chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rec. vaccine Tuesday night. Wed AM - was very sick, nausea, very dizzy & lightheaded, low grade fever (94) chills. I was never this sick from a flu vaccine. General malaise. I will never get a flu vaccine again sick for 3-4 days.
Pt. c/o "feeling high" like she had some drink.  She felt light headed. Denies SOB denies chest pain.  @ 1040 BP 160/100, HR 84, RR 18.  @ 11:49 BP 160/82.  @ 1050 BP 160/90, HR 80, RR 18, no dizziness, Ox.Sat 97%,  160/82.  Stated she is fine and wants to go home.
Patient is a 69 y.o. female admitted to the hospital on 11/18/2022 for weakness and fatigue.  Patient found with COVID and with abnormal urinalysis.  She improved with Zosyn then transition to Keflex on discharge.  Patient stable for discharge home on 11/23/2022.   Discharge Diagnosis and Associated Hospital Course   Severe sepsis COVID-19 infection -Likely secondary to COVID, possibly UTI.  Patient's husband with COVID infection. -COVID-positive 11/19/2022.  UA consistent with UTI; urine culture not sent.  Blood cultures NGTD. -CT C/A/P with possible colitis. -De-escalate Zosyn to Keflex for total 7-day course (last dose 11/25/2022).  Continue supportive care; and isolation 11/30/2022.  If new oxygen requirement, start steroids.  Continue home midodrine.   Acute on chronic hypotension -Possibly dehydration, consider sepsis.  Recently started on midodrine during last hospitalization September 2022 for septic shock.  Home BP 70s/40s. -S/p 1 L IVF in ED and albumin 25 g x 4 doses. -Continue home midodrine.   Fall from standing -Unwitnessed fall occurred while inpatient on 11/20/2022.  XR pelvis and CT head nonacute. -PT/OT consulted.  Continue fall precautions.   Metastatic pancreatic cancer Cancer related pain -Known history with mets to lung and abdomen, s/p Whipple July 2021, on palliative chemo.  Follows with Dr.  -Continue Oxley PRN, long-acting morphine.  Follow-up with Dr. outpatient.   History of PE -Diagnosed October 2021.  Continue home Eliquis.   Chronic anemia -Likely secondary to malignancy and chemotherapy. Hgb stable. -Follow-up outpatient.   Elevated troponin -Likely demand ischemia.  Troponin 71, delta negative.  EKG nonischemic.  TTE unchanged. -No further work-up Hypothyroidism -Continue home Synthroid.   Anxiety and depression -Continue home Effexor.   GERD -Continue PPI.   Malnutrition -In the setting of malignancy, POA. -Encourage oral intake.  Continue home dronabinol.
Low grade fever shaking chills with rigors Exquisite muscle, bone, joint pain making walking and remaining upright difficult. All Signs & Symptoms fully resolved by 9 am the following morning.
An hour after, I was dizzy, eyes were drying out and liquid coming out of my pupil. Arm was heavy with tremors in legs and arms all night and I still have them. Chest pains and pounding in my heart. Joint pains in hand and feet. Cant sleep at night and feel nervous and agitated and like ants feeling and headaches. The next day, the news that J and J vaccines had side affects. 6 months later, my legs are jumpy, cant sleepy and agitated and insomnia because my body in tingling all night. Eyes are dry. My mind goes blank and cant do normal stuff like before. My left arm is still hurting and does not have any strength, I was very active and cant do it anymore. Four day later went to the doctor, all test were normal and they couldn't understand because PT had no preexisting conditions. Doctors cant explain why I am having all these symptoms. Medications like Tylenol and try melatonin and chamomile tea. Scheduled to go Optomologiest and the eye still has a stain on white of my eyes.
Left Bell's palsy 3 days after receiving first dose of Moderna Covid 19 vaccine.
Moderna COVID-19 vaccine booster dose #4 administered in full dose (0.5mL) by error. No adverse event reported.
Pt mom was feeding peanut butter cracker (never had peanuts before) when noted eyes becoming red, swelling as well as mouth; Back to clinic DPH given approx 15min later pt vomited approx 1235 hives noted getting worse; Given Adrenalin;
Red knot at injection site, warm to touch about 0.5-1.0 cm in diameter Narrative:
Pt recv vax on 10/9/97; 12 hr post vax pt exp fever (102F), chills, headache & body aches
Pt received 2nd Pfizer vaccine at 12:52. at 13:05 Pt stated that her throat felt like it was closing up. Assessed pt throat looks clear. EMS called to evaluate pt. VS T96.7, P 107, BO 109/74, pOX 97%. Pt evaluated by EMS throat clear and lngs clear per EMS.   Pt taken to high risk for further observation. released at 13:50 with stable VS.
