chrisvoncsefalvay/vaers-outcomes huggingface dataset:
cracked tooth the night of the shot; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TOOTH FRACTURE (cracked tooth the night of the shot) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     Concomitant products included CITALOPRAM and ALPRAZOLAM (XANAX) for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced TOOTH FRACTURE (cracked tooth the night of the shot). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1000 mg,per every 6 hours; IBUPROFEN at an unspecified dose and frequency and AMOXICILLIN at a dose of 500 mg,every 8 hours. At the time of the report, TOOTH FRACTURE (cracked tooth the night of the shot) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient had a cracked a tooth and needs a root canal. On 31 MAR 2021, night of the first shot cracked tooth and had high pain tolerance and dealt with the pain. On 05 APR 2021 took Tylenol 1000 mg every 6 hours and Motrin.  On 09 APR 2021 the dentist started on Amoxicillin 500 mg every 8 hours. On 15 APR 2021 stopped ibuprofen and Tylenol.  Patient afraid the amoxicillin and ibuprofen/Tylenol would interfere with the COVID shot.  Second dose is scheduled for 28Apr2021. Caller said had a dental surgery coming up on 28 APR 2021.Patient wants to know if can take the Moderna shot 1 week earlier.   This case was linked to MOD21-079532 (E2B Linked Report).; Sender's Comments:  MOD21-079532:
Patient mother reports. Seen by RN on 12/22/2014 erythema at sight approximately 3 inches in diameter. Pt reports itching and pain to touch. Pt mother reported using hot and cold compress. Pt seen by provider on 12/22/14 at 9:57 AM and Benadryl 12.5mg/5ml was prescribed.
tested positive for Covid 19; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (tested positive for Covid 19) 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.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (tested positive for Covid 19). At the time of the report, COVID-19 (tested positive for Covid 19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Company comment: This is a spontaneous case concerning a patient of an unknown age and gender with no reported medical history, who experienced the non-serious event of special interest COVID-19, on an unknown lapse of time after receiving the second dose of mRNA-1273.  The benefit-risk relationship of mRNA-1273 is not affected by this report.  Concomitant medication information was not provided by the reporter.                            Treatment information was not provided by the reporter.; Sender's Comments: Company comment: This is a spontaneous case concerning a patient of an unknown age and gender with no reported medical history, who experienced the non-serious event of special interest COVID-19, on an unknown lapse of time after receiving the second dose of mRNA-1273.  The benefit-risk relationship of mRNA-1273 is not affected by this report.
Started as extremely painful around the injection site and couldn't move arm. Then it went on to be red from the injection site to his chest, and he had a fever. As of today's follow-up, it's still very painful and he's been put on an antibiotic per his doctor.
Began having severe lumbar pain on March 15, 2021. Progressively got worse, and requested and had MRI on May 6, 2021. Started having severe abdominal pain on May 10-12, which kept getting worse, along with lumbar pain.  Abdominal pain became focal to right inguinal area, two spots especially. Had CT scan with barium and contrast on June 2, 2021. Negative. Had right hip X-ray June 4, 2021, which was negative. On June 6, two lesions opened up at the exact spots of focal pain in right inguinal abdominal area. Abdomen got distended, and bowels were affected.  Drained copious clear fluid, On June 7, walk in clinic diagnosed staph by appearance,  no culture. By June 12, 2021, couldn?t stand pain, no abdomen was distended and no  BM. Went to ER. Had CT scan for to r/o Chron?s, Diverticulitis, bowel obstruction, or other pathology. Negative. ER Doctor suspected shingles, based on rash, lesions, history of back pain and abdominal pain, and focal spots in single dermatome.
No adverse events were reported; Products were administered post TE; This spontaneous report was received from a registered nurse referring to a 4-year-old patient of unknown gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.     On 14-APR-2023, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (rHA) injection (lot # W001518, expiration date: 13-JAN-2024 or lot # W007040, expiration date: 29-FEB-2024; no exact lot# and expiration date was provided) and varicella virus vaccine live (oka/merck) (VARIVAX) injection (lot # W008711, expiration date: 14-MAR-2024 or lot # W017552, expiration date: 01-JUN-2024; no exact lot# and expiration date was provided) (both strengths, doses, routes of administration and anatomical locations were not reported), both for prophylaxis (product storage error). No additional adverse event (AE) was reported (no adverse event).  This case was received from the same reporter with another 17 cases: 2305USA007704, 2305USA009079,2305USA009080,2305USA009081,2305USA009082, 2305USA009083, 2305USA009084, 2305USA009085, 2305USA009086, 2305USA009087, 2305USA009088, 2305USA009089, 2305USA009091, 2305USA009092, 2305USA009093, 2305USA009094, 2305USA009095.
Chills and fever up to 100.3 deg began ~12 hours after injection and lasted ~18 hours.
