chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer (patient). A 74 year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# and expiry date not reported), at the age of 74, via an unspecified route of administration, on Feb 17, 2021, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. On Feb 17, 2021, patient received the first dose of Pfizer vaccine. Two hours later, she felt dizzy for 3-4 seconds but then it went away. At 5:30-6 pm, she developed nausea, headache, chills and "felt crappy." It would come and go. Then at 10 am the next morning she developed a headache and still feeling unwell. She then took some Tylenol around 2 pm and then felt okay. She was great last night. Then this morning, she felt a little nausea, headache, had chills and still feeling rundown. Nausea still lingers, comes and goes. She wants to know how long side effects usually last. Can I take Tylenol or ibuprofen for side effects? She is due for the second vaccine on Mar 10, 2021. Will the side effects be worse with the second dose? Patient received treatment with Tylenol around 2 pm for headache and still felt unwell. Then she felt okay and was great last night. The outcome for dizzy recovered on Feb 17, 2021; and for the events nausea, headache, chills and "felt crappy" unknown. Information on the batch/lot number requested. Follow-up attempts completed. No further information expected.
Information has been received from a registered nurse referring to unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On unknown dates, the patients were vaccinated with doses of improperly stored ZOSTAVAX (lot # L035506, expiration date 16-DEC-2016, lot # L044529, expiration date 09-FEB-2017; dose and route were unknown). No adverse effects had been reported. The temperature excursion included 6.3 Fahrenheit degree for 2 hours and 48 minutes, 9.2 Fahrenheit degree for 13 hours and 57 minutes, 20 Fahrenheit degree for 8 hours and 24 minutes, 18 Fahrenheit degree for 1 hour and 28 minutes, 5.2 Fahrenheit degree for 6 minutes, 19.8 Fahrenheit degree for 11 hours and 13 minutes, 9 Fahrenheit degree for 7 hours and 37 minutes, 15.8 Fahrenheit degree for 1 hour and 19 minutes, 23.8 Fahrenheit degree for 4 hours and 52 minutes, 13.7 Fahrenheit degree for 9 hours and 18 minutes, 8.5 Fahrenheit degree for 20 hours and 27 minutes, 7.7 Fahrenheit degree for 24 hours. Data logger was involved. This is one of two reports received from the same reporter. Additional information has been requested.
Within three days had head to toe rash, itching, no temp, no known exposure to disease.  Given Tylenol prn
Within 3-months of vaccine getting Proquo (MMR+Varicella) , we found the muscle above heart was hard like stone.  We rushed to emergency on Jan-15th-2017 to hospital, where X-Ray report was normal.  He was prescribed MRI/Ultrasound at Hospital and later was referred to Oncolocy cancer department for the Tumor above the heart muscle.
Leg cramp and it was not all the time, It was on and off; Pain in right leg that radiated; Fatigue; Fever low grade; First dose on 31MAR2021, 2nd shot on 28MAY2021; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Leg cramp and it was not all the time, It was on and off), PAIN IN EXTREMITY (Pain in right leg that radiated), FATIGUE (Fatigue), PYREXIA (Fever low grade) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 31MAR2021, 2nd shot on 28MAY2021) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054C21A and 006B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-May-2021, the patient experienced MUSCLE SPASMS (Leg cramp and it was not all the time, It was on and off), PAIN IN EXTREMITY (Pain in right leg that radiated), FATIGUE (Fatigue), PYREXIA (Fever low grade) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 31MAR2021, 2nd shot on 28MAY2021). On 28-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 31MAR2021, 2nd shot on 28MAY2021) had resolved. On 31-May-2021, MUSCLE SPASMS (Leg cramp and it was not all the time, It was on and off), PAIN IN EXTREMITY (Pain in right leg that radiated), FATIGUE (Fatigue) and PYREXIA (Fever low grade) had resolved.            No concomitant medications were provided. No treatment medications were reported.
Vaccine was BUD of 10 weeks in the fridge at time of administration.  Vaccine expired 3/30/22.  Calling patient to advice re-vaccination per CDC guidelines.
Patient was given both vaccines at her appointment today, about 45 minutes after leaving mom called to say that the patient was having a reaction to the vaccines, Rash (hives) on face and swollen face and ear. No trouble breathing. Had only had orange juice and crackers that day. Advised patient to go to the ER to be examined and take some benadryl. Was seen at Medical center and given an oral steroid and observed for a period of time. No wheezing. and was discharged and told to follow up with us in the office tomorrow. Called Mom to check on patient later in the day and Pt. was doing fine no symptoms.