Breakthrough case admission after three vaccines Moderna 2/17/21 Lot# 006M20A;  Moderna 3/17/21 Lot# 001B21A;  Moderna 12/13/21 Lot# 58H21A
Intermittent Tightness and Pain in Chest still  24 occuring 24 hours after injection.
Adverse event was a daily nosebleed that occurred once a day, typically within about an hour or so after waking up.  Patient had not experienced any nosebleeds in at least 15 years prior to vaccination.  Nosebleed was anterior in nature from a single nostril and usually lasted between 3-5 minutes before subsiding.  Nosebleeds began approximately two weeks following first dose, started to subside approximately 10 days after nosebleeds began, but then started back up following second dose on 4/7/21 and did not completely subside until approximately 10 days thereafter.
Patient heard a loud pop as soon as the pharmacist administer the vaccine. Immediately upon standing the patient's arm was extremely sore.  Later the patient experienced pain, tingleness , and numbness going down into her elbow & hand.  After several weeks, the patient experienced pain radiating into her shoulder & neck. At this time, the patient did say her right arm is starting to hurt like the left arm .  The  patient went to see her doctor due to she thought she has rheumatoid arthritis but they wouldn't give her a referral.
This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Vaccination worker inadvertently administered 0.25 mL vaccine as the third primary dose instead of 0.5mL to an immunocompromised patient) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Immunocompromised. On 08-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 08-Feb-2022, the patient experienced ACCIDENTAL UNDERDOSE (Vaccination worker inadvertently administered 0.25 mL vaccine as the third primary dose instead of 0.5mL to an immunocompromised patient). At the time of the report, ACCIDENTAL UNDERDOSE (Vaccination worker inadvertently administered 0.25 mL vaccine as the third primary dose instead of 0.5mL to an immunocompromised patient) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications was reported. No treatment drug details was reported.
At 3:53pm, patient started feeling lightheaded and dizzy. EMS was called. Vitals and blood sugar was taken. Pulse: 97. BP: 122/88. O2: 98. Sugar: 89. Patient denied having breakfast. Patient has no past medical history. Patient claimed that she had a shooting pain in arm down to forearm from the first dose. Patient refused EMS to hospital.
Pt had her 2nd dose injection at 0930 in the morning, arrived 3 hours later at a different site (both same company facilities) C/O redness, itching and hives.  Pt vital signs taken and given Benadryl 25mg oral twice (50mg total). Redness subsided moderately and she was sent home after evaluation by MD.
Swelling and itching similar to a bee sting on day 8 post vaccine. Large red patch on upper left arm
Crest in her scalp and around her earlobe, broken out with shingles; had some pain that went from the injection site up through her neck and to the area of her skin; had some pain that went from the injection site; A spontaneous report was received from a consumer concerning a 76-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced crest in her scalp and around her earlobe, broken out with shingles (Herpes zoster), had some pain that went from the injection site (vaccination site pain), and had some pain that went from the injection site up through her neck and to the area of her skin (pain of skin).  The patient's past medical history was not provided. Concomitant product use included hydrocodone and gabapentin.  On 27 Feb 2021, prior to the onset of the events, the patient received the second of two planned doses of mRNA-1273 (Batch number: 022M20T) intramuscularly for prophylaxis of COVID-19 infection.   On 27 Feb 2021 the patient experienced pain that went from the injection site, up through her neck and to the area of her skin that seems to have broken out with shingles. The patient thinks that the shot reduced her immunity to give her shingles or got it from the vaccine. The patient also experienced crest in her scalp and around her earlobe.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The outcome of the events, crest in her scalp and around her earlobe, broken out with shingles, had some pain that went from the injection site, and had some pain that went from the injection site up through her neck and to the area of her skin, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Day after (JAN 14) vaccination injection area had  some  swelling, redness and sore to the touch / almost all symptoms were gone by next day  Day 4  (JAN 17) til present time there is some itching   Day 8 (JAN 21) in addition to itching my arm was red, warm and swollen Day 11 (JAN 24) my arm is red, warm and swollen from injection area down to elbow / still some soreness
Same day, had low-grade fever. The next AM had malaise. Then was ok for 2 days. On 10/29/00, had same redness and tenderness. On 10/30/00, very tender, red, warm and swollen on right deltoid and shoulder; thought it could be cellulitis but called your hotline and informed of.
