chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Myopericardit is After COVID-19 vaccine; This is a literature report.  A 16-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "admission" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; UNKNOWN MANUFACTURER), for COVID-19 immunisation. The following information was reported: MYOPERICARDITIS (hospitalization, medically significant, life threatening), 3 days after the suspect product(s) administration, outcome "recovered", described as "Myopericardit is After COVID-19 vaccine". The patient underwent the following laboratory tests and procedures: Electrocardiogram: showed mild diffuse ST segment elevations; obtained during the episode showed striking ST, notes: ST segment elevation in the inferolateral leads; normal; Magnetic resonance imaging heart: showed subepicardial enhancement without evidence, notes: of acute infarction; Troponin (3-57): 10819 ng/L, notes: High-sensitivity; downtrending, notes: discharged on hospital; Echocardiogram: Normal. Therapeutic measures were taken as a result of myopericarditis.  Clinical course: A 16 year old previously healthy male presented with two days of chest pain and subjective fevers three days after receiving the second dose of the Pfizer COVID-19 vaccine. High-sensitivity troponin I was 10,819 ng/L (reference range: 3-57), and ECG showed mild diffuse ST segment elevations (Image 1). He was admitted for suspected myopericarditis and treated with ketorolac, prednisone, and IVIG. Shortly after admission, he experienced sudden crushing, substernal chest pain. An ECG obtained during the episode showed striking ST segment elevation in the inferolateral leads. He was started on a nitroglycerin drip, supplemental oxygen, low dose aspirin and received 3 doses of morphine. The acute chest pain responded rapidly to these measures, and the nitroglycerin drip was stopped after 24 hours without recurrence of symptoms. An echocardiogram was normal. Cardiac MRI showed subepicardial enhancement without evidence of acute infarction. He was discharged on hospital day #4, chest pain free for 24 hours with downtrending troponin. Conclusion(s): This case highlights the importance of recognizing coronary vasospasm as a potential complication of COVID vaccine-induced myopericarditis.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Administration of an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided.  Treatment information was not provided.  The patient received an expire dose.
Inflammation, headache.  Felt like all my organs were swollen.  Especially uncomfortable during sleep from 2-4:30am.  Seemed reduced upon waking.  Managed to work a few hours at computer, then back to bed with body aches.  Pretty much gone within 30 hours of receiving shot.
nearly killed me; Initial information received from on 28-Jan-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who reported nearly killed me while receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.    On an unknown date, the patient received suspect influenza vaccine produced by unknown manufacturer at an unknown dose (lot number, expiry date, strength, form, frequency not reported) via unknown route in unknown administration site for influenza immunisation. Information on batch number was requested.  On an unknown date the patient developed serious event nearly killed me (near death experience) (unknown latency) following the administration of influenza vaccine. This event was assessed as medically significant.  Reporter stated anyone with egg allergies was to be asked first. It nearly killed me cause I didn't.  It is unknown if there were lab data/results available.  Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event (nearly killed me).  At time of reporting, the outcome was Unknown for the event nearly killed me.; Sender's Comments: Sanofi comment dated 07-Feb-2022: This case involves an unknown age and unknown gender patient who reported nearly killed me while receiving vaccine influenza vaccine. The time to onset was unknown for near death experience. Additional information regarding condition at the time of vaccination, concomitant disease or risk factor and other lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine cannot be assessed.
urinary tract infection.; This is a spontaneous report from a contactable consumer (Patient, self-reported). A (Age: 62, unit: unknown, as reported) female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1, via an unspecified route of administration on 03Mar2021 as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reportedly, Caller got 1st dose on 03Mar2021. Today, being treated for a urinary tract infection. Caller is prescribed Nitrofurantoin (Macrobid). Caller asked if the antibiotic will interact/cause issues with the vaccine working. On an unspecified date, the patient experienced urinary tract infection. Therapeutic measures were taken as a result of urinary tract infection. Outcome of the event was unknown.    No follow-up attempts are possible, information about lot/batch number cannot been obtained.
Developed 'lump" then white spot per mother, Began draining, 2 months post vaccine still draining, visible scarring approx .5 X 10 cm, Palpable area 1.5
Abdominal pain followed by decreased sense of taste and taste ?off? Taste aversion to previous enjoyed food and drinks.  Decreased pleasure in eating although appetite is good.
