chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Narrative: The patient received two doses of Pfizer COVID 19 Vaccine in April 2021 and Jan 2022. The patient tested positive for COVID 19 on 12 Jan 2022. The patient was admitted to a community hospital with dizziness and confusion due to COVID 19. The patient left the facility against medical advice and ended up admitted to another hospital on 19 Jan 2022 with covid pneumonia. The patient was treated with dexamethasone and discharged on 1 February 2022 in stable condition. Reported per EUA.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Chest pain, Cough, Dyspnoea, Ischaemic cardiomyopathy
Clinical narrative: Narrative: The patient was admitted to the hospital on 6 Oct 2021 with chest pain. The patient was discharged on 8 Oct 2021. The patient was readmitted on 16 Oct 21 with chest pain and coughing. The patient was discharged on 19 Oct 21. The patient presented to the ED with worsening shortness of breath and coughing on 20 Nov 2021 and was admitted to the hospital on 21 Nov 21. The patient was discharged in stable condition on 24 Nov 21. The patient presented to the ED with chest pain and shortness of breath on 1 Jan 2022 and was admitted. The patient was discharged on 6 Jan 2022. The  patient was readmitted on 10 Jan 2022 with chest pain and tested positive for COVID 19. The patient was discharged on 11 Jan 2022 in stable condition. The patient was readmitted to the hospital on 23 Feb 2022 with chest pain and shortness of breath. The patient is diagnosed with ischemic cardiomyopathy. Reported per EUA.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Narrative: The patient was admitted to the hospital on 6 Oct 2021 with chest pain. The patient was discharged on 8 Oct 2021. The patient was readmitted on 16 Oct 21 with chest pain and coughing. The patient was discharged on 19 Oct 21. The patient presented to the ED with worsening shortness of breath and coughing on 20 Nov 2021 and was admitted to the hospital on 21 Nov 21. The patient was discharged in stable condition on 24 Nov 21. The patient presented to the ED with chest pain and shortness of breath on 1 Jan 2022 and was admitted. The patient was discharged on 6 Jan 2022. The  patient was readmitted on 10 Jan 2022 with chest pain and tested positive for COVID 19. The patient was discharged on 11 Jan 2022 in stable condition. The patient was readmitted to the hospital on 23 Feb 2022 with chest pain and shortness of breath. The patient is diagnosed with ischemic cardiomyopathy. Reported per EUA.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Chest discomfort, Chest pain, Chills, Cough
Clinical narrative: Narrative: The patient received two doses of Pfizer COVID 19 vaccine in Feb/Mar 2021. The patient tested positive for COVID 19 on 1 Jan 22. The patient presented to the ED on 8 Jan 22 with chest pain. The patient previously complained of myalgias, chills, runny nose. Then, he developed a cough with chest congestion, and pressure. The patient was admitted on 8 Jan 22 with diagnosis of COVID 19. The patient was monitored and treated with dexamethasone and fluids. The patient was discharged on 9 Jan 22 in stable condition. Reported per EUA.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Respiratory tract congestion, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: Narrative: The patient received two doses of Pfizer COVID 19 vaccine in Feb/Mar 2021. The patient tested positive for COVID 19 on 1 Jan 22. The patient presented to the ED on 8 Jan 22 with chest pain. The patient previously complained of myalgias, chills, runny nose. Then, he developed a cough with chest congestion, and pressure. The patient was admitted on 8 Jan 22 with diagnosis of COVID 19. The patient was monitored and treated with dexamethasone and fluids. The patient was discharged on 9 Jan 22 in stable condition. Reported per EUA.
