chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient received bnt162b2 (BNT162B2), administration date Aug2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Osteoarthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 01), for Covid-19 immunization. The following information was reported: OSTEOARTHRITIS (non-serious) with onset 2021, outcome "unknown", described as "my osteoarthritis has gotten extremely worse and it triggered a severe flare up of symptoms"; ARTHRALGIA (non-serious), SPINAL PAIN (non-serious) all with onset 2021, outcome "unknown" and all described as "I have severe pain in my knees, wrists, cervical spine and ankles"; ARTHRITIS (non-serious) with onset 2021, outcome "unknown", described as "severe flare up". Therapeutic measures were taken as a result of osteoarthritis, arthralgia, spinal pain, arthritis. Additional Information: She wanted to make aware that after her second dose in August 2021, her osteoarthritis has gotten extremely worse and it triggered a severe flare up of symptoms. She has had severe pain in her knees, wrists, cervical spine and ankles. Does not know if anyone who currently suffers from osteoporosis has reported having experienced these issues. Was being treated by a Rheumatologist, Orthopedic and pain management. She wanted to bring this to light to inform patients who have osteoarthritis her need to consider these side effects as they are life altering and debilitating. Can be reached should anyone have any questions.  The lot number for bnt162b2 was not provided and will be requested during follow up.
48 horus after second vaccine  Right eye periorbital swelling and mild drainge Throat swelling described as feeling like it was hard to swallow - no acute distress Question of increased respiratory rate - normal respirations noted in clinic 2.5 x 2.5 cm nodule, well demarcated and moveable with sudden appearance to forehead Onset of floaters in B/L eyes occurred 4 hours later, after administration of oral benadryl and prednisone Tx: Patient was given Benadryl 50mg orally and Prednisone 60mg orally. Withing one hour throat tightness resolved, respiratory rate reamined normal, left eye swelling was improving and nodule to forehead was decreasing in size. Floaters were persistent. 24 hours later pt reports no recurrence of throat tightness, normal respiratory rate, resolution of left eye swelling, some decrease in size of forehead nodule. Floaters have been persistent and unchanged.   *24 hours after second vaccine pt has onset of palpable lymph nodes to anterior cervical chain, single node to left supraclavicular chain and left axillary swelling. This was not considered an allergic reaction and attributed to immune response to vaccine.
Severe (L) shoulder pain which has currently lasted for 2 weeks. Pain limiting course of motion and activities. No weakness or numbness. Icing and using NSAIDs.
Breakthrough case admission after three vaccines Pfizer 4/9/21 Lot# EW0150;  Pfizer 4/30/21 Lot# EW0172;  Pfizer 11/20/21 Lot# 320308D
Arthralgia - severe, malaise- severe, fatigue severe, headache- moderate, swelling/induration, redness, diarrhea, chills-moderate, pain-severe- took 500mg acetaminophen every 4-6hrs..
8SEP95 lt upper arm swollen, red & warm; t101, swelling noted to bend of arm; took to PMD recvd Kenalog inj;26SEP95 tc to pt mom pt is fine now
Received vaccine at 9:00 AM. Low grade fever of 99 degrees and fatigue began the same day around 5:00 PM. Nausea and vomiting began at 10:00 PM. He vomited multiple times until 3:00 AM. Following day he still experienced nausea, unable to eat and soreness in legs. All symptoms subsided by 5:00 PM the following day.
Severe eczema developed on my hands on setting around June 11, 2021 with raw and peeling skin. I was prescribed a burst of Prednisone x 10 days as well as itraconazole 100 mg tabs. Note: I'm not convinced that this event is related to the vaccine; however, after filling out my online V-Safe check in I was contacted from the V-Save COVID-19 Follow Up line and was resulted to fill out a VAERS report.
This spontaneous report as received from a nurse refers to a unknown numbers of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with (Oka/Merck) VARIVAX, lot # reported as K002929, expiration date 26-FEB-2016 and Lot # J013900, expiration date 30-OCT-2015. Dose and route were not reported. The nurse reported an excursion of 13.64F for 1h 15 minutes affecting (Oka/Merck) VARIVAX. Nurse reported that there have been multiple excursions to this product over the past two years, potentially over 15F. The product had been administered post excursion. There have been no reports of adverse effects to any patient. Patients did not seek medical attention.  This is one of several reports from the same source. Additional information has been requested.
Check out itching at site and on back. Saturday and Sunday began day within shot. Red area with peeling skin noted at place of site. Left arm. Skin peeling from back area. Temperature 99 degree.
Persistent L ear burning,  paresthesia of L side of face, chest pain in L side of chest.
