chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient (pregnant) received BNT162b2 (BNT162B2), on 29Dec2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 32 years, in left arm for covid-19 immunisation. The patient was pregnant at time of vaccination. The patient's relevant medical history included: "Panhypopitutirism" (unspecified if ongoing); "Known allergies- Avocado" (unspecified if ongoing), notes: Avocado allergy. The patient was 27 pregnant at the event onset. Concomitant medication(s) included: DESMOPRESSIN; HYDROCORTISONE; LEVOTHYROXINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient who completed initial course of Pfizer COVID vaccines, last dose 02/03/21, who tested detected for COVID upon admission for chest pain.  Provider discharge note below:  "79 year-old female with past medical history of anemia, PMR, and hypertension who presented to emergency department via EMS on 3/4 for chest pain. Her symptoms started hours prior to arrival. Her pain was described as pressure-like substernal pain with radiation to her back. Associated symptoms included shortness of breath and diaphoresis. Palliating factors included nitro and ASA.  Initial vitals notable for hypertension, otherwise normal. She received Zofran for nausea and fentanyl for pain. CBC demonstrated leukocytosis with left shift. She had mild hyperglycemia and hyperchloremia on CMP. Troponin was elevated at 111, with significant positive delta troponin of 334. EKG demonstrated no acute changes. Echo demonstrated EF: 45%, apical hypokinesis and RVSP: 32 mmHg. CTA C/A/P demonstrated small pericardial effusion.  Cardiology was consulted and the patient subsequently underwent left heart cath with placement of DES.  On 3/12, code blue was called on the patient. CPR was performed. Contacted family and they arrived at bedside, they requested to discontinue CPR and pt did not have pulse at the end of CPR. Pt passed away on 3/12/22."
Swollen arm; Little bit of a rash around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen arm) and VACCINATION SITE RASH (Little bit of a rash around the injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Swollen arm) and VACCINATION SITE RASH (Little bit of a rash around the injection site). At the time of the report, PERIPHERAL SWELLING (Swollen arm) and VACCINATION SITE RASH (Little bit of a rash around the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Very high pitched Tinnitus-Non-Stop everyday  (sounds like the phasers on Sci-Fi all day)
Ache; with the 5th dose just a little tired; Chills; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Ache), FATIGUE (with the 5th dose just a little tired) and CHILLS (Chills) in a 64-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Flu shot (Had Pneumonia 1 day after flu shot). Past adverse reactions to the above products included Pneumonia with Flu shot. On 07-Sep-2022, the patient received fifth 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 PAIN (Ache), FATIGUE (with the 5th dose just a little tired) and CHILLS (Chills). At the time of the report, PAIN (Ache), FATIGUE (with the 5th dose just a little tired) and CHILLS (Chills) outcome was unknown. Patient previously had Moderna vaccines as 1st Dose on 11-Mar-2021, 2nd Dose on 08-Apr-2021 with lot number 030B21A, 3rd Dose on 29-Oct-2021 with lot number 047C21A and Dose 4 on 08-Apr-2022 with lot number 046L21A. It was reported that patient received Dose 5 which was recorded as Moderna Bivalent on patient's record card, However, the state registry information on patient's record list was stated as Monovalent. No concomitant medications were reported. No treatment details were reported.   This case was linked to MOD-2022-679862, MOD-2022-679857 (Patient Link).
Bronchitis; experienced Loss sense of smell, nausea, diarrhea,  body aches, ear ache, brain fog, fever, cough, fatigue, intermittent whistling sound while breathing, cough keeps me from sleeping, ear ache due to ear infection; started 10/21/22, Dr visit  on 10/25/22, symptoms ongoing
Patient presented to the ED and was subsequently hospitalized for DVT within 6 weeks of receiving COVID vaccination.
After receiving the first dose of the Moderna vaccine, I developed a severe headache and COVID arm - a raised red rash on my right arm that was painful, warm, and itchy. After receiving the second dose of the Moderna vaccine, my COVID arm returned, along with body chills and aches, severe back pain akin to back labor, and a severe headache. After about 48 hours, all but the chills subsided and I was left with a pins and needles type feeling in both of my feet. On 04/19/21, I noticed the tingling feeling creep up my legs and into my calves. On 4/20/21, it progressed into my fingertips and my legs felt week. I went into Urgent Care, where they took vitals, my temperature, and did a brief exam. The Nurse Practitioner, called the Hospital's Neurologist, who ordered bloodwork and fit me into his schedule that afternoon. Bloodwork consisted of a full metabolic panel, B12, thyroid, HIV, and Lymes. All results were normal except for the lymphocyte count, which was elevated to 3.6. Following the bloodwork, I met with Dr. who did a neurological exam and ultimtately gave me the diagnosis of Acute inflammatory demyelinating polyneuropathy (AIDP). Today, 4/21/21, the tingling has progressed into my knees and fingers and my legs feel more weak than yesterday.
