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 Medication use information was not provided by 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.  Treatment Medication use information was not provided by reporter.  This case contains information for the 67th 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
patient was under the age of 18.  Pharmacy staff at the time of immunization didn't verify age and or recognize the difference with Pfizer and Moderna
Patient described about an hour after vaccination, her arm "felt on fire; burning sensation." She stated her elbow felt stiff. She reported no swelling or redness. No anaphylactic symptoms. Her PCP recommended she take Benadryl and ice her arm. Followed-up with patient next day. Her arm is sore, but no longer "burning."  She is experiencing body aches, which is to be expected.
Mom reported at next OV to writer that she didn't want ROTATEQ as 24 hours after last shots pt had extreme hoarseness, "would cry and no sound came out". Called nurse and saw MD 1 week later. NO meds or tx given.
pt recv vax 10JUN96 & exp a h/a, node swelling (including the groin nodes), neck stiffness, a little nausea, & a roseola rash all over body;5JUL96 pt could not get out of bed & had swollen feet & NSAID;liver enzymes were found to be elevate
His symptoms started with a swollen leg (site of the injection).  His left leg was the size of a grape fruit and my son was unable to walk.  His temperature on the morning of Feb 4, 2012 was 103.  Throughout the day, my son refused to eat and drank very little.  He slept all day. When we put him down for bed we noticed he was hot -- very hot.  His temperature registered 104.  We were advised from the on-call pediatrician to give him Tylenol and push the fluids.  We did.  By 11:30 PM on Feb 12, 2012, my son's temperature was 105.  He was blue in the lips, the hands, and the toes.  His body was shaking.  The color of his skin turned into a lace like pattern of white and purple.  We took him to the ER where he was immediately put into the Code room.  The doctors wrapped his body in warmers, while trying to find a vein for an IV.  By the time he got to the ER his temperature of "off the charts," according to the doctor.  This meant, his temperature was higher than 105.5  We spent the entire evening and early morning of Feb 5 in the ER.  My son's temperature continued to spike to 104 and then fall.  This pattern repeated all night.  We were sent home and the same pattern of previous shaking, high temperature, and lack of interest in food continued until Monday, Feb at 1:30 PM.
Awoke in the morning with intense ringing/roaring and acute hearing loss in the left ear that persisted.  F/u with ENT that next morning and had an audiogram that showed loss in the higher frequencies, started on high dose steroids.  Hearing improved subjectively but audiogram still showed losses in higher frequencies.
Patient lost consciousness immediately after receiving Fluarix lot # AfluA298BA for approx 30 seconds and had a brief tonic-clonic seizure affecting her neck, arms, and hands.
After receiving vaccines, patient had syncopal episode. Pt recovered and was in stable condition and went home with family.
Lichenoid Dermatitis / more than twenty bumps in number; This spontaneous case was reported by a consumer and describes the occurrence of LICHENOID KERATOSIS (Lichenoid Dermatitis / more than twenty bumps in number) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concurrent medical conditions included Adhesive tape allergy.   In December 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) (unknown route) dosage was changed to 1 dosage form. On 01-Feb-2021, the patient experienced LICHENOID KERATOSIS (Lichenoid Dermatitis / more than twenty bumps in number). At the time of the report, LICHENOID KERATOSIS (Lichenoid Dermatitis / more than twenty bumps in number) had not resolved.            No concomitant medications were reported.  It was reported that a week after patient got his second shot last 25-Jan-2021, a blue bump appeared on his hand. Three weeks after, it started to increase in number which appeared in his hands and legs both left and right. He said it comes in different sizes and described it as if covering the ankles for the big ones and same size as nail head for the small ones. He also added to have itchiness, swelling and pain when touched. He consulted his dermatologist last April and was first diagnosed as psoriasis. He also said that it flared up last May.  Later on, his doctor said it was not psoriasis and he had undergone biopsy and diagnosed him with Lichenoid Dermatitis. At the time of reporting, he estimates it to be more than twenty bumps in number. The old ones were now red in color and not pronounced as they were, and the new bumps still appears to be blue.  No treatment medications were reported.
Tdap (Adacel) was given instead of DTaP. Nurse that administered vaccine was filling in at our office.
