chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 1/16/13 pt received flu shot. Approximately 1.5 hrs post-administration, pt experienced severe nosebleed as reported by his mother. The duration of nosebleed is unknown. Pt has no history of nosebleeds. Pt did not require medical attention.
Starting the morning after the vaccination a lump and red itchy rash developed at injection site that grew to about 3 - 4 inches in diameter. The patient also developed muscle aches and lethargy.  The next day her muscle aches and lethargy had resolved and the rash had stopped spreading. She started to use Benadryl cream and cortisone cream to treat rash and itch.
Patient called and complained that starting the evening of the injection, she had: fever, headache, shortness of breath and fatigue. She states her symptoms continued for 36 hours. She states as of today she still has the shortness of breath and has seen several doctors but so far no help or explanation. She has an upcoming cardiologist appt as well as a pulmonologist.
I had my second dose of the Pfizer vaccine on Tuesday at 4:30 pm.    Wednesday morning, I woke up with a moderate headache and some minor body aches.  Those symptoms lasted throughout the day  Around 5 pm, I developed at low grade fever ( up 2 degrees from my normal) which lasted 5-6 hours.  My arm was mildly sore for 2 days.  When I woke up on Thursday morning, I felt fine.
Provider discharge documentation. a 85 YO female who presented to the hospital for evaluation of generalized weakness. The patient states that she had a sore throat on 1st of  May and was seen in the walk-in clinic.  She was prescribed Flonase but Covid swab was sent which came back positive and the second.  She was called with the results and the patient was prescribed a course of PAXLOVID which she completed. She states that she was feeling fine and was doing well except for the persistent cough (which she admits she has had for years).    She presented to the emergency room on the 11 th with symptoms of nausea, diarrhea and vomiting. During that evaluation, she was found to have a urinary tract infection. She was prescribed Keflex.  Her urine culture showed greater than 100,000 is trachea coli sensitive to all antibiotics tested.    She came back on the 16th feeling completely tired and fatigued.  She is very weak.  She is constipated, having some persistent cough, vague complaints of chest pains in the left upper chest area, describing this to be more like a heartburn type symptoms which she gets frequently.  She also reported of shortness of breath that emergency room although she denies feeling short of breath during the time that I evaluated her.    The companion is very concerned because apparently, after she started taking the Keflex, she has rapidly downhill. She is now unable to get out of bed, needing a lot of assistance with transfers.  She has not been able to walk.  She also does not have an appetite. She has no motivation and just not feeling up to par.  She also reports that she is having a lot of chest congestion and is considering that her infection might be going down into her chest.  I have advised them that her  chest x-ray came back negative for any evidence of infection or PNA. She does have persistent cough without any sputum production or expectoration.    ED work up shows that troponins were elevated.  She also has minimal changes on her EKG that did not seem to be significant. The rest of her work up was unremarkable. CBC and CMP are both unremarkable. UA noted. TSH was normal. Coags were normal.  She was given aspirin and IV heparin was started. Cardiology has been consulted. She underwent a stress test which was negative for evidence of ischemia. Her fatigue improved with supportive care and refraining from Keflex. Her repeat urine culture was negative. She participated with PT/OT who recommended home with therapy but she refused any home therapy. She was found to be iron deficient, given IV Venofer for 3 days and will start PO iron on discharge. She was discharged home in stable condition with strict return precautions. "
Patient received Janssen COVID vaccine on 4/6/2021. Patient states that approximately two weeks after receiving vaccine, location of injection started to swell and was hot to the touch. Patient reported adverse event to pharmacist on 4/21/2021 in which she stated that the "heat" in the injection site had improved but it was still swollen.
Headache, Myalgia, Arthralgia, Fever & CoughWheeze Narrative:  Took OTC meds with relief
p/t diagnosed with covid 11/2022 after completing primary series @ a local  Vaccine Clinic .  received pfizer booster 4/2021 @ the local DOH. +covid11/2022; suffering seizures 12/6/2022. Hospitalized from 12/6-12/15/2022.
