chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hospitalized 09/23/2021; COVID-19 positive 09/17/2021; fully vaccinated  DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Acute hypoxemic respiratory failure (HCC) [J96.01] Acute hypoxemic respiratory failure due to COVID-19 (HCC) [U07.1, J96.01] COVID-19 [U07.1]   HOSPITAL COURSE: 73-year-old female with history of chronic respiratory failure on 3-4 L of oxygen at baseline, chronic obstructive pulmonary disease, previous colorectal cancer, OSA, and aortic stenosis who presented with worsening dyspnea, hypoxia, hemoptysis, abdominal pain, and diarrhea after being diagnosed with COVID-19 9-17.  She had symptoms for 2 weeks prior to admission.  The patient required non-rebreather while in the emergency department.  CTA was negative for PE, but showed diffuse bilateral peripheral airspace disease.  CT of the abdomen and pelvis showed an atrophic pancreas, but no acute process.  Steroids were started in the emergency department and the patient was admitted to the hospitalist service for further continuation of care.  The patient's oxygen requirement worsened to the point where she was on 100% via high-flow nasal cannula.  Her diarrhea and abdominal pain improved without intervention.  IV vancomycin was started as her sputum culture grew Staph aureus.  IV Lasix was administered.  The patient was discussed with pulmonology who reported that prognosis was poor in the setting of her pre-existing lung disease.  Goals of care were discussed with the patient by this provider.  The patient was clear that she would not want intubation and mechanical ventilation in the case of worsening respiratory failure.  The patient desaturated overnight 9-25 the and was hypoxic despite high-flow nasal cannula and non-rebreather.  Comfort measures were initiated after discussion with the patient and her son.  The patient passed away 09/26/2021 at 11:40 with family at bedside.
Localized reaction. Redness and swelling with pain. No fever. 5 day duration. Complete resolution.
Woke up the am following administration of Gardasil and Menactra with rash on left side of torso, no itching, no swelling, no heat, no SOB. Vaccines given at 11am on 8/23/07. Rash appeared a.m. of 8/27 Calamine/ Caladryl lotion applied.
Patient was under the age that the Emergency Use Authorization order allowed to be administered. Patient did not have any other adverse events.
I am experiencing brain fog and muscle cramps on a regular basis.; I am experiencing brain fog and muscle cramps on a regular basis.; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07Apr2021 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included anxiety, depression, cardiac arrhythmia (reported as quadrant of heart with different rhythm than others), crohn's (reported as chrohn's). The patient had no known allergies to medications, food, or other products. The patient had 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. From 07Apr2021, the patient has been experiencing brain fog and muscle cramps on a regular basis. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events experiencing brain fog and muscle cramps on a regular basis was not resolved at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Headache, achiness, fatigue 12-36 hours after vaccine was administered.  Daily headache beginning 4/12/2021
This literature marketed report has been received from authors of a published article, referring to 17 adolescent patients of unknown gender. The patients' medical history, concurrent condition and concomitant therapy were unknown. The purpose of this longitudinal study was to identify individual and interpersonal factors associated with human papillomavirus (HPV) vaccine series completion in a sample of low-income adolescent girls and boys. On an unknown date patients were vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (manufacturer unknown) (dose, frequency, route, batch/lot number and expiration date were not provided) for prophylaxis (product origin unknown). On an unknown date, patients experienced side effects of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (manufacturer unknown). The outcome of the event was unknown. The event was considered to be related to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (manufacturer unknown). Findings highlight important opportunities for improving completion of the HPV vaccine series among adolescents. Intervention efforts should involve health care providers and parent-adolescent dyads and prioritize evidence-based strategies for reducing missed opportunities for series completion. This is one of three reports regarding the same literature (linked case# 1902USA011603 and 1903USA008997). Sender's Comments: US-009507513-1902USA011603: US-009507513-1903USA008997.
Chills, fever 102.4 at the highest, body aches all over, threw up, constant nauseousness.  Just took tylenol.  Fever broke about 9pm. Still a little nauseous this morning but not bad.
Patient reported she got flu shot Friday 10/5 at store. Then preceded to have dizziness the following mornings after that.
