chrisvoncsefalvay/vaers-outcomes huggingface dataset:
factor 5 liden; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COAGULATION FACTOR V LEVEL ABNORMAL (non-serious), outcome "unknown", described as "factor 5 liden". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of coagulation factor v level abnormal.  Additional Information: The female patient received first dose at, she did not mention that she had factor 5 Liden and was on blood thinners.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
headache, sore throat, cough, fever, chills, and body aches for 3 days, starting 11/6/21.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 50-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 49 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 29Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), on 20Dec2020 as dose 1, single (Batch/Lot number: unknown) and on 11Jan2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Eosinophilic oesophagitis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Feb2023) Positive, notes: Rebound - tested positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Additional information: Paxlovid was used for COVID 19 Treatment from 12Feb2023 to 17Feb2023. Rebound - tested positive on 23Feb2023 after becoming symptomatic - headache, myalgias, congestion.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The efficacy of a vaccine varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect vaccines to the reported vaccination failure and COVID-19 cannot be ruled out.
Pt. had seizure for 2-3 minutes, 4 hrs. after vaccines. No previous hx. of seizures.
Swollen lymph nodes on right underarm; This is a spontaneous report from a contactable health care professional, the patient. A 22-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration on the right arm on 06May2021 at 11:00 (at the age of 22-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 other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8B1) via an unspecified route of administration in the right arm on 14Apr2021 at 11:00 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. On 07May2021 at 20:00, the patient experienced swollen lymph nodes on right underarm, 1 day after vaccine. The event did not result in a visit to the doctors or other healthcare professional office/clinic, and 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 swollen lymph nodes on right underarm was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Was given a flu shot and Shingles shot same day within minutes of each other. Patient's scalp on the left side was VERY sensitive to the touch.  Scalp painful to the touch.  Went on for several days with subsequent rash, then blisters in eye brows and scalp.  No treatment until Dr. appt on 11/01 amd 11/02/2011.
Information has been received concerning a female patient of unknown age. Patient's concurrent conditions, medical history and allergies were not reported. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose, route not reported). Concomitant medications were not provided. On an unknown date the patient sustained a reaction to her left arm after receiving the vaccine. The outcome of the event was not reported. The causality was not provided. Additional information has been requested.
pt recvd vax on 2APR93 & 9APR93 pt devel a fever of 101.4 which lasted 1 noc; 13APR93 devel a pinpoint rash on trunk & extremities;
Before 12 o'clock and within 30 minutes I started feeling achey,  the aches intensified all afternoon, followed by the chills, and by 4 o'clock I was wrapped up in  blankets on the couch. My hands were freezing cold and I was shaking uncontrollably.  At 5 o'clock while walking upstairs to bed, I became nauseated and began to pass out. I fell to the ground and kept my head down until the feeling passed.  My heart was racing and pounding. My husband helped to bed, my heart rate was 93 and it continued racing well into the evening. (my heart rate usually runs 60's) I continued feeling nauseated on/off during the evening. I was fine in the morning, just tired. Today, I am tired, however, I am fine.
Patient received a Shingrix vaccination on 3/28/19, and got rashes on her upper arm. The rash persisted and spread on her arm. Her physician told her to take 3 Cetirizine 10mg tablets three times daily for 1 week, and the rash became smaller, but is still present.
Patient received TWINRIX #1 and Influenza vaccines approximately 1535. At 1545, I was notified that patient was having SOB, cough, and was slightly diaphoretic. His cough and SOB persisted; at 1555 epinephrine 1:1000 0.3 mg given SQ RT upper arm. B/P 210/110, pulse 110. Patient remained alert and oriented. SOB decreased, but cough remained. Ambulance called to transport patient to ER for further evaluation and treatment. B/P was 200/100 at 1600, then 198/100 at 1605. Ambulance arrived around 1610 to transport patient. Patient remained alert and oriented throughout episode.
Nausea, severe vomiting from 5AM until 7:30AM, headache but no fever,  called DR. to ask for advice, slept a few hours, light meal of soup and drank light liquids then sleep again for several hours. Able again to eat light meal of soup and a sandwich. Sluggish all day with severe fatigue, stomach has very sore muscles from vomitting. Dr. suggested drinking fluids to stay hydrated and to go to ER if not able to keep down liquids, etc.
01/04/22 presents to ED for "worsening abdominal pain and high blood sugar". PMHx of "chronic pancreatitis"
On 6/4/00, the pt developed fever, chills, and a cough. On 6/12/00, he developed lower extremity weakness. On 6/14/00, he was admitted to the hospital and treated with IV immunoglobulins. Dx with Guillain-Barre Syndrome.
