chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: She knows a lot of people that didn't take 2nd dose because of side effects.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (She knows a lot of people that didn't take 2nd dose because of side effects.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (She knows a lot of people that didn't take 2nd dose because of side effects.). At the time of the report, VACCINATION COMPLICATION (She knows a lot of people that didn't take 2nd dose because of side effects.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was provided by the reporter. No treatment medication was provided.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma and Hypersensitivity. Concomitant products included CEFPODOXIME PROXETIL, CLAVULANATE POTASSIUM for Allergy, MONTELUKAST SODIUM for Asthma, IRBESARTAN for Blood pressure, FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) and BUDESONIDE for Chronic sinusitis, PRAVASTATIN, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) and DENOSUMAB (PROLIA) for an unknown indication.    On 20-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication was provided.   This case was linked to MOD-2021-328250.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: dose given past the 12 hour post puncture time; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose given past the 12 hour post puncture time) in an 18-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 15-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose given past the 12 hour post puncture time). On 15-Sep-2021, EXPIRED PRODUCT ADMINISTERED (dose given past the 12 hour post puncture time) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment information was reported.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose given past the 12 hour post puncture time) in a 48-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 15-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose given past the 12 hour post puncture time). On 15-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Dose given past the 12 hour post puncture time) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication use was unknown. Treatment information was unknown  This case was linked to MOD-2021-327879.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Sleep disorder, Vomiting
Clinical narrative: Pain in left breast; Pounding heart; Brain fog; Bowel pain; Wakes out of deep sleep; Headache; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of BREAST PAIN (Pain in left breast), PALPITATIONS (Pounding heart), FEELING ABNORMAL (Brain fog), ABDOMINAL PAIN (Bowel pain) and SLEEP DISORDER (Wakes out of deep sleep) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 062E21A and 091D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Tumor and Surgical procedure. Concurrent medical conditions included Celiac disease.   On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Aug-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 experienced BREAST PAIN (Pain in left breast), PALPITATIONS (Pounding heart), FEELING ABNORMAL (Brain fog), ABDOMINAL PAIN (Bowel pain), SLEEP DISORDER (Wakes out of deep sleep), HEADACHE (Headache) and VOMITING (Vomiting). At the time of the report, BREAST PAIN (Pain in left breast), PALPITATIONS (Pounding heart), FEELING ABNORMAL (Brain fog), ABDOMINAL PAIN (Bowel pain), SLEEP DISORDER (Wakes out of deep sleep), HEADACHE (Headache) and VOMITING (Vomiting) outcome was unknown.            No concomitant treatment was provided. No treatment medication was provided.   This case was linked to MOD-2021-329010.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Immobile, Pain, Respiration abnormal
Clinical narrative: became almost immobile; chronic severe pain to the point of immobility; Abnormal breathing; joint pain; This spontaneous case was reported by a patient family member or friend and describes the occurrence of IMMOBILE (became almost immobile), PAIN (chronic severe pain to the point of immobility), RESPIRATION ABNORMAL (Abnormal breathing) and ARTHRALGIA (joint pain) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Osteoarthritis (osteoarthritis in her spine and hip).    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 IMMOBILE (became almost immobile), PAIN (chronic severe pain to the point of immobility), RESPIRATION ABNORMAL (Abnormal breathing) and ARTHRALGIA (joint pain). At the time of the report, IMMOBILE (became almost immobile), PAIN (chronic severe pain to the point of immobility), RESPIRATION ABNORMAL (Abnormal breathing) and ARTHRALGIA (joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was reported.; Sender's Comments: This case concerns a 90 year-old female patient with medical history of osteoarthritis, who experienced the unexpected non-serious event of Became almost immobile. The event occurred an unknown number of days after an unspecified dose of mRNA-1273 vaccine. Seriousness criteria of Medically significant override completed based on medical judgement and review of source document that does not support seriousness criteria.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder and Allergy. Concomitant products included SYNTHROID for Thyroid disorder, SINGULAIR, CLARITINE, FAMOTIDINE, and VITAMIN D3 for an unknown indication.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA. The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, MYALGIA outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       This case was linked to MOD-2021-328256 (Patient Link).
