chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; One of our Medical assistants has given an expired booster dose of Moderna Covid-19 vaccine.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (One of our Medical assistants has given an expired booster dose of Moderna Covid-19 vaccine.) and NO ADVERSE EVENT (No adverse event) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 064A22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 15-Aug-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (One of our Medical assistants has given an expired booster dose of Moderna Covid-19 vaccine.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (One of our Medical assistants has given an expired booster dose of Moderna Covid-19 vaccine.) 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 EXPIRED PRODUCT ADMINISTERED (One of our Medical assistants has given an expired booster dose of Moderna Covid-19 vaccine.).    Patient Allergies with medications, food and other products was reported as unknown.  Patient ever had COVID positive test or diagnosis was reported as unknown.  Medical history relating to mentioned AE and both Acute and Chronic illnesses at the time of Vaccination was reported as unknown   Other vaccines given within 1 month prior to Moderna COVID-19 vaccine was reported as unknown.  AE cause patient to seek medical care office visit, Urgent care, ER, hospitalized was reported as unknown.   The patient experienced a similar event in the past was reported as unknown.   The vial did not underwent any temperature excursion.  No concomitant medication were reported.   No treatment drug were reported.
Severe joint pain throughout especially in back down my spine, fever-over 102, chills, then too hot, aches. Gross armpit (L) swelling the size of a large orange. Lymph swelling on the left side of my neck. Sweating, extreme malaise. Very tired, slept nearly two days- a very uneasy sleep. Fever blister on my lip the first in my life. Day three at approximately 2:30pm my fever broke, swelling in the armpit still very tender but could now move my arm. Injection site sore but wnl the entire time. Took 2000mg of TYLENOL q4-6h. Barely unable to leave my bed Saturday. On Sunday a little improvement, difficult night on Sunday. Was sweating with fever most of Monday with painful armpit swelling- unable to do my job to full capacity due to my left arm/hand. I am a DDS.
Nerve demyelination; Muscle weakness; She moves slowly and has to use a cane for balance; She was started on Vitamin D for a deficiency that was discovered; Trouble getting off the toilet; This is a spontaneous report from a contactable consumer (patient). A 60-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6204), via an unspecified route of administration, administered in Arm Right on 16Mar2021 (60-years-old at the time of vaccination) as dose 2, single for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: not reported), via an unspecified route of administration on 24Feb2021 (60-years-old at the time of vaccination) as dose 1, single for covid-19 immunization. On 20Mar2021 patient reported she first noticed she was having trouble getting off the toilet. She was experiencing muscle weakness in her left leg that was leading to foot drop. She moves slowly and had to use a cane for balance. She had seen 2 neurologist who believe this was nerve demyelination, was seeing a doctor since April. She had MRI's done of her brain and spine, also she had blood work done to test for other diseases. She was started on Vitamin D for a deficiency that was discovered. On an unspecified date, the patient underwent lab tests and procedures which included blood work: unknown result, magnetic resonance imaging (MRI) Brain: they cannot figure out what is wrong, magnetic resonance imaging spine: they cannot figure out what is wrong, nerve test: they cannot figure out what is wrong. Therapeutic measures were taken as a result of she was started on vitamin d for a deficiency that was discovered. The clinical outcome of the events was unknown at the time of report.
Pt had DTP/OPV/HIB began crying til 240PM; mom stated pt screamed & face turned red & could not calm down pt x 2 hrs 40mins;
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions and drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with PROQUAD injection, lot # M042500 with expiration date: 17-APR-2018, therapy type: recombinant human albumin (rHA) (dose and route of administration were not reported) reconstituted with properly stored sterile diluent (manufacturer unknown). Temperature excursion ranged from minus 9 to 8 degrees Celsius for 7 hours. There was no previous temperature excursion. Digital data logger was used. Product quality complaint was not involved. No adverse effects were reported.
