chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient, of 80-year-old male, with significant past medical history of hypertension, paroxysmal atrial fibrillation, hyperlipidemia, coronary artery disease s/p stent, and BPH.   Patient comes from urgent care after being found hypoxic.  He refers that for the last 3 weeks felt weak, with loss of appetite and poor oral intake.  He went to a to the urgent care to get it evaluated and he could get some IV fluid because he felt dehydrated.  Patient refers that in the past when he gets severely dehydrated had episodes loss of conscious and this time he wanted to avoid that. He states that on February 4th got tested positive for COVID-19 because his fiancee tested positive the previous day.   He quarantined and was asymptomatic.  On February 27nd got first dose of COVID-19 vaccine.  But since he   tested positive feels that has no energy. Besides this patient denies fever chills shortness of breath, chest pain, abdominal pain, diarrhea nausea, vomiting, headache, lightheadedness, loss of sense of smell or taste.
2019 Novel Coronavirus RNA detected 11/26/2021 Hospitalized 12/3/2021 DX  Pneumonia and ARDS
Tightness in chest similar to indigestion/acid reflux. Fairly persistent. Would feel it come and go in waves but did from about 6pm until I went to sleep. At times it accompanied a somewhat disoriented feeling but not always.
diagnosed with shingles.; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 02Mar2021 at 14:45 (at the age of 59-year-old) as a single dose for COVID-19 immunisation. Medical history included mild hypertension, moderate high cholesterol, asthma, sulfa drugs allergy, penicillin allergy and fruit allergy (reported as citrus and tropical fruits). The patient received other medications (unspecified) within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Mar2021, the patient diagnosed with shingles within 26 days of vaccination. The event resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of shingles and included treatment with unspecified antiviral medication and antibiotics from an unknown date. The clinical outcome of the event shingles within 26 days of vaccination was resolved on an unknown date in the year 2021.   No follow-up attempts are needed. No further information is expected.
Fever 101.1, nausea, tenderness in arm.  No redness at site of injection.  No vomiting.
Within 3 minutes of administering the vaccine into the Right upper arm, mother notified medical assistant that she noted a red rash developing on the patient. Nurse checked on the patient, no swelling, or difficulty breathing noted and patient did not try reaching or scratching at the site. Pediatric Doctor notified, per Doctor patient to be observed for 20 minutes to monitored for reaction. After 20 minute wait time, patient re-checked. No breathing difficulties, swelling or increased fussiness noted. Patient was eating well and significant decrease in rash noted. Mother informed to contact office if any worsening of symptoms and to take to Urgent Care of nearest ER if any swelling, difficulty breathing or change.
9/21/15 left arm itching, 36 hours post injection left arm 13 cm x 14 cm raised red area with warmth, left arm tightness and swelling, soreness, intermittent fever, left arm itching and general malaise. Left wrist positive pulse and normal sensation to touch.
swelling lt deltoid-warm, red, tense, area twice size of rt calf; seen in ER: given Epi, Solucortef, DPH; ice to area;
Pt was given a flu shot at a clinical on 11-16-06. The nurse who gave the shot said "it didn't feel right" and questioned if the had given the shot with a syringe she had used on the previous patient.  Pt was sent to hospital emergency department for evaluation and testing.
Evening after dose given had low-grade fever, myalgias, headache. Took Ibuprofen that helped with symptoms the following AM.
10 minutes after pain in arm was shooting down to hand and to chest, 10 mins later stomach ache, 30 mins after adminstration tongue, face and throat swelled up. Hand of injection arm went purple, cold and numb. Toes went purple and cold. Had to get taken in ambulance to er hospital due to blood pressure and lack of oxygen. When arrived at hospital broken out in hive,blood pressure went up to 175/104 and severe pain in kidneys, stomach, lower abdominal, legs, arms.   Day 2 high blood pressure, fever, hives, stomach, kidney and lower abdominal pain. Painful to urinate and poop.
pt recv vax & became hypotensive this cont throughout this episode, chest discomfort, h/a, weakness, syncope & later somnolence;no problem p/ 1/2hr;no hives, no SOB;pt had an immed hypersensitive rxn to inj;
Localized skin reaction at site of DTaP. Initial erythema, swelling and warmth began several hours after receiving shot. Seen by provided about 48 hours later; 10cm x 15cm area. NO systemic symptoms, no respiratory component/complaints. Treated with Keflex and Benadryl. Mom reports similar reaction with prior DTaP.
