chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 11:03 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 11:03 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) 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 32.61.  No concomitant medications were reported.  Batch number 044B21A underwent temperature excursion on 15-April-2021 with temperature 34 degrees Fahrenheit from 09:00 AM. This vial was moved to fridge on 06-April-2021 and beyond use date for the vial was reported as 09-May-2021. Product moved to clinic on 15-April-2021.  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).
At site of injection, large red area, hot and itchy, the next morning had pain in armpit area that radiated to the breast area.  Could not lay my arm down to my side due to pain. Could no sleep on my side due to pain. The extreme pain continued for two more days, missed work one day. Aleve did not relieve the pain, moist heat did help.
Pt received both FLUZONE QUAD and PREVNAR 13 in left deltoid 2-7-19. Patient says never reacted to flu shot in past so thinks might be PREVNAR 13. Area below injection site became pink, swollen, and warm 2 days after receiving shot (was not yet swollen when received SHINGRIX the day after, in apposite arm) was able to golf and was not concerned enough to call/see MD. It is "going down" and improving. No injection site pain or swelling.
The caller took their regular blood pressure medicine yesterday. After taking the medicine, she had horrible nightmares.; This is a spontaneous report from a Pfizer-sponsored program. A unspecified year-old contactable female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number, Expiration date: unknown) via an unspecified route of administration on unspecified date at single dose for COVID-19 Immunization. The medical history and concomitant medication were not reported. The caller took their regular blood pressure medicine yesterday. After taking the medicine, patient had horrible nightmares. The patient asked what medicines she could take and medicines that they should not take moving forward. The outcome of the event was unknown.  Follow-up activities have been completed and lot/batch number has been requested.
Given Td/Influenza (same syringe)on 11/6, already had flu like symptoms at time of vacination. 11/9 showed increased signs of flu like symptoms, pain in neck and chest. 11/10 began vomiting, complained of chest pain rapid heart beat, had fever. 11/11 was given antibiotics at job corp center and sent home w/complaints of chest pain and coughing up green and black "stuff". Continued to vomit thru 11/12, had appointment to go to private doctor on 11/13. 11/13 0500 am collapsed. Taken to emergency room. BP low and continued to decrease. Showed enlarged heart and liver, kidneys shutting down. Dignosed with myocarditus, inflamation of heart muscle. Placed on ventilator for three days. Survived illness at this point heart functioning at 30%. Continued treatment indefinite at this point in time.
Headache began approximately 8 hours after injection accompanied by fatigue, general malaise, and mild body aches. Left arm began to hurt approximately 10 hours after injection. Left arm became red and hot to the touch between shoulder and bicep approximately 14 hours after injection. The general malaise and mild body aches continued for approximately 72 hours. Left arm redness and heat increased quickly from hour 14 through hour 19, continued at that level until approximately 72 hours after injection, and then gradually decreased until approximately 96 hours after injection. Left arm pain increased steadily for the first 72 hours, but continued gradually decreasing until approximately 144 hours after injection. The headache and fatigue worsened from hour 8 through approximately hour 72, stabilized from hours 72 through 96, and then the fatigue quickly decreased between 96 and 100 hours after injection. The headache did not decrease or disappear until approximately 318 hours after injection.  No further symptoms or side effects continued after that.
Hand and foot was swollen; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Hand and foot was swollen) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Hand and foot was swollen). At the time of the report, PERIPHERAL SWELLING (Hand and foot was swollen) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient took unspecified concomitant medications.  No treatment medications were taken by the patient.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Follow-up information received on 16-JUN-2021 contains non-significant information: Contact information updated. On 06-Aug-2021: Follow up information included no new event outcome and the re-challenge for the suspect vaccine were updated.
Breakthrough COVID infection in fully vaccinated patient. Positive date 08/25/2021.
A physician reported the occurrence of an injection site reaction in a 5-year-old female who received diptheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix).  There was no relevant medical history.  The vaccinee had no adverse experiences following receipt of prior immunizations.  On 05/01/2002, the vaccinee received her fifth injection of Infanrix.  The vaccinee received an application of tuberculin purified protein derivative on the same day.  On 05/02/2002, the vaccinee developed an injection site reaction characterized by redness and swelling.  On 05/04/2002, the vaccinee was seen by the physician, who noted an area of redness and swelling at the injection site measuring five inches in diameter.  The physician suspected that the vaccinee may be allergic to tetanus toxoid and prescribed cetirizine hydrochloride (Zyrtec).  The reaction had improved by 05/06/2002.  The reporter considered the event to be probably related to Infanrix administration.
sinus congestion, burning, chills, cough nad back pain from coughing a lot. DX with acute sinusitis, nasal congestion and cough. Negative Rapid antigen test in clinic on 4/10/21. RX'd Augmentin x10 days.
