chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pfizer Dose 1 4/8/21 (EN6205) Pfizer Dose 2 4/29/21 (EM9809) Pfizer Dose 3 12/16/21 (FG3527) COVID Positive 2/7/22  2/7/22: The patient is 75 year old with known history of oxygen-dependent COPD, chronic respiratory failure, personal history of non-small cell cancer, PE diabetes mellitus chronic kidney disease, diastolic heart failure, paroxysmal atrial fibrillation, aortic stenosis and other medical problems.  He was previously hospitalized on 1/27/2022.  Was treated for acute on chronic heart failure, COPD exacerbation, rapid ventricular response, likely upper GI bleed, anemia and other medical problems.  He received levofloxacin and was discharged to home on oral prednisone. He received vaccinations for  SARS-CoV-2 including booster shot.   He presented to emergency department with worsening cough and worsening shortness of breath of 4 days duration. Increased oxygen requirement.  He required to 8 L oxygen to maintain saturations.  His baseline is at 4.5 L in recent past.      Cough is mostly nonproductive.  Reports orthopnea.  Denied recent weight gain or weight loss. Denied subjective fevers.  He did report generalized weakness, tiredness, diarrhea and felt unwell.  Denied nausea or vomiting.  Denied current hematemesis, melena hematochezia.  He tested positive for  SARS-CoV-2 today.  2/22/22: 75-year-old male patient with a history of 4.5 L dependent COPD at home continuously, non-small cell lung cancer, PE, type 2 diabetes, chronic renal failure stage 3, paroxysmal atrial fibrillation, aortic stenosis was admitted to the hospital on 02/07/22 with complaints of cough and shortness of breath.  Knows to with SARS-CoV-2 virus on admission and started on treatment.  Patient completed a course of Actemra, remdesivir, doxycycline and steroids.  Patient was slowly weaned off of the BiPAP to OptiFlow.  Patient subsequently transition to nasal cannula oxygen.  And electrolyte abnormalities which were all corrected during the hospital.  Patient also had acute exacerbation of his chronic stage I diastolic heart failure with preserved ejection fraction.  Patient was diuresed while in the hospital.  Pulmonology consultation was obtained.  Patient was noted to have cavitary lesions in his lung per the CT of the chest.  The Patient's case was discussed in detail with him and his daughter and the poor prognosis without any significant recovery.  Hospice consultation was obtained and the patient with his daughter decided to be discharged to home with hospice.  All the questions were answered at the time of discharge.
Flushing/sweating, dizziness. BP 106/60 (pulse 63). Final BP 120/82 (pulse 75).
Spontaneous report was received from a physician, referring an identified patient, age and gender was not reported. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 25-APR-2018, the patient was vaccinated with an expired dose of VAQTA (lot # M027879 and expiration date 24-JAN-2018), 25U /0.5 ml, intramuscular for prophylaxis (anatomical location of vaccine was not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1804USA011371.
Redness, swelling, and pruritus at injection site 1 week post vaccine. Lymphadenopathy developed shortly after injection site reaction, starting in right axilla. Lymphadenopathy has extended up right side of neck and posterior right skull, as well as down right rib cage. Patient was also lightheaded and dizzy. Conservative treatment to this point, including topical as well as oral benadryl, ibuprofen, and acetaminophen. As of the writing of this description, symptoms are ongoing without any response to treatment.
After receiving vaccine, patient complained of not feeling well and feeling faint. Patient laid on floor with feet elevated. Bp 96/58, P 70, R 18. Color was pale with no signs of respiratory distress or other skin changes noted. Given cool compress and juice. Transferred to cot to monitor for half hour. Before leaving patient noted to have pink color back to skin, was tolerating sitting without feeling dizzy, and vitals: Bp 110/80, P 88, R 16.
Uncontrolled shaking, passed out, shortness of breath, dizziness, vomiting.
This spontaneous case reported by a consumer, describes the occurrence of loss of libido (loss of sexual desire and ability to keep an erection), hypoesthesia (numbness in genital area) and feeling hot (warm-to-touch in genital area) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. Concomitant products included Prilosec (omeprazole) for an unknown indication. On Mar 31, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 31, 2021, patient experienced loss of libido (loss of sexual desire and ability to keep an erection), hypoesthesia (numbness in genital area) and feeling hot (warm-to-touch in genital area). The patient treated with Cialis (tadalafil) for decreased sexual feeling, at an unspecified dose and frequency. At the time of the report, loss of libido (loss of sexual desire and ability to keep an erection), hypoesthesia (numbness in genital area) and feeling hot (warm-to-touch in genital area) outcome: unknown/not provided. Diagnostic results: On an unknown date, testosterone: Normal.