This spontaneous report was received from a certified medical assistant and refers to a 4 month old (at the time of the report the patient was 6 month old) female patient. Information on the patient's concurrent conditions, medical history or concomitant medications was not reported. On 27-APR-2016 at 10:21, at the age of 4 month old, the patient was vaccinated with her first dose of ROTATEQ (lot# number reported as L033543, expiration date 30-MAY-2107, orally, dose was not reported). The temperature excursion was 34F and the time frame was 65 hours. There was no previous temperature excursion and the call was not because of a data logger. No adverse events, signs or symptoms were reported. No product quality complaint (PQC) was involved. The patient had no illness at the time of vaccination. This is one of several reports received from the same source. Lot number L033543 has been verified to be a valid lot number for ROTATEQ. Additional information is not expected as all required correspondence has been received.
Information has been received from a pharmacist via a company representative referring to an unknown number (reported as "few patients") of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates these patients were vaccinated with ZOSTAVAX (strength, dose, route, lot# and expiration date were not reported). On unknown dates, six months to a year after receiving ZOSTAVAX, all these patients developed shingles. The outcome of the events was unknown. Causality assessment was not reported. Additional information has been requested.
Fever, chills, headache, muscle and joint pain, fatigue, loss of appetite within 7hours after vaccination. Fever overnight. Felt little better in the morning.  Experiencing Severe headache. Given Tylenol 6hrs apart. Ibuprofen in the am for headache.
Within 24 hours, golf ball size red induration evenly around injection site. Patient complained of itching at site of injection. Mother treating patient at home with Benadryl.
Feeling like bronchial tubes swelled up; Feeling like bronchial tubes closed; Unable to breathe/difficulty breathing; Could not hold head up; Very fatigued; arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of BRONCHIAL OEDEMA (Feeling like bronchial tubes swelled up) and BRONCHIAL OBSTRUCTION (Feeling like bronchial tubes closed) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (first week of Jan2021) in January 2021 and Knee replacement (On physical therapy 3 times a week) on 14-May-2021. Concurrent medical conditions included Shellfish allergy, Grass allergy and Asthma. Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), MONTELUKAST, SALBUTAMOL (ALBUTEROL HFA) and HYDROCODONE for an unknown indication.    On 07-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jun-2021, the patient experienced PAIN IN EXTREMITY (arm was sore). On 08-Jun-2021, the patient experienced BRONCHIAL OEDEMA (Feeling like bronchial tubes swelled up) (seriousness criterion medically significant), BRONCHIAL OBSTRUCTION (Feeling like bronchial tubes closed) (seriousness criterion medically significant), DYSPNOEA (Unable to breathe/difficulty breathing), POSTURE ABNORMAL (Could not hold head up) and FATIGUE (Very fatigued). The patient was treated with SALBUTAMOL (ALBUTEROL HFA) for Breathing difficult, at a dose of ~10 puffs. On 09-Jun-2021, BRONCHIAL OEDEMA (Feeling like bronchial tubes swelled up), DYSPNOEA (Unable to breathe/difficulty breathing), POSTURE ABNORMAL (Could not hold head up) and FATIGUE (Very fatigued) had resolved, BRONCHIAL OBSTRUCTION (Feeling like bronchial tubes closed) outcome was unknown. On 10-Jun-2021, PAIN IN EXTREMITY (arm was sore) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case concerns a 73-year-old male with serious unexpected events of bronchial edema and bronchial obstruction, and nonserious dyspnea, posture abnormal, pain in extremity, and fatigue. Event latency 2 days after first dose mRNA-1273. 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.; Sender's Comments: This case concerns a 73-year-old male with serious unexpected events of bronchial edema and bronchial obstruction, and nonserious dyspnea, posture abnormal, pain in extremity, and fatigue. Event latency 2 days after first dose mRNA-1273. 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.
