chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Skin disorder, Therapeutic response unexpected
Clinical narrative: Chronic skin condition in the legs; chronic skin condition on the injection arm has cleared after the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISORDER (Chronic skin condition in the legs) and THERAPEUTIC RESPONSE UNEXPECTED (chronic skin condition on the injection arm has cleared after the vaccine) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 048B21A) for COVID-19 vaccination.     Concurrent medical conditions included Skin disorder NOS (Chronic skin condition). Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SKIN DISORDER (Chronic skin condition in the legs) and THERAPEUTIC RESPONSE UNEXPECTED (chronic skin condition on the injection arm has cleared after the vaccine). In 2021, THERAPEUTIC RESPONSE UNEXPECTED (chronic skin condition on the injection arm has cleared after the vaccine) had resolved. At the time of the report, SKIN DISORDER (Chronic skin condition in the legs) had not resolved.            No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-Sep-2021: Follow up document received on 27-Sep-2021 added patient demographic details, current condition, Dose 1 and Dose 2 details
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: little bit tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (little bit tired) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concomitant products included DULOXETINE HYDROCHLORIDE (CYMBALTA), DULOXETINE, CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), MONTELUKAST SODIUM (SINGULAIR), COLECALCIFEROL (VITAMIN D3 1000), OMEPRAZOLE, TRAZODONE, AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) and ALPRAZOLAM (XANAX) for an unknown indication.    On 13-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 FATIGUE (little bit tired). At the time of the report, FATIGUE (little bit tired) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information provided.    This case was linked to MOD-2021-237444, MOD-2021-237444 (Patient Link).
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chromaturia, Haematuria
Clinical narrative: Hematuria (literally clots of blood and urine was very red/pink). Last from 10 September 2021 to 17 September 2021. Self treated with cranberry juice, vitamin C, 1 gallons of water minimum daily, frequent urination and time. Eventually improved on its own. No medical treatment was administered.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: C-reactive protein increased, Chest pain, Dyspnoea exertional, Echocardiogram normal, Electrocardiogram normal
Clinical narrative: 2 hours following injection, the patient had onset of chest pain.  Chest pain persisted with worsening over the next 48 hours prompting visit to Hospital emergency department.  Patient had negative troponin but elevated D-Dimer (974) and elevated CRP (43.3).   Echocardiogram as normal.  EKG was unremarkable.  Chest pain has persisted with spread across the chest wall since that time.  She has also developed dyspnea on exertion, starting the day after vaccination.  The dyspnea on exertion has increased in severity and is now limiting with minimal exertion.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Fibrin D dimer increased, Troponin normal
Clinical narrative: 2 hours following injection, the patient had onset of chest pain.  Chest pain persisted with worsening over the next 48 hours prompting visit to Hospital emergency department.  Patient had negative troponin but elevated D-Dimer (974) and elevated CRP (43.3).   Echocardiogram as normal.  EKG was unremarkable.  Chest pain has persisted with spread across the chest wall since that time.  She has also developed dyspnea on exertion, starting the day after vaccination.  The dyspnea on exertion has increased in severity and is now limiting with minimal exertion.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Dizziness, Headache, Hypoaesthesia
Clinical narrative: Within 4 hours of receiving vaccine:  Body aches Low back pain Fever Headache Dizziness Numbness/tingling in all fingertips Chills
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Paraesthesia, Pyrexia
Clinical narrative: Within 4 hours of receiving vaccine:  Body aches Low back pain Fever Headache Dizziness Numbness/tingling in all fingertips Chills
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea exertional, Fibrin D dimer normal, Palpitations, Presyncope
Clinical narrative: Patient reports onset of palpitations within 24 hours of palpitations, including heart racing, with associated dizziness and near syncope.  She admits to dyspnea on exertion following vaccination, again, starting within 24 hours of injection.  She has not had chest pain.  Her dyspnea on exertion has progressed in severity and she is now short of breath with moderate exertion.  On 9/25/21 she had near syncope event while driving prompting ER trip.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Troponin normal
Clinical narrative: Patient reports onset of palpitations within 24 hours of palpitations, including heart racing, with associated dizziness and near syncope.  She admits to dyspnea on exertion following vaccination, again, starting within 24 hours of injection.  She has not had chest pain.  Her dyspnea on exertion has progressed in severity and she is now short of breath with moderate exertion.  On 9/25/21 she had near syncope event while driving prompting ER trip.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: Fever; Chills; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body aches) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025a21a and 00f21a) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body aches). The patient was treated with IBUPROFEN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body aches) had resolved.      No concomitant medication were reported.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.  This case was linked to MOD-2021-331467 (Patient Link).
