chrisvoncsefalvay/vaers-outcomes huggingface dataset:
all over super soreness; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (all over super soreness) and PYREXIA (fever) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Apr-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 28-Apr-2021, the patient experienced PAIN (all over super soreness) and PYREXIA (fever). At the time of the report, PAIN (all over super soreness) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided No Treatment information provided
The patient reported that she is experiencing a flare-up and that her arm is being affected/affects of Rheumatoid Arthritis.; This is a solicited report from a non-Pfizer sponsored program (marketing program name not available) from a contactable consumer, based on information received by Pfizer from Amgen (manufacturer control number: US-AMGEN-USASL2021113064), license party for etanercept (ENBREL).  This serious solicited report was reported to Amgen on 21/JUL/2021 by a consumer from a commercial program and involves a 48 year old female patient who experienced a flare-up and that her arm is being affected/affects of rheumatoid arthritis [PT: rheumatoid arthritis] while receiving Enbrel. No historical medical condition was reported. No current medical condition was reported. No concomitant medications were provided. No co-suspect medications were reported. The patient began Enbrel on an unknown date. On a unknown date, the patient had a flare-up and that her arm was affected. Advised that when she took the Covid shot she began feeling the affects of rheumatoid arthritis. No treatment information was received. The outcome of the event rheumatoid arthritis was reported as unknown. Action taken with Enbrel was reported as unknown for the event rheumatoid arthritis. The causal relationship between the event rheumatoid arthritis and Enbrel was not provided by the consumer. The reporter did not and would never have access to lot number. The reporter declined consent for follow up. No follow up attempts are possible. No further information is expected.  Amgen comments: This individual case report does not change the safety profile of the product.  The reporter's assessment of the causal relationship of the event with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.   Amgen's Causality Assessment:  The event rheumatoid arthritis  was assessed as unrelated to etanercept by Amgen.   The reporter's assessment of rheumatoid arthritis with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.; Sender's Comments: Based on the information provided, the event "The patient reported that she is experiencing a flare-up and that her arm is being affected/affects of Rheumatoid Arthritis" is unrelated to the use of suspect product etanercept and BNT162B2 and is likely to be an intercurrent event in this 48 year old female patient. This case will be reassessed should additional information become available.
FELT SICK/FEELING UNWELL; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. 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, batch number: Unk) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced felt sick/feeling unwell. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of felt sick/feeling unwell was not reported. This report was non-serious.
my face is swollen, specifically in cheeks and nasolabial fold; can feel kind of protruding out; Temperature was 100.9 / fever; Chills; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284) solution for injection, via an unspecified route of administration on 14Jan2021 15:45 at a single dose for Covid-19 immunization. The patient medical history was not reported. Concomitant medications included vitamin C [ascorbic acid] (VITAMIN C [ASCORBIC ACID]), and zinc. Patient reported she got the vaccine on Thursday (14Jan2021) around "15:45" (not clarified) and she came home yesterday, and on 15Jan2021 had just like fever, chills and like "slightly high" (not clarified) temperature it was 100.9, so she took some Tylenol, took some Benadryl last night, went to bed, and then woke up this morning (16Jan2021) and her face was very swollen. Specifically, in her cheeks and then kind of her nasolabial fold, she do have a history of  fillers but the last time she got fillers done with, probably 7 months ago. She was not having any difficulty breathing or shortness of breath, but it was just really swollen and like she can feel it like it was kind of protruding out. Right now she doesn't have any fever or chills, that was just yesterday. Right now, her temperature was normal 98.4. The last time she took the Tylenol and Benadryl was last night. She has not taken anything this morning. Outcome of the event face is swollen was unknown while the outcome of the other events was recovered.  No follow-up activities are needed. No further information is expected.
At 11:50 am (1 hour and 50 minutes) after receiving the shot my eyes started swelling.  I took a Benadryl immediately which relieved some of the swelling.  At approximately 9:30 p.m. I noticed a rash on my left cheek which was gone by the following morning.
Right arm erythematous and warm to touch. Redness noted to elbow joint. Afebrile.
