chrisvoncsefalvay/vaers-outcomes huggingface dataset:
It was enough to keep him in bed all day; lessening of strength in his core; felt something was off in the evening. When he woke up, he did have the same symptoms as before but they weren't as severe,unpleasant; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt something was off in the evening. When he woke up, he did have the same symptoms as before but they weren't as severe,unpleasant), BEDRIDDEN (It was enough to keep him in bed all day) and ASTHENIA (lessening of strength in his core) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036H21A, 028A21A and 025A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FEELING ABNORMAL (felt something was off in the evening. When he woke up, he did have the same symptoms as before but they weren't as severe,unpleasant). On 17-Nov-2021, the patient experienced BEDRIDDEN (It was enough to keep him in bed all day) and ASTHENIA (lessening of strength in his core). At the time of the report, FEELING ABNORMAL (felt something was off in the evening. When he woke up, he did have the same symptoms as before but they weren't as severe,unpleasant), BEDRIDDEN (It was enough to keep him in bed all day) and ASTHENIA (lessening of strength in his core) outcome was unknown.            No concomitant medication information was provided  No treatment medication information was provided    This case was linked to MOD-2021-390838 (Patient Link).
In May of 2021 I suddenly developed a sore right shoulder and upper arm, this progressively got worse.  The issue appeared coincident with a common cold that I contracted while in out of town at my mother's funeral. My PCP referred me to Spine clinic, believing I may have a spinal issue, however an MRI of my thoracic spine was OK. As the pain progressed in my right shoulder/upper arm, I was losing range of motion and the pain was getting worse.  I was given Meloxicam 15mg to alleviate swelling, and referred to physical therapy.  My therapist noted that my range of motion limitations were not consistent with his experience with rotator cuff impingements, which is what I had been diagnosed with by Spine Clinic.  Subsequent visits at Spine clinic have resulted in an ultrasound of my right shoulder and an MRI. I then received a cortisone shot in my right shoulder about 4 weeks ago, and am for the moment pain free. I am still in PT. I have not yet talked to my PCP, I see her on September 30 for my annual physical. I contacted her today to tell her about my submission of this form. I submitted information regarding my rotator cuff impingement diagnosis in a vSafe report on Sunday 9/5 and was contacted by a CDC medical person on Tuesday 9/7 by phone, and asked to complete this online form.
Temp of 100.0, body aches, nausea, migraine lasting 24 hours.  I took 2 500mg Tylenol and it helped
Next day after 2nd dose of Pfizer vaccine, the school nurse called me to report my son had "red, irritated" eyes.  I had just dropped him off at school not even an hour before.  The nurse stated, "He told me he had allergies, but I just wanted you to know.  I'l send him back to class and tell him to come back if it gets worse."  I honestly blew it off because we had all woken up late and I thought he possibly was still sleepy.  He stayed at school and the afternoon he came in and went to sleep, which I expected.  He woke up about 2 hours after school and both eyes were bloodshot and he was squinting.  He said his eyes were bothering him.  This has never happened before.  He does wear glasses but has never had irritated eyes before.  I gave him Ibuprofen and used saline eye drops.  He appeared to have some light sensitivity and described having floaters in last hour at school during the day.  It is now 10 pm at night approximately 18 hours post the 2nd Pfizer vaccine, and his eyes are still reddened and irritated.  If it persists tomorrow after he wakes up, I will take him in to be seen by a doctor.
This spontaneous prospective pregnancy report as received from a registered nurse refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. The registered nurse provided that on 24-NOV-2015, the patient tested positive via a urine screening that she was pregnant. The last menstrual period (LMP) date and estimated date of delivery (EDD) were not known. On 24-NOV-2015, the patient was also inadvertently vaccinated with a dose of GARDASIL 9 (lot # L017407, expiration date 15-AUG-2017; dose and route of administration were not reported). The pregnancy outcome was outcome pending. The foetal outcome was unknown. Additional information has been requested.
inflamed right upper arm from shoulder to elbow; overactive bladder,kidney; frequent urination; flu-like pain in lower back and right shoulder--general sluggishness and irritability
Received vaccination at hospital during annual flu shot administraion. Vaccination to Right deltoid.  Swelling and tenderness of right elbow on 11/07/2006. Increasing fatique and general joint tenderness to all joints-onset evening of 11/07/2006. Low grade fever, running nose, sore throat and general mailaise, onset 11/10/06. Fever resolution on 11/13/06. R elbow continues to be swollen and inflamed as of this report. Right arm weakness persists.