This was all after I got the covid-19  booster vaccine on 12/14/2021.   Right ear was plugged/clogged  for two days.  Right nostril was blocked.  Couldn't breath out of it for two days. Was feeling excessively sleepy for two days. Had very bad cough for two days. Had a slight fever (99.5F)  for one day. Have pain in chest. Still have it.  It never went away. Sharp pain at bottom of rib cage on left side after side of xiphoid process near coastal cartilage.   Regular muscle type pain at top on left side below clavical.
Appoximately 2-3 days after receiving flu vaccine began to feel shaky in the morning.  As day progressed became achy and felt she had fever.  Around 7:30 PM began to vomit and have diarrhea.  Symptoms lasted about 10 hours and then subsided.
patient received  vaccine , looked at his arm , and started to freeze up, almost passing out , eyes rolled back  and we got him to the floor and he came around saying he could move his arms (both) and his fingers were seizing up, we got ice packs, hewas clammy, but breathing fine , and hew was speaking  and complaining about his inability to move. no issues breathing , we called 911
Fever to 101.2-rectally after imms x 1. 99.0 x 3. No TYLENOL administered.
30-45 minutes post immunization/blood draw, pt c/o "not feeling good", "feeling cold", skin flushing. B/P taken. Reported - pt taken to urgent care. Pt left facility oriented. Ambulatory, alert and orientated.
This spontaneous report as received on 19-JUN-2015 from a consumer refers to a female patient of unknown age with a history of receiving both doses of VARIVAX (Merck) as a child. On an unspecified date in 2014, she was told by her physician that she had no antibodies/varicella titers for the varicella virus in her body. She was pregnant at the time of the test. Her physician prescribed that she received a booster dose of VARIVAX (Merck) after her pregnancy. On an unspecified date in June 2015, the patient was vaccinated with a booster shot of VARIVAX (Merck). On 17-JUN-2015 the patient experienced an itching sensation at the injection site. On 18-JUN-2015 the patient developed a hard lump the size of a grapefruit on her arm. The patient reported she went to an unspecified urgent care clinic to receive an unknown treatment. On 19-JUN-2015 the patient developed pustules on her arm. No further information was provided. The outcome of antibody test negative, rash pustular, skin mass and injection site pruritus is unknown. Additional information is not expected.
Pt had a TETANUS shot a week ago, then started having pain in the area of the injection, but then in the last couple days or so has had pain, swelling, erythema of her left wrist.  Her left shoulder has been painful ever since the TETANUS injection.  Pt prescribed PREDNISONE 40 mg QDX 3 days, then 20 mg QDX 2 days.
Tested positive for Covid 19 virus; Tested positive for Covid 19 virus; This is a spontaneous report from a contactable consumer (patient), via medical information team. A 57-year-old male patient received BNT162B2 (COMIRNATY) via an unspecified route of administration on 23Mar2021 (at 56-year-old) (Lot Number: FP7534 or EP7534) as dose 1, single, and on 13Apr2021 (at 56-year-old) (Lot Number: EN8729) as dose 2, single; both in arm left for COVID-19 immunisation. The physician denied any other medical history or immunosuppression. There were no concomitant medications. The patient didn't have any medical conditions in terms of making him compromised for the COVID 19 virus and he had no medical history or problems with being immune compromised. He tested positive for the COVID 19 virus on 28Sep2021 at a large testing site. He stated he works in an office and has zero exposure to the public, and he did go out to buy coffee and a few things here and there. He stated he did not have any positive contact with any persons infected by COVID-19 and also had very little exposure to the public except for occasional shopping trips. The outcome of the events was unknown.  Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot EP7534 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EP7534, fill lot EP7532, and the formulated drug product lot EP7528. A complaint sample was not returned, and photographs were not received. There were no deviations that may have caused a complaint of this nature. No root cause or corrective/prevent ative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.
Per patient, after vaccine was given returned to school. States he was not feeling well after the vaccine. Felt nauseous and had a headache. Returned home and while eating dinner, got up to cut a lemon when he felt like he was going to faint and cut his index fever. Finger started to bleed when he felt "he went somewhere else" and passed out. Next woke up on the ground in his Mom's arms. Was aware of surroundings per patient. Got up to sit in a chair where he passed out again. Ambulance was called and taken to the Emergency Room. Noted to have "allergic" reaction vs. seizure and advised to followup.
