chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration
Clinical narrative: after expiration date,Expired moderna vaccine given to 7 patients/The patient was administered her second dose of an expired dose of Moderna; The first dose was given on 28 Sep 2021 and second dose on 04 Nov 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (after expiration date,Expired moderna vaccine given to 7 patients/The patient was administered her second dose of an expired dose of Moderna) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The first dose was given on 28 Sep 2021 and second dose on 04 Nov 2021) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The first dose was given on 28 Sep 2021 and second dose on 04 Nov 2021). On 04-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (after expiration date,Expired moderna vaccine given to 7 patients/The patient was administered her second dose of an expired dose of Moderna). On 04-Nov-2021, EXPIRED PRODUCT ADMINISTERED (after expiration date,Expired moderna vaccine given to 7 patients/The patient was administered her second dose of an expired dose of Moderna) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The first dose was given on 28 Sep 2021 and second dose on 04 Nov 2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter. No treatment information was provided.  Patient first dose vial moved from freezer to refrigerator on 28 Sep 2021, same day dose was administered. The second dose vial was removed from the freezer to refrigerator on 04 Nov 2021.   This case was linked to MOD-2021-400101 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Dec-2021: Updated report type. Added patient demographics, dosage details and new event.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: booster shot could give me swelling and painful underarm of shot arm; I was wondering if a boosyer shot could give me swelling and painful un; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE SWELLING (booster shot could give me swelling and painful underarm of shot arm) and VACCINATION SITE PAIN (I was wondering if a boosyer shot could give me swelling and painful un) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (booster shot could give me swelling and painful underarm of shot arm) and VACCINATION SITE PAIN (I was wondering if a boosyer shot could give me swelling and painful un). At the time of the report, VACCINATION SITE SWELLING (booster shot could give me swelling and painful underarm of shot arm) and VACCINATION SITE PAIN (I was wondering if a boosyer shot could give me swelling and painful un) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Heart rate, Tachycardia
Clinical narrative: Heart rate has going up and stabilizing; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Heart rate has going up and stabilizing) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Heart disease, unspecified.    In March 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 TACHYCARDIA (Heart rate has going up and stabilizing). At the time of the report, TACHYCARDIA (Heart rate has going up and stabilizing) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: high (High) heart rate has going up and stabilizing..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication was provided by reporter.  No concomitant medication was provided by reporter.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Influenza like illness, Myalgia, Pyrexia
Clinical narrative: Like mild flu symptoms; Sore left arm; Low fever 99F; Chills; Achiness; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Like mild flu symptoms), VACCINATION SITE PAIN (Sore left arm), PYREXIA (Low fever 99F), CHILLS (Chills) and MYALGIA (Achiness) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2020, the patient experienced INFLUENZA LIKE ILLNESS (Like mild flu symptoms), VACCINATION SITE PAIN (Sore left arm), PYREXIA (Low fever 99F), CHILLS (Chills) and MYALGIA (Achiness). On 31-Dec-2020, INFLUENZA LIKE ILLNESS (Like mild flu symptoms), VACCINATION SITE PAIN (Sore left arm), PYREXIA (Low fever 99F), CHILLS (Chills) and MYALGIA (Achiness) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Dec-2020, Body temperature: 99 (Low) 99 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-410982, MOD-2021-410984 (Patient Link).
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Like mild flu symptoms; Sore left arm; Low fever 99F; Chills; Achiness; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Like mild flu symptoms), VACCINATION SITE PAIN (Sore left arm), PYREXIA (Low fever 99F), CHILLS (Chills) and MYALGIA (Achiness) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2020, the patient experienced INFLUENZA LIKE ILLNESS (Like mild flu symptoms), VACCINATION SITE PAIN (Sore left arm), PYREXIA (Low fever 99F), CHILLS (Chills) and MYALGIA (Achiness). On 31-Dec-2020, INFLUENZA LIKE ILLNESS (Like mild flu symptoms), VACCINATION SITE PAIN (Sore left arm), PYREXIA (Low fever 99F), CHILLS (Chills) and MYALGIA (Achiness) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Dec-2020, Body temperature: 99 (Low) 99 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-410982, MOD-2021-410984 (Patient Link).
