chrisvoncsefalvay/vaers-outcomes huggingface dataset:
YF-VAX temperature excursion from May 1 to July 1 for cumulative time 490.67 hours with lowest temperature 32.25F (0.13888889C) with no reported adverse event; YF-VAX was already administered to 20 patients post-excursion with no reported adverse event; Initial information received on 06-Jul-2022 regarding an unsolicited valid non-serious case via health professional. Agency number: 01178883  This case involves report of YELLOW FEVER VACCINE - [YF-VAX] was already administered to 20 patients post-excursion with no reported adverse event and yf-vax temperature excursion from may 1 to july 1 for cumulative time 490.67 hours with lowest temperature 32.25f (0.13888889c) with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date in May-2022, Reportedly YF-VAX vaccine temperature excursion from May 1 to July 1 for cumulative time 490.67 hours with lowest temperature 32.25f (0.13888889c) with no reported adverse event (product storage error) at unknown latency.  On an unknown date in Jul-2022, the 20 patient received YF-VAX vaccine (lot number: UJ409AA, expiry unknown, lot number: UJ563AA, expiration date : 23-May-2023) post-excursion with (unknown: formulation, strength, dose, route in unknown administration site) for Immunization (poor quality product administered, latency same day). No adverse event was reported.  It was reported that "the stability document they were sent states YF-VAX is not suitable for use if the temperature is under 1C. Caller asks to verify information. It was due to something wrong with the refrigerator (not human error). YF-VAX is not supported by the extended stability data; caller states YF-VAX was already administered to 20 patients; asks what they should do about the patients who already received YF-VAX post-excursion; asks if there's any bloodwork they can do for YF-VAX to check immunity?. This situation is reported as a medication error due to YF-VAX being administered to 20 patients post-excursion that was not supported by the extended stability data."   Action taken: Not applicable.  At time of reporting, the outcome was Unknown for both 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.
Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 18-Jul-2022; No adverse event; The patient administered the vaccine after the 30 days by used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient administered the vaccine after the 30 days by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 18-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 38-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 18-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient administered the vaccine after the 30 days by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 18-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient administered the vaccine after the 30 days by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 18-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (The patient administered the vaccine after the 30 days by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 18-Jul-2022).    No concomitant medications was provided by the reporter.  Patient received full dose. The vial had not undergone any temperature excursions. The vial was initially stored in the refrigerator on 04-jun-2022.  No treatment medications was provided by the reporter.
11/3 4 days post vax, started itching, no rash. Broke out next day. Told at ER had poison ivy. Presents today w/ red raised rash on R arm from antecubital area to outer lower arm. No rash on L, pt stated did have on 11/6. Private MD felt Per follow-up: Pt received the flu and pneumonia vaccine on 10-29-1999. Pt here today stating he started itching on 11 3-1999 or 11-4-1999, but had no rash. Stated on 11-5-99 broke out in rash on right arm and had itching around ankles. States went to hospital to the ER. States was told he had poison ivy and was given CELESTONE injection and was told to take BENADRYL over the counter. States was also given cream to put on rash. Presents today with red raised rash on right arm from antecubital area down outer lower arm. No rash noted on left arm pt stated did - have rash on left arm on Sat 11/6 or Sunday 11-7. Pt went to private MP Dr. Pt's wife reported that Dr felt rash was due to pneumonia vaccine.
Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Medium, Systemic: Joint Pain-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Weakness-Medium, Additional Details: patient describes a severe pain in the left arm starting the morning after injection that originally traveled down his elbow to his wrist and up to his neck. Neck and elbow have since resolved, but patient describes a current pain in the wrist, inability to move arm to shoulder height, unable to rotate arm around the shoulder joint, and a pain in the upper arm, still ongoing after 12 days
This spontaneous report has been received from a pharmacist referring to a patient of unknown age. On 17-NOV-2015 the patient was vaccinated with improperly stored M-M-R II (dose and route not reported, lot # L020189, expiration date: 03-JUN-2017) (Incorrect product storage). No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Left supraclavicular lymph node was swollen; In general there is a slight feeling of pressure at the site and some tenderness if prodded; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE LYMPHADENOPATHY (Left supraclavicular lymph node was swollen) and VACCINATION SITE PAIN (In general there is a slight feeling of pressure at the site and some tenderness if prodded) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.  On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 15-Jan-2021, the patient experienced VACCINATION SITE LYMPHADENOPATHY (Left supraclavicular lymph node was swollen) and VACCINATION SITE PAIN (In general there is a slight feeling of pressure at the site and some tenderness if prodded).   At the time of the report, VACCINATION SITE LYMPHADENOPATHY (Left supraclavicular lymph node was swollen) and VACCINATION SITE PAIN (In general there is a slight feeling of pressure at the site and some tenderness if prodded) outcome was unknown. Not Provided    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.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Pt felt  fainted after receiving vaccine. Pt did not follow faint but had to lie down for some time
Hives/rash developed 2 days following Moderna Booster. Steroid shot received 4 days  following  shot. Betamethasone ointment applied. Rash has continued since though  not as severe.
