chrisvoncsefalvay/vaers-outcomes huggingface dataset:
red raised wett at injection site; tender; caused her unable to work; Headache; nausea; run down; This spontaneous case was reported by an other health care professional and describes the occurrence of INJECTION SITE URTICARIA (red raised wett at injection site), TENDERNESS (tender), ILLNESS (caused her unable to work), HEADACHE (Headache) and NAUSEA (nausea) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Amoxicillin, Vioxx, Celexa) and Adhesive tape use.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE URTICARIA (red raised wett at injection site), TENDERNESS (tender), ILLNESS (caused her unable to work), HEADACHE (Headache), NAUSEA (nausea) and FATIGUE (run down). At the time of the report, INJECTION SITE URTICARIA (red raised wett at injection site), TENDERNESS (tender), ILLNESS (caused her unable to work), HEADACHE (Headache), NAUSEA (nausea) and FATIGUE (run down) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment details were reported.   Action taken with mRNA-1273 in response to the event was not applicable.
COVID-19; Missed dose; This spontaneous case was reported by a non-health professional and describes the occurrence of COVID-19 (COVID-19) and PRODUCT DOSE OMISSION ISSUE (Missed dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19) and PRODUCT DOSE OMISSION ISSUE (Missed dose). At the time of the report, COVID-19 (COVID-19) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Missed dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant product were reported No treatment information was provided.   Reporter did not allow further contact
Fever 2nd day, soreness, swelling, rash at site. Day 2-4 fatigue.
pt recv vax 9AM 10AUG95 & 1230 pt began to cry for approx 2 hrs high pitch cry- mo nursed pt & then pt went to sleep; pt vomited later in evening;
stage 1 kidney failure; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient received BNT162b2, on 03Dec2021 at 17:00 as dose 1, single (Lot number: FH8C28) at the age of 48 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Sulfa drugs" (unspecified if ongoing). There were no concomitant medications. Patient didn't received other vaccine in four weeks and other medications in two weeks. Patient had no COVID prior vaccination and no COVID tested post vaccination.   The following information was reported: RENAL FAILURE (disability) with onset 01Mar2022, outcome "recovering", described as "stage 1 kidney failure". The event "stage 1 kidney failure" required physician office visit. Patient was diagnosed as stage 1 kidney failure per Creatinine, EGFR and anion gap levels measured via blood test. Prior to vaccine, kidney levels had been normal throughout life. Therapeutic measures were not taken as a result of renal failure.
Employee received the Pfizer vaccine dose #1 on 08/24 at the  vaccine event. The injection was in the left upper arm in deltiod. Started have symptoms the next day after vaccination (8/25): Swollen lymph node under arm, fatigue, and warm to touch. Has been off of work since 08/25. Advise to call back if symptoms worsen and get better if a follow up call. As well to put  cold compress on site and take ibuprofen or Tylenol
Developed blood clots in left calf; This is a spontaneous report received from contactable reporter (Other HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Jan2021 as dose 2, single (Lot number: FJ9262) at the age of 52 years intramuscular, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EJ1686, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 30Dec2020, when the patient was 52-year-old, for COVID-19 immunization. The following information was reported: THROMBOSIS (medically significant) with onset 14Jul2021, outcome "recovering", described as "Developed blood clots in left calf". The event "developed blood clots in left calf" required physician office visit. Therapeutic measures were taken as a result of thrombosis. Clinical course: There were no other vaccine in four weeks and no other medications in two weeks. The event (AE) resulted in: Doctor or other healthcare professional office/clinic visit. AE treatment included ultrasound, baby aspirin. The patient had no COVID prior vaccination and not COVID tested post vaccination, The patient has no known allergy and no other medical history. The patient received dose number 3 of COVID 19 vaccine (Pfizer) on 19Jan2022 (Lot number: FJ6369), Intramuscular on left arm.; Sender's Comments: Based on the available information and the known product safety profile, a causal relationship between the reported event thrombosis and BNT162B2 is considered possible. 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.
Immediately following the withdrawal of the needle from his right arm, patient felt a sensation of pressure in his eyes, redness and watering of the eyes, as well as blurred vision. After about 10 to 15 minutes, patient was asked to try to read printed letters, and he had trouble making it out. After the 15 minutes, patient was given aspirin and administered his own eye drops. Symptoms had subsided slightly by 2pm or so.