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: soreness; fever; tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (soreness), PYREXIA (fever) and FATIGUE (tired) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F20A) for COVID-19 vaccination.     The patient's past medical history included Heart attack, COVID-19 (Covid positive during his stay in nursing home in summer of 2020) in 2020, Leg amputation in July 2020 and Stent placement (had heart attack during procedure which followed by getting stent.). Concurrent medical conditions included Drug allergy (Norco allergy).    On 29-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 (soreness), PYREXIA (fever) and FATIGUE (tired). At the time of the report, PAIN (soreness), PYREXIA (fever) and FATIGUE (tired) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medications was not reported.  Treatment medications was not reported.   This case was linked to MOD-2021-412501, MOD-2021-076510 (Patient Link).
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Myalgia, Pyrexia
Clinical narrative: malaise; body aches; fever; This spontaneous case was reported by a physician and describes the occurrence of MALAISE (malaise), MYALGIA (body aches) and PYREXIA (fever) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 036A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-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 MALAISE (malaise), MYALGIA (body aches) and PYREXIA (fever). At the time of the report, MALAISE (malaise), MYALGIA (body aches) and PYREXIA (fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment information was provided.   This case was linked to MOD-2021-411081 (Patient Link).
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac discomfort, Discomfort, Facial discomfort, Feeling abnormal, Limb discomfort
Clinical narrative: don't feel right since his booster dose; feels heavy; Stretching from his left side up to his heart & face feels different; His left side feels different/Stretching from his left side up to his heart; Things are a blur; feels like his heart is fat & engorged; arm feels different; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (don't feel right since his booster dose), FEELING ABNORMAL (feels heavy), FACIAL DISCOMFORT (Stretching from his left side up to his heart & face feels different), DISCOMFORT (His left side feels different/Stretching from his left side up to his heart) and VISION BLURRED (Things are a blur) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031H21A, 028A21A and 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concurrent medical conditions included Hypertension (high blood pressure). Concomitant products included LOSARTAN and CARVEDILOL for Hypertension.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MALAISE (don't feel right since his booster dose). In December 2021, the patient experienced FEELING ABNORMAL (feels heavy), FACIAL DISCOMFORT (Stretching from his left side up to his heart & face feels different), DISCOMFORT (His left side feels different/Stretching from his left side up to his heart), VISION BLURRED (Things are a blur), CARDIAC DISCOMFORT (feels like his heart is fat & engorged) and LIMB DISCOMFORT (arm feels different). At the time of the report, MALAISE (don't feel right since his booster dose), FEELING ABNORMAL (feels heavy), FACIAL DISCOMFORT (Stretching from his left side up to his heart & face feels different), DISCOMFORT (His left side feels different/Stretching from his left side up to his heart), VISION BLURRED (Things are a blur), CARDIAC DISCOMFORT (feels like his heart is fat & engorged) and LIMB DISCOMFORT (arm feels different) outcome was unknown.            Treatment information was not provided by the reporter.   This case was linked to MOD-2021-411093 (Patient Link).
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Vision blurred
Clinical narrative: don't feel right since his booster dose; feels heavy; Stretching from his left side up to his heart & face feels different; His left side feels different/Stretching from his left side up to his heart; Things are a blur; feels like his heart is fat & engorged; arm feels different; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (don't feel right since his booster dose), FEELING ABNORMAL (feels heavy), FACIAL DISCOMFORT (Stretching from his left side up to his heart & face feels different), DISCOMFORT (His left side feels different/Stretching from his left side up to his heart) and VISION BLURRED (Things are a blur) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031H21A, 028A21A and 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concurrent medical conditions included Hypertension (high blood pressure). Concomitant products included LOSARTAN and CARVEDILOL for Hypertension.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MALAISE (don't feel right since his booster dose). In December 2021, the patient experienced FEELING ABNORMAL (feels heavy), FACIAL DISCOMFORT (Stretching from his left side up to his heart & face feels different), DISCOMFORT (His left side feels different/Stretching from his left side up to his heart), VISION BLURRED (Things are a blur), CARDIAC DISCOMFORT (feels like his heart is fat & engorged) and LIMB DISCOMFORT (arm feels different). At the time of the report, MALAISE (don't feel right since his booster dose), FEELING ABNORMAL (feels heavy), FACIAL DISCOMFORT (Stretching from his left side up to his heart & face feels different), DISCOMFORT (His left side feels different/Stretching from his left side up to his heart), VISION BLURRED (Things are a blur), CARDIAC DISCOMFORT (feels like his heart is fat & engorged) and LIMB DISCOMFORT (arm feels different) outcome was unknown.            Treatment information was not provided by the reporter.   This case was linked to MOD-2021-411093 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes, Pyrexia
Clinical narrative: They both developed fever blisters.; They both had fevers.; This spontaneous case was reported by a nurse and describes the occurrence of ORAL HERPES (They both developed fever blisters.) and PYREXIA (They both had fevers.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 10-Dec-2021, the patient experienced ORAL HERPES (They both developed fever blisters.) and PYREXIA (They both had fevers.). At the time of the report, ORAL HERPES (They both developed fever blisters.) and PYREXIA (They both had fevers.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment drug details was reported.    This case was linked to MOD-2021-411071 (Patient Link).