Sore throat - 1/28/21 woke up  Arm pain - 1/28/21 woke up  Itchy eyes - 1/28/21 evening  and currently  Itchy ears - 1/28/21 evening and currently  Itchy in the arm of vaccine - 1/28/21 evening and currently
I tested and also got a positive; I tested and also got a positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Feb2021 as dose 1, single (Lot number: EL9269), in right arm, on 02Mar2021 as dose 2, single (Lot number: FH8020), in right arm, on 12Oct2021 as dose 3 (booster), single (Lot number: FH8020), in right arm and on 06Apr2022 as dose 4 (booster), single (Lot number: FM0698), in right arm for covid-19 immunisation. The patient's relevant medical history included: "heart arrhythmias" (unspecified if ongoing). Concomitant medication(s) included: SIMVASTATIN, stop date: 17May2022; VENLAFAXINE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I tested and also got a positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Other medication in 2weeks reported as yes. Patient's covid symptoms started on 17May2022. Patient's husband had a positive antigen test that day, so patient tested and also got a positive. Patient started Paxlovid two days later so that patient could stop taking simvastatin two days prior to start of Paxlovid. Patient's covid symptoms were body aches, chills and fatigue, lasting for 5 days. On day 13, patient started symptoms of a head cold and got a positive antigen test. These symptoms lasted 5 days. Patient did a second full quarantine. other medication in 2weeks product reported as simvastatin and venlafaxine. Treatment started on 19May2022 and stop on 24May2022.
This spontaneous report as received from a health department nurse refers to unspecified number of patients of unknown age. On an unknown date the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX (lot no., dose unknown). No concomitant medication was reported. No adverse effects were reported. Product quality complaint was not reported. The outcome events was unknown. This is one of several reports from the same reporter. Additional information has been requested.
Received Td after scalp laceration 3/13/05. Started feeling weak and tired 3/14. Continues to feel this way today with addition of cough and feeling hot, tenderness at injection site. 3/16 doing better, less weak, more cough.
Experienced constant shooting aching pain at the sign of the injection. The next day after 2nd dose. 2-3 days later my left side back and shoulder and arm I experienced burning sensation, which was constant and worsened at night, the pain level would be a 10 out of 10.  From then on any movements for any duration my shoulder and back would worsen. I been seen by my primary doctor (and 2 other general practioners for other opinion). Had 3 ER visits due to pain and ROM, 3 orthopedic specialists, 1 chiropractor, 2 urgent care visits, physical therapy. No definitive answers given for why arm pain, or what the remedy/solution is. This has been an everyday chronic pain scenario from the days after vaccination to present.
630PM SOB, chest congestion & tingling around mouth, tongue numbness lasted about 1hr;took DPH & liquid DPH;
Redness itching of entire left arm, lips, face and also generalized redness and itching. Shortness of breath and wheezing with hoarse voice. Anaphylaxis.
"could not function Saturday"; sore left arm/lingering sore left arm especially if she lifts her arm; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES ("could not function Saturday"), VACCINATION SITE PAIN (sore left arm/lingering sore left arm especially if she lifts her arm), CHILLS (chills) and PYREXIA (fever) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037F21A, "0,2 or Z"1B21A and 036A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Oct-2021, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES ("could not function Saturday"), VACCINATION SITE PAIN (sore left arm/lingering sore left arm especially if she lifts her arm), CHILLS (chills) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. At the time of the report, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES ("could not function Saturday"), VACCINATION SITE PAIN (sore left arm/lingering sore left arm especially if she lifts her arm), CHILLS (chills) and PYREXIA (fever) was resolving.            No concomitant medications were reported.
A non-serious spontaneous report of asthmatic children got H1N1 LAIV was received from registered nurse /health care professional concerning 2 or 3 children of unknown gender. The patients had medical history of asthma. No concomitant medications have been reported for these patients. In 2009, the patients received H1N1, Intranasal. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Rapid raising of heart beat up to 157 beats per minute; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Feb-2021 and was forwarded to Moderna on 22-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Rapid raising of heart beat up to 157 beats per minute) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Atrial fibrillation, Shellfish allergy and Penicillin allergy. Concomitant products included METOPROLOL TARTRATE, LEVOTHYROXINE SODIUM (SYNTHROID), APIXABAN (ELIQUIS), VITAMIN D NOS and MINERALS NOS, VITAMINS NOS (CENTRUM A TO ZINC) for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PALPITATIONS (Rapid raising of heart beat up to 157 beats per minute). At the time of the report, PALPITATIONS (Rapid raising of heart beat up to 157 beats per minute) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This patient experienced rapid raising heart beat 15 minutes after vaccine administration. Her Cardiologist gave her a "heart rate monitor device" and for one week she had the same rapid heart beat only once. Her Cardiologist recommended she get the second vaccine, while her Immunologist did not. Treatment included the patient's on a beta blocker and was able to take that medication.   Most recent FOLLOW-UP information incorporated above includes: On 17-Mar-2021: Follow-up information received on 17-Mar-2021 processed at same time as initial report. Follow-up information included update to patient demographics, medical history, concomitant products used, vaccine information update and medical confirmation.