Admitted with Rhabdo after being found down at home, dx with COVID pna shortly after admit. Fully vaccinated. O2, remdesivir, singulair, zinc, steroids. 8/25 Discharged to inpatient hospice. Comfort was maintained the several hours he was on hospice He died at 16:20
running a fever of 103; The initial case was missing the following minimum criteria: ICH - Unspecified AE. Upon receipt of follow-up information on 25an2023, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient received BNT162b2 (BNT162B2), on 01Oct2021 at 12:00 as dose 3 (booster), single (Lot number: FC3184) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "R/A", start date: Jan2017 (ongoing), notes: rheumatoid arthritis; "Polymyalgia rheumatica", start date: Jan2017 (ongoing); "B/P" (unspecified if ongoing); "Blood clots" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing); "Allergies" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL taken for blood pressure abnormal (ongoing); WARFARIN taken for thrombosis, start date: Aug2019 (ongoing); ATORVASTATIN taken for blood cholesterol abnormal (ongoing); MONTELUKAST taken for hypersensitivity (ongoing). Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/lot number: FM9810, Administration time: 10:57 AM, Anatomical site of injection: Left arm), administration date: 11Feb2021, when the patient was 74-year-old, for Covid-19 immunization; BNT162b2 (DOSE 2, SINGLE, Batch/lot number: EN6200, Administration time: 10:44 AM, Anatomical site of injection: Left arm), administration date: 04Mar2021, when the patient was 74-year-old, for Covid-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 01Oct2021 at 16:00, outcome "recovered" (Oct2021), described as "running a fever of 103". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia.  Additional information: The event pyrexia lasted for 4 days. Patient did not go to hospital or family doctor.
Patient developed left sided pleuritic chest pain and dyspnea on 3/8 in the evening. She presented to the ED 3/9 and was found to have a segmental left lower lobe pulmonary embolism (left lateral basilar segment) with associated LLL pulmonary infarction. She had tachycardia to low 110s, mild hypoxia to 89% on room air with no evidence of pneumonia or typical COVID infiltrates. She had no known COVID exposure. She had one prior pulmonary embolism in 1999 treated for 6 months with coumadin, and was subsequently found in 2000 to be heterozygous for Factor V Leiden. She is being admitted to the hospital for treatment of pulmonary embolism.
headache; chest pain; felt like he was not getting any oxygen and also had a rash; his heart is "fluttering", felt like he was not getting any oxygen; felt like he was not getting any oxygen and also had a rash; whole body "slowed up" that he could not even put his clothes on; calmness and relaxation; not necessarily a bad thing but it was different/everything went crazy; swelling of the whole body; This is a spontaneous report from a contactable consumer (reported himself). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: unknown), via an unspecified route of administration on 22Jul2021 as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient wants guidance on receiving second dose after he experienced some adverse events after receipt of the first dose of the Pfizer Biontech COVID19 vaccine on 22Jul2021. On an unknown date Jul2021, the patient experienced three days of "calmness and relaxation" and that like someone had given him a drug, which the patient described as "not necessarily a bad thing but it was different." On 26Jul2021 (fourth day), the patient stated that "everything went crazy" and that his whole body "slowed up" that he could not even put his clothes on. The patient also had a headache, chest pain and that his heart is "fluttering", felt like he was not getting any oxygen and also had a rash. On an unknown date Jul2021, the patient also had swelling of the whole body. The patient stated that the event expect swelling of the whole body was only lasted for 6-8 hours then it completely resolved on an unknown date Jul2021. The outcome of the event swelling of the whole was unknown   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Right upper thigh (leg), Area erythematic induration 10cm X 7 cm, No fluctuance, Dx-cellulitis
HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 01-JUN-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch/lot number. No concomitant medications were reported. On JUN-2021, the subject experienced headache. The action taken with covid-19 vaccine was not applicable. The outcome of headache was not reported. This report was non-serious.
shingles on forehead and around her eye; worsening shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles (experienced on 3rd May 2019).   On 6th May 2019, the patient received Shingrix (intramuscular). In May 2019, less than a week after receiving Shingrix, the patient experienced shingles and condition aggravated. On an unknown date, the outcome of the shingles and condition aggravated were not recovered/not resolved.   It was unknown if the reporter considered the shingles and condition aggravated to be related to Shingrix.  Additional details were reported as follows: The patient started symptoms of shingles on 3rd May 2019. The patient went to the physician and was diagnosed with shingles on 6th May 2019. On same day, the physician administered Shingrix to the patient in an attempt to prevent shingles from developing further. The shingles had continued to spread and it was worsened on 8th May 2019. The shingles were on the patient's forehead and around her eye.
Initial information received on 18-Jun-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA164901, 2018SA175593 and 2018SA175612. This case involves Adult female patient who experienced hives, hypertensive, Tachy, panicy, short of breath and swollen face, while she received vaccine INFLUENZA VACCINE (reported as flu vaccine). The patient's past medical history included Rubber sensitivity. The patient's past medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported in unknown administration site. The patient developed a non-serious hives (urticaria), hypertensive (hypertension), tachy (tachycardia), panicy (pain), short of breath (dyspnoea) and swollen face (swelling face) following the administration of INFLUENZA VACCINE. (Other relevant tests included No lab data.). Final diagnosis was swollen face, short of breath, panicy, tachy, hypertensive and hives. The patient was treated with SOLUMEDROL. The patient outcome is reported as Unknown for hives, hypertensive, tachy, panicy, short of breath and swollen face. List of documents held by sender: none.