This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 3-year-old female patient who received FLULAVAL QUADRIVALENT 2017-2018 season) (batch number 7PL77, expiry date 31st May 2018) for prophylaxis. On an unknown date, the patient received FLULAVAL QUADRIVALENT 2017-2018 season. On an unknown date, unknown after receiving FLULAVAL QUADRIVALENT 2017-2018 season, the patient experienced injection site swelling, injection site warmth, injection site erythema and vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site swelling, injection site warmth and vaccine administered at inappropriate site were unknown and the outcome of the injection site erythema was recovered/resolved. It was unknown if the reporter considered the injection site swelling, injection site warmth and injection site erythema to be related to FLULAVAL QUADRIVALENT 2017-2018 season. Additional details were reported as follows: This case was reported by patient's father. The patient received flu vaccine on left thigh, which led to vaccine administered at inappropriate site. The patient got the flu vaccine last year (2017) and she had a severe reaction of a large red spot, swelling and warmth at the injection site. The reporter described the size of redness as that of a softball size and it lasted for 4 days. The reporter consented to follow up. The reporter didn't have the Healthcare Professional (HCP) information at time of the call, but was open to receiving the authorization form.
I was coughing a lot for probably a week. I was also wheezing. I actually had been hospitalized twice for the last month in a half. I was diagnosed with pneumonia the first time and exacerbation of asthma. I was hospitalized from 03/15/23 to 03/19/2023. I was home for a while and went back to the hospital on 04/04/23 and came on 04/09/23. This time the symptoms extreme cough, lethargy, shortness of breath. This was not the same as before this time I was diagnosed with Human Metapneumovirus. I was given supportive treatment with IV steroids and seen by a pulmonologist along with breathing treatments. Today I still have coughing, but it has improved and controlled with medication. I am very tired. I could sleep 24 hours a day. I didn't realize I had such a problem with asthma this was a surprise to me.
Dizziness, abdominal cramps due to mentrual cycle. Vitals wnl. Crackers, orange juice given.
9am-lighted headed, loss of appetite  11am- 3pm- high fever 103.4, achy, nauseous, loss of appetite, arm soreness 3pm-9pm- arm soreness, lack of appetite, dizzy
Flushed; This is a spontaneous report from a contactable other healthcare professional (patient). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 07Jan2021 20:00 at a single dose for COVID-19 immunization. Medical history included HTN and pericarditis. Concomitant medication included valsartan, spironolactone, amlodipine, desvenlafaxine succinate (PRISTIQ) and ascorbic acid (C 1000). The patient experienced flushed on 08Jan2021 at 19:00. No treatment was received for the adverse event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. There were no known allergies. No allergies to medications, food, or other products. Outcome of the event was not recovered.   Information about batch/lot number has been requested.
The 13 year old male patient came to clinic on 1.26.2022  (with his parents) for his second Pfizer vaccination. The patient is 13 years old and I noted on the vaccine record card that it indicated a pediatric Pfizer lot number (FK5618) recorded given as first dose on 01.05.2022. The vaccine was pulled from storage and it concurred with the vaccine record card that Pediatric Pfizer Lot # was administered as first dose on 01.05.2022. However the system shows the data as being altered to 59276-1055-1 (pediatric lot #) and another source shows the Lot as FK5618 and the as 59267-1000-01(which is pediatric lot # and the adult Pfizer.    I did not administer a second vaccine at this time and explained to the parents that an error had occurred and that I would have report it and await direction from my supervisors for further appropriate dosing and that we would contact them in due course with a resolution.  The error was reported via e mail to my supervisors the same day.
Myalgias - low back, legs Arhtralgias - hips, knees Nausea UPper abdominal pain Fatiigue Weakenss Symptoms were severe and lasted 24 hours, not totally gone then but almost. Treatment - acetaminophen - frequent, antacids - famotidine, Mylanta, Pepto Bismol, ondansetron, electric blanket
Patient received vaccine 12/4/06-noted in evening site warm to touch with redden lines. Seen in office at 0930 12/5/06. Treated with Penicillin, warm compresses follow up appointment 12/6/06.
Janssen COVID-19 Vaccine EUA Headache, soreness, whole body muscle aches, fatigue
Day after received vaccine at 2 month well child check mom reports infant extremly fussy and intermittently inconsolable.  Family called  office to report tempature of 94 degrees and were instructed to retake temp with new thermometer.  Per mom report infant temp remained at 94 and infant remained fussy although eating well and waking  to feeding.  No blood in stool noted.  Infant seen in the office 05/22/2019 for "possible reflux".  Infant noted to be gray, mottled, hypothermic (t= 94) , bradycardic (HR= 70s) and hypotensive (BP= 51/30).  Infant sent to the ER for further treatment and work up.
Patient presented for the outpatient procedure of a cataract extraction.  Found to be hypertensive and very short of breath.  Sent to primary care physicians office who in turn ordered a CT scan. Found to have Pulmonary Embolism and Deep Vein Thrombosis
56 year age of patient receive Fluzone High Dose/ no AE; 56 year age of patient receive Fluzone High Dose/ no AE; Initial information received on 17-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 56 years old female patient who received vaccine 0.5 ml INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot UJ238AA (Expiry date 14-Apr-2020) via intramuscular route in the right deltoid on 07-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history and concomitant therapies were not provided.  It was an actual medication error case due to inappropriate age at vaccine administration and overdose.  It was reported that patient who is 56 years of age received the Fluzone HD.  The patient did not experience any adverse reaction.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.  List of documents held by sender: none.
