chrisvoncsefalvay/vaers-outcomes huggingface dataset:
he had a "pretty significant tinnitus" from the skull; he also had pressure at the base of the skull, he had pressure at the occipital region and sides of his head just above the soft tissues at the temporal area,; nerves tingling in his skull; This is a spontaneous report from a contactable consumer (patient himself). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: not reported), via an unspecified route of administration on an unspecified date as 1st dose, single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, the patient experienced he had a "pretty significant tinnitus" from the skull, he also had pressure at the base of the skull, he had pressure at the occipital region and sides of his head just above the soft tissues at the temporal area and nerves tingling in his skull. The adverse events started 3-4 days after getting the first dose of the vaccine. He said it got worse after the second dose of the vaccine. He has already visited his physician, acupuncturist, and neurologist. The outcome of the events was unknown. There was not product quality complaint (PQC) present.  Information about Lot Batch number has been requested.
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Weakness-Medium
cardiomyopathy; anoxic brain damage; had trouble breathing stating she felt she had something in her throat/ loss of breath; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 34-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Dec2022 at 10:00 as dose 3 (booster), single (Lot number: GK1337) at the age of 34 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Migraines" (unspecified if ongoing); "obesity" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "COVID" (unspecified if ongoing), notes: If COVID prior vaccination Yes; "Depression" (unspecified if ongoing), notes: Other medications in 2 weeks: :depression and anxiety medicine; "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: IBUPROFEN; OMEPRAZOLE. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EW0151, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 08Apr2021, when the patient was 32-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: ER8727, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 18Mar2021, when the patient was 32-year-old, for COVID-19 immunization. The following information was reported: BRAIN INJURY (death, hospitalization, life threatening) with onset 21Dec2022 at 04:30, outcome "fatal", described as "anoxic brain damage"; CARDIOMYOPATHY (death, hospitalization, life threatening) with onset 21Dec2022 at 04:30, outcome "fatal"; DYSPNOEA (death, hospitalization, life threatening) with onset 21Dec2022 at 04:30, outcome "fatal", described as " had trouble breathing stating she felt she had something in her throat/ loss of breath ". The patient was hospitalized for cardiomyopathy, brain injury, dyspnoea, (hospitalization duration: 2 day(s)). The events "cardiomyopathy", "anoxic brain damage" and "had trouble breathing stating she felt she had something in her throat/ loss of breath " required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Dec2022) Negative. Therapeutic measures were taken as a result of cardiomyopathy, brain injury, dyspnoea. The patient date of death was 22Dec2022. Reported cause of death: "Ischaemic cardiomyopathy". No autopsy was performed.  Additional information: 12 days after dose, had trouble breathing Stating she felt she had something in her throat. This led to loss of breath, cardiomyopathy, and anoxic brain damage which resulted in her death. Treatment includes: Ventilator and medications and will need to contact hospital.; Reported Cause(s) of Death: Ischaemic cardiomyopathy
63M with T3 paraplegia from remote MVA, chronic decubitus ulcers, neurogenic bowel/bladder, hx of bladder cancer s/p chemotherapy, and ILD who was admitted on 7/24 with increased SOB and lethargy for 5 days duration, s/p PEA arrest w/ ROSC after roughly 30 minutes of CPR on 7/25, later found to be in new cardiogenic shock with new onset biventricular failure with LVEF of 10-15%. Prior echo in 2019 showed LVEF of 50-55%.
The patient reports that she had a witnessed seizure event after having breakfast at a local restaurant. EMS was called and they administered Ativan for witnessed seizure activity. Patient was transported to the emergency department for further evaluation and treatment. Patient is seizure-free since her arrival to our emergency department. Coincidently the patient had her second Covid vaccination yesterday and there is concern that the seizure might be associated with her vaccination.
