chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Covid 19/Covid; Bruises and bleeding after injections; Bruises and bleeding after injections; Spondylitis ankylosing aggravated; This spontaneous case was reported by a consumer and describes the occurrence of ANKYLOSING SPONDYLITIS (Spondylitis ankylosing aggravated) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ankylosing spondylitis.    Concurrent medical conditions included Ankylosing spondylitis.   In July 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. In 2022, the patient experienced ANKYLOSING SPONDYLITIS (Spondylitis ankylosing aggravated) (seriousness criterion medically significant). In September 2022, the patient experienced VACCINATION SITE BRUISING (Bruises and bleeding after injections) and VACCINATION SITE HEMORRHAGE (Bruises and bleeding after injections). On an unknown date, the patient experienced COVID-19 (Covid 19/Covid). In 2022, ANKYLOSING SPONDYLITIS (Spondylitis ankylosing aggravated) had resolved. At the time of the report, VACCINATION SITE BRUISING (Bruises and bleeding after injections) and VACCINATION SITE HEMORRHAGE (Bruises and bleeding after injections) was resolving, and COVID-19 (Covid 19/Covid) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive.         Concomitant and treatment medications were not reported.  Patient received Moderna covid-19 booster vaccine with number of 4782588.  It was reported that patient had covid, covid-19, had a flare up ankylosing spondylitis, bruises and bleeding after injections and bruises and bleeding after injections with adalimumab solution for injection.  On unknown date, Covid 19 was resolved.  The reporter's causality for the events of bruises, and bleeding after injections, had a flare up ankylosing spondylitis with Adalimumab Solution for Injection was not provided.  The reporter's causality for the events of Covid with Adalimumab Solution for Injection was no reasonable possibility.  Company comment: This spontaneous case concerns a 42-year-old female patient with medical history of ankylosing spondylitis, who experienced the unexpected, serious (medically significant) event of ankylosing spondylitis an unknown time after a dose of mRNA-1273. Ankylosing spondylitis can present relapses as part of the natural history of disease, so that could be a contributory factor for the event. Information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. Outcome was reported as resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Next day after receiving Adacel developed fever, chills and swollen left supraclavicular lymph node. Area was red and swollen.
She mentioned that with the mRNA Pfizer COVID-19 Vaccine she kept getting COVID-19, and not only her, but her family and neighbors also; She mentioned that with the mRNA Pfizer COVID-19 Vaccine she kept getting COVID-19, and not only her, but her family and neighbors also; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "She mentioned that with the mRNA Pfizer COVID-19 Vaccine she kept getting COVID-19, and not only her, but her family and neighbors also". Clinical course: She mentioned that with the mRNA Pfizer COVID-19 Vaccine she kept getting COVID-19, and not only her, but her family and neighbors also. Then she added that the only people she knew without COVID were people who didn't get the vaccine. She mentioned her question came because since she was about to get her yearly flu shot, she wanted to get the regular flu shot because it helped so a change of formula to mRNA had her scared. Caller was asking why Pfizer wants to turn flu shot to MRNA, knowing that the covid-19 vaccine was not working. She also mentioned that people did not take flu shots because they said that it did not work well.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from an RN concerning a retired 60 year old white female pt with allergies to NSAIDS, Augmentin and Novocain who on 28OCT2003 was vaccinated in the left deltoid with a first dose of pneumococcal 23v polysaccharide vaccine. There was no concomitant medication. On 31OCT2003 the pt developed left arm redness and pain. The pt recovered from left arm redness and pain on 02NOV2003. There were no laboratory or diagnostic tests performed. The pt was not ill at the time of vaccination and had no adverse events prior vaccination. No additional information is expected The RN also reported that three other pts who had similar experiences following vaccination with dose of pneumococcal 23v polysaccharide vaccine.
Patient began to feel a little dizzy about 25 minutes after her vaccination with some diaphoresis.  Patient vital signs were taken and mask removed for ventilation. B/P 186/98, HR 101. and O2 sats were 98% on room air. Patient resting and reevaluated after 10 minutes and vital signs as followed B/P 139/93, HR 81, and O2 sats were 98% on room air. Patient reported feeling better all symptoms resolved. and patient released accompanied by spouse .
Shingles; This case was reported by a nurse via call center representative and described the occurrence of shingles in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number F49L5, expiry date 1st December 2021) and (batch number 9557F ?, expiry date unknown) for prophylaxis.   On 16th December 2019, the patient received the 1st dose of Shingrix. On 16th December 2019, the dose was an unknown dose. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The registered nurse reported that the patient experienced Shingles after receiving the dose of Shingrix. The reporter did consent to follow up.
