chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient got lightheaded and clammy. Eyes rolled to back of head about 3 minutes after injection. MT assessed pulse, slow but steady. RE got BP cuff and took BP. 1st BP reading was 146/96 with pulse of 59. Sat O2 was 100% Staff went to get patient water per patient request. Resident claims he 'lost hearing' for a small time period. BP reading at 1147 was 148/91. SS, CNP, was summoned to vaccination area to assess patient. Spoke with patient / family. He has had similar reaction before after knee surgery. Patient feeling better. CNP requests continued observation until DBP is below 80. BP reading at 1153 is 135/79. Patient released from observation and left vaccination clinic.
This spontaneous report as received from a nurse practitioner refers to two unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot # M033905, expiration date 20-JUL-2018 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 15 to 46 degrees Fahrenheit (-9 to 8 degrees Celsius) for 8 hours. Data logger was involved. Previous excursion of 6 to 14 degrees Fahrenheit / -14 to -10 degrees Celsius for 2 hours was also reported. Additional information has been requested.
COVID-19 Treatment/Vaccination failure; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old male patient received BNT162b2 (BNT162B2), on 04Apr2021 as dose 1, single (Lot number: EM9810), on 25Apr2021 as dose 2, single (Lot number: EW0175), on 17Aug2021 as dose 3 (booster), single (Lot number: FC3182) and on 16Jan2022 as dose 4 (booster), single (Lot number: FL3197) at the age of 58 years for covid-19 immunisation. The patient's relevant medical history included: "History of cancer (AML) treatment (Vidaza, Venetoclax) ongoig." (ongoing); "Chronic GVHD" (unspecified if ongoing); "CKD" (unspecified if ongoing); "lymphedema (lower legs and feet)" (unspecified if ongoing). Concomitant medication(s) included: ISAVUCONAZONIUM; SODIUM FLUORIDE 5000 PLUS; CALCIUM 500+D; ATOVAQUONE; ATORVASTIN; SIROLIMUS; PENTOXIFYLLINE; VENETOCLAX; AMLODIPINE; GRANISETRON; DOCUSATE; PANTOPRAZOLE; VALACYCLOVIR [VALACICLOVIR]; CYANOCOBALAMIN. Past drug history included: Cytarabine, reaction(s): "allergies", notes: Known allergies: Yes. The following information was reported: COVID-19 (medically significant) with onset 2022, outcome "unknown", described as "COVID-19 Treatment"; VACCINATION FAILURE (medically significant) with onset 2022, outcome "unknown", described as "COVID-19 Treatment/Vaccination failure". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Unknown Results, notes: Indication: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.   Clinical Course: Patient received anti-viral treatment, started from 16jun2022 to 21 jun2022 for covid-19 with lot number GC4718 and treatment of COVID-19. also, patient received other medication in 2weeks which includes Multivitamin-min-folic-vit K lycopodium 400-20-370 mcg tablet. Mild symptoms of covid was reported as (sore throat, nasal congestion, runny nose, dry cough). The vaccine received reported as yes. Other medication in 2weeks reported as yes.
4/29, 8:10 p.m.- Right arm hurts, upper arm is numb (not like my spinal cord damage, but like when your arm is squeezed tight by a blood pressure cuff). The numbness has spread around my back along my shoulder blade.  4/29, 9:40 p.m.- Numbness has spread down my arm and into my little finger. 4/29, 10:06 p.m.- Numbness/pain spread over the upper right side of my body running from spine to sternum, feels numb, but also like I?m on fire. Muscles hurt like someone took a baseball bat to that arm. 4/30, 5:30 a.m.- The burning and numbness spread across my spine and into my left shoulder blade.  I started running a fever. 4/30, 12:46 p.m.-I?m still in pain, but the numbness pulled back some so that it?s only going from spine down my right arm, no left side involvement, but I now can?t feel my ring finger or little finger and it bothers me to use them.
Patient received 1st dose Moderna  on 2/6/2021, received 2nd Moderna on 3/6/2021 . Then patient received Pfizer at Vaccine clinic on 10/18/2021, reached out to patient next day on 10/19/2021, asymptomatic. No symptoms, no headache, no chills, no fever, no swelling, no itching, asymptomatic.
pt c/o sweaty palms, tight chest, tightness in R and L shoulder and up neck within minutes of injection given. Pt vitals were monitored and WNL. Pt felt better in chest and some in shoulder within a few minutes of laying down. Symptoms started back within 5 minutes. Epi Auto Injection given in thing and 911 notified. Pt refused transportation to ER via ambulance. Pt was checked out by EMT's and released. Discharged an hour after event to husband.
