chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 14-Aug-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 18 years old female patient who received a once dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot u58418A via intramuscular route in the left deltoid instead of second dose of MENB not produced by Sanofi Pasteur lot number not reported on 14-Aug-2018 instead of second dose of menb vaccine dose. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was also a case of actual medication error due to wrong vaccine administered. It was unknown if patient had any adverse event after vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Headache; light sensativity; vommitting; severe chills; uncontrollable shaking; Is pregnant Yes / last menstrual date 05Aug2021; Dose Number: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Nov2021 09:00 (Batch/Lot number: unknown) at the age of 33 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Date of last menstrual period: 05Aug2021. The patient was 14 weeks pregnant at the time of exposure to bnt162b2; 12 weeks pregnant to influenza vaccine. The patient was 14 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 12May2022. Concomitant medication(s) included: FLU, administration date 02Nov2021. Vaccination history included: Bnt162b2 (product=COVID 19, brand=Pfizer, brand unknown=False, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, dose administration date: 07Apr2021, Vaccine Administration Time: 04:00 PM, Dose Number: 2, Location of injection: Arm Left), administration date: 07Apr2021, when the patient was 32 years old, for COVID-19 immunisation; Bnt162b2 (product=COVID 19, brand=Pfizer, brand unknown=False, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, dose administration date: 16Mar2021, Vaccine Administration Time: 08:00 PM, Dose Number: 1, Location of injection: Arm Left), administration date: 16Mar2021, when the patient was 32 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 11Nov2021 09:00, outcome "unknown", described as "Dose Number: 3"; HEADACHE (non-serious) with onset 12Nov2021, outcome "recovered" (Nov2021), described as "Headache"; PHOTOPHOBIA (non-serious) with onset 12Nov2021, outcome "recovered" (Nov2021), described as "light sensativity"; VOMITING (non-serious) with onset 12Nov2021, outcome "recovered" (Nov2021), described as "vommitting"; CHILLS (non-serious) with onset 12Nov2021, outcome "recovered" (Nov2021), described as "severe chills"; TREMOR (non-serious) with onset 12Nov2021, outcome "recovered" (Nov2021), described as "uncontrollable shaking"; MATERNAL EXPOSURE DURING PREGNANCY (non-serious) with onset 11Nov2021 09:00, outcome "unknown", described as "Is pregnant Yes / last menstrual date 05Aug2021". Therapeutic measures were not taken as a result of headache, photophobia, vomiting, chills, tremor.  Additional information: The patient received FLU other medications within 2 weeks of vaccination. Facility where the most recent COVID-19 vaccine was administered: Workplace clinic. 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 lot number for bnt162b2 was not provided and will be requested during follow up.
Left arm where injection was given is a very large purple area, since 12-18-07. I have hoarsenes (12-20-07), wheezing (12-18-07), chest tightness (12-20-07). Running noise(12-19-07). I have ashma.
Areflexia in upper and lower extremities, altered mental status, fingers/toes numb.  Guillain-Barre diagnosed by nerve conduction studies. Patient was treated with IVIG.  Patient also received Haldol, Droperidol, Ativan, IV fluids, and potassium replacement.
This spontaneous report was received from an other health professional, refers to a 17 year old male patient. No medical history or concurrent conditions were reported. On 31-JUL-2015, the patient was vaccinated with an unspecified dose GARDASIL 9 lot # K026247 (dose was not provided). Concomitant therapies were not provided. No adverse effects were reported. The reporter refers that product quality complaints were not involved. Additional information has been requested.
Information has been received from a health professional concerning a 12 year old female with no medical history and no allergies, who on 14-APR-1998 was vaccinated with a first dose in the left arm of varicella virus vaccine live (Oka/Merck) (lot #625043/1567E). There was no illness at the time of vaccination. It was reported that the patient's mom called the office over the weekend of 17-DEC_2005 concerning a chickenpox rash. The patient's mother called the office again on 19-DEC-2005 to state the child had a lot of chickenpox over her body. Subsequently the patient recovered. Medical attention was not sought. Additional information is not expected. The patient's sister experienced chickenpox following vaccination with varicella virus vaccine live (Oka/Merck) (WAES0601USA00403)/
No adverse event; They wanted the bivalent booster, but received the 0.5 ml of Moderna vial intended for ages 6-11; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (They wanted the bivalent booster, but received the 0.5 ml of Moderna vial intended for ages 6-11) and NO ADVERSE EVENT (No adverse event) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 064A22A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (They wanted the bivalent booster, but received the 0.5 ml of Moderna vial intended for ages 6-11). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (They wanted the bivalent booster, but received the 0.5 ml of Moderna vial intended for ages 6-11) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (They wanted the bivalent booster, but received the 0.5 ml of Moderna vial intended for ages 6-11).    No concomitant medication were reported.  The pharmacist stated they accidentally gave a group of people the wrong dosage of the Moderna booster. They wanted the bivalent booster, but they gave the one intended for ages 6-11. Reporter stated that they were figuring out what they need to do - revaccinate or wait for a while.  Treatment medication information was not provided.
