chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a healthcare professional and described the occurrence of injection site reaction in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date the subject received a dose of FLULAVAL. At an unspecified time after vaccination with FLULAVAL, the subject experienced an unspecified injection site reaction. At the time of reporting the outcome of the event was unspecified. It was reported that 3 additional subjects experienced unspecified injection site reactions following administration of FLULAVAL. Another subject, A0949617A, experienced an entire arm reaction and chest reaction in addition to injection site reactions. This case was considered to be serious. Linked cases include A0949617A, A0950780A, A0950782A and A0959783A.
extreme fatigue for the following two days. really painful soreness around vaccination site. mild nausea. mild fever. muscle aches and chills.
Information has been received from a physician concerning a 26 year old female with no medical history or drug allergies, who on 12-APR-2007 was vaccinated with a first dose of Gardasil. There was no concomitant medication. Three days after vaccination, the patient developed a severe generalized rash all over her body. The patient was referred to a dermatologist who treated the rash with hydrocortisone (Cotizone). No laboratory diagnostic studies were performed. Subsequently, the patient recovered after a couple days. No product quality complaint was involved. Additional information has been requested.
Back pain; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BACK PAIN (Back pain). At the time of the report, BACK PAIN (Back pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. Treatment information was also not reported.   Reporter did not allow further contact
HAS NOT BEEN WELL THE WHOLE TIME; This spontaneous report received from a consumer via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced has not been well the whole time. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of has not been well the whole time was not reported. This report was non-serious.
Body aches; Chills; Fever of 102 Fahrenheit; Severe headache; Could not get out of bed for 36 hours, immobilized; This case was reported by a nurse via call center representative and described the occurrence of general body pain in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd October 2019, the patient received the 1st dose of Shingrix. On 23rd October 2019, less than a day after receiving Shingrix, the patient experienced general body pain, chills, fever, headache and bedridden. On an unknown date, the outcome of the general body pain, chills, fever, headache and bedridden were unknown.   It was unknown if the reporter considered the general body pain, chills, fever, headache and bedridden to be related to Shingrix.  Additional details were provided as follows: The patient experienced body aches, chills, fever of 102 degree F, fatigue, severe headache and could not get out of bed for 36 hours, immobilized. The reporter did not consent to follow-up. This case was linked to case US2019206669 reporter by same reporter for different patient.      Lab Comments: On 23rd October 2019, Lab test performed
Arm pain the next day,  4 days after vaccine I developed a severe migraine that has lasted 4 days and continues, my right leg thigh hurts like a strain , eyebrows itching and flaking
flu like symptoms / viral-like symptoms / Tests for several common viruses came negative; Myalgia; fever; malaise; This case was reported by a physician via call center representative and described the occurrence of influenza-like symptoms in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd May 2018, the patient received the 1st dose of Shingrix. On 22nd May 2018, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, myalgia, fever and malaise. On 24th May 2018, the outcome of the influenza-like symptoms, myalgia, fever and malaise were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, myalgia, fever and malaise to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the Shingrix vaccine and developed flu like symptoms, myalgia, fever and malaise.  The patient got better after a couple of days. The patient also had viral-like symptoms but the tests for several common viruses came negative. No vaccine administration information was available to reporter. The reporter consented to follow up. This case had been linked with case US2021090809, reported by the same reporter for patient's husband.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021090809:same reporter (patient's husband)
patient received Moderna COVID-19 vaccine after Beyond Use Date; A Moderna COVID-19 vaccine vial was removed from the refrigerator yesterday; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received Moderna COVID-19 vaccine after Beyond Use Date) and PRODUCT STORAGE ERROR (A Moderna COVID-19 vaccine vial was removed from the refrigerator yesterday) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049E21A and 007C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Sep-2021 at 8:45 AM, the patient experienced PRODUCT STORAGE ERROR (A Moderna COVID-19 vaccine vial was removed from the refrigerator yesterday). On 01-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received Moderna COVID-19 vaccine after Beyond Use Date). On 01-Oct-2021, EXPIRED PRODUCT ADMINISTERED (patient received Moderna COVID-19 vaccine after Beyond Use Date) and PRODUCT STORAGE ERROR (A Moderna COVID-19 vaccine vial was removed from the refrigerator yesterday) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant was not reported.  No treatment medication was reported.  The vial was left out at room temperature until 01OCT2021 when a dose was given at 8:33AM.
