chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of vomiting blood in a adult male patient who received SHINGRIX for prophylaxis. On 19th September 2018, the patient received SHINGRIX. On 19th September 2018, 4 hrs after receiving SHINGRIX, the patient experienced vomiting blood (serious criteria hospitalization, GSK medically significant, life threatening and other: as per reporter) and hemoglobin decreased (serious criteria hospitalization, life threatening and other: as per reporter). The patient was treated with blood transfusion, auxiliary products (Blood Transfusion). On an unknown date, the outcome of the vomiting blood and hemoglobin decreased were unknown. It was unknown if the reporter considered the vomiting blood and hemoglobin decreased to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that the patient was vomiting blood. The pharmacist reported that the patient's hemoglobin decreased and went as low as 7.2. On 19th September 2018, less than a day after vaccination, the patient's hemoglobin went from 14.2 to 12.5, then on 2nd October 2018 his hemoglobin went down to 7.5, and then on the same day at the hospital his hemoglobin went down to 7.2. The patient went to the emergency room on 2nd October 2018 and was hospitalized and received a blood transfusion. Limited information was provided by the pharmacist from the physician.
The vaccination site has become red, hot and swollen, and tender. I had had an initial sensation of heat the day of the vaccination but it ceased after day to. That sensation was as if a pipe of hot water was running on the inside of my left arm--the arm in which the vaccination was given. This is different in that it is around the vaccination site and visible.
Information has been received from a nurse referring to a 49 years old female patient. On 27-SEP-2017, the patient was vaccinated with FLUZONE high dose (lot # UI870AA, intramuscular). Drug Reactions/Allergies included aspirin, oxycodone hydrochloride, oxycodone terephthalate (PERCODAN). There was no illness at the time of vaccination. Concomitant therapies included senna (SENOKOT) and multivitamins. On 13-NOV-2017, the patient was vaccinated with a PNEUMOVAX 23 (lot # N014946, expiration date 01-FEB-2019) subcutaneously for prophylaxis. On 14-NOV-2017, the patient developed a spot 3 inches below injection site and the site of injection at upper arm was red/erythema, warm, swollen/swelling and tenderness. On the same day, the patient visited physician office. On an unknown date in 2017, the patient started on cephalexin (KEFLEX) (500mg, twice a day (bid), oral (PO), 7days) and diphenhydramine hydrochloride (BENADRYL) as treatment for the events (also reported as no prescription drug treatment for the experience required). There was no lab diagnostics/studies performed. There was no temperature excursion occur as a result from a Digital Data Logger. The outcome of the events was recovered on an unknown date in November 2017. The causality between PNEUMOVAX 23 and the events was unknown.
pt recv vax 21OCT96 & 30OCT96 pt exp a fever, ranging from 101 up to 104;nausea, sleeping more than usual;gen rash consisting of red tiny dots about the size of pin head;also devel OM;
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  It was reported that, there had been no power outages that would have impacted the Moderna vaccine. However, the healthcare professional reiterates that because her facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. They were filling out a temperature excursion assessment with the State at this time. It was reported that, no adverse reactions were reported by the patient.  No treatment medication was provided.
Fine erythematous to skin colored papules on the trunk as well as localized erythema and induration at the site of the injections in the bilateral thighs.  Right thigh showed this lesion, resolved, then left thigh showed it on about 25 Jul.
Itching and diffuse hives; Itching and diffuse hives; This is a spontaneous report from a contactable nurse. A 43-year-old female patient received a single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot#: EL0140) as the first dose via intramuscular in the left arm on 30Dec2020 11:45 for COVID-19 immunization. Medical history included multiple allergies. Concomitant medications were not reported. It was unknown whether the patient received any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown whether the patient diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient had itching and diffuse hives on 30Dec2020 12:15. Emergency department (ED) evaluation. Diphenhydramine hydrochloride (BENADRYL) and steroids prescribed. The event was reported as non-serious. The outcome of the events was recovering.