Moderna COVID-19 Vaccine EUA. I slept for 36 hours. Upon awakening I was unable to walk on my own due to dizziness and disorientation and this caused me to throw up a lot. The migraines increased in frequency and pain. The vaccine greatly aggravated my Meniere's, Tourette's, visual dependency syndrome, vestibular migraines, and sensory integration disorder. I have had to move in to the smallest room in the house. I sleep on the same bed that I sit on all day. When I  am having bad days I have to be put in a wheelchair to be taken to the bathroom that is 5 feet away. I was not doing well before the vaccine but this is vastly worse. I have injured my shoulder and have an appointment with an orthopedist because I have fallen or have tried to keep myself from falling so many times.
Myalgia, Rash, UrticariaPruritus, Diarrhea & NauseaVomiting
This spontaneous report was received from a medical assistant referring to 12 months old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 10-JAN-2018, the patient was vaccinated with VARIVAX (lot # N019128, expiration date 22-JUN-2019) (dose and route of administration were not reported) for prophylaxis. There was no adverse effect reported. It was Confirmed that sterile diluent (lot # M046371, expiration date 05-JUL-2019) used for reconstitution was properly stored. No adverse effects reported. Administered dose of vaccine experienced the temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 56 hours 11 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter.
Migraine continuous since vaccine date. Cramping since 3 days post vaccine Abnormal large amounts of vaginal discharge Cystic acne since 3 days post vaccine Very swollen lymph nodes since 2 days after second vaccine, still swollen today. Very soar throat since 2 days post vaccine
Shoulders, left breast, left pec on back down my arm and tingling in finger. Very bad pain in shoulder and whole arm. Shot given in left arm.
This spontaneous report was received from a healthcare workers referring to a 30 to 40 patients of unknown age and gender. Since an unknown date in September 2015 (the vaccinations occurred within the past 2 weeks) the patients were vaccinated with improperly stored doses of GARDASIL 9 (dose and frequency were not reported, lot # K026246 with expiration date: 28-JAN-2017 and lot # L007560 with expiration date: 15-JUN-2017). No adverse effects reported. This is one of the several reports received from the same reporter. Additional information is not expected. Reporters did not wish to be contacted.
RASH SYSTEMIC, ITCHNESS, REDNESS (FACE AND ALL OVER)
This case was reported by a consumer (also the subject) and described the occurrence of sneezing in a female subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included cat allergy. On either 12 or 13 October 2011 the subject received a dose of FLULAVAL (unknown route, left arm). One hour after vaccination with FLULAVAL, the subject experienced sneezing, itching, throat closing and swelling of eyes. It was noted that the subject had not eaten prior to the vaccination. The subject reported that co-workers had received the vaccine at the same time and no-one else experienced any adverse reactions. The subject was treated with prednisone and ZYRTEC. At the time of reporting the events were improved. The consumer refused to provide contact information for follow-up. No information is available.
10am-Soreness at site  Approx 5pm-Headache, then muscle aches, fatigued, started feeling warm,  then nauseous, stomach cramps.
Symptoms began 36 hours after administration  Heart palpitations  Anxiety Tachycardia  Difficulty breathing  Runny nose  Pins and needles in arms and legs  Heaviness in legs  Difficulty opening mouth / heavy tongue for  5 minutes  2/3 times Body tremors  Weakness  Nausea / vomiting 60 hours after administration
Fatigue; a patient was given GARDASIL 9 vaccine, two injections of GARDASIL 9 were administered on the same day by accident; This spontaneous report was received from a physician, referring to a 18 year old male patient. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported.  On 26-FEB-2021, the patient was vaccinated with two injections of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 ml, intramuscularly, for prevention for human papillomavirus (strength, frequency, lot# and expiration date were not reported) by mistake. On the same date, the patient experienced fatigue symptoms. The patient did not receive any treatment. It was unknown if diagnostic laboratories were performed.  At the time of reporting, the outcome of fatigue was reported as unknown. The causality assessment between fatigue with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was not provided.
developed petechiae on legs, feet, abdomen - first noticed 3 weeks after dose1 - has since had dose2
Sore at injection site. Sore shoulder same side as injection. Sore neck. Fever. Runny nose. Hurts to look down. Sore throat. Extremely difficult to breath.
arm soreness, joint pain, chills, fatigue  x 48 hours  headache start at same time but has gotten worse on day 3 post vaccine and not relieved by acetaminophen
pt recv vax & devel an inj site rxn;no further details known as of the date of this report;this is one of four pt from this site who exp above rxn;
Rash / possible reaction to smallpox vax. Generalized vaccinia vs. hypersensitivity Dx.
pt recv vax & devel a fist-size reddened area @ the inj site;the hlth care professional described the area as hot to touch;It also reported that pt suffered from malaise & fatigue approx 2wk post inj;
Feeling tired and weak; flulike achiness; fever (100.9); stuffed head sensation
pt recv vax; woke up in am w/ digging into hands due to itching & reddened rash;
Patient had been slowly declining over the past year due to dementia and age.  On the date of her second vaccination, Feb. 17, she was getting around with her walker.  On Friday, Feb. 19, she was so weak she was no longer able to walk with her walker, and she declined every day thereafter.  On Monday, Feb. 22 she began crying and saying "help me".  That lasted approximately a week.  her health declined every day until Saturday, March 6, when she passed away at 6:15a.