Tenderness, lump and itch formed at injection penetration site several days after the initial shot. Remains after several days
extremely cold; I felt weak; Feeling hot; nauseated; still feel tired and weak; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), NASOPHARYNGITIS (extremely cold), ASTHENIA (I felt weak), FEELING HOT (Feeling hot) and NAUSEA (nauseated) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE, CALCIUM and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 08-Mar-2021, the patient experienced NASOPHARYNGITIS (extremely cold), ASTHENIA (I felt weak), FEELING HOT (Feeling hot), NAUSEA (nauseated) and FATIGUE (still feel tired and weak). On 08-Feb-2021, PAIN IN EXTREMITY (sore arm) had resolved. On 08-Mar-2021, NASOPHARYNGITIS (extremely cold), ASTHENIA (I felt weak), FEELING HOT (Feeling hot) and NAUSEA (nauseated) had resolved. At the time of the report, FATIGUE (still feel tired and weak) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment include Hydration Fluids, Tylenol and Aspirin. Patient was also taken to emergency department on 08-Mar-2021 and left same day. Concomitant medication included senior vitamin.   This case was linked to MOD-2021-044677 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: TCR
UTI; This case was reported by a pharmacist via call center representative and described the occurrence of recurrent urinary tract infection in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th February 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced recurrent urinary tract infection. The patient was treated with antibiotics nos. On an unknown date, the outcome of the recurrent urinary tract infection was unknown.   The reporter considered the recurrent urinary tract infection to be unrelated to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had experienced recurrent urinary tract infection and had been off and on antibiotics, so she had not yet received the 2nd dose of the Shingrix series. The pharmacist stated that the urinary tract infection was unrelated to the Shingrix vaccine. The reporter consented to follow up. No further patient details were provided by pharmacist on the call, though she did grant permission to follow up. She reiterated the urinary tract infection was not related to the Shingrix.
Knee pain; Headache; Arm and Forehead Tingling; Room spinning; This is a spontaneous report received from a non-contactable consumer, the patient. A 57-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: er2613), via an unspecified route of administration on 22Mar2021 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 23Mar2021, the patient experienced room spinning, knee pain, headache, arm and forehead tingling. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events room spinning, knee pain, headache, arm and forehead tingling were not recovered.   No follow-up attempts are needed. No further information is expected.
This is a spontaneous report from a contactable consumer who reported for his/her mother. An 83-year-old female patient started to receive PREVNAR 13, via an unspecified route of administration at single dose on 05Apr2017 for immunisation. The patient received it is one time every 10 years on the left arm. Medical history included hypothyroidism and diuretic. Concomitant medication included SYNTHROID at 0.088 ug 1x/day from an unspecified date and ongoing for hypothyroidism, hydrochlorothiazide (HCTZ) at 25 mg 1x/day from an unspecified date and ongoing for diuretic. The patient experienced arms swelled up and got real hard knot on 09Apr2017 with outcome of recovering, arms, itching in the arm and she keeps having itching spots here and there on 09Apr2017 with outcome of not recovered, diarrhea on 09Apr2017 with outcome of recovered, fatigue on 09Apr2017 with outcome of unknown, she has been miserable for the last 3 weeks on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included blood test on unknown date. Reporter stated that no treatment was taken.
12/31/20 developed headache, some blurry vision, nausea and splotchy rash.  Took Benadryl around 2100 and went to sleep.  Woke up with tongue swelling and difficulty speaking, decided to go to emergency room on 1/1/21.  When she first presented she had significant swelling noted to her tongue.  SoluMedrol IV, Pepcid IV, and Benadryl IV given in ED.  Also administered 0.3 mg Epinephrine.  Discharged with Pepcid and Prednisone for 3 days and Benadryl prn
itching; Muscle spasms; body aches; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching), MUSCLE SPASMS (Muscle spasms), PAIN (body aches) and FATIGUE (fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 09L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-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 PRURITUS (itching), MUSCLE SPASMS (Muscle spasms), PAIN (body aches) and FATIGUE (fatigue). At the time of the report, PRURITUS (itching), MUSCLE SPASMS (Muscle spasms), PAIN (body aches) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-022474, US-MODERNATX, INC.-MOD-2021-047944 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-047944:Crosslinked (MOD21-018111) US-MODERNATX, INC.-MOD-2021-022474:Crosslinked (MOD21-018111)
four straight days of moderate flu-like symptoms; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on 21Mar2021 at 16:30 (age at vaccination 52-years-old) in the left arm as a single dose for COVID-19 immunisation. The patient had no medical history reported. The patient had no allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. Concomitant medications included losartan (MANUFACTURER UNKNOWN) at a dose of 25mg per day taken for unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Mar2021 at 06:00 since the vaccination, the patient experienced moderate flu-like symptoms for four straight days of moderate flu-like symptoms, minus fever. On the fifth day (26Mar2021) of reporting also he does not know how much these symptoms will be longer and persists. The events did not result in doctor or other healthcare professional office/clinic visits, and the emergency room/department or urgent care. The patient did not receive any treatment for the adverse events. The clinical outcome of the events of flu-like symptoms was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.