chrisvoncsefalvay/vaers-outcomes huggingface dataset:
on his other arm he noticed blood clots; he noticed a bruise on his arm; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (on his other arm he noticed blood clots) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetic.   On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (on his other arm he noticed blood clots) (seriousness criterion medically significant) and CONTUSION (he noticed a bruise on his arm). At the time of the report, THROMBOSIS (on his other arm he noticed blood clots) and CONTUSION (he noticed a bruise on his arm) outcome was unknown.            No concomitant medication was not reported. No treatment medication was not reported  Action taken with mRNA-1273 in response to the event was not applicable.  Very limited information regarding these events has been provided at this time. This Spontaneous report states that two doses are given on the same date (unknown batch lot#). Information needs to be clarified.  Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. This Spontaenous report states that two doses are given on the same date (unknown batch lot#). Information needs to be clarified.  Further information has been requested.
This spontaneous case, initially received on 08-Sep-2016, was reported by a Non-Health Professional and concerns a 27-year-old female patient. Weight: not provided; Height: not provided. Administration of company suspect drug(s): The patient received AFLURIA not reported on 08-SEP-2016. Dose: 0.5 ml, Route of administration: Intramuscular. Batch number: 13049221A. No additional suspect drugs. Adverse reactions/events and outcomes: On 08-Sep-2016, the vaccine has been administered that had particles in the vials - no adverse event (outcome: unknown, special circumstances: poor quality drug administered).
patients PCP office called to inform us that patient was positive for a DVT today. She was calling to inform us of the adverse event following her vaccination 04/12/2021. Blood clots were the reason that was reported for this vaccine to be pulled from the market the very next day 04/13/2021. Called the office back and left message with them to report as well since they have lab work and other patient information
light headedness, dizziness, nausea, sweating onset about 2 minutes after vaccination. patient laid down which helped symptoms then sipped some orange juice. continued to feel lightheaded and dizzy when upright even after 45 minutes so he elected to have ambulance come and check him out. he was transported to the hospital for further treatment
Two days after experiencing expected side effects ( fever, headache, muscle ache } ,  all symptoms had resolved the previous day and throughout the second day.  While having dinner on the second day, one alcoholic beverage was consumed with an immediate response of high fever ( 101.6) and body aches.  Maybe a warning not to consume alcohol would be appropriate for at least 2=3 day following Covid vaccination ?   Note ( Same reaction reported to me by co-worker after the event and after they had also consumed alcohol ).
discomfort at the site of injection; This case was reported by a consumer via call center representative and described the occurrence of injection site discomfort in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd July 2020, the patient received the 2nd dose of Shingrix. On 23rd July 2020, 1 days after receiving Shingrix, the patient experienced injection site discomfort. On an unknown date, the outcome of the injection site discomfort was not recovered/not resolved.   It was unknown if the reporter considered the injection site discomfort to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient had discomfort at the site of injection.  No additional information were provided. The reporter did not consent to follow up. This case has been linked with case US2020140198, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020140198:same reporter
Narrative:  Patient was found to have hypotension in PCP office during appointment after receiving the vaccine earlier in the day. Patient was sent to UC where upon drawing labs it an elevated D.dimer was discovered. Patient was transferred to outside hospital and evaluated, records from outside er visit shows no medications were administered and patient was discharged later that day with no interventions noted. Patient stated in outside ER he had been feeling very tired and week consistently for a "long time".
Developed COVID Symptoms, Fever (99) Cough, non productive, arthralgias, myalgias, headache, malaise. Took home Covid Test, was Positive.
On 2/26/07 had chills, dizziness, "felt exhausted", rash appeared on "mostly trunk", sore on arms, on upper legs. Saw MD that day recommended bed rest, fluids and completed CXR. No results - No more chills, dizziness, energy ok. Rash still present.
