chrisvoncsefalvay/vaers-outcomes huggingface dataset:
16 hours after 2nd Moderna vaccine, woke to body aches, chills, weakness, burning hot arm and very sore at injection site and surrounding area.
? Principal Problem: Acute on chronic low back pain ? Hypoglycemia ? Acute hypoxemic respiratory failure due to COVID-19 (CMS/HCC)     Assessment & Plan Note:     53y.o. year old female who presented to the hospital 12/25 due to fever and shortness of breath onset approximately 12/23. She has had low back pain for 3 weeks with recent nondiagnostic MRI. She denies urinary urgency, frequency or dysuria to me. Patient came to this country from her home country many years ago. She is on chronic Prednisilone 20 mg daily.  PMH also includes HTN, DM, lung CA, asthma and prior DVT. CXR 12/25: no acute process Currently requiring 2 L O2/NC Patient does not recall COVID vaccine but chart does note Pfizer vaccine x 1 10/2021. I have counseled the patient regarding COVID infection. I have discussed Decadron and REmdesivir Lovenox per IM
Extremely liquid blood after the vaccine. The period and bloodshots are both very liquid. Will perform blood tests to see whether there is something wrong.
I was exposed on 4/23/22 and then on 4/25/22 I tested negative and again on 4/27 but then on 4/29 I tested positive. The only symptom I had was a runny nose and I thought it was just allergies. I consulted my doctor who advised that I just monitor symptoms since I wasn't experiencing many. I followed quarantine procedures and then tested negative on 05/05/2022 without experiencing any worsening symptoms.
Client was walking out of entrance when she slumped to the floor. First encountered lying on floor, awake, no compliants. BP 118/64 P 72 R 16. Able to sit in chair, no visual signs of injury. Stated she felt okay. No dizziness, nausea or discomfort. Stayed 15 minutes. family with client.
Patient developed rash around site of injection. No pain reported, only itchiness. As of 10/29/2015 1 pm, still has rash near site of injection.
fever, chills, tiredness. fatigue, nausea, diarrhea, headaches, blood pressure became high
Stroke like symptoms; Water in lungs; A spontaneous report was received from a consumer concerning an 83-year-old, male, patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced stroke like symptoms and water in lungs.   The patient's medical history was not provided. Concomitant products known to have been used by the patient included, insulin aspart, insulin glargine, ticagrelor, sacubitril valsartan sodium hydrate, furosemide, carvedilol, omeprazole, and sertraline.    On 04 Jan 2021, one day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 05 Jan 2021, the patient began experiencing stroke-like symptoms and had water in his lungs.    On 06 Jan 2021, the patient was hospitalized and had a computed tomography (CT) scan and magnetic imaging resonance (MRI) scan of the brain.  On 09 Jan 2021, the patient was discharged from the hospital. Treatment information for the events was not provided.   Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events, stroke like symptoms and water in lungs , was not reported.; Reporter's Comments: This case concerns an 83 year old male patient who experienced serious unexpected events of Cerebrovascular accident and Pulmonary oedema. The events occurred the next day of their first dose of their first of two planned doses of mRNA-1273. Concomitant medications included, insulin aspart, insulin glargine, ticagrelor, sacubitril valsartan sodium hydrate, furosemide, carvedilol, omeprazole, and sertraline. 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.
AFTER RECEIVING THE VACCINE SHE FELT HER LIPS TINGLING. ON SITE EMS RESPONDED. VITALS BELOW. 50MG DIPHENHYDRAMINE WAS GIVEN ORALLY.  SHE WAS RELEASED TO HOME. IT WAS SUGGESTED SHE CONFIRMED WITH HER PRIMARY IF SHE SHOULD GET THE 2ND DOSE.
Extremely painful period started two weeks in advance of expected date. Stomach cramps, flow and body ache and fatigue
pt recv vax 11AUG95 & 17MAR97 pt exp fever & abd pain, which persisted until 19MAR97 & 20MAR97;pt mom noticed first two lesions 18MAR97;19MAR97 in afternoon pt devel 35 chickenpox lesions;
Bilateral swelling and edema lower extremities.  Pain in thigh, calf and foot of both lower extremities.  Fatigue.   Ultrasound of LE's were negative for thrombosis.  CT with contrast of chest, abdomen and pelvis showed PE of LUL.  Negative test for CHF.  Primary MD and Cardiologist confirmed diagnosis of adverse vaccination reaction with residual bilateral neuropathy of both LE's.  Treatment:  Spironolactone, Gabapentin, compression socks.  Swelling and edema largely resolved, but moderate to severe neuropathic pain of LE's. Awaiting Neurologic consultation. Awaiting Neurology consult.
