chrisvoncsefalvay/vaers-outcomes huggingface dataset:
76 y.o female with h/o COPD on 2 L home oxygen, type 2 diabetes, hypertension, having been found unresponsive at HCF. With GCS 3 patient intubated, and mechanically ventilated at a local HCF. Diagnosed with COVID-19 and acinetobacter bacteremia. Right upper extremity with occlusive DVT in right brachial and basilic vein with nonocclusive thrombus in right axillary vein, initiated anticoagulation. Previous CT revealed no PE, However,  did show dilated pulmonary arteries. Repeat CT chest with contrast 09/14 revealed small amount of thrombus in left jugular and extensive chronic findings including goiter and marked enlargement of left pulmonary artery prior to previous.  Pt was transferred to another HCF for vascular surgery evaluation, advised nonsurgical, continuing anticoagulation. Pt persistently, off sedation, demonstrated no significant improvement with cognition/neurologic status. MRI brain 9/13 revealed no acute intracranial abnormally. EEG resulted abnormal with severe generalized slowing, consistent with severe encephalopathy, concern for possible epileptiform discharge prompted Neurology evaluation, provided Keppra. Pt was provided broad-spectrum antibiotics with cefepime and doxycycline, negative repeat blood cultures prompted discontinuation of antibiotics after 5 days of therapy. HCF provided counsel with family members regarding goals of care, ultimately, decision made to transition to comfort measure on the afternoon on 09/18/2021.  Pt succumbed to illness, suffered cardiopulmonary collapse as result of acute respiratory failure with hypoxemia secondary COVID-19 viral pneumonia at 1;45am on 09/29/2021
fever, nausea, tiredness, headache, chills, diarrhea, loss of appetite, stiff and sore I felt like this for 2-3 days, but  didn't  feel better until day 5.
Patient was erroneously administered an Inactivated Polio Vaccine. She was not due for the next shot in the series until 17 Apr 2017. The mistake occurred due to a misreading of the vaccine checklist printed from the database.
Started with fever of 101. Then whole body felt hot to the touch. Body aches that made it difficult to move. Extremely painful headache. Gland under clavicle on left arm swollen along with glands in neck and head. No response to anything for pain except Tylenol, but it didn't help the aches. Took Benadryl and symptoms cleared up completely.
Pt states that she has had excruciating pain in the left arm that the flu shot was given since the shot and nothing her Dr has done for her has helped. She also stated that she knows it wasn't staff's fault.
1/9/03 Mother called to say child had "weeping blisters" in area where vaccine given. I recommended she come into clinic. Child was examined by RN. Child had redness & swelling of left upper arm as well as a large area of blisters with discharge. Referred to ER. Phone call to Mother on 01/13/03: child was seen on 1/9/03 at Hospital ER and was given Keflex although they told the mother it wasn't an infection. Child's arm looked "purple" to mother on 1/10/03 so she took her to ER where she was put on some type of cortisone. Mother says she is much better. Redness and swelling gone and blisters are dried up with scabs.
she received a COVID-19 booster vaccine; She had chills last night; She felt Wiped out; This is a spontaneous report from a contactable health care professional, based on information received by Pfizer (manufacturer control number: EC-2021-101432), for bnt162b2.  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, (booster) single for covid-19 immunisation. The patient medical history were not reported. Concomitant medication included Lenvima for unspecified indication from an unknown date and unknown if ongoing. The patient received a covid-19 booster vaccine, she had chills last night and she felt wiped out on an unspecified date. Therapeutic measures were taken as a result of she had chills last night and she felt wiped out. The outcome of the events she had chills last night and she felt wiped out was unknown.  The lot number for [bnt162b2], was not provided and will be requested during follow up.
Started feeling cold and had a  headache around 10 pm the day of the shot. Woke up around 3am freezing, shivers, fever, severe headache(so bad I didn't want to open my eyes), muscles aching(like the flu)and nausea. Those feelings continued throughout the day. The nausea started subsiding around 4pm on the 17th. but feeling cold, totally out of it and having the headache continued until that night. The following day I felt very sluggish and eyes very heavy. This feeling continued on Sunday as well. As of today I still feel tired, off balance, and sluggish.
Palpitations felt warm, skin flushing Narrative:  Per EOH report on 12/23/2020: "Employee had an adverse reaction pm 12/22/2020 on day of vaccination." Report states employee "felt warm, palpitations, flushing. Had high blood pressure (no history of). Was released, driven home by family member." Systolic BP in 180s-190s, diastolic BP in 100s-120s. BP was monitored to progressively decrease to 140s/90s and employee was released to husband to be taken home. Was recommended that husband take employee to ER for further assessment if symptoms persist or if condition worsens. Employee was in no further distress and was released home.
