chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Narrative:  Admission Date: Oct 13,2021 Discharge Date: Oct 17,2021 Condition of patient at discharge: Deceased Primary Diagnosis during Admission/Treatment: COVID Pneumonia Secondary Diagnosis(es) during Admission/Treatment: Severe COPD, bacterial pneumonia 69yo male with past medical history of COPD (on 3L 02 at home), CAD s/p high risk PCI (1/14/20), HTN, HLD, PVD, CKD, hypothyroidism, tobacco abuse, depression and alcohol abuse presented to the Emergency Department with dyspnea and lightheadedness on 10/12/2021. Patient stated he has become progressively more dyspneic over the previous 48 hrs. EMS was called with reported sats in the 70's on arrival. Endorsed increased cough productive of green sputum, usually clear. Denies any fevers, chills, chest pain, wheezing, sick contacts, N/V, abdominal pain, leg pain/swelling, or diarrhea. In the Emergency Department, patient was afebrile, HR 104, RR 20, BP 81/58. Labs notable for WBC 10.88 with left shift, Cr 2.14 (b/l ~ 1.4), BNP 688, trop 0.3, lactic acid 0.9, COVID positive. Patient had received 2 doses of the moderna vaccine on 1/14/2021 and 2/11/2021 . CXR notable for left lung opacity suspicious for Pneumonia. Blood cx drawn in ED. Given 2L IVFs and started on cefepime and azithromycin. The patient was admitted 10/13/2021 for respiratory failure secondary to COPD exacerbation in addition to COVID Pneumonia and likely superimposed bacterial pneumonia given consolidative process on imaging with elevated procal to 5.81. Patient was started on broad spectrum antibiotics with cefepime and azithromycin and was further broadened to vancomycin and meropenem due to worsening respiratory status. Infectious workup including blood cultures were unremarkable. Started on treatment dose lovenox 80mg twice given concern for PE with elevated d-dimer and RLE DVT on doppler ultrasound. Patient was initially stable on nasal cannula, but had to be escalated to HFNC due to worsening oxygen requirements. Unfortunately, patient's respiratory status continued to decline despite substantial support in addition to worsening shock and levophed was used for blood pressure support. Patient became obtunded and developed worsening respiratory distress warranting consideration for intubation. Talked to next of kin who ultimately decided for comfort care due to declining status. Patient passed on 10/17/21 at 12:28pm. Symptoms:  & HOSPITALIZATION and DEATH from COVID pneumonia in fully vaccinated patient Treatment:
mom states pt stated feel weak & faint;pt falls in restroom, head hit toilet stall, body hit floor, limp position, unresponsive x 30sec;T100.2;
This spontaneous report was received from an administrator referring to a patient of unknown gender and age. The patient's concurrent conditions and medical history were not provided. On 06-SEP-2018, the patient was vaccinated with an improperly stored PROQUAD (dose, route and anatomical location were not reported, lot number reported as R011216, expiration date 15-OCT-2019) for prophylaxis. The temperature and the time frame of the excursion was for 8 hours from 15 degrees to 46 degrees Fahrenheit (42.5 degrees Fahrenheit). There was no previous temperature excursion. The reporter also mentioned that the sterile diluent used to reconstitute PROQUAD did not undergo a temperature excursion. No adverse effects were reported.
the night of January 28-29 at around 2:00 a.m. a burning sensation on both arms woke me up.  it was burning from shoulder to elbow.  I figured it was a reaction to the shot and didn't take any medicine for it because i didn't want to ruin whatever it was doing to help me prevent COVID.  I have arthritis and feel that since that first shot my arthritis has flared up.  My whole body is in pain now all the time.
Pt came into pharmacy with arm red & swollen around injection site. She said it felt hot and tender to touch - told her to go to take care clinic - she is going to Dr. tomorrow. (rt arm) 1/15/13.
Patient reported feeling itchy during 15 min observation, nothing noted on skin. Resolved at end of obs period.
10 PM 10/13 hives on face, arms, neck, chest and swelling of eyes, face. No difficulty breathing. To ER 2 AM 10/14/03. Received medications there. At 4 PM 10/14 hives and swelling reoccurred, eyes "hurt", took Prednisone and 1 hour later symptoms gone. 10/22 complete recovery.