This spontaneous report as received from a pharmacist refers to a 61 years old female patient with sulfur allergies, who on 14-JUL-2012 was vaccinated with a dose of ZOSTAVAX (dose and route not reported) lot # (671075/1197AA). Concomitant medications included DECAVAC administered on 15-JUL-2012. On 15-JUL-2012 the patient experienced small flat red rash, oval shaped at the injection site. The patient also had a lump under her arm on the right side, and experienced fatigue and flu symptoms and additional redness at the injection site. On 17-JUL-2012 the pharmacist reported that patient's lymph node, right armpit area, was swollen and the size of lymph node was as big as her hand. The treatment was given for events: ibuprofen and BENADRYL. No adverse event was reported regarding the DECAVAC. The outcome of the events was reported as not recovered/not resolved. Additional information has been requested.
Staff member administered Dtap and IPV only. Did not reconstitute with Hib. I called the health dept and was told dose is valid, Adjustments made in system. Patient is coming back in for nurse visit only to get HIB. Spoke to mom, patient is doing well. No concerns at this time. Injection site looks normal. No erythema.
One day post vax the pt developed a low grade fever and an injection site reaction characterized by redness, swelling and warmth.  Pt was treated with Benadryl and cold packs.
After getting my second vaccine, I instantly became tired and sore. I woke up in the middle of the night sick. I started with vomiting and diarrhea. My left arm was swelled and hurt. My body was achy and I could hardly walk. Swelling ended up going into my arm pit and left chest. That afternoon I had some trouble breathing along with chest pains. The pains lasted all day and then my throat became sore. I slept most of that evening. The next morning I woke up and my chest pain became a little worse, along w/a severe sore throat. My arms, legs, feet, and hands were very achy. I ended up going to the emergency room because I didn?t feel right. Returned home after they said that was normal symptoms after the shot. Within two hours, my face started swelling, throat hurt worse and I couldn?t swallow, and my lips were swelling.  I also had a rash in various places that itched pretty bad.  I ended up being covered in hives that were raised up like knots everywhere.  I returned to the ER and finally they said I was having an allergic reaction to the vaccine. I was hooked up to IV meds, then returned home. The next day (Sunday) my legs were swelling and it was very hard to walk.  The rash became worse and was popping up all over.  Didn?t feel like moving because my hand and feet hurt so bad. On Monday my leg was swelled double the size, hot and red. I was told they were worried about a blood clot, so I had blood work done. All of my levels were elevated, d-dimer was 2500. I was sent to Chillicothe Er to have testing done. They suspected blood clots in my lungs, however that came back ok. I was put on more meds and watched for awhile. After a CT scan and getting new meds, I left, but had to return to have a Doppler completed on my leg. It came back negative for blood clot, however the swelling still comes and goes. I ended up taking two kinds of steroids and a couple other meds to help the reaction. To this day, I am still tired easy, have some shortness of breath, my legs, feet and hands still swell and they ache pretty bad.
Severe pain in legs and back; Severe pain in legs and back; extreme night sweats; brain fog; migraines; lower flank pain (kidney area); swollen and painful armpits; swollen and painful armpits; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Apr2022 (Lot number: FK9896) at the age of 34 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Sulfur medications" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: FF2582, Location of injection: Arm Left), administration date: 22Sep2021, when the patient was 34 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: FE3592, Location of injection: Arm Left), administration date: 05Sep2021, when the patient was 34 years old, for Covid-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), BACK PAIN (non-serious) all with onset 02Apr2022, outcome "not recovered" and all described as "Severe pain in legs and back"; NIGHT SWEATS (non-serious) with onset 02Apr2022, outcome "not recovered", described as "extreme night sweats"; FEELING ABNORMAL (non-serious) with onset 02Apr2022, outcome "not recovered", described as "brain fog"; MIGRAINE (non-serious) with onset 02Apr2022, outcome "not recovered", described as "migraines"; FLANK PAIN (non-serious) with onset 02Apr2022, outcome "not recovered", described as "lower flank pain (kidney area)"; SWELLING (non-serious), AXILLARY PAIN (non-serious) all with onset 02Apr2022, outcome "not recovered" and all described as "swollen and painful armpits". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain in extremity, back pain, night sweats, feeling abnormal, migraine, flank pain, swelling, axillary pain.  Additional Information: The case was not serious. Seriousness criteria (Results in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect) was not reported. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications received within 2 weeks of vaccination. Reported Event: Severe pain in legs and back, extreme night sweats, brain fog and migraines, lower flank pain (kidney area), inability to thermo regulate during the day, swollen and painful armpits. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Drug exposure during pregnancy; Sore arm; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Drug exposure during pregnancy) and VACCINATION SITE PAIN (Sore arm) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 28-Jul-2020 and the estimated date of delivery was 28-Apr-2021. On 25-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Drug exposure during pregnancy) and VACCINATION SITE PAIN (Sore arm). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-fourth week of the pregnancy.  On 25-Mar-2021, EXPOSURE DURING PREGNANCY (Drug exposure during pregnancy) had resolved. On 26-Mar-2021, VACCINATION SITE PAIN (Sore arm) had resolved.        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 product use was provided. Treatment information was not available.
