chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Systemic: Fainting / Unresponsive-Mild, Additional Details: fainted and fell on the floor. He tried to get up again but fell again. He did not hit his head while falling.
she was getting angry; Abdominal Pain- Can't stand abdominal pain anymore; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (Abdominal Pain- Can't stand abdominal pain anymore) and ANGER (she was getting angry) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 037KZOA) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in January 2021.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced ABDOMINAL PAIN (Abdominal Pain- Can't stand abdominal pain anymore). On an unknown date, the patient experienced ANGER (she was getting angry). At the time of the report, ABDOMINAL PAIN (Abdominal Pain- Can't stand abdominal pain anymore) and ANGER (she was getting angry) outcome was unknown. Not Provided          Patient reported that she noticed hair started falling off when she brushes it after she had COVID.  Patient confirms that she was on a lot of concomitant medication but declined to mention any of them..  Treatment information was not provided.   This case was linked to MOD-2021-090523 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Patient medical history updated which is missed from the initial source document and those reports were submitted On 03-Aug-2021: Follow-up receive- No new information
This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), ERYTHEMA (arm was red) and PAIN IN EXTREMITY (arm aches) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 023M20A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL and BUDESONIDE (PULMICORT) for an unknown indication.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced FATIGUE (Fatigue), ERYTHEMA (arm was red) and PAIN IN EXTREMITY (arm aches). At the time of the report, FATIGUE (Fatigue), ERYTHEMA (arm was red) and PAIN IN EXTREMITY (arm aches) outcome was unknown. Not Provided          Treatment was unknown.
p/vax pt c/o stomach cramps, h/a, chills;h/a severe enough to require APAP#3;started improving 5/5/99 was better 5/6/99 & returned to school 5/7/99;
hot, feels dizzy, tongue feels thick; BP 100/72, pusle 86; treatment given @ clinic; pt released 1PM;
This spontaneous report as received from nurse refers to multiple unspecified patients of unknown age and gender. Information on pertinent medical history and concurrent condition was not provided. On an unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M042853, expiry 17-JUL-2018; lot # M041990, expiry 28-JUN-2018 and lot # M035486, expiry 05-JUN-2019 (dose and route not reported) for prophylaxis. No adverse effects reported. No additional information was provided. Temperature: 32 F to 35 F. Time frame: 30 minutes. Data logger was used. Previous temperature excursion? Yes. 32F to 35F (34.6F) for 5 minutes. 32F to 35F (35.1F) for 30 minutes. This case is one of the 3 reports from the same source. Additional information has been requested.
On 2/25/08 infant breastfed well at 3 AM. At approximately 6 AM 2/25/08 infant was found with blood in nose, apneic and pulseless; 911 called, fail resuscitation attempted. Infant was declared dead at hospital ED after failed attempt to revive her. She was a former 32 week preemie who slept in same bed with parents. 4/18/08-autopsy report received: Cause of Death:Sudden unexplained infant death in infancy.
Breakthrough COVID infection in fully vaccinated patient. Positive date 10/20/2021.
Within a minute I had a hot flash that started in my calf and went through my body. In less than a minute I was lightheaded and almost passed out (or fell asleep). I beeped my horn and the nurse came right over. They took my blood pressure and it was 150 over 120. (I've never had high blood pressure before. The second reading was 140 over 110. In about 5 minutes my BP was normal 120 over 80.
Pt presented to the clinic on Friday the 18th to inform us that he got his 2nd MMR overseas while at a deployed location and had an abnormal tender bruise that spread to the inside of his left arm. The bruise was about the size of a hand on the triceps of his left arm and a little bit has spread to the inside of his arm. Pt stated it was sore and tender but doesn't hurt and denies any other symptoms. Pt was called 22 Dec 2020 to follow up and pt stated the bruise is taking it's course but is decreasing in size.
Right Shoulder area (same right shoulder where Shingles Vaccine was administered Aug 8, 2013) muscles and joint felt as though the shoulder was dislocating, when shoulder was in a resting position. Onset was while patient was sitting in a meeting August 13, 2013.  Patient called Primary Care Physician within 2 hours of onset to ask if this would be expected side effect from recent Shingles Vacination, or if other patients who had recent Shingles Vaccine had similiar side effect. Patent saw Dr that afternoon (Aug 13, 2013). Subsequent weakness in right leg and continued problem in right shoulder persisting at least 1 year to present (June 20, 2014)
Administered a Dose of Heplisav-B that Underwent a Temperature Excursion; Initial Report Received 24-Sep-2021 and 27-Sep-2021  A nurse reported that a 52-year-old female received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No medical history was reported.  The patient had no known allergies.   No concomitant medications were reported.  On 27-Aug-2021, a dose of HEPLISAV-B (Lot # 935840, Expiration Date 11-Sep-2022, NDC # 43528-003-01) was administered in the left deltoid.   It was reported that the HEPLISAV-B administered had undergone a temperature excursion.  No adverse reactions were reported by the patient at the time of report.   No additional information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Injection site was so sore I couldn't sleep. Woke up the next morning and my entire body hurt, I also had difficulty breathing. I was extremely sleepy. Shot was Wednesday, by Friday morning I had painful swollen lymph nodes under my left arm. Still having difficulty breathing. Body still hurts.