cannot move her arm and it is very painful; cannot move her arm and it is very painful; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (cannot move her arm and it is very painful) and PAIN IN EXTREMITY (cannot move her arm and it is very painful) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included RIVAROXABAN (XARELTO), LEVOTHYROXINE SODIUM (SYNTHROID) and PARACETAMOL (TYLENOL) for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced MOBILITY DECREASED (cannot move her arm and it is very painful) and PAIN IN EXTREMITY (cannot move her arm and it is very painful). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MOBILITY DECREASED (cannot move her arm and it is very painful) and PAIN IN EXTREMITY (cannot move her arm and it is very painful) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included Ice.   This case was linked to MOD-2021-044200, MOD-2021-044200 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Follow up received contain second dose information
Severe leg pain, from hip all the way down both legs. Severe spasms, getting progressively worse each day. Needs crutches  or cane to walk. Severe muscle and joint pain every day. Given steroid pack with first urgent care visit. Given muscle relaxer with second urgent care visit. First given Trimadol. Side effects with Trimadol included nusea, vomitting, upset stomach, and nightmare. Felt drunk. Couldn't  operate car or walk straight. Changed muscle relaxer.
Within 24h after IM injection of vaccine pt c/o malaise, myalgias, pain at injection site.
Headache, Fatigue, Malaise Body aches, Sore Muscles Narrative:
not gotten second dose yet; This case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in October 2019 ).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient had not gotten the second dose of Shingrix till the time of reporting, which led to incomplete course of vaccination. The reporter was advised as per frequently asked questions and PI (product leaflet) that the patient should just go ahead and get the second dose and did not need to restart the series. The reporter did not consent to follow up.
This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE DECREASED (Close to diabetes diagnosis) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination. The patient's past medical history included Cervical cancer (Surgery on unknown date) and Hepatitis C. Concurrent medical conditions included Myelodysplastic syndrome, Chronic obstructive pulmonary disease and Obstructive sleep apnea syndrome. Concomitant products included OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) for Antacid therapy, BUMETANIDE for Diuretic therapy, METOPROLOL for Heart disorder, POTASSIUM for an unknown indication. On 04-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jun-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Jun-2021, the patient experienced BLOOD GLUCOSE INCREASED (Close to diabetes diagnosis) (seriousness criterion medically significant). At the time of the report, BLOOD GLUCOSE INCREASED (Close to diabetes diagnosis) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Jun-2021, Blood glucose: 133 (High) blood glucose increased. On 24-Jun-2021, Blood urea nitrogen/creatinine ratio: 21 (High) Blood urea nitrogen/creatinine ratio increased. Bun/Creatinine ratio 21. On 24-Jun-2021, Protein total increased: 8.1 (High) Total protein increased. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Products known to have been used by the patient, within two weeks prior to the event, included Unspecified medication for heart. Patient reported that she experienced diabetes diagnosis, metabolic panel showed elevated glucose and before there are no signs of diabetes. She also had bun/creatinine and total protein is high. Treatment information was not provided. Sender's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.
Rash at injection site noted. No pain, itching or redness noted at site.  Rash resolved in 3 days.
she received the first dose towards the end of June, 2019. She did not get the second dose due to COVID starting.; No additional AE's reported.; This spontaneous report was received from a pharmacist and referred to a currently 19-year-old female patient. The patient's concomitant medications, pertinent medical history and drug reactions/allergies were not reported.  Towards the end of June 2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route, lot# and expiration date were not reported) for prophylaxis. She did not get the second dose due to coronavirus disease (COVID) starting (inappropriate schedule of product administration). The patient was wanting her hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) in the pharmacy.The pharmacist would like to know if the series should be restarted or if they could continue with the second dose and count the first? No additional adverse events were reported (no adverse event). No other information known.
J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 5/2/2023 HYPERTENSIVE HEART AND CKD, STAGE 5 (GFR < 15), W HEART FAILURE J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 5/2/2023 LOWER GI HEMORRHAGE
Swollen red arm -given shot in,  fever up to 102, body aches and pains, bad headache, weak/fatigued. This was my second shot. I had same side affects after first shot. Second shot side effects were a little less.
Patient received PREVNAR 13 on 11/11/2017, to which he had an initial reaction of swelling and a large protuberance developing where the vaccine was administered. The patient stated that he did not experience itching or redness until several days after the initial reaction. He stated that he treated the itchiness and redness with over-the-counter hydrocortisone, which seemed to help. On the day the pharmacy was notified (11/17/2017), the patient stated that his arm was beginning to bruise at the injection site and the reaction area seemed to be getting larger. He also stated that he had contacted his primary care physician, Dr. to alert him of the reaction prior to calling the pharmacy.
This spontaneous report was received from a Registered nurse regarding a 12 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 26-JUN-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis. No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1804USA005153.