chrisvoncsefalvay/vaers-outcomes huggingface dataset:
injection site seemed irritated and tender; headaches; injection site seemed irritated and tender; at and around the injection site it has swollen up to the size of a marble; the area is hard; experienced sleeplessness; does suffer with slight boughts of insomnia; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (experienced sleeplessness; does suffer with slight boughts of insomnia), VACCINATION SITE IRRITATION (injection site seemed irritated and tender), VACCINATION SITE INDURATION (the area is hard), HEADACHE (headaches) and VACCINATION SITE PAIN (injection site seemed irritated and tender) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INSOMNIA (experienced sleeplessness; does suffer with slight boughts of insomnia). On 13-Apr-2021, the patient experienced VACCINATION SITE INDURATION (the area is hard) and VACCINATION SITE SWELLING (at and around the injection site it has swollen up to the size of a marble). On an unknown date, the patient experienced VACCINATION SITE IRRITATION (injection site seemed irritated and tender), HEADACHE (headaches) and VACCINATION SITE PAIN (injection site seemed irritated and tender). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Headache, at a dose of 1 dosage form once a day. At the time of the report, INSOMNIA (experienced sleeplessness; does suffer with slight boughts of insomnia), VACCINATION SITE IRRITATION (injection site seemed irritated and tender), VACCINATION SITE INDURATION (the area is hard), HEADACHE (headaches), VACCINATION SITE PAIN (injection site seemed irritated and tender) and VACCINATION SITE SWELLING (at and around the injection site it has swollen up to the size of a marble) outcome was unknown.            Concomitant medication was not provided by the reporter.    Reporter did not allow further contact
Pt states that after getting her third rabies injection the next day she arm became sore and within a couple of days she had severe pain when moving her arm. Now, 6 weeks past the incident, she cannot lift her arm up to shoulder height and cannot move her left arm without pain.
Erythema multiform developed 3 days following a Hep B 1 injection.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. On 23-JUL-2015 the patient was vaccinated with a dose of VARIVAX (Merck) (lot # K015969, expiration date 23-SEP-2016, dose and frequency were not reported), which was improperly stored. No adverse symptoms were reported. This is one of several cases received from the same source. Additional information has been requested.
flu-like feeling; Redness; Plague pileup; Itchiness; This spontaneous case was reported by a health care professional and describes the occurrence of PLAGUE (Plague pileup) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included CERTOLIZUMAB PEGOL (CIMZIA), GLIPIZIDE, VITAMIN D3, FISH OIL and FLAXSEED for an unknown indication.   On 09-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) (unknown route) 1. On 19-Mar-2021, the patient experienced ERYTHEMA (Redness), PLAGUE (Plague pileup) (seriousness criterion medically significant) and PRURITUS (Itchiness). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu-like feeling). At the time of the report, INFLUENZA LIKE ILLNESS (flu-like feeling), ERYTHEMA (Redness), PLAGUE (Plague pileup) and PRURITUS (Itchiness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No treatment medications were provided Action taken with mRNA-1273 Is not applicable Concomitant medication includes Cocoa butter   This case was linked to MOD-2021-100453 (Patient Link).
pt recv vax 19MAY97 & presented to office today w/painful, swollen, red, warm to touch, area of rt deltoid & upper arm;bullseye bruise surrounds inj site;circumference swollen area about 2in more than corresponding area lt arm;afeb;itching;
Patient brought back in office by guardian 2/2/09 with a c/o (R) BELLS Palsy noted after one day vaccines for 5 y.o. given KINRIX, MMR, Varicella, Influenza vacc.
Received 2nd booster about a month ago, Got COVID again about a month after and it was their worst case of COVID; Received 2nd booster about a month ago, Got COVID again about a month after and it was their worst case of COVID; Still ill/They were sicker; Still having mild congestion issues; 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), in 2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown (booster), single (Batch/Lot number: unknown) and as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Received 2nd booster about a month ago, Got COVID again about a month after and it was their worst case of COVID"; NASAL CONGESTION (non-serious) with onset 2022, outcome "not recovered", described as "Still having mild congestion issues"; ILLNESS (non-serious) with onset 2022, outcome "not recovered", described as "Still ill/They were sicker".  Clinical course: Patient learned of another AE yesterday evening. They think this may already have been reported, but until they can confirm I wanted to send along. Patient received 1st booster about 6 months ago, one month later (around Dec) they got COVID. Same patient received 2nd booster about a month ago, Got COVID again about a month after and it was their worst case of COVID. They were sicker then they were the first time, hit harder then before. They are still ill, still having mild congestion issues.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Screaming for over 3 hours with high pitched uncontrollable screaming, fever over 102.
