chrisvoncsefalvay/vaers-outcomes huggingface dataset:
dose administered to patient after more than 1 temperature excursion; dose administered to patient after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 1:48 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 1:48 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 50.04  No concomitant medications were reported.  Batch number 030B21A underwent temperature excursion on 03-Apr-2021 with temperature 34 degrees Fahrenheit at 09:00 AM. This vial was moved to fridge on 30-Mar-2021 and beyond use date for the vial was reported as 29-Apr-2021. Product moved to clinic on 03-Apr-2021.  Vial was stored in cooler 1, on 03-Apr-2021, temperature excursion at 8 AM: 38, 9 AM: 34, 10 AM: 38, 11 AM: 42, 12 PM: 41, 1PM: 41 and 2 PM: 41.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
had a reaction of poly-myalgias 5 days after receiving the vaccine; overall aches in the arms and legs; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A 72-year-old male patient received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SIMVASTATIN. The following information was reported: MYALGIA (non-serious) with onset Mar2021, outcome "unknown", described as "had a reaction of poly-myalgias 5 days after receiving the vaccine"; PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "unknown", described as "overall aches in the arms and legs". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of myalgia, pain in extremity.  Additional information: During the call the caller transferred the phone to the MD (call recording disclaimer provided) to provide additional details that the patient has a C-reactive protein of 31.3. He also takes simvastatin and the MD has discontinued that medication. His CK was normal but the patient continued to complaint of overall aches in the arms and legs. The patient received 80 mg of Depomedrol.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
blood pressure was very high; difficult breathing; still really bad at night; a rash/ a lot of rash had  expread really fast all over her body; fever really bad; got pain in the arm and swollen; got pain in the arm and swollen; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (blood pressure was very high), DYSPNOEA (difficult breathing), FEELING ABNORMAL (still really bad at night), PAIN IN EXTREMITY (got pain in the arm and swollen) and PERIPHERAL SWELLING (got pain in the arm and swollen) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042521a, 032m20a and 011m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   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) (unknown route) dosage was changed to 1 dosage form. On 03-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Feb-2022, the patient experienced PAIN IN EXTREMITY (got pain in the arm and swollen) and PERIPHERAL SWELLING (got pain in the arm and swollen). On 06-Feb-2022, the patient experienced DYSPNOEA (difficult breathing), FEELING ABNORMAL (still really bad at night), RASH (a rash/ a lot of rash had  expread really fast all over her body) and PYREXIA (fever really bad). On an unknown date, the patient experienced HYPERTENSION (blood pressure was very high). At the time of the report, HYPERTENSION (blood pressure was very high), DYSPNOEA (difficult breathing), FEELING ABNORMAL (still really bad at night), PAIN IN EXTREMITY (got pain in the arm and swollen), PERIPHERAL SWELLING (got pain in the arm and swollen), RASH (a rash/ a lot of rash had  expread really fast all over her body) and PYREXIA (fever really bad) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure increased: high (High) very high.         Patient height was reported as 5 Foot and 4 inches.  It was reported that patient had allergies (medications, food and other products) to a drug that was no longer in the Market.  Concomitant medications included vitamins. No treatment medications were provided.  Patient had no COVID test or diagnosis. Patient did not experienced a similar event in the past.   This case was linked to MOD-2022-474191 (Patient Link).
Information has been received from a physician and Licensed Practical Nurse via field representative referring to a 12 month old male patient. The patient's pertinent medical history and drug reactions or allergies were unspecified. On an unknown date, the patient was vaccinated with one dose of VARIVAX (Merck) (lot number, expiration date and dose were unknown) subcutaneously due to a childhood vaccine recommendation. Other suspect therapies included M-M-R II (lot number, expiration date, dose and route were unknown). COncomitant medications included other unspecified vaccines. On an unknown date, the patient developed a chickenpox rash over 25% of his body (on his leg, groin, face and hands). The patient sought medical attention via office visit. The outcome of the event was unknown. The causality between the event and suspect therapies was unspecified. Additional information has been requested.
Fatigue, cold sweat/chills, slight headache, muscle/joint pain, skin painful to the touch (typically occurs to me right before getting a fever or becoming sick)
This spontaneous report as received from a medical assistant refers to an unspecified number of patients. On an unknown dates, the patients were vaccinated with doses of oral ROTATEQ lot # L013193, expiration date 20-JAN-2017 (dose, route and site of administration were not reported). The vaccine was improperly stored in temperature 68.2F for 2 hours. No symptoms were reported. This is one of several reports from the same reporter. Additional information has been requested.