Headache, muscle and joint aching, chills and fever. Chills occurred again at 11:30 when ibuprofen wore off. Temperature 99 by morning.
Vaccine expired on 13-OCT-2021 and placed in refrigerator on 04-Nov-2021; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 13-OCT-2021 and placed in refrigerator on 04-Nov-2021) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 13-OCT-2021 and placed in refrigerator on 04-Nov-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 13-OCT-2021 and placed in refrigerator on 04-Nov-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vial did not had any temperature excursion and the patient had no adverse event.    No concomitant medication information was provided. No treatment medication information was provided.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On 29-OCT-2013 the patient was vaccinated with ZOSTAVAX (lot # H019034; expired date 17-JAN-2014) (dose, route and injection site were not reported). On unknown dates the patient developed two cases of shingles (dates of shingles cases unspecified, but patient had a current case at the time of the call) following vaccination with ZOSTAVAX. Action taken was not provided. The patient present status was reported as not recovered/not resolved at the time of report. The patient's had contacted pharmacist for medical attention. Additional information has been requested.
(R) thigh cellulitis and bruising and hard lump. (L) thigh bruising and hard lump. Fever at home.
A rash on left side of the chest; A rash in the arm pit; Headache; A rash on the left thigh; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), RASH (A rash on the left thigh), RASH (A rash on left side of the chest) and RASH (A rash in the arm pit) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 10-Apr-2021, the patient experienced HEADACHE (Headache), RASH (A rash on the left thigh) and RASH (A rash in the arm pit). On an unknown date, the patient experienced RASH (A rash on left side of the chest). At the time of the report, HEADACHE (Headache), RASH (A rash on the left thigh), RASH (A rash on left side of the chest) and RASH (A rash in the arm pit) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medications were given to the patient.
Immediatley after injection employee developed hard, golf ball size lump under injection site. Warm, red and tender. Benadryl given. Pt. observed further for 15 minutes.
Tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Tired). At the time of the report, FATIGUE (Tired) outcome was unknown.            Concomitant medications was not provided by the reporter. Treatment information was not provided. Patient stated it was likely the let down effect
Cellulitis at sites of injection per primary care physician. We never saw arms as patient refused office visits that Thursday and Friday. They went to PCP.
Information has been received from a licensed practical nurse concerning a 60 year old female consumer who on 19-MAR-2008 was vaccinated IM with zoster vaccine live (Oka/Merck) (lot # 658861/1822U). No adverse reaction reported. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Follow-up information has been received from a health professional concerning this 60 year old with female consumer who on 19-MAR-2008 was vaccinated with zoster vaccine live (Oka/Merck) (lot # 658861/1822U). Subsequently, on 19-MAR-2008 the patient complained of hurting upon administration of the injection which was given IM, and soreness at the injection site for a couple of days. At the time of the report the patient's status was unknown. Additional information has been requested.
Patient's daughter stated that on 11/17/16, the patient brought to her attention that the injection site was red, swollen (with a small knot), warm to the touch.  She is not running a fever and she isn't having trouble breathing.  No treatment has been sought at this time.
dizziness; headache; not feeling great; Arm was hard; Arm was sore; both shoulders were heavy; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (both shoulders were heavy), PAIN IN EXTREMITY (Arm was sore), DIZZINESS (dizziness), HEADACHE (headache) and MALAISE (not feeling great) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (both shoulders were heavy). On 16-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore) and INDURATION (Arm was hard). On 01-Mar-2021, the patient experienced DIZZINESS (dizziness), HEADACHE (headache) and MALAISE (not feeling great). On 15-Feb-2021, MUSCULOSKELETAL DISCOMFORT (both shoulders were heavy) had resolved. On 19-Feb-2021, PAIN IN EXTREMITY (Arm was sore) and INDURATION (Arm was hard) had resolved. At the time of the report, DIZZINESS (dizziness), HEADACHE (headache) and MALAISE (not feeling great) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-033822.
Was inadvertently provided MMR-V (proquad) instead of MMR, in addition to Varicelle single component vaccine. No adverse events reported as of 3/12 by mother.
