chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: Unknown. The reporter is the patient. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "got 2 shots and the booster/just recovered from Covid omicron". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: I just recovered from Covid omicron. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Clinical course: Patient was prescribed Paxlovid. Active Drug substance names were Nirmatrelvir tablets and Ritonavir tablets. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
SHORT OF BREATH; TIREDNESS; DIZZINESS; NAUSEA; HEADACHE; This spontaneous report received from a health care professional concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included on the previous day of report, patient took sleeping pills.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 20-APR-2021, the subject experienced dizziness. On 20-APR-2021, the subject experienced nausea. On 20-APR-2021, the subject experienced headache. On 21-APR-2021, the subject experienced short of breath. On 21-APR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from nausea, headache, and dizziness, and had not recovered from tiredness, and short of breath. This report was non-serious.
Rash, swelling, pain that has gotten larger each day.  Looks like a giant hive.  Started dime size, today it is larger than a baseball.   Itching all over body started 4/15/2022
Sore arm; Tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation, reaction(s): "Tired", "Sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm"; FATIGUE (non-serious), outcome "unknown", described as "Tired".  Additional information: Patient had all vaccines and all of then had been Pfizer and patient had no issues other than may be sore arm and been tired.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300352612 same patient, different dose/event;
Fatigue w/in 12 hrs that lasted more than 2 days, after which fatigue continues even now. We believe he fainted  while operating a scooter which resulted in an emergency room visit. Complains of chest pain. Concerned this could be myocarditis- he?s on government insurance so medical access is limited.
Chest pain at night for four days, Denies SOB, worsening with exertion, association with food, recent injuries or falls, no hits to chest, similar in the past, recreational, drug use,  or radiation of pain. Went out of state 2 weeks ago (08/01)
I had a temperature of 102.8 for 2 days. I had a fever, chills, body aches, nausea, diarrhea, and a headache. My right arm is still a little sore, and it goes into my shoulder as well. I am still testing positive for covid.
For history of present illness " Patient is a 90 y.o. male with medical history of coronary artery disease status post CABG and PCI stenting, recurrent rectal carcinoma status post surgical removal/chemo and radiation therapy, CKD stage III, hypertension, diabetes who presents today to ER with shortness of breath.  Patient was diagnosed with COVID 10/14/22, was admitted to Hospital.  Discharged home 10/16 on room air and with oral Decadron to complete 10 day course of steroids.  Patient completed his steroid course.  Patient has a pulse oximeter at home, checks his oxygen daily.  Yesterday he woke up and checked his SpO2 which was 86%.  Also have some difficulty breathing.  This prompted patient to go to ER.  Patient did not require any supplemental oxygen at rest but with ambulation his oxygen level did drop.  CT PE done showed no PE but showed patchy consolidation bilateral lower lobes (left greater than right) concerning for bronchopneumonia.  Significant labs included: Inflammatory markers raised CRP 73. Potassium 3.2. Patient was admitted to Hospital for management of pneumonia." 10/27:  Patient was successfully weaned from nasal cannula to room air.  He underwent home oxygenation evaluation by respiratory therapy, maintain his oxygen saturation above 90% of the time with walking and did not require supplemental oxygen.  Patient endorsed no dyspnea or chest pain or tightness.  He endorsed some cough with scanty sputum production.  No nausea or vomiting, no abdominal pain.  Legionella and pneumococcal urine antigen negative.  MRSA screen negative.  Initial sputum culture without oropharyngeal contamination, repeat sputum culture ordered.   Since patient made significant improvement, he was discharged in stable condition home with oral antibiotics.  Patient will be discharged with oral azithromycin and Omnicef to complete 7 day course of antibiotics for pneumonia.
Intestinal and stomach pain, bloating, loss of appetite, nausea, no vomiting, but some acid reflux, chills. Started Monday, November 26 late afternoon, worked Tuesday with a lot of discomfort, did not feel like working on Wednesday, Thursday not much better, Friday pain is easing some and a little less bloating, still no appetite. Took nothing for symptoms.
A report has been received from a Health Professional concerning a 5 year old, Male subject, who had been receiving Nasal FLUMIST (INTRANASAL). FLUMIST (INTRANASAL) started on 13-oct-2014. It was reported that the patient moved and was inadvertently sprayed in the eye with FLUMIST which started on 13-Oct-2014. The outcome of the event of PATIENT MOVED AND WAS INADVERTENTLY SPRAYED IN THE EYE WITH FLUMIST is unknown. The report was considered to be non-serious.