Pt reported "most painful shot I've ever had" & still painful (8 days later). "It's itchy - further down my arm". Arm "feels weird" pain in posterior arm and down ulnar distribution to 4th & 5th digit.
Information has been received from a physician concerning a female teenager who was vaccinated in the arm with the first dose of Gardasil (dose and date not provided). It was reported that the patient experienced injection site pain after receiving the first dose. At the time of the report, it was unknown if the patient  recovered. Additional information has been requested.
Fever yesterday 10/8/03, small amount redness. Developed large 9cm diameter red, swollen, firm lump on left thigh today. Walking fine. No fever today.
flu like symptoms; Hypertension; sore arm; chest pain; Fever; Chills; Nausea; Worst headache; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), HYPERTENSION (Hypertension), PAIN IN EXTREMITY (sore arm), CHEST PAIN (chest pain) and PYREXIA (Fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product FOLIC ACID for an unknown indication.    Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN), QUETIAPINE FUMARATE (SEROQUEL), RISPERIDONE (RESIDON), ALUMINIUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETICONE (PEPSID), METOPROLOL TARTRATE (LOPRESSOR), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), SENNA ACUTIFOLIA, TAMSULOSIN HYDROCHLORIDE (FLOMAX RELIEF), LEVOTHYROXINE SODIUM (SYNTHROID), TESTOSTERONE PROPIONATE (TESTOSTERONE [TESTOSTERONE PROPIONATE]), CLOPIDOGREL BISULFATE (PLAVIX), UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (ANORO), OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) and VITAMIN B2 [RIBOFLAVIN] for an unknown indication.   On 02-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started FOLIC ACID (unknown route) 1 mg. On 03-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), HYPERTENSION (Hypertension), PAIN IN EXTREMITY (sore arm), CHEST PAIN (chest pain), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea) and HEADACHE (Worst headache). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), HYPERTENSION (Hypertension), PAIN IN EXTREMITY (sore arm), CHEST PAIN (chest pain), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea) and HEADACHE (Worst headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Apr-2021, Blood pressure measurement: 165/105 mmHg High.         Treatment details not provided Action taken with mRNA-1273 in response to the events was not applicable
Patient inadvertently received vaccine after date of expiration. Moderna Company analyzed vaccine and advised lot 007B21A maintained activity needed to protect against covid 19 on date vaccine was administered.  Patient also did not call in   to complain of adverse event.  This is administrative error without adverse event.
Minor soreness at injection site; This is a spontaneous report from a contactable consumer (patient). An elderly patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 25Jan2021 14:00 at single dose for COVID-19 immunization. Medical history included hypertension and known allergies with penicillin. The patient's concomitant medications were not reported. The patient experienced minor soreness at injection site on 25Jan2021. No treatment was given to the patient. The patient did not have prior covid vaccination and was not tested for covid post vaccination. The patient recovered from the event on an unspecified date.    Information on the lot/batch number has been requested.
Pt was suspected to have MS 12/06/02.  Reportedly had grand mal seizure 08/03/03.
Pt recvd 1st vax & later exp generalized allergic reactions (e.g. rash,tightness in throat & chest,nausea & swelling of eyes & eyelids).
Report feeling  of fatigue started day 0 and  mild diarrhea started on day 5.  Treatment: None Outcome: Does not interfere with ADLs continues  to work.
High fever (101-101.4); Headaches; Body aches; received the first dose of the Shingrix vaccine on 8/2/2020 /  second dose on 9/2/2020/ Inappropriate schedule of vaccine; This case was reported by a consumer via call center representative and described the occurrence of fever in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on 2nd August 2020, refer case US2020AMR186080).   On 2nd September 2020, the patient received the 2nd dose of Shingrix and Influenza vaccine Quadrivalent 2020-2021 season. On 2nd September 2020, less than a day after receiving Shingrix and Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced fever, headache, general body pain and drug dose administration interval too short. The patient was treated with IBUPROFEN (ADVIL). On 4th September 2020, the outcome of the fever, headache and general body pain were recovered/resolved. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   It was unknown if the reporter considered the fever, headache and general body pain to be related to Shingrix and Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided as follows: The patient reported for herself. Patient received the flu shot at the same time as the second Shingrix vaccine. The patient experienced high fever (101-101.4), headaches, and body aches within 12 hours of receiving the second dose on 2nd September 2020.  The patient received 1st dose on 2nd August 2020 and 2nd dose on 2nd September 2020 which led to shortening of vaccination schedule. On 3rd September 2020, patient took three Advil 200mg tablets to help reduce the fever and the fever reduced. On 3rd September 2020 at night (around 6pm) patient took two to three more Advil tablets.  All information was not available. Lot number and expiry was unavailable.  HCP was not yet aware of the adverse events, but patient would be following-up with them. Patient gave permission to follow-up with their HCP and provided the contact information. The reporter consented to follow up; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR186080:same reporter
The vaccine was Pfizer and it was a booster as I was fully vaccinated.  Within two days I developed significant gum inflammation in my entire mouth as well as ulcers on the roof of my mouth.  I head headaches with it and some diarrhea.
