chrisvoncsefalvay/vaers-outcomes huggingface dataset:
complaints of continued fatigue, generalized weakness, fever, cough and shortness of breath since she was diagnosed with COVID on 12/28/2021.  Patient is fully vaccinated.  Patient has been managed outpatient but came to the ED on 1/12/2022 due to symptoms worsening.  Work-up at that time revealed COVID-19 pneumonia Monia on CT imaging, however the patient was not hypoxic at the time and was deemed appropriate for outpatient therapy.  Patient complaining that over the last 5 days she has continued to feel worse and is running fevers and has increased shortness of air.  Patient called EMS and when they checked her sat there was hypoxic at 84% on room air.  Patient was given O2 and brought to the ED for evaluation.  Patient had coarse and patchy bilateral parenchymal opacities on her CXR.  COVID labs are elevated with LDH 506, CRP 7.11, lactate 2.3, ferritin 3,711, D-dimer 1.07.  WBC 5.78.  Patient will be admitted to hospital medicine service for further evaluation and treatment.
Atypical shingles outbreak 12 days after shot affecting multiple quadrants around eye and mouth. Preceded by ear pain and headaches.  Also, unusual rash on arm.
Diarrhea off and on; Achiness; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea off and on) and PAIN (Achiness) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 010M20A) for COVID-19 vaccination.     No medical history provided.    On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced DIARRHOEA (Diarrhea off and on) and PAIN (Achiness). At the time of the report, DIARRHOEA (Diarrhea off and on) and PAIN (Achiness) outcome was unknown.
3/4/21: Severe pain throughout whole body. The more I moved the worse it got. Left work early. 3/25/21: Woke up with pain started getting ready for work the more I moved the worse it got. Called off work. Severe fatigue. Third day was not as bad but suffered with pain for 1.5 weeks.
9/10/21 symptoms started in left foot - nerve pain, saw orthopedic specialist who requested more tests Numbness and tingling began to travel up left leg over the next few days, on day 5 numbness and tingling made a rapid ascending progression up right leg and began in hands and arms, walking was becoming difficult and was advised to go to the ER, evaluated in ER and admitted to ICU for Guillane Barre syndrome, numbness and tingling ascended up torso and head, breathing was slightly difficult and could no longer walk.  IVIG infusion started and significant improvement in GBS symptoms was achieved after the second treatment but it also caused an allergic reaction in the form of meningitis and had to be discontinued.  Discharged after 4 days with minimal ambulatory function to recover at home, after several weeks full physical functioning did return.
I HAVE EXPERIENCED TENDERNESS, SWELLING AND OCCASIONAL PAIN IN MY LEFT ARM PIT...LIKELY LYMPH NODES.  THE PAIN WAS MOST APPARENT THE MORNING AFTER RECEIVING THE VACCINE BOOSTER (11/16/2021), BUT HAS SUBSIDED IN SUBSEQUENT DAYS.  I HAD NOT EXPERIENCED PAIN OR DISCOMFORT WHEN I RECEIVED THE FIRST DOES  (03/18/2021) AND SECOND DOSE (04/15/2021)....SO MY RECENT REACTION IS UNEXPECTED.  HOWEVER, I DID RECEIVE THE FLU SHOT AT THE SAME TIME AS THE BOOSTER SHOT.
1/27/2022 COVID vaccine received around 2:30pm and dizzy, nausea, pain in the neck, headache all evening. Sporatically, bilateral breast pain 1/28/2022 Dizzy, nausea, chills, pain at the site - LT arm,  Dizziness getting milder 2/2/2022 6:30am to wake up with the alarm clock and Severe Vertigo started incapable of doing anything, but laying in bed. Took a medication to subside. Strong dizziness remains not capable of work. 2/3/2022 Dr appt and put off work for a week, strong dizziness remains in bed for 3 days. Dizziness, fainting spell not unconcious and nausea continues. 2/8/2022 Dr appt put me off work another week. I tried to go to work but cannot stay for a full shift, need to come home early a couples of time dizziness, fainting, nausea remains and vertigo spinning 2/23/2022 Physical therapy appt 2/24/2022 Acupuncture with herbal remedies 2/28/2022 Dr phone appt to send me to Urgent care to check on my heart and lab work All the lab work so far is normal. EKG and heart monitor appears normal. Went for MRI on brain and audiocanal study - Waiting on result. Off and on, not being able to work for a full month.
