chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Left arm swollen, very red from shoulder to elbow, extreme pain in whole arm, swelling caused an indent at injection site but no open area. This started on the following morning after the injection. These symptoms lasted through Tuesday, December 18th, then it began to resolve with less swelling and redness. Pain decreased then, but arm is still sore to touch in the area of the injection.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021 at 4:03 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 4:03 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 40.76.  Concomitant products were not provided.  On 20-Mar-2021, Excursion time was 09 AM and 10 AM, with temperature as 34, and 37 respectively. Total doses given for the day was 184 for 9AM vials. Condition of vaccine prior to administration was not frozen. 9 AM vaccine was moved to fridge on 09-Mar-2021 and. Vial was moved to clinic on 20-Mar-2021. 19 vials from 9 AM were sent to clinic. Vaccine BUD date was 08-Apr-2021 for 9AM.  On 20-Mar-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: Not provided, 9 AM: 34, 10 AM: 30, 11 AM: 41, 12 AM: 45, 1PM: 44, 2 PM: 44, 3 PM: 44, and 4 PM: 44 and 5 PM: 43.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported
I am feeling feverish now; 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 PYREXIA (I am feeling feverish now) 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 PYREXIA (I am feeling feverish now). At the time of the report, PYREXIA (I am feeling feverish now) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
A 13-year-old patient was given a Pfizer booster vaccination. His father, notified via cell phone, stated he was at work and requested the patient's mother be called. Unable to reach the mother. Voicemail message left for the mother with instructions to report any adverse effects and to call this clinician with any questions.
The pt experienced swelling, pink, hot to the touch, and a hard mass to the left arm injection site.
22mins post vaccination pt reported tightness in the chest, Resp distress/SOB. Vitals: 98/70, 77, 16 Pt was assessed by NP, noted to be alert and verbal.  Symptoms resolved and pt was cleared to go home.  Pt stable and released from the vaccination site.
Arthus Type Reaction - erythema, induration, pain, thoughout upper arm.
red mark at the injection site that's about 6 inches long; felt like somebody grabbed me in the chest; I started pouring sweat; I could hardly catch my breath; Arm was sore at the injection site; A spontaneous report  was received from a Consumer concerning a 87 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events- chest discomfort, hyperhidrosis, dyspnea, vaccination site pain and vaccination site erythema.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 16/Jan/2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 011J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 16 Jan 2021, the patient experienced that her arm was sore at the injection site that night. She also reported that on Tuesday night (02Feb2021), she bent over to pick something up and had a cardiac episode. She describes it as if "somebody grabbed me in the chest and I started pouring sweat, and I could hardly catch my breath." She reported 2 such episodes that same evening (02Feb2021). She also reported that she currently has a red mark at the injection site that's about 6 inches long (4 Feb 2021)  Laboratory details were not provided.  No treatment information was provided. The patient did not go to the hospital, but did inform her doctor and set an appointment.    Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the events- chest discomfort, hyperhidrosis, dyspnoea, vaccination site pain and vaccination site erythema was considered unknown.; Reporter's Comments: This case concerns a 87 Years-old, female patient who experienced events of chest discomfort, hyperhidrosis, dyspnea,  vaccination site pain and vaccination site erythema. 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.  Further information has been requested.
Information has been received from a physician concerning a 5 yr old male who on 20Sep99 was vaccinated with a dose of varicella virus vaccine live. On 24Aug04 the pt presented with breakthrough chickenpox, less than fifty lesions were noted. There was no product quality complaint involved. The reporter indicated that the pt's sister (WAES0409USA00192) had a similar experience following exposure to varicella virus vaccine live. Additional information has been requested.