Information has been received from a RN concerning a 15 month old male who on 8/31/99, the pt experienced petechia and a fever of 102F. A physician visit was required.
I woke up about 12 hours after with a headache and chills. The day after, I only had some arm pain. A few days later, I had the diverticulitis flare up. I was place on antibiotics and that resolved the issue. I had Dose 2 (EL3246)on 1/26/21 and it was a similar situation, except that it was about 2 weeks later when the flare up occurred. I don't know if it was another reaction or it just wasn't resolved the first time.
Diffuse progressive urticaria without airway or GI involvement. Developed overnight with visible progression over the morning hours prior to arrival to the ED. Markedly improved with epinephrine and benadryl
red recurring every month at the same site; itchy/recurring every month at the same site; swollen/recurring every month at the same site; Initial information received on 22-Mar-2021 regarding an unsolicited valid non-serious case received from a physician.  This case involves child patient who had red recurring at the same site (erythema), itchy/recurring at the same site (pruritus) and swollen/recurring at the same site (swelling), while he/she received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (formulation: Pre filled syringe, lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date (every month), the patient developed a non-serious red recurring at the same site (erythema), itchy/recurring at the same site (pruritus) and swollen/recurring at the same site (swelling) unknown latency following the administration of INFLUENZA QUADRIVAL A-B VACCINE..  The patient mother reported that ever since her child received the flu shot in November, every month at the same time in the exact same place as the flu shot and patient gets red, itchy and swollen. The patient mother said it happened a few weeks to a month after the flu shot but has been recurring every month at the same site.  No laboratory data was provided.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was unknown.  There will be no information available on the batch number for this case.
positive COVID-19 test; positive COVID-19 test; This is a spontaneous report from a contactable nurse (patient) received via Medical Information Team.  A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  The patient received the first dose then tested positive for the COVID-19 virus, on an unspecified date. The patient underwent lab tests and procedures which included SARS-COV-2 test: positive. The patient outcome of the event was unknown.    The information on the batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 virus test positive and suspected LOE  due to temporal relationship. There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Right deltoid swelling < 24 hours s/p immunization warm, painful, with red bump.
Noticed it a week ago from vaccine redness, swelling and rash down to elbow took BENADRYL, went to urgent care and got seen and received antibiotic it has cleared up.
Breakthrough case admission after 3 vaccines Moderna 2/16/21 Lot# 031M201;  Moderna 3/16/21 Lot# 040021A  Moderna 1029/21 Lot# 939904
low white blood count; low red blood count; low hematocrit; blood test showed minor drop in one other thing that he cannot remember; This is a spontaneous report from a contactable consumer (patient). A 67-years-old male patient received second dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: ER2613, Expiration date and NDC number was not reported), via an unspecified route of administration on 28Mar2021 as dose 2, single (at the age of 67-years-old) for COVID-19 immunization 2 months ago. Medical history included Large Cell Non-Hodgkin's Lymphoma from 1994 to unknown if ongoing and because of it his immune system dropped/knocked down (ongoing). Patient stated that due to a prior cancer, his immune system drops down sometimes for no apparent reason. Concomitant medications were not reported. Historical vaccine included BNT162B2 (Lot number: either EN6198 or FN6198), dose 1 via an unspecified route of administration on 07Mar2021 as dose 1, single (at the age of 67-years-old) for COVID-19 immunization. On 28Apr2021, patient had a last blood test and results showed minor drop in white blood count, red blood count, hematocrit and one other thing that he cannot remember (4 results that are below normal indicating that his immune system was not up to par), doctor told him this indicates a little low immune system/ weakened immune system. Patient stated it was not a major drop, but it was lower than a normal one. Patient mentioned that some of his doctors stated that the vaccine would help him fight the virus and others stated that the vaccine would build up his immunity. Patient wanted to know which statement was most accurate with the Pfizer BioNTech COVID-19 vaccine and wanted to know the effect of the vaccine especially if his immune system was low. Patient was concerned if his immune system will be knocked down, what precautions should he take. The outcome of all the events was unknown.
