chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Peripheral swelling, Pruritus, Pyrexia, Rash erythematous
Clinical narrative: Rash that looked like pimples or red bumps that appeared all over both arms, left breast, middle chest, left side of ribs, and torso; Rash looked like hives; Sun sensitive that rash or hives would get worse; Fever of 101 Fahrenheit; Chills; Hard to lift arm; Arm swelling; Burning in arm; Feels like bees were stinging; Hot to touch arm; Itchiness; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Rash that looked like pimples or red bumps that appeared all over both arms, left breast, middle chest, left side of ribs, and torso), URTICARIA (Rash looked like hives), TEMPERATURE INTOLERANCE (Sun sensitive that rash or hives would get worse), HYPOKINESIA (Hard to lift arm) and PERIPHERAL SWELLING (Arm swelling) in a 36-year-old female patient who received mRNA-1273 (batch nos. 004M20A and 0121L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (unknown route) dosage was changed to 1 dosage form. On 15-Feb-2021, the patient experienced HYPOKINESIA (Hard to lift arm), PERIPHERAL SWELLING (Arm swelling), BURNING SENSATION (Burning in arm), PAIN (Feels like bees were stinging), FEELING HOT (Hot to touch arm) and PRURITUS (Itchiness). On 20-Feb-2021, the patient experienced RASH ERYTHEMATOUS (Rash that looked like pimples or red bumps that appeared all over both arms, left breast, middle chest, left side of ribs, and torso), URTICARIA (Rash looked like hives), TEMPERATURE INTOLERANCE (Sun sensitive that rash or hives would get worse), PYREXIA (Fever of 101 Fahrenheit) and CHILLS (Chills). On 17-Feb-2021, HYPOKINESIA (Hard to lift arm) had resolved. On 21-Feb-2021, PYREXIA (Fever of 101 Fahrenheit) and CHILLS (Chills) had resolved. At the time of the report, RASH ERYTHEMATOUS (Rash that looked like pimples or red bumps that appeared all over both arms, left breast, middle chest, left side of ribs, and torso), URTICARIA (Rash looked like hives), TEMPERATURE INTOLERANCE (Sun sensitive that rash or hives would get worse), PERIPHERAL SWELLING (Arm swelling), BURNING SENSATION (Burning in arm), PAIN (Feels like bees were stinging), FEELING HOT (Hot to touch arm) and PRURITUS (Itchiness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Feb-2021, Body temperature: 101 f High.         Concomitant and Treatment medications were provided by reporter.   This case was linked to MOD-2021-118566 (Patient Link).
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Temperature intolerance, Urticaria
Clinical narrative: Rash that looked like pimples or red bumps that appeared all over both arms, left breast, middle chest, left side of ribs, and torso; Rash looked like hives; Sun sensitive that rash or hives would get worse; Fever of 101 Fahrenheit; Chills; Hard to lift arm; Arm swelling; Burning in arm; Feels like bees were stinging; Hot to touch arm; Itchiness; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Rash that looked like pimples or red bumps that appeared all over both arms, left breast, middle chest, left side of ribs, and torso), URTICARIA (Rash looked like hives), TEMPERATURE INTOLERANCE (Sun sensitive that rash or hives would get worse), HYPOKINESIA (Hard to lift arm) and PERIPHERAL SWELLING (Arm swelling) in a 36-year-old female patient who received mRNA-1273 (batch nos. 004M20A and 0121L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (unknown route) dosage was changed to 1 dosage form. On 15-Feb-2021, the patient experienced HYPOKINESIA (Hard to lift arm), PERIPHERAL SWELLING (Arm swelling), BURNING SENSATION (Burning in arm), PAIN (Feels like bees were stinging), FEELING HOT (Hot to touch arm) and PRURITUS (Itchiness). On 20-Feb-2021, the patient experienced RASH ERYTHEMATOUS (Rash that looked like pimples or red bumps that appeared all over both arms, left breast, middle chest, left side of ribs, and torso), URTICARIA (Rash looked like hives), TEMPERATURE INTOLERANCE (Sun sensitive that rash or hives would get worse), PYREXIA (Fever of 101 Fahrenheit) and CHILLS (Chills). On 17-Feb-2021, HYPOKINESIA (Hard to lift arm) had resolved. On 21-Feb-2021, PYREXIA (Fever of 101 Fahrenheit) and CHILLS (Chills) had resolved. At the time of the report, RASH ERYTHEMATOUS (Rash that looked like pimples or red bumps that appeared all over both arms, left breast, middle chest, left side of ribs, and torso), URTICARIA (Rash looked like hives), TEMPERATURE INTOLERANCE (Sun sensitive that rash or hives would get worse), PERIPHERAL SWELLING (Arm swelling), BURNING SENSATION (Burning in arm), PAIN (Feels like bees were stinging), FEELING HOT (Hot to touch arm) and PRURITUS (Itchiness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Feb-2021, Body temperature: 101 f High.         Concomitant and Treatment medications were provided by reporter.   This case was linked to MOD-2021-118566 (Patient Link).
Age: 71.0
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue) in a 71-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced FATIGUE (fatigue). On 06-Apr-2021, FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment details were not provided.    This case was linked to MOD-2021-118579 (Patient Link).
