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 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021 at 4:27 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 13-Feb-2021 at 4:27 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, 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.   The age of patient was provided as 41.64.  Concomitant products were not provided.  On 13-Feb-2021, Excursion time was 09 AM, temperature was 32, total doses given for the day was 152, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Feb-2021, vial was moved to clinic on 13-Jan-2021. 30 vials were sent to clinic. Vaccine BUD date was 10-Mar-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 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.
Systemic: Diarrhea-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Severe, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Seizure-Mild, Systemic: Shakiness-Mild, Additional Details: Patient reported dizziness, then temporarily lost consciousness (associated with a possible seizure) while remaining seated. Patient quickly regained consciousness, then reported that he had also experienced nausea, tingling in fingertips, and sweating. Paramedics arrived and checked patient's vitals, then patient was released. Patient reported (to paramedics) a history of fainting post blood draws. Pharmacist advised patient to remain in the observation area for a minimum of 30 minutes.
I had my 1st COVID vaccine Pfizer, on Saturday May 22nd at 9:30am. That Saturday and Sunday I had a sore arm, and couldn?t move it. I also had nausea and fatigue. On Monday May 24th, my arm felt less painful, but I still had nausea and mild fatigue. On Tuesday, May 25th, I had more fatigue again, slight nausea, and my feet were sweating. By night, that day, I had some shortness of breath and pressure in my chest, not too bad, so I went to bed, but before I checked my oxygen (96) and pulse at home (70) and they were fine. I had the more serious reaction on Wednesday, May 26th. That morning I developed the strongest shortness of breath and pressure/pain in my chest. I couldn't breathe well. Then, I had tingling in my knees and in half of my hands, a weird sensation in my face, and my hands and legs were shaking. I called my primary care doctor ´s office and nurse recommended to go to the Urgent care or emergency Room. After the call, I started feeling lightheaded and having more difficulties breathing, like I was going to pass out, so my husband took me to the Hospital ER. The doctor said it was a vaccination reaction and probably hyperventilation, but I don´t have anxiety. They tested me for COVID there and it was negative. They also did a blood panel test that came back ok.   The pressure and pain in my chest, and the shortness of breath continued Thursday and Friday about 5 or 6 times a day at random times (they lasted between 20 minutes to an hour each time) and then progressively were decreasing in the next days. I noticed my chest muscles were very tender for a couple of weeks after the shot. I had a follow up appointment with my primary care doctor.  I had my 2nd COVID Pfizer vaccine on Saturday 6/12/21. After a few hours from the shot, I had an even more intense pain in my arm (left one this time) that the first time. I lasted all Saturday and Sunday. I took Tylenol, as recommended by my doctor but pain in my arm and headache were so strong that I could not sleep on Saturday night. I took ibuprofen on Sunday, 3 times. Had the pressure on my chest sensation for a couple of times but it was not as bad as with the first shot. Headache went away after 3 days but pain in the arm lasted for a few days. After 2 weeks from the second shot, the pain in my arm came back for a couple of days. I could not move it much, so I took Tylenol again. That symptom disappeared in the next few days. There is another thing that I am not sure if it is related to the vaccine, but my period was delayed for 3 months (I am not pregnant) and it has been very heavy. My last period before this one finished a week before my first shot and my current period came 4 days ago (August 14, 2021). The other (maybe unrelated) thing is that I just had a food allergic reaction to cherries and peaches, for the first time in my life. I never had allergies to food before. I consider myself a healthy person. I am asking my primary care doctor to refer me to an allergist. I hope this report helps doctors and other people.
5:30 PM A SEVERE SORE THROAT BEGAN, WITH DIFFICULTY SWALLOWING, THROAT BURNING, ESOPHAGUS BURNING, CHILLS, SHAKES, CALLED PHYSICIAN AT 7PM DR TOLD PATIENT TO TAKE BENADRYL 25MG P.O. 20 MINUTES LATER SHE BEGAN VOMITING (7:30PM). WENT TO HOSPITAL AT 8:07PM FAINTED, CAME TO, BEGAN VOMITING BP 60/40, EKG DONE, CHEST XRAY, BLOODWORK DONE 3 TIMES (ALL NORMAL) ER GAVE BENADRYL 25 MG IV & IVF AND PATIENT RECOVERED.
