chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received booster 10/27/2021 and presented with chest pain, MINOCA on 11/5/2021.  Discharged 11/6/2021 and returned to care on 11/8/2021 due to persistent back pain and new-onset AF-RVR.  Cardiac MRI (11/10/2021) demonstrated small pericardial effusion and findings suggestive of myocarditis.  Patient improved and was discharged on 11/11/2021 with follow up.
Swollen lymph nodes under left arm pit and left groin. Swelling lasted 10 days
Narrative:  Received coronavirus dose 1 on 1/19/21, developed syncope episode resulting in hospitalization on 1/22/21. Received coronavirus dose 2 on 2/16/21, developed syncope episode resulting in hospitalization on 2/22/21.
On 8/27/14 Tdap vaccine given in (L) deltoid per pt. developed localized redness, quarter sized at injection site. (L) arm feels painful. Denies swelling, did c/o some systemic sx of chills, body aches, bone aches, headache and nausea - worst symptoms Thursday NOC.
Bilateral swelling of big toe, 2nd toe, and 3rd toe on left/right feet.  began with swelling.  blisters, then developed.  inflammation, heat, and pain also present. became difficult and painful to wear socks.  shoes were also uncomfortable.  swelling and sensitivity were present all day, but flare ups occured in evening which included further swelling, pain, redness, and tingling sensation.  PCP diagnosed anti-fungal and said would improve.  after 7 days on anti-fungal ointment, no improvement. Referred to dermatologist.  Dermatologist diagnosed Pernio/Chilblain, likely related to 2nd Vaccine. prescribed topical steriod and suggested keeping toes and feet warm at all times.
Less than 24 hours after injections the patient began vomiting. Vomiting lasted 24 hours. 48 hours after injections patient developed a fever of 103.1.
Patient developed diffuse urticaria (onset 2330), abdominal cramps - given benadryl, tylenol, simethicone with significant improvement in symptoms over 1-2 hours. Patient discharged with instructions to continue antihistamines, referred to allergy/immunology for follow up
eight days after shot. i noticed my arm was really sore and started to itch, felt real dry and warm, by the next day the spot got bigger and Saturday and Sunday it was getting bigger and  its  Bright red like a sunburn.
diagnosed with covid 19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (diagnosed with covid 19) 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.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced COVID-19 (diagnosed with covid 19). At the time of the report, COVID-19 (diagnosed with covid 19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    No concomitant medication was reported.  No treatment medication was provided.   This case was linked to MOD-2021-013204 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Aug-2021: Follow-up information received contains NNI.
vaccination time 1636. at 1705, pt reported itchy throat and tongue swelling. MD notified. pt taken to office for further monitoring, possible treatment.
gave a 10 year old a Menquadfi booster dose with no reported adverse event; Initial information received on 16-May-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 10 years old male patient gave a  menquadfi booster dose with no reported adverse event while receiving vaccine MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID (BOOSTRIX) for Prophylactic vaccination; and HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL) for Prophylactic vaccination.  On 15-Apr-2022, the patient received a  dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE lot U7249AA (expiry date: 11-Mar-2024) via intramuscular route in unknown administration site for Immunization.  On 15-APR-2022 (Latency: Same day) the patient developed a non-serious gave a 10 year old a menquadfi booster dose with no reported adverse event (product administered to patient of inappropriate age) following the administration of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE.  Action taken with MENINGOCOCCAL VACCINE (MENQUADFI) was not applicable.  It was not reported if the patient received a corrective treatment for the event (gave a 10 year old a Menquadfi booster dose with no reported adverse event).  At time of reporting, the outcome was Unknown for the event gave a 10 year old a menquadfi booster dose with no reported adverse event.     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 the guidelines. 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.
COVID arm - warm, itchy, raised, large welt over the area of the injection. Resolved within 3 days. Did not require treatment other than ice. UCTD flare - ongoing. Seemed to aggravate all of my UCTD symptoms (i.e. joint pain, all over pain, fatigue, costochondritis).