Age: 96.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Narrative: Documenting VAER as required for pt who died and received COVID vaccine months before
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Narrative:  Documenting VAER as required for pt who died and received COVID vaccine months before.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Extra dose administered, Fall, Loss of consciousness
Clinical narrative: Narrative: Patient reported that the evening after his 4th covid shot (2nd booster) he fell in his bathroom after "passing out" . Initial report was that he fell prior to going to the bathroom, but during the er report it was found he fell after standing up after using the toilet and becoming lightheaded, did not report losing consciousness there. He fell on his knee that had a previous replacement done and had residual pain there. ER found no acute issues and patient was  discharged home with no interventions noted.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Narrative: COVID vaccinated x 2 with COVID positive test resulting in hospital admission.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Narrative: Documenting VAER as required for pt who died and received COVID vaccine months before.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Dysphagia, Endoscopy, Laryngoscopy, Swallow study
Clinical narrative: Dysphasia I have had many Dr's appointments with ENT, Gastrointerology, Speech Pathologists and went to urgent care/ ED several times. No one can figure out what is wrong. This is still an ongoing event.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Dyspnoea, Electrocardiogram, Erythema, Muscle spasms
Clinical narrative: Hives all over body, redness, soreness, swelling all over, hard to breath, shortness of breath, rash, itchy feeling all over skin, swelling of leg, cramping, severe cramps.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Peripheral swelling, Pruritus, Rash, Scan brain
Clinical narrative: Hives all over body, redness, soreness, swelling all over, hard to breath, shortness of breath, rash, itchy feeling all over skin, swelling of leg, cramping, severe cramps.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling, Ultrasound scan, Urticaria
Clinical narrative: Hives all over body, redness, soreness, swelling all over, hard to breath, shortness of breath, rash, itchy feeling all over skin, swelling of leg, cramping, severe cramps.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Dysarthria, Facial paralysis, Neck pain, SARS-CoV-2 test positive
Clinical narrative: 11/2/21 presents to ED with "with slurred speech and right-sided facial droop" and "blurred vision and left-sided neck pain". PMHx "arthritis, carpal tunnel syndrome, osteopenia, cyst of the right kidney".
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vision blurred
Clinical narrative: 11/2/21 presents to ED with "with slurred speech and right-sided facial droop" and "blurred vision and left-sided neck pain". PMHx "arthritis, carpal tunnel syndrome, osteopenia, cyst of the right kidney".
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: No adverse event. Patient was underage to receive Moderna vaccine
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event, but patient was underage to receive Moderna vaccine for COVID-19.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Cough, Dyspnoea, Lethargy, SARS-CoV-2 test positive
Clinical narrative: 02/09/22 presents as "direct admission" from OSH "for continuity of care".  "2/1/22 she began feeling lethargic and SOB with cough, pt received a COVID test which returned positive" PMHx of "ESRD-HD T/Th/Sat, HTN, dCHF, MDS-on chemo last administered 2/1/22, IDDM"
Age: 87.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Confusional state, SARS-CoV-2 test positive
Clinical narrative: 12/03/21 presents to ED for "increased confusion". PMHx of "hypertension, hyperlipidemia, dementia"
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Abdominal pain, COVID-19, Colitis, Headache, SARS-CoV-2 test positive
Clinical narrative: 12/04/21 presents to ED for "abdominal pain and headache". PMHx of "abdominal pain 2/2 hiatal hernia, GERD, recent admission for acute on chronic abdominal pain, colitis and UTI"
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Urinary tract infection
Clinical narrative: 12/04/21 presents to ED for "abdominal pain and headache". PMHx of "abdominal pain 2/2 hiatal hernia, GERD, recent admission for acute on chronic abdominal pain, colitis and UTI"
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Abdominal pain, COVID-19, Colitis, Headache, Hiatus hernia
Clinical narrative: 12/04/21 presents to ED for "abdominal pain and headache". PMHx of "abdominal pain 2/2 hiatal hernia, GERD, recent admission for acute on chronic abdominal pain, colitis and UTI"
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test positive, Urinary tract infection
Clinical narrative: 12/04/21 presents to ED for "abdominal pain and headache". PMHx of "abdominal pain 2/2 hiatal hernia, GERD, recent admission for acute on chronic abdominal pain, colitis and UTI"
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Fatigue
Clinical narrative: 12/04/21 presents to EC ED for "sob and fatigue". PMHx of "renal transplant, CAD, AFib"
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Dysstasia, Headache, Pain