Chills, low grade fever and headache 36 hours. Strong radiating arm pain and armpit lymph node discomfort continues 60 hours and counting, including a red, swollen tender and itchy area 2 inches below the injection site
Ringing in right ear/ringing had been going on for 5 months/tinnitus; Pain in her right ear; No ringing but had fullness in left ear; Left ear started hurting a few days; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Ringing in right ear/ringing had been going on for 5 months/tinnitus), EAR PAIN (Pain in her right ear), EAR DISCOMFORT (No ringing but had fullness in left ear) and EAR PAIN (Left ear started hurting a few days) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 032M20A) for COVID-19 vaccination.     The medical history information was not provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced TINNITUS (Ringing in right ear/ringing had been going on for 5 months/tinnitus) and EAR PAIN (Pain in her right ear). In 2021, the patient experienced EAR DISCOMFORT (No ringing but had fullness in left ear) and EAR PAIN (Left ear started hurting a few days). The patient was treated with PREDNISONE in 2021 for Adverse event, at an unspecified dose and frequency; PREDNISONE in 2021 for Adverse event, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) in 2021 for Ear pain, at a dose of UNK, prn. At the time of the report, TINNITUS (Ringing in right ear/ringing had been going on for 5 months/tinnitus), EAR PAIN (Pain in her right ear), EAR DISCOMFORT (No ringing but had fullness in left ear) and EAR PAIN (Left ear started hurting a few days) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Magnetic resonance imaging head: normal (normal) Brain MRI done a few weeks ago was normal.         Patient's ENT had put her on Prednisone twice. She was looking for another ENT for second opinion.   Patient was fine after her first dose.
Pharmacist administered 0.25mL (Booster dose, full dose is 0.5mL) of Moderna Covid-19 vaccine, when patient was to receive 0.3mL of Pfizer Covid-19 vaccine for second dose of original Covid-19 vaccine series. Patient was notified and administered second 0.25mL dose of Moderna Covid-19 vaccine to provide a full dose and to complete the original vaccine series. CDC guidance does not recommend mixing mRNA vaccines for original series, but if inadvertently administered recommends no further intervention and patient is considered fully vaccinated for the original series.
Server joint pain,fatigue,fever,chills,flu like symptoms. Approx 48 hrs. Felt great after 48 hrs. I have RA and my RA symptoms almost completely disappeared for 4 days . Had an energy burst for those 44 days.
sore throat; swollen gland; nasal congestion; COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Apr2021 as dose 1, single (Lot number: ER8737), in left arm, on 24Apr2021 as dose 2, single (Lot number: EW0161), in left arm and on 02May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 61 years, in left arm for covid-19 immunisation; covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 29Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Fibromyalgia" (unspecified if ongoing); "migraines" (unspecified if ongoing); "hx of breast cancer" (unspecified if ongoing), notes: hx of breast cancer and chemo damaged my heart.; "chemo damaged my heart." (unspecified if ongoing), notes: hx of breast cancer and chemo damaged my heart.; "chemo damaged my heart." (unspecified if ongoing), notes: hx of breast cancer and chemo damaged my heart.; "Known allergies: Itchy with latex" (unspecified if ongoing). Concomitant medication(s) or other medication in 2 weeks included: AIMOVIG and THYROID MEDICATIONS. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID-19"; NASAL CONGESTION (non-serious) with onset 08Jul2022, outcome "recovering"; OROPHARYNGEAL PAIN (non-serious) with onset 08Jul2022, outcome "recovering", described as "sore throat"; LYMPHADENOPATHY (non-serious) with onset 08Jul2022, outcome "recovering", described as "swollen gland". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Jul2022) Negative, notes: Had a negative home test on 06Jul2022; (08Jul2022) Positive, notes: home test had a very slight mark for positive; (09Jul2022) Positive, notes: 09Jul2022 home test was positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 29Jun2022 to 04Jul2022. Therapeutic measures were not taken as a result of oropharyngeal pain, lymphadenopathy, nasal congestion. The patient had a negative home test on 06Jul2022. Started with nasal congestion on 08Jul2022 and home test had a very slight mark for positive. On 09Jul2022, the home test was positive and had more symptoms, sore throat, swollen gland, nasal congestion.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Fever, nausea, pain at injection site, weakness, all-over muscle aches, Headache, fever, chills, unbearable pain in abdomin, diarrhea, anxiety, exhaustion.
Heart attack; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criteria death and medically significant). The cause of death was not reported. It is unknown if an autopsy was performed.            No concomitant medications were reported. Treatment information was not provided.  Company Comment: This spontaneous case concerns a male patient of unknown age, with no medical history reported, who experienced a fatal and medically Significant serious unexpected event of Myocardial Infarction 2 days after receiving a dose of mRNA-1273.222 vaccine. The details of previous doses were not provided. The cause of death was reported as died of natural causes. There was no information provided about the patient's age, underlying medical conditions, concomitant medications, clinical course of the event, associated symptoms, final diagnosis, diagnostic and treatment details. It is not known if an autopsy was performed. The benefit-risk relationship of mRNA-1273.222 vaccine, is not affected by this report.; Sender's Comments: This spontaneous case concerns a male patient of unknown age, with no medical history reported, who experienced a fatal and medically Significant serious unexpected event of Myocardial Infarction 2 days after receiving a dose of mRNA-1273.222 vaccine. The details of previous doses were not provided. The cause of death was reported as died of natural causes. There was no information provided about the patient's age, underlying medical conditions, concomitant medications, clinical course of the event, associated symptoms, final diagnosis, diagnostic and treatment details. It is not known if an autopsy was performed. The benefit-risk relationship of mRNA-1273.222 vaccine, is not affected by this report.; Reported Cause(s) of Death: Died of natural causes
Received Varicella vaccine on 5/13/05. On 5/27/05 reported feeling achy/feverish and developed red, raised rash on numerous parts of body. Went to ED on 5/28/05 and diagnosed with chickenpox.