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Influenza, Myalgia, Pain, Pyrexia
Clinical narrative: like a severe case of the flu and dry heat for like 6 hours; pain; Fever; vomiting; aches; headaches; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (like a severe case of the flu and dry heat for like 6 hours), PAIN (pain), PYREXIA (Fever), VOMITING (vomiting) and MYALGIA (aches) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A, 042L20A and 050E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) for Allergy, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder, MONTELUKAST SODIUM (SINGULAIR), FAMOTIDINE and COLECALCIFEROL (VITAMIN D3) for an unknown indication.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA (like a severe case of the flu and dry heat for like 6 hours), PAIN (pain), PYREXIA (Fever), VOMITING (vomiting), MYALGIA (aches) and HEADACHE (headaches). The patient was treated with IBUPROFEN for Pain, at an unspecified dose and frequency. At the time of the report, INFLUENZA (like a severe case of the flu and dry heat for like 6 hours), PAIN (pain), PYREXIA (Fever), VOMITING (vomiting), MYALGIA (aches) and HEADACHE (headaches) outcome was unknown.            This case was linked to MOD-2021-328226, MOD-2021-328265.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: like a severe case of the flu and dry heat for like 6 hours; pain; Fever; vomiting; aches; headaches; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (like a severe case of the flu and dry heat for like 6 hours), PAIN (pain), PYREXIA (Fever), VOMITING (vomiting) and MYALGIA (aches) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A, 042L20A and 050E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) for Allergy, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder, MONTELUKAST SODIUM (SINGULAIR), FAMOTIDINE and COLECALCIFEROL (VITAMIN D3) for an unknown indication.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA (like a severe case of the flu and dry heat for like 6 hours), PAIN (pain), PYREXIA (Fever), VOMITING (vomiting), MYALGIA (aches) and HEADACHE (headaches). The patient was treated with IBUPROFEN for Pain, at an unspecified dose and frequency. At the time of the report, INFLUENZA (like a severe case of the flu and dry heat for like 6 hours), PAIN (pain), PYREXIA (Fever), VOMITING (vomiting), MYALGIA (aches) and HEADACHE (headaches) outcome was unknown.            This case was linked to MOD-2021-328226, MOD-2021-328265.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Fibromyalgia, Myalgia, Pain, Pain in extremity, Vaccination site erythema
Clinical narrative: Ache in her hand; Felt pain all over; She felt like she had fibromyalgia attach; Body ache all over; Her arm was really red for 3 or 4 days at the injection site.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Ache in her hand), PAIN (Felt pain all over), FIBROMYALGIA (She felt like she had fibromyalgia attach), MYALGIA (Body ache all over) and VACCINATION SITE ERYTHEMA (Her arm was really red for 3 or 4 days at the injection site.) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 040A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced PAIN IN EXTREMITY (Ache in her hand), PAIN (Felt pain all over), FIBROMYALGIA (She felt like she had fibromyalgia attach), MYALGIA (Body ache all over) and VACCINATION SITE ERYTHEMA (Her arm was really red for 3 or 4 days at the injection site.). In April 2021, PAIN IN EXTREMITY (Ache in her hand), FIBROMYALGIA (She felt like she had fibromyalgia attach), MYALGIA (Body ache all over) and VACCINATION SITE ERYTHEMA (Her arm was really red for 3 or 4 days at the injection site.) had resolved. At the time of the report, PAIN (Felt pain all over) had resolved.            In Concomitant  products Blood pressure medications were reported. No Treatment details were reported.; Sender's Comments: This case concerns a 72-year-old, female patient with no relevant medical history, who experienced the unexpected event of fibromyalgia, pain in extremity and pain along with expected  events of myalgia and vaccination site erythema. The event occurred approximately 1 day after the second dose of Moderna COVID-19 Vaccine. The rechallenge was not applicable as events occurred after second dose and no further dosing was reported or planned, based on information provided.The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: arm pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (arm pain). At the time of the report, VACCINATION SITE PAIN (arm pain) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant drug details were reported. No treatment details were reported.   This case was linked to MOD-2021-328331, MOD-2021-328332 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia, Vaccination site erythema
Clinical narrative: Arm redness/entire upper left arm was red; Fatigue; Fever; This spontaneous case was reported by an other health care professional and describes the occurrence of FATIGUE (Fatigue), PYREXIA (Fever) and VACCINATION SITE ERYTHEMA (Arm redness/entire upper left arm was red) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 042L20A) for COVID-19 vaccination.     The patient's past medical history included Lymph node dissection (Around the time she got the first dose, she was recovering from surgery (two lymph nodes were removed due to the cancer).) in January 2021. Concurrent medical conditions included Cancer. Concomitant products included GABAPENTIN for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced FATIGUE (Fatigue) and PYREXIA (Fever). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Arm redness/entire upper left arm was red). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, FATIGUE (Fatigue) and PYREXIA (Fever) had resolved and VACCINATION SITE ERYTHEMA (Arm redness/entire upper left arm was red) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided. For second shot she was with radiation.  The arm redness didn't start until 2 days after second shot, and it lasted several days, might be a week.   This case was linked to MOD-2021-328337, MOD-2021-328319 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Feeling abnormal, Heart rate, Hepatic enzyme