Clinical narrative: chills; headache; fever; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (Pfizer-BioNTech COVID-19), on 23Dec2021 as dose 3 (booster), single (Lot number: FJ1611) at the age of 72 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "right branch bundle" (unspecified if ongoing); "diverticulosis" (unspecified if ongoing); "hiatal hernia" (unspecified if ongoing); "hemorrhoids" (unspecified if ongoing); "chronic fatigue (positive for Epstein Barre virus)" (unspecified if ongoing), notes: chronic fatigue (positive for Epstein Barre virus),; "depression" (unspecified if ongoing); "positive for Epstein Barre virus" (unspecified if ongoing); "Allergy to animal(cats, dogs)" (unspecified if ongoing); "Dust allergy" (unspecified if ongoing); "Allergy to molds" (unspecified if ongoing); "Pollen allergy" (unspecified if ongoing); "some perfumes" (unspecified if ongoing). Concomitant medication(s) included: BENADRYL; XANAX; VITAMIN D NOS; FLOVENT; ALBUTEROL [SALBUTAMOL SULFATE]. Past drug history included: Tetracyline, reaction(s): "allergies:Tetracyline", notes: known allergies Tetracyline. Vaccination history included: BNT162b2 (lot number=EW0177, dose number=1, vaccine location=Left arm), administration date: 24May2021, for COVID-19 Immunization; BNT162b2 (lot number=EW019, dose number=2, vaccine location=Left arm), administration date: 14Jun2021, when the patient was 72-year-old, for COVID-19 Immunization. The following information was reported: CHILLS (non-serious) with onset 23Dec2021 at 22:00, outcome "recovered"; PYREXIA (non-serious) with onset 23Dec2021 at 22:00, outcome "recovered", described as "fever"; HEADACHE (non-serious) with onset 23Dec2021 at 22:00, outcome "recovered". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chills, headache, pyrexia. Additional information: Prior to vaccination patient was not diagnosed with COVID-19. The patient had not received any other vaccine within 4 weeks. Within 8 hours patient started with a really bad headache, chills, fever, basically as if she had the flu - this lasted a full day and a half from onset.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Epstein-Barr virus test, Headache, Pyrexia, SARS-CoV-2 test
Clinical narrative: chills; headache; fever; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (Pfizer-BioNTech COVID-19), on 23Dec2021 as dose 3 (booster), single (Lot number: FJ1611) at the age of 72 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "right branch bundle" (unspecified if ongoing); "diverticulosis" (unspecified if ongoing); "hiatal hernia" (unspecified if ongoing); "hemorrhoids" (unspecified if ongoing); "chronic fatigue (positive for Epstein Barre virus)" (unspecified if ongoing), notes: chronic fatigue (positive for Epstein Barre virus),; "depression" (unspecified if ongoing); "positive for Epstein Barre virus" (unspecified if ongoing); "Allergy to animal(cats, dogs)" (unspecified if ongoing); "Dust allergy" (unspecified if ongoing); "Allergy to molds" (unspecified if ongoing); "Pollen allergy" (unspecified if ongoing); "some perfumes" (unspecified if ongoing). Concomitant medication(s) included: BENADRYL; XANAX; VITAMIN D NOS; FLOVENT; ALBUTEROL [SALBUTAMOL SULFATE]. Past drug history included: Tetracyline, reaction(s): "allergies:Tetracyline", notes: known allergies Tetracyline. Vaccination history included: BNT162b2 (lot number=EW0177, dose number=1, vaccine location=Left arm), administration date: 24May2021, for COVID-19 Immunization; BNT162b2 (lot number=EW019, dose number=2, vaccine location=Left arm), administration date: 14Jun2021, when the patient was 72-year-old, for COVID-19 Immunization. The following information was reported: CHILLS (non-serious) with onset 23Dec2021 at 22:00, outcome "recovered"; PYREXIA (non-serious) with onset 23Dec2021 at 22:00, outcome "recovered", described as "fever"; HEADACHE (non-serious) with onset 23Dec2021 at 22:00, outcome "recovered". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chills, headache, pyrexia. Additional information: Prior to vaccination patient was not diagnosed with COVID-19. The patient had not received any other vaccine within 4 weeks. Within 8 hours patient started with a really bad headache, chills, fever, basically as if she had the flu - this lasted a full day and a half from onset.
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: 01/18/22 presents to ED for "recurrent abdominal pain". PMHx of "PAD, PCI with DES on brilinta" Recent PMH of "total aortic occlusion"
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Abdominal pain, COVID-19, SARS-CoV-2 test positive
Clinical narrative: 01/18/22 presents to ED for "recurrent abdominal pain". PMHx of "PAD, PCI with DES on brilinta" Recent PMH of "total aortic occlusion"
Age: 87.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Fall, SARS-CoV-2 test positive, Syncope
Clinical narrative: 02/14/22 presents to ED for "urinary retention, BLE swelling and decreased appetite". PMHx of "anemia, A fib, CKD, CHF"
Age: 87.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Decreased appetite, Peripheral swelling, SARS-CoV-2 test positive, Urinary retention
Clinical narrative: 02/14/22 presents to ED for "urinary retention, BLE swelling and decreased appetite". PMHx of "anemia, A fib, CKD, CHF"
Age: 94.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Failure to thrive, SARS-CoV-2 test positive
Clinical narrative: 01/26/22 presents to ED for "hypoxia". PMHx of "COPD, Afib on eliquis, and recent COVID pneumonia."