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, SARS-CoV-2 test
Clinical narrative: Chest pain/like some kind of dull pain, sharp pain sometimes; Chest discomfort; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain/like some kind of dull pain, sharp pain sometimes) and CHEST DISCOMFORT (Chest discomfort) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041J2A, 043L20A and 037620A) for COVID-19 vaccination.     The patient's past medical history included COVID-19. Concurrent medical conditions included Type 2 diabetes mellitus, Blood pressure abnormal and Blood cholesterol abnormal. Concomitant products included ATORVASTATIN for Blood cholesterol abnormal, LISINOPRIL and AMLODIPINE for Blood pressure management, METFORMIN for Type 2 diabetes mellitus.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced CHEST PAIN (Chest pain/like some kind of dull pain, sharp pain sometimes) and CHEST DISCOMFORT (Chest discomfort). At the time of the report, CHEST PAIN (Chest pain/like some kind of dull pain, sharp pain sometimes) had not resolved and CHEST DISCOMFORT (Chest discomfort) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive.         No treatment information was provided.   This case was linked to MOD-2021-411019 (Patient Link).
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes, Pyrexia
Clinical narrative: Fever blisters; Fevers; This spontaneous case was reported by a nurse and describes the occurrence of ORAL HERPES (Fever blisters) and PYREXIA (Fevers) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. On 10-Dec-2021, the patient experienced ORAL HERPES (Fever blisters) and PYREXIA (Fevers). At the time of the report, ORAL HERPES (Fever blisters) and PYREXIA (Fevers) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported.   This case was linked to MOD-2021-411041 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: I received the Moderna vac and got really sick both times; This spontaneous case was reported by an other health care professional and describes the occurrence of ILLNESS (I received the Moderna vac and got really sick both times) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    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 ILLNESS (I received the Moderna vac and got really sick both times). At the time of the report, ILLNESS (I received the Moderna vac and got really sick both times) 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 concomitant drug details were reported.  No treatment information was provided.   This case was linked to MOD-2021-413612 (Patient Link).
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: The only thing he got previously is a 24 hour reaction of fever & chills, maybe, after the 1st dose; The only thing he got previously is a 24 hour reaction of fever & chills, maybe, after the 1st dose; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (The only thing he got previously is a 24 hour reaction of fever & chills, maybe, after the 1st dose) and CHILLS (The only thing he got previously is a 24 hour reaction of fever & chills, maybe, after the 1st dose) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included LOSARTAN and CARVEDILOL for Blood pressure high.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced PYREXIA (The only thing he got previously is a 24 hour reaction of fever & chills, maybe, after the 1st dose) and CHILLS (The only thing he got previously is a 24 hour reaction of fever & chills, maybe, after the 1st dose). At the time of the report, PYREXIA (The only thing he got previously is a 24 hour reaction of fever & chills, maybe, after the 1st dose) and CHILLS (The only thing he got previously is a 24 hour reaction of fever & chills, maybe, after the 1st dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatment medication were reported.   This case was linked to MOD-2021-411018 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Myalgia
Clinical narrative: fatigue; muscle soreness; headache; joints sore; fatigue; muscle soreness; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of FATIGUE, the first episode of MYALGIA, HEADACHE, ARTHRALGIA and the second episode of FATIGUE in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 06-Dec-2021, the patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Dec-2021, the patient experienced the first episode of FATIGUE and the first episode of MYALGIA. In December 2021, the patient experienced HEADACHE, ARTHRALGIA, the second episode of FATIGUE and the second episode of MYALGIA. At the time of the report, HEADACHE, ARTHRALGIA, the last episode of FATIGUE and the last episode of MYALGIA had not resolved.            The  concomitant medications on use were not provided. No treatment information was provided.   This case was linked to MOD-2021-412034 (Patient Link).