trouble sleeping; Was very achy all day yesterday with headache; Was very achy all day yesterday with headache; Minor chills; This is a spontaneous report from a contactable consumer reporting for themself. A patient of an unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL8982/expiration date: not provided), via an unspecified route of administration, on 21Jan2021 as a single dose for COVID-19 IMMUNIZATION. Relevant medical history included patient got sick and had suspected COVID on "03Aug" and became a long hauler and still have lingering symptoms. The patient previously received the first dose of BNT162B2 on an unknown date. Concomitant medication was not reported. On 21Jan2021, the patient had trouble sleeping that night, was very achy all day with headache and had minor chills. The woke up feeling well. The outcome of the events had trouble sleeping that night, was very achy all day with headache and had minor chills was recovering.   No follow-up attempts are possible. No further information is expected.
This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (generally miserable), DIZZINESS (she is lightheaded), PAIN IN EXTREMITY (she has had a sore arm), HEADACHE (really a bad headache/ periodically a headache on left side of her head) and VACCINATION SITE PAIN (she still feels a burning pain on her left arm (injection site)) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Thyroid disorder NOS (Thyroid shut down). Previously administered products included for COVID-19: Augmentin (She claims that the Augmentin that she was prescribed with during that time screwed up her guts) in February 2020. Past adverse reactions to the above products included Abdominal disorder with Augmentin. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced FEELING ABNORMAL (generally miserable), HEADACHE (really a bad headache/ periodically a headache on left side of her head) and ARTHRALGIA (joint aches). On 10-Mar-2021, the patient experienced DIZZINESS (she is lightheaded) and PAIN IN EXTREMITY (she has had a sore arm). On an unknown date, the patient experienced VACCINATION SITE PAIN (she still feels a burning pain on her left arm (injection site)). At the time of the report, FEELING ABNORMAL (generally miserable), DIZZINESS (she is lightheaded), PAIN IN EXTREMITY (she has had a sore arm), HEADACHE (really a bad headache/ periodically a headache on left side of her head) and ARTHRALGIA (joint aches) outcome was unknown and VACCINATION SITE PAIN (she still feels a burning pain on her left arm (injection site)) had not resolved.    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Mar-2021, Body temperature: 100.5 f High. No concomitant medications were reported. No treatment medications were provided by the reporter. Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Updated patient demographics, medical history and added new event.
Site - warm, and very firm - palpable lump under armpit started within 12 hours of injection.
pt recv vax FEB97 & devel a fever of 100 & felt quite ill;golf ball size lump appeared @ the inj site;approx 5cm in diameter w/warmth & redness in lump which persisted for 1mo;
Vaccine (SHINGRIX) given 5/24/18. On 5/26/18 patient noticed 4in red circle around injection site.
Patient stated she had a feeling of racing heart beat shortly after vaccination. She was instructed to stay in our observation area for at least 15 min. or as long as she needed. She sat down briefly  but did not wait as asked and got up after a short time (less than 10 min)  and wandered into the store. She was then "found" by kitchen staff when others who had come to the store had been looking for her. At that time she stated she was feeling tired and light headed. We assessed patient and after further questions found out she had not eaten anything so far today and being diabetic was likely having low blood sugars. We offered water and a banana as well as juice. She accepted water and ate half of the banana. Did not take Juice.