Chest pain, fever, body aches, headaches, blurry vision.  All seemed to last about 5 days. Pain at injection is still sore. Wife had same exact adverse effects.
Felt faint 30 minutes after receiving the vaccine. Later that day had difficulty breathing, tight chest. Next morning checked my vitals and O2 sat was at 90 and pulse was 122, several hours later resting pile was 132 and O2 sat was 94, that night resting pulse was 131, O2 sat was 95.  Slept most of the day, took Benadryl and ibuprofen to help with itching.
Middle back pains; Headache; Fatigue; Chills; Low grade fever; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received (not pregnant at the time of vaccination) first dose of BNT162B2 (PFIZER-BIONTECH COVID -19 VACCINE, solution for injection, Lot Number: unknown, Expiry date: not reported) via an unspecified route of administration, administered in left arm on 24May2021 at 12:15 (58-year-old at the time of vaccination) as dose 1, single for COVID-19 immunization. Medical history include Allergy NOS. Concomitant medications included herbal remedies (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date. The patient had allergies to medications, food or other products (unspecified). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27May2021 at 01:00, the patient experienced middle back pains, headache, fatigue, chills and low-grade fever. The events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events middle back pains, headache, fatigue, chills and low-grade fever was not recovered at the time of this report.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
She got her vaccines, one in one arm and the one in the other.  The arm became very swollen and very very sore.  That evening, all night she was in bed, very uncomfortable.  In the morning yesterday when she stood up she almost fainted twice.  She was very very fatigued, very weak and her stomach hurt.  She had a bad headache as well.  The headache has continued through this morning and her stomach is still hurting.  She has not contact the pharmacist for this as she stated that she had only given 2 other RSV vaccine.  She contacted her doctor who told her if she did not feel better in a couple of days she should see her.  She was not told to take anything for her symptoms.  She took some Maalox and generic Prilosec
1 red spot on belly 5-17-09 in AM, 101.7 fever on 5-17-09 at 8:00 AM TYLENOL was administered, fever went down did not appear again. 7 chicken pox appeared on 5-18-09 at 7:00 has not made a full recovery yet.
HEADACHE, FATIGUE, RESTLESS LEGS, SUPRACLAVICULAR LYMPHNODE
Injection site pain; Tiredness/ feeling extremely tired; Headache; Muscle pain; Injection site swelling; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW6204) via an unspecified route of administration in the left arm on 02Mar2021 at 09:00 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes II, high cholesterol, Obese, HBP (blood pressure high) and COVID-19 (Prior to the vaccination, the patient was diagnosed with COVID-19). The patient received doxycycline (MANUFACTURER UNKNOWN) and metaxalone (SKELAXIN) on unknown date for an unspecified indication and experienced drug allergy. The patient received unspecified medication within two weeks of vaccination. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 02Mar2021 at 09:00, the patient experienced injection site pain, tiredness, headache, muscle pain, injection site swelling, nausea and feeling extremely tired. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported event. The clinical outcomes of injection site pain, tiredness, headache, muscle pain, injection site swelling, nausea and feeling extremely tired were recovered on an unknown date in 2021. The patient also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 06Apr2021 as a single dose for COVID-19 immunisation.  No follow-up attempts are needed. No further information is expected.
On day 1-3 Tingling and  pain in injection site.  On day 5 began hurting in all joints and numbness and overall fatigue  By day 7 Neuropathy was noted with vision disturbances (seeing quadruple and not able to focus.  Loss of balance and actually sprung right ankle.  All symptoms continue to worsen and compounded
Initial unsolicited case received from a healthcare professional on 17 November 2014. It pertains to 2 of 3 patients reported from the same facility who experienced adverse events following vaccination; the other patient is captured in case number 2014SA159421. Two patients, genders and ages not reported, received FLUZONE ID, (lot numbers and date of vaccination not reported). They subsequently reported numbness and tingling in their arms with loss of grip strength. Only one of the patients had seen a primary care physician, who felt it was an injection site issue and instructed the patient to follow-up in a few months. Another had not yet seen a physician and was scheduled to follow-up with a physician later that month. It was not clear which of the three total patients reported had been seen by physicians. The patients were not ill at the time of vaccination, and laboratory data was reported as unknown. The patients had not recovered. Documents held by sender: None.
Rt shoulder pain approx 5 hrs after injection then had myalgias, joint fatigue and subjective fever.
Multiple pulmonary embolism without an appreciable thrombotic source or an inciting illness or injury.
