chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dose administered after 30-day Use By Date or after manufacturer date of expiry; No adverse event; Bivalent dose administered to patient after 30-day use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Bivalent dose administered to patient after 30-day use by date), PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date or after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 021H22A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Nov-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 21-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Bivalent dose administered to patient after 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date or after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Bivalent dose administered to patient after 30-day use by date), PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date or after manufacturer date of expiry) 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 (Bivalent dose administered to patient after 30-day use by date) and PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date or after manufacturer date of expiry).    No concomitant medication was reported. The patient have received first dose and second dose with unknown lot number. HCP stated she did not have any patient demographics or clinical history and she was just calling to know if the was a valid dose. No treatment information was reported.
2NOV98 3PM chills, hot, sweaty, aching all over, h/a upset stomach 8PM diarrhea x 2 9PM, T103, severe chills all noc, aching, h/a;3NOV98 felt better & slept 8-012noon;cont aching;
12 days after Modern Booster experienced Dermatographic urticaria and has been continuous since January 26th. Scratching or rubbing the skin leaves big welts for about an hour, particularly on the head, arms, and trunk area.
Administration of a pediatric dose of Engerix-B to an adult patient; Administration of a pediatric dose of Engerix-B to an adult patient; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 21-year-old female patient who received HBV (Engerix B pediatric) (batch number LP724, expiry date 18th May 2023) for prophylaxis.   On 14th July 2021, the patient received Engerix B pediatric. On 14th July 2021, unknown after receiving Engerix B pediatric, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.  Additional details were provided as follows: The adult patient received pediatric dose of Engerix-B, which led to underdose and adult use of a child product. The reporter consented to follow up.
I saw that a flat red rash over and beyond the  injection site (about 2 inches across) on pt's upper left arm appeared this morning (which is the morning  after pt got the vaccine).  Pt has a sore arm, his face is  flushed, he feels tired and nauseous.  He says he feels as if he is starting to get the flu.  Pt is lying in bed today. He does not want to walk around. (He had woken up at 3am this morning and took the bandage off  because it was itching).
This spontaneous report as received from  physician's assistant refers to a patient of unknown age and gender. On 26-AUG-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # L003855 exp date 05-FEB-2017) (dose and route not reported). The temperature excursion was 53.8 F for 10.75 hours from 17-AUG-2015 to 06-NOV-2015. No adverse event was reported. This is one of several reports received from the same source. Additional information is not expected as all follow up information to complete the case was received.
Patient described full body aches and significant nausea lasting about 2 weeks after the vaccination.  Additionally he reports hip / back pain that began 2 days after the vaccine and continues now about 1 month after the vaccine.
Aches; Chills; Severe tiredness; Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches), CHILLS (Chills), FATIGUE (Severe tiredness), HEADACHE (Headache) and PYREXIA (Fever) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes mellitus.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced PAIN (Aches), CHILLS (Chills), FATIGUE (Severe tiredness), HEADACHE (Headache) and PYREXIA (Fever). At the time of the report, PAIN (Aches), CHILLS (Chills), FATIGUE (Severe tiredness), HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  Treatment medications were not provided.   This case was linked to MOD-2021-022063 (Patient Link).
Injection site right arm was itched; Injection site right arm was sore; Injection site right arm was red; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PRURITUS (Injection site right arm was itched), VACCINATION SITE PAIN (Injection site right arm was sore) and VACCINATION SITE ERYTHEMA (Injection site right arm was red) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 006C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 08-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site right arm was itched), VACCINATION SITE PAIN (Injection site right arm was sore) and VACCINATION SITE ERYTHEMA (Injection site right arm was red). At the time of the report, VACCINATION SITE PRURITUS (Injection site right arm was itched), VACCINATION SITE PAIN (Injection site right arm was sore) and VACCINATION SITE ERYTHEMA (Injection site right arm was red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant product use was not provided. Treatment information was not provided.   This case was linked to MOD-2021-138694 (Patient Link).
Patient was diagnosed with COVID; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and COVID-19 (Patient was diagnosed with COVID) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 05-Mar-2021, the patient experienced COVID-19 (Patient was diagnosed with COVID). At the time of the report, PAIN IN EXTREMITY (Sore arm) had resolved and COVID-19 (Patient was diagnosed with COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, SARS-CoV-2 test: positive (Positive) He is off qurantine.         No Concomitant medications was reported Treatment information was not provided   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: F/U Received on 06-MAY-2021, Dosage form updated.
About 30 hours after the second Moderna vaccine injection I experience a fever of 101 and mild chills in the evening.  I have a sense of malaise and fatigue.  The next morning I had a severe headache so I took a Tylenol 650 and sleep for two hours.  After that, I felt fine  ever since .
