chrisvoncsefalvay/vaers-outcomes huggingface dataset:
69 Y female with h/o type II DM, OSA, HTN and idiopathic pulmonary fibrosis s/p double lung transplant (8/8/16) on Myfortic, tacrolimus, prednisone who presented to the ED secondary to AMS in the setting of hypoglycemia and decreased po intake found to have COVID 19 disease   COVID 19 disease - Symptom onset on 9/4. COVID positive on 9/10. No reported fevers." Given her lack of hypoxia and need for supplemental oxygen, she did not meet criteria for Decadron. Remdesivir was indicated given the patient's tachypnia with RR 30 on presentation.  D/w transplant physician who agreed with starting Remdesivir and recommended at least a 5 day course.  (9/10 - 9/14) for which she remained hospitalized. Mild transaminitis but improving. 9/13 Dr. advised that pt was a candidate for monoclonal antibodies (Regeneron) so this was administered after.  D/w lung transplant pulmonologist who agreed. - at discharge satting well with exertion and at rest - 20 day isolation from symptom onset - f/u with COVID transitions team   AMS  Patient presented due to AMS, likely secondary to hypoglycemia. CTH negative and mental status improved following administration of D50. Also presented to the ED 7/8 also for AMS which was also deemed to be secondary to hypoglycemia.   - Mental status now normal   Hypoglycemia / Type II DM (HbA1C 5.7 8/9/21) BG 36 upon presentation to the ED in the setting of decreased po intake and continued insulin use. Received D50 in ED with improvement. Patient was on PTA NPH 28 units in AM, Humalog 10 units for breakfast and 16 units for lunch and dinner.  Her evening NPH was stopped 8/10/21 due to AM hypoglycemia.  - Blood sugars consistently between 80 and 160 here and she only requires a few units of insulin a day - discharged and told to hold NPH and f/u with diabetic educator   Thrombocytopenia, anemia, nutripenia.   Patient with chronic thrombocytopenia, plt ~100s. Down to 71 early in her course, possibly related to COVID infection.  Myfortic dose lowered and counts slowly increasing. - CTM closely.  plt 99K at discharge and are slowly uptrending. She is to continue lowered dose of 180 mg BID rather than her usual 540 mg bid. Check labs in 2-3 days and f/u with transplant team   Idiopathic pulmonary fibrosis s/p double lung transplant (8/8/16)   - Continue PTA prednisone 7.5 mg daily, prograf and myfortic (lower dose) for immunosuppression.  - Continue CMV prophylaxis with Valcyte 450 mg BID - Continue PCP prophylaxis with Bactrim MWF - Continue Azithromycin for BOS prophylaxis.    HTN  - resume PTA Coreg
12AM twitching tingling in legs pain in thighs started 1AM shivering severe by 2AM Had to put blanket in mouth teeth were chattering so badly finally fell asleep or passed out 4AM woke up had to use bathroom light shivering but severe pain in thighs 8AM woke up pain and shivering gone
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE 4/15/2022 -- RECURRENCE OF SAME SYMPTOMS
About five days post shot began developing folliculitis. Type of folliculitis is unknown. Started on the belly/chest area and has begun spreading elsewhere. 7 days post shot symptoms of ?vaccine arm occurred; beginning as an itch and then swelling and becoming hot. Otherwise no other side effects.
I had fatigue, sore throat, congestion, headache, and body aches. These lasted for about 2 days on most of the symptoms and about 5 days on the fatigue. I went on Dec 28th to a clinic to get tested for Covid-19, positive result. I also took an at home Covid-19 test, positive result on Jan. 2nd.
My whole body became extremely cold and my teeth  jaw  began uncontrollably chattering. I was shaking like a freezing character in a cartoon. My heart was feeling like it was racing. My chest felt squeezed slightly but enough I felt strain getting a full breath. My vision was foggy and I felt exhausted and weak. I sat in the bath with the warm shower going over and covered myself with warm towels soaked in hot water trying to warm up and calm my heart.  The extreme chattering cold and racing heart lasted about 30 minutes.
No adverse effect from shot for 6 days. On 7th day, the shot site started itching, with a noticeable small swelling.  Itching is extreme and constant.  Using ice pack to relieve itching, but it comes back.  No other adverse symptoms from the shot.  Just concerned about the delay of these symptoms.
Moderate to severe headache, neck pain, chills, painful eyes, nausea, fever of 101.5-102.0 for first 24 hours.