1509: Patient received COVID vaccine in L arm and was instructed to sit in waiting area for 15 minutes to watch for any reactions. 1522: Patient presented to front desk stating she had burning and numbness in her L arm 13 minutes after vaccine. She was examined by immunizations technicians and told it may be a local reaction or may be a hit nerve. She was then instructed to wait an additional 15 minutes in waiting area where the immunizations technicians can keep an eye on her.  1525: Patient presented to front desk again stating she was having "difficulty breathing and felt like her throat might be closing" Patient was talking normally and able to answer questions. She was placed on high flow oxygen 15LPM. Another member of the immunizations team brought two providers to the patient for additional evaluation. Patient was still breathing normally and answering all questions. She stated that she was feeling nauseas, dizzy, had difficulty breathing and still felt like her throat was closing. Provider stated her symptoms were enough to determine possible anaphylaxis and administer the epi-pen.    1530: Epi-pen was administered to L thigh. Patient was answering all questions. Immunizations technician called 911 for local EMS transport to hospital.  1532: Vital signs were obtained. BP: 126/81 P:76. Patient was still answering all questions and breathing normally. She stated she felt like it was easier to breathe and her throat was not closing anymore. Oxygen flow was lowered due to patient feeling "jittery" to 10LPM.  1547: Local EMS arrived and took over patient care. Patient was still alert and oriented answering all questions for the EMS personnel.
soreness in the left arm; This is a spontaneous report from a contactable consumer (patient). This 39-year-old female patient received dose 1 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on an unspecified date (at the age of 39-years-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 05Mar2021, the patient experienced soreness in the left arm after the vaccine. The outcome of soreness in the left arm was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Inoculation: (L) arm. No symptom of fever. No reaction on 1st day. Next day red spot on (R) foot, followed next day a bigger one above it. Also, on (L) arm, below inoculation, a 3 1/2 in. red spot, and smaller ones on (R) arm above and below elbow. On Sept. 17 saw Dermatologist. Use: Clobetasol for 2 wk. Spots begin disappear when I again saw DA, Oct 8, and said use only CERAVE cream moisturizer for 2 wk. Then on Oct 27 saw Dr. in same office. By then, some spots were partially clearing, and said use triamcinolone for 2 wk. Today Nov. 18 - 3 months from day of inoculation - some red spots still continue, but not worse. The large one in the (L) arm, is still there, but, lighter and broken down in smaller parts. Hives, string of low key pimples, did appear also after 1 wk. or so after inoculation, in the lower back and in both legs. They usually start to disappear after applying of corticosteroids. The first spots below and on the ankle and adjacent area have almost disappeared after first two weeks. Since then I have only applied CERAVE. I will be 87 at end of this year. I have had vaccine shots of all kinds during my lifetime, without any reactions. Maybe my present reaction to PCV-13 is rare, even so for dermatologists, so are not up to par with the proper treatment. Seven years ago I was inoculated with the regular bacterial pneumonia vaccine without any complication. And 14 years ago I came down with a bacterial pneumonia. My blood type is AB positive. I have a tuberculosis antibody, or antigen, in my system, as a result to an exposure of that ailment while out of the country before 1970. If you can recommend another form of treatment for the PCV-13 allergy, I would appreciate your advice, thank you. It's already 3 months since the PCV-13 shot and some spots still linger, and some few new pimples appear on arms and legs. Will see again Dr. Dec. 15.
Hours after the shot was administered, The lower half of my body started to freeze up. By the time I woke up the next morning, I was in so much pain it was very difficult to walk. Starting from my hips (bilaterally) down to my feet were inflamed and my muscles started to knot up and made it very difficult to walk or touch.  I went to urgent care 36 hours after the shot when I noticed I broke out in a full-body rash and still had difficulty walking. From there they gave me a covid test, took pictures of my rash, and gave me predniSONE. Once on that, I started to feel a bit better and went on with my daily workouts for the next two weeks. Then at week 3 of getting the shot my legs bilateral were unstable where wabbly and inflamed again. I had to hold onto countertops to walk or my legs would give out. This is when I went to my primary care.  From there they said to just rest and I may just be having a bad reaction. I took time off of work to rest and hope that they would get better, but after another 3 weeks went by and nothing got better, it got worse, I went to the hospital. They did an ultrasound to make sure there were no blood clots. That came back negative and they referred me to a neurologist who denied my visit. So now I am in the same amount of pain with no answers.  To this day nothing has changed, I am just trying to get though my days in pain.
