chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Red itchy bump on injection site; Red itchy bump on injection site; Red itchy bump on injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Red itchy bump on injection site), VACCINATION SITE INDURATION (Red itchy bump on injection site) and VACCINATION SITE PRURITUS (Red itchy bump on injection site) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red itchy bump on injection site), VACCINATION SITE INDURATION (Red itchy bump on injection site) and VACCINATION SITE PRURITUS (Red itchy bump on injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Red itchy bump on injection site), VACCINATION SITE INDURATION (Red itchy bump on injection site) and VACCINATION SITE PRURITUS (Red itchy bump on injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        patient reported delayed adverse events after getting the 1st shot on 14Mar2021. Last night on22Mar2021 she noticed the large red bump on injection site which is 1 inch wide and 1.5 inch long and itches quite a bit.   No treatment info provided
Unevaluable event; This case was received via FDA VAERS on 08-Jun-2021 and was forwarded to Moderna on 08-Jun-2021.    This regulatory authority case was reported by a health care professional and describes the occurrence of UNEVALUABLE EVENT (Unevaluable event) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-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. On 09-Mar-2021, the patient experienced UNEVALUABLE EVENT (Unevaluable event) (seriousness criterion hospitalization). At the time of the report, UNEVALUABLE EVENT (Unevaluable event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant product use was not provided. It was reported that the patient had an ED visit and/or hospitalization within 6 weeks of receiving COVID vaccine. Treatment information was unknown.  Very limited information regarding this event has been provided at this time.  No further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time.  No further information has been requested.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. Information about concurrent conditions and medical history was not provided. On 15-JUN-2015 the patient was vaccinated with an improperly stored dose of GARDASIL (dose and route of administration were not reported). It could not be determined whether the patient received the product with lot # L007531 with expiration date: 04-NOV-2016 or lot # K007264 with expiration date 02-MAR-2017. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Headache Fatigue, injection site pain and swelling Narrative:  Other Relevant History:
Discharge Provider: MD Primary Care Provider at Discharge: DO   Admission Date: 9/9/2022 Discharge Date: 9/13/2022   79 y.o. male with past medical history significant for A. fib, HTN, HLD, single kidney with CKD IV, dilated cardiomyopathy, prostrate cancer, anemia who presents to ED for hypoxia. Tested positive for COVID on 9/7/22. Since then, he has had worsening SOB, cough, diarrhea. He developed Tmax 102.2F. Daughter, who is RN, came to the house and noted that patient was hypoxic, SpO2 84% on room air and tachycardic w/ HR in the 120s.  Upon presentation to the emergency department, patient was hemodynamically stable, tachycardic with heart rates in the 100, temperature 102.2° F. He was saturating low 90s on room air.   Initial lab work reveale patient noted d sodium 131, chloride 97, crit 2.34, BNP 14175, hemoglobin 10.5.  COVID-19 positive.  UA showed large blood.  Chest x-ray showed cardiomegaly with diffuse interstitial prominence consistent with vascular congestion. He was diagnosed with acute hypoxic respiratory failure secondary to COVID, acute on chronic CHF with preserved ejection fraction. He was treated with Dexamethasone 6 mg daily day # 4/10, Mucinex, albuterol p.r.n..  He was treated with Zithromax for 3 days, discontinued on discharge. Initially required oxygen, but by the time of discharge he was on room air.    Pt has known a. fib., acute on chronic CHF with preserved ejection fraction Severe MR and Aortic stenosis s/p AVR (bioprosthesis), Mitral valve repair with band and tricuspid annuloplasty with band  Rate was well controlled, initially INR was low, but by the time of discharge was therapeutic of 2.0.  He should continue current dose of meds as per cardiologist.    On admission he had hematuria which resolved by the time of discharge.  Renal ultrasound shows single left kidney with multiple left renal cysts, no hydronephrosis, prostatmegaly noted. Recommend outpatient follow-up with Dr. his urologist.   Chronic kidney disease stage 4, with solitary kidney and renal function was closely monitored.  Stable, creatinine at time of discharge was 2.07, with baseline creatinine of 2.5. PT recommended out patient PT for right knee pain.