Fever of 103.4 degrees within 8-9 hours after vaccine.  Probably would have gone higher if didn't take Tylenol.  Fevers persisted for 2-3 days, with chills, myalgias, and fatigue.   Headache every day for 7 days following vaccine, requiring treatment with naratryptan on 3-4 of those days. Unable to work on one of the days in the week following the vaccine.
Pt recv vax on 12/8/98; on same day pt exp fever, sore throat, chest congestion, hoarseness, dizziness, wheezing, difficulty breathing; tx=Tylenol & orange juice
Covid 6 month to 4 year multidose vial, not mixed with required diluent. Bacteriostatic 0.9% Sodium Chloride used, by mistake.
This case was reported by a consumer via sales rep and described the occurrence of alopecia in a 17-year-old female patient who received BEXSERO. The patient's past medical history included alopecia (experienced on and off, since the patient was 6). Previously administered products included prednisone (the alopecia got resolved after treatment). On an unknown date, the patient received the 1st dose of BEXSERO (intramuscular). On an unknown date, 28 days after receiving BEXSERO, the patient experienced alopecia (serious criteria other: serious as per reporter). The patient was treated with prednisone. On an unknown date, the outcome of the alopecia was unknown. The reporter considered the alopecia to be unrelated to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The patient's mother reported to a field representative that her daughter experienced alopecia 4 weeks after receiving a BEXSERO vaccine. For this latest bout of alopecia the patient had seen her trained dermatologist, who did not think it was related to BEXSERO. The alopecia was being treated the same way as it was in the past. The reporter did not want any of her information to be shared.
Rash L Arm, Fever to 103.4 vomiting/diarrhea 3 days post vaccine siblings did not become ill
Approximately 5 minutes after receiving the dose my heart started pounding hard and fast, I then began to start feeling clammy,  sweat at the hands and felt dizzy, and around my left side of mouth to chin felt numb. I advised the pharmacist and he told me to sit down and breath.  My heart continued to feel pounding and felt light headed. After monitored for 30 mins I was sent home. At approximately 7:05pm my breast and back began to feel extremely heavy and heart felt discomforting. About 30 minutes after my whole chest was in extreme discomfort, I was beginning to have trouble breathing and taking deep breaths, light headed, and my right leg started twitching and at the same time my face would twitch moving to the left. I was unable to sleep that night due to the chest and back discomfort, and my heart rate dropped to 41. Two weeks after the vaccine I still feel my heart differently, chest still feels discomfort here and there. Those areas do not feel the same. My heart beat is my main concern now cause it has not felt the same.
It started with a sore throat as I flew home sore throat got worse and I became more and more congested a rapid test showed an immediate positive I went the next day to urgent care an EKG and chest xray showed no results I was prescribed Paxlovid and within twenty-four my symptoms subsided although I was still wiped and tire within five to seven days I was symptom free with congestion in about TEN days I felt OR better or well
Client's mom-states child vomited and sent limp in her arms-after having injection child appears pale and listless. Parents took child to their doctor for immediate attention and evaluation.
I have had severe muscle pain and weakness since the vaccine.  It was so severe they thought it was Lyme but that has been ruled out with blood work.  I also have continual fatigue.  I feel achy all the time, and certain movements cause pain such as bending my arms and squatting down.  This all began the day of the vaccine and has not stopped.
Very sick and running a fever, couldn?t move, stay awake, was nauseous, and weak next day around lunch and lasted for over 24 hours. I was better the next day, but got 2 cold sores on chin. My cold sore seemed infected and had pus in it. I began getting more and more cold sores each day and by a week since the vaccine 9/9, had more than 10 on nose in nose, all over mouth, between nose and mouth and going down to chin. My lymph node under my chin became hard, hot, firm, and round, in size similar to an adult spoon and has not gone away. Teeth are constantly sensitive and hurt when I breath, jaw and mouth are in constant pain too. Around neck and ear mild pain with strange giant zits like I have never had before. Continuous headache, mouth tingling and itching and swelling
2 days after vaccine administration right arm swollen, red, hot to the touch.  Has been feeling generally fatigued, slight fever.  Arm started swelling right away after shots, slowly worsening, worse in the evening, may be getting worse still 2 days later.  Very sensitive to touch, itching "like crazy".   Left arm slightly swollen but much less so.    Treating at home with ice, acetaminophen, and diphenhydramine which do help temporarily.
This spontaneous case, initially received on 02-Nov-2016, was reported by a health professional and concerns a 68 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 15-Sep-2016 the patient received AFLURIA. Dose regimen: Not reported, Route of administration: Not reported. Batch number: WT54306. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 15-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage without adverse event). Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursion identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016.