At about 2:00 a.m. on Feb. 6th I was awakened by nausea and vertigo that lasted until about 10:00 that morning.  Sat. afternoon I was feeling much better.
Patient was in hall on way out, she fell/passed out and began to suspected seizure. 911 was called patient transported hospital.
More than 36 days for second shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (More than 36 days for second shot) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient was hospitalized. Start date of covid-19 infection is 05-Mar-2021.) on 05-Mar-2021.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (More than 36 days for second shot). At the time of the report, INTENTIONAL PRODUCT USE ISSUE (More than 36 days for second shot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The adverse event was reported through chatbot. Concomitant medications were not reported. No treatment information was provided.
Very bad chills which caused shaking.  High temperature, 102 degrees, sore arm.  This started around 9:00 p.m. and went until 3 a.m.  Then I took 2 extra strength Tylenol.  By 9 a.m. by temperature was back to normal.
Patient is COVID positive 11/16/2021. Patient is fully vaccinated. 58-year-old male presented to the ED with 10 days of worsening shortness of breath. He states that once he started exercising, he started to gasp for air and his caregiver called EMS. He has history of bilateral lower extremity DVT as well as history of PE. He was on Coumadin for 2 months before he stopped it in February as he said that it made him feel uncomfortable taking Coumadin. The patient denies any fever, chills, nausea, vomiting, or diarrhea at this point, though still having shortness of breath and is planned for thrombectomy today. Admitting DX: SOB, hypoxia, bilateral pulmonary embolism, Pneumonia due to COVID,  Pulmonary embolus. Elevated troponin. Treatment: Completed 3 days Remdesivir/Vitamin D/ IV Decadron 6mg daily. Heparin drip transitioned to coumadin 2.5 mg daily. Maintained on albuterol inhaler. Discharged to home.
Irregular heartbeat episode, lasting approx. 18 hours continuously. Not rapid, just irregular. No treatment. No other side effects. I have had isolated irregular heartbeat for years, but never sustained over more than an hour.
This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer. A 68-years-old female patient received PREVNAR 13 (NDC number: 000051971-05), via an unspecified route of administration in the right arm on 31Dec2015 at 0.5 ml single. Medical history included ongoing seizure; hurt her left leg from an unknown date and unknown if ongoing. The patient had x-ray of head a long time before when first began having seizures, maybe 30 years before, which showed black spot on left side of her head. It didn't go all the way down into her brain, hadn't grown, no explanation why it was there. Thought to be the cause of her seizures. The patient previously took PREVNAR 13 about 10 years before and experienced no adverse event. Concomitant medication included DILANTIN for seizure. Patient used to be on 200 mg in the morning and 200 mg in the evening until about six months before when she had her phenytoin level checked and it was too high. At that time, she decreased her dose to 100mg one in the morning and 200 mg at night. On 01Jan2016 at 18:00 the patient had seizure which the patient believed was due to the PREVNAR 13. They were at a friend's house, her friend knew she was having a seizure because she grabbed the card table she was eating off of, was shaking it, and her friend could not get reporter's hand off of it. Has history of accident in which she hurt her left leg. Thought she hurt it again during the seizure as it was still sore. They called the ambulance to take her to emergency room, where she spent 18 hours. The patient was happy enough to walk to the ambulance to go. While at hospital, they attempted to release her on three different occasions. They started to release her the first time, but she couldn't walk so they kept her. Next time they told her she was free to go, she couldn't speak so they kept her. Next time they said they were keeping her for more tests, did EKG and heart ultrasound, which came back fine on 02Jan2016. An head scan on 02Jan2016 was normal. The patient also had lab work on the same date, including phenytoin level, which showed she had no phenytoin in her system because she had been without her phenytoin for 18 hours. After this seizure, she increased her phenytoin (NDC: 0071036924, Lot: M38474, EXP: July2017) to 200 mg in the morning and 200 mg in the evening. The patient recovered with sequel from seizure on the same date. The patient was blacked out for 4 days; she does not really remember things that happened after she got the vaccine on 31Dec2015, with outcome of recovered on 04Jan2016. During the emergency room visit the patient couldn't walk and couldn't talk; she couldn't remember at what point visit these happened, but they resolved completely.