31weeks and 2 days pregnant at time of shot, expected due date 10/09/2021.  Within 24 hours of shot had expected reaction to shot, fever/chills, muscle/joint pain, headache. 48 hours after, developed allergy like symptoms of cough, stuffy nose, mucus build up. 72 hours after, still cough, still stuffy nose.
numbness in their arm; This case was reported by a physician via sales rep and described the occurrence of numbness of upper extremities in an unspecified number of patients who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced numbness of upper extremities. On an unknown date, the outcome of the numbness of upper extremities was recovered/resolved.   It was unknown if the reporter considered the numbness of upper extremities to be related to Bexsero.  Additional details were reported as follows: The age at vaccination was not applicable. The reporter reported that the several patients received 1st dose of Bexsero and had numbness in their arm which persisted for about 2 weeks. No further information was available. This case has been linked with case ID US2020AMR185359 and US2019AMR199127, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2019AMR199127:same reporter US-GLAXOSMITHKLINE-US2020AMR185359:same reporter
PT ATES SHE DEVELOPED A RASH ON HER FACE THE NEXT NIGHT AFTER SHE RECEIVED THE VACCINATION (SHE RECEIVED ON MONDAY MORNING, RASH APPEARED ON TUESDAY NIGHT) AND A LOW RADE FEVER STARTING DAY AFTER VACCINE AND LASTED FOR 3 DAYS.
Red, swollen hives on arms and legs 2 hours after vaccine reaction. Photos taken.
This patient had Varivax on 01/26/01. She thinks she has varicella now. Rash. On 02/20/01 a few lesions, more lesions on 02/21/01, lesions on her back, and back of her thighs, one on her abdomen. None on her face, or neck. Itch. No new lesions on 02/22/01. One was scratched and is now crusted. To see private MD for diagnosis. None on her scalp.
Fully vaccinated, not boosted.   VACCINE LOT NUMBERS NOT DOCUMENTED.   COVID infection breakthrough, with inpatient hospital stay, non COVID admit
Swelling, redness at injection site, resolved now. Persistent bilateral hand and foot pain/swelling since the injection 6 months ago.
left arm pain/right arm pain; neck pain; back pain; trouble sleeping; Pain near scapula; pain to elbow; felt like something hit her; could not walk straight; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt like something hit her), GAIT DISTURBANCE (could not walk straight), PAIN IN EXTREMITY (left arm pain/right arm pain), NECK PAIN (neck pain) and BACK PAIN (back pain) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In June 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jun-2021, the patient experienced FEELING ABNORMAL (felt like something hit her) and GAIT DISTURBANCE (could not walk straight). On an unknown date, the patient experienced PAIN IN EXTREMITY (left arm pain/right arm pain), NECK PAIN (neck pain), BACK PAIN (back pain), INSOMNIA (trouble sleeping), PAIN (Pain near scapula) and ARTHRALGIA (pain to elbow). The patient was treated with NAPROXEN SODIUM (ALEVE) for Pain, at a dose of 1 dosage form; PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form and PARACETAMOL (TYLENOL EXTRA STRENGTH) for Pain, at a dose of 1 dosage form. At the time of the report, FEELING ABNORMAL (felt like something hit her), GAIT DISTURBANCE (could not walk straight), PAIN IN EXTREMITY (left arm pain/right arm pain), NECK PAIN (neck pain), BACK PAIN (back pain), INSOMNIA (trouble sleeping), PAIN (Pain near scapula) and ARTHRALGIA (pain to elbow) outcome was unknown.            No concomitant medication were reported    This case was linked to MOD-2021-262385 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 10-Sep-2021: TCR Received on 10-Sep-2021,Contain Non Significant Information
Information has been received regarding a case in litigation concerning a minor male patient who on 7/10/98 and 11/6/98 was vaccinated with doses of hepatitis B virus vaccine (lot # 624499/1165E and 624318/1038E respectively). Concomitant therapy on 7/10/98 included a dose of HIB conjugate vaccine (lot # 627434/0723H). It was reported that on 9/3/98 the patient received another dose of HIB conjugate vaccine (lot # 627559/0726H). Subsequently, as a result of the exposure to thimerosal and the mercury contained in thimerosal, the patient sustained neurological injuries and as a result of those injuries has been diagnosed with autistic spectrum disorder. Upon internal review, the patient's experience was considered an other important medical event (OMIC). No additional information was provided.
my chest is burning and looks like I spilled scalding water all over my chest and stomach.  At first it was burning and painful.  It is now a large area of red and a few blisters.  My breasts are covered and painful, my stomach has some scalding as well.
