chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Boostrix instead of Infanrix; Patient receiving Boostrix, 3 years of age; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 3-year-old patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, unknown after receiving Boostrix, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   Additional Information: GSK Receipt Date: 22-APR-2022 Reporter's comments: The advisory service reported that a patient received dose of Boostrix vaccine instead of Infanrix. The HCP (health care professional) stated another advisory service reported the AE (adverse event), so did not provide any information about the situation, only wanted to know how to proceed.  Additional Supportive Information: The health care professional reported that a patient received Boostrix vaccine instead of Infanrix at inappropriate age, which led to wrong vaccine administered and inappropriate age at vaccine administration. This case is linked with case US2022068744 reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022068744:Same reporter
A spontaneous report was received from a consumer concerning  a female patient who received Modena's COVID-19 vaccine (mRNA-1273) and  experienced generalized fatigue, muscle weakness, arm pain, neck pain, shoulder pain and headache.  The patient's medical history was not reported.  No relevant concomitant medications were reported.  The patient received her first of two planned doses of mRNA-1273 intramuscularly in the left deltoid for prophylaxis of COVID-19 infection on 30-Dec-2020.  On an unknown date, the patient experienced generalized fatigue, muscle weakness, arm pain, neck pain, shoulder pain, and headache.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcomes of the events, generalized fatigue, muscle weakness, arm pain, neck pain, shoulder pain and headache, were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
A metallic type taste in the mouth followed by numbness of the tongue starting from back of the tongue and progressing to entire tongue. Pt was moved to first aid room where v/s and ecg monitoring were started. The numbness never progressed to swelling, scratchiness, or anything else. No further treatment was provided and symptoms resolved on their own within 15-20 minutes. Pt did not feel further evaluation was necessary.
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient fainted in store after receiving first dose of Pfizer Covid vaccine. Patient regained consciousness within a minute and reported no other injuries. Patient was guided by pharmacist on duty to lie down with feet propped up. Patient remained in room for approximately 30 minutes after which patient confirmed that he was feeling fine. Patient will call pharmacy if any new symptoms develop
cellulitis/ travelled down the arm / cellulitis at injection site; body aches; fever; she had dose 1 of Shingrix about 18 months ago, and received dose 2 about 2 months ago; This case was reported by a consumer via call center representative and described the occurrence of cellulitis of arm in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included skin cancer (had skin cancer). Previously administered products included Shingrix (1st dose received 18 months ago).   In December 2020, the patient received the 2nd dose of Shingrix. In December 2020, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced cellulitis of arm (serious criteria GSK medically significant), general body pain and fever. The patient was treated with antibiotics nos. On an unknown date, the outcome of the cellulitis of arm, general body pain and fever were recovered/resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the cellulitis of arm, general body pain and fever to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The patient had no events reported with dose 1. The patient received 2nd dose 2 months ago and experienced fever, body aches, and cellulitis which began at the injection site, and travelled down the arm. The patient received dose 2 late than athe recommended schedule, which led to lengthening of vaccination schedule. The physician visit was required. The patient was put on unspecified antibiotics and recovered. The reporter did not consent to follow up. This case was linked with caase US2021048467, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021048467:same reporter - husband´s case
On 11-2-18 fever 102. On 11-4-18 acting "very" tired and "emotional per mom". Crying, screaming, laughing.
Next day, had chills and fever lasting 24 hours. subsided and then returned 4 days later resulting in high fever: 103 and bad blood counts: low nutraphils, low white count.
Dull pain at site of injection and fatigue - same day Nausea and fatigue, slight sensation of heat under skin (but no fever) - midday day after injection
Chills; Headache; Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), HEADACHE (Headache) and VACCINATION SITE PAIN (Pain at the injection site) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 012A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 CHILLS (Chills), HEADACHE (Headache) and VACCINATION SITE PAIN (Pain at the injection site). At the time of the report, CHILLS (Chills), HEADACHE (Headache) and VACCINATION SITE PAIN (Pain at the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: unknown (High) Heart beating much faster.         Concomitant product use was not provided. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was  not applicable.