Patient developed a 3cm erythematous, warm, circular area at site of injection the morning after she received it. Treatment - Benadryl PO prn, Motrin prn, cool compresses.
moderna bivalent blue cap which was administered 23 hours after it was punctured; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (moderna bivalent blue cap which was administered 23 hours after it was punctured) and NO ADVERSE EVENT (no adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (moderna bivalent blue cap which was administered 23 hours after it was punctured) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (moderna bivalent blue cap which was administered 23 hours after it was punctured) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (moderna bivalent blue cap which was administered 23 hours after it was punctured).    Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter.   Reporter did not allow further contact
The patient received the first dose of GARDASIL 9 on 11/10/2021 and did not get the second dose yet.; No additional AEs were reported.; This spontaneous report was received from a pharmacist referring to a 41-year-old patient of unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions/allergies were not reported.  On 10-NOV-2021, the patient was vaccinated the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection for prophylaxis (dose, strength, lot #, expiration date and route of administration were not provided) and did not get the second dose yet (inappropriate schedule of product administration) (also reported as "the patient's hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) schedule was interrupted"). No additional adverse events were reported (no adverse event).
consistent pain in injection site, left arm. Left arm unable to lift or carry objects, even slight amount of weight.  Left arm is difficult to lift up.
Woke up at 2AM and was not able to breathe. Tongue and throat were swelling, heart was racing, crawled to front room to call 911. Was dizzy, weak, throat and tongue were swelling.
Patient denied having previous COVID vaccinations and gave incorrect birthdate. Computers lost connectivity at outreach clinic and registrar and nurses were unable to search for patient's vaccination record online. Patient given dose of Janssen COVID vaccine. Later, nurse discovered patient had previously received two doses of Pfizer vaccine ( one each on 2/13/2021 and 3/6/2021). Patient admitted to giving incorrect information after dose had been administered.
Started with headache and tired, then chills, then left breast itchy, then arm and armpit became sore, body aches and backache all night. I took Bismuth 525mg at 9am, acetaminophen 1000mg at 11am, felt better for a few hours, took acetaminophen 500mg at 6pm.
June 22nd, in the evening, a very sudden onset of chills  - almost like I was having a seizure - it hit hard and fast. I was asking for blankets. My lips turned blue. My teeth were chattering. My fever got up to 102. I couldn't move and was exhausted. I had muscle cramps in my torso and then got dehydrated. I took a Robaxin - about 30 minutes - after chills fever started. It felt like sepsis. It seemed like a relapse of what I had been through with  prior infection except before the vaccine when I had the infection  I didn't have the  nausea and vomiting.  I had rapid heartrate and low blood pressure. I was transported by ambulance to ER - I was nauseous and vomited. I'm still feeling fatigued and  - not myself - "feeling a little stupid."  Could be from my body having gone all the infections. I am not working - I took until August 10th off. I still get pretty tired easily and by 8 at night - I don't even feel  process of getting sleepy - I just get knocked out all of a sudden. I don't take Flexural or Trazodone at night because of just falling asleep so quickly.  Note: I may have had the second dose of the Shingrix vaccine a month before this vaccine - and the first dose was a couple years before that. I don't remember the date I had the Shingrix 2nd dose but it was possibly within a month before.
Initial report received from a health care professional on 06 July 2010. A 54-year-old female patient who was a physician, no medical history reported, received on 25 June 2010 a left deltoid intramuscular injection of ADACEL, lot number not reported. Nine days later, the patient developed herpes zoster brachial plexus. The patient self prescribed VALTREX 1000 milligrams (mg) daily (qd). The patient stated the herpes zoster involved C7-C8 dermatome. The outcome was not reported. Documents held by sender: None.
Smallpox vaccination on 2/25/2003 with a major reaction documented on 3/4/2003. Started itching on day 1, with onset of fever, chills, pain and lymphadenopathy within a week, all of which persisted for 2 months. Blistering and pustule formation from 3/9/03, scab fell off approximately 1 month after vaccination. Approx 4/30/2003 he noticed a small lesion, gradually increasing with vesiculation at the vaccination site. Associated with fever and chills. He also noticed a growth on his nasal bridge which started 1 month ago. Evaluated by a dermatologist on 5/5/03: 8 mm erythematous, vesicular plaque noted with surrounding tape irritation. 1mm filliform verrucoid papule noted on superior aspect of nasal bridge.
Tingling like pins and needles sticking in my hands and feet for a few days snd Went to hospital ER on June 22. They thought maybe a clot, did cat scan, no clot sent me home with warning about high blood pressure. Saw clinic doctor next day about BP and tingling. Told me to eat less salt.  BP is normal now but still having pins and needles in hands and feet.
redness, swelling at injection site, heat, itching on neck, arm and redness swelling on the inside of the elbow joint
Information has been received from a consumer concerning a male who on an unspecified date was vaccinated with a dose of MMR II (dose, route and lot number not reported). The reporter stated that "MMR may have silenced my son". It was not specified if the patient sought medical attention. No further information is available.