This is a spontaneous report from a contactable consumer. A 58-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8737 and expiry date: unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 04Apr2021 as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. Time the Vaccination Was Given: about 3-4pm. Patient's medical history included herpes zoster since 10 years ago and takes immunosuppression medication. The patient reports he takes medications and he doesn't want to list all of them. The patient experienced shingles (when he got in the shower), pain on 18Apr2021, felt pain on his shoulders (after 2 weeks), headache (which he states is pretty common) and reddish spots on an unknown date. He takes an immunosuppression medication and it may have triggered the shingles. He mentioned the word immunosuppressed. When attempting to clarify if he was immunosuppressed he said, his immune system is weak. The patient shingles is very close to the injection point, almost the same spot as where he received the injection. Consumer wants to know if he can proceed with receiving the 2nd dose even if he has not fully recovered from his shingles yet and asks if he can receive the second dose beyond the 21 days. He reports he did not get diagnosed by a doctor but he feels strongly that shingles is what it is based on the symptoms. Clinical course of events includes; e reports 3-4 days later maybe about the 22nd or 23rd the pain started to go away and now he has no pain, reddish spots were gradually getting smaller. When asked if he had any treatment caller reports he did have a video appointment with a provider and they wanted him to take antiviral medicine and he did not take the medicine. He stated if it was on his whole back or something dramatic like that but it improved and he has no pain now, so he decided not to take medicine. He can tolerate it and it did not cause him too much of a problem. He did note that he works 12 hours a day and he is pretty healthy and has no other effect. Upon follow-up; it was reported that; the patient who was administered the first dose of Pfizer Covid-19 Vaccination and 14 days after that dose developed shingles. There is no evidence of whether the shingles is or is not related to the Pfizer COVID-19 Vaccination he is not sure if it is related. He is due to have the second dose of Pfizer COVID-19 Vaccination but he is not 100% cured of shingles, he can still see spots there. He called to ask should he wait a little time to get the second Pfizer COVID-19 Vaccination relative to shingles.The outcome of the event shingles was recovering, pain was recovered on an unknown date in Apr2021 and felt pain on his shoulders was unknown, reddish spots was not recovered. Patient: Sex: Patient referred to as male during this report but sex not verified with caller who was unwilling to complete report. No Follow-up attempts are needed. No further information is expected.
Her neck  swollen 5 days/ neck was swollen; She had pain/ pain; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 16-Feb-2021 and was forwarded to Moderna on 16-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Her neck  swollen 5 days/ neck was swollen) and PAIN (She had pain/ pain) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced SWELLING (Her neck  swollen 5 days/ neck was swollen) and PAIN (She had pain/ pain). At the time of the report, SWELLING (Her neck  swollen 5 days/ neck was swollen) and PAIN (She had pain/ pain) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant product use was not provided.  Treatment information was not provided.   This case was linked to MOD-2021-015272 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Follow up included NNI
arthritis worsened; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (arthritis worsened) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A20A and 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis (suffering with arthritis for 5 or 6 years.). Concomitant products included ABATACEPT (ORENCIA) and GOLIMUMAB (SIMPONI) for Arthritis.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, 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 experienced ARTHRITIS (arthritis worsened). The patient was treated with METHOTREXATE for Arthritis aggravated, at a dose of UNK (4 pills once a week). At the time of the report, ARTHRITIS (arthritis worsened) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: low (Low) Low.         She stated that on 12-May-2021, her doctor told her that her antibodies were very low, stated it may be because of the medications. She also stated that methotrexate is a cancer drug but also was found that it's useful for people with arthritis. She has been taking a biological infusion for her arthritis once a month for the last 4 years in which Orencia was the first one she used and Simponi was the second one.