This spontaneous prospective pregnancy report as received from a medical assistant refers to a 26 year old female patient. The patient's concurrent conditions included mild cervical dysplasia and concomitant therapy included unspecified prenatal vitamins. The patient did not have any known drug reactions or allergies. On 20-SEP-2016, the patient was vaccinated with GARDASIL 9 injection intramuscularly in the left arm, once, lot # M013636, expiration date 15-FEB-2018 for abnormal Papanicolaou (PAP) smears. The patient became pregnant with Last Menstrual Period (LMP) of 05-OCT-2016 and Estimated Date of Delivery (EDD) of 12-JUL-2017. The pregnancy outcome was pending. Lab diagnostic studies performed on unknown dates included: biopsy, urine test, which revealed positive result and PAP smear test (abnormal result, positive for human papillomavirus (HPV). No treatment was given for the adverse events. The patient did not seek medical attention. No product quality complaint was involved. Additional information has been requested.
Information has been received from a medical assistant concerning a 17 year old female with PENICILLIN allergy, who tends to pass out with needles and whose father had epilepsy (had a brain injury 20-25 years ago de to an accident) who on 03-FEB-2010 was vaccinated intramuscularly with third 0.5mL dose of GARDASIL (lot number 0670Y). There was no concomitant medication. The medical assistant reported that one and a half minutes later, the patient said she was going to pass out and then the patient passed out. The patient's eyes rolled back, she shook which lasted 15 seconds. The mother's words were "she's having a seizure" and she was holding down the patient. The patient was watched at the office for 30 minutes after this occurrence and she was fine. It was noted that the patient received the first and second doses of GARDADIL at another provider's office. The second dose of GARDASIL (dose, route and lot number not reported) was given on year ago (in February 2009). The patient did not report any problems with the first and second doses of GARDASIL. It was noted that the patient's mother was going to have her daughter follow up with a neurologist. No lab studies were performed. The patient sought unspecified medical attention. On 03-FEB-2010 the patient recovered. Follow up information was received from the office receptionist. It was reported that the patient received did not received other vaccinations at the time of the third GARDASIL vaccine on 03-FEB-2010. Upon internal review, she's having a seizure was determined to be an other important medical event. No further information is available.
Headache, Myalgia, chills, loss appetite Narrative:  Other Relevant History:
Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 36-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L202A and 205J202A) for COVID-19 vaccination.     The patient's past medical history included Asthma, Leiomyosarcoma (cancer) and Infertility. Concurrent medical conditions included Pregnancy since 11-Feb-2021 and Kidney absent (since birth). Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for Vitamin supplementation, ESTROGEN NOS and VITAMIN D NOS (VITAMIN D NOS 3000 iu) for an unknown indication, PROGESTERONE.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 10-Jan-2021 and the estimated date of delivery was 20-Oct-2021. On 25-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  second week of the pregnancy. The delivery occurred on an unknown date. For neonate 1, Estimated date of conception-02-02-2021. At the time of the report, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Feb-2021, Pregnancy test positive: positive positive positive.         no treatment given  no concomitant provide
Missed the 2nd shot (7 months post 1st shot); Had side effects after first shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Had side effects after first shot) and PRODUCT DOSE OMISSION ISSUE (Missed the 2nd shot (7 months post 1st shot)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced VACCINATION COMPLICATION (Had side effects after first shot). On 10-Sep-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed the 2nd shot (7 months post 1st shot)). On 10-Sep-2021, PRODUCT DOSE OMISSION ISSUE (Missed the 2nd shot (7 months post 1st shot)) had resolved. At the time of the report, VACCINATION COMPLICATION (Had side effects after first shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided. No treatment information mentioned.  Patient called in to report that she missed the second dose and it has been 7 months since. Mentioned having some side effects to first dose and says she reported it so did not provide details now.   Reporter did not allow further contact