Age: 94.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Hypoxia, SARS-CoV-2 test positive
Clinical narrative: 01/26/22 presents to ED for "hypoxia". PMHx of "COPD, Afib on eliquis, and recent COVID pneumonia."
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Asthenia, COVID-19, Fall, SARS-CoV-2 test positive
Clinical narrative: 02/07/22 presents to ED for "fall". PMHx of "diabetes, not on insulin, CAD, CVA and  MI"
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Fall, SARS-CoV-2 test positive
Clinical narrative: 02/07/22 presents to ED for "fall". PMHx of "diabetes, not on insulin, CAD, CVA and  MI"
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: 02/10/22 presents to ED for "Altered Mental Status". PMHx of "hypertension, obesity, previous uterine cancer"
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Mental status changes, SARS-CoV-2 test positive
Clinical narrative: 02/10/22 presents to ED for "Altered Mental Status". PMHx of "hypertension, obesity, previous uterine cancer"
Age: 87.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pfizer COVID 19 vaccine had been stored improperly in freezer rather than fridge or ultra low freezer. Vaccine not viable
Age: 87.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Pfizer COVID 19 vaccine had been stored improperly in freezer rather than fridge or ultra low freezer. Vaccine not viable
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Mobility decreased
Clinical narrative: Reported having upper arm/ shoulder pain in the days after receiving the vaccine. Still has persisted into May.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Reported having upper arm/ shoulder pain in the days after receiving the vaccine. Still has persisted into May.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Wheezing
Clinical narrative: Whole body Bone hurt; whole body muscle bone hurt; This spontaneous case was reported by a nurse and describes the occurrence of BONE PAIN (Whole body Bone hurt) and MYALGIA (whole body muscle bone hurt) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007b21a and 002a21a) for COVID-19 vaccination.     Patient did not have a history of the following medical conditions such as Anaphylaxis, Asthma,  Hypersensitivity reactions, Hay fever, hives or urticaria.    On 24-Feb-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021 at 10:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced BONE PAIN (Whole body Bone hurt) and MYALGIA (whole body muscle bone hurt). At the time of the report, BONE PAIN (Whole body Bone hurt) and MYALGIA (whole body muscle bone hurt) outcome was unknown.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient's weight was reported as 210. Lab test such as Body temperature, Heart rate , Respiratory rate and blood pressure measurement was not done. Concomitant medication information was not provided by the reporter. Treatment information was not provided by the reporter. This case was linked to MOD-2022-555946, MOD-2022-556083 (Patient Link).
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Bone pain, Myalgia
Clinical narrative: Whole body Bone hurt; whole body muscle bone hurt; This spontaneous case was reported by a nurse and describes the occurrence of BONE PAIN (Whole body Bone hurt) and MYALGIA (whole body muscle bone hurt) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007b21a and 002a21a) for COVID-19 vaccination.     Patient did not have a history of the following medical conditions such as Anaphylaxis, Asthma,  Hypersensitivity reactions, Hay fever, hives or urticaria.    On 24-Feb-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021 at 10:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced BONE PAIN (Whole body Bone hurt) and MYALGIA (whole body muscle bone hurt). At the time of the report, BONE PAIN (Whole body Bone hurt) and MYALGIA (whole body muscle bone hurt) outcome was unknown.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient's weight was reported as 210. Lab test such as Body temperature, Heart rate , Respiratory rate and blood pressure measurement was not done. Concomitant medication information was not provided by the reporter. Treatment information was not provided by the reporter. This case was linked to MOD-2022-555946, MOD-2022-556083 (Patient Link).
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Heart rate irregular
Clinical narrative: Whole body Bone hurt; whole body muscle bone hurt; This spontaneous case was reported by a nurse and describes the occurrence of BONE PAIN (Whole body Bone hurt) and MYALGIA (whole body muscle bone hurt) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007b21a and 002a21a) for COVID-19 vaccination.     Patient did not have a history of the following medical conditions such as Anaphylaxis, Asthma,  Hypersensitivity reactions, Hay fever, hives or urticaria.    On 24-Feb-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021 at 10:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced BONE PAIN (Whole body Bone hurt) and MYALGIA (whole body muscle bone hurt). At the time of the report, BONE PAIN (Whole body Bone hurt) and MYALGIA (whole body muscle bone hurt) outcome was unknown.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient's weight was reported as 210. Lab test such as Body temperature, Heart rate , Respiratory rate and blood pressure measurement was not done. Concomitant medication information was not provided by the reporter. Treatment information was not provided by the reporter. This case was linked to MOD-2022-555946, MOD-2022-556083 (Patient Link).