I61.9 - ICH (intracerebral hemorrhage) (CMS/HCC) I63.9 - CVA (cerebrovascular accident) (CMS/HCC) I63.81 - Right-sided lacunar stroke (CMS/HCC N17.9 - Acute kidney failure, unspecified R29.810 - Facial weakness
Pt reports being awake but unable to speak, move arms/hands, and arms/hands contracted to core.  This lasted for approximately 5 minutes.
Received the first dose of the Moderna vaccine on Tuesday, March 23, 2021 afternoon and woke up on Thursday, March 25, 2021 with debilitating back pain (could not stand up or sit down without assistance). Two days later, around March 27, the back pain had subsided but was replaced with constant tingling in both of my legs all the way to my feet. The tingling has not gone away since March 27, 2021. I started taking 60 mg of Cymbalta each day in February 2022, which has helped lessen the leg neuropathy, although it has not gone completely away.
On 08/25/1997 this pt received one dose of varicella vax. Subsequently she developed chickenpox. She sought medical attention.
Fever; Chills; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s).  A 25 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Fever"; CHILLS (non-serious), outcome "unknown", described as "Chills".  Additional information: Event: Fever and chills with first dose similar to when I got the covid vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient stated arm started swelling and hurting very badly on Sunday afternoon (she received the vaccine in the morning). By Monday, most of the swelling went down though it was still sore. Today, around a patch of normal skin of 3-4 inches in diameter from where the vaccine was injected is a ring of red skin. The arm is still sore but not aching.
By the evening of the day I received my booster vaccine, the left half of my left eye became very bloodshot. It did not affect my vision, nor did it bother me. My eye felt slightly wetter. The next morning it was still very bloodshot on that side. By the late afternoon the bloodshot look had diminished. By the next morning it looked less bloodshot but still not normal.
Prior cesarean birth at 41 weeks 04/2011; 7 pounds 21 inches. Current pregnancy estimated due date 04/23/2022.   Immediately following my 10/01/21 booster vaccine, I had fever (101) and chills, nausea, lethargy for six days. I missed several days of work and had a virtual urgent care visit to ensure my pregnancy was not in danger. Treated with rest, hydration, and as much Tylenol as was safe to take.   Began a new job in mid October and noticed my heart rate had significantly increased. It has continued to rise into 140s with normal activity (walking, bending, etc) and causes me to feel shortness of breath. On 12/25/21, this feeling was so severe that I spent 7 hours in the ER. I assumed it was asthma-induced but it was tachycardia and low BP, without much improvement after 2L boluses of fluids. Standing HR in 120s and feeling faint. Have followed up with OBGYN who referred me to PCP. PCP made minor medication adjustment (increased dosage of famotidine from 10-20mg to 40mg daily) and has requested a cardiac event monitor; we are awaiting insurance approval. These symptoms have me working a light duty assignment as I am unable to complete my usual duties as a hospital nursing assistant while these symptoms continue.
Extreme chills, 102.5 degree fever, dizziness, headache, pain in legs, trouble walking, unable to eat, barely able to drink, severe pain in shoulder bone, pain in arm, fatigue.
Injection site started  to itch. A rash appeared the next day and was hot to touch. Rash is 4 x 8 area. I took ibuprofen for the swelling and for the heat. After I contacted by health care provider I was told to take Claritin. I took an allergy medicine. Still have rash but itch is subsiding.
Patient came in with large welts/hives on his face and arms. Patient stated that he noticed this morning and that they were very itchy.
According to shot record brought by mother the patient was due for MCV. After giving vaccine it was noted in the registry that it was given on May 11, 2006. The patient recieved 2 doses.
Diagnosed with COVID on 10/12/2022. Received Paxlovid due to symptoms of respiratory, fever, coughing . Was sick for ~10 days
Presented to Medical Treatment Facility on 6/14/06 c/o L shoulder pain related to reaction to anthrax immunization. L shoulder with 34.5cm redness and L bicep with 30cm of redness. Area tender to touch and pruritic. Diagnosed as severe local reaction to anthrax immunization. Quarters x 24 hours, Z pack, and Benadryl ordered. RTC prn.