10/19 has 80-90% blockage with main artery 100% blocked Quadruple bipass (11/15), fatigue, SOB, fallen from being dizzy, pacemaker implantation, stress test 6/12
Left side of face went numb/Left side of my body numb; Very large hot red spot at injection site; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Left side of face went numb/Left side of my body numb) and VACCINATION SITE ERYTHEMA (Very large hot red spot at injection site) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced HYPOAESTHESIA (Left side of face went numb/Left side of my body numb) and VACCINATION SITE ERYTHEMA (Very large hot red spot at injection site). At the time of the report, HYPOAESTHESIA (Left side of face went numb/Left side of my body numb) and VACCINATION SITE ERYTHEMA (Very large hot red spot at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medication includes Diuretic. The treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Follow-up document was received on 17-JUN-2021. Added Reporter contact details and additional Event-left side of my body numb.
a week later, it was in both the eyes; This spontaneous case was reported by a consumer and describes the occurrence of VISUAL IMPAIRMENT (a week later, it was in both the eyes) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VISUAL IMPAIRMENT (a week later, it was in both the eyes). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, VISUAL IMPAIRMENT (a week later, it was in both the eyes) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient reported that he had an effect of aurora borealis between 15-30 minutes in the left eye after the second dose and his peripheral vision was wavy and could not focus on the vision. After the first vaccine, patient had this in both the eyes.  Concomitant product use was not provided by the reporter.   This case was linked to MOD-2021-066830 (Patient Link).
Pt's mother called and reported that pt had a golf size red raised area on the back this on 8/23 at approxiamtely 11:15am. Mother reported on 8/25/02 the area of redness was approx. baseball size. Mother was encouraged to take pt to her doctor for follow up.
Day after vaccines were administered mother noticed a raised red streak down the arm of the infant in the arm the IPV was administered.  The streak lasted about 2 weeks and faded into a scar which remains.  Visited doctor 2 days after streak appeared - doctor was unsure of cause of streak.
Fever, Screaming/crying, sleepiness/changed sleep pattern. Administered acetaminophen at 3:30PM and 7:30 PM.
Change in taste; Sense of smell diminished; A spontaneous report was received from a consumer concerning a 69-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events change in taste / taste disorder and sense of smell diminished / hyposmia.  The patient's medical history was not provided. Concomitant medications reported were linaclotide, amlodipine, CBD oil, ezetimibe, finasteride, gabapentin, losartan, Montelukast and lorazepam for drug use for unknown indication.  On 31 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Unknown) via unknown route for prophylaxis of COVID-19 infection.  On 3 Feb 2021, the patient experienced the events, change in taste and sense of smell diminished.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, change in taste and sense of smell diminished was unknown.
Post vaccination pt presented with mental status changes and oliguria following a several day history of feeling fatigued. He also had a rash on his shins. He was admitted to the hospital approximately 2 weeks post immunization. He was afebrile but tachycardic. PE showed flaccid paralysis, decreased deep tendon reflexes and bilateral Babinski signs. A petechial rash was noted on both shins. The event was managed with plasmapheresis and hemodialysis. The pt has since recovered. It was noted that "it is likely that the influenza vaccine triggered the antibody formation and immune complex deposition and led to the development of TTP."
PEDIARIX (DTAP-IPV-HBV) and ACTHIB given. Left thigh swollen (PEDIARIX) and left deltoid swollen (HIB). PREVNAR 13 not given this date. Twin administered PEDIARIX HIB PCV13 with no adverse effects same date and time.
shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication.   On 21-OCT-2014 the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (dose, route, lot# and expiration date were unknown) for the long-term prevention of shingles and/or zoster-related conditions (for prophylaxis). Subsequent to inoculation, the patient was treated for shingles.  As a direct and proximate result of patient's use of the zoster vaccine live(ZOSTAVAX) vaccine, patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.  Additional information has been requested.