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Insomnia, Nervous system disorder, Tinnitus
Clinical narrative: Ringing in ear created an effect that triggers vertigo; Ringing in ear created an effect that triggers vertigo; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient received BNT162b2 (BNT162B2), on 08Dec2021 as dose 3 (booster), single (Lot number: 3313BA) at the age of 47 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "vertigo", start date: 26Nov2020, stop date: 26Nov2020. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1:, Batch/lot number EP7533, Dosage text First dose, arm, doesn't recall if left or right arm.), administration date: 31Mar2021, when the patient was 46-year-old, for Covid-19 Immunization, reaction(s): "Ringing in ears"; BNT162b2 (Dose: 2, Lot:, EW0161, Location: Arm), administration date: 21Apr2021, when the patient was 46-year-old, for Covid-19 Immunization, reaction(s): "Ringing in ears", "some trouble in sleeping because of the ringing", "ringing in ears has gotten worse".  The following information was reported: TINNITUS (non-serious), outcome "not recovered", VERTIGO (non-serious), outcome "unknown" and all described as "Ringing in ear created an effect that triggers vertigo".  Additional Information: The patient two days after the caller received Pfizer Covid 19 Vaccine, the caller noticed a ringing in ears. About one week later, was advised by doctor that the ringing in ears should go away within 90 days. Unfortunately, the ringing in ears has been going on for a year and has not stopped. She received booster dose Pfizer Covid 19 Vaccine on 08Dec2021, not in Jun2021. Her height: 5'2 or 5'3, feels like shrinking. She clarifies feeling like shrinking did not occur after receiving any dose of Pfizer Covid 19 Vaccine, it was just because the she was getting old.She did not taken other products. The ringing in ear also created an effect that triggers vertigo. The caller's vertigo would come and go prior to receiving the Pfizer Covid 19 Vaccine, now after receiving Pfizer Covid 19 Vaccine, the ringing in ear was constant and has gotten loud and the vertigo is an everyday issue. She did not taken prior vaccinations (within 4 weeks) any other vaccinations within four weeks prior to the first administration date of the suspect vaccine and none relevant tests.  No follow up attempts are needed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus, Vertigo
Clinical narrative: Ringing in ear created an effect that triggers vertigo; Ringing in ear created an effect that triggers vertigo; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient received BNT162b2 (BNT162B2), on 08Dec2021 as dose 3 (booster), single (Lot number: 3313BA) at the age of 47 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "vertigo", start date: 26Nov2020, stop date: 26Nov2020. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1:, Batch/lot number EP7533, Dosage text First dose, arm, doesn't recall if left or right arm.), administration date: 31Mar2021, when the patient was 46-year-old, for Covid-19 Immunization, reaction(s): "Ringing in ears"; BNT162b2 (Dose: 2, Lot:, EW0161, Location: Arm), administration date: 21Apr2021, when the patient was 46-year-old, for Covid-19 Immunization, reaction(s): "Ringing in ears", "some trouble in sleeping because of the ringing", "ringing in ears has gotten worse".  The following information was reported: TINNITUS (non-serious), outcome "not recovered", VERTIGO (non-serious), outcome "unknown" and all described as "Ringing in ear created an effect that triggers vertigo".  Additional Information: The patient two days after the caller received Pfizer Covid 19 Vaccine, the caller noticed a ringing in ears. About one week later, was advised by doctor that the ringing in ears should go away within 90 days. Unfortunately, the ringing in ears has been going on for a year and has not stopped. She received booster dose Pfizer Covid 19 Vaccine on 08Dec2021, not in Jun2021. Her height: 5'2 or 5'3, feels like shrinking. She clarifies feeling like shrinking did not occur after receiving any dose of Pfizer Covid 19 Vaccine, it was just because the she was getting old.She did not taken other products. The ringing in ear also created an effect that triggers vertigo. The caller's vertigo would come and go prior to receiving the Pfizer Covid 19 Vaccine, now after receiving Pfizer Covid 19 Vaccine, the ringing in ear was constant and has gotten loud and the vertigo is an everyday issue. She did not taken prior vaccinations (within 4 weeks) any other vaccinations within four weeks prior to the first administration date of the suspect vaccine and none relevant tests.  No follow up attempts are needed. No further information is expected.
