chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Non-granulomatous bilateral anterior uveitis; This is a literature report from Chest, 2021, Vol 160 (4 Suppl), Pgs A1233-A1234 (DOI: 10.1016/j.chest.2021.07.1134), entitled "RARE EXPRESSION OF SYSTEMIC SARCOIDOSIS AFTER A NOVEL RNA VACCINE".  Here is a rare presentation of a (Ethnic Group) male with sarcoidosis after exposure to an unusual antigen. CASE PRESENTATION: A 32-year-old man came to the emergency department with dyspnea, dry cough, and bilateral eye redness of one week of evolution and ten days after the second dose of the SARS-CoV-2 vaccine. Before these symptoms, the patient experienced multiple desquamating tattoos and bilateral eye redness after the first dose of the vaccine, which presumed that resolved with tobramycin and dexamethasone eye drops. Physical examination was notable for tattoo peeling with surrounding erythematous papules and tenderness to palpation. Eye examination revealed an intact visual acuity bilaterally with hyperemia and conjunctival injection. Ophthalmology made the diagnosis of non- granulomatous bilateral anterior uveitis. Routine laboratories were unremarkable including angiotensin-converting enzyme levels except for erythrocyte sedimentation rate on 32mm/Hr and arterial blood gas with a partial pressure of oxygen of 72 mmHg. Chest radiograph revealed innumerable bilateral centrilobular nodules. Chest Computerized tomography showed bilateral centrilobular diffuse pulmonary nodules with associated mediastinal paratracheal and mediastinal lymphadenopathy. Skin biopsy revealed a nodular infiltrate of histiocytes with black foreign body deposits with non-caseating sarcoid granulomas. Treatment consisted of prednisone and azathioprine resulting in an improvement of symptoms the following days. DISCUSSION: The side effects of this novel ribonucleic acid vaccine are not well described yet, but the authors' case raises the suspicion if the vaccine arouses or unmask autoimmune diseases like the one previously described. CONCLUSION(S): More studies and data are required on side effects to assess other possible complications, response to the vaccine, and which patients are at risk of developing autoimmune or serious health conditions.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event Iridocyclitis and BNT162B2.  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.
After dose #1, I had no real side effects other than a sore arm for a few days. In the days/weeks that followed I noticed that I was having night cramps in the back of my thighs and also had occasiona; cramps in the back of my thighs; strong pain in the front of my shoulder joints; This is a spontaneous report from a contactable consumer (patient) reported that:  A 58-years-old male patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: was not reported), via an unspecified route of administration, administered in Arm Left on 24Feb2021 11:00 (At the age of 58 years) as DOSE 1, SINGLE for covid-19 immunisation. The patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: was not reported), via an unspecified route of administration, administered in Arm right on 24Mar2021, 11:00 (At the age of 58 years) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history included Atrial fibrillation and irritable bowel syndrome. No known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After dose 1, the patient had experienced I had no real side effects other than a sore arm for a few days. In the days/weeks that followed I noticed that I was having night cramps in the back of my thighs and also had occasional strong pain in the front of my shoulder joints on 26Feb2021. After dose#2, I also had very little side effects initially, other than a bit of a "fog" for about 24 hrs and a sore arm. In the days/weeks that followed, I continued to have thigh cramps and pain in my shoulder joints. I also have new symptoms that are getting worse over the past few weeks including pain and weakness in my hips and pain and weakness in my muscles of my forearms and hands. I also have mild numbness and tingling in my hands/feet and am sensitive to heat in ways that didn't bother me before. I have no fever but I feel flush. I am concerned that the vaccine may have triggered some type of autoimmune response attacking my joints and muscles. I plan to see my dr. in a few weeks. Please advise if I am in any immediate risk. No treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The patient has not recovered from the events.  No follow-up attempts needed. No further information is expected.
This case was reported by a pharmacist and described the occurrence of an adult male subject not responding to therapy following vaccination with Hepatitis B vaccine. On an unspecified date the subject completed his Hepatitis B series. At an unspecified time after completion of the Hepatitis B vaccine series, the subject was found to have not responded to therapy. At the time of reporting the outcome of the event was unspecified. This event occurred in two subjects with this case, A0734383A serving as the master and linked to A07343B5A and A0734386A in error-void.