1 hr /p receiving Td & MMR returned to DHC /w swollen itching eyes, no respiratory distress, treated /w Benadryl 50 mg
Narrative: 57 year old female admitted on July 29 2022 with fever and hypoxia.. She had received Moderna vaccine x 3 on July 23 2021, April 13 2022. She was treated with remdesivir 200 mg x 1 then 100 mg IV daily x 4 days and dexamethasone 6 mg daily x 4 days. She symptomatically improved and was discharged home on 8/3/22.
unspecified route of administration in the left arm on 03Apr2021 at 14:45 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Medical history included fruit allergy (apples and avocado). Concomitant medications included duloxetine (MANUFACTURER UNKNOWN) from unspecified date. The patient previously received ampicillin (MANUFACTURER UNKNOWN) and clindamycin (MANUFACTURER UNKNOWN) both started on unknown dates for unknown indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021, 30 minutes after vaccination, the patient experienced headache and nausea. On 04Apr2021, 12 hours after vaccination, the patient experienced sore lymph node in left armpit. On 04Apr2021, 16 hours after vaccination, the patient had lab test of body temperature and found slightly elevated and also experienced aches and pains and malaise. On 05Apr2021, 36 hours after vaccination, the patient experienced sore lymph node in right armpit. After 48 hours of vaccination the patient still experienced symptoms and had to leave work due to nausea. The patient did not receive any treatment for the reported adverse events. The clinical outcome of the events headache, nausea, sore lymph node in left armpit, aches and pains, slightly elevated temperature, malaise and sore lymph node in right armpit was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Patient received vaccination. Several hours later, she experienced swelling and irritation at the injection site. The following day the swelling went away but the area was still warm and irritated.
neck rash; hip replacement; This spontaneous case was reported by a physician and describes the occurrence of HIP ARTHROPLASTY (hip replacement) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) dosage form. On 15-Dec-2020, the patient experienced HIP ARTHROPLASTY (hip replacement) (seriousness criterion medically significant). On an unknown date, the patient experienced RASH (neck rash). At the time of the report, HIP ARTHROPLASTY (hip replacement) had resolved and RASH (neck rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported  No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   there is no reasonable possibility that the events of hip replacement surgery, after First dose of covid vaccine developed rash around neck and after second dose of covid vaccine patient was fatigue are related to humira (adalimumab); Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This infant had a fever of 102-103 for three days following immunization. On 08/24/01 still 101.
Pt received Tdap BOOSTRIX IM in (L) deltoid at a Public Health Clinic at approx 0930 on 4-19-12. On 4-21-12 in the a.m pt. developed hives over the entire body. Guardian tx with BENADRYL, but as of 4-23-12 the hives have not resolved. Guardian to call pt's MDfor f/u.
This case was reported in a literature article and described the occurrence of systemic lupus erythematosus flare in a subject of unspecified age and gender who was vaccinated with influenza (unspecified manufacturer). Subject's medical condition included Systemic Lupus Erythematosus. On an unspecified date, the subject received an unspecified dose of influenza unspecified (unknown route and injection site, batch number not provided). 6 weeks after vaccination with influenza unspecified, the subject experienced systemic lupus erythematosus flare (SELEN-SLEDAI defined disease flare). Plasma samples were obtained from the subject on the day of influenza vaccination and at 6 weeks post vaccination. Plasma samples were tested for 52 soluble inflammatory mediators using XMAP technology. TNFR family members, RNFRI, TNFRII, Fas, FasL, CD40L, were increased. This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the event was unspecified. Summary of the article: This literature article referred to 28 Systemic Lupus Erythematosus (SLE) patients (age and gender not specified) who exhibited SELENA-SLEDAI defined disease flare after 6 (n=13) or 12 (n=15) weeks post influenza vaccination (manufacturer, dosage and injection sites unknown) on an unspecified date. Subject's medical history and concomitant medications at the time of the event were unknown. Twenty-eight SLE patients exhibited SELENA-SLEDAI defined disease flare after 6 (n=13) or 12 (n=15) weeks post influenza vaccination (manufacturer, dosage and injection sites unknown) on an unspecified date. These 28 patients were part of a study conducted to understand mechanisms and identify biomarkers of flare to help prevent damage and improve management. Plasma samples were obtained from SLE patients on the day of influenza vaccination (BL) and at 6 and 12 weeks post (FU). Each SLE patient was matched to a unique SLE patient who did not flare (NF), and to a healthy control (HC). Samples from 13 SLE patients with flare were compared to samples from a non-flare year (self nonflare, SNF). Plasma samples were tested for 52 soluble inflammatory mediators using XMAP technology. SLE patients who exhibited disease flare had significantly (p <0.01) higher levels of BL pro-inflammatory mediators, including Th1, TH2, and TH7-type cytokines compares to NF/SNF SLE patients and HC. Regulatory cytokines, including IL-10 and TGF-Beta were increased (p < 0.01) at BL in SLE patients not exhibiting disease flare (BF/SNF) compared to SLE flare and HC, TNFR family members, TNFRI, TNFRII, Fas, FasL, CD40L, were increased a BL in SLE flare patients. Select serum cytokines and chemokines are elevated in patients before SLE disease flare, providing important pathways to dissect for mechanisms of flare, therapeutic selection or development.
