chrisvoncsefalvay/vaers-outcomes huggingface dataset:
NO SMELL; NO TASTE; COLD; NASAL CONGESTION; HARD TIME BREATHING; FEELS BAD; BODY ACHES; This spontaneous report received from a consumer concerned a 34 year old female. The patient's weight was 135 pounds, and height was not reported. The patient's past medical history included bipolar disorder, and concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included patient had no known drug allergies and does not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-MAR-2021, the subject experienced feels bad. On 30-MAR-2021, the subject experienced body aches. On 05-APR-2021, the subject experienced hard time breathing. On 06-APR-2021, the subject experienced no smell. On 06-APR-2021, the subject experienced no taste. On 06-APR-2021, the subject experienced cold. On 06-APR-2021, the subject experienced nasal congestion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from no smell, no taste, hard time breathing, feels bad, body aches, cold, and nasal congestion. This report was non-serious.
Numbness throughout arm that was injected.  Pt explained that it only lasted a couple of hours.
Pfizer-BioNTech Covid-19 Vaccine I had mild side effects. My arm was sore for 5 days but no swelling or redness. On the day of the vaccine, I had mild abdominal bloating and cramps and frequent stools. The next day I had fatigue and weakness and bodyaches for about 8 hours.
> 48 hours of intractable hiccups 5 days of fever, peaking at 102.6 F Debilitating headache
This spontaneous report was received from a certified medical assistant via sales representative refers to a 74 year old female patient. Medical history was not reported. In July 2014 the patient was vaccinated with an expired dose of ZOSTAVAX vial 19400 plaque forming units (PFU) lot number, expiration date, route and dosage were not reported. Concomitant therapy was not reported. The reporter informed that the patient transported ZOSTAVAX from the pharmacy to the office to be administered. Also mentioned that she called the pharmacy when she noticed an expired product was dispensed an the pharmacist told her that the vaccine was safe to administer because ZOSTAVAX retains potency past the indicated shelf life. No adverse symptoms were reported. Additional information has been requested.
My heart rhythm went out of sinus.  Very fast and thready..  Lasted several hours.
Heat & soreness at injection site.  Then muscle ache at the site.  Heat disappeared overnight.  20 hrs later lethargy and headache.  Continued muscle ache, but 12 hrs later feeling normal again.  24 hrs after that injection site area red/hot and redness in both armpits .. not itchy or problematic.  Disappeared overnight.  Arm muscle continued to be tender to the touch.
real sick now; Initial information received on 07-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health-care professional.  This case involves 7 patients who were real sick now while receiving vaccine influenza vaccine.  The patient's past medical treatment(s), vaccination(s) and family history were not provided. It was unknown if the patient had any medical history, concomitant disease or risk factor  On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (formulation, strength, route: unknown) lot number not reported in unknown administration site as flu vaccine.  On an unknown date the patients were real sick now (illness) (unknown latency) following the administration of influenza vaccine..  It was unknown if there were lab data/results available. It was unknown if the company suspect product inappropriately used as per local Marketing authorization  Action taken wwas not applicable.  It was not reported if the patient received a corrective treatment for the event (real sick now).  At time of reporting, the outcome was Unknown for the event real sick now.
Patient fully vaccinated (2 doses) for COVID who admitted for COVID complications testing positive for COVID upon admission.  Provider note below:   "87 yo M PMH gout, HLD, PAF, CAD, lupus anticoagulant positive, OSA, history of embolic stroke, solitary left kidney, HFrEF 30-35%, CKD4, severe aortic stenosis, chronic narcotic use, chronic respiratory failure, presented 9/27 with weakness, cough, and worsening SOB. He was found to be COVID+ despite being fully vaccinated in March. On 10/3 he developed increasing O2 requirements with CXR demonstrating progressive multifocal lung consolidation bilaterally compared to admission. He was transferred to the CCU for intubation. He was extubated 10/5 and transferred out of the ICU on 10/9. He is currently on 2-3L O2 via nasal cannula. He is continued on Lovenox for his hypercoagulable state secondary to COVID. "  Patient was discharged to skilled nursing facility on 10/26/21.  Readmitted back on  10/29/21 due to change in level of conciousness.  Discharged home with hospice care, see providers discharge note below for second admission on 10/29/21:  "Patient is an 87 year old male with history of chronic hypoxic respiratory failure, CKD Stage IV, HFpEF, and severe aortic stenosis who presents to the Hospital from the nursing facility after being found to be unresponsive and hypoxic. Medics reports that patient's oxygen saturation was in the low 80s at time of arrival to the nursing facility. patient's mental status remains altered. He awakens, however, he only occasionally will answer yes/no questions by nodding or shaking his head. Appears to deny chest pain and reports feeling comfortable presently on BiPAP. Patient was recently hospitalized at Lakeland from 9/27 - 10/26 for COVID pneumonia which required intubation.Due to his poor overall functional status and serious co-morbidities, the idea of Hospice was introduce to pt and family. They are open to the idea of Hospice. Hospice team was consulted, pt and family understand and consent signed.  Pt is going home with Hospice. "
Patient reports the next morning (7/10/18) he woke up and had fever of about 101 degrees, body aches and chills. The symptoms lasted for about 24 hours.