I got the shot and was very sick; allergic to something in the shot; Initial information received on 22-Oct-2020 regarding an unsolicited valid non-serious case from a patient.  This case involves a patient of unknown demographics who got the shot and was very sick (illness) and patient was allergic to something in the shot (drug hypersensitivity), while the patient received vaccine influenza vaccine.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medication was not reported.  On an unknown date, the patient received a dose of suspect influenza vaccine (lot number and expiration date not reported) via unknown route in unknown administration site for prophylaxis vaccination.   On an unknown date, (latency unknown) after initiation of suspect vaccine therapy, the patient was very sick the next couple days (illness)and found out that the patient was allergic to something in the shot (drug hypersensitivity) which could be the reason people think the shot gave them the flu.    No laboratory data was provided.   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on the batch number for this case.
Administered with expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine). On 21-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not provided.  The vial was initially stored in the refrigerator: it was taken directly from freezer, thawed and given to the patient on the same day 21-Dec-2021. The vial did not undergo any temperature excursions.  The patient had no adverse reaction so far, patient waited 15 min in the clinic, was observed fine and left.
Site: Redness at Injection Site-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: rash at site of both vaccines given pfizer 5-11 and afluria-Mild, Additional Details: gave 7.5 ml benadryl 12.5/5 WITH 15 MINUTES
mom called office voiced pt had episode of eye rolling back in head, palms became clammy & pt became unresponsive for 1-2min;mom voices pt remembers hearing but does not remember that happened;did not see MD or go to ER;fainted;
Received vaccine on 12/29/03.  On 12/31/03 AM noticed swelling, redness.  Since then, increased swelling, redness, warm to the touch and now painful.  No breathing problems or swelling with throat or mouth.
After vaccination 18 days, I found rashes on his face and back. I am not sure whether it was caused by vaccination .And I am worried whether he can accept the second dose. I tookMy son to see his doctor . His doctor said he can still vaccinate. Before the second dose, no medicine will be taken. So 21stdayafter first, my son got Sencond dose. Rashes more.
Shortly after 3rd shot in 2004, began to break out in itchy/burning rash, started on ankles and spread up legs, trunk to neck and down arms. Could not be subdued by creams, ointments, steroids, or ingestion of medication. Received 4th shot in series in 2008 condition got worse and continued to spread. Rash was observed by a doctor while being treated for eye injury. Rash consisted of spots that were intense in itching and burning. Scratching would lead to lesions, ruptures, bleeding. Was given various remedies but none would cease the pain. Rash still comes and goes to this day.
jump in liver enzymes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2023NVX-US-000001481.  A female patient received bnt162b2 (BNT162B2 NOS), in 2022 as dose number unknown (booster), 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: HEPATIC ENZYME INCREASED (non-serious), outcome "unknown", described as "jump in liver enzymes".; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300190704 Same patient, different dose, different event;US-PFIZER INC-PV202300190704 Same patient, different dose, different event;
headaches, neck pain, nausea - started on 4/6/2021; First ER Visits on 4/20/21 - Blood tests, MRI, CT; Ongoing symptoms from 4/6/2021 - 6/11/2021 during that time Hematology visits with additional blood tests, Ophthalmology visit due to pressure behind right eye, Neurology visits with MRI/MRV due to neck pain, headaches and nausea; 6/12/21 ER Visit and admitted inpatient for observation - more blood tests, MRI, CT and Lumbar Puncture due to intensified symptoms with Tremors all over body, inability to walk, difficulty swallowing and difficulty speaking - these symptoms have been constant from 6/12/21 up through today 7/26/21
Approximatley 7-8 hours after getting the shots the child began itching with hives and no fever.  During the day the itching goes away, but comes back at night. Mother took child to the family doctor on Friday (48 hrs later) and was told the MMR did this. Mother giving medicine from doctor to help with the itching.  Child is slowly fetting better.  On 2/1/11 child still had hives over the entire body, but they were getting better.
Initial misuse report received from a healthcare professional on 16 October 2013. The cases were received on 21 March 2014. A 4-month-old patient had received only ACTHIB powder with a sterile water diluent from PENTACEL. It's was vaccine underdose. No adverse event was reported. List of documents held by sender: none.
Pain at injection site, body aches, headache, fatigue, fever, chills, vomiting. I did my best to drink plenty of fluids and took Tylenol. Most symptoms were gone 24 hours later except for sore arm and fatigue.
Bleeding from rectum, as though having a period, for about 5 to 10 minutes with spotting before and after then nothing
I had Covid arm and was on both sides of my arm. Very feverish and to hot to touch.