Iritis; blood shot eyes; This case was reported by a pharmacist via call center representative and described the occurrence of iritis in a 74-year-old male patient who received Herpes zoster (Shingrix) (batch number YA724, expiry date unknown) for prophylaxis.   Concomitant products included triamcinolone (Triamcinolone Cream).   On 31st July 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 9th August 2019, 9 days after receiving Shingrix, the patient experienced iritis and bloodshot eye. The patient was treated with steroids nos (Oral Steroid (Brand Unknown)) and difluprednate (Durezol Eye Drops). On an unknown date, the outcome of the iritis was not recovered/not resolved and the outcome of the bloodshot eye was unknown.   The reporter considered the iritis and bloodshot eye to be related to Shingrix.  Additional information received were as follows: The patient received Shingrix on left arm. The patient experienced blood shot eyes (may had been a little before this date, but this was the date it was diagnosed) and progressed into iritis, which was pretty severe. The patient's eye doctor believes it was related to the Shingrix. The patient was prescribed an oral steroid and Durezol 0.05 percent eye drops, 1 drop each eye four times a day until resolved. The patient was also using topical triamcinolone cream all over body (for a previous diagnosis, which they held for the vaccine but had been using this month a lot). The oral medication was unknown. The reporter consented to follow up. The expiry date was unknown.
Patient presented to the pharmacy in need of 2nd Covid vaccine. Patient stated that she received Moderna. This is what our pharmacy is using. Proceeded with 2nd vaccine. Patient called later at home stating that she was wrong and her 1st vaccine was pfizer.
Rash, itching and weeping on hands, face, arms and legs. Had a runny nose and a cough. Per doctor's visit on 4/13/98; typical varicella. Treated with Benadryl elixir prn for itching.
fatigue; malaise; This case was reported by a medical representative via call center representative and described the occurrence of fatigue in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st February 2021, the patient received the 1st dose of Shingrix. In February 2021, less than a week after receiving Shingrix, the patient experienced fatigue and malaise. On an unknown date, the outcome of the fatigue and malaise were not recovered/not resolved.   It was unknown if the reporter considered the fatigue and malaise to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. On Monday, the reporter who reported that doctor himself had his first Shingrix shot and experienced fatigue and malaise. The reporter did not consent to follow up.
mom reports leaving clinic 4FEB98 @ 2PM p/vax;6PM pt started having fever, redness, swelling around nose lip, chin & ears, trunk & arms got papular, red rash w/itching;pt taken to ER started coughing;hoarse cry & breathing problems;
I had extreme chest pain on the 24th of March. It really hurt to breathe and it felt like I had pressure on my chest. I went to the Emergency room and they did a chest x-ray and a Covid-19 both of which were negative. I went home and I returned to the ER because the chest pain became worse. The chest X-Ray the second day showed I had pneumonia. I was told that it could have been from the Covid-19 in December or if was community acquired.  I was prescribed with antibiotics and discharged. I still feel some chest pain  after about a week and I have already finished the full course of antibiotics. I've seen my Primary Care physician, my cardiologist and my Pulmonologist.
8 cm x 5 cm red, hard, warm to touch, blistered area surrounding injection site. Observation, patient instructed to call clinic if area worsens or other symptoms develop.
Extensive DVT of left leg; pulmonary embolism in both lungs; SOB; Calf pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old male patient received bnt162b2 (BNT162B2), administration date 19Aug2021 15:00 (Lot number: FC3181) at the age of 54 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Batch/Lot No: EW0191), administration date: 29Jul2021, when the patient was 54 years old, for COVID-19 Immunization. The following information was reported: DEEP VEIN THROMBOSIS (medically significant, life threatening) with onset Nov2021, outcome "unknown", described as "Extensive DVT of left leg"; PULMONARY EMBOLISM (medically significant, life threatening) with onset Nov2021, outcome "unknown", described as "pulmonary embolism in both lungs"; DYSPNOEA (life threatening) with onset Nov2021, outcome "unknown", described as "SOB"; PAIN IN EXTREMITY (life threatening) with onset Nov2021, outcome "unknown", described as "Calf pain". The events "extensive DVT of left leg", "pulmonary embolism in both lungs", "sob" and "calf pain" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: unknown results. Therapeutic measures were taken as a result of deep vein thrombosis, pulmonary embolism, dyspnoea, pain in extremity. Additional information: The events resulted in Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). Events treatment included direct oral anticoagulants (DOAC) medications. COVID test post vaccination with nasal swab. No other vaccine in four weeks. No other medications in two weeks. No COVID prior vaccination. No known allergies.   No follow-up attempts are possible. No further information is expected.