Pt recvd vax & w/in hrs exp some of the following sx abdo rash, diarrhea, & h/a;
Information has been received from a nurse practitioner concerning a healthy male who on 6/11/04 was vaccinated SC with a third dose of MMR (lot # not reported). On 6/22/04, the patient developed a maculopapular rash on his face and chest, his pharynx was (a little red) and he developed a node 10-12mm. The patient sought unspecified medical attention and did not receive treatment. At the time of this report, the outcome was unknown. Additional information has been requested.
The evening I got my shot I had a very bad migraine. But what concerned me was I took two birth control pills that evening, having accidentally skipped my pill the previous day. I had trouble sleeping all night with a random pains and woke up with a blood pressure of 75/45 and resting heart rate of 50 or less. I am an EMT, so I stayed supine and improved over 30 minutes, but almost went to the ER and would have, had I not been a medical professional. The propensity to clot with the Janssen as well as increased intake of birth control did not cross my mind but I want others to be aware of the potential interference there.
After receiving the injection - they had me sit down and stay for 10-15 minutes to make sure I had no reaction. I left, felt fine and did errands. The next day I woke up with severe chills, weak and tired. And my arm hurt where the shot had been given. I also had diarrhea - which according to the prescription info sheet, is not a side effect. I called the pharmacy - told them what happened and she asked if I was sick when I got the shot and I said "No". She guessed that maybe I had the "stomach flu". My husband heard on TV. that the "norovirus" was going around and that diarrhea was a symptom. So maybe it was that virus. Hard to say. I did feel better on Saturday - still a little bit tired and weak. But better than how I felt on Friday.
I developed heart palpitations, I immediately noticed my blood pressure going up. I contacted my doctor and went in and changed up my medication. In December I went into urgent care and my blood pressure was really high. I was having PBC's and they were happening frequently. I was given a shot but it didn't help anything, everything was still high and I was admitted into the hospital. As of now my blood pressure has become more stable but I'm still experiencing PBC.
This spontaneous report as received from a licensed practical nurse refers to a female patient of unknown age. Information regarding her pertinent medical history, drug reactions/ allergies and concomitant medications was not provided. The patient was vaccinated with the first, second and third dose of GARDASIL 9 (which had a lot # of M034780 with an expiration date of 15-APR-2019; however, the dose, frequency, anatomical location and route of administration details were unknown) on 14-SEP-2012, 28-NOV-2012, and 20-MAR-2013, respectively, for prophylaxis. Then, on 27-MAR-2017, she was inadvertently vaccinated with another dose of the vaccine, having the same dosage details as provided earlier. Despite this, no adverse effects were reported. Additional information has been requested.
Pain at injection site, erythema, induration 1x1 cm with larger area of erythema 10x10. Tx - antihistamine, 0.1% triamcinolone.
The vaccine did not prevent shingles as intended; herpes zoster or shingles; Information has been received from a lawyer regarding a case in litigation referring to a female patient of unknown age. Information about concurrent condition, medical history and concomitant therapy was not reported. In 2011, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date not reported) at a pharmacy, as recommended for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2012, the patient was treated by a physician, for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), and/or despite receiving zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events herpes zoster and vaccination failure was not reported. The lawyer considered the events to be related to zoster vaccine live (ZOSTAVAX).
This sponanteous report as received from a healthcare worker refers to a patient of unknown age and unknown gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 28-JUL-2014 the patient was vaccinated with (Oka/Merck) VARIVAX (lot # not provided) 0.5 ml, subcutaneous. The (Oka/Merck) VARIVAX was improperly stored which exposed to 8.5F for 20 minutes on multiple occasions to total time of ten hours. No adverse effect was reported. Additional information has been requested.
