chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PATIENT RECEIVED THE VACCINE ON 02/16/2021 AT 1300. PATIENT ALERTED US ABOUT HER HISTORY OF SEVERE ALLERGIC REACTION TO A THYROID MEDICATION (PATIENT CANNOT REMEMBER THE NAME), SO WE FLAGGED THE OBSERVATION AREA TO CLOSELY MONITOR HER FOR 30MINS AS PER STATE GUIDELINES. AT THE 20MIN MARK, PATIENT COMPLAINED OF LIGHTHEADEDNESS AND FEELING NAUSEOUS. WE GAVE BENADRYL  AND TOOK HER VITAL SIGNS. VITAL SIGNS ARE NORMAL WITH A 98% OXYGEN SATURATION ON ROOM AIR. PATIENT RECOVERED AND LEFT ON A STABLE CONDITION.
child received Dose 2 of Pfizer series at 2 weeks post Dose 1 instead of 3-8 weeks post dose 1.  Parent was notified of vaccine error. Parent and child waited in clinic waiting area for roughly 15-20 minutes with no side or adverse effects noted by the time of their departure
By 2am extreme headache, by 4am- vomiting, chills, to sleep til 5p, headache, chills and muscle aches. Back to normal in 72 hours; By 2am extreme headache, by 4am- vomiting, chills, to sleep til 5p, headache, chills and muscle aches. Back to normal in 72 hours; By 2am extreme headache, by 4am- vomiting, chills, to sleep til 5p, headache, chills and muscle aches. Back to normal in 72 hours; By 2am extreme headache, by 4am- vomiting, chills, to sleep til 5p, headache, chills and muscle aches. Back to normal in 72 hours; This is a spontaneous report from a contactable nurse (patient). This 48-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 23Dec2020 09:00 at single dose in Arm Right for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was Hospital. Medical history included Migraines. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication received within 2 weeks of vaccination included nortriptyline, bupropion, magnesium sulfate, fish oil , ca. The patient experienced By 2am extreme headache, by 4 am vomiting, chills, to sleep till 5p, headache, chills and muscle aches on 24Dec2020 02:00 AM, Back to normal in 72 hours. The outcome was recovered. No treatment received for the adverse events. The events were assessed non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Information on the lot/batch number has been requested.
Narrative:  53 yo man with history of PTSD, seizure disorder, fibromyalgia, HLD, OSA who developed malaise, dyspnea with exertion, production cough on 7/18/2021. His wife and step-daughter were also ill. He also has significant, diarrhea and poor PO intake since the symptom onset. He had one episode of brief syncopal episode after coughing spell. He and his family were tested positive on 7/20. Exposure without wearing facial covering to a group of people: eating out in restaurants.
Next day dizziness that passed, returned daily, became severe day 5, causing nausea, vertigo, stiff neck, fatigue, chills, headache, severity lessening day 9 (so far).
My mom had no reaction the day she received the vaccine but 9 days later, the area where she was injected turned sore, red, and hot.
The pt experienced possible apnea 10-15 minutes post vax. The pt was sent home on an apnea monitor. Per F/U 4/9/01: The pt was admitted and placed on apnea monitor with no subsequent significant episodes of apnea or bradycardia. The family received CPR training. Her exam at discharge was within normal limits. She is to continue with apnea monitor and follow-up with MD.
PRESSURE IN EAR AND JAW; MASSIVE EAR AND JAW PAIN; PRESSURE IN HEAD; MASSIVE PAIN IN HEAD; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case.  No concomitant medications were reported. On 2021, the subject experienced pressure in ear and jaw. On 2021, the subject experienced massive ear and jaw pain. On 2021, the subject experienced pressure in head. On 2021, the subject experienced massive pain in head. Laboratory data (dates unspecified) included: Scan (NR: not provided) was unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the massive pain in head, massive ear and jaw pain, pressure in head and pressure in ear and jaw was not reported. This report was non-serious.
Patient experienced extreme swelling, pain, blistering, peeling of skin on both feet. Patient said she went to the hospital 2 days after vaccination and saw her oncologist, which referred to it as "burning foot syndrome."
Information has been received from a physician concerning a 23 year old female who on 23-APR-2008 was vaccinated with the first dose of GARDASIL, (Lot# 0151X), 0.5ml IM to the left deltoid. There was no concomitant medication or other pertinent medical history reported. The physician reported that "3 to 5 seconds post vaccination the client developed trembling of her face muscles which lasted for 6 seconds, and she was pale. This incident occurred just now and the physician observed it happening." The client reported to the physician" she could feel her face muscles shaking." At the tine of the report, the client was resting and being monitored. No product quality complaint was involved. Additional information has been requested.