Information has been received from a health professional concerning an 8 year old female with asthma and a history of a rash in 12/06/1997 to Septra who on 04/30/1996 was vaccinated with the first dose of varicella vaccine in the left deltoid. Concomitant therapy included montelukast sodium, Advair and HHN with Ventolin. There was no illness at the time of vaccination. On 06/18/2001 the pt was diagnosed with chicken pox. The pt had 100 lesions on her back and trunk. It was also described as a papular rash with vesicular eruptions on the trunk and abdomen. The pt sought unspecified medical attention. On an unspecified date, the pt recovered. No further info is available.
severe dry mouth and lip swelling, inner lip gum issues. it was starting to clear up then i went for the second shot and it started all over again. i mentioned the reaction to the tech at when i went for my second dose.  I went thru my food history, healthcare supplies, nothing changed but the shot. Ive never had a flu shot and never had the flu. I literally slept next to mr covid and nothing. the shot tech said Wow, then checked his phone. so no, i didnt follow up, just sucking it up.
Patient experienced swelling and bleeding. Applied a cold pack per protocol and advised to follow up if condition worsened.
Sustained rapid heart rate over 150, chest pain , sob , nausea, elevated d-dimer and abnormal ekg
Itchiness on the injection sight. Blister on the injection sight, it popped and a liquid came out. Blister left a mark on my arm. 10/18/2021 blisters came on my two big toes on each foot. High dosage of prednisone was prescribed for me. Blisters came on my on my elbows. I went to a dermatologist because I had blisters appearing on different parts of my body and was diagnosed with dermatitis.
Information was received from medical records from a case in litigation (MARRS#1307USA014180) regarding a 30 year old female. The patient was hospitalized on 04-SEP-2012 for PE (MARRS# 1307USA014180). It was noted that she recently received a "pneumonia shot" (manufacturer not specified), date was not specified. The patient reported that she had experienced restrictive range of motion, pain and swelling. The patient spiked a fever and infectious disease was consulted. An incision and drainage was done in the right upper arm, anterior deltoid area. Blood cultures were drawn. The patient was started on empiric vancomycin and her right arm was elevated. The swelling and pain subsequently improved within 24 hours and the patient was changed to oral doxycycline. The patient was discharged from hospital on 09-SEP-2012 when her PE and blood clot was noted to be resolving. All available medical records will be provided upon request. Additional information is not expected.
Initial case was retrieved from the scientific literature on 28 September 2010.  The safety of immunizing with TDAP: less than 2 years following previous tetanus vaccination: Experience during a mass vaccination campaign of healthcare personnel during a respiratory illness outbreak.  "Serious adverse events: Three SAEs were identified among HCP, all of whom reported Td/IT > or = 2 years prior to current TDAP vaccination; none were pregnant or aged > or = 65 years.  One case of Guillain-Barre' syndrome was identified.  This 37-year-old patient with no previous history of adverse events following vaccination noted bilateral symmetric ascending weakness 10 days after vaccination.  Absent deep tendon reflexes were documented; the patient had electrophysiologic studies that were consistent with demyelination, and a diagnosis of GBS was made by a neurologist.  By 6 weeks after onset, the patient had completely recovered.  This case is linked to 2010-05551 and 2010-05553.  Documents held by sender: None.
After 1st dose on 3/25 lot# 008B21A I had a patch of redness on my right arm 2 days after the shot. I no longer get my period due to continuous birth control but started break through bleeding for 2 days.   After the 2nd dose on 4/24- I experienced arm pain and that evening. The next day I had fever, increased heart rate, body aches, headache, nausea, and fatigue.  That afternoon of 4/25 I started to get a rash on my arms. The next morning Monday 4/26 I woke up at 5am with a rash all over my body that itched and burned. This lasted for the next 12 hours.  I continued to have nausea, fatigue and headaches for the next 2 days.
Extreme  fatigue , cough, and A-Fib event resulting in ER visit and put on Eliguis
Weakness, low fever, chills, sensitivity to touch/light/sound, headaches, muscle aches, shakey
Moderna COVID-19 Vaccine EUA, developed diarrhea on 02/08/2021 which is continuing 02/09/2021 with mild nausea
Approx 1 hour after receiving gray cap Pfizer (tris buffer), pt began experiencing palpitations and presented to ED. no heart problems other than baseline were found but she required pharmacologic intervention, was admitted x 2 days at Facility. According to patient, no other abnormalities were found and her providers concluded it must have been the vaccine. Pt tolerated 2 doses of purple cap Pfizer without incident.
fever of 101; chills; This is a spontaneous report from a contactable consumer and nurse.  A 59-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) for COVID-19 immunization.  The patient experienced a fever of 101 and chills on an unspecified date.  The patient underwent lab tests and procedures which included body temperature: 101 on an unspecified date.  The clinical outcome of fever of 101 and chills was unknown.    The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Swollen bicep, pain radiating to armpit- started after injection. Still having symptoms today 10/23. No redness or streaking.