Pt described dificulty moving arm + lifting objects  Pt advised by her daughter to take Ibuprofen (daughter is a doctor)
pt states has lt shoulder;lt arm, wrist & hand pain;neck & head pain;lt jugular vein pain;blurred vision;
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 68-year-old male 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 10:02 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 10:02 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.   Age of patient was reported as 68.24.  Concomitant products were not provided.  On 20-Mar-2021, Excursion time was 10:00 A.M., temperature was 37 degrees Fahrenheit, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Mar-2021, vial was moved to clinic on 20-Mar-2021. 19 vials were sent to clinic. Vaccine BUD date was 08-Apr-2021.  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 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 on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
rash; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN9809), via an unspecified route of administration in left arm on 18Feb2021 11:00 (at the age of 73-years-old) as dose 1, single for COVID-19 immunization. Medical history included ongoing blood pressure high, ongoing diabetes mellitus, ongoing fibromyalgia, ongoing depression, ongoing anxiety, ongoing cholesterol, and ongoing glaucoma. The patient's concomitant medications were not reported. The patient said she has a lot of medical conditions; they might have been diagnosed since 2008. Prior to vaccination, the patient did not have any other recent vaccinations or started any new medications. The patient experienced rash on an unspecified date in Feb2021. No treatment was received for the event. Outcome of event was not resolved.  No follow-up attempts are possible. No further information is expected.
headaches increased shortness of breathe while at rest and or talking heart rate up sweating pillow case and sheet wet from top back up stomach pain weakness and very tired. Decreased O2 level higher need for O2 not on O2 before but since hot covid19 on O2 . increased coughing hard with some mucus
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 19-Aug-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication use was unknown. Treatment information was unknown. Date of refrigeration was on 7-May-2021.   This case was linked to MOD-2021-365131 (Patient Link).
09DEC2022 COVID-19Test-Positive. For four months I have had difficulty breathing before Covid-19 I was running 25 miles a week , following my testing positive condition are improving  I had a general tightness in my chest or Exercise Intolerance conditions are improving but I certainly cannot run. Other symptoms are High Blood Pressure and elevated heart rate.
My son developed break-through chicken pox and just after his scabs started to heal he developed bruising and was eventually diagnosed with ideopathic thrombocytopenia purpura.
This spontaneous report was received from a physician assistant via company representative who refers to a 5 year old patient of unknown gender. The physician assistant reported that on an unknown date the patient was vaccinated with a dose of GARDASIL (dose, route and lot # were not reported). The outcome and action taken were not reported. Additional information has been requested.
Pericarditis; This spontaneous case was reported by a physician and describes the occurrence of PERICARDITIS (Pericarditis) in a 30-year-old patient of an unknown 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERICARDITIS (Pericarditis) (seriousness criterion medically significant). At the time of the report, PERICARDITIS (Pericarditis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Relevant concomitant product usage were not reported by the reporter. No treatment details were added.  Patient does not have any cardiac related historical events.  Company comment: This spontaneous report concerns a 30 year old patient with no relevant medical history who experienced a serious expected event of pericarditis. The event occurred unknown duration after receiving a dose of mRNA-1273. There is no information on the vaccine doses and hence re-challenge was unknown. The outcome of the event was not reported. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-363499 (Patient Link).; Sender's Comments: This spontaneous report concerns a 30 year old patient with no relevant medical history who experienced a serious expected event of pericarditis. The event occurred unknown duration after receiving a dose of mRNA-1273. There is no information on the vaccine doses and hence re-challenge was unknown. The outcome of the event was not reported. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Extreme pain in injection arm so strong, from my upper back, and down to my thumb, I almost passed out, and it would not let up, I put heat on it for 8 hours and took Tylenol, I became sick to my stomach, and throw up all the way home in my car, the next day I was total wiped out, and today 10/31/09, I feel like fainting all day, and I am weak all day.
On 04/14/2021 patient lost his memory for about 3 - 4 hours starting at 1600.  I called paramedics who suggested that he needed to go to ER due to an abnormal EKG.  At the ER he was tested and Dr. concentrated on his memory loss, no mention about his heart report and he was sent home.  04/15/2021 I spoke with RN regarding the ECG report which I did not understand; she was concerned and suggested that patient return to the ER. The doctor called early on 04/16/2021 and demanded that patient go to the ER, he was having a heart attack and needed to get there immediately; the doctor called the ER and let them know we were on the way.  We arrived at the ER at approximately 0900 and another ECG was performed and it was noted that he was having trouble with his heart and a Cardiologist was assigned to him.  By 1600 the patient was having a pacemaker implanted into his left chest wall. The patient is now living with a pacemaker, but still suffering from dizziness, weakness, short of breath, and is now experiencing muscle or nerve pain on his feet, legs, and arms.  The 3 - 4 hours that the patient suffered memory loss on 04/14/2021 is memory he has not been able to recall up to this date; he continues suffering from short terms of memory loss where he can't recall where he placed certain objects.
Pt received AFLURIA and PNEUMOVAX 23 on 9/23. Pt developed sores in his mouth the next day. He did not seek medical treatment, but missed 1 day of work. Cleared up in a day or 2.
Patient received vaccine at 1:48 pm then approximately 5 minutes afterwards fainted and fell to the floor while sitting in a chair. I went over and rolled patient over having her lay face up and then proceeded to ask her questions. We had a staff member called 911 while I was helping her.  I asked her how she felt and she responded and said she felt "hot all over and dizzy." Her pulse was low (~40 bpm). 911 informed us to lie her down on the floor until EMS arrived which we already had been doing at the time. After getting off the phone with 911, she started feeling better and her pulse returned to a normal rate (~80 bpm). EMS still took her to the hospital for further evaluation.
