chrisvoncsefalvay/vaers-outcomes huggingface dataset:
71-year-old male with history of lymphoma on chemotherapy and heart transplant in 2011 on immune suppressants presenting with fever, fatigue, cough, shortness of breath x4 days.  Patient is afebrile upon arrival with otherwise normal vital signs.  He did desaturate to 88% while at rest and was placed on 2 L nasal cannula.  He has clear breath sounds bilaterally without any focal findings.  Work of breathing is not increased and very stable in my opinion.  He appears clinically euvolemic and denies history of heart failure.  No wheezing warranting treatment beta agonist.  Patient will require admission given his acute respiratory insufficiency, will need to discuss appropriate Campus placement with the Heart Transplant Service and anticipate he will require transfer to Grand Rapids.  Given his reported dyspnea, EKG ordered.  Will obtain routine screening labs, COVID-19 swab.  With his reported fever, although not objectively present during this visit, and current immunocompromised state, will treat via the emergency department sepsis protocol and collect blood cultures.  Fri May 21, 2021 1059 EKG with a normal sinus rhythm, rate of 88 beats per minute, no acute ischemic changes are noted.  Patient has a right bundle-branch block.  EKG is unchanged from that of January 21, 2021. BNP is 404, no chest pain to warrant cardiac biomarkers.   [SR] 1113 COVID-19 is detected.   [SR] 1125 CMP was sodium of 128, chloride 95, glucose 303, creatinine 0.87.  Magnesium is 1.9.  Phosphorus 2.1.  Urinalysis with trace blood, no urinary tract infection.  Urinalysis without urinary tract infection.   [SR] 1147 INR subtherapeutic at 1.2.   [SR] 1149 Received a critical result from lab, white blood cell count is 0.04, patient is by definition therefore neutropenic.  Platelets are 21 K without reported active bleeding.  Hemoglobin is 9.3.  Have a call out to Oncology to discuss need for IV cefepime given the reported fevers at home although etiologies presumably viral with COVID-19 test.  Further, I do not know if IV Decadron is appropriate given his profound neutropenia, especially having recently finished a high-dose course of 100 mg prednisone orally x5 days.   [SR] 1150 CXR: Airspace opacities are seen involving both the lungs, more prominent in the right lung, as described above. These are likely due to consolidation/pneumonia. Viral pneumonia can also have similar appearance. Correlate clinically.    [SR] 1218 Discussed case with Dr. from transplant team who agreed with admission to his service .  He did recommend that I broaden his antibiotic regimen to include both IV vancomycin and IV cefepime.  He recommended that I do provided dose of IV Decadron despite the neutropenia to treat his acute respiratory failure secondary to COVID-19.  Still awaiting call back from Oncology.   [SR] 1454 After multiple pages, I have not been connected to Oncology.  Patient was transported by EMS.  He will need a formal oncology consult upon arrival to admitting facility.   [SR]
Per patient, the evening after dose 1 he developed throat discomfort, difficulty swallowing, and shortness of breath. The pain was moderate but main issue was difficulty swallowing. He did not seek medical attention but took tylenol. Symptoms self-resolved.
Client developed nausea and headache immediately following vaccine administration. symptoms completely resolved in 10 minutes and client was able to leave site with family after 30 minutes of observation.
After receiving the vaccine, that night I had a fever and body aches for 48 hours. At the end of that, I got diarrhea for most of 2 weeks, accompanied by abdominal pain and loss of appetite, and occasional nausea. On December 23, the pain was so bad that I wound up going to the ER, getting rehydrated, and getting pain medication and medication to stop the cramping. I had a CT scan with contrast, that showed nothing remarkable.   This is almost the same reaction I had after my second dose (which was Moderna) in March of 2021. I had over a week of severe diarrhea and abdominal pain, resulting in 2 urgent care visits for rehydration. A CT scan revealed a mass which they said was probably a viral infection. At the time, I thought maybe the vaccine taxed my immune system and a virus took the opportunity to get a foothold. That may still be true, but having this same severe bowel reaction twice seems related to the vaccine. I don't think I should have the vaccine again, even though I am a strong believer in the vaccine and was a contact tracer for 1.5 years! It has also cost me a fortune in urgent care and ER expenses after these two reactions. I am still not well.
Pt reports entire arm stiff, unable to move, bleeding profusely, reported to ER just in case, apparently needle struck a vein. Pt released.