High blood pressure. Havent had any problems in years and now shooting skyhigh for no reason. Even at total rest.
Pt. began noticing red, raised hives/welts on bilat. arms, chest, neck and back, approximately 1 hour after receiving influenza vaccine. Pt was itching, scratching, anxious, and shaking. Has used BENADRYL & ALLEGRA since then which does help, but continues with rash 1 week post injection.
COVID 19 Diagnosis; body ache; fever; A spontaneous report was received from a physician concerning a 44 year old, female patient who experienced fever and body ache.  The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter.   On 22 Dec 2020, approximately 9 days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number unknown) intramuscularly in the for prophylaxis of COVID-19 infection.   The physician called to report that one of the nurses got the Moderna Covid-19 vaccine on 22 Dec 2020 and early in the morning of 31 Dec 2020, started having Covid-19 symptoms to include fever and body ache. She was tested and the results were positive. Treatment information was not provided/unknown.   Action taken with mRNA-1273 in response to the events was not provided/unknown.   The outcome of the events fever and body ache were unknown/not reported.   The reporter did not provide causality for the events fever and body ache; Reporter's Comments: This case concerns a 44-year-old female who "started having COVID-19 symptoms" and reported NS events of unexpected SARS-CoV-2 test positive (COVID-19), pain and expected pyrexia. Event onset occurred on Day 10 after the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Patient presented for 1st Dose Covid vaccination.  Clinic was doing new electronic registration documentation and nurse did not verify age.  Client was administered Moderna vaccine but was only 17 years old.  Patient has been reached out to receive second dose per CDC guideline.  Nurse will assess age every time on every client going forward.
Headache, Fever, Body/joint Ache, Fatigue the day after, with fatigue and body/joint aches and slight headache for the following days in decreasing intensity.    Rash on upper arm appearing  9 days after, increasing in size daily.
My joints hurt, my lungs felt like I am about to get bronchitis, extremely tired. Slept all day. Freezing cold for most of the day, then towards the end, my body felt like it was on fire.
This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a adult female patient who received Influenza vaccine Quadrivalent. On an unknown date, the patient received Influenza vaccine Quadrivalent at an unknown dose. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and influenza were unknown. It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine Quadrivalent. Additional details were provided as follows: The age at vaccination was not reported. The patient caught the flu after she had an unknown manufacturer's flu shot in 2017-2018 season. The patient had denied permission to contact their physician. This case was considered as suspected vaccination failure as details regarding the lab test confirmation for targeted disease and exact time to onset of event were unknown.
Immediately after receiving vaccine,  my arm hurt, which was to be expected.  An hour or so later,  my arm (left front, from elbow to just below my shoulder) started to feel like it was burning and the pain intensified when touched. It is now 37 days later and the pain/burning has not subsided. It feels like my nerve endings are on fire and I can't use my arm. No one else I know has had this problem and I'm becoming quite concerned. I keep dropping things when i try and use my arm, most annoying and painful.
With second COVID vaccine, patient experienced flushing, dizziness, lightheadedness, and diaphoresis. Patient was given water/juice and was discharged in stable condition home.
Acute migraine, Fever, Flu like symptoms, Palpitations, Tremors and involuntary muscle contractions, Acute stomachache that did not allow me to eat, urinary tract infection, low levels of hemoglobin, blurred vision and dizziness
accidently given Pfizer covid vaccine instead of influenza vaccine; no adverse reactions noted at time of administration or next day
Arm pain for >7 days, sought medical treatment at clinic (out of state and therefore did not go to PCP). Received prednisone and Norco. Pt was told by clinic "shot hit bursa" although I'm not sure how they could determine where shot placed. Pt still having arm pain after 10 days when called pharmacy to report.
Patient died 11/21/04. Child has respiratory distress and died in route to ER. Cause of death currently unknown. Suspected heart failure. Discharge Summary received on 12/15/2004 states pt experienced cardiopulmonary arrest. Medical Record received on 12/15 states pt expereinced vomiting and diarrhea. Follow up: COD, ischemic and congestive cardiomyopathy due to congenital heart dx. Autopsy Report received which stated patient experienced cardia fibroma, hemorrhagic pulmonary edema and congenital heart disease.
