chrisvoncsefalvay/vaers-outcomes huggingface dataset:
rash near the injection site of arm; red near the injection site of arm; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE RASH (rash near the injection site of arm) and VACCINATION SITE ERYTHEMA (red near the injection site of arm) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Dec-2020, the patient experienced VACCINATION SITE RASH (rash near the injection site of arm) and VACCINATION SITE ERYTHEMA (red near the injection site of arm). On 01-Jan-2021, VACCINATION SITE RASH (rash near the injection site of arm) and VACCINATION SITE ERYTHEMA (red near the injection site of arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.; Sender'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.
Information has been received from a physician's assistant concerning a 16 year old male patient with no history of seizures who on an unspecified date was vaccinated with a dose of GARDASIL (dose, route and lot # not reported). The physician's assistant reported that on an unspecified date, the patient suffered a seizure after leaving the office, following a GARDASIL immunization. The physician's assistant did not know if the patient was admitted to the hospital, only that the patient was transported to a hospital. It was also not known which shot in the series this was, first, second or third. At the time of the report, the patient's outcome was unknown. Upon internal review, a seizure was considered to be an other important medical event. Additional information has been requested.
Patient had no adverse event. Patient's doctor wanted recombivax 40mcg, which is not available. So she injected one prefilled Heplisav B 20mcg/0.5cc into another Heplisav B and the injected 1cc of Heplisav into the patients arm.
Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # M005714, expiration date 03-OCT-2017; lot # M011117, expiration date 07-DEC-2017, dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as there was no consent to contact the physician.
Information has been received from a certified medical assistant referring to multiple unspecified patients of unknown age and gender. On unspecified dates, the patients were administered an unspecified number of improperly stored doses of Oral ROTATEQ (lot # K016278, expiration date: 21-APR-2016 and lot# K023534, expiration date: 22-MAY-2016, oral, strength and dose were unknown). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Moderna COVID- 19 Vaccine EUA: patient presents to clinic two weeks after vaccination with a painful, itchy, red rash on hands and feet that started 12 days after vaccination. Patient states symptoms are improving  with hydrocortisone topical and denies fever, chills, myalgias, arthralgias, bleeding, nausea, and mouth sores.  Patient able to manage symptoms at home.
Pink rash on the arm; Head ache/tired of having a head ache every day/ slight head ache; arm has been itching; arm is swollen from the injection; A spontaneous report was received from a consumer concerning a 74-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced  arm has been itching it's been happening/vaccination site pruritus, found a pink rash on the arm/vaccination site rash, head ache, tired of having a head ache every day, slight head ache, the arm was swollen from the injection/vaccination site swelling.  The patient's medical history was not provided. Concomitant medications included aspirin, blood pressure medicine, pill for the bladder,and vitamins.  On 4 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (batch number: 013M20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 4 Feb 2021, the patient experienced arm has been itching it's been happening,the arm was swollen from the injection. On 10 Feb 2021, the patient  found a pink rash on the arm, mentioned that he had head ache, tired of having a head ache every day, and at the time of call, he said that he had slight head ache.  Treatment medication included paracetamol for headache.  Action taken with mRNA-1273 in response to the events were  not reported.   The outcome of events, arm has been itching it's been happening, found a pink rash on the arm, head ache, tired of having a head ache every day, slight head ache, the arm was swollen from the injection, were  unknown.
FATIGUE; BODY ACHES; LOWER BACK PAIN ON LEFT SIDE/BACK PAIN; PAIN IN HIS WHOLE UPPER ARM (SHOULDER TO ELBOW) OF THE INJECTION SITE/LEFT ARM SORENESS; COLD CHILLS; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 50 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included headaches, blood pressure abnormal, iodine allergy, non-alcohol user, and non-smoker.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. Concomitant medications included losartan for blood pressure abnormal, and verapamil for headaches. On 13-APR-2021, the subject experienced body aches. On 13-APR-2021, the subject experienced lower back pain on left side/back pain. On 13-APR-2021, the subject experienced pain in his whole upper arm (shoulder to elbow) of the injection site/left arm soreness. On 13-APR-2021, the subject experienced cold chills. On 13-APR-2021, the subject experienced injection site pain. On 05-JUN-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and cold chills on 15-APR-2021, lower back pain on left side/back pain, and fatigue on 06-JUN-2021, and injection site pain on APR-2021, and had not recovered from pain in his whole upper arm (shoulder to elbow) of the injection site/left arm soreness. This report was non-serious.
sore @ inj site-wave of nausea-throat pain, ear pressure, watery eyes;
On 2/26/2021 at around 11:00AM, I wasn't able to formulate a sentence and I had trouble speaking. A few years ago, I had a stroke after undergoing open heart surgery, and my husband thought I was displaying similar symptoms, so he took me to the ER at University Hospital. They ran a brain scan and it was determined that I hadn't had a stroke, but a seizure. I was then put on a ventilator, and I stayed on it until about 9:00PM that night. I spent the night in the ER and was released late in the morning on 2/27/2021. After that, I made an appointment to see my cardiologist, Dr.. Dr. prescribed Keppra, which is an antiseizure medication. Since then, he has been following my progress, and I have undergone brain scans at his practice every 6 months. So far, everything seems to be fine. I am currently concerned, though, as I would like to receive the Moderna booster when it finally comes out. However, I'm afraid it could cause me to have another seizure. One doctor recommends I not get it, whereas another doctor recommends that I do, so I'm confused. In about 2 weeks, I plan to get my antibody levels checked.
