chrisvoncsefalvay/vaers-outcomes huggingface dataset:
He is now experiencing a swollen lymphnode; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 36-year-old male patient received BNT162b2 (BNT162B2), on 04Nov2022 as dose 1, single (Lot number: FP7140) at the age of 36 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: OMEPRAZOLE; EMPAGLIFLOZIN. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 06Nov2022, outcome "not recovered", described as "He is now experiencing a swollen lymphnode". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of lymphadenopathy.  Additional information: Patient received his first COVID vaccine ever on Friday 04Nov2022, monovalent adult formulation. He was now (at the time of this report) experiencing a swollen lymph node. He had no questions, just wanted to report the side effect that was swollen lymph node. No investigations were conducted. Patient thought there was one more. Patient thought it was 325 plus VACD0T, it might be an O. It was Pfizer Mono SB 7140. Patient did not know if it was clinical trial or not. Patient just had a swollen lymph node. Patient did not take anything. Patient had put down below it ice and that was it. Everything was okay other than just swollen lymph nodes. Patient had lab work done that was previous. Patient did not have done prior vaccination. The case was reported as non-serious.
Day Of:            very tired,  sore arm,  burning eyes 1 Day After:  extremely tired, weak, - unable to focus or sit upright at desk to work,  in bed and slept most of day after vaccine                              Painful Arm,  extending some to shoulder & neck - vaccine arm side                              Unable to control body temp - chills, sweats (periodic)                              Aches - focused in previously susceptible areas - Hip, Back, Knee, elbows,                                stomach pain - heartburn feel lower left side (previously susceptible area) 2 Days After:  Same as day 1,  approx 35% improvement,  still tired, aches, body temp,  stomach,  - able to work at desk for 2 hrs in am  then rest required,  very tired  even with large additional doses of caffeine. Report filed Day 2,  anticipating full recovery by day 3.
I had dizziness for the majority of the day Saturday and Sunday.  I was fatigued, but made myself stay awake up the whole day Saturday.  I  had a very weird dream Saturday night and woke up very tired Sunday morning around 8 am. I went back to bed 11:15 am and slept until 1:30.  The dizziness lasted the rest of Sunday.  I have only slept for 5 hours between Sunday night and today (Tuesday March 9th).
This spontaneous report as received from a physician refers to his 68 year old female wife with subclinical hypothyroidism and without any pertinent drug reactions or allergies. On 15-APR-2014, the patient was vaccinated with ZOSTAVAX (dose, strength, frequency, lot number and expiration date were not reported). Secondary therapies were not reported. Concomitant therapies included simvastatin (manufacturer unknown) and SYNTHROID. On 22-JUN-2014, patient developed a rash on her back. It was toward her left side and had possible crossed over to her right side. It was at the T3 or T4 level on her back close to the spine. The rash seem like tiny vesicles that were red, raise and itchy. There was no pain. No treatment was given for the adverse event. No labs diagnostics studies were performed. At the time of the report, the outcome of vesicular rash was reported as not recovered. It was reported that the patient sought medical attention by sending an email to her primary care physician. Additional information has been requested.
patient reports pain and difficulty elevating left arm after injection; He went to the walk in clinic and was prescribed a steriod; Later he had an MRI that showed a rupture of the left supraspinaturs tendon of the rotator cuff; He is now doing physical therapy but still has pain in the arm.
Patient reported to pharmacy having been to urgent care for cellulitis in the arm which was vaccinated. There was a clear bruise at the injection site, redness and warmth to the touch. She was prescribed a course of antibiotics (bactrim ds 800-160mg) for 10 days. As of return to pharmacy patient was picking up the antibiotic and cellulitis was unresolved. Urgent care also told patient that vaccine had been administered in the wrong spot, but based on bruising, shot looked to have been administered in the deltoid.
Mild cough, mild sneezing, moderate headache, very mild body aches, moderate to severe arm pain at injection sight. Mild chills. Onset of arm pain immediate. Arm sight is still painful. Mild cough. But remaining symptoms resolved within 12 hours.
Fasciculations of muscles - started first in deltoid where injected, since spread to face, abdominal muscles.
Patient reports she still has a mark on her arm where she received the vaccine a year ago. There is a small bump where injection was given and the skin around it is white/lightened. She didn't notice any injection site problems immediately after vaccine.
