chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient got initial dose and missed second dose, now is at day 21; Case reference number US-BN-2022-001169 is a spontaneous case report initially received on 01-Jun-2022 from other health professional (reference number: USBAV22-0255) and concerns a 19-year-old female patient.  The patient's medical history and concomitant medication details were not provided.  On 16-May-2022, the patient received the first dose of RabAvert (Rabies Virus (Inactivated, Strain Flury LEP), batch number were not provided), at an unknown dose and site of administration, at intramuscular route for pre exposure prophylaxis.   As reported, the patient missed their second dose and are now at a day 21. (Explicitly coded as 'missed dose').  At the time of this report, it was unknown whether the patient experienced any adverse events due to Rabavert vaccine.   Additional information received from Bavarian Nordic on 03-Jun-2022 included local case ID.; Reporter's Comments: A 19-year-old female patient missed the second dose after the patient received the first dose of RabAvert for pre exposure prophylaxis, which is considered as product dose omission issue. No associated adverse events have been reported with the reported medication error. Product dose omission issue is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product dose omission issue has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A 19-year-old female patient missed the second dose after the patient received the first dose of RabAvert for pre exposure prophylaxis, which is considered as product dose omission issue. No associated adverse events have been reported with the reported medication error. Product dose omission issue is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product dose omission issue has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Blisters; Hives extreme itchiness on left arm and toes , ankles and bottom of feet/ hives; Hives extreme itchiness on left arm and toes, ankles and bottom of feet./ Itchiness; This is a spontaneous report from a contactable consumer (patient). An adult female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 28Jul2021 at 18:00 (Lot Number: FA7484) as single dose for COVID-19 immunisation. Medical history included low vitamin D and estrogen levels. The patient reported known allergies to FLAGYL and as a child to raw shrimp shells. There were no concomitant medications. The patient reported hives, extreme itchiness on left arm and toes, ankles and bottom of feet. The shot was Wednesday evening. Hives, blisters, itchiness Saturday (on 31Jul2021 at 8:00). Saturday night took BENADRYL because itchiness was so bad. Since the vaccination the patient has not been tested for COVID-19. The patient outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Patient received the bivalent pfizer as her first dose in error, no adverse reactions noted from patient.
The day after I got my 2nd dose I woke up with a mild fever of 99.9 which came and went throughout the day and continued on and off for 3 days. During those 3 days, I had severe body aches and fatigue. I slept 16-18 hour nights and struggled to stay awake. I had hot and cold flashes throughout the evenings from the night of the vaccine and the 2 nights following that (3 nights total). I had a loss of appetite during those 3 days and on day 4 finally started to feel normal.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with doses of improperly stored VARIVAX (Merck) (dose, route, lot# and expiration date were not reported). No adverse events were reported. No PQC (product quality complaint) was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Severe bruising on right forearm, upper thighs on both right and left legs, back of knees on right and left legs and shins of both legs.
Pt went to ER on 7/25/01 AM, due to about a 2" area of redness and swelling to left thigh X 2 days, post vax.  Follow up on 10/25/2002: "From follow-up correspondence received on 09/11/01 it was reported the pt developed a 2 inch area of redness not a 72 inch area as previously reported.  The redness and swelling of the left thigh lasted for two days after the injection; it did not develop two days after the injection as previously reported.  The correct initial for the pt's last was also provided.  This case is closed."
Vaccine given at 1325. Patient stated after a couple minutes that he was feeling light headed and had tunnel vision.  1330 B/P 126/68 99%, HR 40. Laid patient down diaphoretic, 1335 B/P 110/62   % HR 48, 1340 122/70 HR 55, 1345 122/68 98% HR 56, Cal-Fire arrived evaluated, patient was feeling better by that point, he refused transport. He waited a bit longer before calling his fiancé to come pick up.
Breakthrough case admission after 3 vaccines ; Moderna 8/2/21 lot# 005C21A;  Moderna 8/31/21 lot# 033C21A;  Moderna 3/24/22 Lot# 033K212A
Flushing, sweating, dizziness, anxiety, head pain. Vitals wnl.