This spontaneous report was received from a nurse who reported that an unknown number of patients, names and other demographics unknown, received an unknown number of doses of PROQUAD (lot # M039448, expiration 20-MAR-2018) and VARIVAX (see MARRS # 1707USA002713) following a temperature excursion of -4.5C for two hours and two minutes. No adverse effects were reported in any patients. No other information is available. There was no previous temperature excursion. Call was because of a data logger. This is one of two reports from the same reporter. Additional information has been requested.
rapid heartbeat; temperature; nausea; chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), NAUSEA (nausea), HEART RATE IRREGULAR (rapid heartbeat) and BODY TEMPERATURE INCREASED (temperature) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 010M20A) for an unknown indication.     The patient's past medical history included No adverse event.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 11-Feb-2021, the patient experienced CHILLS (chills), NAUSEA (nausea) and BODY TEMPERATURE INCREASED (temperature). On 12-Feb-2021, the patient experienced HEART RATE IRREGULAR (rapid heartbeat). At the time of the report, CHILLS (chills), NAUSEA (nausea), HEART RATE IRREGULAR (rapid heartbeat) and BODY TEMPERATURE INCREASED (temperature) outcome was unknown.            Reporter did not allow further contact
Severe lower back pain began and skin numbness from my back to abdomen. I thought it might be shingles but rash hadn't yet developed when I returned to doctor on 10/27 so he thought it was a pinched nerve. On 10/28 the rash started to develop and on 10/29 when I returned to the doctor he confirmed it was shingles.
the evening of vaccine pt states she had body aches and chills.  Pt took temp that night 101.2.  Pt with a lot of pain and some warmth to the injections site, no swelling.  Scalp and down back of neck became very, very red and sore and warm to touch.  Pt states she also got hives or rash on chest, back of neck and on shoulders.  Pt states the symptoms resolved 3 days later.  Pt just now notifying our office of these symptoms
This medically confirmed spontaneous report (initial receipt 08-Jan-2015) concerns a 20 year-old male patient who received the flu shot (non-CSL product) in the past without any issues. The patient did not take any concomitant medications, and had no history of febrile reactions to any vaccines, including previous flu shots. He did not receive other recent immunisations.  On 07-Jan-2015, in the evening, the patient received intramuscular AFLURIA (batch number 09949221A) 0.5mL annually. This was the first time he received AFLURIA. On 08-Jan-2015, in the morning, the patient reported that he experienced 102 degrees Fahrenheit (oral) after the AFLURIA administration. The patient believed that AFLURIA caused his fever and that he now has the flu. The patient will see his physician later on 08-Jan-2015 for further assessment. The outcome was reported as unknown. Reporter's comments: The reporter counseled the patient on flu incubation periods and antibody responses, reported that the fever was related to the AFLURIA, and reported that the patient could have received H1N1 vaccine at another pharmacy (there were none listed in the patient's pharmacy profile) at the reporter's pharmacy. Follow-up (16-Jan-2015): Clinical course, AE start date and outcome.
She first experienced a sore throat, runny nose, and nasal congestion on Tuesday, March 21, 2023. The next day, she complained of a headache, stomach pain, right shoulder pain, and bilateral leg pain. She also had fever that got up to a 104-degrees at its highest point. As of today, has a runny nose, nasal congestion, and a low-grade fever.
Itchy, red, inflamed, hot to touch area developed over the injection site on 7/29/22 at 4am. It was approximately 2x2 inches. Benedryl for the skin was applied and decreased it's appearance. No other signs or symptoms developed. First 3 Moderna vaccines were "fine." Patient did state that she has many allergies.
Right upper extremity redness and swelling at injection site.  Visit to urgent care.  Diagnosed with cellulitis.  Records not available at time this report filed.
had injection site reaction the day following the vaccine administration which lasted 3-4 days. It was swollen and hot and then went away.  Suddenly on 05/19/2021 developed a delayed rash around injection site, 16 days post vaccination. Rash is not hot and is minimal itching.
The pfizer covid-19 vaccine 12+ gray cap was pulled from the fridge instead of the pfizer covid-19 Bivalent 12+ gray cap vial.  This was not noticed until pharmacist on duty was reporting waste report into EPRN and the lot# and vial information did not match the Pfizer Bivalent vaccine.  Patient was called she appreciated the call to let her know what happened.  She plans to call her provider in the morning. She can get the new booster in 2 months time.
patient got his first vaccine as pfizer on 06/01/2021. He got his second vaccine 11/05 of moderna. Patient did present his vaccine card and the moderna on 11/5 was not documented. He wanted a booster shot and it has not been 6 months to be eligible. booster vaccinated to day 12/7/21
Symptoms include: L upper arm swelling, diffuse redness of L upper arm, significant pain at L shoulder, and increased skin temperature  2-3 hours after vaccination and over a 24 hour period Treatment includes: LUE rest, cool/cold compress, prophylactic antibiotics (omnicef),  zyrtec allergy tablets   Outcome: Clinic office visit, continue to follow patient progress with daily care calls
After 1st does my knee swelled to double the size. 2 days before my 2nd does I woke up in considerable pain. I had a knot in my neck/shoulder. 24 hours after 2nd dose I lost the ability to raise my arm more then 60* even though I had a knot in my neck prior to shot I could still lift my arm. There was nothing wrong with my knee prior to the Vaccine.