Hypothermia; Myalgia; Joint pain; Tachycardia; Headache; This is a spontaneous report from a non-contactable other HCP (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT number: FF8839, expiration date unknown) intramuscularly in the arm left on 28Sep2021 at 12:30 PM at age of 58-year-old as unknown dose number for COVID-19 immunization. Patient was not pregnant at time of vaccination and events onset. Medical history included hypothyroid, osteoporosis, known allergies to penicillin. Patient previously received influenza vaccine (reported as Flu) on 13Sep2021 within 4 weeks at age of 58-year-old for influenza immunization. Concomitant medications were not reported. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Patient had hypothermia, myalgia, joint pain, tachycardia, headache; all on 29Sep2021 at 12:00 AM with outcome of recovering. Patient received naproxen as treatment for the events. The events didn't result in emergency room visit or physician office visit. The events were reported as non-serious.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event hypothermia cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. 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.
Approx 1 1/2 weeks following immunization, left shoulder decreased mobility and ROM. States cannot lift left arm >90 degrees. Taking Aleve to relieve symptoms. Referred to another clinic approx 2 weeks ago for evaluation. Appt with NP on 9/11/03.
Arm hurts - barely can lift, nausea, fever -even with Tylenol and Advil, headache, tired, sore throat.
I tested positive for COVID-19 on March 4, 2023. I had congestion, slight temperature and a sore throat, also had a slight headache as well as a cough. I was prescribed PAXLOVID, it took about 5 days to fully recover. I still have slight lung congestion but better.
Within 5 minutes of receiving the vaccine, my heart started racing, my blood pressure shot up to 190 over ? (Usually my BP is low normal), my face was very flushed.
Ear pain and facial drooping, vision loss presion in arm. Two visits to hospital emergency room diagnosis as Bell's Palsy
I have been nursing a toe that they have wanted to amputate. After vaccination the toe started to heal within 48 hours; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (I have been nursing a toe that they have wanted to amputate. After vaccination the toe started to heal within 48 hours) in a patient of an unknown age and gender 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 THERAPEUTIC RESPONSE UNEXPECTED (I have been nursing a toe that they have wanted to amputate. After vaccination the toe started to heal within 48 hours). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (I have been nursing a toe that they have wanted to amputate. After vaccination the toe started to heal within 48 hours) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications information was reported. No treatment medications were provided.
Moderna COVID-19 vaccine EUA difficult time gathering all information due to poor cell reception. Called about 42 hours 1/28/21 after first dose, reported she fainted in her driveway, was instructed by nurse to call ambulance or go to her PCP. She had an appointment the next day so she waited until the next day and saw APRN. 1/29/21 called to follow up on initial report and get infor for health checker website, she had sore arm and chills AM 1/26/21 at aprox. 24 hours after first dose, right ear was itchy, hot and swollen. 36 hours later B/P dropped and stated she fainted in driveway. 1/29/21 feeling okay.  Dose 2- she had a box of benadryl chewable with her in case she needed, administered 2/25/21 and waited in clinic for 30 minutes no issues. 3/1/21 she called clinic and reported 2/27/21 AM she had welts on upper body and face. In the PM her ear gor itchy and her throat swelled some, but was able to swallow. Stated she did not take benadryl as she wanted to see what was happening to her. Sunday AM noticed her upper lip swollen some and stayed that way most of the day. 3/1/21 she called today to report reactions,
Patient's husband reported on 2-1-18 that patient had a colored drainage from the injection site of her flu shot which was administered 10-19-2017. Husband stated her arm had a red area since 10-19-2017.
Information has been received from a Certified Medical Assistance concerning a 9 month old patient who on an unspecified date was inadvertently vaccinated with a dose of pediatric VAQTA. No symptoms were reported. It was unknown if the patient sought medical attention. Additional information has been requested.
Vomiting, nausea, fever, headache, body ache lasting 6 days thus far.
Severe pain, swelling and redness of right arm.  Muscle weakness (difficult to raise arm even for light duty activities for ~36 hours). Nausea and vomiting developed 22-24 hours later.  Fully recovered by day four.
Hives that are still coming/ appearing even after 6 months after the second dose  have been taking allegra  and singuliar tried before
Moderna vaccine was given to unauthorized age group. No signs or symptoms of adverse events noted. Pt waited 15 minutes s/p vaccination injection for monitoring. Dr. notified, no orders given.
Mild pericarditis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: PERICARDITIS (medically significant), outcome "unknown", described as "Mild pericarditis". Clinical course: The patient experienced Mild pericarditis following Covid booster.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recvd flu vax in rt arm & exp inc pain in arm as day went on; 29OCT93 very sl rash & t100.8; 30OCT93 inc rash & arm swelling t99.8; 31OCT93 temp normal total body rash hot & itchy;
Was blood work tested for pregnancy on Tuesday October 4. Lower than expect htc but still within acceptable. Started bleeding and loss of pregnancy October 7.  I, the patient also had several urine tests positive over the week prior. They were not increasing in darkness on test line. Personally felt something was up with pregnancy before I had my blood work done.