Soreness and pain, sometimes very sharp, in upper arm in area of injection since receiving first dose. Arm was still sore when second injection was received on 5/5/2021. Upper arm area around injection area is still very sore. Sharp pains are a constant. Pain makes a sound sleep almost impossible at night. Pain disrupts sleep and must put my arm above my head to help lesson the pain. I will be making an appointment to my primary health care provider in near future.
12 hours after vax till now (27 hours). Crushing body pain, fevers up to 101.6, severe headache, chills, nausea and insomnia
The day after I received the fifth vaccine, I developed light sensitive, migraines, vertigo, my eyes were jumping towards my vestibular nerve. I went to the doctor who referred me to a vestibular doctor, he put me through a serious of test where they watched where my eyes went when they do certain things. The test results showed my vestibular nerve had been irritated, and I had vestibular neuritis. I was prescribed two rounds of Methylprednisolone and a high dose of Prednisone, Doxycycline. In November I had and MRI that showed I had a partial empty Sella. I had an appointment with an ophthalmologist who did not find anything with my optic nerve. I had an angiogram that showed increase pressure on my brain. On April 17 I had a lumbar puncture that showed I have an opening pressure of 33. I am on Acetazolamide to help with the increased pressure on my brain.
developed "angioedema" at the injection site; developed "angioedema" at the injection site; This is a spontaneous report received from a non-contactable other healthcare professional. A patient of unknown age and gender received BNT162B2 (BNT162B2, Solution for injection, lot number and expiry date were not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  The patient previously received JUVEDERM VOLBELLA XC in the lips on an unspecified date. The healthcare professional reported a patient injection with an unknown number of syringes of JUVEDERM VOLBELLA XC in the lips. The patient was injected with the Pfizer COVID vaccine an unspecified amount of time later and developed "angioedema" at the injection site. Outcome of the event was recovered on an unspecified date.   No follow-up attempts are possible; information about lot/batch number cannot; Sender's Comments: Based on known safety profile, the contribution of the suspect drug to the onset of event angioedema cannot be excluded.
Entire upper arm red, hot and very firm to touch. Photo taken. Child afebrile & is able to move arm & play.
Information has been received from an RN concerning an 18 year old Caucasian male pt with no known allergies who on 15DEC2003 at 4:30 PM was vaccinated IM in the left deltoid with a dose of pneumococcal 23v polysaccharide vaccine. On 16DEC2003 in the am, post vaccination, the pt's arm was swollen, red and hurting. It was noted that the reaction was minimal.  There were no diagnostic laboratory tests performed. The outcome was recovered. Unspecified medical attention was sought. There was no product quality complaint involved. The reporter also mentioned the patient's father who was vaccinated with dose of pneumococcal 23v polysaccharide vaccine and experienced a similar reaction. No further info is expected.
No additional AE; Pharmacist called stating a patient received their 2nd MMR II dose only 2 weeks after the 1st dose. Caller stated the first dose was administered 7/14/2023 and the 2nd was administered 7/31/2023. Caller stated the patient has had no symptoms. No addi; This spontaneous report was received from a pharmacist concerning a 17-year-old male patient. No information on patient's medical history, current conditions and concomitant medications was provided.     On 14-JUL-2023 the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and the second dose was administered on 31-JUL-2023 (also reported as 2 weeks after) (Inappropriate schedule of product administration) (doses, routes of administration, anatomical locations, lot numbers, and expiry dates were not provided) as prophylaxis.  It was reported that the patient had no symptoms. No additional adverse event (AE) (no adverse event).
Sore arm on the second day; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6d07) via an unspecified route of administration in the left arm on 10Mar2021 at 16:30 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Mar2021 at 13:00, on the second day of vaccination, the patient experienced sore arm. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event sore arm was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Redness at injection site 4 days duration. Headache next day, fatigue 24 hrs.
