chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pediatric dose was given to adults mistakenly; Moderna COVID-19 vaccine administered to patients post temperature excursion; Poor quality vaccine administered; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) 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 assessments were provided for WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered).    Concomitant product use was not provided by the reporter.  It was reported there was a temperature excursion between 26 May 2022 to 30 Sep 2022 and lot AR5186C was affected between 08 Sep 2022 to 27 Sep 2022. AR5186C was previously reported. Pediatric dose was given to adults mistakenly and were reported to CDPH, VAERS, CAIR and each patient that received the error dose, with instructions to re-vaccinate 2 months from the initial error dose. 051B22A was kept in the freezer upon receipt of shipment on 01-Aug-2022 and individual vials were put in the refrigerator on the day of use.  No treatment information was provided.  This case contains information for the 74th of 104 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-669791 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-669791:Master case
Ongoing hospitalization began 8/3/21 with bilateral interstitial infiltrates, mild hypoxia, temperature 101.2, fever, weak, short of breath, increased fatigue, cough. Treatment: dexathasone 6 mg IV daily, supplemental oxygen. Treating empirically for superimposed pneumonia with Zosyn. Treatment began 8/3/2021.
Severe arthritic flare in left hand.  Moderate flu-like symptoms.  Improved (but not completely recovered) two days later.
headache, productive cough yellow in color, chills, sweats, shortness of breath not new, body aches, sinus congestion, nasal congestion, sneezing.  starting 1/3/2022
Antibody test result came back negative; This spontaneous case was reported by a consumer and describes the occurrence of ANTIBODY TEST NEGATIVE (Antibody test result came back negative) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 021B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ANTIBODY TEST NEGATIVE (Antibody test result came back negative). At the time of the report, ANTIBODY TEST NEGATIVE (Antibody test result came back negative) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jun-2021, Antibody test: Negative. On 10-Jun-2021, Antibody test: Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Noticeable Symptoms immediately after the 2nd shot - chills and sweating.  Months after the 2nd shot: Metallic taste - unable to eat, food tasted nasty Left shoulder and arm constant pain, especially when I lay down (Like constant cramping) Left hand fingers - numbness and tingling Left leg weakness Left hand weakness - hard to grip anything Demyelization to Pons and Superior Cerebellar region - ruled out MS and stroke, double vision cleared up after a month  Dr.  ( Ophthalmologist) prescribed Prednisone 20mg tab once a day  and Pyridostigmine BR 60mg tab 3 times a day - suspected Myasthnia gravis or other autoimmune disorder
found dead in apartment, no suspicious circumstances. Autopsy results: lymphoma; no known cause of death.
This case was reported in a literature article and described the occurrence of anaphylaxis in a 5-year-old male subject who received Flu seasonal TIV Dresden. This case refers to patient 12 in the literature article. Concurrent medical conditions included asthma and allergy to nuts (cashew and pistachio). On an unknown date, 3 hrs after receiving Flu seasonal TIV Dresden, the subject developed anaphylaxis. Serious criteria included GSK medically significant and life threatening. Additional event(s) included generalized urticaria, pruritus, rash and shortness of breath. The subject was treated with antihistamine and Steroid (Unspecified). The outcome of anaphylaxis was recovered/resolved. The outcome(s) of the additional event(s) included generalized urticaria (recovered/resolved), pruritus (recovered/resolved), rash (recovered/resolved) and shortness of breath (recovered/resolved). The investigator considered that there was a reasonable possibility that the anaphylaxis, generalized urticaria, pruritus, rash and shortness of breath may have been caused by Flu seasonal TIV Dresden. Additional information was provided: This case was reported in a literature article and it described the occurrence of a vaccine-triggered anaphylaxis in a 5-year-old male patient who had received an unspecified trivalent influenza vaccine (manufacturer unknown). The patient was a male. The subject's medical history included atopic disease with asthma, cashew and pistachio nuts allergies. No further information on the patient's concurrent medical conditions, medical or family history, or concomitant medication was provided. On an unspecified date, between the 1st of January of 2009 and the 31st of December of 2011, the patient received an unspecified dose of an unspecified trivalent influenza vaccine (dosage unknown; administration route and site unspecified; batch number not provided). On an unspecified date, 3 hours after the vaccination, the patient developed generalized urticaria, pruritus, rash and shortness of breath. This was classified as anaphylaxis by the emergency department doctor. According to the authors the case was considered as Brighton level 2 and setting of initial evaluation was emergency department. The patient was treated by oral antihistamine and oral steroids. At the time of reporting the outcome of the events was recovered. This event was classified as vaccine related according to the authors. The authors concluded that "Anaphylaxis after vaccination is rare in all age groups. Despite its rarity, anaphylaxis is a potentially life-threatening medical emergency that vaccine providers need to be prepared to treat. This is 1 of the 28 valid cases reported in the same literature article.