Headache; pains; occasional dizziness; aches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), PAIN (pains), DIZZINESS (occasional dizziness) and MYALGIA (aches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. refused) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache), PAIN (pains), DIZZINESS (occasional dizziness) and MYALGIA (aches). At the time of the report, HEADACHE (Headache), PAIN (pains), DIZZINESS (occasional dizziness) and MYALGIA (aches) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       concomitant and treatment details were not provided.
PROQUAD was administered to a 15 year old instead Of MMR II and VARlVAX; PROQUAD was administered to a 15 year old instead Of MMR II and VARlVAX; This spontaneous report was received from a medical assistant referring to a 15 years old patient of unknown gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.      On 30-SEP-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) recombinant Human albumin (rHA) (0.5 milliliter, lot # T012418, expiration date 06-OCT-2021; strength, frequency and route of administration were not reported) instead of rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) and varicella virus vaccine live (oka/merck) (VARIVAX) (strength, vaccine dosage detail, route of administration, lot# and expiration date were not reported) for prophylaxis (product administered to patient of inappropriate age and wrong product administered).
major headache, severe shivers & chills, sore muscle ache all over, flu like symptoms, fatigue, sore injection site 3 days. Lasted 24 hrs.
A day to 2 days later, she started with itching and red underneath breast area on both side.; A day to 2 days later, she started with itching and red underneath breast area on both side.; she had joint pain all over her body on next day; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (A day to 2 days later, she started with itching and red underneath breast area on both side.), ERYTHEMA (A day to 2 days later, she started with itching and red underneath breast area on both side.) and ARTHRALGIA (she had joint pain all over her body on next day) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE, LISINOPRIL, NAPROXEN and HYDROCODONE for an unknown indication.   On 17-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced PRURITUS (A day to 2 days later, she started with itching and red underneath breast area on both side.), ERYTHEMA (A day to 2 days later, she started with itching and red underneath breast area on both side.) and ARTHRALGIA (she had joint pain all over her body on next day). At the time of the report, PRURITUS (A day to 2 days later, she started with itching and red underneath breast area on both side.) and ERYTHEMA (A day to 2 days later, she started with itching and red underneath breast area on both side.) had not resolved and ARTHRALGIA (she had joint pain all over her body on next day) outcome was unknown.            No treatment information was reported.
Sick as a dog; Diarrhea; Stomach issues; Has lost 10 pounds; Has not been able to eat for weeks; Lost work days; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick as a dog), DIARRHOEA (Diarrhea), ABDOMINAL DISCOMFORT (Stomach issues), WEIGHT DECREASED (Has lost 10 pounds) and EATING DISORDER (Has not been able to eat for weeks) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.     On 18-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jun-2021, the patient experienced ILLNESS (Sick as a dog), DIARRHOEA (Diarrhea), ABDOMINAL DISCOMFORT (Stomach issues), WEIGHT DECREASED (Has lost 10 pounds), EATING DISORDER (Has not been able to eat for weeks), JOB DISSATISFACTION (Lost work days) and HEADACHE (Headaches). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form; PANTOPRAZOLE at a dose of 1 dosage form and LOPERAMIDE HYDROCHLORIDE (IMODIUM) at a dose of 1 dosage form. At the time of the report, ILLNESS (Sick as a dog), DIARRHOEA (Diarrhea), ABDOMINAL DISCOMFORT (Stomach issues), WEIGHT DECREASED (Has lost 10 pounds), EATING DISORDER (Has not been able to eat for weeks), JOB DISSATISFACTION (Lost work days) and HEADACHE (Headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient second dose scheduled for 07 Jul 2021 his asking taken or not. Concomitant product use was not provided by the reporter.  No lab data has been provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Follow-up received contains no new information.
This is a spontaneous case received from a male consumer of unknown age who received his first dose of  ZOSTAVAX on and unknown date. The patient reported that he had received the ZOSTAVAX vaccine about 3 years ago and then three years later he developed shingles. No further information was reported. Additional information has been requested.
Came down with shingles for no apparent reason - not under any type of stress and do not have compromised immune system.
He got extremely weak and sick with pneumonia 3 days from injection had to go emergency hospital.
Pt reports he became "violently ill Thursday evening after receiving Flu shot Thursday afternoon..." including: cough, runny nose, feeling crappy, generalized body aches and pains.