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Migraine, Tremor, Ultrasound scan
Clinical narrative: Migraine; uncontrollable Tremors (night and day); difficulty of breathing; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine), TREMOR (uncontrollable Tremors (night and day)) and DYSPNOEA (difficulty of breathing) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Fibromyalgia, Asthma, Dystonia, Food allergy (Allergic to  mint of all varieties) and Drug allergy (codeine). Concomitant products included TIZANIDINE HYDROCHLORIDE (ZANAFLEX) and TERBUTALINE for an unknown indication.   On 26-Apr-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 26-Apr-2021, the patient experienced MIGRAINE (Migraine), TREMOR (uncontrollable Tremors (night and day)) and DYSPNOEA (difficulty of breathing). At the time of the report, MIGRAINE (Migraine), TREMOR (uncontrollable Tremors (night and day)) and DYSPNOEA (difficulty of breathing) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound scan: normal (normal) Normal.         No treatment medication was reported  It was reported that patient till now experience tremors (night and day), migraine and difficulty of breathing.   The patient underwent laboratory test  X-RAY showed no result.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered dose more than 12 hours after vial  was punctured; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered dose more than 12 hours after vial  was punctured) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) 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) (Intramuscular) 1 dosage form. On 23-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered dose more than 12 hours after vial  was punctured). On 23-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Administered dose more than 12 hours after vial  was punctured) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient is not taking other medication, but is taking supplements.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Inappropriate schedule of product administration, Injection site inflammation, Swelling, Ultrasound scan normal
Clinical narrative: Inappropriate schedule of product administration; swelling up; inflammation in the left arm pit; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swelling up), INJECTION SITE INFLAMMATION (inflammation in the left arm pit) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of product administration) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0039B21A and 022C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced SWELLING (swelling up) and INJECTION SITE INFLAMMATION (inflammation in the left arm pit). On 23-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of product administration). On 23-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of product administration) had resolved. At the time of the report, SWELLING (swelling up) and INJECTION SITE INFLAMMATION (inflammation in the left arm pit) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) The doctor did not see any lymphatic inflammation, abnormal, or anything out of the ordinary. On an unknown date, Ultrasound scan normal: normal (normal) The doctor did not see any lymphatic inflammation, abnormal, or anything out of the ordinary.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were provided. No treatment medications were provided   This case was linked to MOD-2021-331802 (Patient Link).; Sender's Comments: This case concerns a 40-year-old, male patient with no relevant medical history, who experienced the non-serious event of Swelling and expected non-serious event of Injection site inflammation. The events occurred after the first dose of mRNA-1273 (COVID-19 Vaccine Moderna). An additional event of Inappropriate schedule of product administration is added as dose 1 and dose 2 were administered at a time interval of 38 days. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 (COVID-19 Vaccine Moderna) is not affected by this report.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: dose was administered to a patient after 30 day use by date; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose was administered to a patient after 30 day use by date) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination.     Concurrent medical conditions included Iodine allergy (iodine), Drug allergy (Doxycycline), Drug allergy (Prednisone), Drug allergy (Codeine), Latex allergy (Latex), Drug allergy (Sulfa) and Drug allergy (Nalbuphine). Concomitant products included CERTOLIZUMAB PEGOL (CIMZIA), COLECALCIFEROL (VITAMIN D3), MAGNESIUM, POTASSIUM and SODIUM BICARBONATE (SODIUM BICARB.PED) for an unknown indication.    On 22-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose was administered to a patient after 30 day use by date). On 22-Sep-2021, EXPIRED PRODUCT ADMINISTERED (dose was administered to a patient after 30 day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Treatment Information were provided by the reporter   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Significant follow up received. Added patient demographics, relevant history (allergy) and concomitant medication