Clinical narrative: My thyroid is way up/ TSH is 4.46/ My thyroid level is dramatically different; Felt crummy; Exhausted/ Feel so tired; Fever; This spontaneous case was reported by an other health care professional and describes the occurrence of THYROID DISORDER (My thyroid is way up/ TSH is 4.46/ My thyroid level is dramatically different), FEELING ABNORMAL (Felt crummy), FATIGUE (Exhausted/ Feel so tired) and PYREXIA (Fever) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C21A, 042L20 and 016M20A) for COVID-19 vaccination.     The patient's past medical history included Chemotherapy in March 2021. Concurrent medical conditions included Cancer and Thyroid disorder. Concomitant products included GABAPENTIN (GABA [GABAPENTIN]) for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced FEELING ABNORMAL (Felt crummy), FATIGUE (Exhausted/ Feel so tired) and PYREXIA (Fever). On 22-Sep-2021, the patient experienced THYROID DISORDER (My thyroid is way up/ TSH is 4.46/ My thyroid level is dramatically different). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, THYROID DISORDER (My thyroid is way up/ TSH is 4.46/ My thyroid level is dramatically different), FEELING ABNORMAL (Felt crummy) and FATIGUE (Exhausted/ Feel so tired) had not resolved and PYREXIA (Fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, Body temperature: 102.5 (High) Seven hours after third shot, the patient had fever of 102.5 F. In September 2021, Heart rate: 105 (High) Pulse was 105. On 22-Sep-2021, Blood thyroid stimulating hormone: 4.46 (High) TSH is 4.46. On 22-Sep-2021, Hepatic enzyme: 1.12 (High) liver enzyme slightly up 1.12.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient received third shot while being on chemotherapy (1 week on, 1 week off).   This case was linked to MOD-2021-328294, MOD-2021-328337, MOD-2021-328294 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Thyroid disorder
Clinical narrative: My thyroid is way up/ TSH is 4.46/ My thyroid level is dramatically different; Felt crummy; Exhausted/ Feel so tired; Fever; This spontaneous case was reported by an other health care professional and describes the occurrence of THYROID DISORDER (My thyroid is way up/ TSH is 4.46/ My thyroid level is dramatically different), FEELING ABNORMAL (Felt crummy), FATIGUE (Exhausted/ Feel so tired) and PYREXIA (Fever) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C21A, 042L20 and 016M20A) for COVID-19 vaccination.     The patient's past medical history included Chemotherapy in March 2021. Concurrent medical conditions included Cancer and Thyroid disorder. Concomitant products included GABAPENTIN (GABA [GABAPENTIN]) for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced FEELING ABNORMAL (Felt crummy), FATIGUE (Exhausted/ Feel so tired) and PYREXIA (Fever). On 22-Sep-2021, the patient experienced THYROID DISORDER (My thyroid is way up/ TSH is 4.46/ My thyroid level is dramatically different). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, THYROID DISORDER (My thyroid is way up/ TSH is 4.46/ My thyroid level is dramatically different), FEELING ABNORMAL (Felt crummy) and FATIGUE (Exhausted/ Feel so tired) had not resolved and PYREXIA (Fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, Body temperature: 102.5 (High) Seven hours after third shot, the patient had fever of 102.5 F. In September 2021, Heart rate: 105 (High) Pulse was 105. On 22-Sep-2021, Blood thyroid stimulating hormone: 4.46 (High) TSH is 4.46. On 22-Sep-2021, Hepatic enzyme: 1.12 (High) liver enzyme slightly up 1.12.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient received third shot while being on chemotherapy (1 week on, 1 week off).   This case was linked to MOD-2021-328294, MOD-2021-328337, MOD-2021-328294 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: fatigue; fever; This spontaneous case was reported by an other health care professional and describes the occurrence of FATIGUE (fatigue) and PYREXIA (fever) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     The patient's past medical history included Chemotherapy (in March around 6 months ago) and Surgery (two lymph nodes were removed due to the cancer.). Concurrent medical conditions included Cancer. Concomitant products included GABAPENTIN for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced FATIGUE (fatigue) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, FATIGUE (fatigue) and PYREXIA (fever) had resolved.        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.   It was reported that symptoms started maybe 12 hours after first and second shots. These symptoms went away after a couple of days.  Psychologist mentioned that around the time she got the first dose, she was recovering from surgery (two lymph nodes were removed due to the cancer).   This case was linked to MOD-2021-328294, MOD-2021-328319.
