chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection arm warm/ my arm is still warm to the touch), LIMB DISCOMFORT (Injection site arm hurts to move), PAIN IN EXTREMITY (My arm was sore), PAIN (Achy) and FATIGUE (Fatigued) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced VACCINATION SITE WARMTH (Injection arm warm/ my arm is still warm to the touch), PAIN IN EXTREMITY (My arm was sore), PAIN (Achy), FATIGUE (Fatigued) and VACCINATION SITE PAIN (Sore arm at the injection site). On 22-Apr-2021, the patient experienced VACCINATION SITE SWELLING (Injection site swollen/  My arm is still swollen) and VACCINATION SITE ERYTHEMA (Injection site red/  my arm is still red). On an unknown date, the patient experienced LIMB DISCOMFORT (Injection site arm hurts to move). At the time of the report, VACCINATION SITE WARMTH (Injection arm warm/ my arm is still warm to the touch), LIMB DISCOMFORT (Injection site arm hurts to move), PAIN IN EXTREMITY (My arm was sore), VACCINATION SITE PAIN (Sore arm at the injection site), VACCINATION SITE SWELLING (Injection site swollen/  My arm is still swollen) and VACCINATION SITE ERYTHEMA (Injection site red/  my arm is still red) had not resolved and PAIN (Achy) and FATIGUE (Fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant product use was reported. No treatment information was provided.  The patient had the first dose of the Moderna Covid-19 vaccine and had a sore arm at the injection site. On 14-Apr-2021, the patient was achy, and their arm was sore, warm and the patient was fatigued.  On 22-Apr-2021, the patient had their arm still swollen, painful, red, and warm to the touch. The patient also reported that their arm hurts too much to be able to comfortably move it.
Mom reported that around 8:00 pm, he began "coughing a lot & wheezing. Gave Mucinex cough med.  Pt was not very active, wanting to lie around. Kept saying, "Mommy I'm stuck."  She picked him up, and he was able to walk, but he would not voluntarily stand.  After the cough med, he slept OK.  She didn't notice much wheezing.  In the morning he awoke with puffy eyes, hands & feet.  No more cough or wheeze. Grandma gave 1/2 tsp Benadryl.  Mom called the office around noon, and pt was appointed to be seen. She picked him up for an appointment and noticed at 3:40 a rash all over his body (hives).  The rash was not there in the morning. In the office pt was found to be alert, vigorous, in no respiratory distress. He had generalized urticaria & mild facial & hand/feet edema.  Breath sounds were clear & equal with no wheezing. Prednisolone was administered in the office and an RX for Epi-Pen Jr was given (to be used if wheezing or increasing edema developed), along with 4 more days of Prednisolone.  Mom was instructed to take patient to the ER if any wheezing developed or if edema worsened.
Patient was scheduled for Pfizer vaccine due to age = 17 years. She was given Moderna inadvertently.
Patient received COVID-19 vaccine and waited 15 mins prior to leaving clinic. Patient begin to walk back to work area and started to feel numbness and tingling in tongue and throat, face as itching and cheeks red. Patient taking in observation room and emergency response team called for precaution. Patient remained alert. Team arrived taking taking blood pressure which was 185/108, Benadryl given, patient monitored. Team and patient agreed no emergency department care needed. Patient monitored for another 30 mins, blood pressure rechecked 158/95 . Patient allowed to return to unit. Had no signs of distress, denies shortness of breath or any throat discomfort. Patient was stable when leaving unit.
