chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a nurse and described the occurrence of influenza-like symptoms in a male patient who received Shingrix for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, several days after receiving Shingrix, the patient experienced influenza-like symptoms and shingles. On an unknown date, the outcome of the influenza-like symptoms and shingles were unknown. The reporter considered the influenza-like symptoms and shingles to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The physician (patient) had received Shingrix and a couple of days later felt like he had flu like symptoms and also had two pox like bumps appeared on his face. The patient felt Shingrix might have caused a mild case of shingles, he would like to be able to talk with someone about his experience. The physician and patient (for tolerance see case US2018GSK152330) had similar experiences they felt it was caused by Shingrix. The reporter agreed to be contacted for follow up.
Mast cell degranulation/anaphylaxis. I pre-dosed with my normal antihistamines and mast cell inhibitors, as well as an additional dose of Benadryl. As soon as I got the shot I could feel a degranulation and tightening in my throat, but I did not need to use my epi-pen. I did use my inhaler. After about 15 minutes the allergic reaction subsided, and after 30 minutes I felt well enough to go home.
Moderna Covid 19 vaccine EUA  ; injection site turned red and was sore 1/16 morning then went sway. 1/17 I developed a rash . 1/22 night the injection site became inflamed , red ,warm to the touch.  Injection site is still red and my face has become a  little flushed.
Terrible red rash like hives on both hands and part of wrist.  Skin color turned very dark (looked like a burn).
Information has been received from the nurse on 02-JAN-2014. It was reported that GARDASIL were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who had administered dose of GARDASIL on 06-MAY-2015 (lot # H011350, Expiration Date: 21-FEB-2015). No adverse event was reported. This is one of the report from the same source, linked reports. Additional information is not expected.
Gave patient flucelvax  (right upper deltoid) and pneumovax 23 (right lower deltoid) at flu clinic . Patient was concerned with fusion in left arm so we decided to administer both in her right deltoid. By that evening (about 4 - 5 hours later) patient started feeling light headed and having warmth and redness at the injection site. Patient went to the emergency room later that evening because arm became worse and she developed a fever. She was given IV antibiotics in the ER and told to return the following day for another dose of IV antibiotics. Her fever broke after the second dose, but the arm still had some redness/swelling. She was diagnosed with cellulitis. Patient is doing better now. Will follow up again with her tomorrow (1 week after notification).
This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. The patients' pertinent medical history and drug reactions or allergies were not reported. On an unknown date in November 2015 (reported as sometime during the period of 02-NOV-2015 through 06-NOV-2015), the patients might have been possibly vaccinated with improperly stored doses of ROTATEQ orally (dose was not reported, lot number reported as L004456 and expiration date 07-AUG-2016). Concomitant therapy was not reported. No symptoms were reported. Additional information is not expected as the reporter refused additional contact.
Information has been received from a nurse concerning unspecified patients of unknown age and gender.  The patients' concomitant medications, pertinent medical history, and drug reactions and allergies have not been provided. On unspecified dates, improperly stored doses of M-M-R II (dose, strength, frequency, route, lot # and expiration date were unknown) were administered to the unspecified patients for prophylaxis. The M-M-R II were exposed to following temperatures: from 35 Fahrenheit to 49 Fahrenheit, 32 Fahrenheit, 35 Fahrenheit, 35 Fahrenheit, 35 Fahrenheit and 35 Fahrenheit for a time frame of 24 hours respectively. No adverse effects were reported. Data logger was involved, but no previous temperature excursion was reported. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA003579: US-009507513-1612USA003951: US-009507513-1612USA003950.
PAIN ON THE SHOULDER (ON VACCINATION DAY); MILD HEADACHE (DAY AFTER VACCINATION); FEVER (DAY AFTER VACCINATION); This spontaneous report received from a patient 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 not reported, batch number: Unknown) 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 subject experienced pain on the shoulder (on vaccination day), mild headache (day after vaccination), and fever (day after vaccination). Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain on the shoulder (on vaccination day), mild headache (day after vaccination), and fever (day after vaccination). This report was non-serious.
Fatigue; Temperature was 101.2F; Arm was kind of sore; Didn't feel right; Had the shakes really really bad; Internal chills, like quivering; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Arm was kind of sore), FEELING ABNORMAL (Didn't feel right), TREMOR (Had the shakes really really bad), CHILLS (Internal chills, like quivering) and FATIGUE (Fatigue) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm was kind of sore), FEELING ABNORMAL (Didn't feel right), TREMOR (Had the shakes really really bad), CHILLS (Internal chills, like quivering) and PYREXIA (Temperature was 101.2F). On 08-Feb-2021, the patient experienced FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 05-Feb-2021, PYREXIA (Temperature was 101.2F) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm was kind of sore), FEELING ABNORMAL (Didn't feel right), TREMOR (Had the shakes really really bad) and CHILLS (Internal chills, like quivering) outcome was unknown and FATIGUE (Fatigue) was resolving. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Feb-2021, Body temperature: 101.2 f (High) Fever of 101.2 F. On 05-Feb-2021, Body temperature: 101 f (High) Fever of 101 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication list was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Follow-up information received on 26-Apr-2021 contains non-significant information.
