chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient developed full body itch approximately 20 minutes after vaccination. Patient refused treatment here, but went home and took benadryl "around the clock" for "2 days" for continued itching. She saw a "slight" rash and had "slight" chest tightness. She returned today and told me it was "finally gone."
Fever started the  night  of vaccine administration, and continued for 3 days, readings of 100-101. then 9 days post-vaccine papular erythematous rash appeared. Approximately 50  appeared  on trunk then spread. Self -resolved after 48hrs and them self resolved.
Temperature of 103.7 on 06/16/04 at 10:00PM. Fever decreased to 101.8 on 06/17/04 AM. MD notified. Left leg have a knot. Advised to see MD today 06/17/04.
Severe pain & swelling of upper lt arm @ inject site; tx w/sling, moist heat, ASA or APAP PRN;
Patient experienced tingling all over, a dry tongue, and now was experiencing chills. Currently waiting for provider to see her in the ED.
Have had a buzzing in my head and ears since the day after getting my shot. It stops for a few hours once in a while but keeps coming back. Seems to be getting louder.
Site of pneumonia shot swollen, hot, red (4"x6"), fever 102.4, aches and chills, slight nausea. Next 4 days, arm hot, fever steady at 99. Used Naprosyn 230mg (2) BID, hot packs to arm.
77yr old patient with history of T2DM, HTN, chronic pain, afib presented to PCP on 9/20. During this visit, patient endorsed 7/10 knee pain. Patient reported seeing orthopedic surgeon recently and receiving joint injection and aspiration of Baker's cyst. MD prescribed meloxicam 7.5mg PO daily for pain. Patient received Flu Vaccine, High dose trivalent IM in right deltoid on 9/20. On 9/25, patient called office complaining of pain in back, hips and legs. MD changed pain medication to naproxen EC 500mg BID. On 9/28, patient called stating "unable to walk without walker, can not turn self in bed and arms very weak". Patient also endorsed numbness and tingling in arms and legs. Patient instructed to go to ED. Patient instructed to go to ED for rule out GBS. Patient went to Medical Center but left AMA without seeing provider on 9/28. Patient called office on 10/1 stating gotten worse over weekend and endorsed "cannot feel or move legs, worse back pain, and very bad headache". Patient advised to return to ED for evaluation. Patient returned to MC and noted with 3/5 bilateral LE, with "multiple falls over the past week". Patient in process to be transferred but then again left AMA. Patient presented to MC again on 10/2 with slight improvement, able to ambulate with staff, 4/5 bilateral LE. Patient admitted to MC for further monitoring.
I woke up with a runny nose and cough. The next day I took a COVID-19 test at home that came back positive. I called my doctor that same day and was prescribed prednisone, and Bromphen syrup for my cough. My runny nose cleared up after a week. My cough lasted for a about a month.
Client complained of pain, swelling, erythema at injection site. Onset on 3/13/01 and lasted until 4/12/01. Treatment: advised client to see PCP for evaluation.
Patient received his second dose of Moderna COVID19 vaccine on 2/22/21.  Patient was given 1ML instead of 0.5ML.  Patient monitored no adverse event noted during observation.
Contining to have near pass outs; 3rd dose 20Aug2021; 3rd dose 20Aug2021; This is a spontaneous report from a contactable consumer (the patient). A 75 -year-old non-pregnant female patient received the third dose of BNT162B2 (PFIZER COVID-19 VACCINE, Lot Number: FC3181) via an unspecified route of administration, administered in Arm Left on 20Aug2021 10:45 at age of 75 -year-old at single dose for COVID-19 immunisation. Medical history included asthma, hypertension and diagnosed with CML on 06Aug2021. The patient was not diagnose with COVID-19 prior to vaccination. Concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR), fexofenadine hydrochloride (ALLEGRA), diltiazem, and simvastatin (SIM) all taken for unspecified indication(s) from unspecified date(s). The patient did not receive any other medications within 2 weeks of vaccination. The patient previously took the first dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: EH9899) via an unspecified route of administration in left arm on 28Dec2020 10:45AM at the age of 74-year-old for COVID-19 immunization. The patient previously took the second dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration in arm left on 16Jan2021 at the age of 74-year-old for COVID-19 immunization and experienced shortness of breath, body weakness, passed out 27Feb2021 at 13:00; 12Mar2021 - pulmonary emboli - both lungs, DVT right thigh; and syncope. It reported the patient had 3rd dose 20Aug - continuing to have near pass outs in 2021. The patient had 3 episodes of near pass outs this week. The event resulted in Doctor or other healthcare professional office/clinic visit, and Emergency room/department or urgent care. The event was considered as serious due to hospitalization, life threatening illness (immediate risk of death from the event), disability or permanent damage. Hospitalization not prolonged. The patient was hospitalized for 10 days. Nasal Swab in ER was negative on 12Mar2021. Since the vaccination in 2021, the patient had been tested for COVID-19 (unknown result). The outcome of event "contining to have near pass outs" was not recovered.