Patient received expired Covid-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired Covid-19 vaccine) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 083J21A, 032F21A, 017C21A/083J21A and 026B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired Covid-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired Covid-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Treatment information was unknown.   This case was linked to MOD-2022-560262, MOD-2022-561458, MOD-2022-561464 (Patient Link).
Redness and swelling and warmth inferior to injection site.  Unable to evaluate adverse reaction vs cellulitis; tx'd Keflex.
Pain/stinging at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th October 2019, the patient received Shingrix. On 17th October 2019, less than a day after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was captured as adult as per Shingrix indication. The reporter mentioned that she gave 3 Shingrix vaccinations on day of reporting and all 3 patients had complained of pain/stinging during injection of the Shingrix dose. The reporter consent to follow up. This is 2 of the 3 linked cases reported by the same reporter. This case had been linked to the case US2019188954, reported by same reporter.
Awoke with 101.5F fever at 07:00 on 5/2/02. Tylenol given. By 08:00, was in post-ictal state then responsive. Eyes fixed to upper left corner. 911 called. When EMS arrived about 10-15 minutes later, breathing was erratic in ambulance. She began a Grand Mal seizure off and on for 20 minutes and gave breathing treatment and bagged her with O2. 20 minutes to hospital. She stayed overnight at the hospital for observation. Went home on 2/9/02. (Developed a rash in ER that covered chest and back but lasted only 6-8 hours).
we gave 3 doses from a vial that was in the refrigerator for 33 days; we gave 3 doses from a vial that was in the refrigerator for 33 days; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (we gave 3 doses from a vial that was in the refrigerator for 33 days) and PRODUCT STORAGE ERROR (we gave 3 doses from a vial that was in the refrigerator for 33 days) in a 3-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Jul-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (we gave 3 doses from a vial that was in the refrigerator for 33 days). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (we gave 3 doses from a vial that was in the refrigerator for 33 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (we gave 3 doses from a vial that was in the refrigerator for 33 days) and PRODUCT STORAGE ERROR (we gave 3 doses from a vial that was in the refrigerator for 33 days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product was provided by the reporter. Dose administered after 30-day Use By Date or after manufacturer date of expiry. The vial was Initially stored in the refrigerator .The vial had not undergone any temperature excursions.  There were no other vaccines given within one month prior to Moderna COVID-19 vaccine. The AE had not caused patient to seek medical care. It was unknown whether patient experienced a similar event in the past. No treatment medication was provided.
Started with itching, then hives on arms, legs and abdomen. Given BENADRYL.
09:40 PT C/O  OF AN ITCHY THROAT  AND FELT THAT SHE NEEDED A BENADRYL. I INSTRUCTED PT THAT WE WOULD DO AN ASSESSMENT FIRST BEFORE GIVING MEDICATIONS.  PT DENIES THROAT SWELLING OR SOB. PT STATES SHE HAS SEASONAL ALLERGIES AND HTN. PT ALSO STATES SHE DID TAKE HER B/P THIS MORNING, BUT HER PCP JUST ADDED A NEW BP MEDICATION FOR HER HTN.  BP 169/97 HR 77 SpO2  97% 10:15 AM BP 104/91  HR 71 Sp02 98% 10:00 PT SITTING IN CAR, EATING A PROTEIN BAR & DRINKING  WATER. PT STILL DENIES SOB OR TROUBLE SWALLOWING @ THIS TIME.
