chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 35-year-old male. Neither medical history nor concomitant medications were reported. On 20-Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause of the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 12-May-2009 and incorporated into the narrative: Product complaint investigation results.
Soreness at injection site; tingling of the tongue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness at injection site) and PARAESTHESIA ORAL (tingling of the tongue) in an 83-year-old female patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Soreness at injection site) and PARAESTHESIA ORAL (tingling of the tongue). At the time of the report, VACCINATION SITE PAIN (Soreness at injection site) and PARAESTHESIA ORAL (tingling of the tongue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (Fever) in a 17-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1416B) for COVID-19 prophylaxis. Patient was never been diagnosed with or tested positive for COVID-19. Patient did not had any acute illness at the time of vaccination and up to one month before. Patient did not had any chronic or long-standing health conditions. On 08-Jul-2022 at 2:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. In 2022, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient race was reported as "Private". No concomitant medications were reported. The site of administration was reported as RVL. No treatment information was reported. This case was linked to MOD-2022-628906 (Patient Link).
Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 16-JAN-2012 at 07:30 and on 17-JAN-2012 at 7:30, ZOSTAVAX (Lot # 671141/1267AA) was exposed to -8 degrees C for an estimated total time out of range of 14 hours. On 23-FEB-2012, the patient was vaccinated with an out of range dose of ZOSTAVAX (Lot number 671141/1267AA, expiration date 05-NOV-2012) (dose and route administration were not provided). No adverse experience was reported. This is one of 182 reports received from the same source. Additional information has been requested.
Bones pains; Weakness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BONE PAIN (Bones pains) and ASTHENIA (Weakness) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M24A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Blood pressure high. Concomitant products included INSULIN for Diabetes.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced BONE PAIN (Bones pains) and ASTHENIA (Weakness). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at a dose of 1 dosage form. At the time of the report, BONE PAIN (Bones pains) and ASTHENIA (Weakness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The batch number of the second dose mRNA-1273 received was 001B21A  Concomitant medications also include High blood pressure medications and other medications for diabetes.  It was reported that the symptoms of the patient had worsened on a daily basis. And therefore denied for further followup.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: TCR received on 17-JUN-2021 contains information about the worsening events and also denial for further follow up.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 11-SEP-2014 the patient was vaccinated with an expired dose of M-M-R II lot # H015824, expiration date 24-AUG-2014, subcutaneous (dose not reported). No adverse effects reported. Additional information has been requested.
Information has been received from a consumer concerning a 9 yr old female who was vaccinated with a dose of varicella virus vaccine live. Within the last week, in Apr 2005, the pt experienced chickenpox. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
pt recv vax 28OCT95 & same day c/o muscle spasm approx 4 inches below inj site w/in 1 hr p/vax;the next day pt reported a rash covering chest, back & arms;pt recovered;
Information has been received from a registered nurse concerning a female who on 16-AUG-2007 was vaccinated with a first dose of GARDASIL vaccine (yeast) (lot # not reported). On 06-JUN-2008 the patient was vaccinated with a second dose of GARDASIL vaccine (yeast) (lot # not reported). The patient sought unspecified medical attention during the office visit for the second dose. No problems were reported. Patient outcome was not reported. Additional information has been requested.
Patient states that she has been having an intense muscle burning pain that happens 5-8 times a day stretching from where the vaccinations were administered to approximately her elbow. She states that this feeling has never happened before and set in approximately 3 days after the vaccinations were administered. She states that this feeling is "mind numbing" and stops her in her tracks
Patient presents to the emergency department for the evaluation of left shoulder pain.  The patient states that she received her second Covid injection yesterday and feels like potentially the injection was placed into the joint.  She states she had immediate pain at the current injection of the vaccine  pill has not let up since the vaccination occurred.  She denies any associated symptoms such as fevers, chills, body aches, nausea, vomiting, weakness.  Pain is isolated to the left shoulder and is worse with movement of the upper arm.  Denies any numbness or tingling in the left upper extremity.
No additional AE; Caller reported that PROQUAD was administered after being reconstituted with a non Merck diluent; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.       On 16-NOV-2020, measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) 1 dosage form,  lot number T015599, expiration date 02-NOV-2021 (route of administration not provided) for prophylaxis was reconstituted with sterile water, lot number W56778, expiration date 01-FEB-2021, and was administered to the patient. No additional adverse events were reported.
Patient did not have any adverse events. Vaccine was stored frozen and manufacturer said it would not have been effective when it was administered.
This spontaneous report received from a consumer concerned a 66 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on APR-2021 for covid-19 prophylaxis. Age at time of vaccination 66 years old. The batch number was not reported and has been vaccinated. No concomitant medications were reported. On 2021, the patient experienced got Covid. Laboratory data (dates unspecified) included: Antibody test had monoclonal antibody, and COVID-19 virus test Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got Covid was not reported. This report was non-serious. This case, from the same reporter is linked to 20220832455.
States she "just could not get up and move" for 15 days after the injections on 10/27/2010.  "Finally went to see her doctor" and he suspected the vaccinations had caused the malaise.