Patient reports generalized rash and pruritis, with periorbital edema and perioral edema. Took Benadryl over the weekend, did not reach out to office until 2/21/17.
This spontaneous report as received from a Licensed Vocational Nurse (L.V.N.) refers to a patient of unknown age and gender. No medical history or current conditions were reported.On 01-APR-2014 the patient was inadvertently vaccinated with MMR II (lot # 0233AE, expiration date 26-JAN-2014) 0.5 ml, subcutaneously for unknown indication. No concomitant medications were reported. No adverse effects were reported. Additional information has been requested.
(L) arm developed a large square area that was red, swollen, itchy. Inside the wheal itself was a knot. Measurements of square approx: 14x14cm - Knot 3x4cm.
WITH IN 8 HOURS OF 2ND INJECTION I BECAME VERY ILL. I WAS VERY ILL FOR 4 DAYS.  EVEN AFTER THE FOUR DAYS OF BEING ILL I HAD NO ENERGY MY BLOOD PRESSURE WAS EXTREMELY HIGH. I WENT TO THE DR AND MY BLOOD PRESSURE WAS STILL HIGH WHEN THEY TOOK IT THERE AS WELL.  THEN I GOT A RASH. WENT BACK TO THE DOCTOR AND SHE COMPARED WHAT I HAVE TO THE COVID RASH IT IS THE SAME ONLY THE RASH THAT PFIZER IS CALLING A RASH IS ACTUALLY SHINGLES. i AM NOW TAKING MEDICATION FOR SHINGLES OR COVID RASH AS PFIZER CALLS IT.
Flu; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA (Flu) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Concurrent medical conditions included Cancer (the patient was recovering from cancer).    On an unknown date, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA (Flu). At the time of the report, INFLUENZA (Flu) had resolved.            Concomitant product use was not provided by the reporter. The patient had a tiny bruise at the injection site after her first 2 shots. She had a mild case of the flu for 14 hours after the first booster.  The patient did not take any medications to help with symptoms.   This case was linked to MOD-2022-651191 (Patient Link).   Reporter did not allow further contact
Sore arm, temperature off 100.5, weak, unable to walk, severe headaches, chills, sweating, aching in muscles.
numbness, tingling, aching, weakness @ arm from back of deltoid & swelling to tip of fingers;
A nonserious report of expired FluMist administered has been received from a nurse concerning a teenage female. No medical history nor concomitant medications were provided. The patient, her mother, and her two teenage sibling resolved FluMist on 27-Dec-2007. The expiration date on the FluMist was 25-Dec-2007. No adverse event was report at the time of the report nor as of 21-Feb-2008 when the reporter was contacted for follow-up. The event was resolved on 27-Dec-2007. The reporter was provided information regarding additional dosing of the product when a patient is inadvertently administered product after the expiration date. The reporter provided no causality assessment for the event. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. This case is liked to the cases for the patient's mother and two teenage siblings who also received expired FluMist: MEDI-0006351; MEDI-0006352; MEDI-0006354. Additional information received on 21-Feb-2008 and incorporated into the narrative: No adverse event experienced.