Age: 12.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Wrong product administered
Clinical narrative: VACCINE WAS GIVEN TO A 12 YEARS OLD; 0.3 ML OF THE JANSSEN COVID-19 VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a 12 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A expiry: 08-SEP-2022) .3 ml, administered on 07-MAY-2022 10:30 for prophylactic vaccination. Age at time of vaccination 12 years old. No concomitant medications were reported. On 07-MAY-2022, the patient experienced vaccine was given to a 12 years old, and 0.3 ml of the janssen covid-19 vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine was given to a 12 years old and 0.3 ml of the janssen covid-19 vaccine administered was not reported. This report was non-serious.
Age: 12.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: VACCINE WAS GIVEN TO A 12 YEARS OLD; 0.3 ML OF THE JANSSEN COVID-19 VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a 12 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A expiry: 08-SEP-2022) .3 ml, administered on 07-MAY-2022 10:30 for prophylactic vaccination. Age at time of vaccination 12 years old. No concomitant medications were reported. On 07-MAY-2022, the patient experienced vaccine was given to a 12 years old, and 0.3 ml of the janssen covid-19 vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine was given to a 12 years old and 0.3 ml of the janssen covid-19 vaccine administered was not reported. This report was non-serious.
Age: 12.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: VACCINE WAS GIVEN TO A 12 YEARS OLD; 0.3 ML OF THE JANSSEN COVID-19 VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a 12 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A expiry: 08-SEP-2022) .3 ml, administered on 07-MAY-2022 10:30 for prophylactic vaccination. Age at time of vaccination 12 years old. No concomitant medications were reported. On 07-MAY-2022, the patient experienced vaccine was given to a 12 years old, and 0.3 ml of the janssen covid-19 vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine was given to a 12 years old and 0.3 ml of the janssen covid-19 vaccine administered was not reported. This report was non-serious.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Accidental underdose, Fatigue, Lethargy
Clinical narrative: Patient received 0.3 ml; This spontaneous case was reported by a consumer and describes the occurrence of UNDERDOSE (Patient received 0.3 ml) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Patient had no acute illness at the time of vaccination ad up to one month before. Also patient was never diagnosed or tested positive for COVID-19.  The patient's past medical history included Hay fever (Allergy injections result in very minor symptoms) in 1950. Concurrent medical conditions included Blood pressure high (Meds have reduced BP but still on high side) since 1990, High cholesterol (Meds have reduced.  Slightly hi) since 1995, Gout (mprovement-Taking Allpurinol, 300mg No symptoms) since 1998 and Anxiety (Reduced level of anxiety) since 2008. Concomitant products included AMLODIPINE BESYLATE and IRBESARTAN for Blood pressure high, ALLOPURINOL for Gout, ESCITALOPRAM for Tension.    On 04-Mar-2021 at 6:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .3 milliliter. On 04-Mar-2021 at 6:00 PM, the patient experienced UNDERDOSE (Patient received 0.3 ml). At the time of the report, UNDERDOSE (Patient received 0.3 ml) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medication was reported as allergy injections every 3 weeks Injections for Extract (start date: 2016). The body site for vaccination was reported as Muscle/Arm. Other vaccines received within one month prior to any dose of moderna was reported as allergy injections in both arms on 03-Feb-2021 and 24-Mar-2021  No treatment medications were reported.   This case was linked to MOD-2022-560590, MOD-2022-557731 (Patient Link).
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Underdose
Clinical narrative: Patient received 0.3 ml; This spontaneous case was reported by a consumer and describes the occurrence of UNDERDOSE (Patient received 0.3 ml) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Patient had no acute illness at the time of vaccination ad up to one month before. Also patient was never diagnosed or tested positive for COVID-19.  The patient's past medical history included Hay fever (Allergy injections result in very minor symptoms) in 1950. Concurrent medical conditions included Blood pressure high (Meds have reduced BP but still on high side) since 1990, High cholesterol (Meds have reduced.  Slightly hi) since 1995, Gout (mprovement-Taking Allpurinol, 300mg No symptoms) since 1998 and Anxiety (Reduced level of anxiety) since 2008. Concomitant products included AMLODIPINE BESYLATE and IRBESARTAN for Blood pressure high, ALLOPURINOL for Gout, ESCITALOPRAM for Tension.    On 04-Mar-2021 at 6:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .3 milliliter. On 04-Mar-2021 at 6:00 PM, the patient experienced UNDERDOSE (Patient received 0.3 ml). At the time of the report, UNDERDOSE (Patient received 0.3 ml) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medication was reported as allergy injections every 3 weeks Injections for Extract (start date: 2016). The body site for vaccination was reported as Muscle/Arm. Other vaccines received within one month prior to any dose of moderna was reported as allergy injections in both arms on 03-Feb-2021 and 24-Mar-2021  No treatment medications were reported.   This case was linked to MOD-2022-560590, MOD-2022-557731 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Dyspnoea, SARS-CoV-2 test positive
Clinical narrative: 02/09/22 presents to EC ED for "Shortness of Breath". PMHx of "DM, COPD (no home O2), HTN, ESRD M/W/F HD" "hypothyroid, CHF"
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Eye oedema, SARS-CoV-2 test positive
Clinical narrative: 02/12/22 presents to ED for "R shoulder pain and R sided flank pain". PMHx of "HTN, lupus".