Approximately 5 minutes after receiving vaccination, patient experiences vasovagal syncope and fell. She instantly regained consciousness and was laid supine in a isolated area and given juice for approximately 10 minutes, patient was visibly shaken but otherwise physically okay.
Information has been received from a health professional concerning a 13 year old female with a history of nonspecific allergy to metals who was vaccinated with her first dose of Gardasil. Concomitant therapy included DEPO-PROVERA. Subsequently the patient experienced injection site reaction. The patient sought unspecified medical treatment during an office visit. Subsequently, the patient recovered from injection site reaction. Additional information has been requested. Information has been received from a healthcare professional concerning a 13 year old female with a history of nonspecific allergy to metals who on 18-OCT-2007 was vaccinated into the left deltoid with her first dose of HPV vaccine. On 19-OCT-2007 the patient developed an injection sit e rash, it was reported that the rash spread to the patient's extremities after on e month and resolved two months after the injection. The patient sought unspecified medical treatment during an office visit. Additional information is not expected.
I felt like 8-10 hours after the vaccine around 8:00PM, I experienced the general tiredness and weakness and malaise. I had a low grade fever and body aches. 1-2 days after that around 01/06/2021 I felt like my legs were sore like I had done a leg work out. The fatigue and weakness lasted about 24 hours and the muscle aches lasted a couple weeks.
Seven days exactly after receiving the dose, skin on neck broke out in rash. Approximately, 8 hours later, the rash increased area and redness. One percent cortisone was applied.  The next day, raised plaques developed, itchiness, and more redness. Zantac and one benedryl were taken with no relief the next morning. The rash was popping up on the facial skin with little bumps. Benedryl topical cream was applied to neck which decreased the rash on the neck. Claritan was taken at night. The next morning, the face was affected with rash and bumps, the eyes were swollen, red, and itchy. the lips were swollen and burning around the lip line, the tongue was slightly swollen and canker sore on the right side of the tongue. The patient went to employee health for eval. The NP ordered the patient to go to the ED to seek medical attention.
Woke up day after 1st shot with eye irritation.  Diagnosed and Uveitis.
That evening I had pain in my arm and felt extremely tired, that evening &  for the next two days on June 2 and June 3 I had a 101-102 fever. & felt like a truck was laying on my back from hip to hip- completely knocked out. I still get extremely tired out of nowhere
feels paralyzed; Both upper arms esp. left hurt constantly deep to bone; hard to raise left arm up; This is a spontaneous report received from a contactable reporter (Other HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162B2 (COMIRNATY), administered in arm left, administration date 08Oct2021 14:30 (Lot number: 30155BA) at the age of 66 years as dose 2, single for covid-19 immunization. Relevant medical history included: "Drug allergy" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162B2 (Dose Number: 1, Batch/Lot No: FF8839, Location of injection: Arm Right, Vaccine Administration Time: 03:00 PM), administration date: 17Sep2021, when the patient was 66 years old, for COVID-19 immunization. The following information was reported: PARALYSIS (medically significant) with onset 09Oct2021 08:00, outcome "not recovered", described as "feels paralyzed"; PAIN IN EXTREMITY (non-serious) with onset 09Oct2021 08:00, outcome "not recovered", described as "Both upper arms esp. left hurt constantly deep to bone"; INJECTED LIMB MOBILITY DECREASED (non-serious) with onset 09Oct2021 08:00, outcome "not recovered", described as "hard to raise left arm up". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (09Nov2021) negative, notes: Nasal Swab. Therapeutic measures were not taken as a result of paralysis, pain in extremity, injected limb mobility decreased.; Sender's Comments: Based on the limited information provided, a possible contribution of the suspect product administration to the reported events cannot be excluded, due to a  temporal relationship. This case will be reassessed when additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
The patient is 16yo and was given a Moderna booster (which is for 18yr and older).  Patient is not having any adverse reaction to the vaccine.
Pt recvd 2 doses of Engerix-B vax & 3 wks following 1st inject devel hives which lasted 2 days; 3DEC91 12 hrs p/2nd inject devel stomach cramps w/vomiting & hives; sx cleared 5DEC91;
Day after injection, patient believed she was having a heart attack.  She experienced severe chest pain, pain that radiates through her arm to her hands, numb tingly hands, dizziness, nausea, and SOB.  This event lasted about 5 to 10 minutes. The remainder of the week she continued to experience mild discomfort, SOB, dizziness, heart palpitations, and lethargy.  At 2 to 3 days after injection, she did notice some swelling at the injection site.  She did not seek medical attention, but did message her physician.  She was told it was likely from the vaccine and to take some acetaminophen. No physical evaluation was performed on the patient.