Hives, breaking out what looked like blisters, started on prednisone and Benadryl, it helps for a while.
She developed headache and vertigo 30 minutes after Pfizer Covid vaccine 1st dose. She has continued to have daily headaches accompanied by debilitating vertigo as well as brain fog/concentration deficits for the nearly 2 months since her dose. She has no history of headaches or vertigo prior. She is no longer able to drive safely and has had to daily nursing school admission for a semester. We have just started to treat her for possible vestibular migraines prophylactically.
Sore arm, pain with injection- tingling sensation down arm and side of neck which only lasted about 1 hour. Fatigued and headache and dizziness for 1 hour after injection, by the next day I felt normal. Most of my symptoms were the day of the shot. Got stuffy nose the next day and minor headache but felt find otherwise.
Tested positive for COVID-19 this week; COVID-19; This is a spontaneous report from a Pfizer-sponsored program Pfizer. A contactable consumer (patient) reported that a 43-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EL3249), via an unspecified route of administration in left arm on 07Jan2021 13:30 at single dose for covid-19 immunization (vaccination). Medical history included pleurisy. Family medical history was none. There were no concomitant medications. Historically she felt like she had the flu when she had gotten the flu vaccine (years not specified); but she did not feel like she had the flu after getting flu vaccine this year in 2020. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no additional vaccines administered on same date of the Pfizer suspect. The patient received the Pfizer COVID-19 vaccine 07Jan2021; and she tested positive for COVID-19 this week. Then clarified that she was administered first dose of Pfizer COVID-19 Vaccine 07Jan2021. She had onset of COVID-19 around 15Jan2021 when she became unable to smell. She had 2 COVID-19 tests performed on 16Jan2021, one was a rapid COVID-19 nasal swab test with positive result; the other was a COVID-19 nasal swab test that they had to send off to test which was also positive. No medications were taken prior to vaccination/event. She asked if she should still get the second dose as scheduled relative to this event. Second dose was scheduled for 27Jan2021. No emergency room visit required, physician office visit (urgent care) required for event COVID-19. She mentioned she was not the only patient to test positive for COVID-19 that received Pfizer COVID-19 Vaccine same date she received Pfizer COVID-19 Vaccine on 07Jan2021. She declined to provide any further information regarding those patients/events/products/report. The sample of product was not available to return. The outcome of events was unknown.
Takotsubo syndrome; This literature-non-study case was reported in a literature article and describes the occurrence of STRESS CARDIOMYOPATHY (Takotsubo syndrome) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   LITERATURE REFERENCE:    Concurrent medical conditions included Myocardial infarction with nonobstructive coronary arteries (recently diagnosed).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced STRESS CARDIOMYOPATHY (Takotsubo syndrome) (seriousness criteria hospitalization and medically significant). At the time of the report, STRESS CARDIOMYOPATHY (Takotsubo syndrome) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Echocardiogram: takotsubo syndrome Consistent with mid-ventricular Takotsubo syndrome (TTS). On an unknown date, Electrocardiogram ST segment: abnormal (abnormal) abnormal. On an unknown date, Imaging procedure: normal (normal) showed improvement in systolic function prior to discharge.. On an unknown date, Troponin: elevated (High) Elevated.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered STRESS CARDIOMYOPATHY (Takotsubo syndrome) to be possibly related.    Treatment for event included diuretics, betablockers, and angiotensin receptor blockers.  Patient is a postmenopausal woman with a recent diagnosis of MINOCA who developed TTS shortly after receiving the COVID-19 vaccine. Risk factors included sex, age, MINOCA, anxiety about the vaccine, and possibly the vaccine itself may have all contributed to the TTS presentation.  Concomitant product use was not provided by the reporter.  Company Comment :This case concerns a 73 year-old, female patient with a history of Acute myocardial infarction, who experienced the serious (due to hospitalization) unexpected AESI of Stress cardiomyopathy. The event occurred shortly after the mRNA-1273 vaccine, dose number not provided. The rechallenge was not applicable since dose number was not provided. The medical history, of Acute myocardial infarction, patient´s advanced age and gender remain as confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 73 year-old, female patient with a history of Acute myocardial infarction, who experienced the serious (due to hospitalization) unexpected AESI of Stress cardiomyopathy. The event occurred shortly after the mRNA-1273 vaccine, dose number not provided. The rechallenge was not applicable since dose number was not provided. The medical history, of Acute myocardial infarction, patient´s advanced age and gender remain as confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Red wheal immediately after giving V2V 31/2"x4" - Wheal faded after 24 hrs- 3 days later and red/blue discoloration remains.