an improperly stored vaccine was administered on 25JAN202 l.; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported.  On On 25-JAN-2021, the patient was vaccinated with improperly stored dose of hepatitis a vaccine, inactivated(VAQTA) lot # T013546 was confirmed to be valid, expiration date was reported as 27-OCT-2021, but upon internal validation, it was established as 28-OCT-2021 (exact dose, route of administration and anatomical location were not provided) for prophylaxis.  The temperature excursion was above 9 Celsius degrees (C) (13.4 C) for 2 hours and 9 minutes. There were no previous excursions reported. The digital data logger was involved. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T013546; expirationdate: 28-OCT-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Patient received influenza vaccine on 09/23/2019 on 09/24/2019 pt started with pain, hard swollen area, with redness that was warm to the touch.
Bowel movements acting weird, she goes several time a day; Urinating at night more often like once every hour; Urine with extreme urgency and burning sensation; Burning sensation in stomach after eating; Has some taste issues; Leg pain; Fatigue; Left Hip pain; This spontaneous case was reported by a consumer and describes the occurrence of FREQUENT BOWEL MOVEMENTS (Bowel movements acting weird, she goes several time a day), POLYURIA (Urinating at night more often like once every hour), DYSURIA (Urine with extreme urgency and burning sensation), ABDOMINAL DISCOMFORT (Burning sensation in stomach after eating) and TASTE DISORDER (Has some taste issues) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Pain in arm since December 2020, Shoulder pain (Sometimes) since December 2020, Arthritis and Hemorrhoids.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, 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 experienced FREQUENT BOWEL MOVEMENTS (Bowel movements acting weird, she goes several time a day), POLYURIA (Urinating at night more often like once every hour), DYSURIA (Urine with extreme urgency and burning sensation), ABDOMINAL DISCOMFORT (Burning sensation in stomach after eating), TASTE DISORDER (Has some taste issues), PAIN IN EXTREMITY (Leg pain), FATIGUE (Fatigue) and ARTHRALGIA (Left Hip pain). At the time of the report, FREQUENT BOWEL MOVEMENTS (Bowel movements acting weird, she goes several time a day), POLYURIA (Urinating at night more often like once every hour), DYSURIA (Urine with extreme urgency and burning sensation), ABDOMINAL DISCOMFORT (Burning sensation in stomach after eating), TASTE DISORDER (Has some taste issues), PAIN IN EXTREMITY (Leg pain), FATIGUE (Fatigue) and ARTHRALGIA (Left Hip pain) outcome was unknown.            Concomitant products include Blood Pressure medication 40 mg, another one is 5 mg Treatment information includes Acetaminophen, Psyllium Action taken with mRNA-1273 in response to the events were not applicable.
On 10/5/22 pt?s Left arm redness then warmth to touch. Progressed with redness and warmth. Pt came in to my office on 10/7/22 to report. I marked area of redness. Pt with no fever. Requested or call her of Physician to be seen or urgent care. On 10/7 22 pt went to walk in clinic, diagnosed with cellulitis left arm and they stated combination of warfarin treatment contributed.
I was taking medication for hypertension. While it has been slowly getting better over the last year, it was still high enough to take meds, generally around 160/100 without. After the first vaccine it went very low, like 90's/50's, very rare for me. After second dose it went up and I took a pill that next day as it was 178/105. That night it went VERY low, and that is the last medication for hypertension I have taken. My BP has remained low, and most all nights it gets to the 90's/50's. PCP, Nephrologist, and myself are monitoring.   I also have had issues over last two weeks such as hot flashes/sweats (thought it was due to low BP), and started having blood in my urine last week, with some feeling like it was my period. I haven't had a period since my transplant 22 years ago, so this is odd and I have a dr appoint scheduled for next week to look into it.