1MAR90 devel general aches & pains of neck, upper back which slowly over 3 wks devel into hip area, swelling of knees, ankles, feet, hands; to ER 25MAR90 w/dizziness & pressure in back of head & neck, vomiting, joint pain, muscleache & disc
Information has been received from a physician concerning a 29 month old male who was vaccinated with MMR and subsequently, the pt experienced injection site wheal, blanching and skin lesions. The lesions were described as maculopapular, located on his face, trunk and extremities. The pt recovered from symptoms within a week from the onset. No further details were provided.
Bruising at injection site, slight numbness below/adjacent to injection site (did not bleed at time of injection).
Shingles; Information has been received from a lawyer regarding a case in litigation referring to a female patient of unknown age. The patient's, concurrent condition, medical history, concomitant medications, drug reactions or allergies were not reported. In 2009, the patient was vaccinated with Zoster Vaccine Live (ZOSTAVAX) (dose, lot #, expiration date, route of administration and anatomical location not provided) at a health center for the long-term prevention of shingles and/or zoster-related conditions. On an unspecified date, subsequent to inoculation with Zoster Vaccine Live (ZOSTAVAX), the patient was treated by a health care provider at a health center for shingles. As a direct an proximate result of patient's use of Zoster Vaccine Live (ZOSTAVAX) vaccine, she 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 included 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. At the reporting time, the outcome of shingles was considered as not recovered. The reporters considered the event of shingles to be related to Zoster Vaccine Live (ZOSTAVAX).
rt thigh 1 day p/vax pt devel 4cm induration surround inj site rt thigh along w/erythema 10 x 6 cm;no pain;no fever; mild swelling;
Administration error:  On 8/19/21, the patient received a dose of Moderna during his office visit.  The syringe was removed from the refrigerator and administered.  After administration, it was discovered that the syringe had been prepared the day before and was after the 12 hour beyond-use-date.  The dose was Moderna, lot #035C21A, left arm,  the vial beyond use date was 8/19/21 (end of day), however the syringe beyond use date was 8/18/21.  The patient reported no adverse effects from the vaccine.  Moderna was contacted and unable to advise if dose should be counted as valid.  Generally recommends revaccination if expired product is administered, so the offer was made to the patient for revaccination (understanding there was no data to guide).  Patient received 2nd vaccination on 8/24/21 (Moderna, lot# 026C21A, left arm).  No immediate adverse effects reported.  Adverse Reaction:  On 9/1/21, the patient contacted his provider to complain of ankle swelling, calf tightness and pain.  The patient was referred to the urgent care since he was out of town.  The note documented unilateral RLE non-pitting edema and mild erythema.  Patient was hemodynamically stable, vitals normal.  On 9/2/21, the ultrasound confirmed bilateral DVTs.  Right occlusive with extension to femoral; left distal non-occlusive.  Pt was started on apixaban and referred to hematology for consult.  The patient does have a history of DVTs 15 years ago and increased risk due to 'long-sitting.'  No other information available in chart at this time.  Pharmacy was consulted regarding 2nd dose of vaccine.  Since there are no listed contraindications for DVTs, the patient will be scheduled for 2nd dose per usual process.
About two weeks after second dose. I started having pain in one leg, after a few days it was both legs, then the numbness from waist down, tingling and burning sensation on both feet.  Muscle spasms, nerve pain.  Since then its been really hard to do my job. I completely stop working on May 18. Doctors orders. I been going to physical therapy, but not helping, My doctor recommended me to report , because, of all the testing and Xrays  have got, nothing comes up. He referred me to see a Neurologist and Allergist to further make exams, to make sure its not Guillen Barre Symdrome. I have been in medication for pain , disinflamatory medication, but until now everything is the same.
the day after second vaccine I had chills and thoughts of killing myself. I have suffered from multiple sclerosis for years but it has been stable,. The Moderna vaccine has accelerated the symptoms.  I had to go from a walker to a wheelchair immediately. In creased weakness. I cannot stand for more than 45 seconds. I have increased headaches.
tested positive for COVID 4/7/21. Completed COVID vaccine series 1/14/21.
Left arm soft tissue, swelling and redness, tenderness measured 14.5cm x 11cm.  Left arm Cellulitis.
Mild pain/soreness at the injection site beginning 20 days after receiving second dose.  Began 24 hours ago, ongoing
fever; sore arm; This is a spontaneous report from a non-contactable other healthcare professional (nurse). A female patient of (Age: 74; Unit Unknown) received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 19Feb2021 (Batch/Lot number and Expiry date was not reported) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 19Feb2021, the patient experienced sore arm and on 21Feb2021, the patient had fever. Laboratory tests on 21Feb2021 included body temperature was 100.0 degree Fahrenheit (Fever). The patient took Tylenol. The clinical outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number could not be requested. No further information is expected.
Approx 1 hour after vaccine given developed red face, sneezing then sweating. Given benedryl. Now 2 hours later seems ok.