Hives starting approximately 1 week after first covid vaccination.   Hives started out small and got progressively worse for approximately 3 weeks, at which point I got my second dose.  A few days after the second dose the hives again got worse, and I stepped up Zyrtec from one dose per day to two, one in the morning and one at night.  Then I added a third Zyrtec each day approximately 1 week after the second dose to handle the escalating severity of the hives.  At this point, 6/13/2021, the hives are as bad as ever and I continue with 3 Zyrtec per day.
Patient was brought in by her father with his other daughter. They were seated next to the medical staff with the father holding the patient in his lap closest to the medical staff. His other daughter was beside him in a seat next to the window. Patient was to get an Influenza shot and her sister was to get the covid vaccine. The medical staff was working on paperwork and gathering equipment then turned towards her father and the patient he proceeded to raise her shirt sleeve. The medical staff then administered a Pfizer dose of 0.2 ml to the patient in her left deltoid. The medical staff and I immediately realized what had happened. Notified the Lead. We discussed with the father who was happy that she had received the vaccine.
erythema, ecchymosis, pain & edema @ inject are reported in a pt who recvd 1 dose of flu vax; above sx occurred 12 hrs p/flu vax given & resolved w/in 48 hrs;
Employee stated she was taken to ER in ambulance, began to feel painin jaw started experiencing numbness to left side of face. She felt her heart was racing around 9 pm and called ambulance. She admitted having a history of PVC's 2004-2008. States no current health problems. She took Fluzone and to her understanding it has greater side effects than Flulaval which she took last year with no problems. The employee was given 2 days off to recouperate. I instructed her to f/u with her primary MD which had not been done at the time of this report.
Numbness and swelling in both feet and two outside fingers of the left hand. Swelling went away after 10 days but numbness continues in all areas. Nueropothy is now affecting both feet. Has also effected my balance
This case was reported by a nurse via call center representative and described the occurrence of inappropriate schedule of vaccine administered in a 31-year-old female patient who received TWINRIX adult. Co-suspect products included ENGERIX B adult (batch number F2LR7, expiry date 9th October 2016, and Hepatitis A vaccine. On an unknown date, the patient received TWINRIX adult, ENGERIX B adult and Hepatitis A vaccine at an unknown dose. On an unknown date, an unknown time after receiving TWINRIX adult and not applicable after receiving ENGERIX B adult and Hepatitis A vaccine, the patient experienced inappropriate schedule of vaccine administered and wrong vaccine administered. On an unknown date, the outcome of the inappropriate schedule of vaccine administered and wrong vaccine administered were unknown. Additional details were provided as follows: The age at vaccination was not reported. The patient started TWINRIX schedule and then for the second dose in the series received ENGERIX B and Hepatitis A (unsure if it was HAVRIX), which led to inappropriate schedule of vaccine administered and wrong vaccine administered. It was not sure if it was accidental or intentional.
Patient is a 14 year old female who is here for nurse visit for her GARDASIL vaccine. She complained of feeling tired and dizzy, denies a headache or fever. After she received her GARDASIL. Mom witnessed her eyes roll upwards, patient then became limp and her body was twitching for a minute or 2. I witnessed the second episode. She became pale, diaphoretic, and her eyes rolled up. She then became limp and had some upper extremity twitching for about 10 seconds. She had some drowsiness after this episode. She was oriented and answered questions appropriately. PMH: mononucleosis in 2010, Headaches seen by Dr and a normal brain MRI. ROS: positive for fatigue, chronic headaches, No fever, no pulm or GI Sx, no rashes. FH: neg for seizure disorders. General: WDW, Slightly Drowsy, Responsive; Eyes: nl; Ears: nl TMs; Nose: nasal passages clear Pharynx nl; Neck: supple, no masses, no lymphadenopathy; Resp: clear to auscultation bilaterally; CV: RRR, normal S1/S2, no murmurs; ABD: soft, nontender, no masses, no hepatosplenomegaly; GU: not examined; Extremities: nl; Skin: no rashes or lesions. Assessment: Syncope possible seizure disorder immediately after having a GARDASIL vaccine. Plan: Pulse OX=100, Glucose, O2 At 2 liters, Paramedics called Plan to hospital and admission to choc. Vaers report for GARDASIL vaccine. Follow up as needed.
