chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This reaction occurred after I received the Moderna Booster on 10/28/2021. Red, blotchy skin on trunk, back, arms, hands, legs and feet, followed by intense itching. Began on 11/07/21. Oral Benedryl did not help. To primary MD on 11/11/2021. Rx: Medrol "Dose Pk" Upon completion in 5 days, symptoms improved. Then, approx one week later, symptoms returned. To allergy MD Rx: 24 hour Allegra, one capsule twice per day. After about 2 weeks symptoms improved. Then, on or about 03/13/2022, I was stung/bit on right inner thigh by some type of insect. An area approx 8 inch by 6 inch of reddness, swelling, and itching followed. Saw Derm MD at my annual skin exam on 03/15/2021. Rx: topical steroid, OTC topical anti-itch cream, 24 hour Zyrtec at bedtime. Symptoms resolved by 03/18/2022.
arm pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.   The case was reported by the reporter for the her daughter. The age at the vaccination was not reported. The patient received Shingrix and experienced arm pain.  No details about the patients was available at time of report. The reporter did not consent to follow up. This case linked with US2020084176, US2020AMR084983 and US2020AMR084982, reported by same reporter.
This spontaneous report as received from a nurse refers to a 3 year old male patient. Concomitant medications, pertinent medical history and allergy/drug reactions were none. On 27-SEP-2001 the patient was vaccinated with VARIVAX. On 10-AUG-2004, the patient developed shingles. On an unknown date, the patient sought medical attention which included an office visit. On an unknown date, the patient was treated with KEFLEX. There were no lab tests done. The Nurse reported that on patient chart, it was noted that the patient grandmother has a case of shingles on an unknown date approximately in June 2004 (reported as 2 months prior) to patient diagnosis of shingles and Nurse suspected that patient came in contact with his grandmother. The outcome of the event was reported as recovered. The reporter did not provide the causality between the event and the suspect therapy. There were no product quality complaints (PQC) involved. Additional information has been requested.
I believe the patient stated that all three vaccines were administered in the same arm, but our documents don't specify for sure.  The patient started experiencing issues before he had even arrived home, 15 minutes after leaving the pharmacy.  It started out with an upset stomach, then a headache followed.  He said that a few hours later he noticed having chills and muscle soreness with erythema in the injection site.  Most of these adverse reactions had dissipated by the next morning except the redness and soreness which is still there today (10/23/20), three days later.
Extreme pain in both ears. Sore throat, swollen tonsils, strong headaches, foggy vision that comes and goes.
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Seizure-Mild, Systemic: Shakiness-Mild, Additional Details: Patient became rigid, unresponsive, fixed eyes, dilated pupils, shaking (seizure-like movements), when patient was moved to floor, she became alert and oriented.  Dizziness, shakiness, body slower to respond than normal...took some time to get back to normal.  EMS called for monitoring and support.
This spontaneous report as received from a medical assistant refers to an 18 years old male patient. On 18-FEB-2015, at age of 14 years old, the patient was vaccinated with the first dose of GARDASIL 9 (dose and lot # not provided) intramuscularly. The medical assistant reported that the patient missed his second dose of GARDASIL 9 and presented to the office on 17-SEP-2018 requesting his second injection of GARDASIL 9 (dose and lot # not reported) intramuscularly. No adverse effects were reported
Acute respiratory failure (CMS/HCC) CHF (congestive heart failure) (CMS/HCC) Renal insufficiency NSTEMI (non-ST elevated myocardial infarction) (CMS/HCC) Pneumonia due to COVID-19 virus Covid-19
Descending symmetric weakness, ptosis, weak cry, flaccid extremities beginning acutely 1 day after vaccinations and continued for 3 days prior to arrival to hospital. Botulism was primary consideration and treatment ongoing. Could not formally rule out Guillain-Barre.
THIS DOES NOT APPLY TO A SPECIFIC PATIENT. Several patients reported back to the administering pharmacist that they experienced more severe adverse reactions from their SHINGRIX vaccine. These symptoms included severe redness (cellulitis in one case), and severe flu like symptoms (chills, muscle aches, runny nose, headache, congestion/runny nose). When reviewing the cases, it appeared that the patients that had reported the most severe symptoms had received the same lot of the vaccine manufactured by GSK: A5X5B.