Tasted something weird; tongue started tingling all around the edges / tongue or roof of mouth has been tingling on and off; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the arm left on 05Mar2021 at 14:00 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. Medical history included hashimoto's disease, addison's disease (primary adrenal failure), type 1 diabetes mellitus and allergy towards anti-nausea drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included insulin lispro (HUMALOG), levothyroxine sodium (SYNTHROID), prednisone (MANUFACTURER UNKNOWN), iron (MANUFACTURER UNKNOWN), fludrocort (MANUFACTURER UNKNOWN) and extmbe (MANUFACTURER UNKNOWN) all from an unknown date and unknown if ongoing for an unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Mar2021 at 14:40, 40 minutes after the vaccination, the patient had tasted something weird in the back of her throat and immediately after that the patient's tongue started tingling all around the edge. It was reported that since the injections, the patient's tongue or roof of mouth had been tingling on and off. The events did not result in doctor or other healthcare professional office/clinic visits, and the emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events tasted something weird and tongue started tingling all around the edges was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Sudden fatigue, chills, headache, painful arm from injection site to fingers, tingling in left hand and fingers
Faint feeling, lightheaded, Felt jittery, nauseated. Layed down and recovered at site
Little redness and itchy in the area the shot was administered. This came about with in a minute of when the shot was administered. The patient was looked at by the doctor and was told to take Benadryl.
Information has been received from a licensed vocational nurse (LVN) referring to unspecified patients of unknown age and gender. There was no concurrent condition or medical history reported. On unspecified dates the patients were administered improperly stored doses of ROTATEQ (lot # L013202, expiration date 27-JAN-2017) (dosage and strength unknown) (temperature 30.6 degree F, time frame: 63 hours) orally. No adverse effect was reported. Additional information has been requested.
Hives, Cluster of 2 patients (sisters - no individual patient identification provided) developed hives the next day after receiving Menactra (lot number U1932AB, route and site administration not reported) on 09 April 2007, received from a health care professional in the USA on 27 April 2007. Case1: A female patient (one of 2 sisters) developed hives on the arms only, the next day after she received Menactra (lot number U1932AB, route and site of administration not reported) on 09 April 2007. It was unknown if any other vaccines were administered within 4 weeks. The patient was treated by her father, who is a dermatologist, with an unknown medication and the event resolved. The second sister's case is detailed in case 2007-01439.
Tenderness in the shoulder starting the day after immunization and progressing to pain radiating down the arm in the weeks following. Pain persisting for greater than 2 months.
Woke with extreme fatigue and heaviness in arms and legs. No other symptoms. No fever. No cough. This occurred two times on two separate mornings. Lasted for 2-3 hours.   Heavy bleeding on first period following vaccination, bright red blood, normally dark red blood and light and spotty only during regular periods. No other symptoms. No pain. Went away 2-3 days.
Pfizer BioNTech COVID-19 Vaccine EUA, Moderna COVID-19 Vaccine EUA: Mixed Series. Patient received Moderna Vaccine on 4/10/2021 and Pfizer on 8/31/2021.
Pt reports localized hard swelling @ injection site (left deltoid).  Pt reports sl tingling down arm and "itchy" arm.  Reports s/s lasted 3 days.
Child inadvertently received MMR (PROQUAD) instead of MMR thus receiving double varicella vaccination plus VARIVAX. Father of patient consoled by PCM, child stable through out. No adverse reaction.
Patient came in to receive the bivalent covid vaccine and instead she received the non-bivalent pfizer covid vaccine.
On 10/27/2005 received Fluzone vaccine for flu prevention at work. On 12/02/2005, employee noticed tearing in left eye excessive, followed by left sided facial paralysis. Other serious important medical events (OMIC). Patient/employee still is having drooping of mouth (L) and some speech slurring. Is still attending speech therapy clases. no real improvement in condition.
Moderna COVID-19 Vaccine EUA This was the Moderna booster.  I started having lower back pains about 10 hours, 20 minutes after I received the vaccination. I doubled over in pain and  quickly became nauseated as well. The back pain and nausea lasted for about 30 minutes and then quickly went away. I had no trouble sleeping. Twelve hours later, neither the back pain nor the nausea have returned.