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Patient left a voicemail stating that wants to report a side effect; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Patient left a voicemail stating that wants to report a side effect) 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 COMPLICATION (Patient left a voicemail stating that wants to report a side effect). At the time of the report, VACCINATION COMPLICATION (Patient left a voicemail stating that wants to report a side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were provided.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Erythema, Extra dose administered, Flushing
Clinical narrative: He had his 3rd Moderna COVID-19 vaccine on 23 Sep 2021; Flushed face and upper abdomen after 3rd shot; Red face and upper abdomen after 3rd shot; Sinuses hurting  after 3rd shot; Chills after 3rd shot; Fever 102 F after 3rd shot; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (Flushed face and upper abdomen after 3rd shot), ERYTHEMA (Red face and upper abdomen after 3rd shot), SINUS PAIN (Sinuses hurting  after 3rd shot), CHILLS (Chills after 3rd shot) and PYREXIA (Fever 102 F after 3rd shot) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A, 004M20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Sep-2021, the patient experienced FLUSHING (Flushed face and upper abdomen after 3rd shot), ERYTHEMA (Red face and upper abdomen after 3rd shot), SINUS PAIN (Sinuses hurting  after 3rd shot), CHILLS (Chills after 3rd shot) and PYREXIA (Fever 102 F after 3rd shot). On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (He had his 3rd Moderna COVID-19 vaccine on 23 Sep 2021). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) for Adverse event, at a dose of 1 dosage form and PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. At the time of the report, FLUSHING (Flushed face and upper abdomen after 3rd shot), ERYTHEMA (Red face and upper abdomen after 3rd shot), SINUS PAIN (Sinuses hurting  after 3rd shot), CHILLS (Chills after 3rd shot), PYREXIA (Fever 102 F after 3rd shot) and EXTRA DOSE ADMINISTERED (He had his 3rd Moderna COVID-19 vaccine on 23 Sep 2021) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Sep-2021, Body temperature: 102. f (High) 102.F.         No Concomitant medication was provided. Wife had stated that Flushed face and upper abdomen, and Red face and upper abdomen. She stated that it was not a rash that the flushing is happening as a result of the fever. Wife stated, her husband's sinus was hurting but thinks it was because of the AC. we both get that from the AC sometimes. She had stated that she has been alternating between Advil & Tylenol but the fever keeps coming back.and it comes back at 102 F. Wife stated that she tested positive for COVID-19 disease (Case# MOD21-147408 Cross-linked), in AUG2021 and her husband did not test positive and he was fine. Husband was supposed to have surgery in two weeks so we got him a third shot so he would not catch COVID in the hospital.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Sinus pain
Clinical narrative: He had his 3rd Moderna COVID-19 vaccine on 23 Sep 2021; Flushed face and upper abdomen after 3rd shot; Red face and upper abdomen after 3rd shot; Sinuses hurting  after 3rd shot; Chills after 3rd shot; Fever 102 F after 3rd shot; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (Flushed face and upper abdomen after 3rd shot), ERYTHEMA (Red face and upper abdomen after 3rd shot), SINUS PAIN (Sinuses hurting  after 3rd shot), CHILLS (Chills after 3rd shot) and PYREXIA (Fever 102 F after 3rd shot) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A, 004M20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Sep-2021, the patient experienced FLUSHING (Flushed face and upper abdomen after 3rd shot), ERYTHEMA (Red face and upper abdomen after 3rd shot), SINUS PAIN (Sinuses hurting  after 3rd shot), CHILLS (Chills after 3rd shot) and PYREXIA (Fever 102 F after 3rd shot). On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (He had his 3rd Moderna COVID-19 vaccine on 23 Sep 2021). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) for Adverse event, at a dose of 1 dosage form and PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. At the time of the report, FLUSHING (Flushed face and upper abdomen after 3rd shot), ERYTHEMA (Red face and upper abdomen after 3rd shot), SINUS PAIN (Sinuses hurting  after 3rd shot), CHILLS (Chills after 3rd shot), PYREXIA (Fever 102 F after 3rd shot) and EXTRA DOSE ADMINISTERED (He had his 3rd Moderna COVID-19 vaccine on 23 Sep 2021) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Sep-2021, Body temperature: 102. f (High) 102.F.         