This case was reported by a pharmacy technician and described a subject (age and gender unknown) who did not respond to immunization to the Engerix-B immunization series. Past medical history, concurrent conditions and concurrent medications were unknown. On an unspecified date before 27 July 2006, the subject received a dose of Engerix-B. On an unspecified date after vaccination with Engerix-B, it was reported that the vaccine was "not effective." Further information was not reported.
patient had a COVID test for pre travel purposes on 7/28/2021, which came back positive
Information has been received from a physician concerning a 15 month old patient who was vaccinated with a dose of ROTATEQ (lot number and route not reported) at 4 months of age and another dose at 6 months of age. Subsequently the patient experienced dehydration and tested positive for rotavirus and was hospitalized. At the time of the report, the patient's status was unknown. Dehydration and positive for rotavirus were considered to be disabling. This is one of several reports received from the same source. Additional information has been requested.
Severe left sided abdomen pain. Onset when I was trying to go to sleep.  My Primary Care physician is someone at Hospital who only does telephone appointments like 6 weeks out so that is not any help.
After receiving vaccination resident, patient stated "I had three shots last month." 6:00 pm patient denies pain. no redness noted.
Complains of fever onset 2 days ago followed by rash today. Vesicular rash in face & trunk.
SWEATING; HEADACHE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch number. No concomitant medications were reported.  On 07-APR-2021, the subject experienced sweating. On 07-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sweating and headache was not reported. This report was non-serious.
No adverse event; Patient received first dose of Moderna vaccine on 15-Jan-2021 and second dose on 24-Apr-2021; This spontaneous case was reported by a patient family member or friend and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose of Moderna vaccine on 15-Jan-2021 and second dose on 24-Apr-2021) and NO ADVERSE EVENT (No adverse event) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No acute and chronic illnesses were present at the time of vaccination.  The patient's past medical history included COVID-19 (Two weeks after the first shot, the patient had Covid) in January 2021. Previously administered products included for Drug use for unknown indication: Flu shot. Past adverse reactions to the above products included No adverse event with Flu shot. Concurrent medical conditions included Allergy to antibiotic (Erythromycin) and Drug allergy (Codeine). Concomitant products included ALPRAZOLAM, AMLODIPINE, ATORVASTATIN and ESOMEPRAZOLE for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose of Moderna vaccine on 15-Jan-2021 and second dose on 24-Apr-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose of Moderna vaccine on 15-Jan-2021 and second dose on 24-Apr-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test: (Positive) Positive.         The patient received the both the first and second doses on her deltoid (shoulder) muscle.  The patient was taking Alprazolam dose as needed.  No treatment medications were reported.   This case was linked to MOD-2022-658050, MOD-2022-658038 (Patient Link).
11/15/21 presents to ED for "generalized abdominal pain, n/v/d for the past 1-2 weeks". PMHx "CAD s/p PCI LCX 2017, CHFrEF 35%, TIA, Type II DM, ESRD on HD, Recurrent AVF Graft Failure on Eliquis, HTN"
Swelling in wrist. Wrist had small red rash. This was within 15 mins after.
"Moderna COVID-19 Vaccine EUA" exacerbation of pre-existing pain in damaged nerves, headache, nausea and vomiting, dizziness, intense thirst, light sensitivity, fatigue, joint pain
really weak; really bad headache; 100.4 F. fever; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (really weak), HEADACHE (really bad headache) and PYREXIA (100.4 F. fever) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 031A21A) for COVID-19 vaccination.     The patient's past medical history included Heart disease, unspecified.   On 30-Mar-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced ASTHENIA (really weak), HEADACHE (really bad headache) and PYREXIA (100.4 F. fever). At the time of the report, ASTHENIA (really weak), HEADACHE (really bad headache) and PYREXIA (100.4 F. fever) 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.       No Concomitant medications were reported No treatment medications were reported    Reporter did not allow further contact
itchy rash; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old male patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 28Mar2021 at 15:15 (at the age of 62-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not receive any vaccination in four weeks. The patient did not receive any other medications in two weeks. The patient did not have any allergies to medications, food or other products. 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 29Mar2021, the patient experienced broken out in an itchy rash since getting the vaccine. The rash was found on part of the face, part of the arm and around hip girdle. The event resulted in doctor or other healthcare professional office/clinic visit. It was unknown if the patient received treatment for the event. The clinical outcome of the event broken out in an itchy rash was not resolved at the time of report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
PT CAME IN TODAY 5/21/2022 AT 4PM COMPLAINING OF PAIN AND SWELLING AND REDNESS IN HER ARM FROM HER SHINGLES VACCINE FROM 5/14/2022.  PT STATED SHE HAS BEEN TAKING ANTI INFLAMMATORY MEDS AND USING ICE PACKS BUT IS STILL UNCOMFORTABLE
Intractable Vaginal/vulvar itchiness about a month after vaccination. Was treated for bacterial vaginosis based on symptoms at onset.  Symptoms did not resolve. Upon physical examination 2 months after vaccination, doctor suspected vulvar lichen sclerosus, confirmed with biopsy. This is a lifelong condition that has no cure, increases my risk for vulvar cancer, and affects my mental health as well as my daily comfort and sexual health. The treatment is difficult to tolerate and causes further symptoms of its own.