1 WEEK POST-INJECTION--NEW ONSET 5X5CM RAISED, RED, ITCHY AT INJECTION SITE
This case was reported by a consumer (patient's daughter) via agency and described the occurrence of Guillain Barre syndrome in a 78-year-old female patient who vaccinated with Influenza vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. Co-suspect medication included ADVAIR multi dose powder inhaler for problem breathing. On 23 July 2013, the patient started ADVAIR (unknown route) 250/50mcg, unknown dosing. On an unspecified date, the subject received unspecified dose of Influenza vaccine (unknown route, injection site and batch number). In February 2014, at an unspecified time after vaccination with Influenza vaccine and after starting ADVAIR, the subject was hospitalized during 2 weeks due to Guillain Barre syndrome. The subject experienced weakness in foot when walking which moved up into subject's hands. The subject had been taking ADVAIR medication and was on oxygen, however when she went by ambulance to hospital and while in the hospital, the doctor interrupted the treatment with ADVAIR and oxygen since her breathing was good. The doctor put the subject back on ADVAIR due to chest pains. At the time of reporting, the outcome of the events was unspecified.
Pt. received PPD implant at 4:28p.  Then at 4:30 received varicella vaccine.  Within 30 sec. pt. eyes rolled back and pt. became very pale & unresponsive.  BP 70/50 HR 40's.  Ammonia inhalant used & pt. awakened.  Juice & cookies given.  Episode lasted on & off x15 min.  No CPR needed.
developed Covid symptoms/diagnosed positive in Covid19; developed Covid symptoms/diagnosed positive in Covid19; This is a spontaneous report from a contactable nurse (patient's wife). This nurse reported same event for two patients, this is the second of two reports.   A 70-year-old male patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL0142), via an unspecified route of administration in arm (reported as deltoid) on 02Jan2021 at single dose for COVID. Medical history included hypertension and bad cholesterol. Concomitant medication included levothyroxine (low dose of it), amlodipine besilate (EMADINE) for hypertension, losartan for hypertension, levothyroxine sodium (SYNTHROID) for bad cholesterol, lovastatin (LOVASTIN) for bad cholesterol. The patient got his first dose on 02Jan2021, and on 08Jan2021 developed Covid symptoms. On 11Jan2021, he tested positive for Covid19/diagnosed positive in Covid19. The reporter nurse think they were exposed sometime at that pharmacy, she mean there was a lot of people in the line. Tomorrow (unspecified) was supposed to be second dose and his family physician didn't know if he should get that second dose. The outcome of events was unknown.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported drug ineffective and COVID-19 cannot be ruled out.,Linked Report(s) : US-PFIZER INC-2021061825 Same reporter/drug/event, different patient
Patient was given vaccine on 12/1/22 however it expired on 11/30/2022.  Vaccine was not entered into health records correctly so it did not flag as an error.
Time-line: - Started with achiness in both legs - Chills onset about 30 minutes after achiness - Chills briefly (1-2 minutes) were so severe I was shaking (convulsion like), only time this happened - Chills persisted for over 2 hours, covered up and took a nap - Upon waking, entire body had a hot/searing sensation (under skin), but no elevation in temperature - Eyes were extremely dry - Body aches continued into the next morning, hot/searing sensation had stopped - Was fairly fatigued the entire next day, dry eye issue persisted  - After more rest than normal, I seem to be back to normal, no body aches, fatigue, or dry eye issues.
Area was a little bit pink in the subcutaneous zone; Shot had been subcutaneous, at an inch or 2 below the axillary line; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE DISCOLOURATION (Area was a little bit pink in the subcutaneous zone) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Shot had been subcutaneous, at an inch or 2 below the axillary line) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) dosage was changed to 1 dosage form. On 23-Oct-2021, the patient experienced VACCINATION SITE DISCOLOURATION (Area was a little bit pink in the subcutaneous zone) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Shot had been subcutaneous, at an inch or 2 below the axillary line). On 23-Oct-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Shot had been subcutaneous, at an inch or 2 below the axillary line) had resolved. At the time of the report, VACCINATION SITE DISCOLOURATION (Area was a little bit pink in the subcutaneous zone) outcome was unknown.            Concomitant information was not provided. Treatment information was not provided.
First vaccination was given on July 29th and the second was given on August 5th with no AE; Initial information regarding an unsolicited valid non-serious case was received from other health care professional and consumer/non-health care professional via Global Medical Information (Reference number- 00723783) and transmitted to Sanofi on 13-Aug-2021.  This case involves 12-year-old (unknown gender) patient who was given MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] first vaccination on july 29th and the second was given on august 5th (extra dose administered)   Relevant medical history, medical treatment(s), vaccination(s) concomitant medication and family history were not provided.   On 29-Jul-2021, the patient received first 0.5ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot number: U7087AA and expiry date was not provided) and on 05-Aug-2021, the patient received second dose of 0.5ml of same vaccine (lot number: U6920AB and expiry date: 15-Apr-2022) via unknown route in unknown administration site for prophylactic vaccination (extra dose administered)  It was reported that,"Medical assistant stated that they had a set of twins to come in and that one of the twins was over vaccinated with Menactra. MA (Marketing authorization) is calling to see if there is any concern or what should be done at this point because they want to be certain that the patient is going to be ok. Spoke with office staff who states she is in another office and unable to transfer me to that office but will take a number to have her contact us back. Informed office staff information would be emailed to assist with answering the question".  This case was an actual medication error due to extra dose administered (latency: same day)  At the time of reporting, no 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.