Patient was given 1st dose of Pfizer vaccine at 13:55.  At 14:10 patient reported feeling warm and feels heart rate is increased.  She reports that she takes blood pressure and anxiety medications.    VS: 14:10 BP 140/90   SPO2 98%  RR  20  Pulse 96 14:15  BP 138/92   SPO2 97%  RR  20  Pulse 94 14:25  BP 144/88  SPO2 98%  RR 20 Pulse 90  Patient drank water and used her inhaler independently.  Feels her asthma has been flaring up.  Also states mask makes her uncomfortable.  14:40  Patient stayed 45 minutes and "feels cooler".  Discharged home without any issues.
This spontaneous report as received from a physician voice mail received via the SRP Voicemail on 22-AUG-2014 refers to a patient of unknown age and gender. In 2013 the patient was vaccinated with PNEUMOVAX 23 (dose, route and lot # not reported). On an unknown date, ever since receiving PNEUMOVAX 23 in 2013, the patient has been experiencing dysphagia. The outcome of dysphagia was not recovered. Additional information has been requested.
First vaccine May 10th.  For over 5 weeks, I have experienced a constant headache, muscle pain/stiffness, exhaustion and severe brain fog/depression.  5/10 ? received vaccination at 10:30 and was fine until later evening ? got a dull, nauseous headache.   5/11 ? woke up with piercing neck and torso pain. Severe body aches and stiff, sprained feeling muscles. End of day my feet, ankles and knees ached  so bad I couldn't walk.  The aching is ONLY in the areas that I feel the fibromyalgia pain, but super intensified like I haven?t had my meds for a day.  Tramadol and Tylenol  only help for a few hours.   5/12 ? body aches continued, and totally exhausted.  5/13 ? body aches continued, and totally exhausted, felt feverish but had a normal temp.  5/14 - body aches continued, and totally exhausted, night sweats and night terrors.  5/15 ? 5/19:  brain FOG. Severe depression.  I?ve dealt with depression off and on my entire life, this was different. I feel catatonic. I have a constant aching in my spine. My whole body aches anytime I'm moving around - just simply walking, or doing light chores are laborious and will make my shoulders, neck and back hurt. I feel exhausted and fatigued all the time, but it?s also combined with this weird brain fog and depression.  My short-term memory was bad and now it?s is absolutely gone. Still having nightmares. There is probably more, but I can?t remember. I had to keep a log to even report this.   5/20 ? 5/22:  pounding headache with a piercing pain in my right eye, nausea but not quite a migraine.  I thought I was having a stroke.  This, WITH ALL of the symptoms listed in 5/15 ? 5/19 for two full days.  5/23 -  5/26:  I woke up from the headache and nausea several times over the night.  My normal pain meds for fibromyalgia helps for a few hours. Light housecleaning, working in the yard, or taking care of the horses exhaust me and I get a very stiff aching neck and back.   5/27 ? 5/31:  starting to feel a little better.  24/7 muscle pain and dull headache, but less intense.   6/1 ? 6/4:  Felt like I had full on Covid or flu. Fever of 100.5 ? 101.5, severe aching, sore throat, headache.  TESTED for Covid19 at Walgreens rapid testing (results didn?t come back until 6/8), with negative result.  Note; this started after two days of 100 degree weather and a week in the 90?s.  I do not do well in temps above 75 ? 80. I feel like the heat exasperated the condition I have from the vaccine.   6/5 ? 6/7: symptoms easing  6/8 ? current:  tired even with 15 hrs of sleep a day.  Whether I have a full 6 ? 8 hrs sleep or not, I have to take naps, and only have energy for a few hours at a time.   6/10 ? Extreme brain fog, weird depression that is not normal, fatigue  6/14 ? All symptoms starting to ease  6/16 ? feeling as normal as I remember for 48 hours  6/20 -  headache is back, body aches, brain fog and fatigue is back  6/24 ? Only the headache has persisted.
syncope, then hours later, generalized tonic clonic seizure. followed by altered mental status, fever 102.6
This spontaneous report was received from a lawyer referring to a 80-year-old male patient. As concurrent conditions were reported smoker (for 20 years, 1 pack of cigarettes per day), high cholesterol, high blood pressure and chronic obstructive pulmonary disease (COPD). The patient's historical conditions included chickenpox at the age of 4-9 years old. In 2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) for prophylaxis (strength, route, dosage schedule, lot number and expiration date were not reported). On an unknown date, the patient experienced sore arm for 2 days. The outcome of sore arm was unknown. The reporter considered sore arm to be a side effect of vaccination. Subsequently the patient was vaccinated with zoster vaccine live(ZOSTAVAX) and experienced shingles, hearing loss and skin cancer (captured in MARRS 2009USA008295).; Sender's Comments: US-009507513-2009USA008295.
