chrisvoncsefalvay/vaers-outcomes huggingface dataset:
CLOTS; This spontaneous report received from a consumer via social media via a company representative concerned two female patients of unspecified race and ethnicity. The patient's height, and weight were not reported. No past medical histories or concurrent conditions were reported. The patient's received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown expiry: Unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch numbers were not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, two patients developed clots. As per the reporter "uncle and two sisters have clots." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcomes for the two patients of clots was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20211009150.; Sender's Comments: V0: 20211009238-covid-19 vaccine ad26.cov2.s-Clots. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
father got up @ 3-4Am for work, child fine, given formula;mom woke @ 530, child dead;autopsy report not recv as to 23OCT98;heart disease felt to be significant probable cause of death;
Viral syndrome, aching, fever, tachycardia, progressive red rash on upper legs bilaterally, spreading to abdomen and buttocks, spreading up sides to underarms, very painful.
pt recv vax & w/in hr pt devel inconsolable crying which cont for more than 3hr;this is 2nd of 3 pt who devel inconsolable crying p/vax;
Pt recvd vax & 2 days post vax rt eye began to burn; could not blink the eye; kept biting tongue; rt side of mouth was numb; could not chew on the side; dx Bell's Palsy;
Headache, all muscles and major joints aching, continued at least 2 days, 3rd day still achy, some headache.
Recurring fever, chills, cold sweats, body pain / soreness, massive headache, constant discomfort, lethargy
After the 2nd dose he says that he lost all hair from his body and it has not grown it back/by 3Apr2021 he was bald everywhere; This spontaneous case was reported by a patient and describes the occurrence of ALOPECIA (After the 2nd dose he says that he lost all hair from his body and it has not grown it back/by 3Apr2021 he was bald everywhere) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced ALOPECIA (After the 2nd dose he says that he lost all hair from his body and it has not grown it back/by 3Apr2021 he was bald everywhere). At the time of the report, ALOPECIA (After the 2nd dose he says that he lost all hair from his body and it has not grown it back/by 3Apr2021 he was bald everywhere) had not resolved.            No concomitant medications were reported.  Patient reported that, he has not had COVID and that he had seen doctors for loss of hair but had not been given a diagnosis.  No treatment medications were reported.
Patient c/o Right neck pain and bilateral pain in thighs, "hard to get out of bed in the a.m. at first but then the pain goes away."  Getting a little better, but now my neck right side is stiff/sore and only my right thigh is sore."   c/o feeling fatigued and achy as well.N/A
Two separate incidents of nose bleeding 2 days after vaccination on 3/6/2021 which was unusual as I had not have any nose bleeding in many years. My husband did an organ harvest on a patient who died of extensive internal bleeding following his 2nd dose of Pfizer COVID-19 vaccine. a few days ago. This made me connect my unusual nose bleeding  to my recent vaccination. Besides this, I experienced ?usual? side effects of fever on the night of vaccination (3/4/21) and chills/fatigue all day next day (3/5/21).
Patient developed flu-like symptoms the day after vaccine administration. Patient developed painful upper arm under administration, which turned into a red, swollen rash. She is icing area and taking BENADRYL.
Left Eye twitching chronic since day or vaccine Occasional left lip twitching  this issue continues currently   First week after 2nd dose I had a severe migraine for 7 days, chills and body aches, and a very early menstral cycle with black clotting and heavy flow (I haven?t had a bloody cycle in over 6 years since my ablation, this we the worst cycle with bleeding I?ve experienced - similar to having a miscarriage with pain and bleeding)
Cough, weakness, dizziness, fatigue, diaphoresis. Onset Sx shortly after immunization given (per pt hx). Sx all consistent with hypersensitivity to vaccine.
Ten days post vax, the pt developed a slight case of chickenpox. The pt did not receive a 2nd dose of varicella virus vaccine live. The pt sought unspecified medical attention. Additional information has been requested.