Noticed redness and swelling on day 4 (had bandaid on before so didn't notice). Itching on day 4 redness about 2 inches. Day 7 developed blotchy rash at injection site. Day 8 rash spread to about 3 inches, hot to the touch, very itchy, white where injection was and red around.
Information has been received from a nurse concerning a 26 year old female with a history of an ovarian cyst in March 2008, low grade squamous intraepithelial lesion and sulfonamide allergy who on 29-FEB-2008 was vaccinated intramuscularly with her first dose of GARDASIL (lot# 655327/1287U).   Concomitant therapy included ORTHO TRI-CYCLEN LO.  On 08-MAY-2008 the patient was vaccinated intramuscularly with her second dose of GARDASIL (lot# 0151X).  On 10-MAY-2008 the patient experienced pain at the injection site.  She had relief when treated with ice and TYLENOL, but the pain at the injection site persisted when the treatment was discontinued.  The patient sought medical attention by calling the office.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 6/13/2008. Initial information and follow up has been received froma nurse concerning a 26 year old female with a history of an ovarian cyst in March 2008, low grade squamous intraepithellal lesion and sulfonamide allergy who on 29-FEB-2008 was vaccinated intramuscularly with her first dose of GARDASIL vaccine (lot# 655327/1287U). Concomitant therapy included ORTHO TRI-CYCLEN LO. On 08-MAY-2008 the patient was vaccinated intramuscularly with her second dose of GARDASIL vaccine (lot# 0151X). On 10-MAY-2008 the patient experienced pain at the injection site. She had relief when treated with ice and TYLENOL. The patient sought medical attention by calling the office on 16-MAY-2008. The patient recovered after 8 days from pain at the injection site.
moving hurts; left side of her rib is hurt; Breathing hurts; everyday is a little bit worse,more tired than before; This spontaneous case was reported by a consumer and describes the occurrence of DYSKINESIA (moving hurts), MUSCULOSKELETAL CHEST PAIN (left side of her rib is hurt), DYSPNOEA (Breathing hurts) and FATIGUE (everyday is a little bit worse,more tired than before) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058H21A, 004M20A and 025L20A) for COVID-19 vaccination.     Concomitant products included ROSUVASTATIN for Cholesterol, DONEPEZIL for Memory loss, UBIDECARENONE (COQ-10), CALCIUM, COLECALCIFEROL (VITAMIN D3), IRON, FISH OIL and PANTOPRAZOLE for an unknown indication.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. In December 2021, the patient experienced DYSKINESIA (moving hurts), MUSCULOSKELETAL CHEST PAIN (left side of her rib is hurt), DYSPNOEA (Breathing hurts) and FATIGUE (everyday is a little bit worse,more tired than before). At the time of the report, DYSKINESIA (moving hurts) had not resolved and MUSCULOSKELETAL CHEST PAIN (left side of her rib is hurt), DYSPNOEA (Breathing hurts) and FATIGUE (everyday is a little bit worse,more tired than before) outcome was unknown.            Patient reports her body was normally healthy.   No past medical history for heart conditions was reported.   Patient has not tested positive for Covid.  No treatment medication were reported.
The patient is a 62 y.o. male with history of multiple myeloma (since 2018 with stem cell transplant 3/19 with relapse on chemotherapy now), CKD3 (Cr baseline around 1.1-1.3), hx sarcoidosis, HTN (on lisinopril, amlodipine), GERD, gout, OSA, obesity, chronic pain on oxycodone who presents with diarrhea, AKI.  Tested postive for COVID upon admission (1/24/22).