Mother of child presented with child for immunizations on 8/9/11. Mother stated child started limping on left leg around 7:00pm on 8/9/11. Stated he went to bed that way and around 2:00am on 8/10/11 he woke up complaining of left leg pain. No fever or other complaints.
left extremely weak; shakey; hypotensive; abdominal pain; explosive diarrhea that was brown and watery/gooey slimy and green; aches and pains; Soreness on arm; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (Soreness on arm), DIARRHOEA (explosive diarrhea that was brown and watery/gooey slimy and green), TREMOR (shakey), HYPOTENSION (hypotensive) and ABDOMINAL PAIN (abdominal pain) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included BPH since 01-Jan-1995. Concomitant products included FINASTERIDE (PROSCAR) from 01-Jan-1995 to an unknown date and TERAZOSIN HYDROCHLORIDE (HYTRIN) from 01-Jan-2021 to an unknown date for BPH.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced PAIN IN EXTREMITY (Soreness on arm). On 19-Jan-2021, the patient experienced MYALGIA (aches and pains). On 20-Jan-2021, the patient experienced DIARRHOEA (explosive diarrhea that was brown and watery/gooey slimy and green) and ABDOMINAL PAIN (abdominal pain). On 21-Jan-2021, the patient experienced TREMOR (shakey) and HYPOTENSION (hypotensive). On an unknown date, the patient experienced ASTHENIA (left extremely weak). On 18-Jan-2021, PAIN IN EXTREMITY (Soreness on arm) had resolved. On 19-Jan-2021, MYALGIA (aches and pains) had resolved. On 22-Jan-2021, DIARRHOEA (explosive diarrhea that was brown and watery/gooey slimy and green), TREMOR (shakey) and HYPOTENSION (hypotensive) had resolved. At the time of the report, ABDOMINAL PAIN (abdominal pain) and ASTHENIA (left extremely weak) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test negative: negative (Negative) NEGATIVE.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered DIARRHOEA (explosive diarrhea that was brown and watery/gooey slimy and green) and ABDOMINAL PAIN (abdominal pain) to be not related. No further causality assessments were provided for PAIN IN EXTREMITY (Soreness on arm), TREMOR (shakey), HYPOTENSION (hypotensive), ASTHENIA (left extremely weak) and MYALGIA (aches and pains).    The patient denied taking any treatment for the events.  He did follow-up with an infectious diseases doctor who recommended he receive the second dose.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Patient demographics, medical history, concomitant medication details and event details updated. New events (weakness and abdominal pain) added. 2nd dose events reported. On 05-Jul-2021: The patient reportedly saw an infectious diseases doctor who did not think the events diarrhea and abdominal pain were related to the vaccine. Causality updated to not related for those events.
Redness at injection site with warmth reported 1 wk after injection. Now complain of intermittent sharp pain in left upper arm
minor soreness in arm; swollen gland in armpit; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (minor soreness in arm) and LYMPHADENOPATHY (swollen gland in armpit) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Dec-2020, the patient experienced PAIN IN EXTREMITY (minor soreness in arm) and LYMPHADENOPATHY (swollen gland in armpit). At the time of the report, PAIN IN EXTREMITY (minor soreness in arm) and LYMPHADENOPATHY (swollen gland in armpit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Upon in internal review on 21 May 2021, the age was corrected to unknown age.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 03-Feb-2021: Upon internal review on 28 May 2021, it was discovered that the patient age was incorrectly captured as 121 years and DOB mentioned in source document was 01-Jan-1900, which was a MI error. The patient age and narrative has been updated to unknown age with reports re-submission and significant amendment is performed for the correction.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
15 minutes after vaccine given patient had feeling of tongue swelling and chest pain with some shortness of breath.  Was brought from the clinic in the hospital to the emergency department.  Upon arrival in the emergency department the patient had near complete resolution of symptoms.  No significant abnormalities seen or found on exam.  Given 12.5 mg of benadryl IV.  EKG normal. CXR normal. Trop negative x 2.  MOnitored for 3 hrs in the ED and had complete resolution of all symptoms and patient was feeling "normal".  discharged home.