She reported to the emergency room after having angioedema of her lips, chest tightness, wheezing and cough 12 hours after receiving covid pfizer booster
dose administered to patient after more than 1 temperature excursion; dose administered to patient after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021 at 11:49 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 12-Feb-2021 at 11:49 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 74.27.   Concomitant products were not provided.  On 12-FEB-2021, Excursion time was reported at 10:00 A.M and 11:00 AM with  temperature as 35 and 35 degrees Fahrenheit, total doses given for the day was 55, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-FEB-2021, vial was moved to clinic on 12-FEB-2021. 03 vials were sent to clinic. Vaccine BUD date was 03-MAR-2022.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
Mom reports pt has cried since vaccines. child was seen that PM at MD's office. Child was given tylenol with codeine 2ml's. at 6:42pm Mom was instructed to continue tylenol infant drops every 4 hrs, cool compress. To call back if  crying or any other symptoms persist.
a few episodes of a-fib; felt like she might black out; felt like her heart was palpitating; stress; headache; could not sleep; burning in her arm, up through her neck and to her chest.; worry; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (a few episodes of a-fib) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.  Concurrent medical conditions included Heart valve replacement (two artificial heart valves.) since 2004. Concomitant products included WARFARIN SODIUM (COUMADIN) for Heart valve replacement.  On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced VACCINATION SITE PAIN (burning in her arm, up through her neck and to her chest.). On 18-Apr-2021, the patient experienced SLEEP DISORDER (could not sleep). On an unknown date, the patient experienced ATRIAL FIBRILLATION (a few episodes of a-fib) (seriousness criterion medically significant), PRESYNCOPE (felt like she might black out), PALPITATIONS (felt like her heart was palpitating), ANXIETY (worry), STRESS (stress) and HEADACHE (headache). On 23-Mar-2021, VACCINATION SITE PAIN (burning in her arm, up through her neck and to her chest.) outcome was unknown. At the time of the report, ATRIAL FIBRILLATION (a few episodes of a-fib), PRESYNCOPE (felt like she might black out), PALPITATIONS (felt like her heart was palpitating), SLEEP DISORDER (could not sleep), ANXIETY (worry), STRESS (stress) and HEADACHE (headache) outcome was unknown.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  Treatment for the events included Acetaminophen. Echogram scheduled on 05 May 21.  Company comment: Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities; Sender's Comments: Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities
Fever, vomiting, diarrhea, body aches, headache, dehydration
Severe Tension-Type Headache, Malaise, Myalgia, Insomnia, Chills, Sweating, Fatigue, Fever of 100.8 F, Mild Non-suppurative Cough. All tolerated with 600mg ibuprofen.
Patient was given Bexsero at the minimum age range, patient is 14yrs old and provider wanted to double check if we needed to take any action or that patient is at any health risk.
Patient received expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 19-year-old female patient who received Men B NVS (Bexsero) (batch number abxA87az, expiry date 31st January 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 17th March 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 17th March 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 21-APR-2022 Reporter's Comment: The reporter reported that, the patient received expired dose of Bexsero. The reporter consented to follow up. Additional Supportive Information: The reporter reported that, the patient received expired dose of Bexsero, which led to expired vaccine used. This was 1 of 3 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022068142:Same reporter. US-GLAXOSMITHKLINE-US2022068144:Same reporter.
8-10 days after Tetanus shot my shoulders became very sore, especuially the right one where shot was given. Can not even raise above head without severe pain even 7 months later. Soreness went to hips and knees. Brought to Doctors attention the information from CDC website about severe reaction but no action taken to treat. Then went to Orthopedic, then Rheumatologist then Neurologist and problem has yet to be properly diagnosed, treated and Problems persist with joint pain in the mornings and inability to use arms above my head. Atrophy of right shoulder muscles is apparent.
Admtted to observation @ hosp dx febrile convuls Phenobarb given on admission, APAP suppository given on admission; t97.3 ax; mom reported vomiting x 6, ER t101.3 (tympanic);
A non-serious spontaneous report of "accidentally gave" H1N1 to a 72-year-old male was received from a registered nurse. Relevant medical history and concomitant medications were not reported. On 16-Oct-2009, the patient received H1N1. There was no adverse event associated with this vaccination error, therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered to be resolved.
This spontaneous report as received from a consumer refers to herself, a 50 year old female patient with penicillin allergy and no pertinent medical history. On 10-JUL-2015, the patient was vaccinated subcutaneously with 0.65 ml dose of ZOSTAVAX (lot number and expiration date not reported). There was no concomitant therapy. On 10-JUL-2015, the patient experienced a large, hard lump around the injection site after she received the vaccine shot. The patient reported the lump felt itchy and an unspecified hot sensation. There were no treatment given to the patient for the events. There were no lab diagnostics studies performed. The patient reported that the hot sensation lasted for five days and it was no longer there on 15-JUL-2015. The lump around the injection site had gone away on an unknown date in July 2015. The outcome of the lump felt itchy was reported as recovering. The patient sought medical attention (called the pharmacist). The relatedness between the events and the ZOSTAVAX was not reported. Additional information is not expected, no contact details were provided.