Breakthrough case admission after 3 vaccines Moderna 2/23/21 lot# 023M20A;  Moderna 3/23/21 lot# 007B21A;  Moderna 11/22/2021 Lot# 058H21A
100 F fever; Chills; Fatigue; Muscle ache; Weakness; Headache; Eye pain; mild sore arm; This is a spontaneous report from a contactable healthcare professional (patient). A non-pregnant 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: ex9231) via an unspecified route of administration, administered in left arm on 19Jan2021 at 14:00 (age at vaccination was 57-year-old), as dose 1, single for COVID-19 immunization. The patient's medical history included COVID-19. Concomitant medications (medications in two weeks) were reported none. The patient did not receive any other vaccine within 4 weeks. Patient has no known allergies. Prior to vaccination, the patient has been diagnosed with COVID-19 and post vaccination, the patient has not been tested for COVID-19. The facility type where COVID-19 vaccine was administered was reported as other. On 20Jan2021 at 10:00, the patient experienced 100 F fever, chills, fatigue, muscle ache, weakness, headache, eye pain, and mild sore arm. The patient underwent lab test and procedure which included body temperature with a result of 100 Fahrenheit (fever) on 20Jan2021 at 10:00. No therapeutic measures were taken as a result of the events. Outcome of the events was recovered on an unspecified date of 2021.  No follow-up attempts are possible. No further information is expected.
Rash described by dermatology 10/5/2012 erythematous non-indurated scaly and pruiritic patches of bilateral axilla. A&P: Eczematous skin changes of benign nature. Treated with steroid cream by derm, with Absorbine Jr then salicylate/sulfur shampoo.
pt started w/sore throat evening of 8JUL95 sneezed all day Sunday, Sunday noc had temp of 101.0; given 2 doses of APAP alternating w/Advil; hoarse non-productive cough also started Sunday noc; mom called MD; mom felt is an allerg react
i had no adverse reaction til about 12 hours after the vaccine.  terrible headache in back and front of head, nauseous and throwing up.  i was not right for over a week.  heart was pounding and head.  i was very ill for about 24 hours - i almost called an ambulance to go to the er cause i could not have driven. after 8 days i went to a cardiologist as i was still not right. not myself.  exhausted.  could feel my heart beating and pressure was higher than normal.
pt recv 2 doses vax pt devel a fever of 100.2 7 an inj site rxn characterized by a first-sized area of redness, warmth & tenderness;warm compresses reapplied to the site every 20min;fluid filled blister over elbow;pruritic;tx DPH & APAP;
Vaccine was administered at 1215, patient was monitored for 15minutes per CDC guidelines with not adverse reactions noted. Approximately one hour after administration of vaccine patient noted to be moaning, fingerstick BS at 59mg/dL, Dextrose administered, pt proceeded in to cardiac arrest, CPR was initiated and EMS activated. Pt expired approximately 4 hours after incident at ER.
red, warm, extremely swollen spot  but located about 6 inches below the injection site instead of at the injection site as expected.
redness at injection site.  It is very hot and red and swelling  states it is now pink and has cooled down some.
Rib pain in 3,4,5 rib in late March 2021. Pain in ribs spread to whole rib cage. Severe headache, nausea and vomiting Saw doctor on 16Apr2021. Diagnosed as Multiple myeloma. Oncologist on 11 May2021.
Within 2 minutes of vaccine, edema and erythema of left thigh, then flushing/erythema of both legs and arms.  Benadryl 1 tsp given.
Injection site itching; Red rash at the injection site and it is blotchy, itchy; Vaccination site swelling; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (Injection site itching), VACCINATION SITE RASH (Red rash at the injection site and it is blotchy, itchy) and VACCINATION SITE SWELLING (Vaccination site swelling) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced INJECTION SITE PRURITUS (Injection site itching), VACCINATION SITE RASH (Red rash at the injection site and it is blotchy, itchy) and VACCINATION SITE SWELLING (Vaccination site swelling). On 05-Apr-2021, INJECTION SITE PRURITUS (Injection site itching), VACCINATION SITE RASH (Red rash at the injection site and it is blotchy, itchy) and VACCINATION SITE SWELLING (Vaccination site swelling) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant product details were provided by the reporter.  Patient advised the reported AE from the 1st vaccine resolved.  No Treatment information was provided.   This case was linked to MOD-2021-279725 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Follow-up received on 06-Aug-2021 and included non-significant information.
This spontaneous report as received from a Nurse practitioner refers to a patient of unknown age. On an unknown date the patient was vaccinated with improperly stored PNEUMOVAX 23 lot # M039060 for prophylaxis. Temperature was reported as 52.6 FR, timeframe: 2 hours 32 minutes. There was no previous temperature excursion. No adverse effects were reported. This case is linked with case 1707USA006122 and 1707USA006521. Additional information has been requested.