Follow up information from the attending physician provided the patient's date of birth, dates of Prevnar immunization, event onset date and date of death. Information regarding Prevnar was received from a physician regarding a 13 month old female patient who received the third dose at 6 months of age, and died of invasive S. pneumo on 5/2/04. The patient's concurrent illness included a viral upper respiratory tract infection with a past history of jaundice (at 4 days old) and upper respiratory tract infection (at 1 year and 3 weeks of age). Family history included antitrypsin deficiency. Indication for Prevnar was immunization. Product was administered on 9/8/03. Dose regimen was 1 dose 1 time per day. Patient was not taking concomitant therapy. On 4/27/04, the patient presented with a fever of 102-104 degrees F, cough with post-tussive vomiting, and sinus drainage. A white blood cell count was 13K. The child was diagnosed with a viral upper respiratory tract infection. No antibiotics were received. On 5/2/04, the child was found dead by the parents. A culture of brain tissue revealed Streptococcus pneumoniae serotype 19-F. A pneumococcal antibody test revealed: Streptococcus pneumoniae antibody titers are similar to those found in similarly aged children who have not received a full series for age of pneumo. conjugate vaccine. Titers are lower than expected for a fully immunized child. The reported cause of death was Streptococcus pneumoniae meningitis. The child had received Prevnar vaccine at 2, 4, and 6 months of age. The fourth dose was not given.  Nurse follow up on 09/07/04 states: "Complete."  Follow up on 09/10/04 states: "The cause of the death of pt, was an infection around the brain with Streptococcus pneumoniae, a bacteria commonly found in the nose and air passages and a frequent cause of meningitis in this age group. There is no evidence of significant trauma.  Toxicology showed nothing abnormal."
12/11/2022, I was feeling tired and dizzy earlier in the morning. At the time of the event around 11:30AM to noon, I actually went into cardiac arrest. My wife called EMS, and they arrived in a couple of minutes, and they were able to revive and take me to the hospital. I went to emergency room. I was found to be having ventricular tachycardia. I was admitted to hospital and had an angiogram after that. They found the stint from the prior June 2022 had occluded, but they did not think that was the source of the tachycardia. They implanted an ICD to prevent another cardiac arrest. That was done on 12/15/2022. I still had issues with the tachycardia, my cardiologist referred me to an electro cardiologist to find out the cause. 02/08/2023 in the morning, I saw the electro cardiologist. The device tried to pace my heart rhythm unsuccessful. After it could not convert it to normal pacing signals, then it shocked me to convert me back to normal rhythm.  So that was a defibrillation event. I have had follow-up care with the electro cardiologist where they have performed EKGs and so far, the results have been good. At the end of the day, I don't feel majorly disabled because of the care I received.
Patient treated on 1/13/07 at Urgent Care Center for complaining of erythema, edema extending from left outer upper thigh down 2 inches above left knee and to left inner thigh excluding posterior thigh.  Was treated with 2 days of antibiotic. Rash resolved within 3 days. On the fourth day parents noted bruising where the rash had been. Bruising has since resolved.
A physician reported that an 18 month old female received Prevnar, IPV and Infanrix vaccines on 9/8/00. On 9/9/00, she developed a "golf ball-sized" area of swelling at the site of the Prevnar injection. She was seen by the physician, who prescribed cold compresses and acetaminophen. She recovered.
Right arm pain - associated with raising arm above head. MRI indicated torn tendons and bone spur.
C/O "Lame" shoulder (10-10 for 4 days) then muscle (for 5 days) then 6-8" black and blue mark where flu shot was given; was noted on the 15th of October. As of 10-30-07 arm still sore but much better.
left lymph node is very sore, swollen. Left side is where I got my vaccination.
02/20/18 and 2:13P spk w/pt she states shortly after inj. she felt like her arm was had like a rock, very painful, and itchy. The next day down to her elbow was painful, bruised, and some redness. That night she got flu like symptoms, fever, chills, felt like muscle damage. She didn't go to hospital or an urgent care to be evaluated. Now 7 days post inj. she is better, bruising is turning yellow, mild soreness. I offered her an appointment however she refused. I did inform pt she might not want to get another PCV 23 vaccine, and that we would be sending a report to VAERS. Pt states she understands and didn't have any further questions. Under signature: Signed by Medical Assistant on 2/20/2018 2:37:11 PM.