Patient received PNEUMOVAX 23 and FLUZONE High Dose in the Left Deltoid Intramuscularly on 9/25/2017 at 11:13am. Patient called Pharmacy on 9/27/2017, to say her arm was swollen. Patient went to Urgent Care Facility on 9/27/2017 and was P.A. who prescribed a MEDROL Dose Pack and BACTRIM DS Tablets.
pt recv vax 25JAN96&mom called 9PM on 1FEB96&reported that pt had temp of 104.5;no other adverse sx;temp 100 @ 911AM 2FEB96;
I had shortness of breath; I check my heart and it was 36. I called the ambulance, and they took me to emergency room in a HCF, and they eventually game a pacemaker; after been discharge I developed A-FIV, they performed cardioversion electrically, I was discharged and then I went back to the hospital and then Cardioversion was achieved medically.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 12-OCT-2017, the patient was vaccinated with an improperly stored dose of PROQUAD (recombinant Human albumin) (strength and route were unknown) (lot# M044718 and expiration date 07-MAY-2018) for prophylaxis (Incorrect product storage). The sterile diluent (MERCK) was properly stored. No adverse event was reported. The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017, 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 05-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001959.
Information has been received from a medical assistant concerning a 78 year old female caucasian patient who in approximately October 2004 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 649913/0577P).  On 10/19/2004 the patient developed swelling from shoulder to elbow with hard area at site, fever with chills and increased WBC and HGB (per phone conversation with patient).  The patient was reportedly seen by oncologist and antibiotics were given.  The patient reportedly recovered on approximately 10/22/2004.  (It was also reported that on 10/28/2004 the patient called the doctor's office complaining of swelling (size of fist) and redness at injection site.  The patient also had a fever.)  It was also reported that two other patients had a similar reaction and were vaccinated from the same lot.  The medical assistant requested a lot check of 649913/0577P.  The records of testing prior to release of this lot have been checked and found to be satisfactory.  The lot complies with industry standards and was released.  No additional information is expected.
This is in follow-up to report(s) previously submitted on 5/14/2004. Information has been received from a physician concerning a 37 month old female who on 05/30/01 was vaccinated IM with a first dose of varicella virus vaccine live (Lot # 636575/1467K, dilutent # 633772/0489L).  It was reported that the pt had varicella at the time of vaccination. On 07/26/03 the pt was seen by the physician and a clinical diagnosis of varicella was made. She had approximately 31 lesions and had experienced a "breakthrough". Subsequently, 7-10 days later, the pt recovered. No product quality complaint was involved. No further information is expected.
A patient received the first dose on 12Jun2021 and has not receive the second dose yet with no reported adverse event; Initial information was received on 22-Jun-2021 regarding an unsolicited valid non-serious case from a pharmacist and physician.  This case involves a 44-year-old male patient who received first dose of 1 ml RABIES (HDC) VACCINE [IMOVAX RABIES] on 12-Jun-2021 for and has not receive the second dose yet (lot T1C66, expiry date, route, site unknown) for unknown indication (wrong schedule).  Medical history, medical treatment, vaccination, concomitant medications and family history were not provided.  It was a case of an actual medication error due to wrong schedule.  At the time of report, no adverse event was reported.  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.
auto immune reaction called "lichen planus"; it looks like a bruise; developed a rash; This spontaneous case was reported by a consumer and describes the occurrence of LICHEN PLANUS (auto immune reaction called "lichen planus"), VACCINATION SITE BRUISING (it looks like a bruise) and VACCINATION SITE RASH (developed a rash) 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.   In June 2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In June 2021, the patient experienced LICHEN PLANUS (auto immune reaction called "lichen planus"), VACCINATION SITE BRUISING (it looks like a bruise) and VACCINATION SITE RASH (developed a rash). At the time of the report, LICHEN PLANUS (auto immune reaction called "lichen planus"), VACCINATION SITE BRUISING (it looks like a bruise) and VACCINATION SITE RASH (developed a rash) outcome was unknown.            No Concomitant medication was reported. Patient stated that she was prescribed Protopic which affects t cells and the Moderna vaccine also affects T cells. She explained that 6 months ago after receiving her 2nd Moderna shot, she developed a rash, it looks like a bruise. She stated that it is an auto immune reaction called "lichen planus." Patient stated that she doesn't know if it was related to the vaccine. Treatment medication included Protopic ointment was prescribed, but has not used it yet.
