chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: pt's dad noted he was well when recieving vaccine however when they were in line in the coffee shop area of the store pt leaned against dad with light headedness as if to faint.  Store staff called 911 and I rushed over and took pts vitals which were normal with bp 115/72. Pt sipped some water and when I asked if he had eaten today he responded no (215 pm) his dad also reported he had just woken up and doesnt follow a sleep schedule.  I was able to offer him some juice which improved his weakness
Right side weakness, rt arm aches, tired, fever, no nausea, lack of appetite.
Patient complained of itching on her inner left arm with visible redness but no other signs and symptoms of distress. Vitals obtained and within normal limits. 50 mg of Benadryl given PO. After 20 minutes patient had no redness or itching. Patient was discharged into self-care following receiving  education on which signs and symptoms warrant seeking further medical attention.
COUGHING; SORE THROAT; SLUGGISH; HEADACHE; This spontaneous report received from a patient concerned a 53 year old of unspecified sex. The patient's weight was 215 pounds, and height was 72 inches. The patient's concurrent conditions included alcohol consumer, and cigarette smoker, and other pre-existing medical conditions included patient have no known allergies and no drug abuse or illicit drug use.The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 041a21a, and batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 14-MAY-2021 to Left Deltoid for prophylactic vaccination. No concomitant medications were reported. On 28-MAY-2021, the subject experienced coughing. On 28-MAY-2021, the subject experienced sore throat. On 28-MAY-2021, the subject experienced sluggish. On 28-MAY-2021, the subject experienced headache. The action taken with covid-19 vaccine was not applicable. The patient recovered from headache on 2021, was recovering from sluggish, and had not recovered from coughing, and sore throat. This report was non-serious.
majority of vaccine squirted out of the vaccine site. 2nd dose was given as per cdc guidelines.
FEET STARTING SWELLING; NEVER GOT SECOND DOSE OF VACCINE; This spontaneous case was reported by an other caregiver and describes the occurrence of PERIPHERAL SWELLING (FEET STARTING SWELLING) and PRODUCT DOSE OMISSION ISSUE (NEVER GOT SECOND DOSE OF VACCINE) in a 99-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (FEET STARTING SWELLING) and PRODUCT DOSE OMISSION ISSUE (NEVER GOT SECOND DOSE OF VACCINE). At the time of the report, PERIPHERAL SWELLING (FEET STARTING SWELLING) and PRODUCT DOSE OMISSION ISSUE (NEVER GOT SECOND DOSE OF VACCINE) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment information was provided.
arm pain; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 20Mar2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date in Mar2021, the patient experienced arm pain; on the third day she had almost no discomfort. The outcome of arm pain was recovering. It was also reported that the patient received dose 2 of BNT162B2 on 10Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient lips were swelling. Patient was going to call primary doctor. Patient called me on Sunday 1/18/2009 in the afternoon. Patient did receive other vaccines a few days after getting here.
TC from MD @ ER;pt presented to ER this AM w/7-8cm area of redness & induration;treated as cellulitis
redness on arm/in the evening it got worse; itching on arm/in the evening it got worse; burning/in the evening it got worse; inflammation; This spontaneous case was reported by a patient and describes the occurrence of ERYTHEMA (redness on arm/in the evening it got worse), PRURITUS (itching on arm/in the evening it got worse), BURNING SENSATION (burning/in the evening it got worse) and INFLAMMATION (inflammation) in an 80-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     There was no history relating to mentioned adverse event and both Acute and Chronic illnesses at the time of vaccination.  Previously administered products included for Product used for unknown indication: flu vaccine (a few weeks ago) in 2022. Past adverse reactions to the above products included No adverse reaction with flu vaccine. Concurrent medical conditions included Nickel sensitivity (Nickel in the surface), Allergy (contact allergy) and Blood pressure abnormal. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 31-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 31-Oct-2022, the patient experienced ERYTHEMA (redness on arm/in the evening it got worse), PRURITUS (itching on arm/in the evening it got worse), BURNING SENSATION (burning/in the evening it got worse) and INFLAMMATION (inflammation). The patient was treated with IBUPROFEN in 2022 at a dose of the first night. At the time of the report, ERYTHEMA (redness on arm/in the evening it got worse), PRURITUS (itching on arm/in the evening it got worse), BURNING SENSATION (burning/in the evening it got worse) and INFLAMMATION (inflammation) was resolving.            Concomitant medication included Calcium channel blocker generic drug for blood pressure and Statin. It was reported that these events only happened with this dose and she was worried about the duration of the symptoms. It was reported that AE did not cause patient to seek medical care, the patient did not experienced a similar event in the past.