Patient describes that she became ill the day after receiving the vaccination. Nausea, weakness, shakiness, hurt all over and she got a severe migraine. These symptoms lasted 2 days. Also she had chills and questionable fever on 10/01/02.
Bad Headache, lots of sweating Injection site very sore. Lower back Hips & thighs Hurt.
Pt reported severe flu like symptoms for over a week which led to her being prescribed antibiotics, which ended up giving her C. diff - Pt declined to repeat dose - We only discovered this after we called to find out when she wanted to come in for her second part of the series. The patient did not report right away and some details were vague.
Large (4 inches in diameter)red, tender, indurated area on left deltoid where PPV 23 given. Temperature elevation of 100.4 F. Seen by medical provider 3/20 and hot packs prescribed with appointment for follow up in one or four days.
20 x 12 skin color raised elevated patch (non itchy) at the site of PROQUAD.
Initial report received from another manufacturer on 27 February 2008. The other manufacturer received the original report from an anonymous patient. An anonymous patient who did not want to provide any demographics, reported that "in the 60's, I got a live flu vaccine and got the flue." The date of vaccination, trade name, manufacturer name, lot number, route and site of administration were not provided. No additional information was provided. The other manufacturer stated they will forward any follow-up they receive.
a 9-year-old male received a dose of Fluzone QIV while injecting staff held the injection site in a pinch, administered the dose, did not release the site pinch and removed needle, removed the needle vaccine squirted out in her mouth and lip/No AE; a 9-year-old male received a dose of Fluzone QIV while injecting staff held the injection site in a pinch, administered the dose, did not release the site pinch and removed needle, removed the needle vaccine squirted out in her mouth and lip/No AE; Initial information received on 17-Oct-2019 regarding an unsolicited valid non-serious case received from an other health care professional.  This case is linked to case 2019SA295224 (same reporter).  This case involves a nine years old male patient who a 0.5 ml dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE], while injecting staff held the injection site in a pinch, administered the dose, did not release the site pinch and removed needle, removed the needle vaccine squirted out in her mouth and lip lot UJ255AA via intramuscular route in the left arm on 16-Oct-2019, expiry date not reported.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of vaccine underdose.  It was an actual medication error due to Wrong technique in product usage process.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
p/vax pt presented to ER w/T105, tests performed to r/o meningitis, OM;pt also had rash over trunk & extremities;
Within minutes after injection, experienced increasing pain, swelling, erythema and induration. Over next hour, erythema had spread across entire upper arm, wheal was > .5 inch diameter, and had increased pain and swelling. Iced on & off. 5 days later, continue with erythema, pain, and swelling at site. Still with erythema, pain & swelling though decreased in diameter.
Hives X 2, 12 -18 hours after vaccine administered. Patient states no known other abnormalities.
Sharp pain (like a pinpoint pain) in the left calf muscle; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sharp pain (like a pinpoint pain) in the left calf muscle) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Sharp pain (like a pinpoint pain) in the left calf muscle). At the time of the report, PAIN IN EXTREMITY (Sharp pain (like a pinpoint pain) in the left calf muscle) outcome was unknown.            Concomitant medication was not provided. Treatment information was not provided.     This case was linked to MOD-2021-089542 (Patient Link).
Patient came in to the pharmacy showing a large rash red in color that started just below the shoulder of the right arm and extended to just over the elbow. It was also noted that below the skin she had a lump consistent with s/sx of cellulitis.  At this time the patient's physician provided her an antibiotic and the patient's symptoms have already resolved within 48 hours.