15 year old patient received the Moderna vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15 year old patient received the Moderna vaccine) in a 15-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031m20a) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15 year old patient received the Moderna vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15 year old patient received the Moderna vaccine) outcome was unknown. Not Provided      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.   There was no concomitant medications.  Treatment information was unknown.   Most recent FOLLOW-UP information incorporated above includes: On 29-May-2021: Follow-up information received on 31-may-2021 contains non-significant information. Reporter reported via mail that patient has no adverse reactions.
Information has been received from a healthcare worker referring to unspecified patients of unknown age and gender. The patients' medical history or concurrent condition was not provided. On unknown date 3 doses of improperly stored PROQUAD (lot # L003221, expiration date of 30-JUL-2016) (dose, strength and route unknown) were administered to the patients. No concomitant therapy was reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several cases received from the same reporter. Additional information has been requested.
COVID after first dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID after first dose) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID after first dose). At the time of the report, COVID-19 (COVID after first dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications were not reported.  The treatment information was not provided.   Reporter did not allow further contact
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 09-SEP-2011, the patient was administered with a dose of VARIVAX (Merck) (Lot # 0345AA expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of 121 reports received from the same source. Additional information has been requested.
This spontaneous report was received from a Nurse concerning a female patient of unknown age. Information on the patient's medical history, concurrent conditions and concomitant medications were not reported. It was unknown if the patient had any drug reactions or allergies. On an unknown date, the patient was vaccinated with ZOSTAVAX 19400 PFU (route: unspecified injection) (dose number, dose, unit, lot# and expiration date were not reported) for prophylaxis. Other suspect therapies included sterile diluent (MERCK STERILE DILUENT) (indication, route, dose, frequency, lot# and expiration date were not reported). On an unknown date, several days after vaccination, one vesicle appeared at the patient's injection site and resolved on an unknown date. Later, the patient was diagnosed with oral cancer (death and medically significant). It was unknown if the patient received treatment. It was unknown if the patient sought medical attention. Approximately on an unspecified date in 2007 (10 years ago) the patient died. The cause of the death was oral cancer. It was unknown if autopsy was done. No product quality complaint was involved. Causality for the events was not reported. Upon internal review, the event oral cancer was determined to be medically significant.; Reported Cause(s) of Death: Oral cancer.
Within first 2 hours: dizziness  Between 1-7pm: Faster heartbeat Nausea Soreness in sacrum Lower intestine and vagina sore/tight On/off sore throat & metallic taste similar to when sick in December  At 8:15pm: Chills Fever - temp 99.3 (normal is 97.5) Heels sore  10:20pm - Fever - temp 100.4 4:30am - Fever - temp 101.2 9:30am - Fever - temp 99.6 12:30pm - Temp back to normal at 97.5  Minor, dull headache for 2-3 days after  Then, starting on around April 8, I have been feeling, and still feel today: soreness in my left heel, inflammation all over my body, slightly faster heartbeat, sensations in gland areas of my body (lips, neck, groin, etc), headache that comes and goes.
Developed weakness 5/29/08.  Hospitalized 5/30/08 with Guillain-Barre syndrome.  06/10/2008 MR received for DOS 5/30-6/06/2008 with final DX: Guillain Barre Syndrome.  Pt presented to ER with inability to walk, generalized weakness, tingling of the feet and facial paralysis with tingling of the tongue.  Admitted to ICU with paraparesis, upper extremity weakness and bilateral facial palsy with difficulty managing oral secretions. Vital capacity initially decreased but improved with IVIG so intubation was not necessary. Pt had significant dysphagia and dysautonomia with fluctuating hypertension/hypotension  tachycardia and constipation.  Urinary retention resulted in Foley catheter insertion. Pt was able to walk with a walker prior to d/c to rehab facility.