12/17/10 - I was treated for Acute Upper Respiratory Infection, Acute Bronchitis, Asthma, Acute Bronchospasm. Medications prescribed: BIAXIN 500mg BID x 7 days. MEDROL Dose Pk, Albuterol inhaler as needed. 03/25/11 - I was treated for Sinusitis, Right Shoulder Pain. X-rays of Right Shoulder. Medications prescribed: CIPRO 500mg BID. FLONASE Nasal Spray, ALLEGRA, Diclofenac 75 BID. 04/18/11 - I was treated for Severe Right Shoulder Pain. Injections were given at this time: Bupivacaine, Dexamethasone Sodium Phosphate, Lidocaine HCI 1% Injection, Hydrocodone-Acetaminophen 5-500mg. 1-tablet every 6-hours as needed. 05/02/11 - Follow-up for Right Shoulder Pain, Neck Pain. 05/02/11 - MRI of Cervical Spine & Right Shoulder. 05/03/11 - Emergency Room visit - I was treated for Severe Headache. Pain in the Back Of Head, Radiating pain down Right Shoulder and arm. Medications given: TORADOL 60mg. Injection, ZOFRAN 4mg. Injection. 05/04/11 - Follow-up visit for results of MRI of Neck and Right Shoulder. Medication Prescribed: Nabumetone 500mg. 1 tablet Twice Daily. 05/10/11 - New Patient visit for Right Shoulder Pain to the Right Hand. Medications Prescribed: Tramadol 50mg. To take with 500mg TYLENOL. 05/17/11 - I was treated Asthma with Acute Exacerbation, Coughing & Wheezing. Medications Prescribed: ZPack 250mg., Prednisone 20mg, 2-tablets once a day for 3-days. Albuterol Inhaler. HYCODAN Syrup at night for cough. Albuterol Solution for Nebulizer. 05/27/11 - I was treated for Right Shoulder and Right Arm and Hand Pain with Numbness and Tingling. Medication given: Steroid Injection and Methylprednisolone Pak 4-mg. 06/02/11 - Saw doctor today for Right Shoulder Pain, Right arm and Hand Pain with Numbness and Tingling. 06/03/11 - EMG Nerve Test done today. Diagnosed with: Brachial Plexitis. 06/07/11 - Informed doctor that in the past 6-month period I have received 3-doses of Hepatitis B Vaccines. 06/13/11 - MRI done today. Results pending. 06/22/11 - Scheduled follow-up appointment for today. At this time I'm currently being treated by doctor for this condition. If you have any questions or need further information, please feel free to contact me.
BEGAN 1ST WEEK OF APRIL 2021. STARTED WITH SHAKING, HAS PROGRESSED TO INVOLUNTARY MUSCLE MOVEMENTS NON STOP IN FACE. ARMS. HANDS AND CHEST.
Tinnitus - Has been present before and was only observed in ultra quiet environments.   Seemed to be exacerbated by physical stress, such as exercise.  However it has become significantly worse and remains unabated.  It is non-stop and is audible even in loud environments.
I developed an oral HSV-1 infection in the left corner of my mouth & a large painful ulcer on the right side of the roof of my mouth, which made it difficult to eat.
Patient received Moderna COVID-19 on 1/14/21 and 2/10/21 for their primary series of COVID-19 vaccines.  Patient did not report what vaccine they received for their primary series and presented to receive a booster dose of the Pfizer-BioNTech COVID-19 vaccine.  It was discovered when entering into the statewide system that the patient received Moderna for their primary series.  Patient has not reported any ADRs as of the time of the report.
Patient is a 83 y.o. female patient of, MD with history of COVID 19 ( 12/11/22), DM, HTN  presented to Hospital with nausea, emesis, and diarrhea   Hyponatremia Secondary to dehydration from vomiting / COVID  Corrected sodium on admission 124 Patient was given 1 L NS bolus in ED BMP every 6 hours 12/14/22 Na+ 122. Stop hydrochlorothiazide and spirolactone  Ur osm 360, Ur Na 46 Ser Osm 272 0.9NS at 75cc/hr completed Na fluctuating 126 (12/18/22), not much improvement with IV hydration. Added salt tabs  Continue salt tabs. Na improving 130 12/19 => 134 12/20 TSH nl Will check bmp in 1 week   COVID-19 Infection Generalized weakness   Symptoms onset 12/9/22, positive test date 12/11/22 No current oxygen demand Continue paxlovid Anticoagulation: Heparin SQ Consider discontinuation of isolation 12/21/22 PT recommended intensity of skilled Therapy5 to 7 days per week/Duration 10 - 30 days. Swing bed likely 12/20   Sepsis without organ dysfunction - resolved Secondary to  COVID-19 and possible left lower lobe PNA  & POA Presented with tachycardia and leukocytosis. QSOFA score 0 Hemodynamically stable, not requiring vasopressors. Lactic acid 2.0 Pro calc nl Received  1 L NS bolus  in ED.  Workup: CXR with left lower lobe atelectasis and/or airspace disease Blood cultures NGTD urine culture neg Completed Ceftriaxone and azithromycin.    Hypokalemia-resolved  3.1 on presentation Magnesium 1.6 Replace and recheck K of 4.1 (12/18)  DM2 with hyperglycemia Hold home oral medication, Diet Special; Diabetic, Cardiac; Carbohydrate Consistent 60g/meal (1500-2000 kCal equivalent) diet, sensitive SSI + BG checks ACHS, hypoglycemic protocol, and target BG 140-180 Added Lantus 30 units (12/18) titrate based on BG Continue home meds   HTN  Elevated blood pressure Continue nifedipine, clonidine, and aldactone   Constipation - resolved Reports no BM since admission Added schedule laxative and senna s
Patient reports persistent leg pain/ muscle spasm in left leg that started 2 hours after vaccination.