temperature excursion; beyond the 30 days in the refrigerator on 24JAN2023; No adverse event; Dose administered after 30-day Use By Date on 24-Jan-2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date on 24-Jan-2023), PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion), PRODUCT STORAGE ERROR (beyond the 30 days in the refrigerator on 24JAN2023) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7171B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 24-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date on 24-Jan-2023). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion), PRODUCT STORAGE ERROR (beyond the 30 days in the refrigerator on 24JAN2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date on 24-Jan-2023), PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion), PRODUCT STORAGE ERROR (beyond the 30 days in the refrigerator on 24JAN2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date on 24-Jan-2023), PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion) and PRODUCT STORAGE ERROR (beyond the 30 days in the refrigerator on 24JAN2023).    Case included information of patient 4th out of 4 patients.  No concomitant product reported by reporter.  Pharmacist called to report a temperature excursion. Reporter stated that 4 adult patients received the Bivalent booster of Moderna COVID-19 vaccine beyond the 30 days in the refrigerator on 24-JAN-2023 with lot number AS7171B from intact cartons with vial size of 2.5ml. Vial was initially stored in the refrigerator 23-DEC-2022.  No treatment medication reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-704413 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704413:
Developed a large oval red spot around the injection's site approximately 9 days after the injection was administered and it lasted approximately a week but still have some rough skin now about 1 month after the injection. Temperature was sometimes higher (98.2) than my normal (97.7) - General muscle aches thru the whole body. The areas was slightly swollen, warm, a bit rough and hard around the vaccination puncture. It was very itchy and reminded me of when I have gotten insect bites (mosquitos, fleas, wasps, bees.) I get higher than usual reactions to these types of bites. I put some ice on it and used a hydrocortisone cream and it seemed to help.
New onset thrombocytopenia-hospitalist noted possibly related to Keppra use, however proximity of the vaccine to onset is less  than 3 weeks
High fever (103.5 F), nausea & vomiting; SHINGRIX arm knotted feeling with swelling; couldn't lift SHINGRIX arm for 3 weeks after the shot.
rash & swelling on face treated @ ER w/visteral & steroids on 17MAy96
LUMP IN AREA OF INJECTION ON LEFT ARM, WARM TO TOUCH   RED APPEARANCE , RESOLVED IN 48 HOURS AFTER TAKING DIPHENHYDRAMINE AND ACETAMINOPHEN
Approx 2 hours after receipt of 2nd of a series of 3 Hep B vaccines, employee felt dizziness and sluggish.  Employee rested for approx 1 hour and symptoms are still present. Employee stated that she felt the same way from her 1st Hep B vaccine but did not realize it was a reaction from the vaccine until this event occurred.  On the 2nd day after her 1st Hep B vaccine, employee stated her condition worsened and she felt nausea but did not vomit. On the third day after the first Hep B vaccine, employee made a full recovery.
Swelling of his top lip; Swelling of his bottom lip; Rash on back of neck, arms and legs; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Swelling of his bottom lip), LIP SWELLING (Swelling of his top lip) and RASH (Rash on back of neck, arms and legs) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No medical history information was provided.     On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced RASH (Rash on back of neck, arms and legs). On 15-Mar-2021, the patient experienced LIP SWELLING (Swelling of his bottom lip). On 17-Mar-2021, the patient experienced LIP SWELLING (Swelling of his top lip). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 16-Mar-2021, LIP SWELLING (Swelling of his bottom lip) had resolved. At the time of the report, LIP SWELLING (Swelling of his top lip) and RASH (Rash on back of neck, arms and legs) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided.