She just had sore knees; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 88 year-old female patient received bnt162b2 (BNT162B2), administration date Jan2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "AFib" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ARTHRALGIA (non-serious), outcome "not recovered", described as "She just had sore knees". Therapeutic measures were taken as a result of arthralgia.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Additional Information: This is a spontaneous report from a contactable consumer based on information received by Pfizer (manufacturer control number US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-079913). This case was split from master case 202101062172 for a 88 years old patient taking COVID shots and experienced sore knees. She also had the COVID shots, and she was okay in January. She just had sore knees. Sometimes she put seven different topicals on it, like THC sometimes, and it was relieved for an hour or two. She was not going to take anything for it. No more medications. She has had this too long..
generalized seizure-tonic clonic; eyes rolled back; lasted 1 1/2-2 mins, febrile; asymptomatic the next day faint truncal rash;
Patient is a 22 year-old male, 65?, 47.4kg. PT received first COVID-19 vaccine (Pfizer) on 12/27/22 and flu shot the week prior. On 1/3/23, pt went to outside hospital ED and was diagnosed with angioedema/allergic reaction from vaccine, noticed lip/tongue swelling beginning on 12/31/22. Pt received Solu-Medrol 125mg injection, and Pepcid 20mg injection and was discharged on famotidine 20mg bid x 5 days, prednisone 40mg x 5 days, and Zyrtec 10mg x 5 days. On 1/4/23, pt returned to the same outside ED with concerns for worsening throat swelling and difficulty standing, walking, and speaking. Received another dose of Solu-Medrol 125mg injection and NS drip and was instructed to complete PO steroid regimen. On 1/8/23, pt finished steroid dose, but continued to note lip swelling, muscle weakness, difficulty swallowing, and voice change with 1 episode of vomiting the previous day. On 1/9/23, pt returned to the another outside ED, where he noted to have generalized muscle weakness that is up to his thigh and fatigue occurring with walking a few steps. Lumbar puncture done showed elevated protein count, WBC and glucose. Transferred to ICU. Neuro exam in ICU showed 7th nerve palsy ? unable to smile/frown/blow, flattening of nasolabial folds, eyelid drooping; muscle weakness in upper extremity, absent knee, ankle and bicep reflexes; able to stand up and walk with assistance, no ataxia noted. Suspected diagnosis listed: proximal muscle weakness with hyporeflexia and 7th nerve palsy: GB syndrome, suspicion of pharygel-Cervical-Brachial variant, angioedema, ST elevation consistent with Brugada syndrome.
Initial report was received on 23 August 2012 from a health care professional. A 12 year-old female patient with no reported past medical history had received MENACTRA, ADACEL, HPV and Varicella vaccines (lot numbers, routes, sites and dates of administration for all vaccines were not reported) manufacturer for HPV and Varicella were not reported)) and an unspecified amount of time after vaccination, experienced syncope. No further information was provided at the time of the report. The patient's outcome was not reported. The reporter for this case is the same as for case 2012-07890 and 2012-07891. Documents held by sender: none.
Noticed next day (July 3 ) a lump has formed on top of my left shoulder (Bursa Area). 2nd Dose was taken on July 2.
SHAKY; DIARRHEA; difficulty breathing; ACHY SORE ARMS; CHILLS; TIRED; FEVER; This spontaneous report received from a patient concerned a 92 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, diabetes, and cholesterol, and other pre-existing medical conditions included the patient had no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805020, expiry: UNKNOWN) dose was not reported, administered on 17-MAR-2021 11:00 to right arm for prophylactic vaccination. Concomitant medications included simvastatin for cholesterol. On 18-MAR-2021, the subject experienced achy sore arms. On 18-MAR-2021, the subject experienced chills. On 18-MAR-2021, the subject experienced tired. On 18-MAR-2021, the subject experienced fever. On 19-MAR-2021, the subject experienced diarrhea. On 19-MAR-2021, the subject experienced difficulty breathing. Laboratory data included: Fever (NR: not provided) 100.9. On 19-MAR-2021 07:00, Laboratory data included: Fever (NR: not provided) 101.7. On 20-MAR-2021, Laboratory data included: Fever (NR: not provided) Temp Fluctuated between 99 and 101.7. On 21-MAR-2021, Laboratory data included: Fever (NR: not provided) 97.2. On 21-MAR-2021 13:30, Laboratory data included: Fever (NR: not provided) 100.2. On an unspecified date, the subject experienced shaky. Laboratory data (dates unspecified) included: Pulse oximetry (NR: not provided) Unknown. Treatment medications (dates unspecified) included: paracetamol. The dose of covid-19 vaccine ad26.cov2.s was not changed. The patient recovered from diarrhea on 20-MAR-2021, and achy sore arms, and chills on 18-MAR-2021, was recovering from difficulty breathing, had not recovered from fever, and tired, and the outcome of shaky was not reported. This report was non-serious.