Hands and face burning; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 02Mar2021 at 09:30 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included atrial flutter, asthma, meniere's disease, blood pressure high and allergy to artificial dyes, penicillin, and yeast. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included PROPAFENONE, VERELAN, BENICAR, and CLOPIDOGREL, all for unknown indication from unknown date and unknown if ongoing. The patient previously received ASPIRIN, CIPRO, and LEVAQUIN, all on unknown date for unknown indication and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Mar2021 at 09:47, 17 minutes after vaccination, the patient experienced hands and face burning that lasted about 3 minutes. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event hands and face burning was recovered on 02Mar2021.   No follow-up attempts are required, information about lot/batch number cannot be obtained. No further information is expected.
Received my 2nd dose of the vaccine on 03/04/2021, I had violent shaking of my body with chills, that went on for 4 hours, my whole body was shaking in the bed, I could not stop it. I also had a headache, nausea, and fatigue. The next day my temperature was 100.6 and then body aches nausea and abdominal pain. On 03/05/2022, I had a pain in my chest when I pressed on my sternum the pain was very sharp. I was able to take Tylenol that day, as I was not able to get it to stay down until then. I was pondering if I should go to the hospital. By 03/06/2022 things started to moderate. On the 03/07/2022 the fever was gone, but I still had severe diarrhea, moderate headache, body aches, nausea, and fatigue. I was still not able to do normal activities. I also was not able to eat much. By 06/09/2022, things were mild, and I was starting to feel better. By 03/11/2022, I was feeling like I was on the road to recovery, and I was getting over it. I remember it took me a couple weeks to feel entirely back to normal.
full body muscle aches starting around 5 PM and worsening throughout the night; fever the peaked at 101.4 around 8:30 PM; headache; weakness; trouble sleeping night of vaccination; low-grade fever the next day with slight headache
rapid heart beat; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (rapid heart beat) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced HEART RATE INCREASED (rapid heart beat). At the time of the report, HEART RATE INCREASED (rapid heart beat) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.
This spontaneous report as received from a registered nurse refers to a 60 year old female patient with diabetes. On 17-DEC-2013, the patient was vaccinated with PNEUMOVAX 23 lot # J011651, subcutaneous in the right arm. Other suspect therapies included ZOSTAVAX and BOOSTRIX. On 17-DEC-2013, the patient experienced nausea, redness to back of arm, weak, dizzy, the nurse reported that all patients received PNEUMOVAX 23, but that some of the patients may also have received ZOSTAVAX concomitantly and vomiting. The outcome of dizzy, weak, vomiting, nausea and redness to back of arm was reported as recovered/resolved. The outcome of the nurse reported that all patients received PNEUMOVAX 23, but that some of the patients may also have received ZOSTAVAX concomitantly was unknown. The reporter did not assess the relationship between the events and PNEMOVAX 23 and ZOSTAVAX.  This case is related to case numbers: 1312USA010905, 1403USA003215, 1403USA003216, 1403USA003217, 1403USA003218, 1403USA003219, 1403USA003220, 1403USA003221, 1403USA003222, 1403USA003223, 1403USA003224, 1403USA003225, 1403USA003226, 1403USA003227, 1403USA003228, 1403USA003229, 1403USA003230, 1403USA003231, 1403USA003232, 1403USA003233, 1403USA003234, 1403USA003235, 1403USA003236, 1403USA003237, 1403USA003238, 1403USA003239, 1403USA003240, 1403USA003241, 1403USA003242, 1403USA003243, 1403USA003244, 1403USA003246, 1403USA003247, 1403USA003248, 1403USA003249, 1403USA003250, 1403USA003251, 1403USA003252, and 1403USA003253 (same reporter). Additional information is not expected.
pain in her muscles; super sick; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in her muscles), ILLNESS (super sick) and HEADACHE (headache) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced PAIN IN EXTREMITY (pain in her muscles), ILLNESS (super sick) and HEADACHE (headache). At the time of the report, PAIN IN EXTREMITY (pain in her muscles), ILLNESS (super sick) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Jan-2022, SARS-CoV-2 test: positive (Positive) POSITIVE.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Medications were provided by the reporter  No Treatment Information were provided by the reporter   This case was linked to MOD-2022-454729 (Patient Link).