Stabbing pain in left scapula radiating down left shoulder, arm, hand, and fingers, Sunday morning at 6:15 AM, went to Urgent Health, shot of Toridol, Rx Lidoderm patches, then went to Medical Center for x-rays of C-spine, chest, shoulder, shot of Morphine, Rx Flexerol, Dr.  Rx Gabapentin, Relafen, Dr. gave MRI C-spine, cervical disc replacement, Rx Percocet, Dr. gave MRI Bracial Plexus, Diagnosis of Parsonage/Turner syndrome, Rx Gabapentin x
24hr later fever 101, body aches, erythema @ inj site;recheck @ clinic;suggested APAP & ice inject site;48hr later still sl fever, no aches;72hr p/vax resolved;
Fever, headache, body aches/chills and pain in gums and nose (including blood). Gone after 24-hours. Note this was the booster shot and reaction worse than after the second shot.
blood clots, back of leg , tibia, and leg; This spontaneous case was reported by a patient and describes the occurrence of THROMBOSIS (blood clots, back of leg , tibia, and leg) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Patient did not have COVID+ test or diagnosis in the past. Patient had no acute or chronic illnesses at the time of vaccination. Patient was not given any vaccine within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Drug allergy (Morphine allergy).   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Jul-2022, the patient experienced THROMBOSIS (blood clots, back of leg , tibia, and leg) (seriousness criterion medically significant). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN 81) at a dose of 4 times,81mg. At the time of the report, THROMBOSIS (blood clots, back of leg , tibia, and leg) was resolving.            Patient did not seek medical care. Patient did not experience a similar event in the past. No concomitant medications were reported. Patient took 4 aspirin of 81mg.  Company comment: This spontaneous case concerns a 60 year old female with no relevant medical history, who experienced the unexpected serious (medically significant) adverse event of special interest Thrombosis which occurred 2 days after receiving the fourth dose of mRNA1273. Patient reported of blood clots on the back of the leg, tibia and leg, she did not seek medical care but took 4 aspirin of 81mg. Further details regarding the clinical course and diagnostic test done were not provided. The patient's elderly age may be considered as a risk factor for thrombosis. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-613382 (Patient Link).; Sender's Comments: This spontaneous case concerns a 60 year old female with no relevant medical history, who experienced the unexpected serious (medically significant) adverse event of special interest Thrombosis which occurred 2 days after receiving the fourth dose of mRNA1273. Patient reported of blood clots on the back of the leg, tibia and leg, she did not seek medical care but took 4 aspirin of 81mg. Further details regarding the clinical course and diagnostic test done were not provided. The patient's elderly age may be considered as a risk factor for thrombosis. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Information has been received from a nurse practitioner concerning a female who was vaccinated with a first dose of GARDASIL in arm.  On unknown date the patient experienced breakthrough bleeding and spotting.  On unspecified date, the patient recovered from breakthrough bleeding and spotting.  The patient sought unspecified medical attention.  This is one of several reports from the same source.  Additional information has been requested.
Pain in arm; Could not get out of bed for 48 hours; hurting; Sick; Walking was painful; Headache; Chills; Muscle pain; Joint pain; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 12-Apr-2021 and was forwarded to Moderna on 12-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm), ASTHENIA (Could not get out of bed for 48 hours), PAIN (hurting), ILLNESS (Sick) and GAIT DISTURBANCE (Walking was painful) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Connective tissue disorder, Fibromyalgia, Blood pressure and Rosacea.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in arm), ASTHENIA (Could not get out of bed for 48 hours), PAIN (hurting), ILLNESS (Sick), GAIT DISTURBANCE (Walking was painful), HEADACHE (Headache), CHILLS (Chills), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain). At the time of the report, PAIN IN EXTREMITY (Pain in arm), ASTHENIA (Could not get out of bed for 48 hours), PAIN (hurting), ILLNESS (Sick), GAIT DISTURBANCE (Walking was painful), HEADACHE (Headache), CHILLS (Chills), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Patient taken Tylenol for every 4 hours to ease the pain. At the time of reporting patient was feeling fine   Reporter did not allow further contact
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX (lot# and route unknown) to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2013, a healthcare provider administered the ZOSTAVAX vaccine to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. In 2015, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. The patient used the ZOSTAVAX vaccine for the permanent prevention of shingles and zoster-related injuries. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine. As a direct and proximate result of the ZOSTAVAX vaccine, 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 include 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. Additional information has been requested.
Fatigue, muscle soreness, severe chills, headache, rash appearance. Swelling. 4 x 4 demarcation below injection site. Very warm to the touch.
Patient call center and reports shortness of breath, and "tightness in her chest". Patient sent to emergency room.