Both thighs swollen and tender to touch and pt refuses to ambulate for 3 days along with fever and vomiting once.
anemic; This spontaneous case was reported by a consumer and describes the occurrence of ANAEMIA (anemic) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 027L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, the patient experienced ANAEMIA (anemic) (seriousness criterion hospitalization). The patient was hospitalized on 05-Nov-2021 due to ANAEMIA. At the time of the report, ANAEMIA (anemic) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       For mRNA-1273 (COVID 19 Vaccine) (unknown route), the reporter did not provide any causality assessments.  Concomitant medication was not provided.  The patient had 2 pints of blood, all kinds of blood, blood cells, as reported. The patient was wondering if she can get the booster because patient was in the hospital.  Company comment:  This case concerns a 57-year-old female patient with no medical history provided, who experienced serious unexpected event of Anaemia which required hospitalization. The event occurred approximately 9 months after the patient had received the second dose and nearly 10 months after the first dose of the mRNA-1273 vaccine. It was stated that the patient was in hospital and had two pints of blood (all kinds of blood, blood cells, as reported). The outcome of the event was unknown at the time of the report. The re-challenge is not applicable having in mind that the outcome of the event remained unknown and it also remained unknown whether the patient will receive the third (booster) dose or not. Very limited information regarding the event was provided at this point. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 57-year-old female patient with no medical history provided, who experienced serious unexpected event of Anaemia which required hospitalization. The event occurred approximately 9 months after the patient had received the second dose and nearly 10 months after the first dose of the mRNA-1273 vaccine. It was stated that the patient was in hospital and had two pints of blood (all kinds of blood, blood cells, as reported). The outcome of the event was unknown at the time of the report. The re-challenge is not applicable having in mind that the outcome of the event remained unknown and it also remained unknown whether the patient will receive the third (booster) dose or not. Very limited information regarding the event was provided at this point. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
After I received the vaccine, I had pain, aches and burning in the right shoulder. I massaged my arm to help with the discomfort. I went to my doctor and was referred to physical therapy. I believe the physical therapy has helped. I believe the injection was done incorrectly.
patient has developed swelling on the inner left arm toward the elbow; patient has developed redness on the inner left arm toward the elbow; Initial information was received on 21-Sep-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to case 2023SA291630 (CLUSTER).  This case involves 71 years old male patient has developed swelling on the inner left arm toward the elbow and patient has developed redness on the inner left arm toward the elbow after receiving influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant vaccines administered.  On 19-Sep-2023, the patient received a dose of 0.7 ml of suspect influenza quadrival A-B high dose HV vaccine (Frequency : Total, lot U8130DA, strength, expiry date, formulation unknown) via intramuscular route in the left deltoid for Immunization.  On 21-Sep-2023 the patient developed swelling on the inner left arm toward the elbow (peripheral swelling) and developed redness on the inner left arm toward the elbow (erythema) (latency : 2 days) following the administration of influenza quadrival A-B high dose HV vaccine.  Reportedly "The reaction is on the same arm that the vaccine was given, but not technically at the injection site, but it is above the elbow on the same arm. A husband and wife have reported the same reaction. Patient has not experienced any fever."  Action taken with quadrivalent influenza vaccine (fluzone high-dose quadrivalent) was not applicable.  It was not reported if the patient received a corrective treatment for the events (patient has developed swelling on the inner left arm toward the elbow, patient has developed redness on the inner left arm toward the elbow).  At time of reporting, the outcome was Not Recovered for the events patient has developed swelling on the inner left arm toward the elbow and patient has developed redness on the inner left arm toward the elbow.
brieflysevere muscle pain approx  15 hrs later; following day[day #1] severe headache, nausea, chills, low grade fever, fatigue; #2-intermittent headache, loose stools x3, nausea, fatigue; #3- nausea, loose stool x2; fatigue; slight intermittent headache; #4- nausea , weakness; #4- better with some hives at injection site and upper arm
She received Moderna COVID vaccines: the first dose on 4/7/21, the second dose on 5/5/2021, and the third dose on 01/12/2022. She presented to the ED with generalized weakness and nausea on 5/20.. She also noted her sons who lived with her were also sick. She was tested positive covid and hospitalized on the same day. She received steroids, Azithromycin, and Rocephin. She was discharged home with stable condition on 5/22/22.
there was no adverse event.  Patient was given the MCV and he did not need one.  he was watched for 20 min with no side effects noted.