First vaccine on 12/30/20 almost immediately after receiving vaccine metallic taste in mouth, followed by itchy throat and felt throat slightly thighten took Benadryl and received relief  Second dose on 1/20/21 took a Zyrtec per doctor?s instruction prior to receiving vaccine about 15 minutes after receiving second dose tongue numbness and weird taste in mouth now and developed itchy face, managed with Zyrtec although itchiness not resolved, taking Zyrtec every day since second dose, yesterday 1/25 in afternoon still medicated under Zyrtec face began to swell on left side of face, persistent itchy face, itchiness went down to other areas including neck, chest, bumps on left hand now on an oral steroid per my doctor
1. Oval shaped red raised bump of 3-4cm in diameter at injection site on right arm and pain. Pain,swell and redness went away after 1 week but redness has become black now. Even today 4/18/21, there is no pain but more like a permanent dark mark like a scar left after bruise.  2. Two weeks after my first vaccine shot(1/20/21), I started having mild throat pain at right thyroid gland. It would come and go several times everday but never had such pain ever before.  There were couple of pimple like things on right throat. This went on for 4-5 weeks after which I was concerned and got Thyroid sonogram. Result said no increased nodules and acute-subactue Thyroiditis. 2weeks after my 2nd dose pain went away. Pimple like things are like black marks now.
(R) deltoid tenderness since injection, now a raised, erythematous patch 1cm x 2 cm.
Narrative: 76 y/o male presented to ER on 1/8/22 with cough, congestion, and extreme fatigue and weakness. Close contact had COVID. Treated with remdesivir and dexamethasone. Discharged 1/24/22. PMH of a fib, CVA, HTN, OSA, and CAD.
FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. 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 25-JUN-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 26-JUN-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fever was not reported. This report was non-serious.
This case was reported by a physician via sales rep and described the occurrence of injection site cellulitis in a adult patient who received BEXSERO. Concomitant products included IPOL. On an unknown date, the patient received the 2nd dose of BEXSERO .5 ml. On an unknown date, less than a year after receiving BEXSERO, the patient experienced injection site cellulitis and injection site erythema. The patient was treated with antibiotics. On an unknown date, the outcome of the injection site cellulitis and injection site erythema were recovered/resolved. It was unknown if the reporter considered the injection site cellulitis and injection site erythema to be related to BEXSERO. Additional details were reported as follows: The age at vaccination was not reported. The patient received BEXSERO on left arm. The patient was also given separately but sequentially on the same day the polio vaccine called IPOL in the same left arm. The reporting physician neither administered the vaccines nor seen the vaccines being administered. It was unknown which vaccine was administered first or the specific timeline for vaccine administration or timeline regarding how soon the left arm redness and cellulitis developed following the administration of the vaccines. The patient went to a walk-in urgent care clinic and was given and took an unknown antibiotic for the left arm redness and cellulitis. The patient was fine at the time of reporting. The immunization clinic had already reported to VAERS but they wanted GlaxoSmithKline to also be aware. It was currently not known which one of the two vaccines might have caused the left arm redness and cellulitis and no further information was provided. The physician gave consent to contact for any further related questions.
Information has been received from a 69 year old male patient with a "kidney issue", ragweed allergy and urinary tract disorder who on 03-MAY-2007 was vaccinated with 0.5 ml dose of Zostavax. Concomitant therapy included ezetimibe (+) Simvastatin. On 09-MAY-2007 the patient developed rash on left collar bone are which was very painful. As per patient, the rash was red and bumpy with "maybe" two spots of pustule activities. Unspecified medical attention was sought. At the time of report, the patient was not recovered. No diagnostic laboratory tests were undertaken. A product quality complaint was not involved. Additional information has been requested.
Blood sugar increased to 200+. I fought with extreme highs (upper 200s) & extreme lows (40) all weekend. Today is the first day it is back to normal. Other reactions were headache, all over body aches with cramping in leg muscles, injection site tenderness & quarter sized knot that showed up on Monday.
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2022 at 1:59 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2022 at 1:59 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.  Moderna vaccine was pulled from freezer on 16 Dec 2021. Beyond use date of 15 Jan 2022 was printed in red and taped to the top of boxes. On 26 Jan 2022, Staff noticed that vaccine was still in the fridge and expired and 5 doses had been given at that point. On 31 Jan 2022, Moderna confirmed that revaccination was not required.
2nd dose delayed past 35 days; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose delayed past 35 days) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038k20a) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose delayed past 35 days). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose delayed past 35 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.; Sender's Comments: This report refers to a case of Inappropriate Schedule Of Product Administration for mRNA-1273 (Lot number: 038K20A) with no associated AEs.