Appears that ITP has come back.  I have significant bruising on my left triceps, right triceps, and left hand.  I have not sustained any significant trauma that would have caused this type of bruising.  In addition, my right foot is very sore around the metatarsals.
Pfizer-BioNTech COVID-19 vaccine - Immediately after receiving his second dose of the Pfizer covid-19 vaccine, pt expressed dizziness and lightheadedness.  Prior to receiving his second dose, he informed the pharmacist administering the vaccine to fainting after receiving his first dose.  The pharmacist was prepared and when the pt expressed dizziness after second dose pt was able to lay down on the ground with feet up prior to becoming light headed.  Pt also experience sweating and was given an ice pack.  He remained on the ground for approximately 10 min until lightheadedness subsided and was then brought to the observation area where he was observed for an additional 20 minutes without incident.
Chills; Tiredness; Ache; pain and stiffness in the arm; pain and stiffness in the arm; This is a spontaneous report from a contactable other healthcare professional (patient). This healthcare professional reported similar events for two patients. This is the first of 2 reports.  A male patient of an unspecified age (reported 84, unit unknown) received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration on 28Jan2021 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in Feb2021, the patient experienced pain and stiffness in the arm, chills, tiredness and ache even 4 days later after vaccination. The patient would like to know if it is normal to get side effects from the covid vaccine up to 4 days later. The outcome of event pain and stiffness in the arm was unknown; all other events was not recovered.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021147698 same reporter, suspect vaccine, events; different patient
nasal discharge (ridiculous), draining badly; dull taste, no taste at all; Ear pain; sinusitis for more than a month now; Bad colds; 2nd dose received on 1 Feb 2021; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SINUSITIS (sinusitis for more than a month now), NASOPHARYNGITIS (Bad colds), RHINORRHOEA (nasal discharge (ridiculous), draining badly), AGEUSIA (dull taste, no taste at all) and EAR PAIN (Ear pain) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose received on 1 Feb 2021). On 22-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SINUSITIS (sinusitis for more than a month now) and NASOPHARYNGITIS (Bad colds). On an unknown date, the patient experienced RHINORRHOEA (nasal discharge (ridiculous), draining badly), AGEUSIA (dull taste, no taste at all) and EAR PAIN (Ear pain). On 01-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose received on 1 Feb 2021) had resolved. At the time of the report, SINUSITIS (sinusitis for more than a month now), NASOPHARYNGITIS (Bad colds), RHINORRHOEA (nasal discharge (ridiculous), draining badly), AGEUSIA (dull taste, no taste at all) and EAR PAIN (Ear pain) outcome was unknown. Not Provided          No concomitant medications were reported. Treatment included paracetamol and unspecified steroids. Action taken with mRNA-1273 in response to the events was not applicable.
Super swollen knot at the injection spot and ached and nauseous for 2 days. Couldn't use the arm that received the injection
Case number PHEH2014US003673 is an initial spontaneous report from the pharmacist received on 21 Feb 2014. This report refers to a 67-year-old female patient who was accidentally vaccinated with MENVEO (batch number: not reported) intramuscularly on an unknown date in Mar 2013. No adverse event occurred to the patient following this medication error (inappropriate age of vaccine administration).
Developed fever and body aches about five hours after vaccination. Presented to the emergency department on 2/14 with chest pain. Initial troponin was elevated, repeat within normal range. She had elevated inflammatory markers, hypoxia and was admitted to the hospital. Unclear if related to vaccine as also rhino-entero virus positive and had nucleocapsid antibodies so MIS-C also on the differential.
headache, very high resting heartrate (130bpm), body aches all over in every joint, injection site swelling and pain, fatigue, restlessness/sleeplessness, vivid and upsetting dreams
Blurred vision.  I?m having difficulty reading up close.  I didn?t notice this as a symptom of the vaccine at first. The last two days it has been difficult to read emails/texts on my phone. This is a sudden change as this is a daily task.
A few hours prior vaccine, she felt dizzy. She felt dizzy  for about 3 days total. Given time she no longer felt dizzy, we did not f/u with her physician. Our company nurse was notified and we monitored her until she felt well again.
86-year-old female with a history of coronary artery disease, defibrillator/pacemaker placement, hypertension and chronic renal insufficiency was brought to the ED by an ambulance for the concern of a shortness of breath.  The patient is accompanied by her neighbor.  The neighbor states that the patient lives 2 blocks away from her house.  The patient walked to her neighbor's house in the morning without any problem.  It appears that they traveled to visit a mutual friend.  The neighbor states that the patient was not "feeling well" when they left.  The neighbor observed that the patient was not able to get into the car in a rest area while returning back to the home.  She felt short of breath and her neighbor called for the ambulance service.  The patient denied any shortness of breath when the paramedics arrived at the scene.   The patient denies any specific complaint at the time of this examination.  She uses 2 L of supplemental oxygen at the home.