This spontaneous report received from a patient concerned an 81-year-old female of unspecified ethnicity. The patient's weight was 180 pounds, and height was 66 inches. The patient's concurrent conditions included: seasonal allergies, no alcohol use, and nonsmoker. The patient no medical history. The patient was previously treated with covid-19 vaccine (dose number is series 1) (suspension for injection, route of admin not reported, and batch number: 043A21A, expiry: unknown) dose was not reported, 1 total, administered on 12-APR-2021 for prophylactic vaccination. The reporter did not report any adverse events following vaccination with covid-19 vaccine (dose number in series 1). The patient received covid-19 vaccine (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 213D21A, expiry: UNKNOWN) dose was not reported, 1 total, administered to left arm on 12-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-NOV-2021, the patient went to the emergency room and was diagnosed with blood clot (thrombosis in her left leg) (dose number in series 2). The patient was treated in the emergency room at hospital and was discharged on the same day. The patient was treated with blood thinners and the clot had resolved and everything was fine. It took couple weeks to resolve. The action taken with covid-19 vaccine was not applicable. The patient recovered from thrombosis in left leg/blood clot in an unspecified date in DEC-2021.This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20211258312-COVID-19 VACCINE Thrombosis in left leg. This event(s) is considered unassessable. The event(s) 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(s).
constipation; swollen lymph nodes; abdominal pain; vasculitis; fever of a 103 degrees; fatigue; chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ABDOMINAL PAIN (abdominal pain), CONSTIPATION (constipation), VASCULITIS (vasculitis), PYREXIA (fever of a 103 degrees) and FATIGUE (fatigue) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (The patient's medical history was not provided.).    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 02-Apr-2021, the patient experienced PYREXIA (fever of a 103 degrees), FATIGUE (fatigue) and CHILLS (chills). On 07-Apr-2021, the patient experienced ABDOMINAL PAIN (abdominal pain) and VASCULITIS (vasculitis). On an unknown date, the patient experienced CONSTIPATION (constipation) and LYMPHADENOPATHY (swollen lymph nodes). At the time of the report, ABDOMINAL PAIN (abdominal pain), CONSTIPATION (constipation), VASCULITIS (vasculitis), PYREXIA (fever of a 103 degrees), FATIGUE (fatigue), CHILLS (chills) and LYMPHADENOPATHY (swollen lymph nodes) outcome was unknown.            Concomitant product use was not provided by the reporter.    Treatment information was not provided.    This case was linked to MOD-2021-092196 (E2B Linked Report).; Sender's Comments:  MOD-2021-092196:
Vaccinated 2/24/03; 2/25 noted 4cm circular erythema; by evening of 2/25 it had increased and has stayed about the same. 2/28/03 15:30, 8cm diameter erythema, warm to touch, central raised 2cm area, itches. Afebrile. 3/3/03 has subsided. 2/28/03 she plans to use Ibuprofen, local anti-itch medication and will take child to the walk-in clinic tomorrow if not improved or if sx increase. Currently has been afebrile. Has agreed to call me and report outcome. 3/3/03 child improved. No MD visit. VAERS report sent.
It was discovered after vaccination that the vaccine was expired. It was pulled to the fridge on 6/23 and is only valid for 30 days at refrigeration. Patient did not report any adverse effects.
Patient was seen in ED due palpitations and dyspnea. She was recently diagnosed with COVID-19. She was COVID vaccinated and boosted. She presented with A. fib with RVR.  Troponin was elevated at 116 and suspected to be myocardial strain from the underlying atrial fibrillation with rapid ventricular response. Diltiazem bolus and drip administered.  chest x-ray note s small bilateral pleural effusions. Patient was admitted to hospital for further evaluation and treatment The Health department has no further information. No known  outcome. Contact Provider for any additional information.
This spontaneous case, initially received from other non-health professional (consumer) on 26-Oct-2018, concerns an 83-year-old, elderly male patient. On 16-Oct-2018, the vaccine underwent temperature excursion. On an unspecified date in Oct-2018, the patient was inadvertently administered FLUCELVAX QIVc that underwent temperature excursion [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252664 and expiry date: 30-Jun-2019]. The patient did not experience any adverse events after vaccination. The reporter assessed this case as non-serious. This case (201805007) was cross-linked to the original case 201805002 due to same reporter. Follow-up report received from the reporter on 13-Nov-2018: The onset date of the event incorrect product storage was updated as 16-Oct-2018 and expiry date of the suspect vaccine was updated as 30-Jun-2019. The reporter confirmed that, the patient did not experience any adverse events after vaccination. The reporter refused to provide the patient's initials and date of vaccine administration. The narrative and case comment were amended accordingly.
