chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Temperature excursion of the product reaches to negative 1.3 Celsius for 4 hours 24 minutes with no adverse event; Initial information received on 23-Nov-2021 regarding an unsolicited valid non-serious case from an other health professional via regulatory agency (under the reference 00870840).  This case involves 118 patients (unknown demographics).  This case involves temperature excursion of the INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] reaches to negative 1.3 celsius for 4 hours 24 minutes (product storage error).  The patients medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patients received a dose of suspect FLUZONE QUADRIVALENT (lot UT7347MA and expiration date not provided) via unknown route in an unknown administration site for prophylactic vaccination.  It was a case of potential medication error due to product storage error temperature too low (same day latency).  No adverse event reported.  It was reported "I have a question about Fluzone. I have a health department which has all new staff from the clerk to the administrator as well as the nurses, and they went to 3 schools and vaccinated a total of 118 school kiddos with flu vaccine that had experienced a TE (unbeknownst to them of course). they noticed when they went to upload their monthly temps that they had a TE, the refrigerator temperature excursion (TE). I know they likely need to revaccinate, but it's breaking my heart to ask them to do it. please advise?"  The causality of the suspect with the event not 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 the guidelines. 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.
Pt was administered Moderna Covid-19 2nd dose on 10.22.21. Vial had an expiration date of 10.21.21, which was extended by Moderna to expire on 12.21.21 on 10.22.21 (via e-mail from management). This morning new guidance was received stating only vials that were frozen are to be used with new expiration date. The vial used for your patient was previously thawed-out.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 03-AUG-2015, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, dose, route and site of administration were not reported) to obtain permanent prevention and protection against shingles and zoster-related injuries. On an unknown date, after and despite being inoculated with the ZOSTAVAX, the patient was diagnosed with shingles and/or other zoster-related injuries and suffered serious physical, emotional and economic damages as a result of patient's injuries. On or about 03-APR-2017, the patient was treated for shingles. The reporter considered adverse events to be related to ZOSTAVAX. As a direct and proximate result of the ZOSTAVAX, the patient had and would continue 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. By the time of the report, the patient did not recover from shingles as the patient suffer for ongoing injuries. The outcome of vaccination failure was unknown. The events were considered to be related to ZOSTAVAX.
precipitated recurrent facial hives and chronic neurological symptoms (internal tremor, lack of coordination, headaches, fogginess)
itchy, round rash around injection site.  firmness and mild tenderness noted at site as well
Chapped lips; This spontaneous case was reported by a consumer and describes the occurrence of CHAPPED LIPS (Chapped lips) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHAPPED LIPS (Chapped lips). At the time of the report, CHAPPED LIPS (Chapped lips) 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 medication were provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-114465, MOD21-088065 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-114465:Patient case MOD21-088065:
Date of Admission: 10/25/2022   Date of Discharge: 11/6/2022   Admission Diagnosis: Hypervolemia, unspecified hypervolemia type [E87.70] Volume overload [E87.70] Pneumonia 2/2 RSV infection COVID-19 infection   Hospital Principal Problem (Discharge Diagnoses): Acute on chronic diastolic CHF (congestive heart failure) (CMS/HCC)
10/29   Fever 103.1 that persisted 2 hours after taking Tylenol Chills/body aches Headache Redness/swelling at injection site Large axillary lymph node  10/30 Chills/body aches Headache Redness/swelling/pain at injection site Large axillary lymph node Slight shortness of breath Cold sores developed  10/31 Chills/body aches Headache Redness/swelling/pain at injection site Large axillary lymph node Cold sores Shortness of breath Dizziness on standing Vision changes like passing out on walking Rapid heart rate 115-128 Weakness if standing for more than a minute or two Chest heaviness Difficulty walking due to being out of breath and feeling like I was about to pass out with the dark spots in my vision that happen before passing out   11/1 Headache Redness/swelling at injection site Swollen axillary lymph node Shortness of breath Dizziness on standing that improved as the day progressed  11/2 Headache  11/3 Chills  Headache
Patient was given full vial 1.2 ML of undiluted 6 mos-4 yrs. No Adverse even was noted at the time given. Mom was contacted later on that evening and again the next morning and Mom reported patient was doing fine.