Two days after receiving the first vaccine, I woke up with a red itchy rash on both my arms.  The rash continued to get worse each day.  It then went to both of my legs.  I ended up going to the dermatologist for a topical lotion to use.  It has been a month.  The rash has gotten better, but still itches at times.
no additional AE was reported; was given PROQUAD instead of MMRII; PROQUAD was inadvertently administered concomitantly with VARIVAX; This spontaneous report was received from a medical assistant referring to a 12-month-old male patient. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 24-MAY-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 milliliter (route of administration, lot number and expiration date not reported) and inadvertently received measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) 0.5 milliliter, lot number U039255, expiration date 09-JUN-2023 (route of administration not reported) for prophylaxis instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (lot number and expiration date not reported) (wrong product administered and accidental overdose). No adverse event was reported.
Myocarditis or Pericarditis. Inflammation in the pectoral muscle and tissue surrounding the heart. Pain, difficulty breathing normally, inflammation, soreness.
9 days after the injection itchiness started on my left upper arm.  After several scratches to alleviate the itchiness I checked the site & noticed that where the vaccine was administered was red & warm to the touch.  It progressively started getting more itchy.  Then the muscle soreness started.  It felt as if I just had the injection.
Pt had high fever (undocumented) & very fussy in night in spite of APAP; @ unk time in nite mom found pt listless & pale, never lost consciousness or had observed convuls;
my 2 daughters were injected were all poorly by the end of the day; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION COMPLICATION (my 2 daughters were injected were all poorly by the end of the day) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Dec-2021, the patient experienced VACCINATION COMPLICATION (my 2 daughters were injected were all poorly by the end of the day). At the time of the report, VACCINATION COMPLICATION (my 2 daughters were injected were all poorly by the end of the day) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication was reported.   This case was linked to MOD-2021-423278 (Patient Link).
Headache, Myalgia & Fever Narrative:  2nd dose chills HA sore arm, throat, ears, fever day 1-2
fatigue, headache 6 hrs after  vaccine (same as 1st dose),  ~11 pm, severe chills, nausea, joint pain, short of breath ~ 2 am increased heart rate (112, usually in 80's) fever over next 3 days fever, joint pain, injection site redness and area on arm below -day  - continued redness in arm
Pt had brief syncopal episode immediately following completion of 3 vaccinations (Hep A, Typhoid, Flu shot) at around 10:30.  Pt was brought to ER for observation and treatment.  Pt received 1 liter of NS and released once recovered.  At 11:30 Temperature 98.5, pulse 79, RR 19, BP 119/76, Sat O2 98%.  At 15:00 Temperature 98.7, pulse 85, RR 16, BP 125/63, Sat 96%.
A 1/2 hour after injection, my face got really flushed. No rash or itchiness. Just  hot and red. It lasted an hour 1/2 to 2 hours. My upper arm muscles were very sore for two days.  I took two Tylenol after checking with my doctor.  First pregnancy; EDof Delivery 8/14/2021
Dizziness within 30 minutes of injection, severe muscular pain and stiffness 1 hour after injection, low grade fever 2 hours after injection, difficulty breathing 6 hours after injection, blurred vision 12 hours after injection.
Pt stated he was admitted to the hospital with blood pressure issue 180/120, rapid heart rate of 118, general body aches and pains.. Given fluids. All Scans and EKG were clear.
Congestive heart failure; Herpes zoster; This spontaneous report has been received from a lawyer, regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not provided. On an unknown date, the patient was inoculated with zoster vaccine live (ZOSTAVAX) vaccine (dose, route of administration, anatomical location, lot # and expiry date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, after receiving zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered herpes zoster and congestive heart failure. As a result of these symptoms, the patient was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms resulted in physical limitations not present prior to using the vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result of the zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not recovered. The reporter determined the events to be related to zoster vaccine live (ZOSTAVAX).  The events of congestive heart failure and herpes zoster were considered to be disabling.  Upon internal review, the event of congestive heart failure was determined to be medically significant.