Fainted 5 minutes after vaccine Started feeling hot and feverish, sweating, vision blurred, heart racing and then trouble hearing, turned green.
Patient is fully vaccinated. ED visit on 11/27/2021. 75-year-old female presented with complaints of cough and COVID-19 x1 week. She states home pulse ox dropped to 70%. She is not on any medications. She denied chest pain, shortness of breath, leg pain, leg swelling, nausea and/or vomiting. She admitted to congestion. ED assessment is positive for congestion and rhinorrhea and cough. SpO2 98%. EKG: normal sinus rhythm. CXR shows interstitial opacities consistent with COVID-19. She started on steroids and given referral for infusion. Labs reviewed, no significant abnormalities. Patient discharged home.
Patient presented to the pharmacy on 8/13/20 with potential cellulitis of the left arm- redness, heat of upper arm. She stated that it began on 8/11/20; the day that she received the vaccine. Patient was advised to use a cold compress, take a benadryl and to contact her PCP.
No additional adverse events reported; a dose of PROQUAD was given instead of Pentacel; This spontaneous report was received from an office manager, referring to 4-month-old male patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 05-APR-2021, the patient was given a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection (strength, vaccination scheme, anatomical site of injection, route of administration and lot number were not reported; expiration date was reported as 21-DEC-2021) as prophylaxis, instead of hib conj vaccine (tet toxoid), diphtheria toxoid, pertussis acellular 5-component vaccine, poliovirus vaccine inactivated (mrc-5), tetanus toxoid (PENTACEL) (strength, lot number and expiration date were not reported) (wrong product administered). No additional adverse events reported. The parents of the patient had not reported adverse side effects from the shot.
Patient received Covid-19 Vaccine today, 03/24/2021. During the 15 minute post-vaccine observation period, the patient began to feel faint.  Her condition worsened to feeling nauseous and blurred vision, so patient asked to lie down.  We found a quiet area in the employee break room for the patient to lay down.  and provided her a pillow, water, cool compress for her head, and later, orange juice for her comfort. We proceeded to call 911 for medical attention. EMS professionals evaluated patient's vital signs and patient signed waiver refusing to go to hospital, since she was feeling better. Patient left on her own accord with a friend driving her home.
Upon administering Shingrix with a Vantage point syringe the needle came off the syringe and the vaccine contents did not penetrate the patients's arm.  The patient was revaccinated.
Began feeling dizzy and nauseated.   Started vomiting at approximately 5:00pm and continued until 6:30 or 7:00pm. I could not open my eyes because of the extreme dizziness. Chills Sweating I was able to sleep for a few hours and woke up at 10:00pm and the symptoms had subsided. I woke up with a headache on Sunday morning.  That went away and have not had any symptoms since
Starting coughing around 7:15, then chest felt tight and had trouble breathing. Took 2 Benadryl. 3 hours later woke up to extreme nausea. Around 6 am on 11/12/2103 woke up having chills and extreme tiredness and hoarseness with congestion. Generally a healthy person and was completely fine before shot was administered.
Hard, blotchy, lumpy welt.  Cold compress.  Symptom signs still present after one week.
7 week old baby. Born premature at 35 weeks. Administered DTaP and HIB vaccines. Within hours he became almost catatonic. He would not move, did not cry and would not nurse. It was terrifying. Believed to be a reaction to DTaP vaccine. Improved and essentially came back to alertness after 24 hours.
PATIENT IS HAVING REACTION TO VACCINE, HOT ON TOUCH RASH WITH PAINFUL AREA
Patient experienced left-sided chest pain shortly after his first dose of vaccine was administered that did not resolve over the course of 30 minutes. Patient was taken to ER by family to be evaluated. Unsure at this time of outcome.
Huge circular hard red rash at injection site, diarrhea, nausea, increased asthma, pain
I have Rheumatoid Arthritis and I had stopped treatment in March of 2020 . My RA seemed to be under control up until three weeks after the second dose of the Covid-19 vaccine. I just had a little fatigue. I got injured and got a Tetanus shot within a week of the dose. Three weeks after my second dose my Rheumatoid Arthritis flared up all over my body and especially in my left arm. I had joint pain in all of my joints. I have a previous injury and arthritis in that shoulder. My shoulder was on fire and my hands swelled up. I saw my Rheumatologist and after I started on Prednisone the swelling in my joints had gone down and the pain was better. My symptoms improved  in three days.  I also have started back on Methotrexate once weekly and my Humira since then.