Mom noticed red, swollen, hot area on right leg the evening of recieving 12 months immunizations earlier that morning.
This initial spontaneous report was received from a registered nurse (office manager) via a company representative referring to a female patient of unknown age. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions described. On 24-NOV-2015, the patient was administered a dose of GARDASIL injection (lot # reported as 06501X with expiration date 19-FEB-2011; dose and route were not provided). The reporter stated that it was discovered after administration that it was expired. Treatment was not given and no adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
The patient received the first vaccine on 03MAR21 and began spotting on 10MAR21.  A miscarriage was confirmed on 19MAR21.  At the time of the first vaccine (03MAR21) the patient was unaware that she was pregnant as she had a negative home pregnancy test on 02MAR21.  She was told by her OB/GYN to inform us of her miscarriage.
Pt received first dose of the Pfizer COVID 19 vaccine on 3/30/2021.  She presented to the  ED on 4/11/2021 with fatigue, cough, hypokalemia, and generalized weakness.  She was admitted to an inpatient unit and tested for COVID-19 which came back positive.  Anticipated discharge is today, 4/12/2021
sore; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (patient had it twice).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details provided were as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received Shingles vaccine and was sore for 3 days and stated never again. Follow-up would not be possible as no contact details available.
Crushing Chest Pain (felt as though someone was sitting on chest)  Tachycardia  Hypertension.  All started around 4pm on day of vaccination./
Chest pain almost every day since vaccine. Chest feels tight intermittently, feels like I am having a panic attack.  This does not appear to be related to my heart or lungs.  My lymph nodes were also swollen painfully for a few days and I have since developed a rash in my armpits.  This was my booster. First two shots were Pfizer. I have never experienced these symptoms before.
DIFFICULTY BREATHING; WHEEZING; A spontaneous report has been received from a consumer. The report concerns a female patient of Unknown ethnic origin (age 27 years).    No medical history was reported. The following demography was reported for the patient's parent:   Sex: Unknown    No concomitant products were reported.    The patient started treatment with Flumist Quadrivalent (influenza vaccine live reassort 4v) (batch number(s) TH2108), nasal, on 14-SEP-2023.     On 16-SEP-2023, the patient experienced difficulty breathing (preferred term: Dyspnoea) and wheezing (preferred term: Wheezing).     Treatment with Flumist Quadrivalent (influenza vaccine live reassort 4v) was not changed.     At the time of reporting, the event of difficulty breathing and wheezing was ongoing.     The events were considered non-serious.     The reporter considered that there was a reasonable possibility of a causal relationship between Flumist Quadrivalent (influenza vaccine live reassort 4v) and the following event(s): difficulty breathing and wheezing.     Device Information:     Combination Product Report: Yes    Product As Reported: FLUMIST QUADRIVALENT  Common Device Name: Nasal Spray  Procode: CCQ  Product Role: Suspect    Minor correction on 29-Sep-2023: Null flavors to all fields for Reporters added. Narrative amended.