Tinnitus;  my ears were ringing on and off.  A rather high pitched hum.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 14-MAY-2015 the patient was received improperly stored VARIVAX (lot # K026385, expiration date 15-DEC-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
w/in 24 hrs of vax pt exp redness of 2-3 inches around inject site, swelling or upper arm & red streak from inject site to the inner armpit;
About 3-4 weeks after receiving my second covid shot, I noticed the formation of a single bump  in abdominal wall went to doctor and diagnosed (Lipoma). A few weeks later, the growth continued to enlarge and I found another bump (lipoma).   My physician did not say or imply this was the result of the vaccine. Also, I haven't read any articles seeing this as a potential side effect of the vaccine. However, I've never had a single (let alone 2) lipoma's in my life. I'm sure this is coincidental but I wanted to report it, just in case others are reporting similar events and there is potentially a trend.
Woke up on 5/3/21 with severe unbalance. Hard to walk or stand. Felt like I was going to fall over or loose my balance. Very shaky. Still have effects on 05/04/21. Three of my friends were contacting me and they had the exact same thing. One spent the night in the hospital. We have all been vaccinated with the Moderna vaccine and all around the same time. Two on March 19th. Mine on March 26th & my other friend on April 1st. Just wondering if there is any connection to the vaccine. We are all over 65.
A home COVID-19 antigen test result was positive; A home COVID-19 antigen test result was positive; This is a literature report for the following literature source(s).  A 72-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single, as dose 2, single and as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history included: "coronary artery bypass graft" (unspecified if ongoing); "hypertension" (ongoing); "diabetes" (ongoing). Concomitant medication(s) included: ATORVASTATIN; METFORMIN; ASPIRINE; DAPAGLIFLOZIN. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "A home COVID-19 antigen test result was positive". The patient underwent the following laboratory tests and procedures: Blood creatinine: unknown results; normal limits; SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Case report: A 72-year-oldmancalled his primary care physician (PCP) after2days of throat pain, myalgia, mild shortness of breath, and fever. A home COVID-19 antigen test result was positive. He had received 3 doses of the BNT162b2 vaccine (Pfizer-BioNTech COVID-19 vaccine); the most recent dose was 6 months prior. Considering a history of recent coronary artery bypass graft, hypertension, diabetes, and the patient's age, his PCP prescribed nirmatrelvir and ritonavir (Paxlovid) for 5 days. The patient called his PCP after 2 days with active complaints of worsening myalgia. On medication review, the patient's active medications included atorvastatin, 80mg daily; metformin, 1000mg twice a day; aspirin, 81mg daily; and dapagliflozin, 10mg daily. The patient was advised to stop nirmatrelvir-ritonavir use, hold atorvastatin use, and have his creatinine kinase levels checked. The patient's creatinine kinase levels came back   with in normal limits. With rest and over-the-counter analgesics, the patient's symptoms improved without further interventions. HisCOVID-19-related symptoms resolved within 5 days. He was restarted on atorvastatin therapy 1week after finishing nirmatrelvir-ritonavir treatment, with no recurrence of myalgias.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the given information , the possible contributory role of the suspect for the event vaccination failure and covid-19 cannot be excluded.
Swollen, sore, itchy red patch approx 2"x3" in size. Swelling & itching subsided about 05/25/13. Currently still pinkish.
Pt having sx of stuffy nose, cough & feeling malaise; recvd vax on 4NOV91 & pt started feeling ill on Sunday 10NOV91;
a magnet will stick to her injection site.; This is a spontaneous report from a contactable nurse. A 46-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number unknown), via an unspecified route of administration, administered in arm on an unspecified date as unknown, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter stated she had a patient (46 years old female) who has reported that after receiving the Pfizer Covid vaccine, a magnet would stick to her injection site. The 46 years old female patient knows of 8 individuals who had also reported it. Reporter would like to know if Pfizer has any information or guidance regarding this. The reporter called to report on one of her patients who stuck a magnet to their injection site after receiving the Pfizer covid vaccine, and the magnet stuck to her patient's arm. The patient knows 7 women within her friend group and within her family who was able to have a magnet stick to their injection site after receiving the Pfizer covid vaccine. There was no PQC (product quality complaint) present. The outcome of the events was reported as unknown.  Information about lot/batch number has been requested.
Moderna COVID-19 Vaccine EUA (None on first vaccine) 2nd vaccine:  chills (could hardly get warm enough to sleep).  Achy (especially in areas already sore from a workout.  Felt double the ache) Wimpy Red and  slightly swollen at injection site
Headache, chills, slight fever, short of breath (but that might be because I have moderate sleep apnea--not sure).
Rec'd immunization on 1/31/02. Developed lower back pain, pain across shoulders, bilateral groin pain, sensitivity in both knees, hip discomfort radiating down to knees and chills on 2/11/02. Started at work abruptly.
Hep b,throwing up not being able to eat food without throwing it up was very weak had IVs in my head.