administration of expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administration of expired vaccine) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administration of expired vaccine). On 07-Oct-2021, EXPIRED PRODUCT ADMINISTERED (administration of expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were provided. No treatment information was provided.  The first and second vaccine information was not provided. Nurse reported that number of doses/vials were 14-dose vial. On 02-Sep-2021, the vial was initially stored in the refrigerator. The expiration date of vaccine was 2 Oct 2021.   This case was linked to MOD-2021-345445, MOD-2021-345456, MOD-2021-345457, MOD-2021-345460, MOD-2021-345565, MOD-2021-345619, MOD-2021-345620, MOD-2021-345642, MOD-2021-345666, MOD-2021-345833, MOD-2021-345910, MOD-2021-345931 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Oct-2021: significant follow up appended : Reporter / Lot no / Expiration Date Updated .
Systemic: Fainting / Unresponsive-Mild, Systemic: Tinnitus-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: Patient reported brief loss of consciousness immediately after receiving vaccine while in seated position, patient did not fall or hit head. Patient reported some loss of vision and hearing/tinnitus immediately after loss of consciousness. The loss in vision and hearing resolved gradually within minutes of losing consciousness. Patient was met by guardian and, with guardian present, evaluated by EMT team. Patient went home with guardian, walking himself. No other symptoms and no treatment
This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates, the patient were vaccinated with improperly stored ROTATEQ (dose, lot# and expiration date were not reported; oral; therapy type; digital data logger). Temperature excursion information was reported as: below 36 Fahrenheit, more than 25 times (unknown by the reporter). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient is a 77 year old female patient with PMH of COPD who presents for shortness of breath and cough for the past 11 days.   COVID 19+ Influenza A + Acute COPD exacerbation  Viral sepsis, POA Onset of symptoms - 9/15, positive test- 9/26 Fully vaccinated, boosted per notes Meets SIRS criteria on admission with leucocytosis, tachypnea and tachycardia CXR showed COPD changes, CTAPE showed no evidence of PE, 2mm LUL pulm nodule  Legionella, strep pneumo negative BC x 2 - NGTD  On solumedrol for COPD exacerbation, transitioned to prednisone Continue tamiflu at this time given symptoms and oxygen requirements  Continue breathing treatments  Chest physiotherapy  Now weaned to room air ID consulted and appreciate recs, no further recommendations  SW following for DC needs.  Home health set up.   Today, pt stable, symptoms improved so will dc home. Pt advised to f/u with her PCP in 1 week.   Leukocytosis Possibly secondary to above.  Steroids contributing Continue to monitor   Depression Continue citalopram   Discharge Planning ? Medically Stable for Discharge Date: Today ? Patient requires continued hospitalization due to: COVID, influenza  ? Discharge Location: home
17-year-old patient received the Moderna Vaccine; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17-year-old patient received the Moderna Vaccine) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17-year-old patient received the Moderna Vaccine). On 04-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17-year-old patient received the Moderna Vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided   Most recent FOLLOW-UP information incorporated above includes: On 29-Mar-2021: Suspect product dosage details and Current condition of patient; Sender's Comments: This case concerns a 17-year-old patient who received their first of two planned doses of mRNA-1273 (Lot number: 027A21A), reporting Product administered to patient of inappropriate age without any associated adverse events.
Muscle aches and pains Fever mild Diarrhea prolonged 36 hours
Information has been received from a medical assistant referring to a patient of unknown age and gender. Information about concurrent condition, medical history and concomitant medication was not provided. The medical assistant reported that the patient received GARDASIL intramuscularly on 28-AUG-2012 (lot # 1745AA with expiration date 09-MAY-2013; dose unknown) and on 13-JUN-2013 (lot# H021346 with expiration date 01-OCT-2015; dose unknown) and received GARDASIL 9 intramuscularly on 04-AUG-2016 (lot# L043214 with expiration date 30-AUG-2017; dose unknown) and on 26-OCT-2016 (lot#M030380 with expiration date 01-FEB-2019; dose unknown. No adverse effects were reported. Additional information has been requested.
This is a spontaneous report from a contactable pharmacist, based on information received by Pfizer from Merck & Co., Inc. (Manufacturer control number 00909524). A patient of unspecified age and gender received PREVNAR 13 via an unspecified route of administration at single dose for immunisation, SHINGRIX via an unspecified route of administration at an unspecified dose for immunisation and BOOSTRIX via an unspecified route of administration at an unspecified dose for immunisation, all in May2018. Relevant medical history and concomitant medications were not reported. Pharmacist reported the patient started to "experience pain and tingling in the arm" on unspecified date after receiving the suspect vaccines. At the time of the report, the outcome of the events was unknown. No follow-up attempts are possible, information about batch number cannot be obtained.