Received Fluarix vaccine in (L) arm on 11/14. Next day he  developed redness and swelling around it. Office visit  on 11/16; Left upper arm red and swollen with  mild itching. No fever. No pain.  Treatment - Benadryl, Motrin, Cool pack
tested positive for Covid; feeling the initial COVID symptoms; nasal congestion; runny nose; fatigue; This is a spontaneous report from regulatory authority. A contactable Physician reported for a 45-Year-old female patient that: A 45-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on May2021 as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. Caller stated that the husband and wife got the vaccine, the second vaccine dose back in May2021, but got COVID this week, over the last week. Caller stated that the patient was basically says she was having Covid symptoms, so like nasal congestion, runny nose, not severe, not shortness of breath or chest pain, just mainly URI symptoms, fatigue, just feeling the initial COVID symptoms, not really severe, but having COVID symptoms. Caller stated that she knows the symptoms are still going on, the exact day she was unsure. Caller confirms all symptoms began sometime in July 2021 and is persisting. Caller stated that it was not serious from a medical standpoint. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. The outcome of the events was not recovered.  Information about lot/batch number has been requested.
On 11/16/2020 @ 745am mom called to report patient as experiencing pain and swelling around injection site, but also minor pain in chest and minor difficulty breathing (states patient was "running around like normal"). Mom wanted to know if this was normal after a flu vaccine, Advised pain and swelling at injection site was normal but breathing problems or pain in chest isn't and that the patient should follow up with pediatrician.
Two days post vax, pt was brought to hospital/clinic for decreased appetite/irritability. Then pt developed "respiratory distress." She was diagnosed with bacterial pneumonia and was hospitalized for 3 days. Then pt returned and was diagnosed with viral pneumonia. She had complications (partial collapsed lung) and was hospitalized for 3 days.
I had right upper quadrant pain radiating in my back. I was fairly severe. I went to the emergency room on January 31, 2021. They did an ultrasound and a Cat scan, and they diagnosed me with kidney cancer. I had to follow up with a urologist. I saw him on March 08, 2021, and had surgery around March 15, 2021, for a partial removal of the vaccine. I remained hospitalized for 1 day. I did not need to have any chemo or radiation. I was advised to follow up.  I am still having pain. Since October 2022 I have had uncontrollable stool and at times diarrhea. I have taken antibiotics and taken Imodium to slow the process. I had bloodwork done last Wednesday and I have an ultrasound scheduled for next week. The bloodwork indicated that my liver enzymes were elevated. I do not believe it is related to COVID-19 vaccination, but I wanted to report as I am questioning whether it is a gall bladder issue related to the vaccine.
Reporting breakthrough Covid 19 case  Started to feel sick on June 30th and tested positive on July 3rd via home test.    Body aches like similar to the flu - high fever about 5-6 degrees above normal - cough and stuffy head.  Pain in old injuries that are 40 years old and have not been an issue.
27SEP fever of 103 & lethargy; 29SEP irritability & inc heart rate, inc resp rate & fever;
This spontaneous report as received from a physician refers to a patient of unknown age. On an unkonwn date the patient was vaccinated with ZOSTAVAX (dose, route and lot# not reported). It was reported that the patient was having shingles on an unknown date. The outcome of the event was unknown. It was unknown whether the patient sought medical attention. Additional information has been requested.
Raised welt at injection site. Rash is raised (above and beneath the skin) itchy, red and warm to the touch.
My arm is hurting and have body aches. A bump formed in the area of the shot as well as a rash. The day after my vaccine I had a fever, and had to leave work early, and a continuous headache into today, the area is also tender to the touch, also newly developed pain in right breast under my armpit into my breast.
Family notes patient started to have issues controlling blood glucose levels, prior to day of event patient had syncope episodes. 7/21/2021 patient had sudden cardiac arrest.