Extremely confused and agitated.  Vision was reduced significantly.  Not able to understand or comprehend simple tasks.  This went on for 3 days.
had pain in my injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (had pain in my injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 VACCINATION SITE PAIN (had pain in my injection site). At the time of the report, VACCINATION SITE PAIN (had pain in my injection site) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication was reported.  The patient had pain in injection site for about two or three days but not more than that. No treatment medication was reported.
Itching on and off; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching on and off) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced PRURITUS (Itching on and off). At the time of the report, PRURITUS (Itching on and off) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
The student was vaccinated during a morning flu clinic at school. She returned to class and came back down to the clinic and said she felt dizzy and nauseous. She laid down, elevated legs and had water. Temp was 98.1. She returned to class 12 minutes later.
Possible Stroke; Unable to speak/Lack of pronunciations; Fatigue; A spontaneous report was received from a health care professional concerning 75-years old male patient who experienced stroke (Cerebrovascular accident), unable to speak/ lack of pronunciations (Speech disorder) and fatigue (Fatigue).  The patient's medical history included heart attack. Concomitant medications included included Metoprolol, HCTZ, Irbesartan, and Aspirin.  On 08 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 012L201A) intramuscularly in the Anatomical location for prophylaxis of COVID-19 infection.  On 05 Feb 2021, approximately four days prior to the events, the patient received their second of two planned doses of mRNA-1273 (lot/batch: 030L20A) intramuscularly in the Anatomical location for prophylaxis of COVID-19 infection.  On 06 Feb 2021, the patient experienced fatigue.  On 09 Feb 2021, the patient experienced the events stroke and unable to speak/ lack of pronunciations. The events resulted in hospitalisation as seriousness criteria. The patient was admitted to the hospital on 09 Feb 2021. The patient was moved to ICU for 24 hours, and was the patient was discharged from Hospital on 11 Feb 2021. Treatment for the event included Eliquis and 80 mg chewable aspirin.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore, action taken with the drug in response to the events is not applicable.  The events stroke, unable to speak/ lack of pronunciations and fatigue were considered as recovered/resolved.; Reporter's Comments: Based on the current available information, a temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Of note, the patient has a pre-existing history of heart attack which is a strong confounder for the reported CVA and speech disorder. Fatigue is consistent with the known safety profile of the vaccine.
Starting on or about June 16th  - slight swelling noticed in left ankle, and left calf.   Swelling continued in left ankle and left calf even after ice and elevating foot.   June 21st scheduled doctor appointment with orthopedic thinking perhaps leg or ankle injury.
pt recv vax 17MAR97 & MD dx chickenpox in this child 10AUG98;
Patient was given the Johnson and Johnson Vaccine on 4/8/2021 and on 4/29/2021 patient received Moderna Vaccine.  Patient showed no signs or symptoms of reaction of any kind.  Patient denied any pain or discomfort after receiving Moderna shot.
11 mos old experienced febrile seizure with temperature of 101.4 degrees F with 36 hours of receiving influenza vaccine (part 2).
Day 2 sore arm, body aches, 99.8 temp, by evening large red spot around injection site Day 3 swing from chills to fever, red spot enlarges, is swollen and hot, tylenol helps temp down to 99.7 Days 3 - 7 arm gets hotter, stays swollen, hot and very red from above elbow to almost top of arm.  Slowly dissipates. Blood Pressure spiked one day to 162/105 and saw doctor about that.
Muscle pinching pain in right deltoid muscle, similar to a rotator cuff injury; Muscle weakness; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 02Oct2021 at 12:30 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included unspecified daily inhaler from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Oct2021, the patient experienced muscle pinching pain in right deltoid muscle, similar to a rotator cuff injury. Muscle weakness accompanied the pain. Arm movements and weight lifting aggravated the pain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19. On 12Oct2021, the patient underwent COVID-19 test via nasal swab and the result was negative. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events muscle pinching pain in right deltoid muscle, similar to a rotator cuff injury and muscle weakness accompanied the pain; arm movements and weight lifting aggravated the pain was not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Arm is still swollen; Arm / Very red; Arm / hot; This case was reported by a consumer via interactive digital media and described the occurrence of swelling arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th November 2020, the patient received the 1st dose of Shingrix. In November 2020, less than a week after receiving Shingrix, the patient experienced swelling arm, erythema of extremities and skin warm. On an unknown date, the outcome of the swelling arm, erythema of extremities and skin warm were not recovered/not resolved.   It was unknown if the reporter considered the swelling arm, erythema of extremities and skin warm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group of patient was not reported but was captured as an adult as per vaccine indication. The patient was vaccinated with !st dose of Shingrix on last thursday from reporting day. The patient experienced swollen and very red and hot till the reporting day. No further details were provided.