Systemic: Nausea, Systemic: Vomiting, Systemic: palpitation, sweating, tingling on arms and hands, face turned pale for few mins, hyperventilating
TENDONITIS LIKE PAIN IN rue WITH DECREASED RANGE OF MOTION DUE TO PAIN. Narrative:  Other Relevant History:
Sore throat; Fatigue; Nausea; Diarrhea; Feel very sick; This spontaneous case was reported by a patient and describes the occurrence of DIARRHOEA (Diarrhea), MALAISE (Feel very sick), OROPHARYNGEAL PAIN (Sore throat), FATIGUE (Fatigue) and NAUSEA (Nausea) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure, Cholesterol and Acid reflux (esophageal).    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced DIARRHOEA (Diarrhea). 09-Apr-2021, the patient experienced MALAISE (Feel very sick), FATIGUE (Fatigue) and NAUSEA (Nausea). On 10-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE]) for Sore throat, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea), FATIGUE (Fatigue) and NAUSEA (Nausea) had not resolved and MALAISE (Feel very sick) and OROPHARYNGEAL PAIN (Sore throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included Blood pressure pills, acid reflux pill and cholesterol pill.
A 79 year old male patient was prescribed 6 treatments of OncoTICE by his urologist, beginning in June 2003. On the day following his first OncoTICE treatment, the patient experienced fever (101 degrees), weakness, aches, chills, and "did not feel well". After his second treatment he experienced a 99.7 degree fever, chills and an upset stomach. He received 2 more treatments through July 2003, and then was advised to stop the treatment. In September 2003 he had an ultrasound which showed a solid mass on his epididymis. A biopsy is pending but has not been schedule yet. The patient has no pain. An infectious disease specialist has prescribed Isoniazid and Rifampin, but the patient is hesitant to take these medications due to possible liver damage.
Patient called the doctor on 11127/2013, after receiving her flu shot in the clinic on 11/26/2013. She had a rough night with nausea, vomiting, and diarrhea. She was working hard to stay hydrated and was already in the recovery phase of this acute illness when she called the Doctor. She assured the doctor she was going to be okay. She has not had this sort of reaction from the flu shot in the past, so this may be coincedental. Patient wanted to report this to the Doctor.
The patient got a Juvéderm lip filler injection in February. She got her COVID vaccine on April 9. At the end of April she developed angioedema of the lower lip. The timing is suspicious for this being a combination of the lip filler with the modality vaccine, which has been reported in the past.
This spontaneous report as received from a nurse refers to an unspecified number of unspecified patients. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (lot # N022986, expiration date 23-AUG-2019 and ) GARDASIL 9 lot # N020353, expiration date 28-APR-2020 for prophylaxis. The vaccines underwent temperature excursions at or above 0 to 1 degrees Celsius (also reported as 1.2 to 1.4 degrees Celsius) for 83 hours and 38 minutes and at or above -9 to 8 degrees Celsius (also reported as (-5.1 to 1.1 degrees Celsius) for 3 hours and 57 minutes, respectively. Multiple excursions were involved. Digital data logger was involved. No adverse effects were reported.
Janssen COVID-19 Vaccine EUA From the time I was given the vaccine, I have had pressure on the left side of my chest, including my left arm pit, left side of clavicle, left breast, and throat.  I've had dizziness, chills, and a headache.
Called on 2/13/13 with report of blotches that started on left breast a few days later; now also has blotchy areas (largest 1 cm, smallest 3-4 mm) on abdomen, back, right arm, left arm, (R) side of back. Not itchy; no trouble breathing, no fevers, no pain. One near right deltoid that lasted 1 week.
9/16/10 at 1805 pm pt c/o leg soreness at injection site & fever up to 102.8.
Information has been received concerning a 15 day old white female with no pre-existing medical conditions or allergies who on 01-NOV-2007 was vaccinated PO at the incorrect time with her first dose of ROTATEQ (lot# 657667/1392U).  There was no illness at the time of vaccination.  Concomitant vaccinations administered on that same day included the first dose of PEDIARIX (lot# AC21B130AA) in the left deltoid, the first dose of PREVNAR (lot#853981H) in the right deltoid and the first dose of ACTHIB (lot# UF295AA) in the right deltoid.  On 17-OCT-2007 patient was also vaccinated with a dose of RECOMBIVAX HB (MSD) at a hospital.  No adverse reaction was reported.  No medical attention was sought.  Additional information has been requested.