First Covid vaccine 3/9 hard to sleep second vaccine 3/29 nausea on 4/2 work up with bilateral hand swelling progressively worse over next month. Very positive CCP and RF synovitis mcp,pip wrists bl c/w definite rheumatoid arthritis (daughter has RA, second daughter type one diabetes) patient had no joint symptoms prior to vaccine
15MAR93 12AM felt warm to touch & mom gave APAP & juice; sz @ 330-345PM; eyes rolled back & made gurgly sound x 2; didn't talk for 15 mins; seen in ER & fever 104 R 4PM; beginning of ear infect;
edema & effusion of the rt knee 4 days later full ROM; walks w/stiff knee but bends easily when asked; toxic synovitis of rt knee;
Around the time of the vaccine, I retired in November and lost weight and exercised more but I have developed High Blood Pressure.
Patient said he had a terrible headache for 2 days. When he was slp he started waking up gasping for air. Now he is having respiration problems. He was an active person and now he has to stop and catch is breathe after walking down the steps. patient stated that on 8/8/21 he went to the bathroom and blacked out and fell in the tub. He is experiencing dizziness.
Patient given combo vaccine Kinrix on 3/2/20 which these vaccines Dtap and IPV should have been given separate or as a Dtap/Hib/IPV combo.  Was brought to attention by coding on 3/5/20.  PCP Dr. out of office, verified with Dr. on 3/6/20 dosing ok, which it was.  Spoke to, RN who manages vaccines and she spoke to the Health Department  and was concluded that this immunization does count for patient's doses and no additional injections needed.
Itchy spot at injection site; Swelling at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy spot at injection site) and VACCINATION SITE SWELLING (Swelling at injection site) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-May-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy spot at injection site) and VACCINATION SITE SWELLING (Swelling at injection site). At the time of the report, VACCINATION SITE PRURITUS (Itchy spot at injection site) and VACCINATION SITE SWELLING (Swelling at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Complained of warm feeling after receiving first dose of Pfizer COVID-19 vaccine (lot EN6205, exp 6/30/2021). At 1029, EMT  was checking in on client since she was in post vaccine waiting area for 30 min observation. EMT noticed flushed face and neck. Per client felt warm sensation and at 1031 stated metallic taste in mouth, feeling clammy with sweaty hands. PHN joined EMTs. First set of vitals: blood pressure 120/80, temperature 101.7 F. Alert and oriented, no shortness of breath, rash, itching, swelling, blurry vision, or tingling noted per client. Per client sulfa, shellfish, and contrast IV dye allergies. Medication client took this morning: Synthroid 75mcg. Clt reported she ate breakfast at 9am consisting of cereal and coffee, client reported a history of Bell's palsy 20 years ago with full recovery. 1034 temp 100.0 F. Assessed for arm drift, no tongue deviation, clt stated no tingling, able to move all extremities. 1042 vitals: blood pressure 120/100, pulse 77, o2 98, temp 99.0 F. Alert and oriented, clammy hands, no shortness of breath, no swelling. PHN offered client Benadryl, client declined. Informed client she would be kept longer for observation and client agreed. At 1047 temp 98.9 F, respiratory rate 24. At 1051 client stated tingling sensation on inner lips, metallic taste, dizziness, and mild burning sensation around eyes and nose area. PHN assessed for swelling in mouth, lips, face. PHN offered Benadryl again and client accepted. Client called husband who was in parking lot, client not driving. At 1054 Benadryl 50mg/ml IM on left deltoid. Vitals 1056: blood pressure 118/90, pulse 70, o2 98. Client informed vitals would be reassessed every 5 minutes. 1101 vitals: 99.1 F temp, blood pressure 118/78, pulse 77, o2 98. Per client dizziness and metallic taste were improving. 1106 vitals: pulse 75, o2 98, respirations 14, EMT unable to obtain blood pressure. Client complained of tingling on left index finder, PHN assessed bilateral grip strength, equal on both sides. 1114 vitals: blood pressure 128/72, pulse 74, o2 99. Per client, improvement of tingling sensation on lips, no metallic taste, no dizziness, no headache. Per client felt Benadryl effects. Vitals 1118: blood pressure 124/82, pulse 76, o2 96. Vitals 1124: blood pressure 128/78, pulse 75, o2 98. Client able to stand, denied dizziness. At 1133 noticed change in speech, slurred. Per client voice was different. called 911 at 1134. Paramedics arrived at 1142 and assumed care. Client transported to Hospital per client's husband request at 1149.