On 6/28/21 I received my 1st dose, the following cycle was 21 days long (my cycle averages 27 days) with a 10 day luteal phase. On 7/26/21 I received my second dose and was very sick and was off work for several days, visit to the ED for heart palpitations and the following cycle was 22 days long with an 8 day luteal phase. The following cycle was 31 days long with a 9 day luteal phase. The following cycle was a chemical pregnancy and I haven't had a period since. It has been 98 days. I track my hormones with the Mira device and noticed that my estrogen started to wind down cycle after cycle since receiving the vaccine and my LH surge has basically been non-existent. My provider attempted to induce a period but nothing happened so bloodwork was done. In the meantime I have been having some pretty severe hot flashes so the hypothesis was that I was in perimenopause since I am 41. My provider was surprised at the results of the bloodwork. My FSH was 1.67, estrogen <5 and my LH 0.21. My AMH is stable and right for my age, prolactin is normal (11.6) and TSH is normal (1.30) and my follicle count is 6 (normal for my age). So I am not in perimenopause but for some reason my body stopped producing estrogen. I had repeat bloodwork done because my provider couldn?t believe I just stopped producing estrogen and the results were the same. I had an MRI of the pituitary gland done to cover all bases; MRI is normal and no issues with pituitary. I am currently on estrogen patches and prometrium to try to restart estrogen production.
Chills, fever, headache, muscle aches, fatigue beginning around 3pm 1/5/21 and ending around noon 1/6/21
Arm pain, numbness of neck/mouth/cheek, swollen lip on left side resolved in 1 hour.
On 3/31/08 a few hours after receiving the vaccine: cough and nasal congestion worsened, rash appeared on left leg. On 04/01/08: The rash spread to both legs, arms, and torso. On 04/02/08: Pt was sent to see MD for treatment.
Blurry vision; Thought she was going to die; Headache; Nausea; Low grade fever 101.8; Got sick; This spontaneous case was reported by a physician and describes the occurrence of ILLNESS (Got sick), VISION BLURRED (Blurry vision), FEELING ABNORMAL (Thought she was going to die), HEADACHE (Headache) and NAUSEA (Nausea) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Illness (was feeling ill after a procedure) on 09-Dec-2021, Fever (felt ill with a fever) on 10-Dec-2021 and Surgery. Previously administered products included for COVID-19 vaccination: COVID-19 Vaccine Pfizer (Patient received the first two doses of the Pfizer vaccine.). Past adverse reactions to the above products included No adverse event with COVID-19 Vaccine Pfizer. Concurrent medical conditions included Hypertension. Concomitant products included AMLODIPINE for Hypertension, MAGNESIUM and SODIUM POTASSIUM TARTRATE for an unknown indication.    On 13-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Dec-2021, the patient experienced VISION BLURRED (Blurry vision). In December 2021, the patient experienced ILLNESS (Got sick), FEELING ABNORMAL (Thought she was going to die), HEADACHE (Headache), NAUSEA (Nausea) and PYREXIA (Low grade fever 101.8). On 15-Dec-2021, PYREXIA (Low grade fever 101.8) had resolved. At the time of the report, ILLNESS (Got sick), VISION BLURRED (Blurry vision), FEELING ABNORMAL (Thought she was going to die), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2021, Body temperature: 101.8 (High) Body temperature high. On 15-Dec-2021, SARS-CoV-2 test: results pending (Inconclusive) Waiting for the results.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Caller did not take anything for the side effects because of the previous surgeries. It was reported that the patient had blurry vision so the patient did not drive the first two days,thought she was going to die.
the fluzone qiv np vaccine in the back of her arm subcutaneously,with no reported adverse event; Initial information received on 18-Nov-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age female patient who was administered the fluzone qiv np vaccine in the back of her arm subcutaneously,with no reported adverse event after receiving quadrivalent influenza vaccine (Fluzone QIV).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect quadrivalent influenza vaccine, Suspension for injection (strength, dose, expiry date: unknown) lot number not reported via unknown route in unknown administration site for immunization.  On an unknown date the patient was administered the fluzone qiv np vaccine in the back of her arm subcutaneously,with no reported adverse event (incorrect route of product administration) (unknown latency).  It was reported, patient received the FLUZONE QIV NP vaccine in the back of her arm subcutaneously and is inquiring if its effective or would the patient need to be redosed in the deltoid?   Action taken: not applicable  Outcome: Unknown   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 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.
Patient's date of birth was entered incorrected upon being registered in the computer.  Patient was brought in for newborn check and was administered vaccines appropriate for a 2 month old child due to the date of birth being incorrect.  At this time, patient has no side effects reported.
Information has been received from a medical assistant concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On 06-JUN-2017, the patient was vaccinated with an expired dose of GARDASIL 9 (lot # M014929 with expiration date 27-MAY-2017) (dose, strength, frequency, route of administration and anatomical location were not provided), for prophylaxis. No adverse effects were reported. Additional information has been requested.