Face Warm; Face was beet red/big bright red streak on left side of face; This is a spontaneous report from a contactable consumer (patient).   A 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number: EN6206), via an unspecified route of administration, administered in left arm on 03Mar2021 08:30 (at the age of 75-years-old) as dose 2, single for covid-19 immunization.  The patient medical history was not reported. Concomitant medication included hydrocortisone acetate (CORTISONE [HYDROCORTISONE ACETATE]) taken on 02Mar2021. Patient historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE , lot number: unknown) via unspecified route administered on 11FEB2021; 8:25 as dose 1, single for covid-19 immunization. Prior to vaccination, the patient did not receive any other vaccines within 4 weeks. On the day of second dose, at 18:00, patient looked in mirror and her face was beet red. She states that she didn't know what to do, she would normally say it was allergic reaction and take Benadryl but she did not do that, she took 2 Tylenol as treatment. She went to bed at 11:00 pm and her face was still red and she thought she would give it time. When she woke up next day morning, the right side of her face cleared up and left side of her face, which was same side that she had vaccine on, the area was smaller but still a big bright red streak and its warm. She states that she was feeling fine and wants to know if this was an allergic reaction and is she still protected by the vaccine. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected
mom woke up 7am 8/17/99 hearing child gag;child would not respond to name;eyes wee open & looking to rt;father dressed child & he began to shake;taken to hosp & observed x2 days;mom states child did not have a fever;
Information has been received from a certified medical assistant concerning her 9 year old daughter who in January 1997 was vaccinated with a dose of varicella virus vaccine live.  On 02/02/2005, the patient developed about 8 chickenpox lesions.  According to the patients school nurse, there were two children in the patient's class that were never vaccinated with varicella virus vaccine live and contracted wild chickenpox.  The rest of the class that was vaccinated did not develop any lesions to date.  Unspecified medical attention was sought.  At the time of the report, the patient was recovering.  A product quality complaint was not involved.  Additional information has been requested.
Pt vaccinated with DTP developed screamed & cried for 5 hr; 2 seizures; temp 105; extreme localized swelling w/disoloration dx w/pertussis 7OCT90.
Information has been received through the manufacturer pregnancy registry from a physician concerning a 15 year old healthy female (who has had regular menstrual periods in the past) who was vaccinated SC with a 0.5 mL dose of Varivax. The pt had indicated that her LMP was on approximately 15-SEP-2005. The same day of vaccination, in September 2005, the physician did a pregnancy test, which came back positive. The physician noted that it was too soon to tell how far along in the gestation the pt was, or even what the pt will do about the pregnancy. Unspecified medical attention was sought. No further information was available. There was no product quality complaint. Follow up information indicated that the pt had an elective termination in October 2005, one month after finding out she was pregnant. The elective termination was considered to be an other important medical event (OMIC). No additional information is expected.
A few minutes after the vaccine, she had mild tongue swelling.  It only lasted a few minutes, and then she felt fine.  However, her BP went up.  I'm not sure how high.  she then has a short run of asymptomatic V tach.  Taken to hospital observed overnight.  No further events or problems.
Patient passed out about 3-5 min after getting shot. He regained consciousness within a minute or sooner. He was disoriented. His arms and body stiffened when he was out, but I dont think it was a seizure. We called emergency services.
Generalized weakness, body aches, chills, nausea. Swelling at injection site with redness, soreness, pain and warmth. PCP diagnosed me with cellulitis at injection site.
INFLAMMATION; MILD TIGHTNESS IN THE CHEST; LEFT SHOULDER AND ELBOW LIT UP, INJURED ARM (LEFT ARM) FLARED UP, ARM LOCKED AFTER VACCINATION; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included arm injury, got close-lined on shoulder, and concurrent conditions included type 1 diabetes, high cholesterol, and cow-milk lactic acid allergy, and other pre-existing medical conditions included the patient had no unknown drug allegies. he was on blood thinners.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included metformin for type 1 diabetes. On 27-MAR-2021, the subject experienced left shoulder and elbow lit up, injured arm (left arm) flared up, arm locked after vaccination. On APR-2021, the subject experienced mild tightness in the chest. Treatment medications included: cortisone. On an unspecified date, the subject experienced inflammation. Laboratory data (dates unspecified) included: PSA test (NR: not provided) Results unspecified. Additional treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the left shoulder and elbow lit up, injured arm (left arm) flared up, arm locked after vaccination, mild tightness in the chest and inflammation was not reported. This report was non-serious.
Chills, body aches, low-grade fever and headache a couple of weeks later. Everything smells like smoke.
I started my menstrual cycle about 10 days earlier than I should have, on day 20 of my last cycle. I am currently trying to conceive and am concerned that this may have affected or interfered with implantation.
COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Chronic lymphocytic leukemia (Indolent) and Pollen allergy.    On 08-Feb-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2022, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Patient felt like she had a cold by the end of the week patient was fine.
After I received my first vaccine I stopped having periods completely. I didn?t not have a period at all until may when I found out I was 7 weeks pregnant. But before becoming pregnant, December 2020-April 2021, I never had a period. I had very regularly periods before the vaccine. I also developed acne and hair loss, that still has not resolved.
Mom was at clinic with sister. Stated child had seizures with last shots and didn't realize she needed to tell us. Had low grade temp the evening of the shots. At 48 hrs temp went to 103 and began having seizures. Ambulance took child to ER. Fever got to 104. Mom states she was giving Tylenol but it was not working. PMO stated the episode was related to IZ's.