Information has been received from a medical assistant and physician concerning a 10 year old female with no pertinent medical history and no allergies who on 09-MAR-1999 was vaccinated with the first dose of VARIVAX (Merck). On 11-AUG-2008 the patient was vaccinated with the second dose of VARIVAX (Merck) (lot # 660827/0426X) 0.5 ml IM instead of SQ. There was no concomitant medication. The patient did not have any problem with the first dose. On 11-AUG-2008 the patient experienced redness, swelling, hot and pain at injection site and fever. The patient's redness, swelling, hot and pain at injection site and fever persisted. The patient sought medical attention and called office. Additional information has been requested.
This spontaneous report was received from a Licensed Practical Nurse referring to multiple unspecified patient of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not reported. On unknown dates, the patients were vaccinated with an improperly stored dose of VARIVAX lot # K015969 with expiration date of 23-SEP-2016 and lot # L017142 with expiration date of 13-MAY-2017 (anatomical route of vaccination and dose number were not provided). The patients' concomitant medications were not reported. It was also reported by the Licensed Practical Nurse, that the vaccine was exposed to a temperature excursion of -7 degrees C for a time of 2213 minutes. NO additional temperature excursion was reported. Data logger was stated. Furthermore, no adverse events were reported and no product quality issue was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Fever, Chills, body aches, Nasal congestions.  The following day experienced extreme fatigue and a severe headache.
Chills post day 2 and diarrhea post day 3.  Both lasted less than a day
Redness 24 hours after, size of nickel, redness increased 48 hours after, Treated for cellulitis, allergic reaction.
Headache, Arthralgia, Fever, Tachypnea, ErythemaMultiform, UrticariaPruritus, L arm pain Narrative:
Discharge Final Diagnosis: Acute Left basal ganglia ischemia stroke; S/P TPA 4/28  Nicotine abuse   Hospital Course (include Reason for Hospitalization):Patient s a 46 y.o. female who was seen on ICU for medical management. Patient started to have right-sided weakness, was unable to move her right upper or lower extremities while she was talking with her uncle over the phone on 4/28 at 9 PM, her speech was slurry. Patient was transferred to the nearest hospital, initial NIH score was 11. Patient was within the window to administer TPA, NIH score dropped to 6. She was transfer to our facility for further intervention. Upon presentation NIH score was 10, vitals were stable, she was a triage in the ICU for observation. MRI of the brain showed left basal ganglia/corona radiator infarction, echocardiogram showed EF 69%, LDL 126. Patient has significant history of nicotine use, she used to smoke half pack a day since the age of 14 and last week she was doing 1 pack a day. Patient was transferred to 6 S., underwent TEE which was negative. Right-sided extremities muscle power started to improve, she was able to walk with physical therapy 200 feet, was a clear by doctor and neurology team to be discharged home to follow-up as an outpatient Smoking cessation discussed with patient she is aware of possible complication which include heart attack, further stroke lung cancer and mortality
TINGLING TO TONGUE, MOUTH AT 11;25, NO PROGRESSION OF SYMPTOMS AT 11:38. LUNGS CLEAR TO ASUCULTATION, HEART RATE REGULAR. VITAL SIGNS STABLE. 11:47 LAST SET OF VITALS 149/67.  ESCORTED TO AMILY MEMBER AT 11:31
I received the Pfizer Bivalent booster for COVID-19 on 11/3/2022. On 11/27/2022, I felt like I was developing a cold, because I had extreme fatigue, sore throat, and nasal congestion. My friend had already tested positive for COVID-19 on 11/25/2022, so I thought it would be a good idea to get tested myself. On 11/28/2022, I went to an urgent care to undergo an antigen test, and the result was positive. I notified my PCP, who prescribed me azithromycin. Ever since, I have been taking the medicine, resting, and drinking plenty of fluids. My worst day was probably 11/29/2022, because I had practically no energy, plus the congestion was severe. This continued 11/30/2022. I began to feel better the evening of 11/30/2022 and 12/1/2022. At the time of this writing, I feel much better. I don't feel so congested. My throat is no longer sore, and I don't think I sound as nasally when I talk as I did earlier on during my illness. I feel like I'm basically getting over a really bad head cold.