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, COVID-19, Flank pain, SARS-CoV-2 test positive
Clinical narrative: 02/12/22 presents to ED for "R shoulder pain and R sided flank pain". PMHx of "HTN, lupus".
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Sluggishness
Clinical narrative: A little sluggish; My arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of SLUGGISHNESS (A little sluggish) and PAIN IN EXTREMITY (My arm was sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     It was unknown if patient had allergies to medications, food and other products. It was unknown if patient had Acute and Chronic illnesses at the time of vaccination.     On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced SLUGGISHNESS (A little sluggish) and PAIN IN EXTREMITY (My arm was sore). At the time of the report, SLUGGISHNESS (A little sluggish) and PAIN IN EXTREMITY (My arm was sore) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication was provided. It was unknown if other vaccines were given within 1 month prior to Moderna COVID-19 vaccine.  On 11-Mar-2021, the patient received the full dose of Moderna COVID-19 vaccine.  No treatment medication was provided.   This case was linked to MOD-2022-561910, MOD-2022-561912.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 09-May-2022: Follow up includes no new information.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Patient received 0.5 ml of Pfizer covid 19 vaccine for their second booster. Patient is not experiencing any side effects at the moment the phone call was made but was instructed to monitor any unusual side effects/symptoms for the next week.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Patient received 0.5 ml of Pfizer covid 19 vaccine for their first booster. Patient is not experiencing any side effects at the moment the phone call was made but was instructed to monitor any unusual side effects/symptoms for the next week.
Age: 58.0
Sex: F
Vaccine: UNK
Symptoms: Headache, Injection site rash, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Nausea, headache, fever, sore arm, large rash over injection site - within hours of injection, going into 3 days now.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: Patient received 0.5 ml of Pfizer covid 19 vaccine for their second dose. Patient is not experiencing any side effects at the moment the phone call was made but was instructed to monitor any unusual side effects/symptoms for the next week.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Injected limb mobility decreased, Mass, Pain in extremity, Rash, Ultrasound scan abnormal
Clinical narrative: Two days after I got my vaccine, my left arm started hurting really bad at my inner elbow. It was the same arm I received my vaccine on. The pain started to get so severe that I couldn't extend my arm. Then I noticed a bumpy mass that had formed there on my inner elbow. I went to my Dr., and was given antibiotics and was sent to a Radiology office for an Ultrasound of my arm. The results showed some kind of mass. I'm still not sure what the mass is. Although it's gotten smaller over time, it still remains a little sore.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Dyspnoea, Heart rate increased, Sleep disorder
Clinical narrative: Every time I take a nap or fall asleep, I either wake up gasping for air or I feel pain in my heart with rapid heartbeat.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site mass, Pain in extremity
Clinical narrative: My reaction still hadn't subsided after my 1st vaccine, I was nervous, but knew I needed the 2nd one. I decided to get this one in my right arm instead. The same thing happened. My right arm started hurting really bad at my inner elbow, and I got another bumpy mass on my inner elbow. This mass wasn't as big as the left one had been. I haven't gone back to my Dr. because it was the same as before with no and a diagnosis.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram thorax abnormal, Condition aggravated, Rheumatoid arthritis, Small airways disease, Systemic lupus erythematosus
Clinical narrative: I was recently diagnosed with Mosiac Lung disease and I've been in a Lupus and RA flare 1 week after booster.