Ramsay hunt auricular syndrome/ vertigo/ totoal hearing loss of the left ear/ dizziness/ blisters in her ears/ hearing problems/ facial paralysis; vision problems/ blurred vision; bilateral tinnitus; balance issues; herpes zoster with facial nerve involvement; nausea; Bell's Palsy/ droopiness of her face; Information has been received from a lawyer referring to a female patient of unknown age. Information about concurrent condition, history condition and concomitant medication was not reported. On or around 31-MAR-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered nausea, dizziness, balance issues, droopiness of her face, blisters in her ears, hearing problems and vision problems. She was diagnosed with herpes zoster with facial nerve involvement, vertigo, total hearing loss of the left ear, bilateral tinnitus, facial paralysis, Bell's Palsy, Ramsay Hunt auricular syndrome and blurred vision. These injuries lasted for months and were caused by zoster vaccine live (ZOSTAVAX). As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries (conflict information), as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.   Dizziness/vertigo, blisters in her ears, total hearing loss of the left ear, facial paralysis were considered as the symptoms of Ramsay Hunt auricular syndrome.    The lawyer considered all the events to be disability.  Upon internal review, Ramsay Hunt auricular syndrome and Bell's palsy were determined to be medically significant.
Blood glucose levels are constantly monitored using a CGM system.  At the time of vaccine, BG was 180s.  In the three hours after the vaccine, blood glucose levels plummeted to 44 with a double down arrow (rapid life-threathening drop).  Insulin was suspended, and drastic dietary steps were taken to attempt to manage (juice, sugar snacks) the crash.  Levels stayed well under 100 until almost 9pm that evening.  No other factors had changed that day.
The patient presented to the clinic with his mother for 1st dose of Covid19 vaccine.( 5-11y) The vaccine was administered by MA. The patient was given 12 +monovalent dose instead of (5-11y).  Dr was notified and the mother of the patient was also notified The mother had no concerns and scheduled an appointment in 3-8 weeks for the next 2nd dose. Pt had already left the clinic and was back at school stated his mom. Mom did not have any concerns at the time.
COVID-19 vaccine given to 16 year old. Not approved in his age group yet.
fluzone administered to adult patient after product experienced an excursion at low temperature with no reported adverse events; fluzone administered to adult patient after product experienced an excursion at low temperature with no reported adverse events; Initial information received on 16-Feb-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to case 2023SA057733.  This case involves Adult and unknown gender patient to whom influenza quadrival A-B vaccine [Fluzone QIV] administered after product experienced an excursion at low temperature with no reported adverse events.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient was administered unknown dose of suspect influenza quadrival A-B vaccine, suspension for injection (dose, strength: not reported; lot number: UT7683NA; expiry date: 30-Jun-2023) via unknown route in unknown administration site for immunization after product experienced an excursion at low temperature with no reported adverse events (product storage error)(latency: unknown)  (poor quality product administered) (latency: same day).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the events.  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 the guidelines. 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.; Sender's Comments:  SAD20230220001440:other SAD20230216001803:other
Patient came to pharmacy to get Moderna booster. After her shot she told the certified immunizing technician that she didn't feel good. The patient told me she thought she was having a panic attack. Her neck and forehead were burning up. She thought her blood pressure went up. I gave her 2 cold packs to put on her neck and forehead. I gave her a bottled water and took her blood pressure. Her blood pressure was a little high, but she started to feel better after 10-15 minutes. She said she had a much worse reaction to the 2nd dose of Moderna but she didn't indicate anything on her patient form.
Rash below deltoid where shot was administered. "Feels hot". Normal post vaccine soreness on area of injection. No SOB or other symptoms reported.
1wk post vax pt devel varicella lesions approx 20 w/temp 100-103 cont to break out;
Two weeks after receiving Smallpox vaccination at pre-deployment event (AM 17 April 08), patient developed Erythema Multiforme as diagnosed by Dermatologist.  Erythema developed initially in the early morning of 01 May 08 down his left arm per patient.  Pt reported to clinic at 1600 on 01 May 08 to see provider. Provider examined patient given rx for Hydroxyzine HCL 25 mg 1 tablet three times per day and referred immediately to Dermatology where he was seen at 0800 on 02 May 08 and given dx of Erythema Multiforme. The actual Smallpox vaccination site is progressing as normal. NOT disseminated vaccinia.