Mom report redness less than 50 cents piece, size of bottom of cup.  Mom reports some induration.
weakness loss of appetite  continue fluids, continue soft diet, chicken soup Tylenol extra strength for aches and pains and fever
Low grade temp (99.5 degrees) x 2 days, chills, lethargy, aches. S/S began about 14 hrs after vaccine administered. Some HA, sore throat, nasal congestion.
large circular reddened area on lt arm about 3 inches in diameter;warm to touch & hard in center;wet, cold compresses applied, given DPh
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 24-APR-2012, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance for the long term prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 30-OCT-2013, the patient was treated for the onset of a severe vesicular rash, which was diagnosed as severe herpes zoster. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown.  Causality assessment was related. Additional information has been requested.
Was sick after first shot for two and a half weeks straight, chills, severe headache, sweats, fever ringing ears, tingling cheeks with excess salivating, incredible fatigue, nausea, diarrhea, aches and pains. Received second shot on the 9th of April, was in hospital with in Two hours of receiving the shot with swollen lymph nodes and trouble swallowing  with excess salivation. aches and all the above symptoms from first shot starteD almost immedently and lasted a month.
This spontaneous report was received from a registered pharmacist concerning a 79 years old male patient with no pertinent medical history who on 24-JUN-2012 was vaccinated with a dose of ZOSTAVAX (dose and route # not provided) (lot # 0255AE, expiration date on 14-MAR-2013). On 26-JUN-2012, the patient experienced dizziness and lightheadedness after vaccination with ZOSTAVAX. No treatment was given for the events. At the time of the report, the outcome of dizziness and lightheadedness was unknown. The patient contacted his physician. Additional information has been requested.
pneumonia; throwing up; nose bleeds; lost her sense of taste and smell; lost her sense of taste and smell; This is a spontaneous report from a contactable nurse. An adult female patient received second dose of BNT162B2 (BNT162B2) via an unspecified route of administration on 2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunization and tofacitinib citrate (XELJANZ XR), via an unspecified route of administration from Jun2019 (Batch/Lot number was not reported; Expiration Date: 11Feb2022) to an unspecified date, at 11 mg, 1x/day for rheumatoid arthritis. Medical history included rheumatoid arthritis from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced Pneumonia, throwing up, nose bleeds, lost her sense of taste and smell on 2021. Reporter added, "a couple of months ago 8 days after getting second covid vaccine she got pnuemonia and was throwing up, kept getting nose bleeds and lost her sense of taste and smell. Physician told her to hold her xeljanz til she got better." Physician is aware. The action taken in response to the events for tofacitinib citrate was temporarily withdrawn on an unspecified date. Outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
high blood pressure; This is a spontaneous report from a Pfizer-sponsored program . A contactable consumer (patient) reported that a female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was taking the high blood pressure medication every morning ever since she took the vaccine. She was asking if it was possible to take her high blood pressure medication (hydrochlorothiazide) before she would take the second dose. The outcome of the event was unknown.  Information on the Lot/batch number has been requested.
Pt had inconsolable crying 4 hrs + temp 100.3 Ax p/APAP admin; red, swollen leg from inject site to ankle;
01/30/2021 12:01 AM Headache, Body Ache and temperature 101 01/30/2021,  Came to work, symptoms progressed and went home which included HA, body aches, pain at the injection site, chills, sweats, temp 103.9, started noticing, lymph nodes swollen slightly in left axilla where injection was placed 01/31/2021 decrease in body aches, temp 100, lymph nodes swollen in left axilla area 02/01/2021, lymph nodes almost back to normal, no other symptoms
7-6-04:  Patient receives varicella and HepB, dose #3 immunizations.  7-7-04:  rash develops at immunization site with no itching or pain.  Mother gives Benadryl on Wednesday evening 7-8-04:  Arm back to normal, per mother.  Did not take patient to private MD
4/23/2012-mother of patient calls in today to report reaction. She states that on 04/20/2012 patient c/o redness, itching and soreness and on 04/21/2012 there was increased redness, approx. 2 and 1/2 inch in diameter, mother than presented to local ER/Urgent Care, patient was diagnosed with infection and placed on oral antibiotic for five days. Mother reports that he was "doing a lot of itching". Patient with no recent illness/fever and had not had a reaction to vaccination prior to this event. Mother stated that her son has recovered and is "fine".