PATIENT PRESENT AT THE PHARMACY WITH INFLAMMED  ARM, REDNESS AT SITE  AND LIGHT SWELLING
devel pain in shoulder, down to hand, then hip 2 days p/vax;hands & fingers swollen & painful;in good hlth prior w/no hx of arthritis or other problems;
debilitating headache day after shot, headache has not completely gone away since shot. Pain level varies day to day between 3-5 on a good day and 8-10 on bad days. Good and bad days are about equal. There is no way I would ever take a third dose.
No additional AE/PQC's reported; excursions vaccine was administered to patients; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 20-AUG-2021, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX)  lot # T002847, expiration date 23-JAN-2022 (dose number, dose and route of administration were not reported) for prophylaxis.  The vaccine was stored improperly in the temperature between 6 degrees Fahrenheit (F) to 14 degrees Fahrenheit (13.5 F) for the time frame of 57 minutes, and between 6 degrees Fahrenheit (F) to 14 degrees Fahrenheit (7.3 F) for  the time frame of 15 minutes. There was no previous temperature excursion. No adverse event was reported.  This is one of two reports from the same source.; Sender's Comments:  US-009507513-2108USA006114:
experienced sharp pain bottom ocher foot same side of vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered" (2021), described as "experienced sharp pain bottom ocher foot same side of vaccine".  Additional information: Patient experienced sharp pain bottom ocher foot same side of vaccine after a few hours of taking vaccine lasted less 24 hours nothing since. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
First dose as well as second dose of the vaccine was followed by immediate vaginal bleeding which lasted for a week. Bleeding is still ongoing after the second vaccine shot. A red spot in the eye has appeared without any known reason.
Pain in left shoulder; decreased strength in left arm; injection given near top of left shoulder. Pain continues.
On 5/22/2015 I had my yearly physical and checkup with my primary care MD. For a 75 year old I am very healthy, and was that day also, with complete physical exam all normal for heart and lungs. Before leaving I accepted the PCV13 vaccine, PREVNAR. I returned home about 10 AM, feeling fine. That evening my arm felt stiff but nothing bothersome. I went to bed, slept well, woke up next day at 7AM with a slight cough. Later in the day my cough became strong, hacking and productive. For the following 3 days I became much worse, fever, chills and extremely weak. The cough became uncontrollable, very deep, and weakened me even more, to the point that I couldn't get out of bed. On 5/28 I finally had to get to the doctor. I was examined and she told me I had pneumonia. I have been and am finishing up my prescription of antibiotics today and feel much better, but still have a productive cough, very hard at times. My doctor tried to tell me the vaccine can't cause this but I know better. I had no signs whatsoever of an upcoming sickness the day I got the vaccine, and hadn't been exposed to anyone sick. Doctors need to have this information to give to patients before the patient accepts this vaccine. I have always trusted my doctor but am not sure now if I will get any more vaccines. I think I have gotten all of them needed up to today with no previous side effects. I am not one of those people who oppose vaccines.
Patient hospitalized for vaginal delivery at 40.1 weeks gestation of healthy baby boy who was 8# 13.5 ounces. Normal postpartum course. This delivery was within 6 weeks of receiving COVID vaccination.
incidental finding, asymptomatic with positive PCR for covid-19 on 2/18/22. Patient remained asymptomatic
After the shot and prior to the event on 4/22/21, was extremely drousy and slept for 3-4 days during waking hours. No energy. Then on 4/22.21, at 11:30 am started experiencing stomach pain and upset that went into chills, aches all over, cramps and finally vomiting to the point of dry heaves. After which the vomiting ceased. did not eat solid food for 3 days, just soup and cereal in milk. Ate a chicken sandwich on Sunday afternoon and back on liquid. Stomach still upset. No diareha but excessive powerful fladulation. Took Alkaselser and discovered it has asprin in it. Not sure if is reacting to the Covid shot 2 weeks prior. Still in abdominal distress , dizziness and ringing in the ears. Not sure if reaction to the second Covid  shot or something else. Please advise.