Sex: F
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, Pain of skin, Pyrexia
Clinical narrative: I got COVID virus and was mostly a- symptomatic; Skin hurt, Head to toe; Fever; This spontaneous case was reported by an other health care professional and describes the occurrence of ASYMPTOMATIC COVID-19 (I got COVID virus and was mostly a- symptomatic), PAIN OF SKIN (Skin hurt, Head to toe) and PYREXIA (Fever) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASYMPTOMATIC COVID-19 (I got COVID virus and was mostly a- symptomatic), PAIN OF SKIN (Skin hurt, Head to toe) and PYREXIA (Fever). At the time of the report, ASYMPTOMATIC COVID-19 (I got COVID virus and was mostly a- symptomatic) outcome was unknown and PAIN OF SKIN (Skin hurt, Head to toe) and PYREXIA (Fever) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment medication was provided.   This case was linked to MOD-2021-272097.; Sender's Comments: This case concerns an unknown age female patient with no relevant medical history, who experienced the unexpected events of asymptomatic COVID-19 and pain of skin and the expected event of pyrexia. The events occurred after the second dose of mRNA-1273 vaccine. Based on the current available information and temporal association between the use of the product and the start date of events of pain of skin and pyrexia, a causal relationship cannot be excluded. For the event asymptomatic COVID-19, based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination, hence causality is assessed as not applicable. The rechallenge was not applicable since no information about the first dose was available and no additional dosing will be given. The event pyrexia is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273 in not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: tinnitus crunching and whooshing sounds in ears.; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (tinnitus crunching and whooshing sounds in ears.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (tinnitus crunching and whooshing sounds in ears.). At the time of the report, TINNITUS (tinnitus crunching and whooshing sounds in ears.) outcome was unknown.            No concomitant medication were provided. No treatment details were provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: very very sore on arm; felt extremely fatigued; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (very very sore on arm) and FATIGUE (felt extremely fatigued) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PANTOPRAZOLE for Acid reflux (oesophageal).    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (very very sore on arm) and FATIGUE (felt extremely fatigued). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (very very sore on arm) and FATIGUE (felt extremely fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) and on 18-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route).   This case was linked to MOD-2021-328497, MOD-2021-328498.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Mastication disorder, Pain in jaw, Rash, Rash pruritic
Clinical narrative: like welts / like hives on her skin; specially when she was in the sun she had this itchy rashes; her jaw was very sore on the left side; it was actually hard to chew/ sometimes it's still extremely painful to chew; started having weird rashes, mostly in her arms; months after she could still feel pain on the injection site; very very tired; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA, RASH PRURITIC, PAIN IN JAW, MASTICATION DISORDER and RASH in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 41L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included PANTOPRAZOLE for Acid reflux (esophageal).    On 15-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA, RASH PRURITIC, PAIN IN JAW, MASTICATION DISORDER, RASH, VACCINATION SITE PAIN, and FATIGUE. The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, URTICARIA, RASH PRURITIC, PAIN IN JAW, MASTICATION DISORDER, RASH, VACCINATION SITE PAIN, and FATIGUE outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-328497, MOD-2021-328467 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Vaccination site pain
Clinical narrative: like welts / like hives on her skin; specially when she was in the sun she had this itchy rashes; her jaw was very sore on the left side; it was actually hard to chew/ sometimes it's still extremely painful to chew; started having weird rashes, mostly in her arms; months after she could still feel pain on the injection site; very very tired; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA, RASH PRURITIC, PAIN IN JAW, MASTICATION DISORDER and RASH in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 41L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included PANTOPRAZOLE for Acid reflux (esophageal).    On 15-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA, RASH PRURITIC, PAIN IN JAW, MASTICATION DISORDER, RASH, VACCINATION SITE PAIN, and FATIGUE. The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, URTICARIA, RASH PRURITIC, PAIN IN JAW, MASTICATION DISORDER, RASH, VACCINATION SITE PAIN, and FATIGUE outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-328497, MOD-2021-328467 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose, Headache