nerve pain; leg pain; numbness; Nerve damage; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY ( leg pain), HYPOAESTHESIA ( numbness), NERVE INJURY (Nerve damage) and NEURALGIA (nerve pain) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001421A and 047A21A) for COVID-19 vaccination.     no medical history was reported by the reporter.  Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced PAIN IN EXTREMITY ( leg pain), HYPOAESTHESIA ( numbness) and NERVE INJURY (Nerve damage). On an unknown date, the patient experienced NEURALGIA (nerve pain). The patient was treated with GABAPENTIN ongoing since an unknown date at a dose of unknown. At the time of the report, PAIN IN EXTREMITY ( leg pain), HYPOAESTHESIA ( numbness) and NEURALGIA (nerve pain) outcome was unknown and NERVE INJURY (Nerve damage) had not resolved.            other medications involve Cholesterol medications.
Flu injection painful and began to be sore at once. It is now approximately 3 months later and the arm where the vaccine was given is still achy, painful, sore intermittently. Entire upper arm and shoulder affected.
Fever; arm pain; legs went numb; inflammation in the head,spine; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever, arm pain, legs went numb, inflammation in the head, and spine from the X-ray result.  The patient's medical history provided included MS. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.  On unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date after the second dose, the patient experienced fever, arm pain,leg numbness, inflammation in head and  spine. On an unknown date, the lab test performed included X-Ray (inflammation in the head, and spine from the X-ray result)  Treatment details included Solu-Medro.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of events- fever, arm pain, legs went numb, inflammation in the head, and spine from the X-ray result -was unknown.
Tingling down left arm and feet; pain at elbow joint; This is a spontaneous report from a non-contactable consumer, the patient. A 46-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) in the left arm on 26Mar2021 at 09:00, (at the age of 46-year-old) as a single dose for COVID-19 immunisation.  Medical history included autoimmune hashimoto's and hypothyroidism. The patient had known allergies to egg whites and milk. Concomitant medications included levothyroxine sodium (SYNTHROID), vitamin d (MANUFACTURER UNKNOWN) and cetirizine hydrochloride (ZYRTEC). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Mar2021 at 19:00, the patient experienced tingling down left arm and feet and pain at elbow joint. No therapeutic measures were taken to treat the adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.The clinical outcome of the events tingling down left arm and feet and pain at elbow joint was not recovered, at the time this report.  No follow-up attempts are possible. No further information is expected.
2days p/vax pt exp a 121/2 cm round inflamed area @ inject site. area raised approx 1/8'' warm to touch.
Patient with history of 2 COVID vaccines who admitted with COVID detected PCR and dyspnea.  Provider d/c note:  "75 YO year old male with past medical history of Severe COPD, chronic hypotension on Fludrocortisone, alcohol use disorder,  presenting to the local Hospital with complaint of SOB. Patient started to have SOB and increase sputum production and cough 1 week ago. He was seen in ED and found to have positive COVID. Patient was given Prednisone 50 mg QD, Zpack and Paxlovid 5 days. Patient improved the symptoms until 2 days ago. Patient continues to increase dyspnea, cough and sputum production.    Patient saw Dr. as pulmonologist, but last seen 2020, COPD exacerbation since 2016, roughly 3-4 exacerbation a year. Patient last hospitalization was at June/22 with infection of influenza. Was never been intubated. Patient is not on oxygen at baseline since his saturation always above 88%. He smoked 75 pack year, quit 10 years ago.    He uses alcohol on a daily basis 2-6 beers a day, never had a withdrawal symptoms. Last drink 12/9 2 beers, but 6 beers 12/8.    ED Course: In ED, patient has documented hypoxia 86% improved with 2L oxygen, now on RA. SBP 100-130s. WBC 19.6, BG 150, mild hyponatremia, hypochloremia. EKG sinus tachycardia. BCx pending. CXR shows Hyperinflated lungs with underlying emphysema. Right apical/pleural parenchymal opacity. CT chest shows Central peribronchial thickening with peribronchial vascular groundglass, tree-in-bud opacities and more discrete right middle/lower lobe airspace disease compatible with infectious process. Pulmonary emphysema with stable biapical fibrocalcific change; chronic scarring favored. Patient was treated with Rocephin and doxycycline, 500 mL NS. Patient took last dose of Steroid 50 mg this AM. Admitted to the General unit for further management.    Upon admission, patient was treated with additional Prednisone, DuoNeb nebulizer, LABA/LAMA/ICS, VS q4h, Tele, IS, Flutter. Rocephin and doxycycline was given. Patient remains in RA throughout the hospital stay. Patient passed the walk test and will be discharged home with additional 4 days of Augmentin, Mucinex and follow up with PCP for his COPD and will need referral back to Pulmonology as COPD frequent exacerbation.   "
Patient was given Pfizer bivalent covid vaccine on 11/16/2022 thinking it was the very first Covid vaccine. Patient intended to receive the first Pfizer Covid vaccine in the series and was administered Pfizer bivalent booster covid vaccine. Patient experienced no symptoms or had any adverse event.