This case was reported by a physician via sales rep and described the occurrence of shingles in a 51-year-old male patient who received Shingrix for prophylaxis. On 9th October 2018, the patient received the 1st dose of Shingrix .5 ml. On 11th October 2018, 2 days after receiving Shingrix, the patient experienced shingles, painful rash and blister. On an unknown date, the outcome of the shingles, painful rash and blister were unknown. It was unknown if the reporter considered the shingles, painful rash and blister to be related to Shingrix. Additional details were provided as follows: The batch number was unknown. The patient experienced a painful blistering rash in a dermatomal pattern on the arm, chest and neck that did not cross the midline. This was verified as shingles by MD and by Dermatologist. Culture of blisters was not done at these visits but would be considered as follow up. The physician agreed to be contacted for follow up.
Presented with intermittent abdominal pain and was found to have an intussuception near the cecum which was reduced surgically without complication.
Information has been received from a female consumer (age unknown) who, on an unspecified date, was vaccinated intramuscularly with a second dose of Gardasil. Subsequently, on an unknown date, the patient experienced nausea and dizziness after receiving the second dose of vaccine which was administered with a regular needle. Symptoms subsided after 15-20 minutes. The reporting physician stated that the patient was not affected by the first dose of vaccine which was administered with a safety syringe. The patient sought unspecified medical attention. Subsequently, the patient recovered from nausea and dizziness. No product quality complaint was involved. Additional information has been requested.
Felt fine initially.  About 4 hours later got very light-headed and fainted while walking to rest room - resulted in 7 stitches (head laceration) and 2 broken ribs from fall.  A "vaccident".  I was taken to the ER for treatment and spent 2 nights in the hospital.  Over the next 8 or so hours I experienced fatigue, chills/shakes, nausea (threw up 3-4 times), and fainted a second time (while lying down).
Client states has had pain to L arm since injection.  States has achiness to L arm at injection site and up into her shoulder.  (Injection was 10-6-08)
Pain radiating up the neck into the scalp and down the jar on right side after flu shot. Patient was examined and it was determined that she is suffering from a migraine headache. Medications were prescribed and a referral to a neurologist was recommended.
swelling in my left arm /  / arm is very swollen; whole  upper body on the left side only is swollen; seems to be getting worse / this morning it is a lot worse; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling in my left arm /  / arm is very swollen), SWELLING (whole  upper body on the left side only is swollen) and CONDITION AGGRAVATED (seems to be getting worse / this morning it is a lot worse) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included HYDROCORTISONE for an unknown indication.    On 26-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (swelling in my left arm /  / arm is very swollen), SWELLING (whole  upper body on the left side only is swollen) and CONDITION AGGRAVATED (seems to be getting worse / this morning it is a lot worse). At the time of the report, PERIPHERAL SWELLING (swelling in my left arm /  / arm is very swollen), SWELLING (whole  upper body on the left side only is swollen) and CONDITION AGGRAVATED (seems to be getting worse / this morning it is a lot worse) outcome was unknown.            Patient were taking chemo drugs as concomitant. No treatment drugs were reported
BREAKTHROUGH COVID: Fully vaccinated with booster: Acute hypoxic respiratory failure with sepsis secondary to covid-19 infection, and acute pulmonary embolism. Patient was treated with remdesivir, baricitinib, and IV dexamethasone, lovenox, bronchodilators, antitussives, and heated high flow nasal canula as much as 8L of oxygen support.
This spontaneous report was received from a nurse who referred to an unspecified number of patients of unknown demographics. No information regarding the patients' pertinent medical history, concomitant medications and drug reactions or allergies was provided. On unknown dates (reported over the past year), the patients were vaccinated with improperly stored doses of GARDASIL 9 (dose, route of administration, lot# and expiration dates were not reported) as prophylaxis. The vaccines were stored between 47 degrees Fahrenheit (F) and 77F (49F) for 8 hours and 30 minutes and between 32F and 35F (32F) for 16 hours and 30 minutes. No previous temperature excursions were reported. The excursions were detected by a data logger. No adverse effects were reported. No product quality complaint was involved. This is one of three reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA005788: US-009507513-1707USA007385.