Fever for 48 hours; Slept for 24 hours; Slight nausea; no appetite; arm, muscle joint pain; arm, muscle joint pain; arm, muscle joint pain; Continued fatigue; some dizziness; feeling unwell; This is a spontaneous report from a contactable consumer (patient). This 74-year-old female patient (no pregnant) received 3rd dose of BNT162B2 (Lot Number= FF2589), at the age of 74 years old, on 16Oct2021 04:15 PM, Vaccine location in Left arm, at single dose for covid-19 immunization. Other vaccine on the same date was 1st dose of Fluzone HD 65+, vaccine location=Left arm for immunization. Medical history was Diabetes. Concomitant drugs were not reported. No covid prior vaccination. No covid tested post vaccination. No Known allergies. Historical vaccine was 1st dose of BNT162B2 on 23Feb2021 (lot Number= EL9266), 2nd dose of BNT162B2 on 16Mar2021 (lot Number=EM6206), at single dose for covid-19 immunization. Fever for 48 hours. Slept for 24 hours except for when husband woke me to see if I was still alive. Slight nausea, no appetite, arm, muscle joint pain. Continued fatigue, some dizziness, just feeling unwell from 16Oct2021 09:00 PM. No treatment. Outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected
Within 6 days of 2nd Pfizer vaccine, admitted to hospital for emergency appendectomy. I know of 1 other individual who also had emergency appendectomy 5 days after 2nd Pfizer vaccine
Initially seen on 5/30 for pharyngitis x6 days, swollen uvula, LE edema. Given dose of dexamethasone. Seen again on 6/3 for >1 week LE edema, fatigue, penile and scrotal edema. Labs showed H/H and platelets slightly elevated. TSH also very high. Went to outside ED on 6/5 and had negative DVT U/S. Seen again on 6/9 at our clinic with significant facial edema, increased uvula swelling, changes in voice quality, abdominal bloating, and persistent LE edema. Given prednisone course and referred back to ED for airway evaluation and further evaluation/mgmt.
The blood has now gone to her breast.; This spontaneous case was reported by a consumer and describes the occurrence of SENSATION OF BLOOD FLOW (The blood has now gone to her breast.) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced SENSATION OF BLOOD FLOW (The blood has now gone to her breast.). At the time of the report, SENSATION OF BLOOD FLOW (The blood has now gone to her breast.) outcome was unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant products and treatment information were reported. It was reported that the same arm that she received the first shot in, she stated it appears the blood has now gone to her breast.
Started to experience slight swelling and itching at injection site on day 8 after vaccination. 4-5 cm area around injection site is warm to touch and flushed. Level of itching is about the same as a mosquito bite. Swelling is a 1-1.5 cm bump at injection site.
No additional adverse events reported; reporting the administration of expired PROQUAD; This spontaneous report was received from a licensed practical nurse, referring to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history and concomitant medications was provided.  On 03-MAR-2022, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant human albumin (rHA) (PROQUAD) 0.5 ml, lot #: T025508, expiration date: 23-JAN-2022 (formulation, strength, site and route of administration were not provided) for prophylaxis (expired vaccine used). There was no additional event reported (no adverse event).
droopy and swollen eyelid; droopy and swollen eyelid/swollen rt eyelid; painful; chills; achy body; really bad headache; body aches/pain/tiredness; This spontaneous case was reported by a consumer and describes the occurrence of EYELID PTOSIS (droopy and swollen eyelid), SWELLING OF EYELID (droopy and swollen eyelid/swollen rt eyelid), EYELID PAIN (painful), CHILLS (chills) and MYALGIA (achy body) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension. Concomitant products included HCTZ from March 2015 to an unknown date and CARVEDILOL from May 2017 to an unknown date for an unknown indication.   On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-May-2021, the patient experienced CHILLS (chills), MYALGIA (achy body), HEADACHE (really bad headache) and FATIGUE (body aches/pain/tiredness). On 04-May-2021, the patient experienced EYELID PTOSIS (droopy and swollen eyelid), SWELLING OF EYELID (droopy and swollen eyelid/swollen rt eyelid) and EYELID PAIN (painful). The patient was treated with MONTELUKAST SODIUM (SINGULAIR) at an unspecified dose and frequency and LORATADINE (CLARITINE) at a dose of 2 Doses. On 05-May-2021, SWELLING OF EYELID (droopy and swollen eyelid/swollen rt eyelid) had resolved. At the time of the report, EYELID PTOSIS (droopy and swollen eyelid), EYELID PAIN (painful), CHILLS (chills), MYALGIA (achy body), HEADACHE (really bad headache) and FATIGUE (body aches/pain/tiredness) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable. Treatment details included Eye drops every 4 hours and heat applied on face,as provided by the patient.    Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Follow-up information received on 09-Jun-2021, Added patient demographics, medical history, start date and route of concomitant drug and new Event (fatigue). Updated outcome of event (swollen eyelid) to recovered.