Clinical narrative: headache after 2nd shot; Received 6 doses in one shot for the 2nd dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache after 2nd shot) and ACCIDENTAL OVERDOSE (Received 6 doses in one shot for the 2nd dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Sep-2021, the patient experienced HEADACHE (headache after 2nd shot) and ACCIDENTAL OVERDOSE (Received 6 doses in one shot for the 2nd dose). On 20-Sep-2021, ACCIDENTAL OVERDOSE (Received 6 doses in one shot for the 2nd dose) had resolved. At the time of the report, HEADACHE (headache after 2nd shot) outcome was unknown.            Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine was given to 10 patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine was given to 10 patients) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine was given to 10 patients). On 09-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine was given to 10 patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was reported.  No concomitant medication was reported.  Initially, other Health Care professional reported AE patients who received second dose, and Consent for Safety to follow up: Provided   Further, query was updated from Safety in follow-up, regarding the incident which was occurred in a jail, where all patients are male, and where they administered expired vaccine in three different instances to 10 patients each time: 2 of these instances were first doses, while the third instance (described in case MOD21-146004) were second doses.   Most recent FOLLOW-UP information incorporated above includes: On 22-Sep-2021: Follow-up was received on 22-Sep-2021 which  included no new information
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: she started getting hives all over her body along with intense itching; she started getting hives all over her body along with intense itching; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (she started getting hives all over her body along with intense itching) and PRURITUS (she started getting hives all over her body along with intense itching) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Sep-2021, the patient experienced URTICARIA (she started getting hives all over her body along with intense itching) and PRURITUS (she started getting hives all over her body along with intense itching). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Hives and Itching, at a dose of 1 dosage form; CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) for Hives and Itching, at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Hives and Itching, at a dose of 1 dosage form. At the time of the report, URTICARIA (she started getting hives all over her body along with intense itching) and PRURITUS (she started getting hives all over her body along with intense itching) was resolving.            No Concomitant medications were reported.  Patient reported that she has taken Zyrtec, Claritin, and Benadryl. She said that the Zyrtec and Claritin didn't really work but the Benadryl seemed to have worked in alleviating her symptoms somewhat. She said that it made her too sleepy, so she is not sure if it really worked. She said that she just had an appointment with her Internal Medicine doctor who said that it may be an allergic reaction to the Moderna vaccine. She will be getting food allergy testing done to rule out allergies to anything else.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 year old female patient was administered the 1st dose of the Moderna vaccine; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old female patient was administered the 1st dose of the Moderna vaccine) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Sep-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old female patient was administered the 1st dose of the Moderna vaccine). On 23-Sep-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old female patient was administered the 1st dose of the Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.  Nurse declined that the patient had any side effects that she was aware of.   Most recent FOLLOW-UP information incorporated above includes: On 27-Sep-2021: Reporter's address and additional hone number was added.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: tingling in legs; Numbness in legs; This spontaneous case was reported by an other health care professional and describes the occurrence of PARAESTHESIA (tingling in legs) and HYPOAESTHESIA (Numbness in legs) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (tingling in legs) and HYPOAESTHESIA (Numbness in legs). At the time of the report, PARAESTHESIA (tingling in legs) and HYPOAESTHESIA (Numbness in legs) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter reported that a patient received first Moderna COVID-19 vaccine 3 or 4 weeks ago and stated that stated the tingling and numbness was currently a bit better.  No concomitant medication was reported. No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Haemorrhage, Road traffic accident