Red, warm to touch, swollen at injection site- roughly 1.5". 100.4 F temp, high heart rate (ranged from 120-142), throat hurt and felt swollen (didn't hurt while swallowing), fatigued
Patient received a 3rd dose of Pfizer after 1st and 2nd doses were Moderna.
Immunizations given on 4/26/07. Pt sleepy that day. Next day Friday 4/27/07 pt was given Tylenol and Motrin alternating. Pt according to her mother had fever as high as 103. Pt would only breastfeed and refused pedialyte. Pt had Pt had no BM's, Left thigh had 7-8 red bumps around injection site was red and warm. Seen ER 4/29 and Dr office 4/30.
The day after receiving the vaccine, I continued to feel tired, dizzy, with pain on injection site and overall pain, That same day at  night I felt severe dizziness and sensation of room spinning. When I stood up, I lost my balance and fell down on floor which resulted in laceration to my chin, broken tooth and injury to my right jaw and chest.
Left thigh injection sites measure 15 cm x 11.5 cm with erythematous firm cellulitis/indurated.
This spontaneous report as received from a other refers to a 19 year old female patient. On 24-JUL-2017 the patient was vaccinated with M-M-R II lot # M022407, intramuscular in the left deltoid for prophylaxis. Other suspect therapies included sterile diluent. On 31-JUL-2017, 8 days after onset of therapy the patient experienced rubella antibody negative and mumps antibody test negative. The outcome of rubella antibody negative and mumps antibody test negative is unknown. Additional information has been requested.
24 hrs post vaccination - 11/18/09 - Hives on neck, upper body -> Re'cd with BENADRYL & PREDNSONE.  11/19/09 - Increase eruptions over whole body with throat constriction.  Treated in ER with IV EPI & NEPHRINE with good effect. 12/01/09  Hospital  and ED records received for DOS 11/20-11/24/09. Pt. presented to ED with hives all over body one day after vaccination. Treated with epinephrine, solumedrol, pepcid and benadryl and discharged in am.  Later same day developed lip swelling, itching, throat tightening and cough and returned to ER and admitted. Treated with IV steroids, and antihistamines, H2 blockers. Dermatology and allergy consults completed. Lip and throat tightening resolved. Episodes of urticaria continued but less severe upon discharge. DX: allergic reaction, hyperglycemia
more fatigued; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (more fatigued) and NAUSEA (nauseous) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (more fatigued) and NAUSEA (nauseous). At the time of the report, FATIGUE (more fatigued) and NAUSEA (nauseous) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Extreme pain and swelling around injection site. Extreme pain spreading from neck to the fingers. Numbness occurred the 1st day after the shot. Nausea and vomiting occurred the 1st day after the shot.
3pm Saturday 5/1/2021 injection site pain, lump, swelling, hot to touch. Arm felt like it was being ripped off. Midnight Sunday 5/2/2021 fever of 102 degrees, chills, body aches, extreme left arm pain.  Fever of 101 and body aches all day on Sunday 5/2/2021, started to subside after taking one tablet of aleve at 9am.  Took second tablet of aleve at 2 pm, Fever and body aches continued to abate.  7 pm took to tylenol and fever was finally gone. Body aches also gone. 5/3/2021 no fever all day, Arm pain still persists, large red welt about 3 inches across, hot to touch, itchy. 05/04/2021 arm pain, large red welt still 3 inches across, hot to touch and itchy still persists.
Headache, Myalgia, Diarrhea & NauseaVomiting Narrative; 8/11/21 myalgia, headache, nausea, vomiting x 1 and diarrhea x1, one day #1 dose covid vaccine. At home hydrating and resting.
One day after receiving vaccine, noted that in right deltoid red area was red, swollen and warm to touch. Area measuring 10 x 10 cm. MOD notified and came to evaluate and started on antibiotics (augmentation 500/125 BID x10days). Was not clear if reaction was to vaccine or cellulitis. Pain and redness in areas resolved after several days.
Vertigo, nausea, dizzyness, vomitting, hearing loss.  All symptoms lasted 48 hours.  Went to Urgent care and was givenMeclizine 12.5mg and Ondansetron 4mg.  Dizziness and nausea lessened over the next 3 days.   Went to ENT doctor - Hearing  test on 3/29/21 revealed total loss of hearing in right ear.  Hearing in left ear was diminished before vaccination and that was about the same after the vaccination.  ENT injected steriod into right ear on 3/31/21.  Second steriod injection on 4/2/21.  No improvement in hearing so far. Dizziness continues off and on.  Still unstable and needs to use a walker.