It started with pain on the left side and shortness of breath. She was taken to Medical Center and there diagnosed with splenic infarction due to blood clotting. Was prescribed pain medication and blood thinners (Lovenox) to be injected daily for three months.
Fever over 102F, muscle ache, headache, ear ache, weakness and fatigue.  Tylenol 500 mg tabq 8 hrs, and 650mg suppository( one time, when higher fever of 106F), and Ibuprofen 600 mg tab.
After the 1st shot within 10 mins I almost passed out. Dizzy/light headed. That night when I got home I noticed my heart jumping around. I?ve had pvcs since I received my first dose and they never went away. I still have them to this day. And I?ve had moments where my heart rate increases.
Trunk with 20 eryth papules vesicles, several lesions, 25 papules on face.
Hidradenitis suppurativa; COVID-19; Tiredness; Pain in arm; Rash at site of injection; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tiredness), PAIN IN EXTREMITY (Pain in arm), INJECTION SITE RASH (Rash at site of injection), HIDRADENITIS (Hidradenitis suppurativa) and COVID-19 (COVID-19) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa.    No Medical History information was reported.   In May 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. In February 2021, the patient experienced COVID-19 (COVID-19). In 2021, the patient experienced FATIGUE (Tiredness), PAIN IN EXTREMITY (Pain in arm) and INJECTION SITE RASH (Rash at site of injection). On an unknown date, the patient experienced HIDRADENITIS (Hidradenitis suppurativa). At the time of the report, FATIGUE (Tiredness), PAIN IN EXTREMITY (Pain in arm), INJECTION SITE RASH (Rash at site of injection) and HIDRADENITIS (Hidradenitis suppurativa) outcome was unknown and COVID-19 (COVID-19) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, COVID-19: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant drugs not reported. No medical history reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. For HUMIRA, the reporter causality for the events of Side effects was tired, Sore arm, Rash at the injection site and Hidradenitis Suppurativa was not provided and the reporter causality for the event of COVID-19 reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. Treatment drugs not reported.   Reporter did not allow further contact
R arm injection site redness, swelling, itching, warm to touch started 1/5/20. Sent to healthcare agency on 1/7/21.
PT GIVEN TWO INJECTIONS. HEP A GIVEN IM/LD. HPV GIVEN IM/RD. PT. FAINTED ABOUT 2 MIN AFTER HPV WAS GIVEN. PT START TO SWEAT COOL TOWEL WERE PUT ON FOREHEAD AND NECK. AMMONIA INHALANT WAS USE. PT STAYED IM ROOM FOR 30 MINUTES AND FELT FINE. TIME START 11:15 AM-11:45AM.
Caller reported experiencing scrotum and goin pain; Caller reported experiencing scrotum and goin pain; This spontaneous report was received from a male patient of unknown age. The patient's pertinent medical history, concurrent conditions, concomitant medications, and drug reactions or allergies were not provided.  On 16-MAR-2023, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered intramuscularly (dose, dose number, frequency, vaccination scheme, lot number and expiration date were not provided) for immunization.  On 17-MAR-2023 (reported as the day after vaccination), the patient experienced scrotum and groin pain. The patient asked if these symptoms could be related to the vaccine. No treatment was given. The patient sought medical attention, and an ultrasound and a computerized tomogram were made. At the time of reporting, the patient had not recovered from the events.  The causal relationship between the events scrotal pain and groin pain with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.
Worsening skin rash x 2 weeks with intense pruritus, did not respond to topical steroids or oral prednisone. Multiple excoriations noted over her anterior abdominal wall, anterior chest wall, bilateral shoulder and bilateral lower extremities. No excoriations are noted in areas where patient is not able to reach. Has a diffuse maculopapular rash involving both of her inner thighs suspicious for secondary fungal infection.
Little light headed; Left leg felt light; Felt like I was going to get the flu; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Little light headed), LIMB DISCOMFORT (Left leg felt light) and INFLUENZA LIKE ILLNESS (Felt like I was going to get the flu) in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Little light headed), LIMB DISCOMFORT (Left leg felt light) and INFLUENZA LIKE ILLNESS (Felt like I was going to get the flu). At the time of the report, DIZZINESS (Little light headed), LIMB DISCOMFORT (Left leg felt light) and INFLUENZA LIKE ILLNESS (Felt like I was going to get the flu) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported. No Treatment information was reported.
The next day, patient began to exhibit a motor tic-head jerk down to the right.
she complained that her throat began to swell to the paramedic caring for at that time whom alerted this writer. Another provider was alerted to call 911. While I went to assess the patient.  Patient stated that her throat was starting to felt swollen  Anaphylaxis, dizziness, shortness of breath,