administered Flublok instead of Fluzone Quad/no AE; administered Flublok instead of Fluzone Quad/no AE; Initial information received on 23-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to case 2019SA267237.  This case involves a 12 years old patient who vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] instead of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT).  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 suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number not reported via unknown route.  It was of actual medication error due to Inappropriate age at vaccine administration and wrong vaccine administered.  It was unknown where adverse event was experienced or not.  Information on the batch number was requested.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This is a literature report for the following literature source(s): "Hyperinflammatory syndromes after SARS-CoV-2 mRNA vaccination in individuals with underlying immune dysregulation", Clinical Infect Dis, 2021; DOI:10.1093/cid/ciab1024. A 55 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 1, single for Covid-19 immunisation. Relevant medical history included: "MAC" (unspecified if ongoing); "Pulmonary aspergillosis" (unspecified if ongoing); "MDS" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HAEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS (medically significant), outcome "recovered", described as "Hemophagocytic lymphohistiocytosis". Symptom onset after vaccination was 3 days after 1st vaccination. HLH-2004 diagnostic criteria included: fever (greater than or equals to 38.3 centigrade); splenomegaly; cytopenias in greater than or equals to 2 lines (HB less than 9 g/dL, plt less than 100/nL, neutrophils less than 1.0/nL); ferritin greater than or equals to 500 ug/L. The patient underwent the following laboratory tests and procedures: body temperature: greater than or equals to 38.3 centigrade; haemoglobin: less than 9 g/dL; neutrophil count: less than 1.0, notes: Unit:(/nL); platelet count: less than 100, notes: Unit:(/nL); serum ferritin: greater than or equals to 500 ug/L. Therapeutic measures were taken as a result of haemophagocytic lymphohistiocytosis included Anakinra. The event was slowly recovered. Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and HAEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS cannot be completely excluded. 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.
diagnosed with Acute Lymphoblastic Leukemia (ALL) in bone marrow; her platelets were almost at 0; UTI; This is a spontaneous report from a contactable consumer. A 66-year-old female patient (reporter's Mother in law) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 26Apr2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included parathyroid polyps, 5th cycle of chemotherapy, elevated calcium levels. The patient's concomitant medications were not reported. Her mother in law's first dose was in the middle Mar2021, maybe 15Mar2021, she was not sure. Caller reported her mother-in-law received the Pfizer covid vaccine (first dose in Mar2021, second dose 26Apr2021) and then a month after second shot, became diagnosed with Acute Lymphoblastic Leukemia (ALL) in bone marrow. Caller know the vaccine doesn't change genetic makeup, but reporter read about T-cells and that's what gets stimulated with the vaccine but there are T-cells in cancer. The reporter thought patient was having an autoimmune response, her platelets were almost at 0 at the hospital, she had a UTI at the same time and that was why we took her to the hospital. The reporter was thankful it happened that way because it got her to go to the hospital. She received platelets while she was there but she wasn't taking to them and they started to suspect something else so a few days after bone marrow biopsy, we found out she ALL. She also had parathyroid polyps in the past about a year ago. 2 weeks prior to the vaccine, she had perfect lab work you know at a normal follow up so we do have a baseline there. Caller stated the patient was in remission, they caught very early, but caller know it will be time for boosters to be discussed at some point. It's strange with the time line but patient had the second dose of the vaccine on 26Apr2021, a couple weeks prior to this she had perfect labs, the reason they were even monitoring her labs was because it was for her parathyroid in which there was a concern in which it had elevated calcium levels due to a polyps they found. A month after second shot, she all the sudden was diagnosed with ALL, leukemia in the bone marrow. Caller asked if there was something in the vaccine that could bring it to her attention or any reports of effecting the immune system or symptoms with white blood cells. If there was anything with the vaccine that lingers in the body, there was anything reported like that. Her mother in law at the moment was doing well, she was on a 5th cycle of chemotherapy, they want her to do 8 in total, but she had perfect bone marrow and lumbar test due to all the intensive treatment for ALL. The patient underwent lab tests and procedures which included biopsy bone marrow: abnormal, blood calcium: elevated calcium levels, laboratory test: perfect labs, platelet count decreased: abnormal (almost at 0). The outcome of events was unknown.   Information on the lot/batch number has been requested.
