chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pfizer Dose 1 3/8/21 (EN6199) Pfizer Dose 2 4/7/21 (ER8737) Pfizer Dose 3 10/21/21 (FF2593) COVID Positive 1/11/22 COVID Positive 1/24/22  1/24/22: Patient is a 81 year old male who presented to ED via EMS with complaints of chest pain while shoveling snow just prior to arrival. He took 2 sublingual nitro with no relief in symptoms and called EMS. Chest pain was left sided, non-radiating, sharp and constant in nature, no alleviating or aggravating factors. Denies shortness of breath. No diaphoresis, nausea, or vomiting. Chest pain relieved in ED. He is fully vaccinated for Covid-19. Past has a past medical history of hypertension, hyperlipidemia, hypothyroidism, CAD s/p CABG and multiple stents, type 2 diabetes mellitus, seizure disorder, pvd s/p stent, anemia, right lower extremity DVT on Coumadin and history of cva.  On arrival to ED pt was hypertensive 165/65. Labs significant for hyperglycemia 266. Hypomagnesemia 1.3. D-dimer 0.65. CT chest no PE. Chest xray unremarkable. No trop leak. EKG sinus rhythm with RBBB, rate 78, QTC 437. 4 baby aspirin and sublingual nitro given in ED with relief in chest pain.  1/29/22: 81-year-old male with coronary artery disease status post CABG and PCIs, peripheral vascular disease status post intervention presented with left-sided chest pain while shoveling snow, improved with sublingual nitroglycerin in the emergency room.  Patient elevated troponin with no ischemic EKG changes.  Patient admitted for non STEMI, started on heparin GTT Cardiology was consulted patient underwent coronary angiogram with the intervention including stents.  Patient retroperitoneal hemorrhage following the procedure, hypotensive and anemic requiring blood transfusion.  Peripheral angiogram did not reveal pseudoaneurysm or extravasation.  Hemoglobin remained stable.  Patient was supposed to be on warfarin for DVT, repeat lower extremity ultrasound showed no deep vein thrombosis and in the setting of retroperitoneal hemorrhage with anemia, dual anti-platelet it was deemed patient is at significant risk for bleeding and anticoagulation discontinued.  Patient had recurrence of symptoms IVC filter can be considered as an outpatient.  On discharge patient was afebrile and hemodynamically stable he was discharged home.
"s/p 2nd Moderna shot 02/24/2021. arm swelling, feverish, ache, w/o erythema. - f/c/ns, - myalgia, -cough/Wz/SOB, -n/v/d, Smell & taste intact, No rash. Eat/sleep well, BM/Urine OK."
COVID after COVID Vaccines; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID after COVID Vaccines) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0770218) for COVID-19 prophylaxis.    Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for an unknown indication.    The patient's past medical history included Knee replacement. Concurrent medical conditions included Seizures since 1999, Asthma (The patient had this condition for probably a year or a little longer.), COPD (The patient was not sure how long she had this condition, but she knew she had not had it as long as she had the asthma.), Dust allergy, Pollen allergy, Allergy to animal (Allergic to dogs, cats and things like that.), Restless legs, Arthritis, Heartburn and Blood pressure abnormal. Concomitant products included FLUTICASONE PROPIONATE and AZELASTINE for Allergy, MELOXICAM for Arthritis, SALBUTAMOL SULFATE (PROAIR RESPICLICK) and BENRALIZUMAB (FASENRA) for Asthma, BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) for Asthma and COPD, VERAPAMIL for Blood pressure abnormal, ESOMEPRAZOLE MAGNESIUM for Heartburn, ROPINIROLE HCL for Restless legs, TOPIRAMATE (TROKENDI XR) for Seizures.   On 27-Mar-2021, the patient received first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) 1 dosage form. On 10-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Nov-2022, the patient experienced COVID-19 (COVID after COVID Vaccines). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) in November 2022 for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID after COVID Vaccines) outcome was unknown.            Ethnicity of the patient was reported.  The patient stated that she had lot of allergies, she also got unspecified allergy shots at the doctor twice a week.  The patient had to take Paxlovid because she was sick from having COVID. The patient reported that the Paxlovid was dispensed to her on 07-Nov-2022. The patient had brain fog in November with Paxlovid. She mentioned that she could not concentrate long enough, it was difficult to do anything. The patient also mentioned that at the time she was on Paxlovid, it was the only medication that she had a reaction to. The patient also took Aspirin 81 mg once a day and stated she thought she started this medication at the last time when she saw her doctor, on 12-Dec-2022. The patient reported that Paxlovid had been listed as an allergy for her. NDC number of Paxlovid was reported as 00069-1085-30. The patient did not have any laboratory testing related to the event.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Upon follow-up, QE ID (product quality complaint number) was added.