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Asthma, Dyspnoea, Scan, X-ray
Clinical narrative: asthma got worse badly; problems breathing; This spontaneous case was reported by a consumer and describes the occurrence of ASTHMA (asthma got worse badly) and DYSPNOEA (problems breathing) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 00121A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma and Cholesterol. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for Cholesterol.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-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 ASTHMA (asthma got worse badly) and DYSPNOEA (problems breathing). The patient was treated with FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY) for Adverse event, at an unspecified dose and frequency. At the time of the report, ASTHMA (asthma got worse badly) and DYSPNOEA (problems breathing) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Scan: results not reported (Inconclusive) Results not reported. On an unknown date, X-ray: results not reported (Inconclusive) Results not reported.         Symptoms started two to three weeks after second dose. Patient visited many health care practitioners, tried different medication. This has been going on for six months. Now patient was afraid of getting booster dose.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Cystitis
Clinical narrative: Urinary bladder infection; This spontaneous case was reported by a consumer and describes the occurrence of CYSTITIS (Urinary bladder infection) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced CYSTITIS (Urinary bladder infection). At the time of the report, CYSTITIS (Urinary bladder infection) had not resolved.            Chronic conditions or any medication stated as none. Treatment details stated Twice a day, 11 hours apart with name unspecified. No concomitant medications were mentioned.   This case was linked to MOD-2021-411779 (Patient Link).
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: body aches; headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches) and HEADACHE (headache) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A, 030B21A and 003F21A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included ALBUTEROL [SALBUTAMOL], GUAIFENESIN (MUCINEX), FLUTICASONE FUROATE, VILANTEROL TRIFENATATE (BREO ELLIPTA), MOMETASONE FUROATE (FLONASE [MOMETASONE FUROATE]), AZELASTINE HYDROCHLORIDE (AZELASTINE HCL), VITAMIN C [ASCORBIC ACID], ZINC, COLECALCIFEROL (VITAMIN D3), ACETYLSALICYLIC ACID (ASPIRINE), PROPRANOLOL HYDROCHLORIDE (PROPRANOLOL [PROPRANOLOL HYDROCHLORIDE]), EZETIMIBE, SIMVASTATIN (EZETIMIBE/SIMVASTATIN), MONTELUKAST, ZALEPLON and CYCLOBENZAPRINE for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced MYALGIA (body aches) and HEADACHE (headache). At the time of the report, MYALGIA (body aches) and HEADACHE (headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment medications were reported.   This case was linked to MOD-2021-411468, MOD-2021-411494 (Patient Link).
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Slight fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Slight fatigue) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 003A21A) for COVID-19 vaccination.     Concomitant products included ALBUTEROL [SALBUTAMOL], GUAIFENESIN (MUCINEX), FLUTICASONE FUROATE, VILANTEROL TRIFENATATE (BREO ELLIPTA), FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), AZELASTINE HYDROCHLORIDE (AZELASTINE HCL), VITAMIN C [ASCORBIC ACID], ZINC, COLECALCIFEROL (VITAMIN D3), ASPIRIN [ACETYLSALICYLIC ACID], PROPRANOLOL, EZETIMIBE, SIMVASTATIN (EZETIMIBE/SIMVASTATIN), MONTELUKAST, ZALEPLON, CYCLOBENZAPRINE, HYDROXYCHLOROQUINE and AZITHROMYCIN for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced FATIGUE (Slight fatigue). At the time of the report, FATIGUE (Slight fatigue) outcome was unknown.            It was reported that after their second dose the patient traveled Internationally and Nationally extensively.  No treatment medications were reported.   This case was linked to MOD-2021-411362, MOD-2021-411494 (Patient Link).