I did not have an adverse reaction to the vaccine. On 08/08/2022 I started not feeling well with a fever, tired and a sore throat. I tested positive for COVID-19 with a home test on 08/09/2022. I contacted my doctor, and he did not recommend taking PAXLOVID but said if my symptoms got worse to call the office. I took something for the fever maybe twice.
Patient reported that the day after receiving vaccine that her family member noticed that patient's was having tremors to her right arm.
Left eye: bloodshot and hot, eyelid bright red/purple and painful to touch. Whole body chills and fatigue. Pain in injection site. By Monday 7am all symptoms gone except slight muscular pain in injection site.
Flu shot on 10/17/13, achy body 10/18/13, skin pain 10/26/13, unable pee 10/27/13, hospitalized 10/28/13, loss in leg feeling, treatment and test begin 10/29/13, 10 plasma treatments, rehab.
New muscle pain symptom in Day 3. Moderate pain traveling down arm into hand from injection site. Reduced sensation in arm and hand.
FEELING WEAK AND DIZZY  ABOUT 10 MIN. AFTER VACCINATION BP 173/87, GRADUALLY RETURNED TO NORMAL IN ABOUT AN HOUR AFTER VACCINATION CONTINUED TO FEEL VERY TIRED FOR MORE THAN TWO HOURS
02/12: My arm was red, sore, and warm directly below the injection site in a 2 inch diameter circle. 02/13 &14: The symptoms spread to a 5 inch by 6 inch area with some hardness and noticeable swelling and more redness, soreness, and warmth. I took Benadryl at 9:00 pm. 02/15: The redness, soreness, and warmth lessened, but the size of the affected area remained the same. The hardness and swelling moved closer to my elbow, completely across half of the lower part of my upper arm. I took Benadryl at 11:00 am and 6:00 pm.  02/16: I saw my primary care provider who determined it was not bacteria cellulitis. The redness, soreness, and warmth lessened more. The hardness, swelling, and tenderness to touch remained.   02/17:  The symptoms have continued to lessen.  03/04:  I still have slight discoloration.  At times, I still have random pains in the area of the injection site and affected area.
HEADACHES AND CURRENTLY TAKING EXERDRIN EXTRA STRENGHT, FIORICET.
Immediate red lump at site of injection which grew in minutes to the size of a quarter.  Heart racing, throat itched, very dizzy.  Blood pressure and heart rate were high.
Slight nausea; Under the skin irritation; under the skin itchiness; Just feeling sluggish now; This is a spontaneous report from a contactable consumer (patient). This 72-year-old male patient received bnt162B2 (BNT162B2, solution for injection, Batch/Lot Number: EN6203; Expiration date: 26Feb2021), via an unspecified route of administration, in right arm on an unspecified date as DOSE 2, SINGLE for covid-19 immunization (age at vac-cination:72-year-old). The patient medical history and concomitant medication were not reported. The patient did not take any other products other than bnt162B2 vaccine. Previously the patient received first dose of bnt162B2 (BNT162B2, solution for injection, Batch/Lot number: EM9809; Expiration date: 05Feb2021) via an unspecified route of ad-ministration, in right arm on 05Feb2021 at 13:30, as DOSE 1, single for COVID-19 immunization. A couple of days after the second shot, on an unspecified date the patient had slight nausea but only lasted a couple of days. There was no vomiting with second shot like there was with first one. The patient also experienced under the skin itchiness, Under the skin irritation and was Just feeling sluggish now. The patient did not receive any treatment for the event Under the skin irritation. Treatment details for the event's slight nausea and just feeling sluggish was not provided. The outcome of the event slight nausea and under the skin irritation was recovered and the outcome of the event Just feeling sluggish and experienced under the skin itchiness was unknown.  Follow-up attempts are completed. No further information is expected.
Pt. is a48y.o. year old male presents to ER due to progressive SOB. Patient admits to onset of symptoms 7/25. He was seen by PCP and started on Azithromycin. Covid testing was positive 7/27. He did not feel well but was doing ok at home until progressive SOB developed and he presented to ER 8/2. He did go to ER 7/22 and traveled over the weekend.  CXR with multifocal pneumonia consistent with Covid CT chest no PE He has received Pfizer vaccine 4/5 and 4/26/21.  Patient has diabetes and COPD. Leukocytosis on steroids. Patient is requiring 2L O2/NC Will proceed with Remdesivir/Decadron
Tightness of airway, feeling of something caught in throat. Tx: Benadryl 50 mg, Solumedrol 125mg IM (1452).