Initial report received from a healthcare professional on 17 April 2013. A 30-year-old female patient had received an intramuscular first dose of ADACEL (batch number: U4612AA, expiry date: 9-20-15, site of administration was not reported) on 17 April 2013. The patient was pregnant at the time of vaccination. The patient's medical history, risk factors and concomitant medications were not reported. The patient's last menstrual period date was 01 August 2012 and expected delivery date was 10 Jun3 2013. At the time of this report, the patient had no adverse event. List of documents held by sender: none.
Information has been received from a registered nurse concerning a 9 year old male who on 05-NOV-1995 was vaccinated subcutaneously with the first dose of varicella virus vaccine live (Oka/Merck) (Lot # 609296/0441B). There was no concomitant medication. On 29-NOV-1995 the patient experienced a mild case of chickenpox. The patient sought unspecified medical attention. Subsequently, the patient recovered from chickenpox. The office is considering a booster dose. Additional information has been requested.
Patient came to pharmacy 6 days later and reported swollen injection site. The site is warm to the touch, visibly red (4 inch diameter), and swollen. I advised the patient to take benadryl and apply hydrocortisone cream topically to see if it reduces the symptoms and if not, she needs to call her doctor for further evaluation.
Became really nauseous, & almost threw up, but made it to work & took a disintegrating zofran, which helped relieve SE within about 5-10 minutes.  Of course, arm is extremely sore too; can barely lift arm past rib cage.
Menstrual cycle abnormality. 3 days after injection I started my menstrual cycle a week early. Light spotting for 2 days, then it stopped. 1 week later, light spotting for 1 day. 4 days later, light spotting for 1 day. Have not had regular menstruation yet.
Pt vaccinated with DTP experienced excessive crying for 3 days beginning Oct 2, 1990 until Oct 4.
Patient too young for Pfizer, DOB incorrect. Family/patient updated, follow up with peds on guidance for second dose.
Swelling + redness at injection site tingling lips racing heart Prior to shot I advised pharmacist of my alpha gel allergy, assured not an issue. I called pharmacy, next day, due to reaction, again assured not and issue. Called Dr. -allergist's office -RN returned call, advised I take Benadryl. called Seqiris- they said no gelatin in vaccine, allergy should not be an issue. I took 2nd dose of Benadryl 8pm, fine the next day Called Seqiris again days later, after reviewing package insert that mentioned DNA products in vaccine. So, I am not certain that the canine DNA in the shot caused the reaction. I have never had a reaction to the flu shot, have had a flu shot yearly for over 10 years. I thought I should let you know about reaction for possible adverse allergy reaction. [I have had alpha gel allergy since Oct 2018] Thank you.
At approximately 3:00 pm I was called to the observation area after reports from staff that a patient needed the epi pen due to a reaction from his injection. I proceeded to the area with an epi pen and requested for staff to activate EMS by calling 911. I discovered the patient laying on the ground in supine position, alert and oriented x3, multiple abrasions on forehead and knees. Assessed patient for SOB or any other symptoms to which he replied, ?I feel light headed and my knees hurt.? Measured vital signs ? Blood Pressure 108/47, O2SAT 97, Pulse 61. Per observation nurse, LVN, patient was sitting in an observation chair chatting with his girlfriend when he fell over face forward to the concrete ground. LVN then called for help and that is when I and vaccine nurse came to assist. Per Nurse , who administered the first dose of Pfizer to pt at 2:55 pm, he proceeded to the observation area a few minutes after his injection. Time of incident reported by  LVN was 3:00 pm. I continued to monitor the patient until EMS arrived. EMS transported patient to Hospital for further evaluation. - MB, RN
Pt received PNEUMOVAX 4/9/14. 24 hours after administer developed severe pain at site, redness, swelling. Went to ER - required tx with antibiotic and oral steroid to recover took 10 days to improve.