weak; peeing himself; dizzy; fever; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weak), URINARY INCONTINENCE (peeing himself), DIZZINESS (dizzy) and PYREXIA (fever) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.    The patient's past medical history included No adverse event (no historical condition was reported). Concomitant products included VITAMIN D2, ACETYLSALICYLIC ACID (ASPIRIN EC), CARVEDILOL, CALCITRIOL, GABAPENTIN, ALLOPURINOL, AMLODIPINE, CITALOPRAM and ATORVASTATIN for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced ASTHENIA (weak), URINARY INCONTINENCE (peeing himself), DIZZINESS (dizzy) and PYREXIA (fever). At the time of the report, ASTHENIA (weak), URINARY INCONTINENCE (peeing himself), DIZZINESS (dizzy) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
itching; big red oval; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), PRURITUS (itching) and VACCINATION SITE ERYTHEMA (big red oval) in a female patient of an unknown age 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. In February 2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 17-Feb-2021, the patient experienced PRURITUS (itching) and VACCINATION SITE ERYTHEMA (big red oval). At the time of the report, PAIN IN EXTREMITY (sore arm), PRURITUS (itching) and VACCINATION SITE ERYTHEMA (big red oval) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Patient developed headache, chills, nightsweats, and soreness at injection site, similar to previous COVID-19 Moderna vaccinations. Patient received vaccine around 1545, at approximately 0745 the next morning, the patient woke up, walked to the bathroom, urinated, walked to the sink to wash hands and called for her husband because something was wrong. Her husband found her collapsed over the sink, was able to ease her to the floor, she had a limp posture but was conscious initially. She then flopped her head back, face contorted, tongue protruding, unresponsive, started heaving, emesis of "mustard yellow" color coming out of her nose and mouth, urinary incontinence, and flatulence. She regained consciousness after a couple minutes and was not post-ictal. EMS arrived and she was transported to ED, initial BG was 149. Head CT wnl. Platelet count noted 13K (was 400K < 2 weeks prior). She received IVIG and steroids during her hospital admission. She had no recent viral illness, no changes to her environment, medications, and no new medical history.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: vomited-Mild, Systemic: Vomiting-Mild, Additional Details: pt passed out shortly after vaccine. turned white, gave some water and she strate trowing up. we called EMT WHO TOOK OVER. pt refused to go to hospital. went home, follow up with dad she was ok and was keeping her hydrated. had a call into md
A nurse reported that a 43 year old female received an injection of Tetanus Toxoid Adsorbed, on 10/23/00 for a puncture wound. On 10/25/00, she developed an injection site reaction characterized by pain, swelling and "knots" under her arm. As of 10/27/00 , the pain and swelling had resolved.
Pt had rash for 7-14 days per mother. She insisted that we report this, despite it being on the list of possible side effects.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 74 years old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2009, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Information has been received from a physician via company representative referring to a female patient of unknown age. The patient's pertinent medical history and drug allergies were not reported. On an unknown date the patient was vaccinated with a dose of GARDASIL (lot#, expiration date, dose, strength and route unknown). On an unknown date after the vaccination the patient experienced muscle atrophy. The field representative did not know whether the patient received GARDASIL or GARDASIL 9 therefore the event was being taken for GARDASIL. The field representative also reported that the physician said it was debilitating and that the patient used to be a swimmer, and he/she guessed the patient didn't or couldn't swim anymore so the field representative would consider that there was significant disability/incapacity. The outcome of the event was unknown. The reporter considered muscle atrophy was attributed to GARDASIL. Additional information is not expected as the physician refused to be contacted.
Day 1-3: Sore arm, typical of prior seasonal flu vaccines; Day 4-6 (currently on Day 6): Periodic severe throbbing pain in vaccinated arm (Ibuprofen relieves pain). Day 4 & 5: severe sore throat Day 6: Pleuritis (right lung).