Immediately following vaccination, patient went shopping for groceries. At approximately 12:00-12:30 p.m., patient felt a very brief moment of extreme dizziness. Later after returning home, patient began to experience a strange single deep unproductive cough the was rather unusual. In the middle of the night, patient awakened feeling extremely cold. The next morning, patient exercised as usual, but started to feel rather unwell. Temperature was recorded at 101.6 degrees and remained at that temperature until the next morning. Patient began to feel very tired, had a loss of appetite, and lacked energy even to the point of not wanting to walk across the room. This is extremely atypical. On Wednesday 12-14-22, patient recorded a 102 degree temperature which later elevated to 102.6 degrees. Patient is self-employed and was unable to complete work which consisted of accompanying a concert and lost income as a result. On Thursday 12-15-22, patient continued to register a fever, but it was in the low-grade range where it remained until 12-17-22.  Patient also experienced weakness which continues until the present time.
About 24 hours after I received the vaccine I started experiencing severe muscle and joint pain which lasted for at least a week, and I am still having residual joint pain. Body aches included hands feet legs neck back arms, also I experienced painful leg cramps. But then on October 8th my wrist was hurting and I felt it and at the same time noticed my pulse was irregular. I have been having arrhythmias ever since. My heart is missing beats and I have mild aching chest pain. I have no history of heart troubles or any risk factors other than perhaps my age.
Pt vax 3 doses; 27Dec90 titer - 4.7.  Recv 4th dose 03jan91.  15Feb91 titer indicated pt seroconverted.
Patient is a 83 y.o. female patient with history of  Dementia, hypertension, hypothyroidism, atrial fibrillation, bradycardia status post pacemaker, systolic CHF presented to Grady Memorial Hospital with altered mental status.   Covid-19 Virus Infection Date of onset of symptoms: 4/10/2023 Symptoms present on admission: AMS, SOB Date of covid positive test: 04/18/23 Vaccination status: vaccinated Imaging: Fibrotic scaring with R pulmonary nodule Current O2 requirement 6 L>4L (baseline 3 to 4 L of oxygen). Medical therapy: Received 4 doses of IV remdesivir and dexamethasone  CRP 11.5; ferritin 93.  Did not continue steroids at discharge per pulmonology recommendations Pulmonology followed in the hospital and signed off. Anticipated special isolation end date: 4/28/23   Acute on Chronic Respiratory Failure with Hypoxia Etiology: Secondary to COVID.  Chronic respiratory failure due to poor pulmonary reserve from body habitus. Baseline oxygen 3-4 L NC Procalcitonin low at 0.11.  Blood culture x2-NGTD.  No need of ATB. Initially required up to 6L NC, but was able to wean down to 3 to 4 L of oxygen    Metabolic Encephalopathy improved Secondary to COVID and hypoxia Improved in ED after oxygen administration Mental status closer to baseline with some waxing and waning Consulted PT/OT.  Recommended SNF. DC to SNF for continued therapy   Lactic Acidosis Hypovolemia Admit LA 7.4> 2.1 Likely secondary to poor PO intake and diuretic use LA improved with IV fluids   Acute Kidney Injury, resolved Baseline Cr: 0.9. Admit Cr: 1.51> 1.4> 1.16>0.78 Likely prerenal from poor oral intake and use of Lasix.   Cr improved with IV fluids.  Avoid nephrotoxic medications   Chronic systolic CHF Echo from 2021 with EF 35+/- 5%.  Pulmonary hypertension RVSP 55 mmHg. BNP elevated at 10 K on admission. Echo with EF 55+/- 5%, severe tricuspid valve regurgitation, RVSP 74 mmHg. Continue home Lasix 20 mg daily Daily weights and strict I's/O Persistent Atrial fibrillation History of bradycardia status post pacemaker Patient follows with cardiologist and recently had her pacemaker interrogated and PRA reports no abnormalities noted Continue home: Toprol-XL, Xarelto   Hypothyroidism ESS from 3/29/2023--8.05; T4 normal at 1.2 Home dose of Synthroid was recently increased to 125 mcg daily. Recommend repeating TSH and free T4 in 6-8 weeks   Hypotension Patient is having some hypotension and was placed on midodrine by her cardiologist due to this Continue midodrine therapy BP stable   Dementia Without behavioral disturbances at this time Continue home Aricept   Pulmonary Nodule Seen on CT scan According to pulmonology, considering her age and comorbidities she does not need repeat outpatient imaging