Fever overnight following the second injection. Lymph node swelling on left side of head and neck was noticed the first morning along with a burning sensation along the scalp on the left side of head. Lumps formed under hair line on left side of head by second morning after the shot.  Lymph nodes still swollen on left side of head and neck. Lumps on left side of head became tender to the touch by third morning after the shot. Sought help at "On Demand Care" on 10th day after Vaccine was given due to pain. The following issue was addressed by CNP:  Herpes zoster without complication. Prescribed:  acetaminophen, capsaicin and valACYclovir on April 23, 2021.
gullian barre syndrome; Initial information regarding an unsolicited valid serious case was received from a consumer/non-healthcare professional (patient) via social media on 11-Dec-2020.  This case involved a patient of unknown demographics who got Guillain Barre syndrome, after receiving INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of INFLUENZA VACCINE produced by an unknown manufacturer (lot number and expiry date were not reported) via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date (unknown latency), the patient got one flu shot and got Guillain Barre syndrome. The event was assessed as medically significant as per the important medical event (IME) list.  No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown, at the time of reporting.  There will be no information available on the batch number for this case.; Sender's Comments: This case involves a patient of an unknown age and gender who presented with Guillain Barre syndrome after receiving INFLUENZA VACCINE by an unknown manufacturer. Time to onset is unknown. Although, medical history, concomitant medications, additional information on investigations ruling out other etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Complained of blurred vision, and feeling lightheaded and dizzy. Vital signs were within normal limits. O2 saturation normal. Started about 15 minutes after vaccination and lasted another 15 minutes. No medications or other interventions needed. Will follow up with their physician.
Ten hours after my second Moderna vaccine, I developed a fever, chills and body aches. I slept only 3 hours that night due to pain in right knee and spine, agitation and discomfort. The next morning, I started vomiting and was nauseated for a full 24 hours. The intensity of pain increased during those 24 hours. I had to stay on my sofa to remain vertical above the waist and due to extreme fatigue and headache . After that 24 hours, I was able to eat toast and keep down a Motrin tablet that helped with the fever and pain, but I remained on my sofa another 24 hours due to nausea and fatigue and headache. I again got only 3 hours of sleep . The next day, the symptoms were less severe, but I had the additional symptom of intermittent shooting pain near or around my right inner ear.
Appendicitis, emergency appendectomy on 12/15/2021,   Had my booster on 11/10/2021
Pressure in left ear (affected ear of my Sudden Hearing Loss) and increased ringing in same ear
Astronomical pain; A spontaneous report was received from a consumer concerning a 82-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events astronomical pain.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 025J202A) via unknown route for prophylaxis of COVID-19 infection. On 5 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 030L20A) via unknown route for prophylaxis of COVID-19 infection.  On 8 Feb 2021, the patient experienced the events astronomical pain.  Treatment details included the doctors give her steroids but it's don't caring of it.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of event, astronomical pain was unknown.
cellulitis lt thigh-rx w/PCN, APAP, w/in compresses; RTC 27FEB95 recheck;
This case was reported by a consumer and described the occurrence of fever in a male child of unspecified age who was vaccinated with Havrix for prophylaxis. A physician or other health care professional has not verified this report. On 13 September 2006 the subject received a dose of Havrix (dose number not provided). "About a day later, " on an unspecified date in September 2006, the subject experienced a fever "that ranged from 103 to 104 degrees Fahrenheit." The subject was seen in an emergency department and was subsequently hospitalized. The consumer reported that, "various tests were run, but everything was negative and the patient was discharged." At the time of initial reporting 22 September 2006 the outcome of the fever was not reported.
Decreased appetite after immunizations given went 11 hours between feedings. Diarrhea started about 18 hours later -stooling x6-8/day, cranky, afebrile, no vomiting.
devel hives 18hrs p/inj; reported to MD on 18SEP95 when arrived for 2nd vax-(not given);
10/08/2012 client reports experiencing weeping from injection site, tingling in fingers of injection site arm and intermittent headaches. Reports feeling feverish, without elevated temperature.
States she was shivering, low grade fever (described as 98.3 temp), rash around her ankles with peeling skin, arm was extremely painful and was very very tired which lasted 2 days.  She states she received the rash when she got the Shingrix injection which was on 8/29/19 and still has it today (9/5/2019). She is using antibiotic ointment on the rash and states that the rash is responding to treatment.  I have notified her physician and they will be calling her to follow-up.
This spontaneous report as received from a nurse refers to an 18 week 4 days old female patient. On 22-APR-2014 the patient was inadvertently vaccinated with her first dose of ROTATEQ (lot# unknown) 2 ml, orally, at age 18 weeks, 4 days. No adverse effect reported. Additional information has been requested.