This case involves a 4 years old male patient who received an expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (expired product administered). The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient received DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID (INFANRIX) [lot number and expiration date were not reported] via unknown route in an unknown administration site for prophylactic vaccination as a concomitant vaccine. On 29-Nov-2021, the patient received 0.5 mL dose of suspect HIB (PRP/T) VACCINE (Suspension for injection, total, lot number: not reported and expiration date: 02-Oct-2021) via unknown route in an unknown administration site for prophylactic vaccination. It was a case of an actual medication error due to expired vaccine used (Same day latency). It was reported "Caller reporting she received shipment in May and usually has a longer time until expiration, reporting she needs to 'always check the date' Caller with question on whether vaccine needs repeating." At time of reporting, no reported adverse event. 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 the 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. There will be no information available on the batch number for this case.
Guillain Barre Synd onset of weakness on 29Nov90, had illness /w vomiting diarrhea, chills & fever /w onset of 19Nov90 & lasting about 2-3 days
Pt received HIB, MMR, VZV, PCV7 4-29-10.  5-11-10 had OV with c/o rash of > 12 hours duration.  Felt warm, temp none taken.  Return OV 5-12-10, temp 100.7 R, rash diffuse red macular lesions with some clumping, lesions blanch.  Rash does not itch.  Has mild nasal drainage.
Presented to urgent care on 5/28 with complaints of sore throat, Headache, body aches and fever for 103, slight cough, denies chest pain or SOB.  Had a neg rapid strep.  Diagnosed with viral illness 5/30 presented to the ED with chest pain, cough, wheezing and SOB.  Also had diarrhea and low abdominal pain.  Was hypotensive and bradycardia.  Received 2 bolus of Lactated Ringers .  EKG with ST segment elevation.  Concern for MISC.  Transferred to hospital.   5/30 at the hospital he had another bolus of fluid, continued bradycardia admitted to the ICU for potential for hypotension during IVIG for suspected MISC, worsening ST elevation on EKG.  TTE unremarkable.   Started on IVIG, anakinra, lovenox and solumedrol.  Monitored on telemetry.  EKGs consistent with myopericarditis. discharged home on prednisone on 6/4 with a long taper, has follow up with rheumatology and cardiology.  Stool enterovirus positive  culture positive.   He had previously been diagnosed with COVID-19 in November 2020
Redness,swelling, and itching in and around the injection site got worse around 72 hours after injection and has started to subside.  Family dr was contacted and he was unconcerned said it was a normal reaction.
Child crying inconsolably for 4 hours, post vaccination. Left upper thigh painful to touch and red. Mom applied cool compress to area and gave Tylenol at home. Child continued to cry and was instructed to return to office to be checked by MD. Examined by MD and Dx: hematoma on L thigh.
Diagnosed with Bell?s palsy on right side of face. The entire right side of my face would not move, eye would not blink to shut.
Woke up in middle of night (midnight) with tachycardia, weird dreams, and felt feverish. Patient's temperature on Sunday morning was 101.8 (F). Went to urgent care to get tested for influenza, but test came back negative.
Came to ER at 10:09 7/18/07 with complaints of chest pain of severity of 5 on a scale of 0-5 (5 being worst pain)  Stated it started at 9 a.m. 7/18/07.  VS 100.9 - 111-18  109/73 room air sat was 94%.  Other complaints were cough, headache, and trouble breathing.  EKG was normal - tachy.  Diagnosis by ER physician - mylagia, possible reaction to vaccine.  Given 1 gram tylenol.  Instructed to return if wheezing or rash.