Second (which was today), now my throat is really hurting. I was fine prior to injection/I really am not seeing that sore throat is a symptom only "flu like"; Flu like; This is a spontaneous report from a contactable consumer (patient). A 48-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was unknown), dose 2 via an unspecified route of administration, administered in Arm Left on 12Jun2021 12:00 (at the time of 48-year-old) as DOSE 2, SINGLE for COVID-19 immunization. Medical history included, migraine, arthritis, fibromyalgia (chronic pain), known allergies: Latex from an unknown date and unknown if ongoing. The patient's concomitant medications were none reported (other medications in two weeks No). The patient previously received first dose of BNT162B2 on 22May2021 for COVID-19 Immunization and experienced severe headache. Patient was not pregnant at the time of vaccination. The patient previously received theophylline, Flexeril, bactrim DS and experienced drug hypersensitivity, flexeril [cefixime] and experienced drug hypersensitivity, bactrim DS, minocycline and codeine and experienced allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient had not been tested for COVID-19. The patient stated ''On 12Jun2021 14:30 (which was today), now my throat is really hurting. I was fine prior to injection. I was really not seeing that sore throat was a symptom only flu like'' Patient took Advil, been drinking hot tea. Therapeutic measures were taken as a result of ''second (which was today), now my throat is really hurting. I was fine prior to injection, flu like'' The outcome of events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
I developed ringing in my ears, vertigo and also developed Raynaud's Disease three days after my first Moderna vaccination.
the patient had a positive titer on an unspecified date in 2018, then had a low titer on an unspecified date in 2020; This spontaneous report has been received from a physician referring to a female patient with unknown age. Information about current condition, medical history, concomitant therapy and drug reactions/allergies was not provided.   On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose, frequency, route, lot# and expiration date were not reported) as prophylaxis.  On an unspecified date in 2018, the patient had a positive titer. On an unknown date in 2020, the patient had a low titer. The outcome and the causality was not reported.
clots in her left calf; too afraid; This is a spontaneous report from a contactable consumer (patient).  A 72-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right at the age of 72-year-old (as reported) on an unspecified date (Batch/Lot Number: ER8733) as single dose for COVID-19 immunisation.  Medical history included none. There were no concomitant medications. The patient previously took influenza vaccine (FLU) for immunization. Always got flu shot and so she got the shot to be safe. Caller stated she is calling about the COVID 19 vaccine. Caller stated she is just making this agent aware that after her first shot within 2 weeks she developed clots in her left calf. Caller stated she had went to the doctor for the clots and there was an ultrasound done and she was given blood thinners. Clots in her left calf: Caller stated she is not sure when this had developed or if it is still ongoing. Caller stated the doctor has not re-ultrasound her calf so she is not sure. Caller confirmed she is not sure of the outcome. COVID 19 vaccine: Caller stated on the vaccine card there is not a date of when she received the vaccine. Caller stated she could look at her calendar. Caller stated she is not sure when she received the first dose of the vaccine. Caller stated she did not get the second dose because she was too afraid. Vaccine Administered at Facility was No. No AE(s) require a visit to Emergency Room. Physician Office Visit for event clots in her left calf. Caller stated there is no history of blood clots. The patient underwent lab tests and procedures which included ultrasound scan: unknown results on unknown date.  Therapeutic measures were taken as a result of clots in her left calf. The outcome of events was unknown.