Information has been received via company representative from a consumer referring to her daughter, a currently 16 years old female patient. The patient's medical history included syncope when she had menstruating. In approximately 2013, when the patient was 13 year old she had her first dose of GARDASIL (route, lot# and dose were unknown) and following the administration she experienced syncope. She fainted and had a tonic clonic, vasovagal reaction. Shortly after the episode the patient was sat up too soon and had another spell and was therefore sent to the emergency room of an unspecified medical center. The patient received unspecified treatment and was released without being admitted to the hospital. No further doses of GARDASIL were administered to the patient. The outcome of the events was reported as recovered/resolved. The causality was not reported. Additional information has been requested.
Arm swelling with redness and warmth; Lowgrade fever; Chills; Arm swelling with redness and warmth; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE WARMTH (Arm swelling with redness and warmth), PYREXIA (Lowgrade fever), CHILLS (Chills) and VACCINATION SITE ERYTHEMA (Arm swelling with redness and warmth) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 011L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergic reaction to drug, Allergic reaction to drug, Allergic reaction to drug, Migraine since 1988 and High cholesterol since 2018. Concomitant products included CETIRIZINE for Allergy, MECLIZINE HCL for Dizzy, SIMVASTATIN for High cholesterol, TOPIRAMATE (TOPAMAX) for Migraine, FAMOTIDINE for Reflux esophagitis.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Arm swelling with redness and warmth), PYREXIA (Lowgrade fever), CHILLS (Chills) and VACCINATION SITE ERYTHEMA (Arm swelling with redness and warmth). At the time of the report, VACCINATION SITE WARMTH (Arm swelling with redness and warmth), PYREXIA (Lowgrade fever), CHILLS (Chills) and VACCINATION SITE ERYTHEMA (Arm swelling with redness and warmth) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The reporter stated that the patient experienced the same symptoms with both vaccination doses, however, the events were not as severe with the second dose.   This case was linked to MOD-2021-008504 (Patient Link).