Information has been received from a nurse concerning a 4 year old patient of unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. On an unknown date the patient was vaccinated with one dose of VARIVAX lot # N008077, expiry date 09-MAR-2019, subcutaneously for prophylaxis, following temperature excursions of -12.3 Celsius degree for 30 minutes and -9.8 Celsius degree for 3 hours 30 minutes (product storage error). A data logger was involved. No adverse effect was report. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1711USA010722: US-009507513-1711USA010723: US-009507513-1711USA010724: US-009507513-1711USA010725: US-009507513-1711USA010726: US-009507513-1711USA010727: US-009507513-1711USA010728: US-009507513-1711USA010729: US-009507513-1711USA010730: US-009507513-1711USA000697:
Swelling in right arm (arm in which MCV was administered). Right arm soreness. Applied ice.
patients who received a vaccine which was more than 30 days in the refrigerator; patients who received expired vaccine; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients who received expired vaccine) and PRODUCT STORAGE ERROR (patients who received a vaccine which was more than 30 days in the refrigerator) in a 61-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 07-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients who received expired vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (patients who received a vaccine which was more than 30 days in the refrigerator). On 07-Jul-2021, EXPIRED PRODUCT ADMINISTERED (patients who received expired vaccine) had resolved. At the time of the report, PRODUCT STORAGE ERROR (patients who received a vaccine which was more than 30 days in the refrigerator) had resolved.        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.   No Concomitant medications were reported. No Treatment information was reported.   Reporter did not allow further contact
Pt had localized redness, swelling, with hives and itching on bilateral antecubital space. Painful to touch. Pt was seen by provider, administered 25mg of Benadryl IV, observed for 1 hour post treatment. Symptoms cleared, ensured patient had ride home.
Pt received his bivalent vaccine too soon. The previous dose was 8/20/2022
Initial reaction beginning day 1:  fever of 103, most severe headache I've ever experienced, similar to a "brain freeze" when drinking something too cold, severe chills, body aches, dizziness, and blurry vision.  Day 3:  went to urgent care for right-sided weakness and my right foot had been asleep for 11 hours.  Urgent care doctor suspected potential Guillain-Barre and it was strongly suggested to go to ER for neuro workup.  The medical chart said "rare inflammatory immune response due to vaccine".  I went home, hoping it would pass.  Woke up on Day 5 with right-sided facial paralysis.  Went to ER and had an MRI, CT of the head and neck to rule out stroke, EKG, and bloodwork.  Suspected bells-palsy and loss of peripheral vision, medical chart included vaccine-related injury.  Was referred to neurology, despite intense pressure to be admitted, we agreed that I would follow up with neuro.  Appointment with neurologist and complete battery of tests resulted in a positive monoclonal IGM Lamda and positive for myasthenia gravis.  Referred to Hematologist.  Follow up bloodwork in January resulted in the monoclonal IGM Lamda had resolved itself and I was released from care of Hematologist.  Follow up with neurologist, I have now been referred to have chest CT to rule out thymus gland issues.  Still have ongoing symptoms of myasthenia gravis.
Bumps on her feet; Bumps on feet were really itchy; bumps on feet were welts-like during the morning; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (Bumps on her feet), PRURITUS (Bumps on feet were really itchy) and URTICARIA (bumps on feet were welts-like during the morning) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced BLISTER (Bumps on her feet), PRURITUS (Bumps on feet were really itchy) and URTICARIA (bumps on feet were welts-like during the morning). On 13-Apr-2021, BLISTER (Bumps on her feet), PRURITUS (Bumps on feet were really itchy) and URTICARIA (bumps on feet were welts-like during the morning) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported.  No treatment information was reported.
Information has been received from a pharmacy technician referring to multiple unspecified patients of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On unknown dates, the patients received improperly stored PROQUAD (lot # L016393, expiration date 08-NOV-2016; lot # L045678, expiration date 09-MAY-2017; lot # M004891, expiration date 25-JUL-2017, dose and route were unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient is a 71-year-old female, who presents to the Hospital with a several-day history of increasing cough, increasing weakness, shortness of breath.  The patient is on hemodialysis, for which she undergoes hemodialysis 3 times per week.  The patient has had diabetes mellitus, for which she is on insulin with the last hemoglobin A1c of 6.6.  The patient denies chest discomfort, palpitations, or syncope.           7/20/2021tested positive 8/9/2021 discharged  This is a 71-year-old woman who was admitted yesterday with complaints worsening cough shortness of breath and fatigue.  The patient is on hemodialysis for end-stage renal disease.  She is quite drowsy but easily arouses.  She had maximum temperature of a 100.3° F since admission, she is currently afebrile.  On presentation she was saturating at 81% on room air.  She is currently on 8 L of oxygen via OxyMask.  She had an elevated BNP of greater than 70,000. Chest x-ray done on admission revealed mild cardiomegaly  She received the COVID-19 vaccine at dialysis per her nephrologist.