9 days after receiving the moderna covid booster I developed urticaria all over my body (face, back, chest, neck, scalp, legs, arms, hands and feet). This has caused  an intense itching sensation and I have also developed dermatographia.  I have been on oral prednisone, antihistamines and topical steroids for days with no improvement.
I received my flu shot in my (L) deltoid. Around 4:30pm I started to have achyness around the injection site. By 6:30pm, it was extremely painful to move my (L) arm d/t pain from my left shoulder to elbow. The pain became more severe if something touched my arm, with arm movement or with lifting. I tried not to move my arm d/t pain and was not able to on my left side. The pain was less severe the AM of 10-2-10 and it subsided completely that afternoon. I have never had this much pain with a flu shot and it has never radiated down to my elbow.
My mother became ill not even a week after her second covid vaccine.  She was constantly sleeping and had sudden onset breathing issues.  She was hospitalized in mid January 2022 after multiple falls and eventually died on January 25, 2022 as a result of blood bacteria infection and 3 massive blood clots in her lungs.  She was inpatient at Hospital.  Multiple COVID tests were given while she was hospitalized all of which returned back negative.  Death certificate indicated she died from pneumonia as a result of COVID.
1/15/2021: That night after vaccine, feeling very cold, unsure of having fever and very tired. Reports arms and legs were burning that night. Nausous that night also. Employee took Ibuprofen. At 4:00 am, feeling better. Saturday night, 1/16, feeling the same; nauseous, burning feeling in legs and arms, and chills. Reported into work on Sunday, 1/17. Talking to coworker in breakroom and said not feeling right and passed out. Employee has no memory of event after passing out. Staff reporting employee went unresponsive, gurgling like going to aspirate. Staff tipped employee to side to prevent aspiration and took employee to emergency room to be evaluated by physician.  Vitals were stable, labwork unremarkable except potassium of 3.3. Chest xray was normal. No signs of infection. Doctors determined reaction to vaccination on Friday, 1/15
Developed sudden fever of 103.4 (F) unrelieved by Tylenol and Motrin. Also severe body/joint pain, headache and vomiting.
Fever; arm pain at the site of injection; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Fever"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "arm pain at the site of injection".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Adverse event related to breastfed baby. Vaccine was administered at 4:00pm baby was breastfed at 5:30pm and 8pm. Over the next two days she experienced and interruption in her normal sleep schedule, sweating, unusual fussiness, decreased appetite and twitching in her feet. Tylenol seemed to help her fussiness during the day.  I am still experiencing side effects 7 days later including muscle aches, fatigue, weakness, headache, and nausea. I was evaluated at a local ED and all lab work was normal, covid test was negative.
About 3 minutes after getting the immunizations client passed out, for about 30 seconds, and then came to. After coming to, laid client down on the floor, with an ice pack on the back of his neck. Gave client some juice to drink and a sucker. Once feeling, better, client sat up for a couple of minutes. After about 15 minutes, client went home with father.
My father received the first Covid shot 3/2; he woke up 3/3 with severe body aches and weakness, which we thought nothing of.  However, every day, he got weaker and weaker. He has been treated for Liver cancer, he received his first infusion of Opdivo almost 4 weeks before the vaccination.  About 7 days after the shot, he was having trouble swallowing so he went to the ER to get a CT scan. He was found to have greatly elevated troponins, the DR was baffled he wasn?t having any chest pain; they were apparently not trending either., he has never had a heart attack or any other heart problems, takes Nadolol for high blood pressure. The CT scan showed significant growth of his tumors  which had been stable for a year and the last CT scan was the end of January; liver enzymes were also significantly elevated whereas they were stable before.  My father deteriorated rapidly, and died on 3/18/21. The day he got the shot just prior, he was hauling wood, shoveling snow and living a normal life feeling good. The day after the shot he could barely get out of bed he was so weak, until he finally died 16 days later.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old male patient received BNT162b2 (BNT162B2), on 08Apr2021 as dose 1, single (Lot number: EP7534), in left arm, on 29Apr2021 as dose 2, single (Lot number: EW0162), in left arm, on 24Nov2021 as dose 3 (booster), single (Lot number: FH8027), in left arm and on 10Jun2022 as dose 4 (booster), single (Lot number: FM7553) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: MUCUS RELIEF DM, start date: 13Aug2022, stop date: 20Aug2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Treatment for covid-9 test. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: if vaccine received: Yes. other medication in 2weeks: Yes. anti viral details: product: COVID 19 Treatment, brand: Paxlovid, treatment start date: 15Aug2022, treatment stop date: 19Aug2022, indication: Treatment of COVID-19. Adverse event: Tested positive again for COViD-19 after developing runny nose. known allergies: No. other medical history: No.  No follow-up attempts are possible. No further information is expected.
Initial misuse report received on 17  October 2013 from a pharmacist. A patient whose gender, age, medical history and concomitant medications were not reported, received a dose of FLUZONE (lot number, route and site of vaccination was not reported) on an unspecified date. It was reported that a patient should receive high dose of FLUZONE. As of 17 October 2013. Patient did not have any adverse events. List of documents held by sender: none.