Immediately following the injection, I experienced a burning through my veins and body, followed by rapid irregular heart beat and confusion.  I informed the nurse and she had me lay back in the chair a few minutes.  I stayed in the Dr. office about 15 minutes and left.  Since the date of the vaccine, I have experienced rapid, irregular heartbeat, light headedness, confusion, anxiety, insomnia, which has led into depression, weightloss and for a period of time, aghoraphobia.  The symptoms are still present at a minimum.
Patient reports itching approx. 15-30 minutes after injection, following by redness and swelling that progressively worsened over next 24 hours. Patient returned to clinic the next day with patients mother to report a reaction. Right arm swollen and redness diameter was 2 inches by 2.5 inches. Patients mother had already given patient Benadryl and applied over the counter cortisone cream. Patient was prescribed oral prednisone, reaction is localized upon office visit.  Follow up call to patient on 11/6/18 - patients symptoms (localized redness, swelling and itching) have improved with prednisone. Patient and patients mother are asked to contact clinic if symptoms are not resolved in next 24-48 hours and or with any questions or concerns.
Vaccine administered after more than 1 temperature excursion; Vaccine administered 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 (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 30-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 14-Feb-2021 at 10:54 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 14-Feb-2021 at 10:54 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered 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 30.53  Concomitant products were not provided.  On 14-Feb-2021, Excursion time was 9A, 10A, 11A, 2P, 2P temperature was 32, 32,32, 35,35 total doses given for the day was 162, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Feb-2021, vial was moved to clinic on 13-Jan-2021. 30 vials were sent to clinic. Vaccine BUD date was 10-Mar-2021.  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 Fisher brand 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 in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Started with fatigue and diffuse body aches within 4 hours of receiving the vaccine on 10/5. On 10/8 he presented to ED and was found to have an extensive LEFT lower leg DVT extending into the pelvis and small Bilateral lower lobe PE's.
Patient received first dose on 2/21/2021 (Lot EL9266) and then received 2nd dose on 6/3/21. She reported getting COVID and receiving antibody therapy after the 1st dose, so she waited the 90 day period after receiving antibody therapy to get the 2nd dose.
Patient felt sweaty and awful.  At about 5:30 PM she said she felt funny and then just passed out.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2010, a healthcare provider administered the ZOSTAVAX (dose, route, and lot # not provided) to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related injuries. On or about 13-OCT-2016, the patient was treated by a healthcare provider for Shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the event was unknown. Causality assessment was related.
AFTER FIRST VACCINE: CONFUSION, MEMORY PROBLEMS, INABILITY TO CARE FOR SELF
My arm was achy; I was tired for day, or so; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (My arm was achy) and FATIGUE (I was tired for day, or so) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced PAIN IN EXTREMITY (My arm was achy) and FATIGUE (I was tired for day, or so). At the time of the report, PAIN IN EXTREMITY (My arm was achy) and FATIGUE (I was tired for day, or so) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-360509 (Patient Link).
Information has been received from a consumer concerning her daughter who on 12-FEB-2007 was vaccinated with a first dose of GARDASIL. On 21-APR-2007 the patient was vaccinated with a second dose of GARDASIL. On 21-JUN-2007 the patient received a third dose 2 months after the second dose. The reporter did not provided any other information. Per reporter, the patient did not report any adverse event. No further information was provided. Additional information has been requested.
I woke up to find my baby not breathing.  He was completely flaccid and I had to stimulate him awake.  I don't know how long he hadn't been breathing prior to me waking up.  It took me 3-5 minutes to get him breathing again.
Patient's wife states that approx. 2 hours after receiving the vaccine, he started having blurred vision in left eye and feeling dizzy and nauseated. States it has gotten progressively worse now having blurred vision in both eyes.
Information has been received from a physician, author of the article, regarding a 4-month-old boy (patient 2) who presented with a 4-day history of rhinorrhea and nonbloody diarrhea, a 3 days of fever. The patient was wheezing and tachypneic with an oxygen saturation of 95%. He was diagnosed with bronchiolitis, treated with levalbuterol and vaponephrine, and observed overnight. The patient received his first dose of ROTATEQ 11 days before illness onset. Genetic analysis of a fecal specimen obtained 9 days after illness onset detected the VP7 G1 gene of ROTATEQ strain W179-9 (G1P[5]) (100% identity in 854 bases) and the VP4 P[8] gene from RV5 strain W179-4 (G6P[8]) (100% identity in 835 bases). The VP6 I2 gene detected matched that of RV5 component strains W179-9 (G1P[5]), SC2-9 (G2P[5]), W178-8 (G3P)[5]), and BrB-9 (G4P[5]) (100% identity in 342 bases). The VP3 M2 gene matched the sequence of strains W179-4 (G6P[8]), W 178-8 (G3P[5]), and BrB-9 (G4P[5]) (100% identity 500 bases). This strain appears to be a double reassortant with either the W179-9 (G1P[5]) VP7 and VP6 genes inserted onto a W179-4 (G6P[8]) backbone or the VP4 of W179-4 (G6P[8]) and VP3 of W179-4 (G6P[8]), BrB-9 (G4P[5]), or W178-8 (G3P[5]) inserted onto a W179-9 (G1P [5]) backbone. Rotaviruses and adenoviruses were observed by EM. Real-time PCR was positive for adenovirus group F; all other tests were negative. This patient illustrate a spectrum of potential clinical and virologic outcomes associated with routine use of live, attenuated rotavirus vaccines. The diversity of these occurrences included ROTATEQ vaccines-reassortant strain in a recently vaccinated child (patient 2). Patient had upper respiratory symptoms accompanied by vomiting or diarrhea, and his illness was less typical of rotavirus disease alone. Additionally, detection of adenovirus group F in patient 2 specimen provides a plausible alternate etiology. Additional information has been requested. This is one of the several reports received from the same source.