Discharge Provider: Private MD Primary Care Provider at Discharge: Private MD  Admission Date: 6/20/2022 Discharge Date: 6/24/2022  PRESENTING PROBLEM: Hyponatremia [E87.1] Hip pain [M25.559] Fever, unspecified fever cause [R50.9] Pneumonia due to COVID-19 virus [U07.1, J12.82]   HOSPITAL COURSE: Patient is a 87 y.o. female who presented to the emergency department with complaints of fever.  She has a past medical history of asthma, CVA, glaucoma, and memory impairment. Per report from the patient's son, patient has been increasingly confused over the past week.  He states that today, she has become increasingly lethargic and not performing daily activities as usual.  She ate breakfast, however, she refused lunch and dinner. She was sent to the emergency department for further evaluation when it was noted by staff that she had a temperature of approximately 101.4° F. in the emergency department, patient was tachypneic, however, other vital signs were stable.  She did not require supplemental oxygen.  Complete blood count was unremarkable.  CMP was remarkable for hyponatremia.  Troponin was negative.  Procalcitonin was negative.  COVID-19 was positive.  EKG showed sinus rhythm with a first-degree AV block.  Chest x-ray showed findings consistent with COVID-19 pneumonia.  Suspect presenting symptoms are secondary to COVID-19 pneumonia.  Patient has been admitted for further evaluation and management of COVID-19 pneumonia and hyponatremia.     6/24:  Patient did very well during this admission.  Her hyponatremia has improved, it was felt to be in part due to hypovolemia.  I will start her on salt tablets 2 times a day as well.  Patient also was diagnosed with COVID, but steroids were stopped, she did not show any obvious respiratory involvement.  Patient was seen by Physical therapy and has slowly improved, she will go back to the "Private".  Patient will follow-up with Ophthalmology regarding a Pterygium. Patient is otherwise stable for discharge. She will need a repeat BMP on Monday June 27th.
During monitoring period post Pfizer COVID-19 vaccine, pt experienced hypertension, flushing, dizziness, lightheadedness, faint feeling, chills, nausea, rapid heart rate. VS: 155/98, P 101, R 25, O2 98%. Upon assessment, patient oriented x 4, states she was "blacking out" sweating profusely. Stated some tingling of bottom lip. Patient initially refused emergency medication after about 10 minutes agreed to IM Benadryl 25mg x 1. Patient remained in extended Observation for an hour and a half. Ice applied, water, blanket. Notified family members via phone that she had a reaction but began to feel better after an hour and 30 minutes. Patient discharged to home. VS: 125/71, P 59, R 19, O2 100%
head aches; feeling nausea; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (head aches) and NAUSEA (feeling nausea) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (head aches) and NAUSEA (feeling nausea). At the time of the report, HEADACHE (head aches) and NAUSEA (feeling nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment was reported for the events.
Extreme behavior change--screaming, compulsive, hyper, irritable, angry.  This has not resolved.