sometime in the end of May or start of June following my vaccine series, I started noticing a heartbeat and swooshing sound in my left ear.  This happens from time to time throughout the day every day.  On two occasions I've had headaches that feel like loads of pressure simultaneously with the pulsing tinnitus.  During this time, my heartbeat also became irregular, registering >100bpm while resting.  I am a healthy, fit individual who has never experienced any of these symptoms.
Patient received PREVNAR 13 and FLUZONE HI DOSE on 9-18-17. Pt has egg allergy. Patient admitted to hospital on 9-26-17 with chest pain. Over the first night patient had seizure activity. Patient discharged 10-4-17.
Patient described dizziness, decreased heart rate (67 bpm). Thought may be anxiety driven but had patient put feet up and wait an additional 15 minutes. Lasted less than 30 minutes, patient stated fine and left clinic shortly after 30 minutes.
Area of erythema with 3 small nodules. The area measures 1 1/2cm x 2cm. Area at site of immunization injection.
This spontaneous report was received from a pharmacist referring an unspecified number of patients of unknown age and gender. The patients' pertinent medical histories, concurrent conditions and concomitant medications were not reported. On an unknown dates, the unspecified patients were vaccinated with doses of PNEUMOVAX 23 (dose, route, lot # and expiration dates were not reported). Other suspect therapies included PREVNAR 13. It was stated that an unknown number of pharmacist were administering PNEUMOVAX 23 vaccine injections to patients less than a year from receipt of PREVNAR 13 vaccine injections. No adverse events were reported. There was not a product quality complaint involved. Additional information is not expected because the reporter refused additional contact.
Severe drowsiness 45 minutes after injection, slept 12 hours straight during day/evening, awaken for one hour then slept til 6 am. Awake 4 hours then slept 6 more. Chills noted from 2100on 4/1/21 til present.Fever of 100.5 noted at 1830 on 4/2/21, took ibuprofen 600mg po. Pending results. Still 100.5F-101.3F. Keeping fluids down. Body weakness/fatigue noted since 1100 am on 4/2/21.
24-48 hrs. after getting vaccine arm (L. Deltoid) became red, swollen, blistering and painful. May have gone swimming in lake day after vaccine. Never told or showed arm to mom. Came into Dr. office 7/18/17 with redness and blistering after showing mother. Given local antibiotic cream-mupirocin.
Received vaccine 4/1/08 - around 1 AM 4/2/08 family noted pt awake - starting to have hives - no resp distress. Seen in office 4/2/08 for evaluation. Prelone given for rxn with Benadryl.
Information has been received from a physician concerning a patient who was vaccinated with a dose of ROTATEQ on an unspecified date (lot number was available). On an unspecified date the patient experienced nausea and fever after receiving a dose of ROTATEQ. Subsequently, the patient recovered from nausea and fever on unspecified dates. No further information was provided. The patients sought unspecified medical attention. No further information is available.
First shot soreness in left arm and a slight headache.  2nd Shot extreme muscle pain, joint pain. Fever of 101. Difficulty thinking, fatigue. Extreme arm soreness.  Raised welt at the injection site.  I took Tylenol and Motrin on a rotating schedule barely made a difference with pain and fever.  Fever went down to 100.5.  Difficult time sleeping due to extreme joint and muscle pain.  Additionally, squeezing feeling in intestines.
pt was scheduled for her covid booster but when we called to see why she was late she said that her dr recommended not to get the booster because she had a rxn with first dose. she said that her arm became very red and swollen and even developed a temperature with it. she claimed that her arm is still sore.