Within a few minutes of receiving the vaccine my daughter fainted. Her eyes rolled back into her head and she had seizure like tremors. After coming to she received water and crackers and then began vomiting. The following day she complained about chest pain and shortness of breath. She was taking to the emergency room where an EKG was preformed. EKG came back normal. Chest pains and shortness of breath continue for a week after the vaccine.
t101-104 beginning Sat & cont through Tues; also had genl rash onset Sunday seen by MD; did not feel this was related to shots; given meds for throat infect;
Moderna COVID-19 Vaccine EUA   I contracted COVID-19 on 11/24/2020. I received the first dose of the Moderna COVID-19 vaccine around 9:40AM on 1/6/2021. At around 9:45PM on 1/6/2021 I started to feel very nauseous and vomited twice within the hour.
He had a side effect/he's having a side effect; discomfort in his arm; This spontaneous case was reported by a patient family member or friend and describes the occurrence of IMMUNISATION REACTION (He had a side effect/he's having a side effect) and VACCINATION SITE DISCOMFORT (discomfort in his arm) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Jan-2023, 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 30-Jan-2023, the patient experienced VACCINATION SITE DISCOMFORT (discomfort in his arm). On an unknown date, the patient experienced IMMUNISATION REACTION (He had a side effect/he's having a side effect). At the time of the report, IMMUNISATION REACTION (He had a side effect/he's having a side effect) outcome was unknown and VACCINATION SITE DISCOMFORT (discomfort in his arm) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications details were reported.  It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Patient had the Moderna bivalent booster a couple days ago, and he was having a side effect. He woke up with a throbbing discomfort in his arm. He informed he had a hard time putting on his jacket.  No treatment medications details were reported.
COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. Other Case identifier(s): US-PFIZER INC-202200142905 (Pfizer).  A 63 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Jan2022 14:00 (Lot number: FE3594) at the age of 63 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "episode of Bell's palsy" (unspecified if ongoing), notes: lasted for a couple of weeks., probably 25 years ago. There were no concomitant medications. Vaccination history included: Flu vaccine (this was probably 25 years ago.). The following information was reported: COVID-19 (non-serious) with onset 19Jan2022, outcome "recovering", described as "COVID-19". The event "covid-19" was evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of covid-19. Pfizer-BioNTech Covid-19 Vaccine: NDC/Expiry: Unknown, this information is not on the CDC vaccine record card. Second dose is scheduled to be administered on 30Jan2022; caller does not know if that will be changed relative to this event and Paxlovid therapy yet. NDC: Caller no longer had the outer packaging for this product, he only had the individual blister pack which did not have NDC listed on it. Lot/Expiry: Caller no longer had the outer packaging for this product, he only had the individual blister pack which he had to get a magnifying glass to read Lot/Expiry on because they are pretty small numbers.   Additional information: The patient is pretty much out of danger at this time, just about all of her symptoms are gone at this time; but caller mentioned patient is still going to test positive for a while he would assume. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) is None. Additional Vaccines Administered on Same Date of the Pfizer Suspect-If applicable, list all vaccines administered on same date with the Pfizer vaccine considered as suspect s none. The patient did not any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. Patient visited Emergency Room just to verify if she could take a certain stomach medication with Paxlovid for medication referral and they were able to verify it was fine; patient was not admitted to the hospital or seen in the emergency room for any other reason. Physician Office Clinic visit only for testing only. Patient just completed Paxlovid therapy today for the treatment of COVID-19.
Individual is incarcerated. Nursing staff notified at 8:00am that patient's had left arm pain.  Nurse noted Left deltoid area 1 1/2 diameter area reddened, swollen, tender to touch and warm to touch.  Temp taken and was 100.6.  Tylenol and Benadryl was given.  Left arm evaluated at 10:00am and no change noted, temp taken was now 99.1.  Contact on 3/29 and information that arm is normal at this time.
Vaccine administration error.   Pfizer Covid 19 Bivalent dose given for 1st dose of Covid 19 vaccine series.  Pt should have received Covid 19 mRNA monovalent vaccine.   No adverse reaction noted.   No treatment indicated.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On 15-DEC-2014 the patient was vaccinated with an improperly stored VAQTA (lot # J000366, expiry date 22-AUG-2015) (dosing regimen, route and frequency unknown). No concomitant medications were reported. No adverse effect was reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Normal side effects started early morning 01/21/2021 - chills. 4:00 AM intense muscle aches, nausea, fatigue, temperature 101.0 F.  All symptoms besides chills were present the entire day. Previous symptoms stopped by 01/22/2021.  New symptoms appeared 01/22/2021 sternum and rib pain with pressure. Worsening through out day.  01/23/2021 4:00 AM intense rib pain difficulty breathing normally.  Shallow breathing.  Unable to lie flat.  Pressure and pain (Costochondritis possibly) throughout day, unable to take deep breaths.  Unable to do every day activities.  Treating with cyclobenzaprine, advil, heat, and ice.