Clinical narrative: Was Bleeding; had a horrible crazy accident; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (Was Bleeding) and ROAD TRAFFIC ACCIDENT (had a horrible crazy accident) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for an unreported indication: Flu shot.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Sep-2021, the patient experienced HAEMORRHAGE (Was Bleeding) (seriousness criteria disability and medically significant) and ROAD TRAFFIC ACCIDENT (had a horrible crazy accident) (seriousness criterion disability). At the time of the report, HAEMORRHAGE (Was Bleeding) and ROAD TRAFFIC ACCIDENT (had a horrible crazy accident) outcome was unknown.      Relevant concomitant product usage were not reported by the reporter.  He is disabled and had a horrible crazy accident on Friday, he was bleeding and at the emergency room they put staples on his head.   Patient was taken to ER and treatment included Staples on head.  Company Comment: This case concerns an elderly male who experienced serious unexpected event of bleeding and road traffic accident on unknown date after receiving both doses of the vaccine. No relevant medical history. Rechallenge is not applicable. The benefit-risk relationship is not affected by this report.; Sender's Comments: This case concerns an elderly male who experienced serious unexpected event of bleeding and road traffic accident on unknown date after receiving both doses of the vaccine. No relevant medical history. Rechallenge is not applicable. The benefit-risk relationship is not affected by this report.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Feeling abnormal, Heart rate, Heart rate increased
Clinical narrative: I thought i was having heart attack; rapid heart beats; shortness of breath; I felt like I was a 107 years old; I felt like I was gonna faint; rash in the top side of my thigh; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (I thought i was having heart attack), HEART RATE INCREASED (rapid heart beats), DYSPNOEA (shortness of breath), FEELING ABNORMAL (I felt like I was a 107 years old) and PRESYNCOPE (I felt like I was gonna faint) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ESCITALOPRAM, LAMOTRIGINE and LISINOPRIL for an unknown indication.    On 27-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Aug-2021, the patient experienced CHEST DISCOMFORT (I thought i was having heart attack), HEART RATE INCREASED (rapid heart beats), DYSPNOEA (shortness of breath), FEELING ABNORMAL (I felt like I was a 107 years old), PRESYNCOPE (I felt like I was gonna faint) and RASH (rash in the top side of my thigh). In September 2021, CHEST DISCOMFORT (I thought i was having heart attack), HEART RATE INCREASED (rapid heart beats), FEELING ABNORMAL (I felt like I was a 107 years old), PRESYNCOPE (I felt like I was gonna faint) and RASH (rash in the top side of my thigh) had resolved. At the time of the report, DYSPNOEA (shortness of breath) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Aug-2021, Heart rate: increased (High) Rapid heart beats.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient mentioned that she had heart issues and was afraid to get the second dose. No treatment information were reported by the reporter.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Presyncope, Rash
Clinical narrative: I thought i was having heart attack; rapid heart beats; shortness of breath; I felt like I was a 107 years old; I felt like I was gonna faint; rash in the top side of my thigh; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (I thought i was having heart attack), HEART RATE INCREASED (rapid heart beats), DYSPNOEA (shortness of breath), FEELING ABNORMAL (I felt like I was a 107 years old) and PRESYNCOPE (I felt like I was gonna faint) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ESCITALOPRAM, LAMOTRIGINE and LISINOPRIL for an unknown indication.    On 27-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Aug-2021, the patient experienced CHEST DISCOMFORT (I thought i was having heart attack), HEART RATE INCREASED (rapid heart beats), DYSPNOEA (shortness of breath), FEELING ABNORMAL (I felt like I was a 107 years old), PRESYNCOPE (I felt like I was gonna faint) and RASH (rash in the top side of my thigh). In September 2021, CHEST DISCOMFORT (I thought i was having heart attack), HEART RATE INCREASED (rapid heart beats), FEELING ABNORMAL (I felt like I was a 107 years old), PRESYNCOPE (I felt like I was gonna faint) and RASH (rash in the top side of my thigh) had resolved. At the time of the report, DYSPNOEA (shortness of breath) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Aug-2021, Heart rate: increased (High) Rapid heart beats.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient mentioned that she had heart issues and was afraid to get the second dose. No treatment information were reported by the reporter.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: first dose received on 24-MAR-2021/ Hasn't received second dose yet (6 months since first dose); This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (first dose received on 24-MAR-2021/ Hasn't received second dose yet (6 months since first dose)) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (first dose received on 24-MAR-2021/ Hasn't received second dose yet (6 months since first dose)). On 24-Mar-2021, PRODUCT DOSE OMISSION ISSUE (first dose received on 24-MAR-2021/ Hasn't received second dose yet (6 months since first dose)) had resolved.            No concomitant and treatment medication was reported by the reporter.