PRESENTING PROBLEM: Hypomagnesemia [E83.42] Weakness [R53.1] COVID-19 [U07.1]   HOSPITAL COURSE: 67-year-old female with past medical history of alcohol abuse, chronic hyponatremia, severe protein calorie malnutrition, chronic obstructive pulmonary disease, presented with complaints of generalized weakness, diarrhea, right hip pain and fall.     She tested positive for COVID-19.  Right hip x-ray showed greater trochanteric fracture adjacent to right total hip arthroplasty.  She had multiple electrolyte abnormalities.  She was admitted and started on IV hydration and electrolyte replacement.  The next day, she had a big drop of her hemoglobin initially history of black tarry stools a few days ago.  Patient was seen by GI and an EGD revealed multiple nonbleeding gastric and duodenal ulcers.  Patient started on Protonix twice a day which she needs to continue for at least 4 weeks, then go down to once a day.  Her hemoglobin was monitored continuously.  She did have a drop of her hemoglobin down to 6.5 that required 1 unit of packed RBC blood transfusion.     Her oral intake gradually improved, she did not have any further episodes of diarrhea.  Her electrolytes were replaced as needed.  Orthopedic surgery was consulted who did not recommend any surgical intervention for the type of fracture that she has and they recommended outpatient follow-up.   Concern about adequate oral intake and calorie count completed and was meeting caloric needs. PT/OT consulted and recommended SAR but patient refused. Patient was therefore discharged home in stable condition. She was discharged on Diflucan as esophogeal biopsy was consistent with candida esophagitis.
patient's eyes are red; Patient received fluzone high dose QIV on 25-Sep-2022, then he accidentally received a second dose of fluzone high dose QIVon 28-Sep-2022 instead of Covid-19 vaccine with NO AE; Patient received fluzone high dose QIV on 25-Sep-2022, then he accidentally received a second dose of fluzone high dose QIVon 28-Sep-2022 instead of Covid-19 vaccine with NO AE; Initial information was received on 5-Oct-22 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age male (older) patient's eyes are red and fluzone high dose qiv on 25-sep-2022, then he accidentally received a second dose of fluzone high dose given 28-sep-2022 instead of covid-19 vaccine with no ae.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 25-SEP-2022 the patient received fluzone high dose qiv (INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE) (dose, formulation, strength, lot and expiry date: unknown), then he accidentally received a second dose of fluzone high dose given on 28-Sep-2022 instead of covid-19 vaccine with no ae (extra dose administered and wrong product administered) (latency same day) via unknown route in an unknown administration site for immunization.  On an unknown date the patient developed a non-serious patient patient's eyes are red (ocular hyperaemia) (unknown latency).  It was reported that- wife also states that the patient is feeling under the weather. The patient is going to see a doctor today, 05Oct2022, for his red eyes and feeling under the weather  Action taken: not applicable for both suspects.  Corrective- Unknown   outcome was Unknown for all events   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 the Directive 2001/83/EC 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.
Skin red and inflamed cellulitis placed on KEFLEX x10d 500mg bid.
Patient Described Temperature increase, weakness, fatigue, muscle Pain. Symptoms are improving but Still present.
Information has been received from a medical assistant referring to a 12 month old female. No relevant medical history or con current conditions were reported. On 03-AUG-2015 the patient was vaccinated with improperly stored LIQUID PEDVAXHIB (lot # J013944, expiration date 13-AUG-2016; dose and route not reported), and improperly stored (Oka/Merck) VARIVAX (lot#L001330, expiration date 13-JAN-2017; dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
PARTIAL DOSE WAS ADMINISTERED; VACCINE LITTLE SQUIRTED OUT; This spontaneous report received from a parent concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-APR-2021, the subject experienced partial dose was administered. On 07-APR-2021, the subject experienced vaccine little squirted out. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the partial dose was administered and vaccine little squirted out was not reported. This report was non-serious.
Nose runny after FLUMIST. Started coughing within a few minutes after mist. Fell asleep & woke up with a swollen face & eyes. BENADRYL (25mg) given in office at 1800.