Skin allergic reactions: wheal and flare reaction in random areas of the body  7 hours after vaccine. Delayed skin allergic reaction: wheal and flare reaction in (other) random areas of the body 72hrs after vaccine
Information has been received from a nurse practitioner concerning a 12 week old male with a history of cradle cap, circumcision, constipation and candidiasis who on 17-JUN-2008, 18-AUG-2008 and 20-OCT-2008 was vaccinated with the first second and third doses of ROTATEQ.  Suspect therapy included PEDVAX HIB (17-JUN-2008 and 18-AUG-2008) only first two doses given.  It was reported that on 20-OCT-2008 PEDVAX HIB was not given due to vaccine PEDIATRIX.  On 29-JUL-2008 the patient experienced viral pharyngitis.  On approximately 18-AUG-2008 during a well baby visit it was noted that the ear, nose and throat exam were normal and the entire physical exam was "unremarkable."  On 18-SEP-2008 the patient was treated for cold symptoms of nose congestion, cough, runny nose, a fever of 99.1F and one episode of diarrhea.  On 20-OCT-2008 the patient presented for a well exam.  Examination revealed a small cartilege protrusion on the inside of his left ear, otherwise the exam was unremarkable.  No further information is available.
Altered Mental Status      per family he has been acting altered the past couple days.      HPI Patient is an 89-year-old male with a past medical history of COPD, CKD, CHF, CAD, dementia, diabetes, hypertension and cardiomyopathy who presents for altered mental status. Family reports that the patient has been having a lot of blood in his urine and over the past couple days his mental status has been progressively decreasing. Over the past 1-2 hours his mental status has decreased even further. He is typically alert and can tell you his name, date of birth and location. History is limited at this time due to patient's history of dementia and current altered mental status, however he is complaining any pain, fevers, nausea at this time.
Severe raised rash all over body. Head to toe.  Follow up: Resolved over several months; child still has some raised areas on skin.  Prescribed: Homeopathic Rx Thuja H P 200C.
This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On 19-AUG-2017, the patient was vaccinated with a dose of improperly stored ZOSTAVAX (dose, frequency, route and indication not reported, lot # M037015 with expiration date 22-NOV-2017) reconstituted with properly stored sterile diluent (manufacturer unknown) (lot # M035268 with expiration date 19-APR-2019). Temperature that the vaccine exposed to was 40.2 F, the time frame was unknown. There was a previous temperature excursion of 15 F to 46 F for 18 hours and 34 minutes. No adverse effects were reported. This is one of three reports received from the same reporter. Sender's Comments: US-009507513-1709USA007622: US-009507513-1709USA007623.
Pain in right knee X 1 month and pain in left knee X 6 1/2 months.