Nausea; Severe headache; This spontaneous case was reported by an other health care professional and describes the occurrence of NAUSEA (Nausea) and HEADACHE (Severe headache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 011L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced NAUSEA (Nausea) and HEADACHE (Severe headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. On 21-Feb-2021, HEADACHE (Severe headache) had resolved. At the time of the report, NAUSEA (Nausea) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Follow-up information provided. Additional details regarding the event of headache, stop date and the outcome. On 21-Jul-2021: Follow up received: No new information.
pt recvd vax & exp herpes-like sore on lips, swelling on temple & erythema on chest;
at 318pm pt c/o feeling little dizzy. alert and verbally responsive. pt. offered fluids and snacks. pt. drank some water vitals monitored  3:18pm BP 127/108 P-70 R-18 o2SAT 99% RA @330pm BP 117/76 p-69 R-17 o2SAT 99% RA  @333pm pt verbalized releif from symptom (dizziness) no SOB no change LOC alert and verbal  Vitals stable.
This spontaneous report as received from a pharmacist refers to a 74 year old male patient. His medical history, concurrent conditions and concomitant medications were not reported. On 14-NOV-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, route of administration, lot # and expiration date were not reported) (reported as vaccine). On 16-NOC-2016, the patient developed fever (exact temperature was not provided), soreness at the injection site, chills and frequent urination since receiving the dose. The patient was referred to his physician for the further evaluation. At the time of this report, none lab diagnostic studies were performed and no treatment was given for the adverse events. The outcome of the adverse events was reported as not recovered at the time of this report. The relatedness between the adverse events and PNEUMOVAX 23 was not provided. Additional information has been requested.
Red raised areas that start at left eyebrow and go into hairline. Red raised bumps throughout scalp on the left side. Left swollen lymph node behind ear that is continuing to swell. Pressure from lymph node swelling now felt near left eye. All bumps can be itchy at times.
on same day as administered vaccine patient began complaining of excruciating pain at site that prompted a return to office for evaluation.  A second visit on day of report with worsening pain that radiated to L trapezius and L side of neck and distally to end of fingers.  Gripping movement of L hand associated with pain of entire L arm, L posterior shoulder and L neck.  Patient describes circumferential stocking - glove like numbness immediately distal to injection site and extending to fingers lasting a couple of hours.  exam demonstrated limited range of motion of left shoulder due pain and intact though weak strength of left are  compared to right
Left axillary tenderness noted the next morning.  Took Tylenol and alternated with Ibuprofen.   Left axillary swelling and severe tenderness without redness noted the second morning.  Alternating Tylenol and Ibuprofen.
Information has been received from a physician concerning a 35 month old pt who on 22May03 was vaccinated with a dose of varicella virus vaccine live. Concomitant vaccine administered with varicella virus vaccine live included a dose of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). On 26Apr05 the pt experienced chickenpox, described as mild with only 10 to 15 skin lesions. Unspecified medical attention was sought. No product quality complaint was involved. Additional information is not expected.
patient did not receive a full dose, as most of it ran down the patient's arm; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (patient did not receive a full dose, as most of it ran down the patient's arm) in an adult female patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced UNDERDOSE (patient did not receive a full dose, as most of it ran down the patient's arm). At the time of the report, UNDERDOSE (patient did not receive a full dose, as most of it ran down the patient's arm) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication provided.  No treatment medication provided.
Menveo vaccine was mixed with the incorrect diluent; no adverse reactions noted; patient notified and rescheduled to received correct dose.