No Concomitant medication was provided. Wife had stated that Flushed face and upper abdomen, and Red face and upper abdomen. She stated that it was not a rash that the flushing is happening as a result of the fever. Wife stated, her husband's sinus was hurting but thinks it was because of the AC. we both get that from the AC sometimes. She had stated that she has been alternating between Advil & Tylenol but the fever keeps coming back.and it comes back at 102 F. Wife stated that she tested positive for COVID-19 disease (Case# MOD21-147408 Cross-linked), in AUG2021 and her husband did not test positive and he was fine. Husband was supposed to have surgery in two weeks so we got him a third shot so he would not catch COVID in the hospital.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Patient got pregnant after first dose of the Moderna covid19 vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Patient got pregnant after first dose of the Moderna covid19 vaccine) 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. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Patient got pregnant after first dose of the Moderna covid19 vaccine). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Patient got pregnant after first dose of the Moderna covid19 vaccine) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was reported.  Patient wants to know if she should get the second dose, and mentioned that it has been past two and a half months from her first dose of the Moderna COVID-19 vaccine, and that when she got the first dose she was not pregnant. This case concerns a female patient of unknown age with no relevant medical history, who experienced the unexpected non-serious special situation of maternal exposure during pregnancy. The event occurred on unknown date after the first dose of Spikevax (Moderna COVID-19 vaccine). The rechallenge was not applicable since the event occurred after the first dose and it is a special situation. The benefit-risk relationship of Spikevax (Moderna COVID-19 vaccine) is not affected by this report. Maternal exposure was reported before pregnancy, exact temporal relationship is unknown, and more information is requested.; Sender's Comments: This case concerns a female patient of unknown age with no relevant medical history, who experienced the unexpected non-serious special situation of maternal exposure during pregnancy. The event occurred on unknown date after the first dose of Spikevax (Moderna COVID-19 vaccine). The rechallenge was not applicable since the event occurred after the first dose and it is a special situation. The benefit-risk relationship of Spikevax (Moderna COVID-19 vaccine) is not affected by this report. Maternal exposure was reported before pregnancy, exact temporal relationship is unknown, and more information is requested.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: Health issues even before 1st dose of moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Health issues even before 1st dose of moderna vaccine) 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 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (Health issues even before 1st dose of moderna vaccine). At the time of the report, ADVERSE EVENT (Health issues even before 1st dose of moderna vaccine) outcome was unknown.            No Treatment information was provided. No concomitant medication was provided.
Sex: U
Vaccine: COVID19
Symptoms: Acute promyelocytic leukaemia, Anaemia
Clinical narrative: Diagnosed with APL Leukemia; Anemia; This spontaneous case was reported by a consumer and describes the occurrence of ACUTE PROMYELOCYTIC LEUKAEMIA (Diagnosed with APL Leukemia) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ACYCLOVIR [ACICLOVIR] for Antiviral treatment.    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 ACUTE PROMYELOCYTIC LEUKAEMIA (Diagnosed with APL Leukemia) (seriousness criterion medically significant) and ANAEMIA (Anemia). At the time of the report, ACUTE PROMYELOCYTIC LEUKAEMIA (Diagnosed with APL Leukemia) and ANAEMIA (Anemia) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient was diagnosed with APL Leukemia and because of anemia as a result, was told not to get the second dose until cell counts are at an acceptable level.  Treatment information was not provided.  This case concerns a patient of an unknown age and gender, with no relevant medical history, who experienced the unexpected event of Acute promyelocytic leukaemia. The event occurred after unspecified lapse of time after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). Rechallenge is not applicable as there is no information regarding the second dose of the vaccine.  Anemia is a non-serious and intercurrent event. The benefit-risk relationship of drug mRNA-1273 (Moderna COVID-19 Vaccine) in not affected by this report.; Sender's Comments: This case concerns a patient of an unknown age and gender, with no relevant medical history, who experienced the unexpected event of Acute promyelocytic leukaemia. The event occurred after unspecified lapse of time after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). Rechallenge is not applicable as there is no information regarding the second dose of the vaccine.  Anemia is a non-serious and intercurrent event. The benefit-risk relationship of drug mRNA-1273 (Moderna COVID-19 Vaccine) in not affected by this report.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Interchange of vaccine products, Pain in extremity, Pyrexia