Fever, chills, aches, extreme fatigue - 24 hrs. Dehydration and aches, extreme fatigue - 48 hrs. Treatment: ibuprofen and rest and fluids. Swelling of inoculated arm - from upper arm to elbow and below, skin hot and red, tender - 4-5 days duration.
Last December, I started having severe fatigue. Went to doctor as always to ensure all blood levels, my iron levels were about 228. The normal range is 90. Since then, I have been to the hematologist and my levels have gone down a little bit. Last Friday I got retested and will get the results soon. There were no other symptoms that went with my high levels of iron, (ferritin).
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Apr2022 at 11:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 54 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) and as dose 3 (booster), single (Batch/Lot number: unknown). The patient's relevant medical history included: "Hashimotos thyroiditis" (unspecified if ongoing); "IBS" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Known allergy: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: 16Mar1998, stop date: 20May2022. The following information was reported: COVID-19 (medically significant), outcome "recovering", VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: By end of paxlovid, no symptoms and negative, antigen test. Therapeutic measures were taken as a result of covid-19.  Clinical course: Adverse event: Adverse event from paxlovid, not related to vaccine. Paxlovid recurrence with worse covid19 symptoms than original illness. Original illness was mild to very moderate congestion, sore throat, fatigue, very mild cough. By end of paxlovid, no symptoms and negative antigen test. Then 4 days after end of paxlovid, symptoms returned and worsened to include serious cough, shortness if breath, loss of taste, severe congestion, malaise, fatigue. I felt much worse 2nd time around. Cough and shortness of breath continue. This is unrelated to pfizer vaccine, which for me included original 2 doses then 2 booster when permitted. Known allergies: Penicillin. Other medical history: Hashimotos thyroiditis. IBS. Asthma.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information has been received from a licensed practical nurse concerning a 25 year old female, who works at a nursing home facility, who on 06-JUN-2006 was vaccinated (route unknown) with a dose of Pneumovax 23 (Lot # unknown), instead of a tuberculin purified protein derivative, and her arm is swollen. The nurse reported that the employee is scheduled to present to the clinic for a follow up. The patient's outcome was reported as not recovered. No product quality complaint was involved. Additional information has been requested.
a little soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old female patient received BNT162b2 (BNT162B2), on 27Apr2022 as dose 4 (booster), single (Lot number: FJ4989) at the age of 77 years for covid-19 immunisation. The patient's relevant medical history included: "Cholesterol" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing), notes: high blood pressure; "COPD" (unspecified if ongoing); "Menopause" (unspecified if ongoing), notes: it was like menopause again but worse. Concomitant medication(s) included: WIXELA INHUB taken for chronic obstructive pulmonary disease. Vaccination history included: BNT162b2 (DOSE 1,SINGLE, Batch Number: EN53190), administration date: 25Jan2021, when the patient was 76-year-old, for COVID-19 Immunization, reaction(s): "a little soreness"; BNT162b2 (DOSE 2,SINGLE, Batch Number: EL9266), administration date: 15Feb2021, when the patient was 76-year-old, for COVID-19 Immunization, reaction(s): "a little soreness"; BNT162b2 (DOSE 3 (BOOSTER), SINGLE , Batch Number: 330308D or 3303080), administration date: 26Nov2021, when the patient was 77-year-old, for COVID-19 Immunization, reaction(s): "a little soreness". The following information was reported: PAIN (non-serious) with onset 2022, outcome "recovered" (2022), described as "a little soreness".  Additional information: Patient stated that with the other 4 she had within the last year she had absolutely no ill effects except a little soreness with the initial shot part. She stated that she was referring to Dose 1, Dose 2, Dose 3 and Dose 4 of the Pfizer COVID -19 Vaccine and she stated that with Dose 1, Dose 2, Dose 3 and Dose 4 she did not experience any adverse events, that she just experienced a little soreness. She stated that when she initially received those 4 shots and it was nothing and the soreness went away right away and she did not considered a little soreness as an adverse event.  Follow-up attempts are completed. No further information is expected.
no adverse event; Expired vaccine that was administered to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine that was administered to patients) and NO ADVERSE EVENT (no adverse event) in a 59-year-old female patient who received mRNA-1273 (Spikevax) (batch no. O70H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine that was administered to patients). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine that was administered to patients) 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 (Expired vaccine that was administered to patients).    Concomitant medications were not reported.   Patient age was reported as 59 years and 6 months.   ID number was reported as 80777027399.  It was reported that also another lot of vaccines lot number 065F21A was also expired and administered to patient and lot number O70H21A was administered to patient between 08-Apr-2022 and 15-Dec-2022.  Treatment medications were not reported