Information has been received from a physician concerning a 12 month old female with no medical history or allergies, who on 12/31/04 was vaccinated with a 0.5ml dose of MMR (lot # 647279/0417P). Concomitant therapy included a dose of varicella virus vaccine live (lot # 646819/1065N). On 1/5/05, five days later, the patient developed a rash on her trunk and face. Unspecified medical attention was sought. A prescribed drug was required for the rash. No diagnostic studies were performed. It was reported that the patient's rash was still being treated with prescription drug treatment. No product quality complaint was involved. Additional information has been requested. Initial and follow-up information has been received from a physician and a certified medical assistant concerning a 12 month old female with no medical history or allergies, who on 31-DEC-2004 was vaccinated SC in the right lower extremity, at 3:30 pm, with a first 0.5 ml dose of MMR II (lot# 647279/0417P). On 31-DEC-2004, at 3:25 pm. the patient was also vaccinated IM in the left upper extremity with a third dose of COMVAX (lot# 648823/0240P) and vaccinated SC in the left lower extremity with the first dose of VARIVAX (lot# 646819/1065M). Other concomitant therapy included a second dose of FLUZONE (lot# U1533AA). On 06-JAN-2005, at 10:30 am, the patient developed a macular rash on her trunk and face with blanching and a fever of 101. A prescription drug was required for the rash. No diagnostic studies were performed. It was reported that the patient was treated with an unspecified prescription drug. The patient's outcome was unknown. No product quality complaint was involved. Additional information is not expected. This is a consolidation of two reports concerning the same patient. It has been determined that WAES#0501USA02720 is a duplicate of WAES#0501USA00745. Therefore, WAES#0501USA02720 will be deleted from our files and consolidated into WAES#0501USA00745.
Later in the day after I received the vax I started having right arm pain so I applied ice to my arm . When I woke up the pain was still there. The pain has now turned into weakness in right arm.
Patient with history of COVID vaccines who admitted to hospital with COVID detected PCR.  Provider d/c note: "Patient is a 75 year old man who presented to the emergency department with two day history of weakness, found to have COVID 19 infection with one episode of hypoxia noted. He was treated with 5 days of remdesivir and decadron. His diabetes was controlled with insulin use. He was evaluated by  physical therapy who assessed him to be appropriate for home therapy with PT/OT and a home health aid and he was discharged in stable condition on 5/15/2023"
Information has been received from a physician concerning a 12 month old male patient with unspecified pertinent medical history, drug reactions or allergies, who "three years ago", on 09-NOV-2006 was vaccinated with a dose of MMR II vaccine (route unknown, lot # 652481/0094F, HSA). Concomitant medication unspecified. The patient developed rash all over his body 15-20 minutes after receiving the dose of MMR II vaccine, he went to the emergency room for medical attention but he was not admitted. On an unspecified date the patient recovered within 24 hours with the use of BENADRYL. Additional information has been requested.
Large swollen, red, warm area measuring 3 inches x 4 inches and an inch raised at area of injection. Pain and itching at site. Pain in axillary and "armpit" area.
Severe edema and redness radiating from upper left deltoid and into lymph nodes, febrile (101 temperature), required doctor and ER visit, discharged with 10 day course of two separate antibiotics. Patient reporting successful completion of antibiotic course and being stable.
Lack of efficacy: no antibodies after vaccinations; SARS-CoV-2 antibody test negative; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THERAPEUTIC PRODUCT INEFFECTIVE (Lack of efficacy: no antibodies after vaccinations) and SARS-COV-2 ANTIBODY TEST NEGATIVE (SARS-CoV-2 antibody test negative) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 024M20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised (Taking immunosuppressants).   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced THERAPEUTIC PRODUCT INEFFECTIVE (Lack of efficacy: no antibodies after vaccinations) and SARS-COV-2 ANTIBODY TEST NEGATIVE (SARS-CoV-2 antibody test negative). At the time of the report, THERAPEUTIC PRODUCT INEFFECTIVE (Lack of efficacy: no antibodies after vaccinations) and SARS-COV-2 ANTIBODY TEST NEGATIVE (SARS-CoV-2 antibody test negative) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, SARS-CoV-2 antibody test: negative (Negative) Negative antibodies for COVID-19.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient taking unspecified immunosuppressants. Doctor believed her negative test results were due to the fact that she is on immunosuppressants. No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.   Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Added contact Email; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Patient states that on the day of the injection she suffered from a hot arm (pain, redness, swelling) that went all the way down her arm & across her axillary area.  She also states that she has been suffering for seven days with a headache, fever (about 101), chills, nausea/vomiting, and diarrhea. She has missed seven days of work so far. She has not been seen yet for these symptoms, but was advised to seek treatment if she doesn't start to feel any better.
COVID-19 TEST POSITIVE; This spontaneous report received from a consumer concerned a 25 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 24-MAR-2021, the subject experienced covid-19 test positive. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 test positive was not reported. This report was non-serious.; Sender's Comments: : MAC not required as per standard procedure as case was assessed as non-serious.