I got my vaccine at 3pm, I felt fine the entire afternoon, somewhere around 6 r 7 pm my arm hurt it was sore. It was not red, it was not swollen, it was just sore. I decided to take a bath, and went to bed. Felt tired and my arm was sore but it was mild, around 8 or 9 o'clock.  I went to bed at 8 or 9 o'clock and woke up around 2 or 3 in the morning and arm was very sore, would call it moderate. I took 500 Tylenol and 200 ibuprofen together.  Throughout the night my head hurt and i tried to go back to sleep. at 5 in the morning my head was excruciating, I would it an 8. My arm was very sore, I would give it an 8. My body hurt really bad so i give that an 8. so I'm thinking ok this is what you get when you get a vaccine so I went back to bed. from 5-8 am  tossed and turned. at 8 o'clock i got up and was very wobbly and weak and had chills. I checked my temp and it was 101.5. I went down stairs but had to take one stairs at a time because I was so weak, I went to kitchen because I was so thirsty. I tried to fix some ice water and lemon but it spilled. Went back upstairs because I had so many chills. I called my job at the Clinic but all they had was a voicemail. My face hurts my jaw hurts and my neck on the side where they gave me the shot, my right side. I was trying to put something in my stomach but I could only eat a few sunflower seeds. My body head and arm hurts so bad, moving is excruciating. I felt great all week and yesterday.
24 hours later - sudden onset of nausea; Day 2 fatigue; I am nursing; I am nursing; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 40-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in right arm on 16Jun2021 10:00 ( at age of 40-years-old) (Batch/Lot number was not reported) as dose 1, single for covid-19 immunization. The patient medical history included breastfeeding, drug allergy to Penicillin allergy , erythromycin allergy  Bactrim allergy , codeine allergy . The patient concomitant medications included probiotics (PROBIOTICS), paracetamol (TYLENOL), ibuprofen (IBUPROFEN), prenatal vitamins (PRENATAL VITAMINS (ASCORBIC ACID; BETACAROTENE; CALCIUM SULFATE; COLECALCIFEROL; CYANOCOBALAMIN; FERROUS FUMARATE; FOLIC ACID; NICOTINAMIDE; PYRIDOXINE HYDROCHLORIDE; RETINOL ACETATE; RIBOFLAVIN; THIAMINE MONONITRATE; TOCOPHERYL ACETATE; ZINC OXIDE)) taken for an unspecified indication, start and stop date were not reported.The patient did not receive any other vaccines within 4 weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.None other vaccine on same date.On 16Jun2021 she was on nursing day 2 fatigue, on 17Jun2021 24 hours later vaccination the patient experienced sudden onset of nausea. The reporter assessed the event as non serious.No treatment was received for event .The outcome the event she was on nursing day was recovered on an unspecified date in Jun2021, and other events recovered on 17Jun2021.  Information on the lot/batch number has been requested.
Patient began to feel nauseated at 1555, while sitting in observation approximately 5-10 minutes after receiving the Pfizer COVID-19 vaccine IM.  Patient was brought to the EMS room at the vaccination clinic.  Patients vital signs: BP 148/100; PR 125; RR 24; SpO2 100% r/a.  Patient was treated with IV in right a/c.  Patient began to have full uncontrollable body shaking, remained conscious, alert, and oriented throughout event.  Patient did not complain of difficulty breathing or other anaphylaxis symptoms.  Patient was transported to Hospital.
Received varicella vaccine on 12-1-14. Patient started having bumps all over body on 12 9-10 as well as fevers, chills, and joint aches. Patient has not received any treatment so far.
Irregular menstrual cycle- much shorter cycle one month, followed by missing period the next month. Booster Covid vaccine on 12/1/21. Period started as normal on 12/8/21 (per my usual 27-day cycle.) But then got another period just 16 days later, on 12/24/21. Now it is 44 days later, on 2/5/22, and I have not had another period. Use condoms with husband, and have taken 2 negative pregnancy tests in the past 2 weeks so not pregnant. Only 38 years old now, unlikely menopausal. I have very regular periods, have never before had a cycle that was only 16 day, nor that was missed/44+ days, and certainly not back to back.
Information has been received from a 68 year old female consumer reporting on herself who in December 2009, was vaccinated with a dose of ZOSTAVAX (Merck) (dose, route and lot # not reported). Concomitant therapy included hydrocodone. The patient reported that 2 years later, on 01-OCT-2011 she experienced shingles and was hospitalized after receiving ZOSTAVAX (Merck). The patient received unspecified treatment for the AE. The patient sought unspecified medical attention. At the time of the report, the patient had not recovered. Additional information has been requested.
Patient is under the age of 18 which is the age limit for Moderna vaccines.  The technician who entered the information and the pharmacist who administered the vaccine failed to recognize that the age was inappropriate for this vaccine.  The patient was not notified and we were never contacted by the patient with any adverse reactions to the vaccine.  This report is being generated for informational purposes only.