THROAT HOARSE; SNEEZING; COLD; BACK PAIN; ARM SORENESS/ARM FELT SORE/PAIN IN LEGS; MILD HEADACHE; MUSCLE ACHES; FEVER OF 100.4; FLU LIKE SYMPOTOMS; DID NOT SLEEP WELL; This spontaneous report received from a patient concerned a 58 year old male. The patient's weight was 175 pounds, and height was 70 inches. The patient's past medical history included back surgeries, and concurrent conditions included cigarette smoker, and other pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1820095, and expiry: 04-JUL-2021) dose was not reported, administered on 05-MAY-2021 13:00 for prophylactic vaccination. No concomitant medications were reported.  On 05-MAY-2021, the subject experienced did not sleep well. On 06-MAY-2021, the subject experienced flu like sympotoms. On 06-MAY-2021, the subject experienced back pain. On 06-MAY-2021, the subject experienced arm soreness/arm felt sore/pain in legs. On 06-MAY-2021, the subject experienced mild headache. On 06-MAY-2021, the subject experienced muscle aches. On 06-MAY-2021, the subject experienced fever of 100.4. On an unspecified date, the subject experienced throat hoarse, sneezing, and cold. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100.4 F, 99.8-99.9 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine  was not applicable. The patient recovered from did not sleep well, and flu like sympotoms, and back pain, arm soreness/arm felt sore/pain in legs, and muscle aches on 10-MAY-2021, had not recovered from mild headache, and fever of 100.4, and the outcome of throat hoarse, sneezing and cold was not reported. This report was non-serious.
Yesterday, she had COVID19 vaccine (believe Moderna) at 9 am, no immediate or local injection problems until 2 pm when she started itching from left wrist/ hand, up her arm to chest, back, neck, right arm and lower extremities. She took an allegra in the evening which did not help. That night she has persistent itching and shortness of breath with wheezing in her throat. This morning similar symptoms but woke with posterior headache, but over the day the rash improved receding from her legs, back, chest and remained on her chin and bilateral forearms. She was recommended to come to UCC for evaluation.  - prior to the vaccine, for the past week, she reported having sore throat, wheezing in throat, shortness of breath, no coughing or diarrhea - currently being treated for h pylori, taking levofloxacin qday (has one or two more tabs) and metronidazole (has another week). She has taken metronidazole before without adverse effects and no known allergy to levofloxacin. - denies known food allergy or recent change in diet - other than dust but she does not equate this reaction to past reactions to dust, denies known environmental or contact allergy and denies recent contact with plants, nickel, new cosmetic/ personal care product use, or occupational/ home exposure to chemicals - She denies using lotion, change in soap, detergent, clothes, sheets. She lives with family who do not have similar rash. Denies history of similar skin problems or rashes. Apart from augmentin (stomach pain, vomiting), but otherwise no known food or medical allergy. - denies throat/ tongue swelling, history of severe allergic reaction or anaphylaxis
Small pin-point rash on thighs near injection sites, 2 days, post vax.
Headache SORE THROAT, CHILLS, FATIGUE, SORE ARM Narrative:  Other Relevant History:
Very minor sore throat and coughing. I took PAXLOVID. I have had 2 doses of EVUSHELD.
Approx 3x4 inch area of erythema, induration (mild) no warmth or fluctuance.
Information has been received from a physician concerning to his 14 year old niece with peanut and other allergies as well (unspecified) who was vaccinated with GARDASIL.  Subsequently the patient experienced hives that last for weeks after vaccination. The patient was also given other unspecified vaccines at that time.  The patient was now recovered.  Additional information is not expected.
This is a spontaneous report from a contactable consumer (parent). A 15-month-old male patient received PREVNAR 13 on 20Apr2018 at single dose for immunisation. Medical history included ear infection from 13Apr2018, and cold. Concomitant medication included CIPRO for ear infection at 0.3 percent a couple times a day. The patient received some vaccinations at the doctors visit one of which was pneumococcal 13-val conj vac (dipht crm197 protein) and this morning he did have a fever upon waking up (21Apr2018). Treatment included TYLENOL in the morning and subsequently Ibuprofen as well. Lab work was none. Event outcome was recovered.
9 doses were administered post excursion; product storage error; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (9 doses were administered post excursion), PRODUCT STORAGE ERROR (product storage error) and NO ADVERSE EVENT (No adverse event) in a 78-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7170B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (9 doses were administered post excursion), PRODUCT STORAGE ERROR (product storage error) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (9 doses were administered post excursion), PRODUCT STORAGE ERROR (product storage error) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (9 doses were administered post excursion) and PRODUCT STORAGE ERROR (product storage error).    No concomitant medications were reported. Storage condition at the time of the excursion was frozen. Temperature noted in that condition was -2 to -18 C. Excursion duration was for 2hrs. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2023: Live Significant follow-up received: New events added and Narrative was updated
Anxiety/panic attacks (4); Anxiety/panic attacks (4); This is a spontaneous report from a contactable consumer, the patient. A 41-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 an unknown date, as a single dose for COVID-19 immunisation. 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 COVID vaccine. The patient had no relevant medical history and no known allergies. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 10Apr2021, the patient experienced anxiety/panic attacks (4) since second vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events anxiety/panic attacks (4) were recovering at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Very heavy period; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the left arm on 07Apr2021 at 11:15 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergy to sulfa drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) from an unknown date for an unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9267) via an unspecified route of administration in the right arm on 17Mar2021 at 11:15 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21May2021 at 17:00, the patient experienced very heavy period and had been bleeding through super plus tampons at a rate of 1 tampon per hour or two for 5 days. For the past year she had very light periods. The patient reported that it was not normal. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event very heavy period was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Swelling, warmth, tenderness, erythema spreading from site over the next several days, fevers and rigors.