incorrect product storage; No additional AE event reported; This spontaneous report was received from a registered nurse and refers to a currently 4-year-old male patient. Information about medical history, concurrent conditions and concomitant therapies was not provided.  On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot number: U002539 with an expiration date: 24-JUL-2022 (exact dose, route and frequency were not reported) for prophylaxis. The vaccine had undergone temperature excursion at 13.8 Degrees Fahrenheit for 1 hour and 48 minutes (product storage error). No previous temperature excursion. No additional adverse event (AE) reported.  This is one of 5 reports from the same reporter.; Sender's Comments:  US-009507513-2110USA001533: US-009507513-2110USA001521: US-009507513-2110USA001341: US-009507513-2110USA001589:
This spontaneous report was received from a certified medical assistant regarding an unspecified number of patients of unknown demographics. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On an unknown date the patient were vaccinated with improperly stored GARDASIL 9, lot # L048237, expiration date 08-MAY-2017 and lot # L018351, expiration date 11-AUG-2017 (incorrect product storage). No adverse event was reported. It was exposed to temperature of -2 C (degree Celsius) for 410 hours. Previously it was not exposed to temperature excursion. The call was because of a data logger. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
pink disscolouration; swelling below cheek bones; missed second dose; Chills; felt tired; headache; gland swelling; pain in lower part of arm; Hard Knot; cellulitis; This spontaneous case was reported by a consumer and describes the occurrence of CELLULITIS (cellulitis) in an 84-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 Cardiac disorder (heart condition) since an unknown date, Asthma since an unknown date, Drooling (excessive saliva while sleeping) since an unknown date, allergy (allergies-scheduled to have scope to check vocal chords.) since an unknown date, Dysautonomia since an unknown date and Sleep apnea (uses a CPAP machine for sleep apnea,) since an unknown date. Concurrent medical conditions included Throat discomfort. Concomitant products included ERYTHROMYCIN STEARATE (ERITHRIN [ERYTHROMYCIN STEARATE]) for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced CELLULITIS (cellulitis) (seriousness criterion medically significant). On 25-Mar-2021, the patient experienced VACCINATION SITE MASS (Hard Knot). On an unknown date, the patient experienced LYMPHADENOPATHY (gland swelling), PAIN IN EXTREMITY (pain in lower part of arm), ERYTHEMA (pink disscolouration), SWELLING (swelling below cheek bones), PRODUCT DOSE OMISSION ISSUE (missed second dose), CHILLS (Chills), FATIGUE (felt tired) and HEADACHE (headache). At the time of the report, CELLULITIS (cellulitis), LYMPHADENOPATHY (gland swelling) and PAIN IN EXTREMITY (pain in lower part of arm) had not resolved, VACCINATION SITE MASS (Hard Knot) outcome was unknown and ERYTHEMA (pink disscolouration), SWELLING (swelling below cheek bones), PRODUCT DOSE OMISSION ISSUE (missed second dose), CHILLS (Chills), FATIGUE (felt tired) and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patients treatment medication included high-power antibiotics, cephalexin (Keflex )for 6 days. Self treated swollen lymph nodes with heat. Based on the 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.   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: added the event (missed dose) and treatment medication; Sender's Comments: Based on the 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.
Information has been received from a pharmacist concerning an 87 year old female patient who was vaccinated with a dose of PNEUMOVAX 23 (lot# 664871/1142Y) at the end of September 2009. On an unspecified date, the patient experienced arm "muscle" pain at the injection site. The dose of PNEUMOVAX 23 was administered at an unspecified clinic in another state from this pharmacy. There were no lab diagnostics studies performed. At the time of the report, the patient had not recovered. No further information is available.
Day 1 knee soreness that continued.  Day 3 knee soreness and locking up stiffness continues for 2 plus weeks Day 5 hives developed on forearms and knees day 6 swollen and numb upper lip
Starting a few hours after receiving the vaccine, I felt fatigued and wanted to sit down more often. It felt just like when I had COVID. I tried to go to the doctor 5 days later and they thought it was an issue with the injection site; however, she misunderstood me. I continued to feel lousy and had a terrible headache along the hairline in the back of my head. The left half of my left eye felt sandy and hurt to open. So, I thought the only way for me to get a referral to an ophthalmologist was to go to the urgent care. At the urgent care on 05/02/2022, they didn't have all the testing to check my eyes but noticed I had lost some of my peripheral vision in the left eye. So, they told me to go straight to the ER to have an MRI to rule out a stroke. I ended up going to the ER and got an MRI and it was confirmed I had a stroke. I was in the hospital for 3 days and had lots of tests. I'm seeing a neurologist and a cardiologist next week, and an ophthalmologist soon. I still don't have much energy and I've always had lots of energy and I'm normally a very healthy person.
This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 15-MAR-2017, the patient was vaccinated with an improperly stored dose of M-M-R II injection, subcutaneously, lot # reported as M006104, expiration date 01-AUG-2017 (dose was not reported), which was reconstituted with properly stored diluent. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for 2 hours. Data logger was not involved. There were no previous excursions reported. Additional information has been requested.