Respiratory distress. BP 175/116 (pulse 87). Gave sips of water. Slight wheezing - gave albuterol, 2 puffs.
severe burnt sensation on ceiling of mouth, indescribable entire jaws/teeth pain, itchiness, the most severe migraine pain reaching level 100, intense severe tight neck, stiff neck, brain pressure, back of the head tightness, uncontrollable fatigue, lethargy, temple headache, ear clogging, severe inflammation type of swelling on right neck from 6/1/21 to present and ongoing, still sick as of 7/2/21.
Aching; Fatigue; Fever; Headache; Pulse was 135; A spontaneous report was received from a nurse who was also a 34-year old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced fatigue, aching, fever, headache, and pulse was 135.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 13 Jan 2021, approximately 12 hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm at 09:00 for prophylaxis of COVID-19 infection.  On 13 Jan 2021, around 21:00, the patient experienced fatigue, aching, fever, and headache. On 14 Jan 2021, the patient was taken to the emergency room because his pulse was 135. He hadn't been able to bring it down since 13 Jan 2021. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcomes of the events, fatigue, aching, fever, headache, and pulse was 135, were unknown.; Reporter's Comments: This case concerns a female patient, who experienced a serious unexpected events of heart race increased, a non-serious unexpected event of pain, and a non-serious expected event of fatigue, pyrexia and headache. The event of fatigue, pyrexia, pain and headache occurred 4 hours after mRNA-1273 (lot # unknown) administration. The event of heart rate increased occurred on an unknown date after mRNA-1273 (lot # unknown) administration. Treatment details were not provided. Very limited information regarding the events have been provided at this time.  Based on temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
After receiving the vaccine, the patient stated that it burned, but there was no immediate reaction. It wasn't until she woke up the next morning that she noticed redness, warmth, soreness, and pain below the injection site on her right arm to her elbow. The patient stated that she took two 200 mg ibuprofen, which seemed to help with the symptoms.
The Covid-19 vaccination was improperly diluted. Patient was made aware of the situation and that the manufacturer recommends getting revaccinated.
fatigue, soreness at site.  Second dose was on 03/19/2021 (Pfizer/EL9267).   In May 2021, started with pain in back of head and neck pain. Reported this pain to Dr.  In June 2021, started get head tremors and was diagnosed with Cervical Dystonia. Receiving BOTOX infectious ever 3 months, but the effects merely lessen the tremors. It is debilitating and has started arthritis in my spine.  Extension tests (blood, scans, MRI's, etc) were completed to look for underlying events that could be the cause. Nothing was found. Third Booster was given on 01/09/22.  My husband and I were caregivers for our 90 year old person; therefore, we had to get the vaccines to protect her.
Gardasil given 2/27/07 developed lymphadenopathy (L) neck w/in 2 wks of vaccine.
Omental infarction; This is a spontaneous report from a contactable consumer (patient's mother) via medical information team. A 15-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number: not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was reported that the patient received second dose of the COVID-19 vaccine from Pfizer and developed omental infarction. The reporter stated that there were only 50 cases reported in the literature from 1896-2012, but there was a recent related case in the UK and hospital paediatricians mentioned that they had two other recent cases, it seems to her that this information should be considered. The patient was mistakenly diagnosed with appendicitis with clarification. Outcome of the event was unknown.  Information about the Lot/batch number has been requested.
Sore arm, muscle pain, headache, shivering, tiredness, fast heart beat.
Patient received vaccine 12 days before his 18th birthday and the vaccine is approved for 18 and older. Patient completed series after his 18th birthday and had no complaints.
Patient presented to ER due to hematochezia. She required 2 units PRBCs. She was seen by IR and underwent angiogram with embolization. She didn't require insulin drip or NPO but improved with IV fluids. She developed fever but did not have sepsis. UA was consistent with UTI but urine culture was negative. She received 2 doses of ceftriaxone during admission and will complete an additional day of treatment with nitrofurantoin. She didn't have recurrence of her fever. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
Client states left upper arm has sharp pain with movement that started the evening of vaccination. States she is still having pain in upper arm with movement 11/26/2012. Denies any arm redness or edema.