Death; This spontaneous case was reported by an other health care professional and describes the occurrence of DEATH (Death) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3032230) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided.  There was a total of 97 doses consisting of 9 half boxes of vaccines in the vial.  Treatment information was not provided.  Company comment: This regulatory authority case concerns a patient of unknown age and gender with no medical history information reported, who experienced the unexpected serious event of death. The event of death occurred on unknown date. Temporal association with a dose of SPIKEVAX 2023-2024 PFS is unclear. The cause of death was not reported. It is unknown if an autopsy was performed. No further information about the event was provided. The benefit-risk relationship of SPIKEVAX 2023-2024 PFS is not affected by this report.    This case was linked to US-MODERNATX, INC.-MOD-2023-750249, US-MODERNATX, INC.-MOD-2023-750490, US-MODERNATX, INC.-MOD-2023-750486, US-MODERNATX, INC.-MOD-2023-750488 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-750249:Same Reporter US-MODERNATX, INC.-MOD-2023-750490:Same Reporter US-MODERNATX, INC.-MOD-2023-750486:Same Reporter US-MODERNATX, INC.-MOD-2023-750488:Same Reporter; Reported Cause(s) of Death: Death
pt began to fall asleep on mon's shoulder arouseable but immed back to sleep; somewhat limp; AP 110 7 regular, BP 94/60; resp reg 24;
Information has been received from a 56 year old male physician with seasonal allergies, gastrooesophageal reflux disease, and hyperlipidaemia and a history of a "knee scope" complicated by a methicillin-resistant staphylococcal aureus infection of the left knee, pneumonia of unknown etiology in 2003, a tumor bowel resection status post colectomy, and no history of immunosuppression who on 18-APR-2007 was vaccinated with a 1.0 ml dose of Zostavax. Concomitant therapy included allergy shots in both arms every other week (last dose 17-APR-2007) in same triceps region in both arms as Zostavax, LIPITOR, omepraxole, vitamins (unspecified), glucosamine, CELEBREX, and calcium (unspecified). On 18-APR-2007, the patient was vaccinated by a nurse on his staff. The injection began in the left arm, but the needle was too small and a small amount of vaccine was injected, so the remaining vaccine was injected in the right arm using a larger needle. 'Instantly," he experienced severe pain localized to both injection sites in the upper triceps region. The pain was non radiating and persistent. The pain was so severe that the patient had to apply ice and has taken codeine and tizanidine hydrochloride, and had cancelled multiple procedures at work for 29-APR-2007. There was no rash, no fever, no radiculopathy, and no numbness. On 18-APR-2007, the patient had also experienced swelling at the injection site as well as nausea with the initial onset of pain and felt chilled while applying ice to the area. Approximately one hour following the receipt of the vaccine, his vital signs were BP 140/85, HR 61, and 02 saturation 99 percent. Additional information has been requested. This is in follow-up to report(s) previously submitted on 5/14/2007.  Additional information from the physician indicated that the vaccine caused agonizing pain.  He reported that part of the vaccine was given in each arm.  Both arms were extremely painful for 12 hours requiring ice, analgesics, NSAIDS and bedrest.  The physician reported that he was used to biweekly allergy shots and he had no previous history of pain with injection.  The physician recovered on 15-APR-2007.  The physician considered his pain with injection to be disabling.  Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old male patient received BNT162b2 (BNT162B2), on 31Mar2021 as dose 1, single (Lot number: ER8733), in left arm, on 04May2021 as dose 2, single (Lot number: EW0169), in left arm and on 15Jan2022 as dose 3 [booster], single (Lot number: FJ8757) at the age of 35 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa drugs" (unspecified if ongoing), notes: Known allergies: Sulfa drugs. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Clinical course: Rebound COVID starting 2 days after completion of Paxlovid, with different symptoms (sore throat and fever originally and nasal congestion on the rebound case).  No follow-up attempts are possible. No further information is expected.
G47.39 MIXED SLEEP APNEA 4/24/2023 GASTRIC INTESTINAL METAPLASIA, UNSPECIFIED G47.39 MIXED SLEEP APNEA 4/24/2023 HX OF ADENOMATOUS COLONIC POLYPS
Mom state on 28OCT91 p/ 8PM pt w/fever of 104 R; cont all night even p/APAP; 29OCT91 in afternoon fever w/muscle temprs whole body shaking; called MD office; pt slept uncomfortably; given sponge bath & APAP & juice for fever;
2 1/2 year old very severely developmental delayed with mental retardation abuse.  Mom states language regression noted after vaccine.  Now improved.