Immediately: headache, left eye pain, nausea, cold sensation and felt ?weird? but thought it was normal and thought I might feel flying for a bit but that it would wear off so I did not report feeling anything at the clinic. I left the clinic and got in the car to drive home and felt a weird feeling in my throat reminiscent of my esophageal spasm and then it felt like someone had their hand on my throat squeezing my throat and felt like I needed to take deep breaths to expand my lungs. Within a minute or two at most, my lips, tip of my tongue, tip of my nose and face beside my lips and under my cheeks started to tingle and go numb.  My insides felt swollen.   I had a doctors appointment and went there after picking my son up at home.  I reported my feeling to my doctor who prescribed a steroid for 3 days and told me to also take Benadryl or Claritin, which I did. However, today is day 4 after my vaccine and today is the first day my insides don?t hurt.
Pain at injection site followed by body aches, sore throat, chills, fatigue, cold like symptoms. I still have some symptoms today. Took an at home Covid test, negative results. Had the same reaction after 1st dose of Covid vaccine but these symptoms are lasting much longer from the booster.  Due to holidays it has been impossible to obtain a Covid test at a facility or be seen at an Urgent Care facility.
This spontaneous case was reported by a patient and describes the occurrence of CHROMATURIA (orange urine "like orange Gatorade"), ASTHENIA (weakness), ABDOMINAL DISCOMFORT (stomach complaints), PAIN (Achiness) and LYMPHADENOPATHY (visible swollen lymph nodes of left side of neck) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F21A, 025B21A and 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Lymphoma.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHROMATURIA (orange urine "like orange Gatorade"), ASTHENIA (weakness), ABDOMINAL DISCOMFORT (stomach complaints), PAIN (Achiness), LYMPHADENOPATHY (visible swollen lymph nodes of left side of neck), NAUSEA (nausea) and VOMITING (vomiting). At the time of the report, CHROMATURIA (orange urine "like orange Gatorade"), ASTHENIA (weakness), ABDOMINAL DISCOMFORT (stomach complaints), PAIN (Achiness), LYMPHADENOPATHY (visible swollen lymph nodes of left side of neck), NAUSEA (nausea) and VOMITING (vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: elevated liver function (High) elevated liver function. On an unknown date, X-ray: negative (Negative) negative.         Ultrasound was done and the patient was waiting for further results. The patient had no symptoms until 1 week after the booster dose.  No concomitant medication reported. No treatment information was provided.
Headache; Pain; This is a spontaneous report from a contactable consumer (patient's wife) reporting for a patient (her husband) via Pfizer sponsored program COVAX US Support. A 28-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 20May2021 as 2nd dose single and had previously received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as 1st dose single for COVID-19 immunization. The patient was 28-years-old at the time of vaccination. The main concern of the wife is that her husband the second dose of the vaccine on 20May and her husband experienced a bad headache and wanted to know if he can take Tylenol or Ibuprofen or any type of medicine for pain would be okay to take. While paraphrasing the concern, she stated, yes he did, she does not think it is from the Pfizer shot itself, he has been under a lot of stress at work but it is a stressful headache. The outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Had flu like symptoms for 11 hours from 8 pm to 7 am. Fever, chills, extreme body aches, headache, nausea.
Day 5 dizziness and lightheaded, Day 7 severe stomach pain, nausea, headache, Day 8 swollen, red, hot, itchy injection site with a rash approximately 4?x 2? all around site.
foggy; drowsy; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (foggy), SOMNOLENCE (drowsy) and HEADACHE (Headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced FEELING ABNORMAL (foggy), SOMNOLENCE (drowsy) and HEADACHE (Headache). At the time of the report, FEELING ABNORMAL (foggy), SOMNOLENCE (drowsy) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Information has been received from a physician concerning a 63 year old female with sulfonamide allergy, allergy to aspirin and a history of right mastectomy who on 01-NOV-2006 was vaccinated IM with a 0.5 ml dose of Pneumovax 23 (lot #651325/1037P) concomitantly with a dose of influenza virus vaccine (unspecified).  It was reported that that physician had administered both vaccines in the left deltoid, 2 inches apart, because the right arm had poor circulation due to right mastectomy.  Other concomitant therapy included tamoxifen citrate.  On 01-NOV-2006, a few hours after vaccination, the patient experienced nausea and vomiting.  The patient was examined in the emergency room later that evening.  She was treated with unspecified IV fluids and anti-nausea medications and released.  On 02-NOV-2006, the patient recovered from nausea and vomiting.  Nausea and vomiting were considered to be other important medical events.  Additional information has been requested.