Patient is 77 years old with past medical history of COPD, atrial flutter, hypertension, hyperlipidemia, diabetes mellitus, asthma, chronic respiratory failure presented to the hospital with a chief complaint of shortness of breath associated with cough, reduced appetite, fatigue and malaise.  Admits to mild nausea intermittently.  Patient was recently in the ER and attempt to treated outpatient has failed.  He noticed worsening of his symptoms.  And he returned back.  Otherwise patient has no fever, chills, abdominal pain, diarrhea, constipation, difficulty urination, dysuria   In the ED, patient was noted to have elevated troponin.  Cardiology was consulted and an echocardiogram was done.  From cardiology the elevated troponin is likely due to the COVID infection.  Patient had a CTA done which was negative for pulmonary embolism.  CTA was significant for an infiltrate.  Patient was initiated on broad-spectrum hospital-acquired antibiotic.  Venous ABG was done with a PCO2 of 53.  Patient was noted to have hyponatremia and hypokalemia on labs.  HPI per admitting hospitalist.      Clinical Summary   Clinical course Include/ Problem list Acute on chronic hypoxic and hypercapnic respiratory failure Covid-19 -Continue supplemental oxygen -Paxlovid stopped on admission -Continue IV remdesivir (final dose scheduled for 1/18) -Continue IV dexamethasone -Continue albuterol inhaler scheduled and as needed -Continue Spiriva -Continue twice daily Mucinex, twice daily vitamin C, daily vitamin D and zinc -Pulmonology consulted and following   Postobstructive pneumonia -Associated with hilar mass -Continue Zosyn and azithromycin -- >per pulmonology: plan for 2 weeks Augmentin unless cultures indicate otherwise  -Pulmonology consulted and following   Acute exacerbation of COPD, Emphysema -Secondary to above -Continue plan as above   Moderate acute hyponatremia POA -Improving  -Na 135 (on presentation 120) -Continue to monitor   Elevated troponin, likely type II NSTEMI -No chest pain -Cardiology consulted while patient was in the ER  -EKG on admission shows normal sinus rhythm with nonspecific T wave changes -No regional wall motion abnormalities on echocardiogram -Secondary to acute illness as above -Maintained on Eliquis -no abnormalities noted on telemetry  Leukocytosis -likely 2/2 steroids -WBC 13.32  -afebrile -continue to monitor    Transaminitis -improving -Secondary to acute illness vs Paxlovid? -AST 38, ALT 76 -Normal alk phos, bili -Hepatitis panel: Negative  -GGT WNL -Daily CMP   Hilar mass, concern for metastasis vs second lung primary -Larger than prior, measuring 4.8 x 3.0 x 3.2 -Associated with new reticular nodule infiltrates within the left upper lobe, inflammatory versus neoplastic -Follows with Dr., concern for progression of disease -Pending PET scan; May need biopsy -Consulted pulmonology: delay any procedure for minimum 2 weeks d/t current Covid -follow-up with oncology and radiation as OP   Squamous cell carcinoma of the tongue -Follows with Dr., underwent chemo, radiation, and immunotherapy.
Patchy, erythematous rash left chest, bilateral groin, nontender.
R arm redness, swelling, warmth, oval 2 inches dark red center, 1 inch additional pink around. C/O painful arm. Light pink on 2/13, resolving.
This spontaneous report received from a pharmacist referred to a 71 year old female patient. The patient's medical history, concurrent conditions were not reported. Historical drug included PREVNAR 13 which taken on an unknown date in 2015. On 21-OCT-2016, the patient was vaccinated with influenza virus vaccine inactivated (unspecified) (FLU SHOT) and in the opposite arm the patient was vaccinated with PNEUMOVAX 23 (lot number: L027732, expiry date: 23-FEB-2017) (dose and route were not reported). The patient's arm that received PNEUMOVAX 23 had redness and swelling that extended to her back and a bruise under her arm that began 1 or 2 days after the injection that worsened after 3 to 4 days. The redness continued and was present a week ago. The patient also experienced pimples on her abdomen and the front of her legs that began on an unspecified date that improved with BENADRYL taken on unspecified dates. The patient went to an unspecified urgent care center on 23-OCT-2016. The event pimples was resolving. It was unknown of her present status or if she had recovered from the other events. Causality assessment was not reported. Follow up information was received on 09-JAN-2017 from a pharmacist who refers to a 71 year old female patient with a history of codeine allergy that causes hypertension. On 21-OCT-2016 at 10:40, the patient was vaccinated with PNEUMOVAX 23 (lot number: L027732), IM, right deltoid (dose not reported) and FLUCELVAX (lot # 185888, manufactured by Seginus) IM, left deltoid, yearly (dose not reported). The patient had no illness at the time of her vaccination. On 22-OCT-2016, the patient's right arm  that received PNEUMOVAX 23 became red, hot, swollen from elbow up to her shoulder and across part of her back. She also experienced a large bruise on her inner arm. Two weeks later, on 11-NOV-2016, the patient reported she went to her doctor last week and the doctor recommended she take ZYRTEC which she took for one week. The patient's symptoms resolved on 11-NOV-2016. This is one of the two reports received from the same reporter. Additional information has been requested.; Sender's Comments: MERCK 1611USA006698:Mfr number.
pneumonia; This case was reported by a consumer via interactive digital media and described the occurrence of pneumonia in a patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, unknown after receiving Flu vaccine, the patient experienced pneumonia (serious criteria GSK medically significant). Flu vaccine was discontinued. On an unknown date, the outcome of the pneumonia was unknown.   It was unknown if the reporter considered the pneumonia to be related to Flu vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The Flu shot give pneumonia to the patient 5 years in row. The patient never took it again and never had the flu. This case has been linked with case US2019AMR153058, reported by the same reporter.