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination complication
Clinical narrative: Minor to no side effects or pain; Soreness for about 2 days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Minor to no side effects or pain) and MYALGIA (Soreness for about 2 days) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A, 034C21A and 007C21A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis (Arthritis of right shoulder). Concomitant products included PARACETAMOL (TYLENOL [PARACETAMOL]) for Arthritis.   On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Oct-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 VACCINATION COMPLICATION (Minor to no side effects or pain) and MYALGIA (Soreness for about 2 days). The patient was treated with MELOXICAM for Adverse event, at an unspecified dose and frequency and MENTHOL, METHYL SALICYLATE (SALONPAS [MENTHOL;METHYL SALICYLATE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (Minor to no side effects or pain) and MYALGIA (Soreness for about 2 days) outcome was unknown.            Patient had physical therapy for right arm/shoulder.   This case was linked to MOD-2021-406511, MOD-2021-413719 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Depressed mood
Clinical narrative: down for the count for 24 hours; This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSED MOOD (down for the count for 24 hours) 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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DEPRESSED MOOD (down for the count for 24 hours). At the time of the report, DEPRESSED MOOD (down for the count for 24 hours) had resolved.            No concomitant medication was reported by the reporter. No treatment was reported by the reporter.   This case was linked to MOD-2021-411607 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not been feeling well and it has been 30 days since first dose) 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 MALAISE (not been feeling well and it has been 30 days since first dose). At the time of the report, MALAISE (not been feeling well and it has been 30 days since first dose) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.Concomitant medication information was not provided by the reporter.Treatment information was not provided by the reporter.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose, Inappropriate schedule of product administration
Clinical narrative: First shot Pfizer, 2nd shot Moderna Booster mix series; Moderna Booster half dose administered instead of second shot Pfizer; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First shot Pfizer, 2nd shot Moderna Booster mix series) and ACCIDENTAL UNDERDOSE (Moderna Booster half dose administered instead of second shot Pfizer) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058F21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Pfizer COVID-19 Vaccine on 17-Sep-2021. Past adverse reactions to the above products included No adverse event with Pfizer COVID-19 Vaccine.    On 24-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 24-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First shot Pfizer, 2nd shot Moderna Booster mix series) and ACCIDENTAL UNDERDOSE (Moderna Booster half dose administered instead of second shot Pfizer). On 24-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First shot Pfizer, 2nd shot Moderna Booster mix series) and ACCIDENTAL UNDERDOSE (Moderna Booster half dose administered instead of second shot Pfizer) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment mediations were reported.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Peripheral swelling
Clinical narrative: Arm is still swollen; Still not feeling that great; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm is still swollen) and MALAISE (Still not feeling that great) 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 11-Dec-2021, the patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Dec-2021, the patient experienced PERIPHERAL SWELLING (Arm is still swollen) and MALAISE (Still not feeling that great). At the time of the report, PERIPHERAL SWELLING (Arm is still swollen) and MALAISE (Still not feeling that great) had not resolved.            Concomitant information was not provided.   It was reported that the patient took her booster dose on Saturday around noon.  Treatment information was not provided.   This case was linked to MOD-2021-411501 (Patient Link).