MSG LEFTTC 4-9-21 STATES HAS NAUSEA/VOMITING.  STATES HAD CALLED PCP. 4-12-21 10AM RETURNED TC:NO ANSWER.
Redness at injection site; Fatigue; Fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness at injection site), FATIGUE (Fatigue) and PYREXIA (Fever) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.  On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Redness at injection site), FATIGUE (Fatigue) and PYREXIA (Fever). At the time of the report, VACCINATION SITE ERYTHEMA (Redness at injection site) and FATIGUE (Fatigue) outcome was unknown and PYREXIA (Fever) had resolved.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.  No concomitant medication information was reported. No treatment medication information was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Duration of event fever was 24 hour. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
No adverse event occured in terms of the health of the patient.  The patient came in for their first dose of the Pfizer primary series for infants 6 mos to 5 years of age.  The patient received a bivalent dose of pfizer for infants aged 6 mos to 5 years old (as prescribed for the third dose in the primary series) instead of the monovalent dose for infants aged 6 mos to 5 years old (as prescribed for the first and second dose in the primary series).  The bivalent dose was administered in error after the site supervisor accidently picked the wrong vial of infant pfizer from the refrigerator (a bivalent vial instead of the monovalent vial) and gave it to a staff member to prepare.  The site supervisor had mistakenly believed it was a monovalent vial when storing it before the clinic started, and failed to check the lot number both at that time and when handing it to the vaccine preparer which would have alerted the site supervisor that it was a bivalent vial and not a monovalent vial of Pfizer for infants 6 mos to 5 years.  The vaccine preparer handled the vial believing it to be a monovalent vial and did not recognize the lot number as being foreign for such a dose.  The vaccinator did not realize the vaccine they were handed was a bivalent dose as they also did not recognize the lot number as being foreign.  When the vaccine lot number was to be entered into the computer for the patients record, the staff alerted the site supervisor that it was not shown in the drop down menu, but the vaccine had already been administered at that point and it was too late to administer the prescribed monovalent dose.  Following CDC guidelines, the patient's guardian was informed of the error and told to continue with the rest of the Pfizer infant primary series which includes a monovalent dose 3+ weeks after the first dose, and a bivalent dose 8+ weeks after the second dose.
Patient received Tdap and Varicella #1 on 8-17-06, returned to clinic 10/18/2006 to receive Varicella #2, However parent explained that 24 hours after 8/17/06 injections his daughter had a seizure.  Family took patient to emergency room was examined by neurologist. No treatment given.  Family to follow up with pediatrician.
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 48-year-old male patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). At the time of the report, 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 Route), the reporter did not provide any causality assessments. Concomitant and Treatment medications was not specified.
On 8/4/09 finger, toe tingle; denies muscle weakness. 8/24/09 healthy check; above symptoms not stated to Dr. 9/13/09 sx suggest Guillain-Barre, BOOSTRIX given. 10/13/09 neuro confirms Guillain-Barre.
My arm became a little itchy for several days prior to the bumps or rash starting (last night 4/2/21) Today I noticed the area to be hard under the skin also. It feels warm to the touch yet feels cool when not touching it?  It doesn?t hurt. As of yet.
Pain, extreme swelling at injection site. Skin hard and hot to the touch. Fever, chills, sweating. Outcome is my arm is still extremely swollen, painful, hard, red, hot amd still feverish
Itchy; rash like hives on face, eyes, arms, back, legs, mouth; Stuffy nose; 99.5 fever; rash like hives on face, eyes, arms, back, legs, mouth; This is a spontaneous report from a contactable Consumer. A 14-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm Left on 25Aug2021 15:00 (age at vaccination 14-years-old) as dose 2, single for covid-19 immunisation. Medical history included ADHD from an unknown date and unknown if ongoing. Concomitant medication included methylphenidate hydrochloride (CONCERTA) in two weeks. The patient historical vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm Left on 04Aug2021 12:00 (age at vaccination 14-years-old) as dose 1, single for covid-19 immunisation. Patient was not taken any other vaccine in four weeks. On 27Aug2021 17:00, patient experienced Itchy, rash like hives on face, eyes, arms, back, legs, mouth. Stuffy nose, 99.5 fever. Ae resulted in physician office visit. Treatment received with Benadryl, Prednisone RX. Patient has stated that she had not been diagnosed with COVID -19 prior to vaccination and not been tested since the vaccination. Outcome of the events was recovering.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Information has been received from a RN concerning a pt who on 14Jul95 was vaccinated with a dose of varicella virus vaccine live (lot 608657/0419B). Subsequently, on 22Feb1999, the pt developed chickenpox. The pt was seen in the office. The reporter also indicated that 30 other pt's were vaccinated with varicella virus vaccine live and developed chickenpox (WAES0409USA00600, WAES0409USA01045, WAES0409USA01046, WAES0409USA01047, WAES0409USA01048, WAES0409USA01049, WAES0409USA01050, WAES0409USA01051, WAES0409USA01052, WAES0409USA01053, WAES0409USA01054, WAES0409USA01055, WAES0409USA01057, WAES0409USA01058, WAES0409USA01059, WAES0409USA01060, WAES0409USA01061, WAES0409USA01062, WAES0409USA01063, WAES0409USA01064, WAES0409USA01065, WAES0409USA01066, WAES0409USA01067, WAES0409USA01068, WAES0409USA01069, WAES0409USA01070, WAES0409USA01071, WAES0409USA01072, WAES0409USA01073, WAES0409USA01074). No further information is expected.