Patient approached this RN and reports feeling dizzy, lightheaded, and headache. Assisted patient to gurney. Instructed patient to remove mask. Gave patient water and Gatorade. Vital signs at 1410: BP 121/82, P 74, O2 99%.  Patient reports having a baby 8 months ago. After about 23 minutes patient reports feeling back to baseline. Provided extensive education  on vaccine side effects and anaphylaxis. Instructed patient to call PCP, urgent care, or ER with any questions or concerns. Informed patient of symptoms that warranted 911. Patient reports understanding.
Severe swelling, redness & itching requiring several days treatment with BENADRYL & CLARITIN.
The patient complained of chest pain, increased heart rate (130), BA, fatigue.  Advised to seek treatment/ED for chest pain
At 12 days after the vaccine - I developed persistent itching, and rashes that would appear all over my body that would come and go. Also, breathing issues, increased stomach pain and indigestion, lip angioedema, and overall lung spasms.  Visited Urgent Care 2x in a 3 week period and was placed on two rounds of steroids, and 2 steroid injections, but the itching and breathing problems persist. On 3/9/23 visited an allergist who diagnosed me with urticaria demographia and moderate asthma. Placed on antihistamine meds (both morning and evenings), along with prilosec for stomach. Still currently on all meds, and still experiencing these symptoms as of today, 3/15, 40 days post vaccine. I see many people are experiencing very similar symptoms with urticaria.
Arm painful at injection site, later became sl swollen, sl redness extending to elbow. Pain, swelling redness persisted until 2/20, then gradually resolved. No fever.
She received her first COVID19 (Pfizer-BioNTech) vaccination 2/26/2021. She received her 2nd dose 3/20/2021. She received her booster shot on 11/27/2021.  Prior to receiving her 1st Covid vaccine, she was able to do most things by herself. She could walk, talk, eat, do light house cleaning, bath. Since receiving the vaccines she has declined DRASTICALLY and after getting the "booster" she know needs 100% help getting to the bathroom, walking, eating and such. She can't even sit up in her chair and now needs a wheelchair.
Vaccine administered to patients after 32 days in the refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine administered to patients after 32 days in the refrigerator) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jun-2021 at 8:34 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine administered to patients after 32 days in the refrigerator). At the time of the report, PRODUCT STORAGE ERROR (Vaccine administered to patients after 32 days in the refrigerator) outcome was unknown.        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.   no concomitant medications were reported. no treatment medications were reported.
Was in car seat on the way home from doctor office & sibling noted shaking movements. Mom stopped car & found baby shaking & eyes rolling & then became limp & unresponsive. Physician office nearby saw baby in office & gave EPIPEN JR. Transferred to Hosp ER - by squad. Was more alert in ER but refused to walk. Admitted for observation. Temp in ER 104 degrees & 102.6 after event. Was improved in AM & discharged & is fine 4 days later. Suspect febrile seizure.
Received second shingrex vaccine August 15, 2019. Had fever chills and shakes through the night. Tingles in left arm stayed with me. September 9, 2019 I was prescribed Amlodipine because my blood pressure was 199/124. Tingling in left arm continued. September 12, 2019 went to emergency room because tingling in other arm and left leg heading up to my neck and jaw. I had shooting pains in chest and right abdominal. I was kept overnight for a nuclear stress test. Test didn't show any severe blockage. I was prescribed Gabapentin for shingles symptoms and discharge.
first seizure onset about 23 minutes after vaccination and lasted for 2 minutes, pt recovered then went into another seizure at 11:03 for 2 minutes. pt was given epi-pen and Benadryl following second seizure and recovered afterwards
The patient broke out with chicken pox six days after receiving the vaccination. The mother states the patient had both internal and external lesions. The mothers states the patient was "covered" with lesions.