After 2/2/21 morning 2nd Moderna shot, my arm started to felt numb. In the afternoon and evening, Then, my arm started to become disabled. I have limited range of motions: I can not turn and raise my arm. My pain is at the glenohumeral joint, acromium, coraco-acromial ligament, acromioclavicular ligament, and coracoclavicular ligament as well as upper arm muscles and the attachment points to the humerus. It was painful to touch. I could not sleep flat but upright. I could not sleep on my left arm. If I sleep flat, I wait up with shoulder soreness. I have treated myself with Tylenol, heat and herbs. Since the diagnosis is side effect of vaccine, it is hard to treat and the progress is slow.
Arm soreness for 24 to 48 hours after the injection and came back on day 6. Redness, swelling and itching on the injection site started on day 7. And still unresolved.
Child vomited for an hour the day after the shot.  Child had lump on left thigh at injection site for 5 weeks.  Child has been sick with crying, mucus, congestion, whinning, diarrhea after the injections and for a couple days (thick and pasty, not runny), lack of appetite.  Went from 14 ounces of milk at daycare during a 9 hour day to 3 - 5 ounces a 9 hour day.  This has been since the day after her shot.  It was 5 weeks on Tuesday January 6 since her shots and she still has mild symptoms.  She has been to the dr. twice since the shots because of symptoms and the last visit on Monday January 5th was to give it two more weeks.  I called the nurses hotline the day after her shots because of the vomiting and was told it was a viral infection in her intestines.  Even though it states on the vaccination sheets I received from the dr. that vomiting is a symptom.
Tested on 8/9/21 and tested positive to covid after developing covid symptoms on 8/9/21.
Received JANSSEN COVID-19  vaccine EUA at 11:10am, March 12th, 2021. In the evening, began to experience extreme fatigue, and in morning of Saturday, March 13th, 2021 began to experience fever, 100.3F, very bad headache, fatigue, and bad muscle aches--aching legs, back. Fever has is gone as of afternoon March 13th, however,  still experiencing headache, fatigue, and aching muscles, similar with what I experience when I had influenza B a couple of years back.
12/30: Mild but lingering headache - relieved by Tylenol 1/3: Swollen left axillary lymph node; urticaria - seen by allergist - Allegra increased from 180mg > 360mg PO daily.
Initial information received on 21-Dec-2018 regarding an unsolicited valid non-serious case received from an other non healthcare professional (consumer). This case involves a 2 months old patient of unknown age who received only the liquid portion of 0.5 ml of first dose of vaccine PENTACEL (batch number: C5545AA, expiry date: 10-Jun-2019) (route not reported) in the right thigh on 02-Dec-2018.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication include ROTARIX (Rotavirus vaccine). It was case of actual medication error due to Inappropriate reconstitution technique. It was not reported if any adverse event was experienced or not. 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 2001/83/EC and Module VI of the Good Pharmacovigilance 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. List of documents held by sender: none.
Patient developed 9 1/2 x 6 cm oval-shaped area of erythema/ itching at left deltoid about 1 week after flu vaccine was administered. Patient is stable and is currently being treated with oral antihistamine.
2 days post vaccination, client began experiences fever, chills, severe headaches, severe body aches, joint pain, nausea and shortness of breath.  Still experiencing symptoms at this time.  Has taken Advil with some relief.
incessant crying w/high pitched cry; fever 104; gave APAP; episodes began around 1PM; seen in ER 530PM;
Facial swelling; This spontaneous case was reported by a health care professional and describes the occurrence of SWELLING FACE (Facial swelling) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A20A) for COVID-19 vaccination.     Concurrent medical conditions included Dermal filler injection.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2020, the patient experienced SWELLING FACE (Facial swelling). At the time of the report, SWELLING FACE (Facial swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment for the event is not provided.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested
BREATHING DIFFICULTY; CHEST TIGHTNESS; SHAKY; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, Expiry: Unknown) dose was not reported,1 total administered on 09-APR-2021 11:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-APR-2021, initially the patient felt fine. However, later she felt shaky and experience difficulty breathing and chest tightness. At the time of this report, due to possible side effects she experienced, she was advised to seek medical attention. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from shaky, breathing difficulty, and chest tightness. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210420040-Covid-19 vaccine ad26.cov2.s- breathing difficulty. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Individual received both doses of Pfizer COVID19 vaccines and reported testing positive for  SARS-CoV-2 today.