No known adverse event, but patient received vaccine from multiple facilities unbeknownst to us and without declaring the conflict on the consent form.   Dose 1: 4/17/21  Dose 2 : 4/26/21  Dose 3: 5/12/21 Dose 4: 5/19/21
Patient complained of not feeling well after vaccines were administered 7/20/16. Vomited 5 x's between 12:30 AM - 4:00 AM 7/21/16. Fever 101.7.
A 26 year old female was vaccinated with Fluzone 96-97 on 11/19/1996. On 11/21/1996 it was reported that she had developed Bell's Palsy. From follow up of 2/19/97, it was reported that the pt had a past medical hx of obesity and asthma. The pt's recovery status was unknown.  From follow-up information received on 6/14/99, it was reported the pt's recovery status unknown.
Was nervous about getting the shot. Felt clammy and hot.  Felt weak and had a headache.  A Code was called and he was transported to the emergency room for monitoring.
Mild flu symptoms; Fatigue; A spontaneous report was received from a consumer concerning a 70-years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced mild flu symptoms and fatigue.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 24 Jan 2021, prior to the onset of the events the patient received their dose of mRNA-1273 (Batch Number: Unknown) for prophylaxis of COVID-19 infection.  On 25 Jan 2021, the patient experienced the mild flu symptoms and fatigue.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events mild flu symptoms and fatigue was not reported.   The events, mild flu symptoms and fatigue was considered resolved (lasted about a day and a half) on an unspecified date.; Reporter's Comments: Based on the current available information which includes a temporal association between the use of the product and the start date of the reported events, a causal relationship with the event cannot be excluded.  Fatigue is consistent with the known safety profile of mRNA-1273 vaccine.
Information has been received from a registered nurse concerning an unknown number of patients who were vaccinated with a dose of MMR II (dose, route and lot number not provided).  The nurse reported that three different parents mentioned to her that their children stopped speaking after receiving the vaccine.  It was not specified if the patients sought medical attention.  Outcome was not reported.  Upon internal review, children stopped speaking after receiving MMR was determined to be an other important medical event.  No further information is available.
Dizziness for 5 minutes after vaccination. Passed out for less than 30 seconds. Patient stable, released from vaccination site.
beginning of MAY92 pt recvd 1st dose of Engerix-B & devel sl flu-like sx which abated w/o treatment; beginning of JUN92 recvd 2nd dose immed became SOB & hypertensive; observed in ER;
flu for a week; Initial information received on 03-Dec-2020 regarding an unsolicited valid non-serious case from a non-health care professional via social media.  This case involves an adult patient with an unknown demography details who had flu for a week (influenza), while being received vaccine influenza vaccine.  The patient's medical history, past medical treatment, vaccination, family history and concomitant medication were not reported.  On an unknown date, the patient received first dose of suspect influenza vaccine (produced by unknown manufacturer) (batch number and other dosing details were not reported) for prophylactic vaccination.  On an unknown date, (latency: unknown) after starting the suspect vaccine therapy, the patient had flu for a week (influenza). It was reported that the patient took only one flu shoot in life.  No laboratory data was reported.  It was not reported if the patient received any corrective treatment. At the time of reporting, outcome of the event was unknown.  There will be no information available regarding batch number in this case. No further relevant information was reported.
Headache, rooming spinning when eyes closed, blurred vision when eyes opened, nauseated, and heart palpitations
flu; Initial information was received on 13-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer.  This case involves an unknown demographics patient who experienced flu while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   In 2005, (17 years ago) the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (dose, route, batch number and expiry date: unknown) in unknown administration site for prophylactic vaccination (flu).  On an unknown date the patient developed a non-serious event "flu" (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. It was reported "The only time I ever got the flu was a few days after the one time I was forced to get the flu shot if I wanted a job at a school for a year. After getting the flu vaccine I got the flu. That was about 17 years ago. The only time I've ever had the flu on the forty-four years I've been Macrobiotic and vegan since 1978 and I don't think I ever had the flu as a kid either. My parents got the flu shot every year and then got the flu shortly after getting the vaccine."  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (flu).  At time of reporting, the outcome was Unknown for the event flu.