Swollen neck and collarbone on same side as vaccine. Swollen arm at site of vaccine.
Adverse events: tiredness, shaking, palpitation, difficulty in breathing, tachycardia, nausea, headaches, weak, and loss of voice. Treatments: echocardiogram and EKG tests, referred to cardiologist, endocrinology specialists, taking aspirin 81 and MethiMAzole.
After the first dose of the moderna Vaccine, i had severe chills, nausea, vomiting. temp>103f
R Arm swollen (dia 18.5cm) with vaccine left arm 15.5cm. Erythema 17cm x 13cm. Hot around both vaccines.
Second dose given today was Pfizer when first dose was Moderna. Site lead notified. No reactions noted during 15 min observation period.
Service member states a lump began to show up on R arm where injection was. He states he noticed a lump about a month after the injection which has continued to increase. He denies any pain but is tender to the touch. 2" round 1cm raised, moveable abscess. He has not currently received medical treatment. He is being sent to his primary for treatment.
This spontaneous report as received from a certified medical assistants refers to unspecified a patients of unknown age and gender. The patients medical history and current conditions were not provided. On an unknown date in 2015 (reported as "since March 2015"), the patients were vaccinated with an improperly stored PROQUAD (Merck) (expiration date, dose and route were not reported) lot # K020751. Secondary suspects and concomitant therapies were not reported. No adverse effects were noted. There was no treatment given for adverse event. Additional information has been requested. This is one of several reports received from the same reporter.
I had no taste or smell.  I had a cough, nasal congestive, fatigue, headache, and running nose. I also have muscle ache and pains.  I just felt trouble.  I thought I had a really, really bad flu.  I had loss stool and no control of my bowels.  I was dizzy and had brain fog.  I went to urgent care.  They did a Covid-19 test, positive result.  They gave me infusion.
Pt had a syncopal episode status post influenza vaccination. Vaccine administered while pt sat on exam table, she declined to be supine for the vaccine. After vaccine administration pt requested to lay down, she was then assisted to a supine position for about 10-15 minutes. Pt chatted with mother about an upcoming family vacation and used her phone while supine. Pt was discharged after she reported she felt fine and exited exam room. About 5-10 minutes later provider was called to assess pt after a syncopal episode at stores register. Upon assessment, pt was supine and was pale and clammy to touch.  Pt was alert and oriented X4, she denied pain and was crying. BP supine 118/60, HR 60, oxygen saturation on room air 98%, BP sitting up 102/70, HR 65, oxygen saturation 98% on room air. Mother reported they were checking out at register and pt fell forward. Customer who was a paramedic was also on site. Witnesses including mother reported pt did not hit head. Paramedics were called by store personnel and parent declined for paramedics to come and assess pt. Police officer came to the scene and took information from provider and mother. After assessment pt left store with mother in a private vehicle.
Sore arm after COVID-19 vaccination; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm after COVID-19 vaccination) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore arm after COVID-19 vaccination). At the time of the report, VACCINATION SITE PAIN (Sore arm after COVID-19 vaccination) had resolved.            Concomitant drugs were not reported.  The patient had received first booster dose and second booster dose of Moderna vaccine.  The reporter's causality for event sore arm after vaccination with Skyrizi  was reasonable possibility.  It was unknown date if patient was enrolled in a COVID-19 vaccine trial.  Treatment medications were not provided.  This case was identified as part of retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
I am post menopause. I began menstrual cramps on the 1/20/2021. My period started a day later. The flue was heavy and with clots.  My hot flashes stopped for 2 months. My hot flashes resumed  at the end of March 2021.
Myalgia, Arthralgia, Fever lethargy, soreness with localize swelling/redness at injection site Narrative:
My tongue is swelling up; My left ear is really in pain; This spontaneous case was reported by a patient and describes the occurrence of SWOLLEN TONGUE (My tongue is swelling up) and EAR PAIN (My left ear is really in pain) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Immunocompromised.    On 14-Jun-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jun-2022, the patient experienced SWOLLEN TONGUE (My tongue is swelling up) and EAR PAIN (My left ear is really in pain). At the time of the report, SWOLLEN TONGUE (My tongue is swelling up) and EAR PAIN (My left ear is really in pain) outcome was unknown.            No concomitant medications were reported.  Reported that patient received third Moderna shot and It was the one for immunocompromised.  No treatment medications were reported.