On multiple unspecified dates, multiple unspecified patientes received improperly stored vaccine; No adverse effect; This spontaneous report has been received from a medical assistant, concerning a 52-week-old male patient.   The patient's concurrent conditions, historical conditions, previous drug reactions, or allergies and concomitant medication were not reported.  On 12-APR-2019, the patients were vaccinated with improper stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot # R000555 and expiration date 08-JAN-2020) (anatomical location not reported) for prophylaxis. The measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) vaccine was reconstituted with properly stored sterile diluent. No adverse effects reported.  Additionally, temperature for vaccines were total time and highest temperature above 9 degree C (9.9 C); time frame: 4 hours; with no previous temperature excursion. The error was identified via a data logger.; Sender's Comments:  US-009507513-1903USA013366:
Swelling on entire right leg from above knee to top of thigh, first noted on 8/29/00. Mother gave ibuprofen and applied ice. Swelling still present on 8/30/00. Pt referred to doctor for evaluation.
Patient was given the Pfizer booster vaccine for ages 5 years to 11 years; patient is 14 years old. Patient did not receive the correct amount of vaccine for his age.
Patient received an adult dose of the Pfizer monovalent COVID-19 vaccine in their primary series instead of the authorized for their age Pfizer monovalent COVID-19 vaccine 5-11 years.  Parent notified via letter on 3/15/2023.
On approximately May 19, 1999 the pt experienced shingles on the upper arm which subsequently became infected. The pt was treated with antibiotics.
This spontaneous report as received from a healthcare professional refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 22-FEB-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (lot # L027733, expiration date 13-SEP-2017, dose and route were not reported). The vaccine was exposed to the temperature of -9.5F for 15 hours. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Breakthrough COVID-19 infection. Patient fully vaccinated April 10, 2021. Tested positive Aug 25, 2021.
In February of 2022 I started flu like symptoms sore throat, body aches, and chills, I never registered a fever. I rested that day and it was a Saturday and wasn't due to go to work until Monday. I contacted my Job on Monday that is at a health clinic and told them about my symptoms. I was instructed to come in and take a test and that is when I tested positive. I was not prescribe any medication. I was directed to isolated and stay home and relax. I stayed home for 4 days and was instructed to come back into work and wear a N-95 mask.
Patient presents today with a rxn to vaccine, her (L) arm has a red area the diameter of a baseball that is hard and hot. She states it itches. There is also a rash spreading down (L) arm.
1 day p/vax pt devel an inj site rxn characterized by a 12-cm area of redness & swelling;pt recovered w/o specific tx;
TEMP 100.0  the following day 5/14/22 and a slightly sore arm PATIENT WAS GIVEN AN UNDILUTED DOSE OF COVID (5-11)
Pt. received HPV #2 on 11-24-14. Called office on 11-28-14 stating that pt. has had a headache since then. Headache worse in the AM ad with movement of head from side to side. Pt. taking 2 EXCEDRIN which helps with headache.
9mins post vaccination pt reported respiratory distress, flushing/sweating dizziness and lightheadedness.  Pt layed on the floor.  Pt was taken to a cot w/ feet elevated.  Pt given water and orange juice. Vitals: 98/62, 71, 16 Pt stable and released from the vaccination site.
Injection site swollen, hard, reddened, fevered 7"-8" around site. Difficulty moving (arm (R)). Petechia noted at site approx 2" x 1" diameter. Needle site visible at reddened.
No additional adverse events reported; improperly stored vaccines may have been administered to patients; This spontaneous report has been received from a nurse, referring to a patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, and previous drugs reactions or allergies were not provided.  On 23-DEC-2019, the patient was vaccinated with an improperly stored (product storage error) hepatitis a vaccine, inactivated (VAQTA), (Therapy type: Digital Data Logger), lot number S025258 and expiration date 05-NOV-2020 for prophylaxis (strength, dose, dose number, frequency, route of administration, and anatomical location, were not provided).  The vaccine was stored at a temperature above 47 degree Fahrenheit (47.1 Fahrenheit), for a timeframe of 8 to 16 minutes, with no previous temperature excursion. The call was due to a Digital Data Logger.  No additional adverse events were reported.  This case is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2001USA009007:
Pt was only 13, not eligible for Janssem. Monitored and no other adverse outcome noted thus far. Reported as a med error through internal event reporting.