This spontaneous report was received from a health professional regarding multiple unspecified patients of unknown age. No historical or concurrent conditions were reported. On an unknown date, the patients were vaccinated with improperly stored ROTATEQ (lot # K023537, expiry: 22-JUN-2016), (lot# L006184, expiry: 13-DEC-2016), (lot# L004466, expiry: 02-AUG-2016) (incorrect product storage). No concomitant medications were reported. The improper storage temperature was 31.9 degrees Fahrenheit for a time frame of 23 hours and 30 minutes. The temperature was back in range. There was no previous temperature excursion. No adverse effects were reported. No Product Quality Complaint (PQC) was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Over weekend arm was hot and area of inj was raised. Pt used cool compress on arm and symptoms getting better. Patient noticed a lump last night 1" x 2" on neck. Also states (L) ear is hot and red. Has appt tomorrow AM for evaluation.
2JUN92 pt was given Rubella vax 230PM rt arm; pt had localized rxn following inject arm redness, swelling;
Diagnosed with Lupus; fingers are so swollen; I can't even write. So, all I can do is I can use the telephone. I can't text; gotten really sick; Bursitis; Arthritis; major inflammation all over my body; not being able to walk; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Sep2021 (Lot number: FC3182) at the age of 55 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Batch/lot number: FC3182; Anatomical site of administration: Left arm), administration date: 17Aug2021, when the patient was 55 years old, for Covid-19 immunization. The following information was reported: SYSTEMIC LUPUS ERYTHEMATOSUS (medically significant) with onset 25Mar2022, outcome "unknown", described as "Diagnosed with Lupus"; ILLNESS (non-serious) with onset Sep2021, outcome "unknown", described as "gotten really sick"; BURSITIS (non-serious) with onset Sep2021, outcome "unknown", described as "Bursitis"; ARTHRITIS (non-serious) with onset Sep2021, outcome "unknown", described as "Arthritis"; INFLAMMATION (non-serious) with onset Sep2021, outcome "not recovered", described as "major inflammation all over my body"; GAIT DISTURBANCE (non-serious) with onset Sep2021, outcome "unknown", described as "not being able to walk"; PERIPHERAL SWELLING (non-serious) with onset Mar2022, outcome "unknown", described as "fingers are so swollen"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset Mar2022, outcome "unknown", described as "I can't even write. So, all I can do is I can use the telephone. I can't text". The patient underwent the following laboratory tests and procedures: magnetic resonance imaging: (26Mar2022) unknown results. Therapeutic measures were not taken as a result of systemic lupus erythematosus, illness, bursitis, arthritis, inflammation, gait disturbance, peripheral swelling, loss of personal independence in daily activities. Clinical course: Patient was reportedly very healthy prior to the vaccination.   No follow-up attempts are possible. No further information is expected.
Janssen COVID-19 Vaccine EUA reactions. 6 hours after receiving the vaccine I started shaking with severe chills, body aches, vomiting and diarrhea. Vomiting was almost every hour, with inability to keep liquids down, and lasted for 6 hours. Body aches, headaches and chills lasted 12 hours. Still having pain and headaches now.
Red, swollen, itchy  blotch about an 1in (so far) sore to touch
Redness at the injection site for two days. Patient wearing arm sling to minimize movement of the left shoulder, limited ROM d/t pain. No palpable abnormalities and no associated rash or edema or induration. Injection site at the superior medial deltoid.
soreness in arm, lethargic, numb sensation in fingers, right side of lip felt numb, tongue numb; sensoitive to tiouch, felt unbalanced
SUDDEN ONSET OF FEVER WITH CHILLS, HEADACHE, WHOLE BODY WEAKNESS.
1st vaccine: swollen lips, tongue, face and tightness in throat.  Resulted in 3 Emergency Room visits, 1 of which was by ambulance and received EPI pen injection. 2nd dose received on 02/02/21-visit to Emergency Room to treat tongue and lip swelling Treatment received was prednisone, benydryl and observation for several hours. Home treatment: benydryl, prednisone, Zyrtec, montelukeset.
A non-serious spontaneous report of fully congested has been received from a non-health professional concerning a five-year-old male, subsequent to FLUMIST. The patient had H1N1 severe symptoms in Nov-2009. No concomitant medications were reported. The patient received 0.2ml FLUMIST nasally on 10-Nov-2010 for Influenza. The patient received FLUMIST vaccination on 10-Nov-2010 and became fully congested on 11-Nov-2010. The outcome was not recovered.