This spontaneous report was received from a medical assistant concerning an unknown number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with doses of GARDASIL 9, for prophylaxis (dose number, route, lot # and expiration date were unknown), which were improperly stored at 1 Celsius degree for 17 minutes. There was no previous temperature excursion. A digital data logger was involved. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA013334: US-009507513-1704USA013570: US-009507513-1704USA013571.
Patient stated couldn't remember if he ever got a flu shot in the past.  He was instructed to sit for 5-10 minutes for observation.  He stated no egg allergy.  A few minutes after administration, he became dizzy and very sweaty.  We called 911, and assesed for further symptoms.  He was not having trouble breathing.  He appeared very lethargice and very sweaty.  We stayted with him until the abmulance arrived.  They reviewed him for any further treatment, and he left on his own accord.
A report has been received from a Health Professional concerning a 5 year old, male patient. The patient has received no other meds, no other medical diagnoses, no known allergies, used no new soap, detergent or lotion. The patient has no pets. The patient had been receiving nasal FLUMIST started which started during fall season 2012. The child had received nasal FLUMIST at the primary care doctor's office 5 days previously and the patient presented to the emergency department with facial redness, red lips, swelling of the eyelids and hives. At the time of reporting, the event of facial redness. red lips, swelling of the eyelids and hives was improving. The report was considered to be non-serious by the reporter.
This spontaneous report was received from a medical assistant, concerning a patient of an unknown gender and age. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On 22-FEB-2017, the patient was vaccinated with an expired dose of M-M-R II (dose, frequency and route not reported) lot # reported as M001200 with expiration date of 28-AUG-2016. No adverse effects were reported. No product quality complaint was involved (PQC). Additional information has been requested.
Arm hurt and overnight patient couldn't sleep because it became extremely painful.  Patient received steroids (methylprednisolone) and tramadol.  It was five days before she started to feel better.
chest pain, intermittent for 2-3 weeks, did not call covid clinic until day after 2nd dose with chest pain complaints, chest pain was a new onset, evaluated for cardiac workup in EC and discharged home
Information has been received from the mother of a 21 year old female with allergy to corn flour who in August 2006, was vaccinated with her first dose of Gardasil. The patient's second dose was in approximately November 2006 and her third dose was on 02-APR-2007. Concomitant therapy included ethinyl estradiol (+) norelgestromin (ORTHO EVRA). On 18-JUN-2007 the patient experienced cervix bleeding. The patient sought medical attention and no laboratory or diagnostic studies were performed. As of 20-JUN-2007, the patient's cervix bleeding persisted. Additional information is not expected.
PATIENT DEVELOPED PAIN AND INDURATION AT INJECTION SITE THE DAY AFTER TDAP IMMUNIZATION WAS GIVEN. THIS MASS HAS REMAINED AT INJECTION SITE FOR 17 MONTHS AND IS STILL TENDER TO PALPATION.
Day 1- Hives about 5 hours after injection, lasted a few hours, soreness at injection site Day 4- welt and redness at injection site, progressing daily Day 12- spreading redness and swollen at injection site, very hard.  Visited PCP and received antibiotic
No seriousness criteria was reported. Based upon medical judgement this case is considered serious: medically significant event (OMIC). From initial information received on 7/27/04 from a health care professional regarding an adverse event occurring, it was reported that a 68 year old female patient received a booster dose of TD ADS ADULT, lot number U1185AA, administered IM in the left deltoid on 6/17/04. Three days later, on 6/20/04, the patient complained of hoarseness and was subsequently diagnosed with vocal cord paralysis. A CT scan of her larynx showed swelling. She is to have an endoscopy procedure in the future. The patient has not recovered from these events. From additional information received on 9/13/04 from a health care professional, it was reported that the patient had a parathyroidectomy in February 2000, patient was diagnosed with hypercalcemia. She was referred to another physician who ordered a computed tomography scan of the larynx and neck and scheduled a biopsy. Cardiac and pulmonary work up was within normal limits. The patient ws admitted to the hospital on 6/30/04 and discharged on 7/2/04. A 2-dimensional echocardiogram was within normal limits except a trivial percardial effusion. Pulmonary function tests and computed tomography of the chest were within normal limits.