5.5 cm x 6.7 cm area of erythema, inflammation & warmth L deltoid.
10 days after her shot, patient had a hard spot at the injection site that got bigger, red, warm to the touch, itchy and had welts lower down her arm.  She did go to the ER and they did an ultrasound which was normal.  They said it was a reaction they have seen from the moderna vaccine.
Right arm erythema, pain, swelling from injection site. 26 cm long by 11 cm wide cross right elbow. Decreased range of motion. Temp 98.2F.
HIVES TO FOREHEAD AND SEVERE TO BOTH COMPLETE LOWER EXTREMITIES. NO TREATMENT GIVEN.  GRANDMOTHER ADVISED TO TAKE BABY TO URGENT CARE FOR FOLLOW-UP WHEN THEY RETURNED TO CLINIC ON 01/22/2013.
Per child's mother, child awoke at 12:00 am with shaking uncontrollably, lips bluish color, complaining of vaginal pain, vomiting and felt warm. Lasted 45 minutes and resolved. A VERS report was filed 10/25/17 due to High Dose Influenza vaccination given to a child.
Have a rash on her neck and her mouth. Stiffness in her neck and tongue is swollen on the left side. Chest pain from the front to the back. Her face is swollen and she has puffy eyes. She also has a big bump on the side of her neck and she feels dry and itchy.  She has no appetite and she feels sick all over. Everywhere she feels bad at is on the left side where she took the vaccine at.
L shoulder Adhesive Capsulitis developing within days of receiving COVID-19 pfizer vaccine in L shoulder.  Significant L shoulder functional limitation due to pain and stiffness, passive and active ROM severely limited to less than 90 degrees abduction and forward flexion.
No Wheal and observed leakage on first Intradermal administration attempt. Successful 2nd administration subcutaneously.
Sick; Initial information received on 04-Nov-2021 regarding an unsolicited valid social media non-serious case received from a consumer/non-health care professional.  This case involves adult patient (unknown age and gender) who had sick (illness) after receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Nope. Got me so sick. Twice".  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was unknown for the reported event.  There will be no information available on the batch number for this case.
Received call from patient's nephew. He reports approximately 4 days after receiving vaccine, patient's nose and around her eyes began peeling like she had a bad sunburn. Reports they have been peeling ever since.  No other problems.  Patient denies any changes to her normal skin care regimen. Advised if continues, to see her medical doctor.
This spontaneous report as received from a nurse refers to a 10 patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with GARDASIL. Dose, route, lot number and expiration date were not reported. No co-suspect and concomitant therapies were reported. The nurse reported that the patients were administered improperly stored GARDASIL over the last three months (in 2014). No adverse effects reported. This is one of several reports from the same source. Additional information is not expected.
THE PATIENT RECEIVED THE REGULAR DOSE VACCINE INSTEAD OF THE HIGH DOSE VACCINE  CAUSEOF HER AGE
Got extremely sick after each of the original 2 shots/Could not get out of bed; Dizzy; Didnt know who was in the room; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old patient received BNT162b2 (BNT162B2), as dose 1, 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: ILLNESS (non-serious), outcome "unknown", described as "Got extremely sick after each of the original 2 shots/Could not get out of bed"; DIZZINESS (non-serious), outcome "unknown", described as "Dizzy"; MEMORY IMPAIRMENT (non-serious), outcome "unknown", described as "Didnt know who was in the room". The events "got extremely sick after each of the original 2 shots/could not get out of bed", "dizzy" and "didnt know who was in the room" required emergency room visit.  Additional information: Patient just got booster shot and got sick all over again. Patient got extremely sick after each of the original 2 shots, could not get out of bed, dizzy, didn't know who was in the room. Patient was taken to the ER. Patient was in good health.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201283470 same patient/drug/events, different dose;