This spontaneous report as received from a registered nurse refers to a patient of an unknown age and gender. The patient's concurrent conditions, medical history, drug reactions or allergies and concomitant therapies were not provided. On 02-JAN-2019, the patient was vaccinated with an expired dose of PNEUMOVAX 23 (lot # N003993, expiration date 20-OCT-2018, strength and route were not provided) for prophylaxis.
Patient called pharmacy and reported throwing up, cold sweats, bleeding during urination, severe abdominal pain. Symptoms started after she went home.
fever (202.2 F); chills; This case was reported by a consumer via call center representative and described the occurrence of fever in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever and chills. On an unknown date, the outcome of the fever and chills were not recovered/not resolved.   It was unknown if the reporter considered the fever and chills to be related to Shingrix.     Additional Information: GSK Receipt Date: 01-OCT-2022 Reporter's comment: This case was reported by the patient's wife via interactive digital media. Reporter stated that how long can fever and chills last after second shot.
Myalgia, Arthralgia, Diarrhea, chills, fatigue Narrative:  Other Relevant History:
I had a full arm rash and all over itching including some in my throat shortly after taking the vaccine. We knew I was allergic so I had taken medication in advance. Once rash started, two medications were taken- Vistaril and Zyrtec. This seemed to help it go away some though I am still experiencing it. I have alpha gal and I believe that is what made me have a reaction to the vaccine.
Complete loss of smell, loss of taste other than sweet/sour/salty/bitter (no flavor)
Developed swelling and redness over right upper arm (site of DTaP injection days before) in the AM after vaccination.
Patient requested for Moderna covid booster, Intern accidentally gave patient the Pfizer vaccine instead.  Patient reported dizziness after vaccination, but expressed that he usually gets dizzy with the Moderna doses in the past as well.  Patient was monitored on site for 15 minutes and left after feeling well.
Varicella Information has been received from a physician and a school nurse concerning an 7 year old female who on 02-JUL-1998 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Concomitant therapy that day included a dose of measles virus vaccine live (Ender-Edmonston) (+) mumps virus vaccine live (Jeryl-Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). It was also noted that the patient was vaccinated with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl-Lynn) (+) rubella virus vaccine live (Wistar RA 27/#) on 29-JUN-2001. A school nurse reported to the physician that between 24-MAR-2005 and 09-MAY-2005 the child developed a mild case of break through varicella with less than 50 lesion. Unspecified medical attention was sought. The outcome was recovered. A product quality complain was not involved. It was also noted that the patient's sister was vaccinated with varicella virus vaccine live (Oka/Merck) and developed chickenpox (WAES0510USA08944). No additional information is expected.
This is in follow-up to report(s) previously submitted on 3/14/2008. Information has been received from a physician concerning a 14 year old female with asthma, who on 21-NOV-2007 was intramuscularly vaccinated with her first 0.5 mL dose of GARDASIL (Lot # unknown) and on 24-Jan-2008, the patient was intramuscularly vaccinated in her left arm with her second dose of GARDASIL (Lot # 659439/1267U). Concomitant therapy included antimicrobial (BACTRIM, reported as BACTRIN ES). On 21-NOV-2007, after receiving her first dose, the patient experienced abdominal pain, and nausea. This adverse event did not go away and after it was reintroduced on 24-Jan-2008, with the second dose, the AE became noticeably worse. The patient lost 8 pounds since the AE began. The patient sought unspecified medical treatment. The patient's abdominal pain, nausea, and weight loss persisted. Follow up information indicated that the patient had nausea for several months and had recovered on an unspecified date. Additional information is not expected.
A nurse prospectively reported the administration of hepatitis A inactivated and hepatitis B recombinant vaccine to a 26 year old female during her first trimester of pregnancy. On 6/2/04, the patient received a dose of Twinrix (dose number not specified; lot HAB238A6). Following the immunization with Twinrix, on 6/2/04, a pregnancy test for the patient was positive. The dates of her last menstrual period was 4/5/04. The nurse reported that during this pregnancy the patient, never had prenatal care. On 6/1/04, approximately 29 days following the administration of Twinrix, the patient experienced a spontaneous abortion and was seen in an emergency room. On 7/13/04, the patient was seen by a physician and diagnosed with a tapeworm infestation. The outcome of the tapeworm infestation was not reported. Comment: Spontaneous abortion was assessed as medically serious (OMIC).
pt recv vax 11DEC97 & 4JAN98 pt devel a gen rash;f/u was recv which indicated this rxn turned out to be a drug rxn to Bactirm nor r/t varicella;
Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Additional Details: Ice pack administered to child. Advised mother to give motrin as needed for pain. Counseled mom to continue to monitor and seek higher level of care if worsening.