patient reports on way home from receiving vaccine he started having numbness to left arm and roof of mouth, reports symptoms lasted approx. 1 hour and resolved on its own, denies any hives, sob or swelling. Spoke with patient on 02/12/21 and he only reports an "achy shoulder" at this time. Patient advised to seek medical attention for any return or new symptoms
This spontaneous report was received from a Medical Assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 01-FEB-2018, previously reported as 22-FEB-2018, the patient was vaccinated with an improperly stored dose of PROQUAD injection U, lot number N004631 with expiration date on 07-AUG-2018, for prophylaxis (dose, route of administration and anatomical location were not reported). The administered dose of the vaccine experienced multiple temperature excursions in the range approximately between -13.86°C to 0 °C, for a maximum cumulative time of 449 hours, as recorded by a data logger. The vaccine had not had a previous temperature excursion. There was no adverse effect reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1803USA002737.
Right after injection, nausea, dizzy, headache, arm pain, and flush. Day 2-3 Arm pain and developed mouth ulcers. Also, very shaky. 6 days after receiving vaccine experienced extreme Lupus flare. Day 7 experienced nausea, fatigue, and more Lupus flare up symptoms. Received IV infusion Ocrevus in May for Lupus flare up. After first vaccine on day 6-7 I experienced minor Lupus Flare. I was in a study related to vaccine and Lupus patients.
Narrative: Patient passed away due to COVID-19. Pt was fully vaccinated at the time of death.
Insomnia; Extreme fatigue mixed with insomnia; This is a spontaneous report from a non-contactable consumer, the patient. A 48-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0202) via an unspecified route of administration in the right arm on 07Jun2021 at 12:30 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. The patient did not have any other medical history. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications were not reported. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0185) via an unspecified route of administration in the left arm on 17May2021 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 07Jun2021, the patient experienced extreme fatigue mixed with insomnia. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events extreme fatigue mixed with insomnia was not recovered at the time of this report.   No follow-up attempts are possible. No further information is expected.
7:00 to 9:00PM - Redness in eyes, inflammation and pain in eyelids. 9:00 to 10:00PM - Nausea, followed by 30 sec. of severe vomiting. 10:00 to 12:00PM - Chills, cold and "clammy" skin.  Eye pain subsided. 12:00 to 1:00AM - Chills subsided, followed by brief period of diarrhea.  Went to sleep, woke up with "shakiness" in legs, felt fine by late morning.
headache, nausea,nasal congestion, dizziness, Symptoms resolved in 48 hrs , took Tylenol
bad heart palpitations; got worse again and have remained that way since; my heart is beating VERY hard; I'm skipping a beat about every 15 seconds or as bad as every 5 seconds; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28May2021 18:30 (Lot number: EW0185) at the age of 64 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Light Emphysema (and hyper inflated lung)" (unspecified if ongoing); "hyper inflated lung" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose:1, Lot number: EL9264, vaccine location=Right arm), when the patient was 64 years old, for Covid-19 immunnization, reaction(s): "bad heart palpitations". The following information was reported: PALPITATIONS (non-serious) with onset 2021, outcome "not recovered", described as "bad heart palpitations"; CONDITION AGGRAVATED (non-serious) with onset 2021, outcome "not recovered", described as "got worse again and have remained that way since"; HEART RATE ABNORMAL (non-serious) with onset 2021, outcome "not recovered", described as "my heart is beating VERY hard"; EXTRASYSTOLES (non-serious) with onset 2021, outcome "not recovered", described as "I'm skipping a beat about every 15 seconds or as bad as every 5 seconds". The events "bad heart palpitations", "got worse again and have remained that way since", "my heart is beating very hard" and "i'm skipping a beat about every 15 seconds or as bad as every 5 seconds" were evaluated at the physician office visit. Therapeutic measures were taken as a result of palpitations, condition aggravated, heart rate abnormal, extrasystoles.  Additional information: It was reported that, one week after first shot, started having bad heart palpitations. Patient was skipping a beat about every 15 seconds or as bad as every 5 seconds. Since they seemed to improve slightly after 2 weeks or 3 weeks after first shot, patient went forward with second shot. They were not as bad for about a month and a half and then got worse again and have remained that way since. It was now more than three months after. Patient was skipping a beat about every 15 seconds or as bad as every 5 seconds. And patient heart was beating very hard. Not necessarily fast, but very hard at times. Just went to cardiologist. They believes they were probably from the vaccine. They had patient on Diltiazem 120 MG, calcium channel blockers and had taken for 4 days, but no change. No other vaccine in four weeks and no other medications in two weeks prior to covid vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No known allergies.  No follow-up attempts are possible. No further information is expected.