Patient sitting in observation are a and alerted staff she was  feeling lightheaded.  Vital signs taken:  B/P 126/86  P 74 RR 18 O2 98%  Patient given a bottle of water.   Offered to recline patient but she stated she was okay sitting.   Monitored patient for additional 15 minutes.   Patient stated she was feeling better.   Patient declined offer to repeat vital signs prior to departure.
pt exp an inject site react 3" x 3" induration, redness & swelling; unable to move arm; also exp vomiting, h/a, upset stomach & flu-like sx; pt is afebrile; pt recovered;
soft lump; a little sore; swollen lymph node; This spontaneous case was reported by a consumer and describes the occurrence of MASS (soft lump), LYMPH NODE PAIN (a little sore) and LYMPHADENOPATHY (swollen lymph node) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced MASS (soft lump), LYMPH NODE PAIN (a little sore) and LYMPHADENOPATHY (swollen lymph node). At the time of the report, MASS (soft lump), LYMPH NODE PAIN (a little sore) and LYMPHADENOPATHY (swollen lymph node) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No corrective treatment was provided.   This case was linked to -MODERNATX, INC.-MOD-2021-074960, -MODERNATX, INC.-MOD-2021-074909, US-MODERNATX, INC.-MOD-2021-074886 (Patient Link).
Injury to shoulder. Inflammation of rotator and labrum. Decreased ROM and pain until present.
Shortness of breath,  chest pain, belching, nausea, and very tired.
Arm Sore two weeks after shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm Sore two weeks after shot) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm Sore two weeks after shot). At the time of the report, PAIN IN EXTREMITY (Arm Sore two weeks after shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment details were provided.
Body twitching. Laid down on recliner. Felt better after liying on the recliner.
I had shaking, nausea, weak muscles, chills,  and rapid irregular heartbeats.  The irregular heartbeats continued for 3 months and just now finally went away.  The weak muscles lasted 3 weeks.
CG started having a headache, clammy and chest pain. Pain 6/10  BP 119/78, HR 82, O2 100%,. CG refused to lay down, juice offered. 1348 BP 126/76, HR 89, O2 98%, chest pain reduced to 4.5/10 and had no change when ambulating. Due to consistent chest pain, CG was transported via wheelchair to the ER for evaluation.
I do not see the lot number recorded. Patient has strong family history of CAD, history of impaired glucose tolerance and hypercholesterolemia, who presented to our hospital with acute stroke in left cerebellar artery territory.  Unclear if this is related. Patient currently hospitalized.
Got shot at 3 pm on 11/24/2021.  Had sore throat, stiff neck, headache and sore areas of scalp by 8 am next morning.  Travelled for work on 11/29/2021 and saw  Urgent Care in another city.  Prescriped Lidocane for the sore throat.  Returned home on 12/1 still not feeling well.  Developed clear sores on scalp on 12/2.  Developed shooting headaches and diarrhea on morning of 12/4.  Diagnosed with Shingles at 4:00 pm on 12/4.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date in 2014 (reported as since 08-AUG-2014), the patients were vaccinated with VARIVAX (Merck) which was improperly stored, (strength, dose, lot numbers and route were not reported). No adverse effects were reported. Follow up information has been received from the registered nurse on 27-OCT-2014, who stated that it would take some time to get the VARIVAX (Merck) information (patient identifiers, lot numbers, expiration dates and dates of vaccine administration) together and that she might send the information at a later time. Follow up information has been received from the registered nurse on 13-NOV-2014, concerning a patient (age reported as 8, units not reported) of unknown gender. On 29-OCT-2014, the patient was vaccinated with a dose of VARIVAX (Merck) which was improperly stored (lot number K005180, expiration date 10-APR-2016; dose number, dose and route were not reported). The reporter stated that this was the information that they could find and provide and anything further would be much too difficult and time consuming due to their record keeping and tracking system. This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
Development of tinnitus/ringing sensation/buzz as a "generalized sensation" that is generally not pleasant.   Within first 24 hours after administration patient had regular side effects including headache, fever (99.8) , and chills that disappeared after 36-48 hours.
39 y/o found in chair having a syncope episode. Patient retained consciousness and moved to ambulance. Vital stable. complained of dizziness, and feeling light headed. Patient refused transport to hospital. Refusal signed.