Child spiked 101 at 11PM same day of vaccination. Mom noticed redness of left arm the evening of 6/9 and noticed puffiness of left arm next day. Applied ice 6/10/03 in the evening - still puffy and swollen and itchy since last night. Observed localized redness about 2" in diameter with puffiness and swelling of the left upper deltoid, arid, warm to touch.
headache; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, first dose) solution for injection intramuscular in the left arm on 20Jan2021 at 12:30 (at the age of 45-years-old) at single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. After the first dose (Jan2021), the patient just had a slight headache. No treatment was provided for the event headache. The outcome of the event headache was recovering. Since the vaccination, the patient has not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.;
CRAMPING TO RIGHT UPPER ARM AND NECK AREA, PAIN, ITCHING AND TINGLING TO FINGERS, HOT TO TOUCH.
This spontaneous report was received from a health professional refers to a patient of unknown age and gender. The patient's medical history and concomitant medications were not reported. On 21-JUN-2016, the patient was vaccinated with VAQTA (lot # L015460, expiry date: 20-JUL-2017) for prophylaxis (dose and route was not reported), which was stored improperly.
Adverse event: Vaccine administered 6 days after beyond use date and less effective. Treatment: Pt is receiving another dose in office as recommended by Pfizer.
Patient came back to pharmacy 2 days after vaccine administered. She reported extreme soreness on Monday which had resolved but there was a red rash from her shoulder to her elbow. She was concerned it was more than what should be expected with normal redness at sight.
On 4/3/21 around 8pm I noticed my abdomen was inflated and there pain, like gas pain. I took Pepto Bismal and went to bed. I woke up the next morning and was fine. Around 10pm 4/4/21 I have a 101 F fever, I took Tylenol. My face was also in pain and there was bruising underneath my eyes. I could not touch my face because of the pain. The fever and face pain lasted 24 hours but the bruising lasted for 48 hours. I called my doctor, he told me to just take Tylenol for my fever and my symptoms should not last. My breathing was normal, no sinus related symptoms.
11/13/08 Left arm started swelling, itching. Became red, hot. Body temperature was 102 degrees. 11-14-08 went to ER, diagnosis cellulitis treated with antibiotic and BENADRYL. 11-25-08 the arm is fine now except for some itching that remains.
TWITCHING-JERKING OF SHOULDER, ARM, LEG, FOOT FOR A TOTAL OF 15 MINUTES IT LASTED AND EVERY 10 SEC BABY WOULD GIVE 4 TWITCHES OF SHOULDER, ARM, LEG FOOT
4 hours post vax, pt reported extreme irritation, irritability and hot flashes with decreased level of concentration. Also reported pain at site of vaccination.
On 07/25/2023, patient approached the table requesting a Pfizer Covid vaccine. The client said she had never received a COVID vaccine before because she was ?nervous? but wanted to get one today because the security job she was applying for required it. RN, asked the patient for her demographic information and reviewed the patient's immunization record in the Registry to confirm vaccine eligibility. The patient stated that she was allergic to ?pollen, dander, and dust.? The client reported having a history of depression, anxiety, and a benign tumor on her adrenal gland. The patient said she had medical insurance and a primary care provider. RN, vaccinated the patient with a Pfizer Bivalent vaccine lot# GM1767 exp 07/31/2023 in the left deltoid at 8:14am.  The patient completed a 15 minute observation period after vaccination per the CDC guidelines. RN educated the client about possible side effects of vaccination and when to seek medical care.  The patient denied symptoms of distress and walked away with a steady gait.  At 9:18am, the patient returned to the table stating, ?I got a rash on my arms all of a sudden but then the rash went away.? RN, assessed the client's forearms and saw that both forearms had flat red areas of irritation.  The patient said the redness RN observed was there prior to the vaccine and that the new rash she experienced had come and gone away immediately.  The client denied itching or redness in any other area. The patient was alert and oriented x 4.  At 9:20am, the patient gave consent to RN to check her vital signs. BP 160/90 left arm, BP 158/98 right arm, pulse 100 and regular, SpO2 98%, respirations 20 and unlabored. The patient's skin was warm, dry, and appropriate color for ethnicity.  The client denied having a headache or blurred vision. RN referred the client to the neighborhood healthcare clinic on site for her blood pressure.  The client said she wanted to take a nap but would go after her nap. The patient said she smoked 1/3 pack of cigarettes a day.  The patient stayed for observation until 9:30am.  The client said the rash she had seen had not come back.  No new rash was visible to RN.  Repeat vitals at 9:30am were BP 158/98, pulse 102, SpO2 98%, respirations 20. RN reminded the client again to go to her doctor to discuss her heart rate and blood pressure. At 9:37 am,  the patient walked away with a steady gait.