Obtained from CPRS record: FEB 16, 2011 09:36. Person presenting for visit: Veteran. Purpose: Walk in. Chief Complaint: Patient here presents with redness, swelling and warmth to left upper arm. States started after getting PNEUMOVAX done one 2/14/11. Patient denies any shortness of breath or any anaphylactic reactions, patient states took ibuprofen for ache and discomfort, patient states having some pain with movement and touch. Patient denies any other injections or insect bites to affected upper extremity. Vital Signs: Blood pressure: 145/79 (02/16/2011 09:34). Pulse: 66 (02/16/2011 09:34). Respiration: 20 (02/16/2011 09:34). Temperature: 97.8 F [36.6 C] (02/16/2011 09:34). Pain: 1 (02/16/2011 09:34). Symptoms: Symptoms: 1. Erythema Multiform, 2. Urticaria Pruritus. Treatment Drugs Used: 1 - DEXAMETHASONE Dose: 8 Units: MG Freq: ONCE Route: IM.
Diagnosis of diabetes type 2 (6 months ago) 2021; Uncontrolled blood sugar ongoing "high" in the morning; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program.  A 46 year-old female patient received tofacitinib citrate (XELJANZ XR), oral since 29Jul2020 (ongoing) (Batch/Lot number: unknown) at 11 mg 1x/day for rheumatoid arthritis; bnt162b2 (BNT162B2), administration date Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single, administration date May2021 (Batch/Lot number: unknown) as dose 2, single and administration date Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: GLIPIZIDE. The following information was reported: TYPE 2 DIABETES MELLITUS (medically significant) with onset 2021, outcome "unknown", described as "Diagnosis of diabetes type 2 (6 months ago) 2021"; BLOOD GLUCOSE INCREASED (non-serious) with onset 2021, outcome "unknown", described as "Uncontrolled blood sugar ongoing "high" in the morning". The patient underwent the following laboratory tests and procedures: blood glucose: (2021) high, notes: uncontrolled blood sugar ongoing "high" in the morning. The action taken for tofacitinib citrate was dosage not changed. The lot number for bnt162b2 was not provided and will be requested during follow up.  Additional Information: The patient initially, started the therapy on 29Jul2020; a break in therapy several times (product use error) due to covid 19 vaccinations, md held the therapy, several times due to covid 19 vaccines (Apr2021) 1st dose, May2021 2nd dose, Nov2021 3rd dose). She experienced rheumatoid arthritis "flareups" patient was unsure if this was also related to the covid 19 vaccination; however, improved after resuming the therapy. unknown md aware. recent diagnosis of diabetes type 2 (6 months ago) 2021, uncontrolled blood sugar ongoing "high" in the morning. md appointment to see endocrinologist scheduled. no further information, details, or dates, reported.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on current information available, the event Type 2 diabetes mellitus mostly represented intercurrent condition in this patient unrelated to Xeljanz XR.
Developed blotchy, puffy face & hives at neck, back & abdomen. Throat felt tight. Some difficulty breathing. Given epinephrine & BENADRYL by ambulance. Then ORAPRED/BENADRYL.
Accidental needle stick after drawing up adjuvant liquid and having a small hole on unspecified finger; Accidental exposure to vaccine; Exposure via skin contact; This case was reported by a pharmacist via call center representative and described the occurrence of needle stick/puncture in a 54-year-old male patient who received Herpes zoster (Shingrix) (batch number PF454, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced needle stick/puncture, inadvertent exposure to vaccine and exposure via skin contact. On an unknown date, the outcome of the needle stick/puncture, inadvertent exposure to vaccine and exposure via skin contact were unknown.   It was unknown if the reporter considered the needle stick/puncture to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported accidental needle stick after drawing up adjuvant liquid and having a small hole on unspecified finger, which led to needle stick/puncture, inadvertent exposure to vaccine and exposure via skin contact.  The reporter consented to follow up. The pharmacist was reporter and preparer of vaccine.   Follow up information received from pharmacist on 9th December 2019: No adverse event was reported.