First dose of Jynneos was administered intradermally; Case reference number US-BN-2022-003327 is a spontaneous case report initially received from a nurse via Company (reference number: USBAV22-1514) on 23-Sep-2022 and concerns a patient of unknown demographics.   The patient's medical history included keloids.  The patient's concomitant medication details were not provided.  On an unspecified day, the patient was vaccinated with the first dose of Jynneos (smallpox and monkeypox vaccine, live, nonreplicating; batch number: not provided), administered intradermally, at an unknown dose or site of administration, for monkeypox prophylaxis (explicitly coded as 'intradermal injection').   At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos.   Additional information received from Bavarian Nordic on 04-Oct-2022 included the local BN case ID.  This case is linked to cases US-BN-2022-003325, US-BN-2022-003326 and US-BN-2022-003328 (same reporter).; Reporter's Comments: A patient of unknown demographics was vaccinated with the first dose of Jynneos, administered intradermally. Intradermal injection is listed by convention. No associated adverse events have been reported. Intradermal injection has been considered not related to the suspect product, but to a human action. The case is non-serious.; Sender's Comments: A patient of unknown demographics was vaccinated with the first dose of Jynneos, administered intradermally. Intradermal injection is listed by convention. No associated adverse events have been reported. Intradermal injection has been considered not related to the suspect product, but to a human action. The case is non-serious.
Client given full vial of undiluted vaccine. When called about 2 hours later, stated was not experiencing any side effects as of yet
The day after her vaccines pts arm became very sore and it has not improved. She has trouble lifting her arm and needs help to get dressed. Doctor recommend ice and gentle ROM exercises. A sample of LIDODERM patch was given and Rx was prescribed for her nausea.
Discharge Provider: MD Primary Care Physician at Discharge: MD  Admission Date: 8/14/2022   PRESENTING PROBLEM: Hyponatremia [E87.1] Sepsis (HCC) [A41.9] Severe sepsis (HCC) [A41.9, R65.20] AKI (acute kidney injury) (HCC) [N17.9] COVID-19 virus test result unknown [Z20.822]   HOSPITAL COURSE:   This is a 78 y.o. patient with a past medical history significant for Hepatocellular carcinoma, enrolled in a study; HTN, NICM, DM, persistent Afib, CAD, OSA, who presented to the ED with symptoms of fever, n/v and diarrhea, weakness and shortness of breath. In the ED he was afebrile. His lactic acid was elevated at 5.4, he received 4L IVF bolus in the ED. Blood cultures x 2 and UA obtained, and pt was treated with IV zosyn. Patient was admitted to the oncology service for further workup and treatment of sepsis with fevers.   During this admission, patient's initial infectious work up was negative though given persistent fevers, ID was consulted and ultimately ordered a Karius test 8/17/22 which was positive for EBV, CMV so patient was treated for viremia with gancyclovir though 8/27/22.  ID also felt patient had HLH, so that work up was initiated.  Dr. and ID did conclude patient developed checkpoint inhibitor (treatment) induced HLH given criteria met including but not limited to fevers, pancytopenia, BMBx on 8/24/22 with Hemophagocytosis, IL2 >29,000 and liver bx 8/26/22 consistent with HLH.  Patient was started on dex 10mg IV BID and then increased to 20mg IV BID which was suspected to have lead to encephalopathy and nightly dilerium.  Patient began to show progressive liver injury.  Immunology was consulted and was not convinced patient had HLH but did recommend IVIG BID started 8/26 and Anakinra TID, started 8/27 and cyclosporin started 8/29.  Unfortunately, patient continued to have liver failure and progressive decline.  Given no improvement in HLH, patient determined he did not want further care; however, he was deemed by then incompetent to make medical decisions and his daughter/DPOA was activated.  Patient/family decided to proceed with sign on plans for hospice.  In the meantime, while awaiting hospice placement, he was made comfort care overnight last night.  He passed aware today with daughters, partner and Hospice at bedside.       Patient was seen per nursing request as patient had expired.   Upon evaluation, patient was unresponsive with daughters at bedside.   Patient's pupils were fixed and nonreactive to light.  Patient was without heart or lung sounds upon ascultation.    Patient was without pulses x4 extremities.   Patient was pronounced as having expired today, 09/01/2022, at 1058.   Attending was notified.
20 hours after injection:  Injection site soreness Fever Night sweats Back pain Fatigue Migraine
Pt came to ER for jaundice on 2/23.  Seen in ED again on 2/27 for weakness and fatigue.
Patient reported a fever of 100.7 that began at 4am the morning following her vaccine.  Her temperature generally runs "low" so she said this was  relatively high for her.  It had been around this temperature for about two days at the time she reported to us.