Patient was anxious and scared "worked up" prior to vaccine per mom. The patient received Pfizer vaccine at 3pm and at the vaccine table he was verbalizing he was scared,nervous and his hands were cold and clammy, he felt dizzy. He sat at the vaccinator table and we gave him water and crackers, VS 2:57 BP 129/70, HR 78, O2sat 1005. VS 2:58pm 129/80, HR 78, O2sat 98%. VS 3:01pm BP 125/69, HR 70, O2sat 100%.Patient taken to observation area,stated feeling better, walked without feeling dizzy and continued monitoring VS 3:03pm. BP 123/64, HR 68, O2sat 100%. 3:06pm eating cookie VS BP 122/69, HR 64, O2sat 100%. 3:12pm VS BP122/64, HR 60 and sat 100%. Patient stating feeling better, not lightheaded or dizzy. VS 3:16pm BP 124/62, HR 58 and O2sat 100%. Patient left at 3:20 with mom "feeling good".
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion; Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion) in a 24-year-old male 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  The reporter reported that because their facility had not been able to download the digital data logger, they had been put on hold by the local Health Authority at the moment and could not administer the Moderna COVID-19 vaccine to patients until an assessment by the local Health Authority was made. There had been no power outages that would have impacted the Moderna vaccine. However, the reporter reiterated that because the facility was unable to download the digital data logger, this issue was treated as a temperature excursion. The reporter was unable to download the data logger for the months of December 2021, January 2022 and February 2022. The reporter was filling out a temperature excursion assessment with the local Health Authority.   The reporter mentioned that the patient had been administered dose while the temperature excursion assessment was ongoing. The reporter also reported that, no adverse reactions were reported by the patient.  No treatment information was provided by the reporter.
COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on JUN-2021 for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On NOV-2021, the patient experienced covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from covid-19 infection. This report was non-serious. This report was associated with a product quality complaint :90000207823.
EXPIRED IMMUNIZATION GIVEN TO PATIENT EXPIRED 02/09/2021 GAVE TO PATIENT ON 02/11/21
Developed a temperature of 103 on the evening of 4/28/00, with muscle spasms in legs and arms, weakness and dizzy. Mother call physician and treated pt with Motrin and Benadryl. He continued to have temperature until 4/30/00. Spoke to mother on 5/1/00 and child is afebrile.
Symptoms include increased heart rate through out the day without excessive exercise accompanied by shortness of breath.  Separate incidences of blurred vision not corrected by prescription lenses.    Ongoing since May of 2021.
Enlarged lymph nodes on left side pushed enlarged lymph nodes on right side sitting on a nerve, causing pain in jaw and collar bone area. Sent to ER for potential blood clot. Doppler came back negative for blood clot but came back with a mass in left side of neck which prompted two CT scans with contrast that were concern for malignancy. Surgical thoracic biopsy was scheduled confirming HODGKINS LYMPHOMA. Pet scan followed for staging followed by Bone Marrow biopsy. Three opinions led to treatment for surgical port insertion and currently in chemotherapy.
ACUTE HYPOXEMIC RESPIRATORY FAILURE CHRONIC HYPOXEMIC RESPIRATORY FAILURE HYPOXIA 12/3/2022 -- RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Patient felt tired and cold at work today. When she arrived home, she took her temperature. She had a fever of 101.8 degrees. Suggested treatment: rest, TYLENOL and to contact doctor if fever persists or increases.
Pt. noticed fluid filled blisters (yellow) the morning of 9/19/12 around the shot, uncomfortable. Fever and nausea. Physician ordered culture. IM inj. of Lincocin and Clindamycin, Rx Bactroban oint.