Sex: U
Vaccine: MMRV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE details.; Physician assistant calling to report PROQUAD administered to patient too early. First dose given 2/22/2022. Second dose given 4/6/2022.; This spontaneous report as received from a physician assistant refers to a patient of unknown age and gender. Patient's concomitant medications, pertinent medical history, concurrent conditions and drug reactions/allergies were not reported.  On 22-FEB-2022, the patient was vaccinated with the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (dose, strength, route of administration, expiration date and lot number were not reported) for prophylaxis.  On 06-APR-2022, the patient was vaccinated with the second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (dose, strength, route of administration, expiration date and lot number were not reported) for prophylaxis (inappropriate schedule of product administration). The vaccine was reconstituted with sterile diluent (STERILE DILUENT) (dose, route of administration, lot number and expiration date were not provided). The physician assistant also had follow-up question in regards to whether the patient was considered fully vaccinated. No additional adverse event (AE) details (no adverse event). No product quality complaint (PQC).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE's and no PQC's were reported.; An improperly stored dose of VARIVAX was administered to a patient.; This spontaneous report was received from a medical assistant  and refers to a patient of unknown age and gender  The patient's medical history, concurrent conditions, concomitant therapies and drug reactions or allergies were not reported.  On 09-APR-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, used as directed to prevent varicella infection, lot #T017685, which was confirmed to be a valid number, and expiration date: 21-MAY-2022, administered for prophylaxis (dose, vaccination scheme frequency, route of administration, and anatomical location were not provided). It was reported that the patient did not experienced any adverse event.
Age: 4.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE reported; four year old patient was accidently administered GARDASIL 9 today, Apr 18, 2022; This spontaneous report was received from a registered nurse and refers to a 4-year-old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported.  On 18-APR-2022, the patient was administered with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, frequency reported as once, lot #T028583, expiration date: 04-MAR-2023, (dose, site and route of administration were not provided) for prophylaxis (Product administered to patient of inappropriate age). No additional adverse event was reported.
Sex: F
Vaccine: HPV9
Symptoms: Mobility decreased, Myalgia, Pain in extremity
Clinical narrative: difficulty raising her arm; very sore arm and deltoid; very sore arm and deltoid; This spontaneous report was received from a medical assistant via company representative. The patient was reporting on herself- currently 38-year-old female. The patient's medical history, concomitant medications, concurrent conditions and drug allergies were not reported.  On an unknown date, the patient was vaccinated with the first dose of HPV rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (exact dose, route of administration, injection site, lot number and expiration date were not reported) for prophylaxis. On an unknown date in February 2022, the patient was vaccinated with second dose of HPV rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (exact dose, route of administration, injection site, lot number and expiration date were not reported) for prophylaxis.   On an unknown date in February 2022, the patient experienced very sore arm and deltoid, and had difficulties with raising her arm. It was unknown if the patient sought medical attention or if the treatment was given for reported adverse events. The outcome of the events was unknown.  The relatedness between the events and HPV rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was unknown.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE information.; Nurse practitioner reported expired dose of PNEUMOVAX23 administered to patient.; This spontaneous report was received from a nurse practitioner (also reported as nurse prescriber) and refers to a patient of unknown age and gender. There was no information regarding patient's medical history, concurrent conditions or concomitant therapies provided.  On 20-APR-2022, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5 milliliter injection, lot # T027110, expiration date: 23-MAR-2022, (route of administration and anatomical location were not provided) for prophylaxis. No adverse events reported.
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; reporting administration of an expired PROQUAD; This spontaneous report was received from a registered nurse, who was transferred on the line by Customer Center and refers to a 5-year-old patient of unknown gender. The patient's medical history, concomitant medications, concurrent conditions and drug reactions/ allergies were not reported.  On 20-APR-2022, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) lot # T035408 was found to be valid, expiration date 14-APR-2022, frequency reported as: 1 (strength, dose, route of administration and injection site were not reported) for prophylaxis. The reporter confirmed that the vaccine was stored per the recommended storage range until administration. No additional adverse events (AE) were reported.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered
Clinical narrative: Medical Assistant reported an expired dose of PROQUAD was administered to a patient.; This spontaneous report was received from a medical assistant and refers to a 4-year-old patient of unknown gender. The patient's concurrent conditions, concomitant therapies and medical history were not provided.  On 22-APR-2022, the patient was vaccinated with expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant Human albumin (rHA) (PROQUAD) 1 dose, 0.5 ml, administered subcutaneously, lot # T032148, expiration date 20-MAR-2022 (anatomical location was not provided) for prophylaxis (expired product administered).
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No other AE; reports administration of vaccine following temperature excursion; 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 medical history, concurrent conditions or concomitant therapies was provided.   On 28-APR-2022, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) route of administration defaulted to oral, 2 milliliter, lot #1821247, expiration date: 23-JUL-2022 (strength was not provided) for prophylaxis (Product storage error). No adverse events were reported (No adverse event).  On an unknown date, before the vaccination, the sample of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) underwent a temperature excursion at 11.4 Celsius degrees (C) for 4 hours and 45 minutes. Previous temperature excursion at 10.7C for 1 our and 15 minutes was also reported.