INFLAMMATION LOCALISED; TIREDNESS; FEVER; CHOLESTEROL HIGH; PAINFUL FEET; SWELLING OF FEET; BACK PAIN; PAIN IN HIP; This spontaneous report received from a consumer concerned a 38 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination (Dose number in series 1). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: upadacitinib (form of admin unknown, oral, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. No concomitant medications were reported. On 22-JUL-2021, the patient experienced back pain, and pain in hip. On AUG-2021, the patient experienced swelling of feet, and painful feet. On an unspecified date, the patient experienced inflammation localised, tiredness, fever, and cholesterol high (Dose number in series 1). Laboratory data (dates unspecified) included: Cholesterol (NR: not provided) Bit high. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with upadacitinib was not reported. The patient recovered from fever, had not recovered from swelling of feet, back pain, pain in hip, painful feet, and tiredness, and the outcome of inflammation localised and cholesterol high was not reported. This report was non-serious. This case, involving the same patient is linked to 20220119776 (Dose number in series 2, booster case).
Swelling at site larger than fist, delayed itchying and burning (by 1 week) after receiving vaccine. 1st dose of Anthrax series.
(L) upper arm cellulitis with pustule at site of injection. Treatment with Cephalexin.
Patient positive for COVID-19 on 04/08/21 after completing vaccination. On 4/8 Patient directly admitted with fever of unknown origin, found to be COVID +, started on Remdisivir, on 4/9 ID consulted and recommends - Patient should have his remdesivir stopped, and should be started on casirivimab/imdevimab.
APPROXIMATELY 8-10 minutes Following Vaccination,  Patient began to complain of Numbness sensation around lips, radiated to Nose, eyes and developed a  headache. Patient placed on oxygen via nasal (97%) Due to involvement of mouth-lips-Epinephrine 0.3 mg given IM R thigh. EMS Dispatched pER  policy transported to local Hospital.
Offer 4 hours development Cardiac anaphylactic shock with. Blood pressure dropping to 90 when sitting and would not read pressure when standing.  Heart rate at 133 bpm throughout the nest 48 hours  then slowing dropping. Was at 92 after 72 hours and normal 62 the next day.
On 12-18-2017 during prenatal follow up office visit patient was administered a second dose of Flu at Gestational age of 35 weeks and 2 days and EDD 01/20/2018. First dose was administered on 10/21/2017. Patient has been notified and is scheduled for follow up on 12-28-2017. Awaiting on Glaxo Smith Kline Medical advisor to call back with recommendations for patient.
Her initials symptoms were feeling tired and low-grade fever. Her fever spiked to 102 degrees, and she tested positive for COVID. Due to her asthma, it affected her breathing. She has a nebulizer at home and the doctor prescribed albuterol. I gave her 2-3 breathing treatments per day. She was also on steroids for her breathing as well. The first week was rough due to breathing. The second week was recovering.
Jan. 5: developed redness (more than quarter size), itchiness and the site was warm to touch She?s taking over the counter meds.
Information has been received from a pharmacist referring to a currently 26 year old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On an unknown date (reported as when the patient was an infant), the patient received an initial dose of VARIVAX (dose, route, lot # and expiration date were unknown). On 27-SEP-2016, when the patient was 26 years old, the patient was vaccinated with a second dose of VARIVAX (dose, route, lot # and expiration date were unknown). No adverse effects were reported. Additional information has been requested.
HA, fatigue, malaise, neck ache, rash over chest, swollen lymph nodes on side of injection
The influenza vaccination was mistakenly given to infant at 0754 on 20Mar2020 instead of the hepatitis vaccination. There were no adverse reactions noted from the incorrect administration. Infant was closely monitored for over 48hours. The Pediatrician and Immunologist followed care closely.