pt recv vax;MD reported that pt failed to seroconvert&titer levels are below protective levels;MD stated that he has not been able to determine any immunodeficiencies in pt;
Given the vaccine on day 31 days of expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Given the vaccine on day 31 days of expiry) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 037C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Given the vaccine on day 31 days of expiry). On 14-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Given the vaccine on day 31 days of expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   There are no treatment or concomitant medications given.
Red at injection sight, sore, extreme pain, unable to sleep, affected memory, unable to comprehend
COVID-19Vaccine EUA Sore arm for about 2 days  Red area where shot was given size of 50 cent piece Chills that lasted about 10 hours
Walking to bed and headed to restroom. I felt perfectly fine. Blacked out in the restroom. Hit chest on either door handle or toilet. bruised ne and lost bladder control. When i awoke I had chills and fever. Crawled to bed and took temp. 102. Shivering and chills all night. Fever stayed at 102 for evening. Next day it was 101.5 all day. spent day sleeping and through the next night. Chest pain from hitting chest. exhausted entire weekend ..
severe abdominal pain, waking him from sleep. Pain was periumbilical and supra- public region/Pain has recurred twice (24 and 48 hours post vaccination) waking from sleep each successive night; severe abdominal pain, waking him from sleep. Pain was periumbilical and supra- public region/Pain has recurred twice (24 and 48 hours post vaccination) waking from sleep each successive night; Recurrent events were also associated with a left sided headache, dull and throbbing in nature; This is a spontaneous report from a contactable other healthcare professional. A 68-year-old male patient received bnt162b2n(PFIZER-BIONTECH COVID-19 VACCINE, lot: EL0140), intramuscular in the right arm on 29Dec2020 19:00 at a single dose for COVID-19 immunization. The patient's medical history included dyslipidaemia and hypothyroidism from an unknown date and unknown if ongoing. the patient has no known allergies. Concomitant medications included acetylsalicylic acid (ASPIRIN 81), levothyroxine sodium (SYNTHROID), and atorvastatin calcium (LIPITOR). On 30Dec2020 (5-6 hours post injection), the patient developed severe abdominal pain, waking him from sleep. Pain was periumbilical and supra- public region. Relieved with analgesia (over the counter analgesia). CT scan the following days negative for appendicitis. Pain has recurred twice (24 and 48 hours post vaccination) waking from sleep each successive night and relieved with analgesia. Recurrent events were also associated with a left sided headache, dull and throbbing in nature, the initial event was not associated with a headache. The outcome of the event was recovering. The vaccine was administered in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient  was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination.
Time of shot: 3pm Onset of reaction: 9pm Stomach ache and headache Hour later: fever (99.5) and chills Difficulty sleeping Kept her home from school today (4/22/2021)
Individual called with positive test result on 9/14/21.   Individual still symptomatic with cough, congestion, sore throat, and fever.  Advised to isolate from family in separate rooms for at least ten days (s/s onset 9/13/21) and to update mgmt. She did not participate in the study but would like to have the antibody testing done.  Advised to go after isolation period is over to get test done.  Also, advised to callback with any changes.
Patient had requested covid and flu vaccine. Received Boostrix in place of flu vaccine by error.
Information has been received from a certified medical assistant concerning a 90 year old female patient with osteoarthritis, osteopenia, gastroesophageal reflux disease, psoriasis, and no known allergies, who on 10-NOV-2005 was vaccinated (route unknown) with a 0.5 ml first dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included calcium (unspecified), vitamins (unspecified) and propranolol HCL (Inderal).  On 10-NOV-2005, the patient had a reaction at the injection site which included redness with a discoloration, swelling, hardness and pain. On 16-NOV-2005 the patient was treated with ice, acetaminophen (TYLENOL), and diphenhydramine hydrochloride (BENADRYL).  The patient's present status was reported as not recovered.  No product quality complaint was involved.  No additional information is expected.