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: itchy; rash on the tattoo,one is about 6 inches, one 7 inches; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy) and RASH (rash on the tattoo,one is about 6 inches, one 7 inches) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (COVID-19 VACCINE JANSSEN) and SPIRONOLACTONE for an unknown indication.    On 02-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Dec-2021, the patient experienced RASH (rash on the tattoo,one is about 6 inches, one 7 inches). On an unknown date, the patient experienced PRURITUS (itchy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE for Rash, at a dose of 1 dosage form. At the time of the report, PRURITUS and RASH (rash on the tattoo,one is about 6 inches, one 7 inches) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Patient took Primary series of J&J vaccine on 24-Mar-2021.Patient said there is blue ink for her tattoo, and the rash is only in the blue ink. Her doctor said he's never seen it before, gave her Benadryl.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore left arm) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Aug-2021, the patient experienced PAIN IN EXTREMITY (Sore left arm). At the time of the report, PAIN IN EXTREMITY (Sore left arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported.  Treatment information was not provided.   This case was linked to MOD-2021-411865, MOD-2021-410277 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administration beyond 30 days use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administration beyond 30 days use by date) 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 EXPIRED PRODUCT ADMINISTERED (administration beyond 30 days use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administration beyond 30 days use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: half dose administered for first dose on accident; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (half dose administered for first dose on accident) 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 16-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. On 16-Nov-2021, the patient experienced ACCIDENTAL UNDERDOSE (half dose administered for first dose on accident). On 16-Nov-2021, ACCIDENTAL UNDERDOSE (half dose administered for first dose on accident) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The  concomitant medications on use were not provided. No treatment information was provided.  A nursing home resident received a half dose of 0.25mL Moderna first dose administered on accident. No symptoms reported by health care professional.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Body temperature, Chills, Lymphadenopathy, Pyrexia, Reaction to preservatives
Clinical narrative: Reporting it was due to the preservatives in the COVID 19 vaccine; Swelling of lymph nodes under her arm pit; Fever 104/ fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of REACTION TO PRESERVATIVES (Reporting it was due to the preservatives in the COVID 19 vaccine), LYMPHADENOPATHY (Swelling of lymph nodes under her arm pit), PYREXIA (Fever 104/ fever) and CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU VACCINE VII) for an unknown indication.    No Medical History information was reported.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 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 started INFLUENZA VACCINE (FLU VACCINE VII) (unknown route) at an unspecified dose. On an unknown date, the patient experienced REACTION TO PRESERVATIVES (Reporting it was due to the preservatives in the COVID 19 vaccine), LYMPHADENOPATHY (Swelling of lymph nodes under her arm pit), PYREXIA (Fever 104/ fever) and CHILLS (Chills). At the time of the report, REACTION TO PRESERVATIVES (Reporting it was due to the preservatives in the COVID 19 vaccine), LYMPHADENOPATHY (Swelling of lymph nodes under her arm pit), PYREXIA (Fever 104/ fever) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 104 (High) High.         No concomitant medications reported. No treatment medications reported.  It was reported that patient had the symptoms happened with the 2nd and 3rd shots and it was due to the preservatives in the COVID-19 Vaccine. She also reports issues with the flu vaccine with preservatives,but has no issues with the flu vaccine if it does not have preservatives in it.   This case was linked to MOD-2021-411912 (Patient Link).   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: fatigue; muscle soreness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue) and MYALGIA (muscle soreness) 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 06-Dec-2021, the patient 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 an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Dec-2021, the patient experienced FATIGUE (fatigue) and MYALGIA (muscle soreness). On 10-Dec-2021, FATIGUE (fatigue) and MYALGIA (muscle soreness) had resolved.            Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-411159 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received 2 days after its expiration date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received 2 days after its expiration date.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) 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 EXPIRED PRODUCT ADMINISTERED (Patient received 2 days after its expiration date.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received 2 days after its expiration date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.                             Treatment information was not provided by the reporter.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms, Phantom limb syndrome, Proctalgia
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of PHANTOM LIMB SYNDROME (terrible phantom pain/Extreme phantom pain caused by vaccination 2 and boostet), MUSCLE SPASMS (muscle spasm) and PROCTALGIA (anal pain) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 069F21A, 001A21A and 013F20A) for COVID-19 vaccination. The patient's past medical history included Leg amputation in July 2020, Heart attack (heart attack during procedure which followed by getting Stent), COVID-19 (covid + during his stay in nursing home in summer of 2020) in 2020 and Stent placement. Concurrent medical conditions included Drug allergy (Norco Allergy). On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-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 PHANTOM LIMB SYNDROME (terrible phantom pain/Extreme phantom pain caused by vaccination 2 and boostet), MUSCLE SPASMS (muscle spasm) and PROCTALGIA (anal pain). At the time of the report, PHANTOM LIMB SYNDROME (terrible phantom pain/Extreme phantom pain caused by vaccination 2 and boostet), MUSCLE SPASMS (muscle spasm) and PROCTALGIA (anal pain) outcome was unknown. No Concomitant Medications were provided by the reporter. No Treatment Information were provided by the reporter. This case was linked to MOD-2021-411001, MOD-2021-076510 (Patient Link).Most recent FOLLOW-UP information incorporated above includes: On 14-Dec-2021: Follow up received contains Report type changed from Consumer to Other Health Professional.