postnasal drip; 2 ear aches; This spontaneous case was reported by a consumer and describes the occurrence of UPPER-AIRWAY COUGH SYNDROME (postnasal drip) and EAR PAIN (2 ear aches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced UPPER-AIRWAY COUGH SYNDROME (postnasal drip) and EAR PAIN (2 ear aches). The patient was treated with PREDNISOLONE at an unspecified dose and frequency. At the time of the report, UPPER-AIRWAY COUGH SYNDROME (postnasal drip) and EAR PAIN (2 ear aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by reporter.
Pt developed some SOB and rash over body within 45 minutes of injection. Pt needed asthma inhaler and SOB resolved. Rash had disappeared by mother's arrival (45 minutes later). Child taken to MD and started on Zyrtec and prednisone.
Began with lump and redness to site that lasted more than a week.  Progressed to chest symptoms,  w/ occasional wheezing, and increase in frequency of and onset of daily migraines (all three types - abdominal, cranial, and ocular).   -- Dx w/ allergic asthma --increased frequency of headaches & migraines:   Headaches became daily and continue most days; more sensitive to barometric pressure changes, any direction. Cranial migraines became very frequent for 6-7 yrs, have tapered off to occasional w/ Rx; occular migraines were very frequent for 6-7 years, have tapered off;  abdominal migraines were multiple times were multiple times per day originally and dapered to daily. Currently, crainal migraines - 1-3 per month; ocular migraines - 0-3 per month; and abdominal migraines - remain daily. I disicovered that the incorrect paperwork for vaccine was given to me; it did not show the zostavax contained neomycin.  I listed neomycin as an allergy on consent form, but apparently the Pharmacist relied upon the paperwork given to me and didn't read my allergies.
Facial swellings; shortness of breath; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Dec2021 at 09:00 as dose 1, 0.3 ml single (Lot number: FJ1620) at the age of 37 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: SWELLING FACE (hospitalization) with onset 15Dec2021, outcome "not recovered", described as "Facial swellings"; DYSPNOEA (hospitalization) with onset 15Dec2021, outcome "not recovered", described as "shortness of breath". The patient was hospitalized for swelling face (hospitalization duration: 3 day(s)); the patient was hospitalized for dyspnoea (hospitalization duration: 3 day(s)). The events "facial swellings" and "shortness of breath" required physician office visit and emergency room visit. Therapeutic measures were not taken as a result of swelling face, dyspnoea. Clinical course: The patient had no other vaccine in four week and no other medication in two week. Patient had not tested covid post vaccination. The patient had no known allergies.
Swollen glands, muscle pain, fever 104 degrees F x 3d. Cough.
Patient came to see me today, said 30 min after she got the vaccine, she started to "feel her heart".   She said it felt slow, as if she had to take a deep breath to get enough oxygen, even when she's pre-occupied and working, senses her heart "slowed down".   10/9/20 @ 12:30 PM is when she came to tell me about this-  her HR- 97, pulse ox @ room air- 97 %.   She said she feels nervous right now about it.  She also said  has a history of anxiety, and Covid has made her anxious, also has a lot of family stress right now. She will contact her Dr. today to have it checked. Said she has gotten the Flu shot every year since she was 9 yrs old, thinks she'll never get another one now.
Pt had large localized reaction 5" X 2" at injection site that appeared 8 hours after injection. Reaction is resolving well, responding to BENADRYL and ibuprofen.
Caller stated that 12 hrs after shot his daughter had expected side effects...chills, headache and nausea which lasted 24 hrs. 2 days later she had a very painful very heavy period 2 wks early. (dad stated period has always been regular until after shot)
Patient had blood in stool after rotavirus vaccine at 2 months that lasted for a few weeks and again at 4 months that just lasted a few days.