Presented palpitations 10 minutes after receiving the vaccine. Stayed in observation and felt better. It has been stable.
Well appearing adult female with isloated upper lip swelling consistent in appearance with angioedema.  No airway involvement at this time.  No prior lifetime episodes.  No family history of similar events.  The only thing that was a new potential exposure in the past day was her first dose of the Moderna COVID-19 vaccine yesterday morning. 19yo F presents for eval of upper lip diffuse swelling.  Onset was noted about 3am today when patient awoke.  She took 2x tabs oral Benadryl. Presents for eval due to persistent swelling.  Patient previously healthy.  No surgical history.  Takes no meds on routine basis.  NKDA.  Patient had received Moderna COVID-19 vaccine, first dose, yesterday morning between 9-9:30am.  No new food exposures.  No new facial products nor soaps.  No new clothing, laundry detergents, etc.  Patient states she has no known food, seasonal, occupational, or contact allergies.  She has never had similar episodes of facial swelling.  No recent dental work.  Denies fever, chills, N/V/D, URI symptoms.  Denies any adverse reactions to any other lifetime vaccinations.  No significant past family history.  "Some high blood pressure in relatives."  No known history of any family members with angioedema.
sore upper left arm in the bicep; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore upper left arm in the bicep) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product VENETOCLAX (VENCLEXTA) for Acute myeloid leukemia.    Concurrent medical conditions included Acute myeloid leukemia.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started VENETOCLAX (VENCLEXTA) (Oral) at an unspecified dose. On 14-Apr-2022, the patient experienced PAIN IN EXTREMITY (sore upper left arm in the bicep). The patient was treated with PARACETAMOL (TYLENOL) for Pain in arm, at a dose of Extra-strength. At the time of the report, PAIN IN EXTREMITY (sore upper left arm in the bicep) had not resolved.            No concomitant medications were reported.  In August 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   Reported that extra-strength Tylenol was helpful.  It was unknown if he was enrolled in a Covid-19 Vaccine Trial. Reported that physician directed Venclexta seven days per month with infusion therapy and the 21 days off.   The reporter's causality for the event of let upper arm soreness with Venclexta(venetoclax) was a 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.
No Adverse Event; Monovalent vaccine administered on 5APR2023. 2nd dose administered after the published expiration date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Monovalent vaccine administered on 5APR2023. 2nd dose administered after the published expiration date.) and NO ADVERSE EVENT (No Adverse Event) in a 22-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 047C22A) for COVID-19 prophylaxis.     Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 05-Apr-2023, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 05-Apr-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Monovalent vaccine administered on 5APR2023. 2nd dose administered after the published expiration date.). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Monovalent vaccine administered on 5APR2023. 2nd dose administered after the published expiration date.) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Monovalent vaccine administered on 5APR2023. 2nd dose administered after the published expiration date.).    No concomitant medication details was reported. No treatment medication details was reported.
Patient's wife  reported to me that the patient is being treated for Guillain-Barre Syndrome
Syncope -> head injury with HA and vomiting -> sent to ER for head CT (neg).
she fell 6 days ago and she hit her head; she fell 6 days ago and she hit her head; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program Support. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FALL (non-serious), HEAD INJURY (non-serious), outcome "unknown" and all described as "she fell 6 days ago and she hit her head".  Additional information: The caller said that she cannot make it to the vaccination center her 2nd dose vaccine today because she fell 6 days ago and she hit her head.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Shortly after I received the vaccine, and stood up, I felt a bit light-headed so I continued to walk around the store for a few minutes.  Later in the afternoon, my right arm where I had the vaccine was very painful, reducing the ability to raise my arm, which continued through the following day.  On Day 3, it was still a bit sore, but improving. On Day 4, I was totally fine.
Headache,muscle ache,injection site pain, tiredness, chills,joint pain, feeling unwell.
Treatment of COVID-19; Treatment of COVID-19; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High cholera" (unspecified if ongoing), notes: High cholera. Concomitant medication(s) included: ROSUVASTATIN, start date: Jun2022, stop date: 01Oct2022; EZETIMIBE, start date: Jan2015. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 19Sep2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The patient had no known allergies. The patient received paxlovid for the treatment of COVID-19 from 01Oct2022 to 05Oct2022. The patient had no adverse event with paxlovid.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.