At 12 hours through 16 hours after administration of the vaccine I experienced rigorous shivers, feeling freezing cold to the bone for hours and couldn't get warm (even with piles of blankets), periodic heart pain and some chest pressure, periodic knife like stabbing pain in my right knee, mild nausea, dizziness, lightheadedness, severe weakness, sometimes a cough.  At 16 hours I got up to get water and had to hold onto things to keep my balance. After drinking a couple of cups of water, I turned away from the bathroom sink and lost consciousness, fainting and falling onto my bathroom floor. The jolt of the fall woke me up and it took a lot of strength to get up. The symptoms were vicious. When I fainted, the brunt of my weight must of been on my upper left rib cage. My ribs were so sore for a week. It was difficult to walk, breath, blow my nose, or cough.  My health provider recommended a Tylenol regime for pain control so that I could take deep breaths and prevent pneumonia. I had a low grade fever of 99 degrees F for one to two days following the vaccine. During the week that followed I felt periodically very ill, had a constant headache for a day or two, and had extremely foggy thinking and sometimes confusion.  I was very fatigued all week long. I lost my appetite and have still not gained my typical appetite back. Day 8 to 9 is when I was finally feeling closer to normal. Today I feel I may be back to 100%, but my rib cage is still healing, either from a contusion, fracture, or break (likely a contusion).
Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Mild, Systemic: Nausea-Severe, Systemic: Vomiting-Severe
Vaccine expired on 11/27/22 and was administered on 12/30/22, no adverse reactions, medical provider notified
tiredness; tender arm; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (tender arm) and FATIGUE (tiredness) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     Concurrent medical conditions included Cancer.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced TENDERNESS (tender arm). On an unknown date, the patient experienced FATIGUE (tiredness). On 28-Jan-2021, TENDERNESS (tender arm) had resolved. At the time of the report, FATIGUE (tiredness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-016013 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Event added , relevant history added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-016013:Crosslinked (MOD21-020670)
SWOLLEN, HARD, RED, AND ITCHY UPPER ARMS. SPREAD TO RIGHT BACK AND RIGHT HAND. PT TOOK BENADRYL AND TYLENOL ON 5/16/17 AND WENT TO SEE DR ON 5/18/17. DR PRESCRIBED PREDNISONE AND CETIRIZINE.
Information has been received from a pharmacist concerning a consumer's female friend, who on an unknown date, was vaccinated with a dose of ZOSTAVAX (Merck) (dose, route and lot number not reported). It was reported that the patient was diagnosed with an unspecified type of cancer on an unspecified date shortly after the vaccination with ZOSTAVAX (Merck). It was also reported that the patient died six months after she was diagnosed with cancer. It was reported that the cancer was not a congenital anomaly. At the time of the report, the cause of the patient's death is unknown. Additional information has been requested.
Pt. presented to hospital emergency dept. 4 hour after flu vaccine with red rash on trunk, arms and legs. Treated and released.
positive covid test before 14 days after vaccination Narrative: admitted with covid like sx and positive covid test less than 14 days after completing vaccination series
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2), on 06May2022 as dose 4 (booster), single (Lot number: F54989) at the age of 62 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "GERD" (unspecified if ongoing); "allergies" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "type 2 diabetes" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Jul2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19  included Paxlovid from 24Jun2022 to 28Jun2022.
2 years old and given all 5 doses( 5th dose is given only after 4.5 year with no reported adverse event; Initial information received on 02-Sep-2022 regarding an unsolicited valid non-serious case received from a consumer/non-HCP.  This case involves a 2 years old female patient who was given all 5 doses ( 5th dose is given only after 4.5 year) of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (dose, formulation, brand name, batch lot : unknown) produced by unknown manufacturer via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date the patient developed a non-serious event of "2 years old and given all 5 doses( 5th dose is given only after 4.5 year) with no reported adverse event (inappropriate schedule of product administration) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
admit for blood in stool,  hgb 5.6; recevied 2 untis PRBC; COVID + - not symptomatic; EGD done - no bleeding found; colonoscopy done - no bleeding found,  3 rubber band ligations done.  no treatment for COVID.