Dizziness (morning after) Pounding headache Back ache Spiked fever (101.3) Exhaustion Fatigue  Muscle aches Scratchy throat
Received a call from patient's mom a few minutes after leaving the clinic. She stated that patient had difficulty of breathing while in the car and had started to c/o being itchy. She immediately turned around and went back to the clinic. While in the clinic, initial oxygen Sat was 95%, was very itchy with hives on the trunk, with facial erythema but no puffiness nor swelling of the lids nor lips. DUONEB given with resolution of DOB, O2 Sat post-neb was 100%. BENADRYL 7.5  ml and Prednisolone 10 ml PO were given. Facial erythema and hives initially got worse then completely resolved after approximately an hour post-ingestion. Area of MMRV injection was markedly indurated. Consulted Dr. regarding patient's reaction. Advised to repeat a CBC but unfortunately machine does not measure eosinophils (repeat showed decreased platelet from 138 to 88 but no epistaxis/active bleeding).Serum tryptase sent to outside lab. Home meds to include: ZYRTEC, BENADRYL RTC Q 6 hours, Prednisolone 2 mg/kg, Alb nebs prn and EPIPEN Jr. pack. Will schedule f/u with Dr tom. Has previously received Flu without incident, KINRIX and MMRV combination new for patient. KINRIX site of injection without any induration. Patient was discharged home stable with instructions on what to do if hives recur and go to ER for any red flags.
Patient return to clinic on 8/2/18 with complaint of redness and swelling of arm. MD diagnosed as cellulitis and treated with BACTRIM x 7 days.
After receiving my fourth dose of Moderna, my hair started falling out in large amounts. I had seen some hair loss in the previous few months, but it was noticeably worse after that fourth dose. I have very fine hair, but it started falling out to the point where you could see bald patches. My hair line also began to recede about an inch back. I was also losing weight very quickly without trying. I lost 22 pounds. My hair loss got so bad, that I felt the need to purchase a wig. On 06/20/2022, my doctor sent me to have some extensive blood tests. I'm still waiting on some of the results, but the results that have come in have shown low thyroid levels, low iron to the point of anemia, Creatinine levels were high, vitamin D was low, hemoglobin was low, along with other abnormalities. The second round of blood tests they did showed similar results. I am going to see a rheumatologist and an endocrinologist in a few weeks for further investigation. There is a concern that some medications I am on may be causing some of these test results.
Refractory seronegative immune-mediated necrotizing myopathy; This literature-non-study case was reported in a literature article and describes the occurrence of IMMUNE-MEDIATED MYOSITIS (Refractory seronegative immune-mediated necrotizing myopathy) in a 71-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.    No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNE-MEDIATED MYOSITIS (Refractory seronegative immune-mediated necrotizing myopathy) (seriousness criterion medically significant). At the time of the report, IMMUNE-MEDIATED MYOSITIS (Refractory seronegative immune-mediated necrotizing myopathy) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported. Company comment: This is a literature non-study case concerning a 71-year-old female patient, with no medical history reported, who received the second dose of the mRNA-1273 vaccine and developed the unexpected and serious (medically significant) event of IMMUNE-MEDIATED MYOSITIS (reported as necrotizing myopathy). The onset date and the vaccination date were not reported; hence, latency could not be properly assessed. No details of previous doses were provided. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273 is not affected by this report.
No adverse event; A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022) and NO ADVERSE EVENT (No adverse event) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M21A, 027A21A, 027B21A and 014F21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Aug-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022).    No concomitant medication was provided by reporter. A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines. They want to know what their next step would be for these patients.  No treatment medication was provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-704260 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704260:(Master case)
Headache, Myalgia, Chills, temp with acetaminophen was 99.2 Narrative:  2nd dose 1/6 11:00 did OK until about 20:00, developed Achy, chills, HA, took Tylenol with some benefit. Achiness is worst. Chills, but temp is 99.2.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concurrent conditions, medical history, or concomitant medications. On or about 2016, a healthcare provider at a physician's office administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries and conditions (dose, route, and lot # not provided). In or about 2016, the patient was treated by a healthcare professional at the same medical branch for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.
Patient received the PPSV-23 vaccine 1/26/16 and presented back to the clinic on 1/28/16 c/o a rash and pruritus. RN Care Manager note states the rash was a pinpoint rash all over. These were patient's only signs/sx. He was given MEDROL dose pack from clinic stock and was instructed to purchase OTC PEPCID and ZYRTEC 10mg daily.