Clinical narrative: flu like symptoms; arm soreness; fever; mixed with other vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), PAIN IN EXTREMITY (arm soreness), PYREXIA (fever) and INTERCHANGE OF VACCINE PRODUCTS (mixed with other vaccine) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer (Patient had 1st and 2nd dose by Pfizer). Concurrent medical conditions included HIV positive. Concomitant products included BICTEGRAVIR SODIUM, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (BIKTARVY) for HIV infection.    On 23-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Sep-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), PAIN IN EXTREMITY (arm soreness), PYREXIA (fever) and INTERCHANGE OF VACCINE PRODUCTS (mixed with other vaccine). On 23-Sep-2021, INTERCHANGE OF VACCINE PRODUCTS (mixed with other vaccine) had resolved. On 25-Sep-2021, INFLUENZA LIKE ILLNESS (flu like symptoms) and PYREXIA (fever) had resolved. At the time of the report, PAIN IN EXTREMITY (arm soreness) had resolved.            Treatment information was not provided.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Appendicitis
Clinical narrative: Develop appendicitis after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of APPENDICITIS (Develop appendicitis after the first dose) in a 52-year-old female patient 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 APPENDICITIS (Develop appendicitis after the first dose) (seriousness criterion medically significant). At the time of the report, APPENDICITIS (Develop appendicitis after the first dose) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication information was provided. No treatment product information was provided.  Company comment: This case concerns a 52-year-old, female patient with no relevant medical history, who experienced the serious unexpected event of Appendicitis. The event occurred on an unknown date after the first dose of Spikevax. The rechallenge was not applicable although the outcome of appendicitis is unknown, it could be interpreted that appendicitis should have recovered before the second dose is received. The benefit-risk relationship of Spikevax in not affected by this report. Query is added to send the patient Adverse Event Follow up Form, provide notes from a clinic and further details of the date of the first dose of vaccination and date of the event, outcome of the event.   This case was linked to MOD-2021-332183 (Patient Link).; Sender's Comments: This case concerns a 52-year-old, female patient with no relevant medical history, who experienced the serious unexpected event of Appendicitis. The event occurred on an unknown date after the first dose of Spikevax. The rechallenge was not applicable although the outcome of appendicitis is unknown, it could be interpreted that appendicitis should have recovered before the second dose is received. The benefit-risk relationship of Spikevax in not affected by this report. Query is added to send the patient Adverse Event Follow up Form, provide notes from a clinic and further details of the date of the first dose of vaccination and date of the event, outcome of the event.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Pain in extremity, Pyrexia
Clinical narrative: arm hurt for a week; ran a slight fever; She thinks the vaccine was administered too high in her arm and may have hit her bone; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt for a week), PYREXIA (ran a slight fever) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (She thinks the vaccine was administered too high in her arm and may have hit her bone) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination.     The patient's past medical history included Unconscious (patient was found unconscious due to anemia from her bleeding colon.) and Parathyroid gland operation. Concurrent medical conditions included Bleeding colon ulcer, Osteoporosis and Anemia. Concomitant products included FENTANYL for Osteoporosis.    On 08-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced PAIN IN EXTREMITY (arm hurt for a week), PYREXIA (ran a slight fever) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (She thinks the vaccine was administered too high in her arm and may have hit her bone). In September 2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (She thinks the vaccine was administered too high in her arm and may have hit her bone) had resolved. At the time of the report, PAIN IN EXTREMITY (arm hurt for a week) was resolving and PYREXIA (ran a slight fever) 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.   treatment to the events not reported. patient has a history of a bleeding colon and  very sick ,can't go to the bathroom like a normal person. Patient  has the bones of a 200-year-old woman after an operation on her parathyroid glands,and has bad osteoporosis. Patient had a recent event  was found unconscious due to anemia from her bleeding colon. She was given 8 pints of blood following this event. Her gastroenterologist wants to perform an operation on her where they will remove a large part of her colon and hospitalize her for almost a month. Her doctor wanted her to get the COVID-19 vaccine prior to being hospitalized.  Patient is not sure if the vaccine was given by intramuscular injection because she thinks it was administered wrong and  thinks that vaccine was administered too high in her arm and may have hit her bone.   Patient thought that after working with animals who had coronavirus her whole life. She thought she would have a natural immunity, but she does not.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis
Clinical narrative: Bronchitis; This spontaneous case was reported by a consumer and describes the occurrence of BRONCHITIS (Bronchitis) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 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 BRONCHITIS (Bronchitis). At the time of the report, BRONCHITIS (Bronchitis) outcome was unknown.            Concomitant medications were not provided. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow-up received, contains no new information.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Tremor
Clinical narrative: Sore arm after both shots; tired; couldn't stop shaking; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (couldn't stop shaking), PAIN IN EXTREMITY (Sore arm after both shots) and FATIGUE (tired) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced TREMOR (couldn't stop shaking). On 20-Feb-2021, the patient experienced FATIGUE (tired). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm after both shots). On 20-Feb-2021, TREMOR (couldn't stop shaking) had resolved. On 22-Feb-2021, FATIGUE (tired) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm after both shots) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Scar, Skin discolouration, Skin lesion
Clinical narrative: lesions on  legs/ lesions on arms and neck/ skin issues; has scars that are awful; these marks that are gray in color and all over his arms and going up his neck too; This spontaneous case was reported by a consumer and describes the occurrence of SKIN LESION (lesions on  legs/ lesions on arms and neck/ skin issues), SCAR (has scars that are awful) and SKIN DISCOLOURATION (these marks that are gray in color and all over his arms and going up his neck too) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes (Patient AIC is 5.7 to 5.9 for the past three years, takes insulin) since 2016.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced SKIN LESION (lesions on  legs/ lesions on arms and neck/ skin issues), SCAR (has scars that are awful) and SKIN DISCOLOURATION (these marks that are gray in color and all over his arms and going up his neck too). At the time of the report, SKIN LESION (lesions on  legs/ lesions on arms and neck/ skin issues), SCAR (has scars that are awful) and SKIN DISCOLOURATION (these marks that are gray in color and all over his arms and going up his neck too) had not resolved.            No concomitant medications were reported  The patient stated that he's been to the emergency room 4 times for skin issues and still not going away  For treatment the patient had tried 4 different cream and nothing was helping.They don't itch.   This case was linked to MOD-2021-009530 (Patient Link).
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Fatigue, Feeling cold
Clinical narrative: Any little wind that hits him he feels it very cold; muscle pain; joint pain; some chills; did not even want to get up/ had no spirit to do anything; felt as if he was sick again; injection arm was in a lot of pain/ injection arm hurts; felt tired; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (felt as if he was sick again), ASTHENIA (did not even want to get up/ had no spirit to do anything), FEELING COLD (Any little wind that hits him he feels it very cold), VACCINATION SITE PAIN (injection arm was in a lot of pain/ injection arm hurts) and FATIGUE (felt tired) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19. Concurrent medical conditions included Diabetic.    On 24-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Sep-2021, the patient experienced MALAISE (felt as if he was sick again), VACCINATION SITE PAIN (injection arm was in a lot of pain/ injection arm hurts) and FATIGUE (felt tired). On 25-Sep-2021, the patient experienced ASTHENIA (did not even want to get up/ had no spirit to do anything). On an unknown date, the patient experienced FEELING COLD (Any little wind that hits him he feels it very cold), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and CHILLS (some chills). At the time of the report, MALAISE (felt as if he was sick again), ASTHENIA (did not even want to get up/ had no spirit to do anything), FATIGUE (felt tired), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and CHILLS (some chills) outcome was unknown and FEELING COLD (Any little wind that hits him he feels it very cold) and VACCINATION SITE PAIN (injection arm was in a lot of pain/ injection arm hurts) had not resolved.        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.   No concomitant medications were reported. No treatment medications were reported.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Myalgia, Vaccination site pain