pt initially described having a sick feeling day p/vax; next day woke w/sore, red arm in area of inject; following day arm was red, swollen, sore, throbbing from shoulder to wrist; pt seen by MD;
Bilateral pulsatile tinnitus began at some point the day following Shingles vaccine. 5 days later went to urgent care and put on 9 day 40mg prednisone tapering course. 10 days after vaccine went to ER due to persistance of symptoms and regular headches. CTA and performed and normal. 40mg prednisone 16 day tapering course. A total of 70mg taken that day (20 in am, 50 at 11pm). Tinnitus volume reduced by 50% by the next morning. 20 days after vaccine, had 2 days of very quiet tinnitus, which then increased and varied daily. Pulsating became dominant in left ear, but at times sounds central and rarely stronger in the right ear. After completing 2nd course of prednisone, volume is still lower than before treatment
I received 5 doses of the Anthrax vaccine in 1998/1999. I began feeling chronic fatigue and arthralgia/myalgia in 2000 and it has gotten increasingly worse. Information I have read on the internet indicates these symptoms could be a result of the vaccine. Is there a resource for people like me who may be having problems associated with mandatory anthrax vaccination from military service?
This case was reported by a consumer via sales rep and described the occurrence of cellulitis in a female patient who received SHINGRIX for prophylaxis. In October 2018, the patient received the 1st dose of SHINGRIX. In October 2018, less than a week after receiving SHINGRIX, the patient experienced cellulitis (serious criteria GSK medically significant), localized erythema, local swelling, feeling unwell and influenza like illness. The patient was treated with antibiotics nos (Antibiotics (Brand Names Not Known)). On an unknown date, the outcome of the cellulitis, localized erythema, local swelling, feeling unwell and influenza like illness were recovering/resolving. It was unknown if the reporter considered the cellulitis, localized erythema, local swelling, feeling unwell and influenza like illness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not provided. The patient's age was greater than 50 years at the time of reporting. The patient received SHINGRIX within last week of the date of reporting. The patient experienced local redness and swelling and feeling unwell (flu-like per reporter). The patient received antibiotic medication (unknown) and started feeling better within a couple days. The reporter described it as a possible cellulitis infection. The patient felt better and she was recovering per the reporter.
Started with one spot on chin then 2-3 spots appeared. Spots now scabbed over. No TX.
Non-verbal/speech regression, no eye contact, hand flapping, lack of communicating needs, doesn't play with other children likes to be alone, lack of sleep during the night, anxiety self-harm.
COVID-19; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (COVID-19) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 27-Apr-2022 to 02-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-May-2022, SARS-CoV-2 test: positive (Positive) positive antigen test. On an unknown date, SARS-CoV-2 test: negative (Negative) Tested negative after Paxlovid tx. Started mild symptoms at day 14 on 11-May-2022.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  It was reported that on unknown date patient experienced COVID with symptoms SOB, congestion, coughing, fatigue after receiving dose 3 of moderna vaccine.  The device date was reported as 15-May-2022.  Pfizer have permission to contact about this report but does not have permission to contact the patient's healthcare provider.  Company comment:This spontaneous case concerns a 30 year old female patient with no relevant medical history, who experienced the unexpected non serious AESI of COVID-19, unspecified days after receiving the third dose of mRNA-1273 vaccine in the COVID-19 vaccination series. Patient developed shortness of breath, congestion, cough and fatigue. She was treated with Paxlovid and tested negative for COVID-19. Then she started having mild symptoms and subsequently tested positive for COVID-19 antigen test. The event was resolving. No information on the details pertaining to primary doses was available in the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 30 year old female patient with no relevant medical history, who experienced the unexpected non serious AESI of COVID-19, unspecified days after receiving the third dose of mRNA-1273 vaccine in the COVID-19 vaccination series. Patient developed shortness of breath, congestion, cough and fatigue. She was treated with Paxlovid and tested negative for COVID-19. Then she started having mild symptoms and subsequently tested positive for COVID-19 antigen test. The event was resolving. No information on the details pertaining to primary doses was available in the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.
2AM 2APR92 shooting pain in spine & arm & elbow, unable to use arm; 1230PM 2APR92 started w/t101; that evening 930PM went to hosp ER; unable to use arm; MD stated was allergic to diptheria component-put arm in sling;