Patient initially reported her left hand going numb while in class and being unable to effectively complete tasks requiring dexterity in the fingers. She said that this went on for a few days, but not only gets tingling in her fingers in the left hand when she crosses her arms or puts any kind of pressure on the nerves in her arm.  The injection that we administered was in the left arm.
Patient became light headed and fainted for a few seconds about 8 minutes after receiving the vaccine.
Patient received vaccine past the six hour expiration date; A spontaneous report was received from a nurse concerning a 46-year-old, male, patient who received Moderna's COVID-19 vaccine (mRNA-1273) and patient received vaccine past the six hour expiration date.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 31 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 31 Dec 2020, the patient received an mRNA-1273 vaccine dose that was past the six-hour expiration date. The first dose from the vial had been administered more than six hours before the patient received his dose. The patient did not experience any adverse events. Treatment information was not provided.    Action taken with mRNA-1273 in response to the event was not reported.  The event, patient received vaccine past the six hour expiration date, was considered resolved on 31 Dec 2020.; Reporter's Comments: This case concerns a 46 year old, male patient.  The patient's medical history is not provided.  The event occurred on 31 Dec 2020, when the patient was given the first dose of the mRNA-1273  (Lot number: 025L20A), past the six hour expiration date. This report refers to a case of Product administration error where mRNA-1273(Lot number: 025L20A)  was given past 6 hours of opening the vial. There were no reported AEs associated with this case.
Stayed fir Observation for 15 minutes then left.  25 minutes after injection, developed rash and swelling on arm, chest, face with rapid heart rate and shallow/rapid breathing.  Called number on vaccine sheet  and was sent to ER but was turned away due to over crowding (COVID) and told to go to PCP, which was two hours away.  Went to urgent care instead and was immediately treated with steroids and antihistamine.
Triggered auto immune response with intense pain in areas of the body that had only minor aches.   Arm that received injection experienced severe pain for 24 hrs then was moderate (not at injection site) and lasted 2 weeks.  Puncture on arm that was almost healed experience pain on touch.  Fluid in ear (minor) experienced severe pain which lasted for 2 weeks then went to moderate pain which lasted another 2 weeks. Minor ache with crown became moderate pain which lasted one week.   These symptoms lasted weeks then went away completely until left arm became sore with moderate pain. Two months later still have sore arm (mild)  but no other symptoms.
Swollen at site; Redness at site, She started seeing redness at injection site; soreness at site; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE SWELLING (Swollen at site), VACCINATION SITE ERYTHEMA (Redness at site, She started seeing redness at injection site) and VACCINATION SITE PAIN (soreness at site) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced VACCINATION SITE SWELLING (Swollen at site), VACCINATION SITE ERYTHEMA (Redness at site, She started seeing redness at injection site) and VACCINATION SITE PAIN (soreness at site). On 01-Jan-2021, VACCINATION SITE SWELLING (Swollen at site) and VACCINATION SITE PAIN (soreness at site) had resolved and VACCINATION SITE ERYTHEMA (Redness at site, She started seeing redness at injection site) outcome was unknown.        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.   No relevant concomitant medications were reported. No treatment information was provided.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This spontaneous report as received from a Register Nurse refers to a patient of unknown age and gender. Concurrent or medical conditions were not reported. On an unknown date, the patient was vaccinated post supported temperature excursion with VARIVAX (Merck) 0.5 ml, subcutaneous, lot # reported as K0007974 with expiration date 30-JUN-2015 and lot # K010339 expiration date 22-JUL-2016. No adverse effects noted. Lot number K0007974 is an invalid lot number for VARIVAX. This is one of several reports received from the same source. Additional information has been requested.