About 15 minutes after vaccine administration, my tech returning from break noticed the woman sitting in restaurant complaining to her helper about not feeling well.  The tech informed me so I went to investigate.  I found the pt sitting upright in a chair, lucid to place and time.  Pt stated she felt nauseated, a little dizzy and generally not feeling well.  The pt informed my that she had taken a fall earlier but didn't hit her head, she hadn't eaten in over 24hr and hadn't had much to drink in that same time frame.  Around that same time an off duty firefighter came over who helped stay with her until EMS arrived.  BP118/72, P72, mild labored respirations.  Little clinic cardiocheck machine indicated GLu 145 which was probably wrong as im unsure when last calibrated. Pt was transported by EMS.
Information has been received from a licensed practical nurse concerning a patient who in approximately August 2007, was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (Lot#658000/0845U). On 07-AUG-2007, the patient developed injection site pain and swelling. Unspecified medical attention was sought. Subsequently, the patient recovered. No further information was provided. There was no product quality complaint involved. Additional information has been requested. This is one of several reports from the same source.
Patient was initially presented on 3/8/2022 with a chief complaint of shortness of breath and he was informed that the COVID test is positive.  Patient was recently seen in the emergency room 5 days ago and was discharged the diagnosis of COPD exacerbation.  Subsequently COVID-19 PCR tested positive and patient was informed.  SpO2 87 in room air per EMS and patient received albuterol and Solu-Medrol prior to arrival.    Upon evaluation in the ED BP was 128/63 heart rate 88, afebrile and pulse ox was 86 in room air and subsequently improved to 96% on nasal cannula.  Chest x-ray unremarkable for any acute cardiac pulmonary process.  Lab work abnormal for elevated WBC of 19.6, potassium of 3.3 and the rest of the labs were unremarkable.   Patient was subsequently admitted for further evaluation and treatment under Hospital Medicine.  Patient continued to have significant wheezing bilaterally and he was started on dexamethasone 6 mg for 7 days.  Patient was treated with respiratory protocol and bronchodilators as well as Robitussin cough syrup.  Patient subsequently improved with acute component of the respiratory failure and is currently stable with his oxygenation.  Patient was evaluated by PT and OT and recommended for post-acute therapy.  Patient was going to be admitted to VA palliative care prior to admission.
Low-grade fever for several hours, thigh where injection was administered red, swollen, puffy, hot to the touch. Not tender. Area of redness and swelling extended from the top of the thigh to the inner thigh.
local react site lt thigh; pt afebrile; no hives; pt started on Duficef x 5 days;
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm after receiving the first dose of Moderna COVID-19 vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm after receiving the first dose of Moderna COVID-19 vaccine). At the time of the report, PAIN IN EXTREMITY (Sore arm after receiving the first dose of Moderna COVID-19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.
Initial information received on 01-Nov-2018 regarding an unsolicited valid non-serious case received from Other health care professional (Medical Assistant). This case is linked to cases 2018SA304966, 2018SA304965, 2018SA304936, 2018SA304964 and 2018SA304964, same reporter. This case involves a 73 years old female patient who received vaccine FLUZONE HIGH DOSE. The patients past medical history, concomitant medication and family history were not provided. On 22-Oct-2018, the patient received a 0.5ml dose of suspect FLUZONE HIGH DOSE lot UI842AB, expiry date 04-Apr-2018 via intramuscular route in the left upper arm. It was an actual medication error due to expired vaccine used. It was reported that Patient was accidentally given an expired FLUZONE HIGH DOSE (expiry date 04-Apr-2018) on 22-Oct-2018. The patient did not experience any adverse reaction after the injection. 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 and Module VI of the 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.
Sore and tender arm; Sore and tender arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore and tender arm) and TENDERNESS (Sore and tender arm) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 030L20A) for COVID-19 vaccination.     Concomitant products included RAMIPRIL for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced MYALGIA (Sore and tender arm) and TENDERNESS (Sore and tender arm). On 27-Feb-2021, MYALGIA (Sore and tender arm) and TENDERNESS (Sore and tender arm) had resolved.            No treatment medication were provided. Action taken with mRNA-1273 in response to the events was not applicable. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Follow-up information received on 30-JUN-2021  contains no new  information.
Wife called 9-10-10 and stated that on Monday (9-6) he had a reddened area on (R) side of his nose more spots like blisters on Tues. Went to Dr who said it was probably shingles. Wife states that he had not been feeling well when he got shot.
Pt experienced hives, nausea and vomiting. Treated with Benadryl, Prednisone and Tagamet.