p CABGx2, aortic stenosis s/p AVR, arthritis, DM2 with neuropathy, HLD, hypertension, PVD, and renal artery stenosis, hx of UTIs, with baseline dementia, who presented to ED with progressive weakness and AMS that began 3-4 days ago. She reports that she was sick on the 12/22 from a respiratory infection likely bacteria because she was on antibiotics (unsure which one prescribed in the clinic), but did not require oxygen at home or hospitalization.  Since this infection she has not been the same. She has been more week, shaky, and confused. Daughter reports patient has been having loose stools. Denies any falls, recent travels, or sick contacts. She has not been eating and drinking since about Christmas time. She has not had anything to eat or drink today. Denies fever, chills, chest pain, shortness of breath or any other complaints.    Initial vitals were stable. Leukocytosis 15.4, elevated glucose, slight increase in Cr from baseline  0.8-1.0, and hyponatremia 130 were noted on labs. TSH significantly decrease <0.01, and free T4 elevated to 2.2. UA negative for infection, but has some hyaline casts. CT head with no acute findings. Per duaghter the patient cannot care for herself at home. She will be admitted to secure placement or establish home care as well as to be worked up and treated for thyroid and electrolyte abnormal labs.      Brief Summary of Hospital Stay: (Include Significant Findings and Invasive Procedures)  Patient was admitted to the medical service.  She was given IV hydration.  She was treated with insulin for her DM - metformin was held.  She was treatedly with methimazole, but this was discontinued.  She was considered for an ECF, but covid was positive.  Her activity level improved.  She was d/c home."
15 year old patient was given a dose of the Janssen covid vaccine. No symptoms were observed.  The age of the patient was as well as the date of birth was written on the screening sheet  The vaccinators would never  checked the name and date of birth of the patient being vaccinated.  It was always assumed that the name and date of birth was checked at the screening table where the age of the patient was determined.  The persons manning the front desk of the vaccination room would only check the name once.
nerve tingling/ pain in feet, lower legs, hands, forearms, lips, tongue, and face.
Every joint and muscle in my body physically hurt. My arm hurts significantly. Spiked a fever on 6/17/21 of 102.2
Information has been received from a physician concerning a 65 year old female with hypertension who on approximately 14-NOV-2007 six weeks ago was vaccinated with a dose of ZOSTAVAX. Concomitant drug therapy included ZYRTEC, BENICAR and PROZAC. On approximately 26-DEC-2007 the patient developed a rash across both sides of her left arm. The rash had no blisters and no pain, but was itchy. It was unknown whether medical attention was sought. The outcome was unknown. Additional information is not expected.