Localized soreness at injection site after about 6 hours progressed to generalized aches, fatigue, and headache in 24 hours. Resolved in 48 hours.; aches; fatigue; headache; This is a spontaneous report from a contactable consumer (patient). A 38-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EL3247, expiration date was not reported), via an unspecified route of administration, administered in right arm on 01Mar2021 09:15am (at the age of 38-years-old) as dose 2, single for covid-19 immunization at workplace clinic. The patient medical history and concomitant medications were not reported. The patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EL3247, expiration date was not reported), via an unspecified route of administration, administered in right arm on 10Feb2021 10:00 am (at the age of 38-years-old) as dose 1, single for covid-19 immunization at workplace clinic. The patient does not have any allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications were received by the patient within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. It was reported that on 01Mar2021 the patient experienced localized soreness at injection site after about 6 hours at 03:15 pm progressed to generalized aches, fatigue, and headache in 24 hours. No treatment was received for the adverse events. Resolved in 48 hours. The outcome of the events was recovered on 03Mar2021.  No follow-up attempts are needed. No further information is expected.
Dull pain around injection site which still lingers and now affects whole arm. Can't sleep on that side - pain wakens me. For about a week, orange bruise in area of injection.
Flu-like sx reported by phone 4 days p/administration; sx lasted 1-2 1/2 wk; pts never contacted office again; no tx; pts never seen during entire duration of illness; ?concurrent viral infection @ time of administration;
This spontaneous report was received from a nurse refers to unspecified patients of unknown age. The patients' medical history, concomitant medication and concurrent conditions were not reported. Since 09-MAR-2017, the patients were vaccinated with improperly stored doses of ROTATEQ from lot# 27-JUN-2018 and lot# M005080, expiry: 03-OCT-2018, for prophylaxis. No adverse effect reported. The vaccine was exposed to -4.4 degree Celsius for 1,057 hours (44 days) and 9 degree Celsius to 25 degree Celsius for 2 hours. The call was due to data logger. This is one of four reports received from same reporter. Sender's Comments: US-009507513-1708USA007831.
No symptoms at first until my left arm started swelling, and starting having problems walking about 2 months after the vaccine, I use to go dancing 2-3 times a week and now I can't go. Since getting the vaccine my health has gone way down. spent 5 days in the hospital for low oxygen.  in 7/2/2022 to 7/7/2022 approx. sent by Dr. my doctor sent me to another Dr. Lung Dr. so see why I am  not breathing right. 8/25/2022 or 8/26/2022  my last visit but I have to go back tomorrow to pick up an overnight breathing machine.  My blood pressure has always been right and now I run low.
Patient was normal but nervous before vaccine.  Patient was told to sit outside of pharmacy after receiving the vaccine.  Pharmacist notice the patient did not look well, and went to patient's side to assess the situation.  Patient could not keep eyes open, was very sweaty, tried to walk with support but was unable - laid patient on floor with feet up and head supported.  Pulse was slow. Called 911 for support.  Patients was in and out of consciousness, but was able to drink a small amount of water.   Vitals evaluated by EMT upon arrival.  Patient taken to hospital.
pt accidentally received fluzone HD instead of the age appropriate fluzone quadrivalent.  pt seems to be doing fine so far.
Patient collapsed/experienced syncopy 5 to 7 minutes after receiving the covid vaccine in the pharmacy sitting area , he was walking along the aisle the store and collapsed/fell face down. An ambulance was called and patient was taken to the hospital
I went from my body being 99.7% clear of psoriasis, to a body of 80% plus psoriasis coverage.  This occurred approximately 4 to 5 weeks following my 2nd dose of Moderna.  Scheduled to see a dermatologist on April 1, 2021.
My first menstrual cycle after my 2nd dose of COVID vaccine had heavy bleeding and intense cramping prior to my period. In the next few menstrual cycles, I noticed that the intense cramps began up to 5 or 6 days before my period was due, which has never happened before. After 3 months I feel that my pre-menstrual cramping and other symptoms including headache and fatigue have worsened.
This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 82-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number, and expiration date not reported), via an unspecified route of administration, administered in the right arm on 17Feb2021 06:30 (at the age of 82-years-old), as first dose, single dose for COVID-19 immunisation. Medical history included lipoma. Concomitant medications included hydrochlorothiazide (HTZ); levothyroxine, both taken for an unspecified indication, start and stop dates were not reported. The patient previously took ciprofloxacin (CIPRO), denusomab (PROLIA), and risedronate and experienced drug hypersensitivity. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After the first shot, the patient experienced vertigo and dizziness on an unspecified date in Feb2021 06:00. Patient reported events lasted 3 weeks. It was unknown if patient received treatment as a result of events. Patient did not seek consult to physician or urgent care. The outcome of events was recovered on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.