This spontaneous case was reported by a consumer and describes the occurrence of BRUXISM (Teeth was shattering), TREMOR (Could not stop shaking), PAIN IN EXTREMITY (Sore arm), GAIT DISTURBANCE (Could not walk across the room) and SOMNOLENCE (Could not stay awake) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036C21A and 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced VACCINATION SITE REACTION (COVID arm), VACCINATION SITE PRURITUS (Itchy at the injection site all the way to the elbow), VACCINATION SITE SWELLING (Swollen at the injection site all the way to the elbow) and VACCINATION SITE ERYTHEMA (Red at the injection site all the way to the elbow). On an unknown date, the patient experienced BRUXISM (Teeth was shattering), TREMOR (Could  not stop shaking), PAIN IN EXTREMITY (Sore arm), GAIT DISTURBANCE (Could not walk across the room), SOMNOLENCE (Could not stay awake), HYPOAESTHESIA (Part of the face was numb), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Mild aches/body hurt so/aches from the top of her head all the way to her toes she had pain/Aches all over the body), HEADACHE (Headaches), NAUSEA (Nausea) and FATIGUE (Exhausted). At the time of the report, BRUXISM (Teeth was shattering), TREMOR (Could  not stop shaking), PAIN IN EXTREMITY (Sore arm), GAIT DISTURBANCE (Could not walk across the room), SOMNOLENCE (Could not stay awake), HYPOAESTHESIA (Part of the face was numb), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Mild aches/body hurt so/aches from the top of her head all the way to her toes she had pain/Aches all over the body), HEADACHE (Headaches), NAUSEA (Nausea) and FATIGUE (Exhausted) outcome was unknown and VACCINATION SITE REACTION (COVID arm), VACCINATION SITE PRURITUS (Itchy at the injection site all the way to the elbow), VACCINATION SITE SWELLING (Swollen at the injection site all the way to the elbow) and VACCINATION SITE ERYTHEMA (Red at the injection site all the way to the elbow) had resolved. After the second dose The patient had COVID arm and it was itchy, red, and swollen which started at the injection site all the way to the elbow. She stated it "started maybe 5 days after the shot and lasted maybe a week or more". The left side of her face felt same as if it was wearing off and it lasted for 3 days. No concomitant medication were reported. No treatment medication were reported. Patient received the booster shot on 16 DEC 2021, the lot number is 032H21A. This case was linked to MOD-2021-420873 (Patient Link).
About four days after I received my 2nd Pfizer vaccine shot, I developed severe dark, red, puffy under eyes. There was a stinging sensation and I experienced great discomfort. I am on day four and the swelling/redness has gone down, but my under eyes are still very dry and raw.
Initial information received on 06-Dec-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 67 years old male patient who received vaccines ADACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included FLUZONE HIGH DOSE for Immunisation. On an unknown date, the patient received 0.5 mL dose of suspect ADACEL lot U6128AA, expiry date: 20-NOV-2020 in the right arm. On an unknown date, the patient received 0.5 mL dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT lot U6014AB, expiry date: 20-JUL-2020 via intramuscular route in the right deltoid. It was a case of actual medication error due to extra dose administered. It was reported that 67 years old male who received ADACEL & TENIVAC vaccination due to a misunderstanding by the MA for routine Tetanus and Diphtheria vaccination. Both were given in the same arm. It was unknown if any adverse event was occurred. 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 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. Documents held by sender: none.
Patient 10 minutes after the vaccine reported feeling flush and itching all over.   Patient was taken to onsite Paramedic who checked out the patient.  Patient vital normal, no redness, sweating, issue with breathing observed.   Patient had normal O2 sat.   Patient state breathing was normal.   Patient continue to report itching.   Patient observed for 30 minutes continued to have itching but refused further medical care.   Went home to husband and will monitor.
other zoster-related conditions; shingles; Information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown age and gender. No information about the pt's medical history, concurrent conditions or concomitant medications was provided. On an unknown date in 2014, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided), as prescribed and/or administered by a pharmacist at a pharmacy for the long-term prevention of shingles and zoster-related conditions. On unknown dates, subsequent to the pt's zoster vaccine live (ZOSTAVAX) use, the pt was treated by healthcare providers at a family health center for shingles, and other zoster-related conditions. As a direct and proximate result of the pt's zoster vaccine live (ZOSTAVAX) use, the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the events was considered to be not recovered/not resolved. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
11/24/09 at 9:00 am student presented to school medical room with cough, sore throat. Oral temp. 102.2. Notified parent. Referred to follow up with HCP referral 125 issued.