VOMIT; HEADACHE; INCREASE IN BLOOD PRESSURE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included abnormal cholesterol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included fenofibrate for abnormal cholesterol.  On 11-APR-2021, the subject experienced increase in blood pressure. On 11-APR-2021, the subject experienced headache. On 18-APR-2021, the subject experienced vomit.  Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 150/110 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from increase in blood pressure, headache, and vomit. This report was non-serious.
Information has been received from a licensed practical nurse (LPN) concerning an 11-year-old white male student who on 27-MAY-1999, at 5 years of age, was vaccinated SC with the first dose of Varivax. There was no concomitant therapy. The LPN reported that on 05-APR-2006, at 1500, the patient developed 50-75 vesicles on chest, back, legs, arms and face. Medical attention was not sought and no laboratory/diagnostic tests were performed. On 11-APR-2006 the patient recovered. Additional information has been requested.
visual problems/almost like double vision; couldn't focus; almost like i had ADD; felt very tired; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VISUAL IMPAIRMENT (visual problems/almost like double vision), DISTURBANCE IN ATTENTION (couldn't focus), ATTENTION DEFICIT HYPERACTIVITY DISORDER (almost like i had ADD) and FATIGUE (felt very tired) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     The patient's past medical history included Postural orthostatic tachycardia syndrome since 2019. Concurrent medical conditions included Cataract and Allergy NOS.  On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On an unknown date, the patient experienced VISUAL IMPAIRMENT (visual problems/almost like double vision), DISTURBANCE IN ATTENTION (couldn't focus), ATTENTION DEFICIT HYPERACTIVITY DISORDER (almost like i had ADD) and FATIGUE (felt very tired).   At the time of the report, VISUAL IMPAIRMENT (visual problems/almost like double vision) had not resolved and DISTURBANCE IN ATTENTION (couldn't focus), ATTENTION DEFICIT HYPERACTIVITY DISORDER (almost like i had ADD) and FATIGUE (felt very tired) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    Concomitant product use was not provided by the reporter. No treatment information was provided.
TWO DAYS AFTER ADMINISTRATION OF LIVE NASAL FLU VACCINE, DEVELOPED ITCHING, SUBSEQUENT EXTENSIVE URTICARIAL REACTION LASTING SEVERAL WEEKS INCLUDING ANGIOEDEMA OF FACE AND LIPS. MR received. Patient received Flumist on 10/10/2006.  On 10/12/2006 began experiencing hives which continued several weeks.  First sought treatment on 11/01/2006 for urticaria which was treated with Zyrtec, a Methylprednisolone dose-pak and Cimetidine.  On 11/07/2006 she sought treatment for facial swelling and continued hives. Swelling of lips and cheeks were noted, no stridor. Assessment:  Urticaria with angioedema. Prednisone taper. F/U on 11/09/2006 with hives decreasing, but still having itching. Assessment: Urticaria/angioedema likely 2' to live flu vaccine, improving.
Muscle & joint soreness & stiffness in arm where injection was given also red circle around injection site (size of a quarter). Symptoms have persisted for one week.
Roughly 11 hrs after injection woke up with chills, fever, headache.  took Tylonol.  Symptoms improved but persisted for 4 hours.  Headache for 24 hours even with continued use of tylonol.  Extreme fatigue--slept 18 hr first night, awake 4 hours, back to sleep for 12, awake 12, slept 10 hrs.  Fatigue continued for 5 days overall--sleeping 10-11 hours a night and unable to exercise besides short walks.
This spontaneous report as received from a registered nurse refers to a 6 month old patient. The patient's concurrent conditions, medical history and drug allergies were not reported. On 02-DEC-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M007311 (expiry date: unspecified) for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all correspondence has been received. Follow-up information indicated that suspect product with the lot# M007311 had not actually involved in the previously reported temperature excursion. Therefore, case # 1612USA012687 is being deleted from our files on generic rotavirus vaccine, live, oral, pentavalent. This is an amended report, as corrected. The reference type for the E2B number US-009507513-1610USA014706 has been changed from E2B Company Number to E2B Linked Report.; Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705: US-009507513-1610USA014706:
Site: Itching at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Additional Details: GAVE PT MODERNA COVID VACCINE. ABOUT 15 MINUTES LATER PT REPORTS FEELING ITCHY ON THE FACE. WAITED A FEW MORE MINUTES AND THE ITCH BEGAN TO SPREAD TO CHEST AND ARMS. GAVE PT BENDRYL AND ASKED TO STAY 15 MORE MINUTES. RESOLVED WITH BENADRYL.