This spontaneous report as received from a registered nurse refers to a 13 month old female patient. No concurrent conditions were reported. Patient had no medical history or allergy/drug reactions. On 12-JAN-2016 the patient was inadvertently vaccinated with PROQUAD lot#L041626 expiry date: 20-APR-2017 and VARIVAX lot# L021211 with expiry date: 10-JUNE-2017, during the same office visit. Concomitant therapies included albuterol. On the same day shorter after the vaccination while still in the physician's office, the patient developed an unspecified reaction at the injection site. No treatment was provided for the event. Lab diagnostics studies were not performed. There were no product quality complaints (PQC) involved. The reporter did not provide the causality between the reaction at the injection site and the suspect therapy. Additional information has been requested.
Mom states pt became lethargic & limp w/temp fo 104.6; @ inject site there was swelling & incr warmth; Taken to ER; Hx of sore throat & ear infect;
Hospitalized 05/28/2022-06/02/2022; COVID-19 positive 05/28/2022; fully vaccinated plus booster BRIEF OVERVIEW: Discharge Provider: MD Primary Care Provider at Discharge: DO Admission Date: 5/28/2022 Discharge Date: 6/2/2022 HOSPITAL COURSE: Patient is a 65 y.o. who presented to the emergency department due to shortness of breath. Patient began having symptoms of sore throat, cough, fever, fatigue, weakness and reduced appetite on 5/23/22. Patient was hypoxic on arrival 86% on room air. She was placed on 3 L NC. COVID-19 PCR was positive on 5/29. Patient's lab work also noted a AKI with cr at 1.82 likely due to dehydration since she had been having reduced intake. Patient was given a 500 ml bolus in ED. She was also started on Decadron 6 mg. Patient home medications of Lasix/Losartan/Hydrochlorathiazide was held due to AKI. Patient was also given Heparin subQ for DVT prophylaxis. D-Dimer was max at 520 and lowered throughout her stay. She was slowly weaned off oxygen back to baseline of room air. AKI resolved on 6/2. We did have RT walk patient and they did recommend at discharge 2 L NC with activity. Patient slowly improved throughout her stay and was ready for discharge home on 6/2/2022.
Initial information received on 06-Aug-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a female patient (age not reported) who was vaccinated with an expired dose of PENTACEL (batch number, expiration date, dose, route and site of administration was not reported for both vaccines) on an unspecified date. The patients medical history and concomitant medications were not reported. It was an actual medication error due to expired vaccine used. It was unknown whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
This case was reported by a pharmacist via call center representative and described the occurrence of therapy non-responder in a adult patient who received ENGERIX B. Co-suspect products included ENGERIX B. On an unknown date, the patient received ENGERIX B at an unknown dose and ENGERIX B at an unknown dose. On an unknown date, unknown after receiving ENGERIX B and ENGERIX B, the patient experienced therapy non-responder and therapy non-responder. On an unknown date, the outcome of the therapy non-responder and therapy non-responder were unknown. It was unknown if the reporter considered the therapy non-responder to be related to ENGERIX B and ENGERIX B. It was unknown if the reporter considered the therapy non-responder to be related to ENGERIX B. Additional details were received as follows: The age at vaccination was not reported. The reporting pharmacist stated that she had an adult patient who had undergone two full series of ENGERIX-B, but after having titers drawn after each series (after an unknown period of time following completing each series), the patient did not achieve minimum titer levels to achieve immunity, which led the patient to be a therapy non responder. The patient's physician prescribed a 40 mcg dose for a third series for the patient, despite the patient not being a dialysis patient, but the 40 mcg dose was not administered by the time of reporting. The reporting pharmacist did not feel comfortable sharing patient information, and did not have access to lot numbers and expiration dates.
fever; chills; sweaty; This is a spontaneous report received from a contactable physician via a Pfizer sponsored program. A patient of an unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number and expiration Date not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. The patient experienced fever, chills and sweaty on an unspecified date. The outcome of the events was reported as unknown.  No follow-up attempts are possible. No further information is expected.
Information has been received from a physician concerning a 14 year old female patient who in approximately October 2007, was vaccinated with the first dose of Gardasil.  Subsequently the patient experienced lightheaded and nearly passed out.  Unknown medical attention was sought.  At an unspecified date the patient recovered.  No product quality complaint was involved.  Additional information has been requested.
Vaccine was drawn up 09/30/2022 and given 10/03/2022