fever; chills; very bad reaction; very very achy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (very bad reaction), PAIN (very very achy), PYREXIA (fever) and CHILLS (chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (very bad reaction), PAIN (very very achy), PYREXIA (fever) and CHILLS (chills). At the time of the report, VACCINATION SITE REACTION (very bad reaction), PAIN (very very achy), PYREXIA (fever) and CHILLS (chills) outcome was unknown.            No treatment information was provided.  No concomitant medication was provided.
was postmenopausal/ On 14Nov I started spotting blood; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Oct2021 (Lot number: 30145BA) at the age of 52 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "perimenipause" (unspecified if ongoing), notes: for the past 5 years. periods every 3 weeks and very light. Mar2021 was last period. Concomitant medication(s) included: SYNTHROID. The following information was reported: POSTMENOPAUSAL HAEMORRHAGE (medically significant) with onset 14Nov2021, outcome "not recovered", described as "was postmenopausal/ On 14Nov I started spotting blood". The event "was postmenopausal/ on 14nov i started spotting blood" was evaluated at the physician office visit. Patient went to the Gynecologist in Sep2021 for a checkup and all was well. She said patient was postmenopausal. Patient had her first shot on 29Oct. On 14Nov, she started spotting blood. It lasted 3 days and then the spotting happened again on 30Nov for 3 days. (Patient had the second shot on 26Nov). No covid prior vaccination and no Covid tested post vaccination. Therapeutic measures were not taken as a result of postmenopausal haemorrhage.  No follow-up attempts are possible. No further information is expected.
several hr p/vax devel t100, vomiting & high pitch cry approx 1hr only;next day dehydrated & became listless;required hosp;
Lt thigh - 1/2 cm x 3cm erythema, confluent,NT area no fever. At injection site. Tx 1 - cool compress, motrin q6 hrs, f/u prn if worsens.
Facial weakness, headache, fatigue, facial asymmetry Diagnosis: Bell's palsy Treatment: acyclovir 400 mg 5x daily x 10 days and prednisone taper Disposition: patient discharged stable from ER
8 pm felt very tire and lite headache, by midnight body ache , next day felt very cold and had chills  , my hands were very cold and my pinky finger was numb no feelings , no appetite and  body ache was terrible; took Tylenol . Today Saturday 3/13 feel better.
jerking,  chills,shaking, burning from inside out, severe headaches, trouble with balance, walking, memory and vision
Pain to Left arm, worsening over the last 8 days. Painful to raise arm over head, 7/10 and painful to move across body. Denies warmth, swelling, fever, puffiness, redness.
Presented with a swollen tongue and shortness of breath. Reports fever and chills the night prior per patient statement.  Narrative:  Patient escorted to the emergency department to  be examined.
Sore arm and feel feverish on day of shot onwards. On 2/22/21 around 9:30am, I started having intermittent piercing headaches like someone stab me in the head. I can?t function when it occurred. It only lasted about 10-15 seconds. After that, I started taking Aleve and Acetaminophen 500 mg and it seems to stop.
Muscle pain at injection site; Diarrhea; Nausea; Vomiting; Abdominal pain; Chills; This is a spontaneous report from a non-contactable consumer, the patient. A 23-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Jun2021 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included bupropion (MANUFACTURER UNKNOWN) and clonidine (MANUFACTURER UNKNOWN), both taken for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 12May2021 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. On 06Jun2021, the patient experienced muscle pain at injection site, diarrhea, nausea, vomiting, abdominal pain and chills. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events muscle pain at injection site, diarrhea, nausea, vomiting, abdominal pain and chills was resolving at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient was given 8/14/08. Patient developed increased erythema, warmth and tenderness over the next 24hrs. Seen 8/16/08 started on Keflex 200/5 2tsp. bid xiodz.