Myself and two other people got the Janssen COVID vaccine yesterday and all three of us became extremely thirsty after receiving the vaccine. It is not an uncomfortable or painful symptom but I wanted to report it just in case.
This study case was received from the investigator in a trial on 24 May 2013. A 43-year-old male subject was found to have hypertrophic obstructive cardiomyopathy 19 days after receiving an injection of ACAM2000 (lot number, route and site of administration not reported) on 31 January 2013. Relevant laboratory data included an abnormal echocardiogram on 28 February 2013. Treatments were not reported. Past medical history included elevated cholesterol, chest pressure, cardiomyopathy and abnormal ECG. Troponin I, ECG and MRI of the heart were unavailable. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
No adverse event; Administered patient with Moderna COVID-19 Vaccine booster dose only presentation, with a volume of 0.25 ml (25 mcg) instead of 0.5 mL (50 mcg) as a booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (Administered patient with Moderna COVID-19 Vaccine booster dose only presentation, with a volume of 0.25 ml (25 mcg) instead of 0.5 mL (50 mcg) as a booster dose) and NO ADVERSE EVENT (No adverse event) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In July 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In July 2022, the patient experienced INCORRECT DOSE ADMINISTERED (Administered patient with Moderna COVID-19 Vaccine booster dose only presentation, with a volume of 0.25 ml (25 mcg) instead of 0.5 mL (50 mcg) as a booster dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (Administered patient with Moderna COVID-19 Vaccine booster dose only presentation, with a volume of 0.25 ml (25 mcg) instead of 0.5 mL (50 mcg) as a booster dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INCORRECT DOSE ADMINISTERED (Administered patient with Moderna COVID-19 Vaccine booster dose only presentation, with a volume of 0.25 ml (25 mcg) instead of 0.5 mL (50 mcg) as a booster dose).    No concomitant medications information was reported.  Vaccination date: between 22-Jul-2022 and 28-Jul-2022 It was unknown if patient experienced any symptoms after getting the vaccine. Patient administered with a volume of 0.25 ml (25 mcg) drug as booster dose.  No treatment medications were provided.
Administered after the published expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered after the published expiration date) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered after the published expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered after the published expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Pregnant at 29 weeks with normal fetal growth and EDD is 02/09/2022. Had arm injection site pain that started hours after vaccination  and progressed for a few days. After about 17 hours chest pain and body aches started on 11/25/2021 at 6 am. Body aches lasted for about 24 hours while chest pain lasted about 72 hours well into the day of Sunday, 11/28/2021. Adverse events were reported to PCP and OB provider.
PENTACEL was given to a patient after it expired with no reported adverse event; Initial information received on 20-Dec-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 2 months old and unknown gender patient and diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine [Pentacel (VERO)] was given after it expired with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 20-Dec-2022, the patient received a dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine (expiry date:05-Dec-2022) (form, strength, dose, frequency, lot number: unknown) via unknown route in unknown administration site for Immunization, after it expired with no reported adverse event (expired product administered) (latency: same day).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
none. Vaccine was expired on 11/26/21 as well as pt is 60 years old and received Dtap not Tdap
High fever and felt bad for 2 days after the IMZs. Site was inflamed and painful the day after. Second day post IMZ not fever but site still painful. Third day after IMZ pain decreased. Fourth day after IMZ able to return to work.
Patient was given an Adult Hepatitis A vaccine. He should have been given the pediatric dose. He had no complaints after immunization was given
Patient reported throat swelling/difficulty breathing starting 1 day after vaccine and lasting 5-6 days Narrative:
When cleaning my ears  the day after vaccine heard ringing in right ear when cleaning my ears in shower. Did not hear it after that. Ringing is now gone
This spontaneous report was received from a pharmacist refers to a patient of an unknown age and gender. No information regarding the patient's pertinent medical history, drug reaction or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route of administration, indication, lot # and expiration date were not reported). On an unknown date, the patient contacted the pharmacist to report and injection site reaction described as 3-inch by 3-inch red area that was painful and hot to the touch. The outcome of the injection site reaction described as 3-inch by 3-inch red area that was painful and hot to touch was not specified (also reported as the reactions lasted for an unspecified time). The relatedness between the injection site reaction described as 3-inch by 3-inch red area that was painful and hot to touch and ZOSTAVAX was not reported. Additional information has been requested.
Pt received flu shot et 1-2 minutes post vaccination she began feeling dizzy with throat swelling and chest pain. Her BP at the time was 174/98. She has never received flu shot previously and had never had any allergic reactions prior to this one.