Low lying placenta; Vaccine exposure during pregnancy; This is an observational study case, initially received from other health professional on 10-Oct-2019, concerning a 40-year-old, pregnant, female subject of body weight: 157.5 lbs, height: 62 inches and body mass index (BMI): 28.8, enrolled in, a prospective observational study.  The subject's obstetrical history included four previous pregnancies with one full term live birth, two spontaneous abortions and one elective abortion. No birth defects were reported. Also, the subject had no maternal or paternal history with major congenital malformations. The subject did not have a prior history of use of alcohol or illicit drugs during pregnancy. The subject was a smoker (10 cigarettes per day). The subject's medical history included pulmonary venous thrombosis, asthma, hypothyroidism, advanced maternal age and high body mass index (28.8). Concomitant medications included prenatal vitamin (minerals NOS, vitamins NOS) for pregnancy, ProAir HFA (salbutamol sufate) and Pulmicort (budesonide) both for asthma, levothyroxine for hypothyroidism, enoxaparin for pulmonary venous thrombosis and vitamin D2 as a supplement.    The subject's last menstrual period (LMP) date was 02-Jun-2019, the estimated delivery date (EDD) was reported as 09-Mar-2020 and corrected estimated date of delivery (CEDD) was reported as 08-Mar-2020. The type of pregnancy was singleton.   On 19-Jul-2019 and 02-Aug-2019, the subject underwent ultrasound scan and no major congenital malformation (MCM) was noted.   On 25-Sep-2019, at gestational age of 17 weeks, the subject was administered Flu Vaccine Egg Split QIV CSL (Afluria QIV) [influenza vaccine; batch number: P100118566, dose, route of administration, anatomical location and expiry date: not reported] (explicitly coded as 'Vaccine exposure during pregnancy') for influenza immunisation.  On the same date, the subject underwent ultrasound scan and MSAFP/serum (Maternal Alpha-1-phoetoprotein) markers test and no MCM was noted.   On 08-Oct-2019, the subject underwent ultrasound scan and low lying placenta was noted.   At the time of initial reporting, the outcome of the event 'low lying placenta' was not reported.   The reporter did not provide a causality assessment.; Sender's Comments: A pregnant subject developed placenta praevia, 13 days after administration of Flu Vaccine Egg Split QIV CSL. Chronology is plausible. Vaccine was administered at gestational age of approximately 17 weeks. Causality was highly confounded my medical history of previous pregnancies, two spontaneous abortions and one elective abortion, advanced maternal age (40) and tobacco use. However, causal role of the suspect product cannot be excluded and it is assessed as unlikely related. Vaccine exposure during pregnancy is assessed as unrelated per company's conventions.
23days p/vax pt exp multiple, pruritic vesiculopapular lesions on face, trunk & limbs.pt felt fatigued, chills & low grade temp, also exp generalized malaise. treated w/phenergan
Pt did not show for second appt and upon contacting him- his family indicated that he got it last week. Dose 1 was 5/20/21- he got dose 2 on 6/9/21-- closer than the 28 day schedule. ( No known ADR beyond dosing  at lesser interval)
Pain on left arm after vaccination; Fever; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Pain on left arm after vaccination) and PYREXIA (Fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced INJECTION SITE PAIN (Pain on left arm after vaccination) and PYREXIA (Fever). At the time of the report, INJECTION SITE PAIN (Pain on left arm after vaccination) outcome was unknown and PYREXIA (Fever) had resolved.            No concomitant medications provided.   This case was linked to MOD-2021-021153 (Patient Link).
Dad came with child for child's 2nd dose Moderna 0.25ml.  Dad sat with child on his lap, child was already very anxious .  Asked  his dad which site to give vaccine he said thigh, I asked if right thigh was ok he said yes.  I asked dad to hold the child's hands.  I cleaned the right thigh.  I got off my chair to give the vaccine, I held the thigh as I was administering the vaccine the child moved his leg,  all of the vaccine spilled out and the needle scratched the thigh. Cleaned the area and applied the bandaid no distress noted. Supervisor notified. Offered to give repeat dose but Dad declined stated child is already anxious.  Dad was advised to reschedule.
Full body hives, swollen hands, swollen ears, burning skin. Continues after 2 cortisone shots, prednisone and Benadryl.
Information has been received from a registered nurse concerning herself who on 03-JUN-2008 was reconstituting ZOSTAVAX (Oka/Merck) to be administered to a patient, something happened with the syringe and some of the vaccine squirted up on her face, eye, lips and hand. The patient felt dizzy and had facial itching and a canker sore in her mouth since the eye splash. On 04-JUN-2008, the patient recovered from dizzy and facial itching. As the tine of 11-JUN-2008, the patient's canker sore in her mouth still persisted. Follow up information was from the registered nurse reported that the patient was 55 years old and had no pre-existing allergies, birth defects and medical conditions. On 03-JUN-2008 at 2:30 PM, the patient mixed the vaccine and diluent, the vaccine was inadvertently splashed to her face, eyes, lips and hands. There was no illness at time of vaccination. No laboratory diagnostics studies were performed. Additional information is not expected.