Back rash lasted 2 days. Treated for pericarditis. Joint pain 7 days
Breakthrough case after 2 vaccines Pfizer 8/17/21 Lot# FC3181;  PFizer 4/5/22 Lot# FK9894
crying; fever; irritability; Initial information received on 29-Sep-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 3 months old male patient who was crying, had fever and irritability while receiving vaccines INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] and FLUARIX.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of 0.5 ml of suspect INFLUENZA QUADRIVAL A-B VACCINE (formulation, strength: unknown) lot number not reported via unknown route in unknown administration site as Immunization.  On an unknown date, the patient received an unknown dose suspect FLUARIX not produced by Sanofi Pasteur (formulation, strength: unknown) lot number not reported in unknown administration site as prophylactic vaccination.  On 28-SEP-2022 the patient was crying (unknown latency) fever (pyrexia) irritability (unknown latency) the administration of suspect vaccines.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events (crying, fever, irritability).  At time of reporting, the outcome was Not Recovered / Not Resolved for all.
Information has been received from a health professional concerning a healthy male with no past medical history who on 07/29/98 was vaccinated with one dose of Varivax (site unknown). There was no concomitant medication. On 12/18/01, the patient developed varicella which was describes as lesions on the whole body and mouth. The patient was afebrile. The patient was seen in the office on 12/19/01 and was noted to have 67 lesions. The patient was treated with diphenhyramine hydrochloride (Benadryl), avena (aveeno bath) and acetaminophen (tylenol) as needed. Additional information has been requested.
This spontaneous report as received from a consumer refers to a patient of unknown age. On 23-OCT-2013 the patient was vaccinated with GARDASIL dose 2. She had received her first dose of the GARDASIL vaccine sometime in 2012 and got her second dose of that vaccine on 23-OCT-2013. Next Tuesday, she will get her third dose of the vaccine. No side effects have been reported. Additional information has been requested.
Severe anterior chest pain radiating to neck treated at home with Tums without improvement,  Pain was 8/10 initially, revolved to2/10 after 1 hour, treated with ASA and Mylanta in the ED. Symptoms gradually subsided, additional 20mg of Protonix taken, symptoms are still present after 12 hours but 1-2/10.  Patient with history of GERD on protonix 20mg daily for maintenance without aggravation of symptoms for >6 mo at this dose.
Local popular pruritic rash around site on upper arm. Began the day after admin, peaked 5 days after.
No adverse event; On 10 May 2023, 27 patients received 0.25ml of the Moderna bivalent vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (On 10 May 2023, 27 patients received 0.25ml of the Moderna bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 067H22A) for COVID-19 prophylaxis.     It was unknown if patient had acute or chronic long-standing health conditions at the time of vaccination.     On 10-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .25 milliliter. On 10-May-2023, the patient experienced UNDERDOSE (On 10 May 2023, 27 patients received 0.25ml of the Moderna bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (On 10 May 2023, 27 patients received 0.25ml of the Moderna bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (On 10 May 2023, 27 patients received 0.25ml of the Moderna bivalent vaccine).    All patients were over the age of 65. No relevant concomitant medications were reported. The vaccine was administered in the deltoid site. On 11 May 2023 26 patients were contacted, on 12 May 2023 18 patients received an additional 0.25ml, 2 patients made appointments to receive the following week and 1 declined to receive the additional 0.25ml dose. A husband and wife pair stated that they would go to the clinic to receive the additional dose but gave no specifics and one patient was mailed a letter as he was not able to be reached by phone. No treatment medication reported.   This case was for the 27th patient out of 27 reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-723833 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723833:Master case
Periorbital edema noted 6-8hrs after vaccination, resolved within 48hrs.
Pateint States extreme overall body malaise and fatigue as well as pain in upper right extremity. Injection site was right deltoid. There is also presence of an approximately six inches in diameter welt/rash in area just distal and medial to the injection site in the deltoid.