following 15DEC93 immun mom reports pt got fussy w/in 2-3 hrs p/vax; got fussier & fussier; cried all noc could not console; mom reports had fever did not check w/thermometer;
Fever>100, Chills, Sweats, body aches, headache, Local reaction redness and swelling at injection site
Fever (36 hours) Diarrhea (48 hours) Body and Joint Pain (3 days) Loss of appetite
Shortness of breath; joint pain in hands; Headache; coughing with extreme pain and described a feeling of bugs crawling in her lungs, bugs front and back/ painful cough; itching; This is a spontaneous report from a contactable nurse. This case was also received from Pfizer sponsored program.  A 62-year-old female patient received the 2nd dose (at the age of 62-years-old) of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot# not provided), via an unspecified route of administration in Feb2021 at SINGLE DOSE for COVID-19 immunization. Medical history included lung and back problems (back pain). It was reported that the patient normally took an inhaler (not steroid inhaler because she didn't want to interfere with immune response), and other things. The patient previously took prednisone which started at 40mg for 2 days, 30 for 2 days, 20 for 2 days then goes down to zero for back pain (stopped taking 4 days before the second dose of the vaccine). The patient received the first dose of PFIZER-BIONTECH COVID-19 VACCINE (Lot# not provided) on 29Jan2021 (at the age of 62-years-old) for COVID-19 immunization. The patient's 2nd dose of PFIZER-BIONTECH COVID-19 VACCINE was administered a week ago (Feb2021) Friday. It was reported that she got very ill initially which she said joint pain in hands and headache noted in Feb2021 (Saturday) which wasn't so bad. On Saturday afternoon, she reported shortness of breath, coughing with extreme pain (painful cough) and described a feeling of bugs crawling in her lungs, bugs front and back, and itching, and no one else reported it. The patient kept sleeping and waking up, thinking she was alright, but the coughing and lasted until Sunday evening, it was a very painful cough, and a creeping sensation in lungs front and back. She missed work on Monday. The events (joint pain in hands, headache, shortness of breath, coughing with extreme pain (painful cough) and itching) were medically significant as she was unable to go to work. It was also mentioned that since the patient stopped taking the Prednisone 4 days before the second dose of the vaccine. The patient had an exacerbation of pain (it came back). The patient was also wondering when can she start the inhaler and steroid for the back as she has lung and back problems. Outcome of the events were unknown.   Information on lot number/batch number has been requested.; Sender's Comments: Based on data provided, the reported events are assessed as possibly related to BNT162B2. This case will be reviewed upon receipt of further information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
arm is hurting; dry heaves; throwing up; headaches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm is hurting), RETCHING (dry heaves), VOMITING (throwing up) and HEADACHE (headaches) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011DZIA) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jun-2021, the patient experienced PAIN IN EXTREMITY (arm is hurting), RETCHING (dry heaves), VOMITING (throwing up) and HEADACHE (headaches). At the time of the report, PAIN IN EXTREMITY (arm is hurting), RETCHING (dry heaves), VOMITING (throwing up) and HEADACHE (headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  Treatment information not reported.
I have a burning sensation on the left side of my body in T1 dermatome with no rash or visible signs of irritation.
Within 24 hours of vaccine, noted expected side effects of vaccine (mild soreness arm, fatigue, mild headache, low grade fever) but also noticed marked worsening of baseline dysautonomia, with HR to 120s and SBP to low 90s, dyspnea, orthostatic intolerance (whereas dysautonomia had been very well controlled at time of vaccine). Also noted surges of adrenaline and some irritability. Within 4-5 days, developed fevers to 101, sinus congestion, cluster headache with intense facial, jaw and teeth pain, and pervasive fatigue.  These symptoms lasted for 8-9 days (possible URI vs vaccine side effect?; covid test neg), but despite resolution of discrete event, other symptoms continued to worsen. Cont'd. The tooth pain has never remitted, seems to be irreversible pulpitis in as many as 3 teeth, now likely needing root canal or extraction. Fatigue and dysautonomia worsened further over the subsequent 3 weeks with progressive loss of functional reserve consistent with a CFS/ME "crash" to point of mostly bedbound/difficulty doing ADLs/iADLs for 2-3 weeks, now still with significantly limited functional status over 8 weeks after vaccine (mostly housebound, dyspeic with iADLS, SBP dropping into low 80s). Not yet able to get second vaccine dose due to compromised functional status and unstable vital signs. Functional status remains far below pre-vax baseline. Also with intense bouts of retrosternal chest discomfort beginning 10 days after vaccine (attributed to CFS crash by PCP and workup deferred by PCP but unlike any other chest pain previously experienced and associated with marked sob even at rest/lying down, not overtly positional, nonpleuritic, not reproducible to palpation, associated with feeling of pounding heart/palpitations, often would awaken from sleep with discomfort) that lasted every day for over a week, almost all day, before resolving in the setting of multiple days of full bedrest. Pt not able to take NSAIDS, so no trial of anti-inflammatory in case of possible myocarditis.  Conclusions: despite well-managed and improving CFS/ME and absent signs of dysautonomia prior to and at the time of vaccine, the vaccine seemed to trigger a functionally marked and debilitating CFS/ME 'crash' and functionally limiting dysautonomia (tachy, hypotension), moderate chest pain x 1+ weeks of unclear etiology (myocarditis not able to be ruled out), with enduring deficits almost 8+ weeks post-vaccine that limit self-care and preclude safe dosing of vaccine #2 given risk of further functional compromise and inability to care for self.  Now, after 10 weeks, starting to have some improvement in dysautonomia and able to complete basic ADLs.