MODORNA COVID 19 EUA On 5/15/2021 arm was red, hard lump, warm and  painful to touch  took tylenol
None stated.Nurse follow up on 11/02/04 states: "cyanosis; v-fib; cardiopulmonary arrest." Autopsy report received which revealed COD as interstitial pneumonia (compatible w/viral pneumonia), petecchial hemorrhage of the lungs & thymus and Cervical lymphadenopathy.
This spontaneous report as received from a nurse refers to an unspecified number patients of unknown age and gender. On an unknown date of 2014 (reported as since 08-AUG-2014), the patients were vaccinated with (Oka/Merck) VARIVAX which was improperly stored, (strength, dose, lot numbers and route were not reported). No adverse effects were reported. Follow up information has been received from the registered nurse concerning a patient (age range reported as 6-12, units not reported) of unknown gender. On 17-OCT-2014, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX which was improperly stored (lot number K005180, expiration date 10-APR-2016; dose number, dose and route were not reported). This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
Patient was admitted to the hospital on 11/20/2022 in the morning. She admitted for right-sided weakness and impaired speech. Upon awakening the morning of 11/20/2022, patient's spouse noticed the change in her neurological status and called EMS. At the hospital she was diagnosed with Acute ischemic stroke and Sepsis-- patient meets sepsis criteria for tachycardia, tachypnea, and elevated WBC count. Left MCA + right cerebellar. CT negative for hemorrhage. CTA revealed L ICA occlusion with partial thrombosis of terminal segment and occlusion of L M3. TNK not administered; patient out of the treatment window. Thrombectomy not performed; imaging negative for large vessel occlusion. HEAD CT: No intracranial hemorrhage, mass, or definite CT evidence of recent ischemia. HEAD CTA: The left internal carotid artery is occluded proximally through most of its intracranial course with partial thrombosis of the terminal segment, there is occlusion of a distal M2 branch of the left middle cerebral artery. MR HEAD BRAIN WO CONTRAST (11/20/2022): Hyperacute left middle cerebral artery territory infarcts, acute/early subacute superior right cerebellar infarcts, diminished or absent flow within the left internal carotid artery and left middle cerebral artery branches as identified on CTA. Neuro assessment limited due to decreased level of consciousness. Right-sided facial droop present. Left-sided gaze preference. She was not attentive to right-sided stimuli, nor was she able to cross midline with her pupils. Right sided pupil slightly larger than the left. Unable to assess visual acuity. RUE flaccid and not reactive to painful stimuli. LUE positive for drift. RLE withdrawals from pain. LLE negative for drift; full strength. Patient made no attempt to communicate. She was able to follow some commands. Patient received the Janssen Ad26.CoV2.S Vaccine on 10/17/2022 for research study. Per study PI, this event is unrelated to the Janssen Ad.26.CoV2.S Vaccine that was administered on 10/17/2022.
Information has been received from a registered nurse, concerning a 16 year old female patient, who on 11-JUN-2007 was vaccinated with a dose of Gardasil (Lot # not provided). On 11-JUN-2007, following the vaccination, the patient turned pale white, and then fainted. At the time of this report, the patient was recovering from the events. The patient sought unspecified medical attention. Additional information has been requested.
pt recv vax 8OCT98 & approx 10min post vax pt devel a raised, red area @ the inj site;cold compresses were applied;
Fever, achiness, nausea, vomiting Sought treatment for nausea and received medication
Patient indicated that her birthday made her age of 19, but her birthday is different, actually making her 16. This makes the patient 16 instead of 19 putting her outside of the CDC guidelines for the Moderna Vaccine. The patient is NOT currently having any adverse reactions and is doing well with the vaccine.
Kinrix was given to this 4 month old by CMA, thinking this would prevent her from getting an 4th Hep B vaccine however Kinrix is only recommended for 4-6 year old children.  No treatment needed. No adverse reaction or outcome from giving the Kinrix to the 4 month old.
This case was reported by a other health professional and described the occurrence of vaccine underdose in a 21-year-old female patient who received HAVRIX (batch number 59N59, expiry date 5th September 2016). On an unknown date, the patient received HAVRIX. On an unknown date, an unknown time after receiving HAVRIX Junior, the patient experienced vaccine underdose and wrong vaccine administration. On an unknown date, the outcome of the vaccine underdose and wrong vaccine administered were unknown. Additional information received: Maladministration: Adult 21 years of age (Female) was given 720 EL.U instead of 1440 EL.U.