Pain, redness, swelling of left arm, also OPEN SORE NO SKIN at site of reaction QUARTER OF AN INCH WIDE on 11/17/18. After shot, she had myalgia, fatigue, headache, and gastrointestinal symptoms.
About 24 hrs after vaccine on August 7, 2018, inflammation, heat, large, hard swelling at injection site approximately 9cm x 9cm, extremely sensitive to touch. Throughout the day and night, experienced tachycardia (107-114 bpm) including previously diagnosed idiopathic A-fib, periods of diaphoresis, hypertensive (168/101, 159/100, 158/110) episodes, chest discomfort and shortness of breath, anxiety, and from shoulders up, feeling like my head and neck were being electrocuted (like a shock from an outlet). Extreme migraine for which medications did not help, ringing and other sounds that only I could hear. I took benadryl every 3-5 hours, along with regular medications and added a Nadalol  when I saw how high my BP was. Used ice for the redness and drew circles around the inflammation. The next morning the inflammation was still present and had enlarged.
After receiving vaccinations pt slept on the way home. Woke up at home and Mom gave her a snack. While eating it mom notiticed moaning, laying her head down frequently  and heavy breathing. Felt hot. Vomiting violently and repeatedly. Full body tremors at 30 sec. To ED vomiting repeatedly in minutes. Temperature was 106 in Tylenol given. Baby Kegan acting farily normal
sick for a month; Initial information was received on 12-Oct-2020 regarding an unsolicited valid case from the patient.  This case involves an unknown demographic patient who got sick for a month (malaise), after the patient received INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medication were not reported.  On an unknown date (10 years ago), the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and other dosing details were not reported) for prophylactic vaccination.  On an unknown date, the patient got sick (malaise) but no flu, (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  On an unknown date, a month later the patient had recovered from the event.  There will be no information available on the batch number for this case.
2/17/22 diagnosed deep vein thrombosis (diagnosed by MD, oncologist/hematologist) - 4 blood clots found in right calf; no previous history of DVT
Excruciating pain in arm that received the shot, from elbow to shoulder, after 3 hrs. of getting the injection.  Extreme pain inhibited sleep, required constant maximum allowed pain reliever medication for 2 days straight (1/21/21-2/23/21); could not use that arm nor put any pressure on it for 2 days. On a scale of 1-10 (10 being the highest degree of pain) my pain was a 9 for 2 days.
Patient woke up the next morning extremely fatigued with moderate-to-severe soreness at the injection site. A large red rash developed near the injection site and was warm and itchy. The rash is still present 5 days post-injection. Patient took 800 mg of ibuprofen to reduce pain and inflammation.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 28-AUG-2015 the patient inadvertently received an expired first dose of GARDASIL (dose, strength and route were not reported) lot # H0200025 with expiry date: 08-AUG-2015. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
Insomnia; Weight gain; Blood sugar increased/ ELEVATED BLOOD SUGAR; Headache; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Insomnia), WEIGHT INCREASED (Weight gain), BLOOD GLUCOSE INCREASED (Blood sugar increased/ ELEVATED BLOOD SUGAR) and HEADACHE (Headache) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    Concurrent medical conditions included Crohn's disease.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. In March 2021, the patient experienced HEADACHE (Headache). On an unknown date, the patient experienced INSOMNIA (Insomnia), WEIGHT INCREASED (Weight gain) and BLOOD GLUCOSE INCREASED (Blood sugar increased/ ELEVATED BLOOD SUGAR). At the time of the report, INSOMNIA (Insomnia), WEIGHT INCREASED (Weight gain), BLOOD GLUCOSE INCREASED (Blood sugar increased/ ELEVATED BLOOD SUGAR) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2021, Weight: 25 Pounds increased. On an unknown date, Blood glucose: ELEVATED BLOOD SUGAR (25 Pounds). On an unknown date, Liver function test: Elevated.         This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Concomitant medication was not provided.  No information regarding treatment medication was provided.   This case was linked to MOD-2022-624417 (Patient Link).
Three hours after the injection I felt my throat getting sticky / constricting and my heart started pounding.  Resting pulse got up to 112 bpm, and when I arrived at the ER, my blood pressure was 202/85.