fainted; hit head near right eye; a cut and a black eye; a cut and a black eye; shooting pain; numbness on right hand; felt like throwing up; Booster; This is a spontaneous report received from contactable other hcp. The reporter is the patient.  A 41 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm right, administration date 07Jan2022 13:15 (Lot number: 330368D) at the age of 41 years as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation. The patient had no relevant medical history. No known allergies, no COVID prior vaccination, no other vaccine in four weeks, no COVID tested post vaccination. Concomitant medications included: ATORVASTATIN; SERTRALINE; LISINOPRIL. Vaccination history included: BNT162B2 (dose 1, lot number: EN5318, Left arm), administration date: 06Mar2021, when the patient was 40 years old, for covid-19 immunization; BNT162B2 (dose 2, lot number: EL9264, Left arm), administration date: 27Mar2021, when the patient was 40 years old, for covid-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 07Jan2022 13:15, outcome "unknown", described as "Booster"; SYNCOPE (medically significant) with onset 10Jan2022 06:00, outcome "unknown", described as "fainted"; HEAD INJURY (medically significant) with onset 10Jan2022 06:00, outcome "unknown", described as "hit head near right eye"; WOUND (medically significant), EYE CONTUSION (medically significant) all with onset 10Jan2022 06:00, outcome "unknown" and all described as "a cut and a black eye"; PAIN (non-serious) with onset 10Jan2022 06:00, outcome "unknown", described as "shooting pain"; HYPOAESTHESIA (non-serious) with onset 10Jan2022 06:00, outcome "unknown", described as "numbness on right hand"; VOMITING (non-serious) with onset 10Jan2022 06:00, outcome "unknown", described as "felt like throwing up". The patient reported that woke up to shooting pain and numbness on her right hand. Pain was extreme that she felt like throwing up. As she got up, she fainted and hit her head near her right eye, which caused a cut and a black eye. The events "fainted", "hit head near right eye", "a cut and a black eye", "shooting pain", "numbness on right hand" and "felt like throwing up" were evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of syncope, head injury, wound, eye contusion, pain, hypoaesthesia, vomiting.; Sender's Comments: Based on the available reported information, the causal association between the events immunization, syncope, head injury, wound and head contusion and the suspect drug  BNT162B2cannot be excluded. The case will be reassessed once new information is available.  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.
Wednesday 10/19/2022  Left Thigh/ Hip Pain develops at 6am. Pain progressively gets worse. Thursday 10/20/2022 Limping and dragging lefy leg.  Spike Temperature of 101.5 F; went to Emergency Room at Hospital at 20:30PM
Phone call from mother states son is "achy all over, tired, and has headache;" denies rash and fever, states son has some "nausea;" mother treated son with Ibuprofen
client started having chills & fever @ 130AM; c/o muscle aches-t102.4; c/o nausea cont to run fever 31MAR95 PM 1JUN95 fever 99; c/o dizziness & general muscle aches; may see MD if sx persist;
pt stated that the same day after getting the vax she developed neck pain, fever, joint pain in arms, hands and knees, a splitting headache, also had pain in her ears, face, and upper back.  Next day the pain was worse.  Pt contacted her PCP and was told to report to VAERS.  She still has pressure in her head, eye, ear ache and cant do regular every day activities.
One month after receiving the vaccine I had a miscarriage. I saw an OBGYN who said I was healthy and had no concerns for future pregnancy prior to becoming pregnant. I also carried 2 children in the past which were both heathy Normal pregnancies.
a nurse reported that a 6-month-old female received her first injection of Prevnar on 14-NOV-2001. That evening, she developed a fever of 103 degrees F and otitis media
I got the three doses of the vaccine in the same arm. About 24 hours after the third dose of the vaccine my left arm was painful. Over the course of the day my arm became red and swollen all the way down to my elbow. It became hot, extremely painful swollen and painful to touch. I used Tylenol and Advil as well as an antihistamine and Triamcinolone cream. I used the cream and put cellophane over it. I consulted my doctor by Telehealth, and they prescribed the antihistamine and cream. It has been six days and my arm is still red but fading. The swollen area is about half the size. The Lymph nodes under my arm are still painful and my shoulder aches. The swelling remained below the injection site and not above. I have pictures of the arm over time.
pt recvd vax 21NOV92 & on 20MAY93 lab eval showed inc AST & ALT;
This is a spontaneous report from a contactable physician, who reported similar events for 3 patients. This is second of three reports. A patient of unspecified age and gender received a single dose of TRUMENBA on an unspecified date. Medical history and concomitant medications were not reported. The patient experienced arm so sore that he/she could no move it on an unspecified date. The outcome of the event was unknown.
no adverse event; administered VAQTA to patient this morning on 09/10/2020 before realizing it was expired; This spontaneous report was received from a pharmacist, referring to a 64 year old patient of unknown gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported.  On 10-SEP-2020, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated(VAQTA) lot # S018419, expiration date  reported as 12-JUL-2020, for prophylaxis (strength, dose, route and frequency were not reported). No adverse event.