Patient complained of soreness in L arm.  Patient said both arms and hands feel numb and tingle like pins and needles.  Patient vital signs 142/84, O2 97% on RA, Pulse 61, R- 20.
Severe headache, severe body aches, nausea, chills, sweats, dizziness.  Lasted 36 hours.
Injection site pain; Headache; Muscle pain; Tiredness; This is a spontaneous report from a Sponsored Program. A non-contactable consumer reported for self. A male of an unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose via an unknown route on an unknown date for Covid-19 immunization. Medical history and concomitant drug were not provided. Patient reported injection site pain, headache, muscle pain, and tiredness on an unknown date. Outcome of the events was unknown.    No follow-up attempts are Possible. Information on lot/batch cannot be obtained.
Short of breath, patient tested positive at home, went for Regeneron infusion, low sats in office and was admitted to ER.
Pt stated that later in the afternoon, on the day of the immunization, she got really sleepy. then had body aches, upset stomach with some vomiting, had an awful headache, decreased appetite.   today pt called and felt she is on the upswing.  Still having a headache but not as near as bad, feels weak, stomach still a little upset, but sx are improving. she will continue to update if needed.
Prox LUE - painful to touch, red, swollen.  Tenderness & soreness noted yesterday - today redness noted.  Tx - ibuprofen, BENADRYL & ORAPRED.
This spontaneous report has been received from a nurse referring to a 11 year old female patient. Information regarding the patient's medical history, drug reactions or allergies and concurrent conditions was not reported. The patient did not have concomitant medications. On 29-AUG-2017, the patient was vaccinated with GARDASIL 9 (strength, dose, lot number and expiration date were not reported), by intramuscular route for prevention of human papilloma virus (HPV). Other suspect therapies included diphtheria toxoid, pertussis acellular vaccine, tetanus toxoid (manufacturer unknown) and meningococcal vaccine (manufacturer unknown) in the opposite arm (unspecified). The same day after vaccination the patient fainted. The patient's vitals were checked, and coherence questions were asked and a popsicle was given. The patient recovered 30 minutes after vaccination. The causality assessment between GARDASIL 9 and the event was unknown.
Within 1 min after vaccines administered patient became pale, diaphoretic, and complained of abdominal discomfort. Also complained of being light headed and "everything going back" symptoms lasted approximately 5 minutes.
The pt became weak (legs, arms shaking and feel like falling down), agitated, chills all over body after the vaccination which lasted for about 30 mins.
Few hours after vaccines, developed malaise - then had syncopal episode, collapsed to ground, then had seizure - was shaking x few seconds.
nine days after injection, swelling,tenderness, and a red patch the size of a dollar bill appeared at the injection site. There had been no other reaction until this time.
Information has been received from a pharmacist referring to a 37 year old female patient. There were no pertinent medical history and drug reactions or allergies. In approximately January 2016 (reported as "about a month ago"), the patient was vaccinated with one dose of VARIVAX (Merck) (lot # L027287, expiration date 21-JUL-2017, dose unknown, intramuscular) at an unspecified facility. There was no concomitant medicine. On an unknown date, following the administration, the patient developed soreness around the injection site. The patient sought medical attention via contacting the pharmacist. No treatment was given for the event. No lab diagnostics studies were performed. The outcome of the event was unknown. The causality between the injection site pain and VARIVAX (Merck) was unspecified. Additional information has been requested.
Five minutes post vaccine client observed to be diaphoretic, pale.  Client states she is "dizzy".  Onsite police medic monitored for clients' bradycardia and hypotension while laying down until asymptomatic.  Client was cleared to go home.
Swelling and tenderness to left deltoid starting approximately 7 hours after injection.  Erythema and           noted the following day upon awakening.  No fever, (+) pruritus.
Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Hyperventilation-Medium
Developed an unprovoked Pulmonary Embolus without evidence of a DVT or any unrelated risk factors for PE.
Pt had 2 syncopal episodes with in minutes of each other, the first being 1 min. after tdap given (L) deltoid. As NP was listening to apical pulse noted app. 10 sec pause in heart beat & pt. was cyanotic but then recovered. 911 was notified & pt was taken to hospital.