2-3 Hours post-injection he had nausea.  By day 3 post-injection, fatigue, chills, and joint aches.  Resolved by day 5
vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F low; Vaccine administered to 45 patients past 30-day use by date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered to 45 patients past 30-day use by date.) and PRODUCT STORAGE ERROR (vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F low) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered to 45 patients past 30-day use by date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F low). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered to 45 patients past 30-day use by date.) and PRODUCT STORAGE ERROR (vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F low) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter.  It was reported that patient took vaccine on 18-Nov-2021, after the expiration date i.e on 22-Sep-2021.The BUD date was reported as 22-Sep-2021.   On 31-Mar-2021,the vaccines were stored in standard freezer for the lot 031B21A was 2 degrees F high, -1 degrees F low .   No treatment medication was reported.  This case contains information for the sixteenth of 45 patients described by the reporter.
On 3rd vaccine of Hepatitis-B, ENGERIX-B 20 mcg (adult dose) given VS ENGERIX-B 10 mcg. No adverse reaction at this time.
receiving a third (extra) dose; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date) and Shingrix (2nd dose received on an unknown date).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was recovered/resolved.  Additional details were provided as follows: The pharmacist called on behalf of the patient. The reporter stated that, patient forgot they had received second dose, resulting in them receiving a third dose, which led to extra dose administered. No demographics collected. The reporter did not consent to follow up.
Varicella administered 8/5/2004. 8/25/2004 parent reports viral s/s onset. 8/27/2004 erruption of vesicular pustules, . 15 on face, heavy breakout on neck and chest.  Accompanied by fever of 99-101(F, itching, viral symptoms.   Parent called to report due to extent of symptoms and "breakout".
This spontaneous report was received from a healthcare worker and refers to a currently 16 year old male patient with leukemia. No information about concomitant medication was reported. The patient had no pertinent medical history and had an unspecified reaction to BACTRIM. As a child the patient received M-M-R II (dose, frequency, route of administration, lot# and expiration date not reported) and VARIVAX (Merck) (dose, frequency, route of administration, lot# and expiration date not reported). The patient also received chemotherapy as a treatment for leukemia (reported in MARRS# 1506USA006558). On an unknown date in 2015 (when the patient was 16 year old), the patient was administered PROQUAD (Merck) lot # K001853 (dose, frequency, route of administration, expiration date not reported) as a result of titers showing no immunity for varicella, MMR due to the chemotherpay (reported in MARRS# 1506USA006558). No information about concomitant medication was reported. The patient sought medical attention, he saw physician. Additional information has been requested.
Patient reports they experienced nausea, dizziness and sweating, described it as feeling "sick". She felt like she couldn't see well, "things were a blur". On 7/12/16 she felt sleepy, dizzy and nauseous. Around noon of 7/12/16 she noticed a lump growing around her injection site at the back of her arm. She describes it as red and a lump the size of a quarter.
Arm soreness; Nauseous; This is a spontaneous report from a non-contactable consumer. A 34-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration on 03Apr2021 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. It was unknown whether the patient did receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021, the patient experienced arm soreness and nauseous occurred right away after the shot, on the drive home. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events arm soreness and nauseous were recovered on an unknown date in Apr2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Mother reports hives to injection site, chest and neck, lips itching, tongue swelling, cough. Mother making statement 6 days after event. No tx done, mother states s/s of rxn improved on their own.
Cellulitis. Tx with Cephalexin 500mg QID x 7d beginning 1/20/21
On the second day after I received the vaccine, along with other listed side effects I experienced moderate bi-lateral lower back pain.  This was accompanied by brown/orange/light red urine progressively in that order for a period of 6 hours and 3 urination cycles.  This issue resolved with the same pace as the onset.  I have not experienced any other notable symptoms.