An 11 year old female pt, with a history of allergic rhinitis, had received an IM injection of Adacel, lot number C2491AA, on 7/6/06. Thirty days post vaccination, the pt developed transverse myelitis that required hospitalization. Per the reporter, the pt is now a T10, T11 paraplegic, and the event resulted in a questionable permanent disability. There was no illness at the time of vaccination. Additional medically relevant information was not provided. At the time of this report, the pt had not recovered.
8hrs Post vaccine- Fatigue/mild chills/ leg aches 12hrs Post vaccine-Vertigo/nausea lasted 24hrs  54hrs post vaccine-Pounding Migraine that lasted 24hrs  Pain at injection arm 24 hrs post vaccine.
lt arm mid to lower deltoid area w/small bruise;6cm induration, redness, warmth-no other sx;
Arm soreness at injection site area; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: E13247) via an unspecified route of administration in the left arm on 11Mar2021 at 10:15 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included elevated cholesterol and PSA (psoriatic arthritis). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the vaccination. Concomitant medications included rosuvastatin calcium (CRESTOR), omega-3-acid ethyl ester (LOVAZA), minerals nos/vitamins nos (CENTRUM), ubidecarenone (COQ10), magnesium sulfate (MANUFACTURER UNKNOWN) and ergocalciferol (VIT D); all for an unknown indication from an unknown date and unknown if ongoing. The patient previously received amoxicillin (MANUFACTURER UNKNOWN), for unknown indication on an unknown date and experienced drug allergy. On 11Mar2021 at 15:00, the patient experienced arm soreness at injection site area, increased in intensity, peaking between 12-24 hours post injection and then began to decrease in intensity. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the reported events. The clinical outcome of the event arm soreness at injection site area was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Sore throat, developed into cold symptoms, subsided and then developed into flu with fever for a week.  Cough continued for over 2 weeks.  Mother of patient developed flu 5 days following vaccine, with fever for 4 days, nausea, cough.
This spontaneous report was received from a physician and refers to a 17-year-old female patient. The patient's pertinent medical history, concomitant medications, drug reactions or allergies were not reported. On 20-JUL-2018, the patient was vaccinated with the first dose of GARDASIL 9 lot # R010596, expiration date 11-DEC-2020 (exact dose and route of administration were not reported) for vaccination. On 20-SEP-2018, the patient was vaccinated with the second dose of GARDASIL 9 lot # R010596, expiration date 11-DEC-2020 (exact dose and route of administration were not reported) for vaccination. On 23-SEP-2018 (reported as three days later), the patient was not able to walk, was dizzy and weak for an entire day. Since that day, the patient had episodes of being dizzy and had missed two days of school as well as gym class. One month later, on 24-OCT-2018, the patient had another similar episode, she could not walk up the stairs. The patient sought medical attention. On an unknown date in 2018, the patient had difference in blood pressure: sitting 100/75, lying 120/80 (units not provided) and her pulse was: sitting 80, lying 68 (units not provided). The physician noted that on an unknown date in 2018, the patients glucose was 140 (units not provided), yet this was not a fasting sugar. She stated that the fasting number was 89 (units not provided). The physician reported that on an unspecified date in 2018, complete blood count (CBC), complete metabolic profile (CMP), thyroid level, urine levels were all within range and neurological checks were normal. The patient would see a cardiologist. At the time of the report, the outcome of the events was not recovered which was also reported as ongoing. The causality assessment was not provided. The reporter considered the events as disabling.
Extreme body aches and inflammation. Shortness of breath. Lasted for 48 hours until I went to the Emergency Department at the local hospital.
Got sick in the stomach after receiving the first; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Got sick in the stomach after receiving the first) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020. Concurrent medical conditions included Type 2 diabetes mellitus. Concomitant products included INSULIN DETEMIR (LEVEMIR) and INSULIN for Type 2 diabetes mellitus.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (Got sick in the stomach after receiving the first). At the time of the report, ABDOMINAL DISCOMFORT (Got sick in the stomach after receiving the first) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, SARS-CoV-2 test: positive (Positive) Positive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Treatment information was not provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-117145 (Patient Link).