swollen lymph node; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on 05Feb2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was noticing a side effect from the vaccine and one of them was the swollen lymph node and the reason why the patient was calling was because "last night I went to the bathroom and I had a swollen lymph node up on my upper thigh close to the groin area." When asked for any question regarding the concern, consumer stated "Yes, it is. I want, this cause is rare in swollen lymph node and I want to ask you does it stay like that, does it go down? Do I need to go to a doctor? What?" Outcome of the event was unknown.   Information on the lot/batch number has been requested.
Fatigue, headache, body aches, elevated heart rate and blood pressure. Chest Pain.  -Total Time ~12-15 hours.  Arm pain lasted ~96 hours.  Loss of appetite.
Arm warm to touch, swollen, and tender.  On 1/16/2015, she started to be able to bend elbow.  She consulted MD and told to take diphenhydramine.  I recommended to ice and ibuprofen 400-600mg every 6 hrs.
Staff reported had fever of 102F 24 hours after receiving the 2nd COVID vaccine dose along with chills and pain, rash and hardness to injection site. Today (72hrs after) staff reported left eye and left cheek swelling - noted swelling observed.
Patient received Rabivert(rabies) #1 on 01/26/2005 and developed sweaty, dizzy, nausea and headache after first dose. All symptoms resolved within 24 hours except for the headache. RabiVert #2 administered on 02/02/2005-persistant headache. Evaluation by MD, all lab work negative moderate persisitant headache. new mild persistant headache has 2-4 headache free but still has them daily, neuro exam-negative. Follow up report received on 04/06/2005:  Patient continues to have daily intermittent headaches - feels 50% improvement.  He has seen his primary care physician who has noted out of other etio.
Approximately 3-5 week after 2nd dose of vaccine patient experience Myocardial Infarction. Angiography revealed diffuse thrombus in coronary arteries and enlarged heart. Pulmonary Embolism is not excluded.  Patient expired during angiogram procedure
Oral thrush Bumps on the tongue  Very uncomfortable for me to eat and swallow  Burns a tad bit when I swallow  Tongue was very white in certain areas - Lasted for a few days before I got treated for it.  - Had to be treated for oral thrush twice.
Received Vaccine Jan. 4, 2021 at 2pm.  Starting "itching" at 7pm. Went to bed at 9pm and awoke Jan. 5th (at 7am) with HIVES & ITCHING over upper chest, bilateral arms, upper back area and face.  Took OTC Zyrtec 10 mg  po and Pepcid 20 mg po.  Went to work at 7pm.  Took Prednisone 20 mg po at 2am. After working till 7am took Benadryl 25 mg po  before going to bed at 8am Jan 6th.  Symptoms relived by Wednesday evening.
Received a Pfizer vaccine today in the  clinic after she initially received a Moderna for her 1st vaccine.
Non stop joint pain in legs. Daily migraine unable to open eyes at times. Seeing silver waves constantly and vision has become worse
Total body muscle pain that comes and goes and attacks different parts of my body from time to time.  Neck down to toes. But most shoulders, arms hips and legs.
pt recvd vax & w/in hrs exp hives;An ER or MD visit was required & pt was treated w/antihistamine;sx resolved;
This infant started a temp on 02/15/01 of 103, rash on her right arm and neck. The rash was rough, hot, and the arm was swollen. The infant saw the doctor on 02/12/01 at 9 AM. She was admitted to the hospital on 02/15/01 in the evening, at 5 PM temp was 104.4. released on 2/18/01.  Diagnosed with cellulitis
Past the 42 day mark, 6 weeks since 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Past the 42 day mark, 6 weeks since 1st dose) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Past the 42 day mark, 6 weeks since 1st dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Past the 42 day mark, 6 weeks since 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Updated contact details and patient information.
Since few days after the vaccine administration my blood pressure have been without control.  Doctor add me another medicine and doubled my Atenolol original dosis.  As today I have been without control...waiting for a cardiologist appointment.