G2P0010  with EDD 4/19/2021 presented at 26-5 weeks with decreased fetal movement. COVID-19 vaccine one week prior. Noticed decreased fetal movement for 3 days. Creatinine 0.8 in first trimester with normal anatomic ultrasound. Cr increased to 1.1 on day of admission. AST 46, ALT 70, and blood pressure increased. Diagnosed with severe preeclampsia. BPP 2/10, umbilical artery Doppler AEDF, severe polyhydramnios, absent stomach, reversed a wave in ductus venosus. Fetus appropriately grown on ultrasound. Delivered via cesarean. Birthweight 840 grams (appropriate for gestational age).
tested positive for Covid; tested positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) and in Apr2023 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "tested positive for Covid". Clinical course: The patient had had 2 vaccines and 2 boosters. The last in Apr2023 and currently tested positive for Covid.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Symptoms:  Patient was sweaty, dizzy and nauseated  1 minute after the  administration of the vaccine. Treatment:  Patient  laid down and symptoms improved . Outcome: Patient was discharged to POV/Home once the symptoms were improved.
Information has been received from a nurse concerning a 10 year old female who on 26-JUN-2007 was vaccinated with the first dose of GARDASIL (lot no. 655619/1427F). The first dose was administered concomitantly with VARIVAX (Oka/Merck) (MSD). The patient tolerated with the first dose without incident. On 06-MAY-2008 the patient was vaccinated intramuscularly with the second 0.5 ml dose of GARDASIL (lot no. 657006/0188U) into the deltoid muscle of the left arm. There was no concomitant therapy. On 14-MAY-2008, "eight days after the second dose", the patient experienced pain in hip joint and was hospitalized. The patient was discharged on 16-MAY-2008. On an unspecified date the patient was recovered. Additional information has been requested.
muscle aches and myalgia including soreness at injection site  hours after vaccination. Next morning at 5 am, vertigo and dizziness, nausea and fatigue. Today- vertigo resolved. body aches and slight chills.
Diagnosis - Gullian Barre Syndrome  Treatment - rehabilitation hospital, occupational therapy, physical therapy  Outcome - still recovering
Information has been received from a 22 year old female with no pertinent medical history and no drug reactions and allergies who on 20-AUG-2007 was vaccinated intramuscularly with the first 0.5ml dose of GARDASIL (lot number not provided). Concomitant therapy included ZOVIA. In July 2010, a year after she received all 3 injections of GARDASIL, biopsy was performed and the patient found out she had HPV. The patient sought unspecified medical attention. At time of the report, the patient's outcome was unknown. No further information is available.
Patient's upper arm swelling. No rash. No SOB. No chills/fever.
STOMACH UPSET; SLIGHT HEADACHE; SLIGHT PAIN; This spontaneous report received from a patient concerned a 66 year old male. The patient's height, and weight were not reported. The patient's past medical history included stomach issue, and concurrent conditions included high blood pressure.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, on left arm administered on 07-MAR-2021 15:30 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced slight pain. On 08-MAR-2021, the subject experienced slight headache. On 11-MAR-2021, the subject experienced stomach upset. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slight headache on 08-MAR-2021, had not recovered from stomach upset, and the outcome of slight pain was not reported. This report was non-serious.
Fever of 103 after rotation of Tylenol and ibuprofen for three days consistently. Severe dehydration. Muscle cramps. Severe headache not relieved by above mentioned pain medication. Sore, hard arm from injection site down through bicep and armpit
Discharge Provider: MD Primary Care Physician at Discharge: DO Admission Date: 5/16/2023  DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Shock [R57.9] Septic shock [A41.9, R65.21] Pneumonia of right lower lobe due to infectious organism [J18.9]   HOSPITAL COURSE: Patient is a 73-year-old female with multiple medical comorbidities including ESRD on HD, CVA with left-sided residual deficits and dysphagia, seizure disorder, chronic obstructive pulmonary disease, who presented from dialysis with hypotension.  She was given IV fluids but ultimately required vasopressors.  CT scan of her lungs revealed right lower lobe pneumonia and concern for septic shock.  She was admitted to the intensive care unit on broad-spectrum antibiotics.  Given her deterioration from a poor quality of life at baseline she/family decided to pursue hospice care.  She met hospice inpatient criteria and was initiated on a fentanyl drip.    Date of Death: 5/20/23 Time of Death:  5:17 AM Preliminary Cause of Death: Shock