Cough, chest tight, later had fast heart rate and sneezing non-stop just like when I get near cut grass or someone with heavy perfume.  This lasted until I woke up Monday morning.  I took Benadryl.
Headache, Myalgia, Arthralgia, Fever, chills, pain injection site Narrative:
During COVID vaccine administration being held at Medical Center, vaccine was administered by Health Department staff on 12/17/2. At 1:30 pm, during observation, patient stated he was having mild chest pain that was not there prior to vaccine. Client walked to observation room, blood pressure taken 169/89. Patient rated chest pain 1/10, described it as random sharp pain. In ER observation room, client was offered EKG which was declined. Patient was then offered to check in through ER for monitoring, patient also declined. Continued to monitor patient until 2:00 pm, at which point patient stated chest pain had subsided and he requested to go home to relax. Encouraged to return to ER if chest pain returns.
This is a spontaneous report from a contactable physician through a Pfizer sales representative. This physician reported similar events for 3 patients. This is the first of three reports. A patient of unknown age, unknown gender and unknown raced received PREVNAR 13 at single dose for immunization. Relevant medical history and concomitant medication were unknown. On an unknown date the patient experienced sick. The outcome of the event was unknown. Sender's Comments: Linked Report(s) : US-PFIZER INC-2016542415 same reporter/different patient, same product, similar events;US-PFIZER INC-2016542418 same reporter/different patient, same product, similar events.
PT. RECEIVED BIVALENT BOOSTER DOSE. THE BOX DID NOT HAVE EXPIRATION  DATE ON IT. WHEN ENTERING IT INTO THE SYSTEM IT WAS NOTICED THAT IT EXPIRED IN 11/16/22 AND PT. HAD ALREADY RECEIVED THE VACCINE.
Patient vomited a few minutes after recievingher first dose of the COVID vaccine during routine observation. The patient was walking from the vaccine room to observation room when she vomited.  Patient was provided a chair and bottled water and vitals were taken. HR 80bpm, BP 116/62mmHG, RR 18, and temperature of 97.8 degrees. She was monitored for a total of 30 minutes after the event. She only vomited once.
Worsening of Parkinson's symptoms, especially difficulty with start-up movement (standing from a sitting position) for approximately 72 hours.
headache, fever, chills, shivering, nausea, dizziness, stomach cramps, stomach spasms, insomnia, change in bowel movement, tiredness Advil and Tylenol helped a little.  Symptoms lasted longer than 3 days. Migraine triggered by vaccine
Breakthrough Vaccine case. Patient received 1st Moderna vaccine 1/13/2021 and 2nd Moderna vaccine 2/10/2021. Patient had +COVID PCR on 4/22/2021 (mild symptoms on 4/20/2021 in the setting of COVID exposure 4/16/21 and 4/19/21).
This case is 1 of a cluster of 3 patients who experienced similar adverse events following vaccination with MENACTRA. Initial reported received from a health care professional on 25 May 2010. An 11-year-old child, with a history of asthma, received the following injections on 17 May 2010: A right deltoid injection of MENACTRA, lot number U3357BA, a left deltoid injection of ADACEL, lot number sanofi pasteur Ltd. C3314 and lot number sanofi pasteur Inc. U3082BA, and VARIVAX (Merck), lot number 00262. The patient developed a very swollen and itchy unidentified location that looked like a big hard ball. The swelling was reported as improved, however, the area still was a little itchy and red. The outcome for the events was reported as not recovered. Follow-up information was received from the health care professional on 21 June 2010. MENACTRA and ADACEL were administered intramuscularly, and the events occurred in the right arm. The patient did not require treatment, and was not seen by a physician. Improvement was noted at the time of a telephone call with the patient's mother, and the events subsequently resolved. The reporter for this case is the same as for cases 2010-02943 and 2010-02944. Documents held by sender: None.