The pain is only on the left side the same side as covid shot.; STIFF NECK; injection site soreness that lasted for 2 days; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (STIFF NECK), PAIN (The pain is only on the left side the same side as covid shot.) and VACCINATION SITE PAIN (injection site soreness that lasted for 2 days) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 044A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Diabetes. Concomitant products included APIXABAN (ELIQUIS) from 01-Jan-1998 to an unknown date for Anticoagulant therapy, SIMVASTATIN for Cholesterol, METFORMIN from 01-Jan-1998 to an unknown date for Diabetes, METOPROLOL from 01-Jan-1998 to an unknown date for Hypertension, LISINOPRIL from 1998 to an unknown date for Stroke, ACETYLSALICYLIC ACID (ASPIRIN 81) from 01-Jan-1998 to an unknown date for an unknown indication.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE PAIN (injection site soreness that lasted for 2 days). On 28-Feb-2021 at 9:00 AM, the patient experienced MUSCULOSKELETAL STIFFNESS (STIFF NECK). On an unknown date, the patient experienced PAIN (The pain is only on the left side the same side as covid shot.). On 28-Feb-2021, VACCINATION SITE PAIN (injection site soreness that lasted for 2 days) had resolved. At the time of the report, MUSCULOSKELETAL STIFFNESS (STIFF NECK) had not resolved and PAIN (The pain is only on the left side the same side as covid shot.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications included Vitafusion men's multi vitamins, Equate low dose aspirin 81mg No treatment medications were reported. patient consulted his family doctor about Stiff neck and pain  at his regular appointment in June. Patient said it would probably  go away in about 3 months.   Most recent FOLLOW-UP information incorporated above includes: On 05-Oct-2021: Follow up received contains  Reporter Information, , Patient Demographic details, Vaccine Facility Information,  Concomitant medication and event information updated
tested positive for COVID; tested positive for COVID; This is a spontaneous report from a contactable consumer (Caregiver/wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 08Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included several underlying health conditions included type 1 diabetes mellitus, cancer survivor (2002), and he had a heart attack Jan2020. The patient's concomitant medications were not reported. The patient had his first Pfizer vaccine on 08Mar2021. He was scheduled for his second vaccine on 29Mar2021, but he tested positive for COVID on 28Mar2021, so he had to cancel. His primary care doctor sent him for monoclonal infusion therapy on Monday (29Mar2021). He was getting mixed messages as far as his second vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test: positive for COVID on 28Mar2021. The outcome of the events was unknown.   Information about lot and batch number was requested.
Started with pain, redness, lump under the skin on 2/05/19. Did not go away until 02/08/19. On 02/08/19 I started with a new symptom of a stiff neck. On 02/09/19, I still had the stiff neck and then a headache that eventually sent me to the ER twice that weekend. I went to Hospital twice for the headache pain. Today is 02/20/19 and I still have an unexplained headache. I've had a CT Scan and MRI's of my head and neck. My doctor is sending me for a spinal tap to make sure I don't have a CSF leak. Still have an unexplained headache which is very intense.
Injection site erythema; Injection site induration (approximately 2 inches diameter); Injection site pain; Injection site pruritus; Injection site warmth.
Patient developed fever, chills, and left shoulder pain. He is having difficulty raising his arm. Site is not tender touch or warm. He was evaluated by resident physician.
Mishandled and cold chain break for vaccines happened during shipment/No Ae; Initial information was received on 02-Sep-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves five patients of unknown demographics who received the vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot number and expiry date not reported) via unknown route at an unknown administration site for prophylactic vaccination which were  mishandled and cold chain break happened during shipment (product storage error)   The patients medical history, past medical treatment(s), vaccination(s) and family history were not provided.  It is an actual medication error case due to incorrect product storage.  Case details: Reporter stated that inventory personnel at head office said they received Fluzone QIV which were picked up on 24-Aug-2020 at the supplier's and delivered on 28 -Aug-2020 and mishandled and cold chain break happened during shipment. Last Friday, they receive an email that the vaccines were not viable, but they were already administered to five patients.  At the time of this report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
THE DAY AFTER PATIENT RECEIVED THE VACCINATION SHE DEVELOPED REDNESS AND SWELLING AT THE INJECTION SITE. IT SPREAD TO A DIAMETER OF ABOUT 3 INCHES AND BECAME SORE (FELT BRUISED), RED, AND HOT. SHE ALSO DEVELOPED ACHES AND PAIN IN HER BACK AND HIPS. SHE ALREADY TAKES NAPROXEN FOR OTHER CONDITIONS AND I ADVISED HER TO TAKE AN ANTIHISTAMINE (BENADRYL OR LORATADINE). SHE STATED THE TENDERNESS AND HEAT DID DISSIPATE BETWEEN FRIDAY AND SATURDAY.
Pt became red all over, mildly puffy, around the eyes, developed multiple urticarial lesions, vomited within 10-15 min. No resp. distress. Epil 2 ml SQ given. 3x urticaria decreased, then increased. Again sent to ER.
Hospitalization: 4/28/2023 - 5/2/2023 (4 days) Presentation to the ED: nausea and vomiting COVID + date: 4/28/2023 Treatment: no indication for treatment. Discharge to: home.  031L20A 2/3/2021 03M20A 2/23/2021 031H21A 11/20/2021