This spontaneous report received from a patient concerned a 19 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no medical conditions and had no known allergies.The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808986 expiry: UNKNOWN) dose was not reported, administered on 11-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-JUN-2021, the subject experienced high fever. On 12-JUN-2021, the subject experienced brain fogs. On 12-JUN-2021, the subject experienced lower back pain. On 13-JUN-2021, the subject experienced not acting normally. The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lower back pain on 13-JUN-2021, and high fever on 12-JUN-2021, and had not recovered from brain fogs, and not acting normally. This report was non-serious. This report was associated with a product quality complaint: 90000182718. The suspected product quality complaint has been confirmed to be voided (does not meet pqc criteria). based on the PQC evaluation/investigation performed.
Mom reports temp of 103.6(ax) on 26FEB91 sleeping most of day; 27FEB91 acting well temp resolved;
Patient got up to go to the bathroom and fainted. wife got up and realized he was sweating profusely from his back to the point that the sheets were drenched. He spent the rest of the day with a fever of 102. Wife alternated between Tylenol and Advil to bring down the fever. 11/27/206 was a repeat of the profuse sweating during the night but no fevers.
I started with fatigue on 12/24/20 and on 12/25/20 developed fatigue and chills (could not get warm). On 12/25/20 I was walking downstairs when my husband felt I didn't look normal. I fell off the bottom two stairs sustaining injury to both feet. I was able to get myself up to standing position and then sat down. My husband reports that a few minutes later I had what he described was seizure activity for about one minute/stopped breathing and he called 911. Due to COVID visitor restrictions my husband was not allowed to go to the ER with me the night of the incident.  I had full work-up with labs, EKG and head CT that were unremarkable  at Medical Center.  I had an appointment with my primary care physician on 12/28/20 and was referred to neurologist. He did an exam, ordered MRI and sleep deprived EEG. My MRI was completed and reported as no abnormalities. I have the sleep deprived EEG  scheduled on 1/11/21. I have continued pain/physical therapy on both feet/ankles from the date of the incident.
2nd vaccine shot- Pfizer recd shot in the afternoon of 5/10. that night around midnight I woke up unable to move my legs , arms or speak but felt dizzy & faint, nausea . My partner carried me down into the shower where I laid for about 30 minutes, then helping me back upstairs- from what I remember I slept for a few days after the episode . since that day:  Memory loss brain fog severe fatigue rash severe joint pain night sweats fever
Began with fever (lasting 1 day), myalgia, joint pain, lymphadenopathy and fatigue progressively lessening. Rash began on day on 8-4: face chest, back, and stomach.
Horrible sore throat......enlarged lymph nodes....DIAGNOSED POSITIVE STREP...7 days of penicillin v 1500 mg/day.....  Question: might it have been diphtheria instead?
Nausea and uncontrollable bowels with mucous discharge for 2 days.
RASH; THAT NIGHT EXPERIENCED HA, CHILLS, BODY ACHES, COUGH, TIGHTNESS TO THROAT. TOOK ADVIL, TYLENOL. WAS SEEN IN THE ED ON 10/26/14; RECEIVED EXAM, ADVICE; NO TEST ORDERED.
Administered flu shot to student after immunizing older sibling and parent.  Student anxious at time of vaccination. Mother calmed student down and he was able to receive immunization successfully. Pt A & O immediately following shot, stood up and became dizzy, patient was lowered to floor with feel elevated and  vitals taken.  4:30pm BP90/48 P 64 R 18 . 4:40pm BP 88/46 P 66 R 18. pupils equal and reactive.  Per mom, patient had not eaten or had anything to drink.  Patient feeling better after resting and eating banana. He was A&O and left to go home with mom and sibling. Symptoms resolved fully with no further adverse effects.
mild nausea and weakness; mild nausea and weakness; body aches; arm of the injection site was warm to touch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (arm of the injection site was warm to touch), ASTHENIA (mild nausea and weakness), NAUSEA (mild nausea and weakness) and MYALGIA (body aches) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced VACCINATION SITE WARMTH (arm of the injection site was warm to touch). On 07-Feb-2021, the patient experienced MYALGIA (body aches). On 09-Feb-2021, the patient experienced ASTHENIA (mild nausea and weakness) and NAUSEA (mild nausea and weakness). On 06-Feb-2021, VACCINATION SITE WARMTH (arm of the injection site was warm to touch) had resolved. At the time of the report, ASTHENIA (mild nausea and weakness), NAUSEA (mild nausea and weakness) and MYALGIA (body aches) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant products were not provided.  Treatment medication were not reported.   This case was linked to MOD-2021-096674 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: updated event outcome to recovered.