Blood pressure increased and bottomed out; Blood pressure increased and bottomed out; Jitters; This is a spontaneous report from a contactable consumer (patient's neighbor). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiration date were not reported), via an unspecified route of administration, on an unspecified date as unknown dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not provided. The patient's neighbor reported that she was older than him and his blood pressure increased and had bottomed out and also had the jitters on an unspecified date. The reporter declined to complete the safety report regrading her neighbor and reported that he'll be the one to call and report regarding his events. The outcome of the events was unknown at the time of report.   The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
migraine headache, visual and sensory auras.; migraine headache, visual and sensory auras.; tingling at base of neck; dizziness; left sided headache; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 23-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in arm left, administration date 13Mar2021 (Batch/Lot number: unknown) at the age of 23 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Celiac Disease" (unspecified if ongoing); "MCAS" (unspecified if ongoing); "CKD" (unspecified if ongoing); "MTHFR" (unspecified if ongoing); "HLA B27+" (unspecified if ongoing); "Morton's Neuroma" (unspecified if ongoing); "Migraines" (unspecified if ongoing); "Pancreatic Insufficiency" (unspecified if ongoing); "known allergy: wheat" (unspecified if ongoing); "known allergies: lobster, crab" (unspecified if ongoing); "known allergies: dairy" (unspecified if ongoing); "known allergies: potatoes, eggplant" (unspecified if ongoing); "known allergies: Gluten" (unspecified if ongoing); "known allergies: pineapple" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Zofran, reaction(s): "known allergies: Zofran"; Tanalbit, reaction(s): "known allergies: Tanalbit". Vaccination history included: Bnt162b2 (Dose 1, administration time 06:30 PM and vaccine location: right arm. ), administration date: 20Feb2021, for COVID-19 immunisation, reaction(s): "suspicion of a possible MCAS reaction"; Bnt162b2 (Dose 1, administration time 06:30 PM and vaccine location: right arm. ), administration date: 20Feb2021, when the patient was 23 years old, for COVID-19 immunisation, reaction(s): "Fatigue", "Tingling at the base of neck", "migraine headache with visual aura (stars)", "Dizziness", "Brain fog", "Tension".  The following information was reported: MIGRAINE (non-serious), MIGRAINE WITH AURA (non-serious) all with onset Mar2021, outcome "unknown" and all described as "migraine headache, visual and sensory auras."; PARAESTHESIA (non-serious) with onset Mar2021, outcome "unknown", described as "tingling at base of neck"; DIZZINESS (non-serious) with onset Mar2021, outcome "unknown", described as "dizziness"; HEADACHE (non-serious) with onset Mar2021, outcome "unknown", described as "left sided headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of migraine, migraine with aura, paraesthesia, dizziness, headache.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021335236 Same drug/reporter/patient, different dose
Very pleasant 81 yo Facility resident patient of Doctor was admitted for acute hyponatremia and AKI.  In addition, patient was admitted for pneumonia initially thought to be COVID, but he was vaccinated and the pneumonia pattern was not consistent with COVID 19.  The pneumonia was most likely related to a community acquired bacterial infection, and he improved quickly on PO antibiotics, also showing this was likely not COVID 19 pneumonia.     The patient's AKI was treated to very near his baseline CKD.  He was eating and drinking well.  His hyponatremia resolved when he was appropriately hydrated.  He was dehydrated due nausea and diarrhea which resolved.     See above for details.  He will follow up with his PCP in 1 week and will have labs prior to his appointment to follow up on his renal function and electrolytes.
Right after the vaccine I was just tired, and my arm was slightly swollen. Since 10/13/2021, my episodes of explosive diarrhea have worsened. I started having them in July 2021 but after the booster, it has gotten worse. I am also getting frequent UTI's from the diarrhea and have to keep going on different medications for both issues.
This spontaneous report as received from a physician via a company representative refers to a 12 year old female patient. No concurrent conditions or medical history were provided. It was stated the patient received all three doses of GARDASIL injection (strength, dose, route of administration, indication, lot# and expiry date not reported) on unspecified dates. No concomitant medications were reported. The physician reported that the patient developed pseudotumor cerebri while using GARDASIL (date unknown). The patient sought unspecified medical attention and was hospitalized on an unknown date. The outcome of pseudotumor cerebri was unspecified by reporter. The relatedness between the event and GARDASIL was not reported. The reporting physician provided contact information to other physicians who should be contacted as they were the patient's doctors at the hospital. Additional information has been requested.