More than 42 days and no 2nd shot; Not feeling good off and on; Achy off and on; Sick off and on; Tired off and on; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (More than 42 days and no 2nd shot), FEELING ABNORMAL (Not feeling good off and on), PAIN (Achy off and on), ILLNESS (Sick off and on) and FATIGUE (Tired off and on) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 immunisation.     The patient's past medical history included COVID-19 in January 2021.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced FEELING ABNORMAL (Not feeling good off and on), PAIN (Achy off and on), ILLNESS (Sick off and on) and FATIGUE (Tired off and on). On 12-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than 42 days and no 2nd shot). On 16-Apr-2021, FEELING ABNORMAL (Not feeling good off and on), PAIN (Achy off and on), ILLNESS (Sick off and on) and FATIGUE (Tired off and on) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (More than 42 days and no 2nd shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment information was unknown.
Breakthrough Case Received Pfizer with 1st dose on 02/19/2021 and 2nd dose on 03/12/2021.  Per ED Note: Patient is an 84-year-old man that presents the emergency department chief complaint of DIB.  Patient states over the course of the last 3 days he has experienced intermittent chest pain as well as DIB and fevers at home.  Patient states that he is Covid vaccinated from April.  Patient denies anyone else been sick at home.  Patient denies any histories of heart attacks or strokes.  Patient has 1-2 word dyspnea and unable to answer many more questions at this time.  History limited secondary to critical condition. Per H & P: 84-year-old male with history of smoker. Patient was seen in ER for complaints of difficulty breathing and was found to have COVID-19 infection. For the past 3 days prior to admission, patient reportedly had increasing difficulty breathing as well as chest pain and fevers at home. There was no report of any cough or sputum production. Patient reportedly had complaints of fever/chills but there were no reported other URI symptoms such as sore throat or sinus congestion and there were no known sick contacts or COVID-19 positive contacts. There was no reported loss of taste or smell. Patient reportedly had some chest discomfort but details were difficult to obtain because of respiratory distress and conversational dyspnea. There were no reported palpitations or diaphoresis. There was no report of any nausea/vomiting, abdominal pain or diarrhea. It is noted that patient's past medical history could not be obtained due to his critical condition but there was no report of any patient being on any medications at home. In ER, CXR showed bilateral parenchymal changes more pronounced on the left - most consistent with pneumonia. CT angiogram of the chest was negative for pulmonary emboli but it did show COPD with severe peripheral fibrotic markings and patchy and confluent ground-glass densities of the lungs are consistent with viral pneumonia - particularly COVID-19 pneumonitis. EKG showed supraventricular tachycardia with fusion complexes and nonspecific ST-T abnormalities but there were no acute ischemic changes. Labs were significant for leukocytosis with WBC = 17.81, elevated ProTime/INR = 14.8/1.25, elevated fibrinogen = 484, elevated D-dimer = 1230, elevated BUN = 28, hyponatremia with Na = 129, hypokalemia with K = 2.5, low albumin/elevated globulin = 3.2/3.9, elevated LDH = 275, elevated lactic acid = 2.7 and a positive COVID-19 PCR. Patient was admitted for COVID-19 infection / pneumonia / respiratory failure.
Immediately following the SHINGRIX injection, patient complained of pain at the injection site. Patient was advised to take TYLENOL to relieve symptoms. Six days following the injection on 5-29-18, the patient's daughter came to the pharmacy to explain her mother was experiencing continued pain, fever, loss of appetite, nausea, lethargy, and malaise. The pharmacist advised the patient to supplement her hydration with extra electrolytes to prevent dehydration and for the patient to seek further evaluation/treatment at urgent care. Two days later on 5-31-18 the patient's daughter returned to pharmacy again to report patient was feeling better. On June 17, 2018, a different daughter called the pharmacy to inform the staff that patient unfortunately passed away following a fall. The daughter did not give details to her mother's death, and she did not disclose to the pharmacist that the SHINGRIX vaccine contributed to her death.
Pt reported pain while getting the injection, and after (3/17). followed up on 3/18 still in pain. Also a fever and dizziness
Started with fever, extreme arm pain. By 24 hours after injection started to have hand numbness/tingling. By 36 hours after injection, started to have right side headache, muscle aches in right leg, soreness in back right side. Hand numbness/tingling worsened to the point of 48 hours after injection I could no longer use my hand to type on my computer.
Information has been received from a health care provider in a physician office concerning a patient who was vaccinated with ROTATEQ. The health care provided reported something about a "baby spitting up blood" and ROTATEQ. No additional information or details were provided. The patient sought unspecified medical attention. Further information has been requested.