Severe anxiety, Kidney Failure, Hypoglycemia, ER visits, Overall decline, Hospice care, Expired
mild sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), intramuscular, administration date 18Apr2021 (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: PAIN IN EXTREMITY (non-serious) with onset Apr2021, outcome "unknown", described as "mild sore arm". Additional information: The patient got first dose of the vaccine yesterday afternoon, had a mild sore arm due to the injection and asked whether she could use a self-tanner, as it was mentioned on the instructions don't put it on an open wound, patient was wondering whether an injection site was considered to be an open wound.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a healthcare worker refers to a 77 year old female patient. The patient's medical history included reaction/allergy to amoxicillin, AUGMENTIN. On about 02-AUG-2013 the patient was vaccinated with a dose of ZOSTAVAX, subcutaneous in her left upper arm (lot#, dose and frequency unspecified). Concomitant therapies included DIOVAN and COUMADIN. On about 10-AUG-2013, the patient "developed a rash-classic shingles on the left thigh". The patient went to the physician's office for medical attention. The patient was started VALTREX therapy on 13-AUG-2013. No lab diagnostics studies performed. The outcome of the event was reported as not recovered/not resolved. Additional information has been requested.
Parasthesia - both arms, most remarkable in hands, concentrating on lower palm and pinkie, ring and middle finger
I tested positive for COVID19, my symptoms began 1/6/22 with headache, neck pain, body aches, loss of taste and smell, muscle cramp in left calf which lasted for a couple hours, congestion, cough, shortness of breath, chest tightness which lasted 2 weeks, fatigue, fever of 103, sore throat and was ill for 15 days. All symptoms have resolved.
Little bit of sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Little bit of sore arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     The patient's past medical history included Chronic obstructive pulmonary disease.    On 22-Feb-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 PAIN IN EXTREMITY (Little bit of sore arm). At the time of the report, PAIN IN EXTREMITY (Little bit of sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Fever 12 hours after covid vaccine. Temp of 103.4 at highest. General fatigue, shivering and sweats.
Headache - achy - N & V - Temp 99.5. Diarrhea - SOB - (1st symptom SOB) N & V x 2 episodes. Diarrhea x 5-6 episodes.
Crusting and scabbing of lips, nose, face, arms and feet for 2 weeks following flu shot. Resolved spontaneously.
Narrative:  Patient was a 80y male. Being treated outpatient and passed away at home. Cause of death is unknown. Patient received COVID vaccines on 01/07/2021 and 02/02/2021. Due to the time frame vaccinations are likely not related to the death.
10 days (12/13/2021) after vaccination was given a CT scan showed enlarged  lymph nodes in the chest area.  Also, had an emergency room visit on 3/6/22 with sever chest pains. A CT scan was done and showed  Mediastinum: Mildly enlarged right lower paratracheal lymph node measured 1.5 cm in short axis. Multiple additional small mediastinal lymph nodes. in the chest.  This is additional lymph node swelling than what the scan on 12/13/21.  Also showed the Left atrial enlargement in the heart. I went to Primary Care doctor as ER doctor suggested.  This visit was on 3/14/22.  She indicated there was also inflammation in the chest wall. I was referred to Pulmonary.
Injection site became inflamed and under the skin a knot could be felt.  Site was inflamed, hot, and itchy.  Additionally had a fever, fatigue, and am experiencing an adverse reaction to certain smells (raw and cooked meat in particular).  The size of the inflamed site grew until Tuesday, 9/22/2015.  I had to miss work on Monday, 9/21/2015 because I felt so ill.  As of 9/25 when this report is being submitted, the knot is still visible and site still inflamed but now a dull purple instead of bright red.
Information has been received from a registered nurse concerning a female patient who in 2003 was vaccinated with the first dose of GARDASIL. It was reported that the patient did not remember if she ever received her second or third dose of GARDASIL. The nurse reported that the patient memory was not reliable. Additional it was reported that the patient very recently had unprotected sex and has not had a period for one month. Nurse stated that the patient very recently had unprotected sex and had not had a period for one month. A pregnancy test was performed and the result was negative. The nurse stated that due to unprotected sex and the patient could still had the possibility of being pregnant. The nurse reported that the patient had no apparent adverse effect noted due to the possibility of not completing the series. Additional information has been requested.