Clinical narrative: Any little wind that hits him he feels it very cold; muscle pain; joint pain; some chills; did not even want to get up/ had no spirit to do anything; felt as if he was sick again; injection arm was in a lot of pain/ injection arm hurts; felt tired; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (felt as if he was sick again), ASTHENIA (did not even want to get up/ had no spirit to do anything), FEELING COLD (Any little wind that hits him he feels it very cold), VACCINATION SITE PAIN (injection arm was in a lot of pain/ injection arm hurts) and FATIGUE (felt tired) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19. Concurrent medical conditions included Diabetic.    On 24-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Sep-2021, the patient experienced MALAISE (felt as if he was sick again), VACCINATION SITE PAIN (injection arm was in a lot of pain/ injection arm hurts) and FATIGUE (felt tired). On 25-Sep-2021, the patient experienced ASTHENIA (did not even want to get up/ had no spirit to do anything). On an unknown date, the patient experienced FEELING COLD (Any little wind that hits him he feels it very cold), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and CHILLS (some chills). At the time of the report, MALAISE (felt as if he was sick again), ASTHENIA (did not even want to get up/ had no spirit to do anything), FATIGUE (felt tired), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and CHILLS (some chills) outcome was unknown and FEELING COLD (Any little wind that hits him he feels it very cold) and VACCINATION SITE PAIN (injection arm was in a lot of pain/ injection arm hurts) had not resolved.        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.   No concomitant medications were reported. No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Hypoaesthesia, Myalgia, SARS-CoV-2 test
Clinical narrative: contracted COVID-19 a mild case; numbness on her face for several days; muscle pain in legs,muscle pain in jaw; chills; This spontaneous case was reported by a patient and describes the occurrence of HYPOAESTHESIA (numbness on her face for several days), COVID-19 (contracted COVID-19 a mild case), CHILLS (chills) and MYALGIA (muscle pain in legs,muscle pain in jaw) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Aug-2021, the patient experienced CHILLS (chills). On 24-Aug-2021, the patient experienced HYPOAESTHESIA (numbness on her face for several days) and MYALGIA (muscle pain in legs,muscle pain in jaw). On 26-Aug-2021, the patient experienced COVID-19 (contracted COVID-19 a mild case). At the time of the report, HYPOAESTHESIA (numbness on her face for several days), COVID-19 (contracted COVID-19 a mild case), CHILLS (chills) and MYALGIA (muscle pain in legs,muscle pain in jaw) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Aug-2021, SARS-CoV-2 test: positive Positive.     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.   Her concerned is about getting the second dose because she had COVID.  Concomitant medication use was unknown Treatment information was unknown   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a 60-year-old female patient with no relevant medical history reported, who experienced non serious unexpected events of  hypoesthesia, COVID-19 and expected events of myalgia and chills. The events occurred 3-7 days after the first dose of Spikevax. Rechallenge was unknown since information about second dose and reoccurrence of the event was not provided. The benefit-risk relationship of drug is not affected by this report
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Patient tested positive for Covid; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Patient tested positive for Covid) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, 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 SARS-COV-2 TEST POSITIVE (Patient tested positive for Covid). At the time of the report, SARS-COV-2 TEST POSITIVE (Patient tested positive for Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Sep-2021, SARS-CoV-2 test: positive (Positive) positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were mild medicines.  Batch numbers of two doses are not provided.  None treatment medications were reported.; Sender's Comments: This case concerns an elderly 72-year-old male patient with no relevant medical history provide, who was tested positive for COVID-19 (the unexpected event of SARS-CoV-2 test positive). The event occurred approximately 6 and a half months months after the second dose of Moderna COVID-19 Vaccine. There were no reported signs of symptoms of COVID-19 disease, and there was no information that the COVID-19 diagnosis was established. Based on biological implausibility and having in mind that the mRNA-1273 does not contain a virus capable of causing infection, the Company causality for the reported event is not applicable. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.