Patient was nervous before getting vaccine. Within a few minutes after getting injection, he became very pale and clammy and asked for cold liquid. He consented to receive a Juicey Juice juice box and sat down with some cold wet napkins on his neck. He said he felt like passing out and we led him into our vaccine room where he lay on the floor for about 5 minutes. He then wanted to sit up. He felt much better and sat in our waiting room again for 10 more minutes. He left without further incident, having never lost consciousness.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and ender. On 15-DEC-2014 the patient was  vaccinated an expired dose of M-M-R II, lot # H009781, expiry date: 15-MAY-2014, 0.5 ml, subcutaneous, anatomical location was not reported). No adverse experienced reported. Additional information has been requested.
MOTHER OF PATIENT REPORTS PATIENT HAD LOCALIZED AREA OF ERYTHEMA TO BOTH INJECTION SITES ONE DAY POST IMMUNIZATION. REPORTS 2 DAYS POST THE RIGHT ARM (MENVEO VACCINATION) IS RED AND SWOLLEN FROM UPPER ARM TO ELBOW. DENIES ANY PAIN. REPORTS GIVING PATIENT ANTIHISTAMINE-BENADRYL - WHICH IS HELPING AND ICE TO LOCALIZED ARA
REDNESS ABOUT 4 IN. AROUND OFF 4 IN. TO THE LOWER RIGHT AREA OF SMALLPOX VACCINE SITE.  GIVEN BENEDRYL 50 MG.
Headache; Nauseated; can hardly eat anything/can only eat a little bit at a time; feel bloated; she got sick gain/got really sick in her stomach; her stomach hurt/had stomach ache/her stomach was hurting really bad; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of FEEDING DISORDER (can hardly eat anything/can only eat a little bit at a time), ABDOMINAL DISTENSION (feel bloated), ILLNESS (she got sick gain/got really sick in her stomach), ABDOMINAL PAIN UPPER (her stomach hurt/had stomach ache/her stomach was hurting really bad) and NAUSEA (Nauseous) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Food poisoning (Chick-fil-a).    On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Aug-2021, the patient experienced FEEDING DISORDER (can hardly eat anything/can only eat a little bit at a time), ABDOMINAL DISTENSION (feel bloated), ILLNESS (she got sick gain/got really sick in her stomach), ABDOMINAL PAIN UPPER (her stomach hurt/had stomach ache/her stomach was hurting really bad) and NAUSEA (Nauseous). On an unknown date, the patient experienced HEADACHE (Headache) and NAUSEA (Nauseated). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. At the time of the report, FEEDING DISORDER (can hardly eat anything/can only eat a little bit at a time), ABDOMINAL DISTENSION (feel bloated), ILLNESS (she got sick gain/got really sick in her stomach), ABDOMINAL PAIN UPPER (her stomach hurt/had stomach ache/her stomach was hurting really bad), NAUSEA (Nauseous), HEADACHE (Headache) and NAUSEA (Nauseated) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient had Chick-fil-A. Daughter has not seen a doctor or received any treatment for it. Daughter has headache on and off and takes Tylenol for her headache, but her headache is not related to the vaccine.
Hives; This is a spontaneous report from a contactable nurse reporting for herself. A 57-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL3302), dose 1 via intramuscular route, administered in Arm Right on 03Feb2021 11:00 as SINGLE DOSE for covid-19 immunization. The patient did not receive any other vaccine in four weeks, no COVID prior vaccination and No COVID tested post vaccination. The patient had allergic to smallpox vaccination. The patient concomitant medication(s) included folic acid (FOLATE), VITAMIN D3, ubidecarenone (COQ 10), clonazepam, zinc, and vitamin C (ASCORBIC ACID); start and stop date were not reported for all. On 03Feb2021 at 12:00, the patient developed hives within less than an hour after receiving the vaccine, these continued to develop through Saturday morning until she started taking Prednisone per Urgent Care Physician. The AE resulted in Emergency room/department or urgent care visit. AE Treatment included Prednisone for 5 days with Pepcid and Benadryl. The outcome of event was recovering.  Follow-up attempts completed. No further information expected.
Pt's mother phoned office reporting pt's left upper arm red and swollen. Describes as apprx. 6 inch area below shoulder to apprx. 1 inch above elbow. Pt denies pain. Remains playful and energized. Using arm as usual.