CHANGE IN HEARING IN THE RIGHT EAR WHICH HAPPENED THE DAY AFTER THE SECOND DOSE WHICH IS LEADING TO MIGRAINE HEADACHES.
Client received TDAP & Hep A/B vaccines in (L) deltoid on 9/7/10 at clinic. States arm sore next 2 days - stiff & developed a "lump". Client called HD on 9/17 stating arm still swollen lump still remains - no worse but persisting. Denies warmth or redness at site. Full ROM but with soreness. Denies fever. Using ice & MOTRIN for pain. Spoke to client again on 9/20. Lump has decreased in size. Still sore. No redness, warmth or fever.
Pt. received HPV vaccine for 1st time on 6-17-09 at approximately 16:35 as part of P.E. (Pt. had received PPD in other forearm 5 min. prior).  At 16:40 pt. in seat & noted to be pale said she would "pass out" & was placed on table.  MD called.  Vitals assessed.  Pt. drank water, rested and walked out of clinic shortly after.
sore arm at injection site; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 10 year-old male patient received bnt162b2 (COMIRNATY), administered in arm (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing), notes: No medications or underlying conditions. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose: 1, Manufacturer Unknown), for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "sore arm at injection site"; FATIGUE (non-serious), outcome "unknown", described as "fatigue".  Additional information: It was reported, 12 hours following his second vaccine dose of comirnaty (5-11 yo), reported sore arm at injection site and fatigue. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Enlarged supraclavicular lymph node on L side noted 4/1/21 (size of a pea), non-painful.; This is a spontaneous report from a contactable healthcare professional. A 41-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207), via an unspecified route of administration in the left arm on 26Mar2021 at 07:45 (at the age of 41-years-old), as a single dose for COVID-19 immunisation. Medical history included allergy nos. The patient received other medications within two weeks of vaccination. 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 patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021, the patient experienced enlarged supraclavicular lymph node on L side noted 4/1/21 (size of a pea), non-painful. It was unknown if the patient received treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event enlarged supraclavicular lymph node on L side noted 4/1/21 (size of a pea), non-painful was not resolved at the time of reporting.   No follow-up attempts are needed. No further information is expected.
pt recv vax 19MAY97 & w/in 24hr of vax pt exp soreness in the arms;w/in 48hr pt exp a flu-like illness consisting of severe arthralgia, aches & pains, a prolonged low grade fever like 102, nausea, diarrhea;exp arthralgia & weakness
runny nose; Loss of taste; Fatigue; Join pain; Muscle pain; Chills; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (runny nose), AGEUSIA (Loss of taste), FATIGUE (Fatigue), ARTHRALGIA (Join pain) and MYALGIA (Muscle pain) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Depression and Sleep disorder. Concomitant products included ENALAPRIL for Blood pressure management, VENLAFAXINE HYDROCHLORIDE (EFFEXOR SR) for Depression, TRAZODONE for Sleep disorder.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced FATIGUE (Fatigue), ARTHRALGIA (Join pain), MYALGIA (Muscle pain) and CHILLS (Chills). On 05-Mar-2021, the patient experienced RHINORRHOEA (runny nose) and AGEUSIA (Loss of taste). The patient was treated with PARACETAMOL (TYLENOL) on 03-Mar-2021 at a dose of UNK dosage form; PARACETAMOL (TYLENOL) on 04-Mar-2021 at an unspecified dose and frequency and ZINC at an unspecified dose and frequency. At the time of the report, RHINORRHOEA (runny nose), AGEUSIA (Loss of taste), FATIGUE (Fatigue), ARTHRALGIA (Join pain), MYALGIA (Muscle pain) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, Body temperature: 97.3 (Inconclusive) 97.3 degrees Fahrenheit.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient experienced loss of taste and runny nose for which she used Saline in nose and Elderberry liquid syrup.
Info has been received from a consumer concerning a male pt who on 02/26/2003 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot #643249/0358M). The reporter indicated that the pt had a reaction at the injection site which was described as a burning and itching sensation. Unspecified medical attention was sought. Follow up information indicated that it is unknown if the patient recovered. Additional info has been requested.
has not received the 2nd dose.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 52-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose about ten months ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: has not received the 2nd dose).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 12-Sept-2023 Pharmacist reported that a patient had not received the second dose. The Vaccine Administration Facility was the same as Primary Reporter. Forgot to ask about follow-up - mailing address was in health care professional details. Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination.
Given Rotavirus (oral) beyond guidelines. I looked at the Drs order and thought a Dx was the order for the rotavirus.