Patient was sitting in Post vaccination clinic and asked if we could take his blood pressure because He has tinnitus and the ringing in his ear is a bit louder. Patient reports his normal blood pressure  is 135/85. RN took blood pressure 142/86, HR 72, rr 18. Pt reports he had a banana for  breakfast. Pt stated he was okay and just wanted to go back to work. Signed understanding that he should call his doctor or go to the ER if symptoms get worse. Left at approximately 10:55
Heavy sleeping period followed by high pitched screaming that lasted 2+ hours. Inconsolable.
13Nov89 pt vax 2nd hepta B; devel cough, face warm to touch. 14Nov89 pt exp warm feeling in face + itchy feeling in ears + throat, red blotches on face, neck + ears w/ facial flushing + slightly puffy appearance under eyes and lip. see worm
Early the next day after receiving injection her deltoid was swollen, hot to touch, knot @ injection site.  The knot went away and the hot feeling.  Swelling remains and has pain that comes & goes from shoulder to her neck.  Arm hurts with movement. Has seen Dr for pain in arm/neck. Last year the same thing happend on the other arm.  She made several visits to the doctor, was seen by bone & joint specialist, had physical therapy and MRI done last year.  No problem was found.  Pain lasted for 11 months.  Still has residual pain sometime with movement.  Last year she did not consider her flu shot as being the problem with her pain, but now it has happened again this year.  She has no known allergies to foods or drugs.
Pt had waited the requisite 15 minutes and was at the front of the store with her mom.  She felt "hot" and kind of slumped over .  She never lost consciousness. She was pale. Sat on floor. Drank water and seemed to be doing better. Mom took her home and will follow up with her pediatrician.
Has a very large, hard, hot spot on his shoulder. Bruise around injection site. Looks like injection has been trapped. Itches, red and swollen. The annual follow up received 7/14/03 states pt continues to suffer from autism spectrum disorder.
I am experiencing sore throat; I am experiencing fever; I am experiencing headache; I am experiencing chills; I am experiencing muscle ache; This spontaneous case was reported by a physician and describes the occurrence of PYREXIA (I am experiencing fever), HEADACHE (I am experiencing headache), CHILLS (I am experiencing chills), MYALGIA (I am experiencing muscle ache) and OROPHARYNGEAL PAIN (I am experiencing sore throat) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939905, 010M20A and 012L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021, the patient experienced PYREXIA (I am experiencing fever), HEADACHE (I am experiencing headache), CHILLS (I am experiencing chills), MYALGIA (I am experiencing muscle ache) and OROPHARYNGEAL PAIN (I am experiencing sore throat). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) for Adverse event, at an unspecified dose and frequency. At the time of the report, PYREXIA (I am experiencing fever), HEADACHE (I am experiencing headache), CHILLS (I am experiencing chills), MYALGIA (I am experiencing muscle ache) and OROPHARYNGEAL PAIN (I am experiencing sore throat) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. A physician called in to ask how long his side effects from the booster dose would last.
Momentary soreness in his arm; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Momentary soreness in his arm) in a 92-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Concussion (had  a couple of concussions (dates unknown).) and Surgery (had a couple of surgeries (dates unknown),). Concurrent medical conditions included Prostate cancer (prostate cancer (5 or 6 years ago)) and Drug allergy (patient has medication allergy to Tegretol (carbamazepine) and sulfa drugs).    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 02-Jan-2021, the patient experienced PAIN IN EXTREMITY (Momentary soreness in his arm). At the time of the report, PAIN IN EXTREMITY (Momentary soreness in his arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications included anti-hormonal medication once a day (unknown name) for prostate cancer.  The patient had no lasting muscle soreness.   No treatment information was provided.  Company comment: 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.; Reporter'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.