Symptom began in the late afternoon (around 4:30p/5:00pm) on day of injection.  Arm began hurting, though not specifically at injection site.  Entire deltoid was swollen.  Shoulder movement was significantly restricted and shoulder rotation could not occur.  No force could be used with arm at all.  Fingers on right hand were tingly and lost some feeling.  I was unable to get clothes on/off and was unable to use shifter in car.
Starting the day after immunization, pt had temp of ~100, chills, body aches, a rash at injection site that was warm and ~2-3 inches in diameter, she reported no fever today when she reported ae to me. Patient was counselled on common side effects of immunization and told to take tylenol or ibuprofen for pain and report to a physician for evaluation of possible infection at injection site.
Patient presented to the ER for progressively worsening cough, congestion and shortness of breath as well as generalized weakness for the past 2-3 days. evaluated in the ED.  Tested positive for COVID.  Also noted be having urinary tract infection.  Patient diagnosed with generalized weakness secondary to UTI and COVID-19.  Patient is admitted for further management. Patient was placed on empiric antibiotic therapy with Rocephin.  Also placed on empiric dexamethasone for COVID-19. Patient was a DNR. Patient was found by PCT with no pulse or respirations in room. Patient was pronounced deceased.
On the vaccinated arm, between the elbow and deltoid-patient experienced a large red, warm to touch area followed by a bruise for over 1 week.
2 mL were given to patient instead of .8mL.Patient's mom denies patient is having any adverse effects.
PREMATURE VENTRICULAR CONTRACTIONS (PVCS); FLU LIKE SYMPTOMS; This spontaneous report received from a parent concerned an 18 year old male. The patient's weight was 135 pounds, and height was 154.94 centimeter. The patient's concurrent conditions included: non alcohol user, and non smoker, and other pre-existing medical conditions included: Patient reported no history of injuries and surgeries. No known drug allergies reported. No drug abuse or illicit usage reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the patient experienced flu like symptoms. On 31-JUL-2021, the patient experienced premature ventricular contractions (pvcs). On AUG-2021, Laboratory data included: Laboratory test interference NOS (NR: not provided) Negative. On 02-AUG-2021, Laboratory data included: Electrocardiogram (NR: not provided) PVC (Premature ventricular contraction). On 03-AUG-2021, Laboratory data included: Blood test (NR: not provided) Not reported, and Electrocardiogram (NR: not provided) PVC (Premature ventricular contraction). On 11-AUG-2021, Laboratory data included: Electrocardiogram (NR: not provided) PVC (Premature ventricular contraction). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms, and had not recovered from premature ventricular contractions (pvcs). This report was non-serious.
Starting at around 1pm, I started to have severe chest pain on the left. I am still having pain now at 10:40pm.
The patient was given a COVID Pfizer Bivalent vaccine as a first dose of the primary series instead of a monovalent COVID vaccine.
Onset increased head bobbing, arms legs shaking lasts 30-60 sec. No v/d/F/decreased appetite/crying. Parent states increase movement cleared by 2 wks. later. Evaluated at Hospital for poss. infantile spasms 4/12/13. Neg EEG. Mom did not make F up neurology appointment.
Hospitalized for acute hypoxemic respiratory failure, COVID19 11/29/21-12/10/21. Treated with dexamethasone IV and Remdesivir. Discharged to hospice.
Paresthesia and hypersensitivity to skin on L side of face/neck. No overlying rash. neuro exam grossly intact
This spontaneous report as received from a pharmacist via another pharmacist refers to a patient (age and gender unspecified). Patients medical history was unspecified. On 30-JAN-2014, the patient was inadvertently vaccinated with expiry dose of PNEUMOVAX 23 vial, (Lot number 672962/0025AE, expiry date 18-OCT-2013), 0.5 ml, intramuscular. Concomitant therapy was unspecified. No adverse effect was reported. No product quality complaint involved. No further information was provided. Additional information has been requested.