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Pain in extremity, Pyrexia, Respiratory tract inflammation, Tonsillar inflammation
Clinical narrative: Tonsillar inflamation; Something in the throat, it was sort of inflamed; Ear pain; Sore arm; Fever of 37.6°C; This spontaneous case was reported by a consumer and describes the occurrence of TONSILLAR INFLAMMATION (Tonsillar inflamation), RESPIRATORY TRACT INFLAMMATION (Something in the throat, it was sort of inflamed), EAR PAIN (Ear pain), PAIN IN EXTREMITY (Sore arm) and PYREXIA (Fever of 37.6°C) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced PYREXIA (Fever of 37.6°C). On an unknown date, the patient experienced TONSILLAR INFLAMMATION (Tonsillar inflamation), RESPIRATORY TRACT INFLAMMATION (Something in the throat, it was sort of inflamed), EAR PAIN (Ear pain) and PAIN IN EXTREMITY (Sore arm). At the time of the report, TONSILLAR INFLAMMATION (Tonsillar inflamation), RESPIRATORY TRACT INFLAMMATION (Something in the throat, it was sort of inflamed), EAR PAIN (Ear pain), PAIN IN EXTREMITY (Sore arm) and PYREXIA (Fever of 37.6°C) outcome was unknown.            This case was linked to MOD-2021-118729 (E2B Linked Report).; Sender's Comments:  MOD-2021-118729:
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue after 1st dose) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN) for an unknown indication.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced FATIGUE (Fatigue after 1st dose). On 08-Apr-2021, FATIGUE (Fatigue after 1st dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication include Birth control pills.   This case was linked to MOD-2021-118764 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: nausea after her 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea after her 1st dose) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and VITAMIN D [VITAMIN D NOS] for Blood pressure abnormal.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced NAUSEA (nausea after her 1st dose). At the time of the report, NAUSEA (nausea after her 1st dose) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment drug included Pepto Bismol.  Action taken with mRNA-1273 in response to the event was not applicable.  Patient took 2nd dose of Moderna COVID-19 vaccine on 29 Apr 2021 in her left non dominant upper arm.   This case was linked to MOD-2021-118782 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Batch number was added. Concomitant drugs were added.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: small red circle on arm at injection site; swelling after vaccination; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE ERYTHEMA (small red circle on arm at injection site) and VACCINATION SITE SWELLING (swelling after vaccination) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 03-May-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 VACCINATION SITE ERYTHEMA (small red circle on arm at injection site) and VACCINATION SITE SWELLING (swelling after vaccination). At the time of the report, VACCINATION SITE ERYTHEMA (small red circle on arm at injection site) and VACCINATION SITE SWELLING (swelling after vaccination) outcome was unknown. Not Provided      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.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow up was received on 11 may 2021 included additional event
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patients were given Moderna vaccine more than 6 hours after first vial puncture.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients were given Moderna vaccine more than 6 hours after first vial puncture.) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination.     No medical history was reported.     On 08-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients were given Moderna vaccine more than 6 hours after first vial puncture.). On 08-May-2021, EXPIRED PRODUCT ADMINISTERED (patients were given Moderna vaccine more than 6 hours after first vial puncture.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant  information was  provided. No Treatment information was  provided.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Discomfort, Feeling of body temperature change, Myalgia, Peripheral swelling
Clinical narrative: Body discomfort; bone pain; body aches; Left arm was a little swollen but not like the first time with the 1st dose; My body was hot and cold; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (Body discomfort), BONE PAIN (bone pain), PERIPHERAL SWELLING (Left arm was a little swollen but not like the first time with the 1st dose), FEELING OF BODY TEMPERATURE CHANGE (My body was hot and cold) and MYALGIA (body aches) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 040B21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included METFORMIN, LOSARTAN, VITAMIN D [VITAMIN D NOS], ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and ATORVASTATIN for an unknown indication.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced PERIPHERAL SWELLING (Left arm was a little swollen but not like the first time with the 1st dose) and FEELING OF BODY TEMPERATURE CHANGE (My body was hot and cold). On 20-Apr-2021, the patient experienced DISCOMFORT (Body discomfort), BONE PAIN (bone pain) and MYALGIA (body aches). At the time of the report, DISCOMFORT (Body discomfort), BONE PAIN (bone pain), PERIPHERAL SWELLING (Left arm was a little swollen but not like the first time with the 1st dose), FEELING OF BODY TEMPERATURE CHANGE (My body was hot and cold) and MYALGIA (body aches) outcome was unknown.            Treatment medication was Panadol before and after the 2nd dose.   This case was linked to US-MODERNATX, INC.-MOD-2021-058154 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-058154:Dose 1
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Nausea, Pyrexia, Vomiting
Clinical narrative: no energy/lack of energy; nausea; vomiting; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (no energy/lack of energy), NAUSEA (nausea), VOMITING (vomiting), PYREXIA (fever) and CHILLS (chills) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-May-2021, the patient experienced NAUSEA (nausea), VOMITING (vomiting), PYREXIA (fever) and CHILLS (chills). On 10-May-2021, the patient experienced ASTHENIA (no energy/lack of energy). On 09-May-2021, PYREXIA (fever) and CHILLS (chills) had resolved. At the time of the report, ASTHENIA (no energy/lack of energy), NAUSEA (nausea) and VOMITING (vomiting) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medications include Aleve, TUMS, Pedialyte electrolyte powder.    This case was linked to MOD21-088917 (E2B Linked Report).; Sender's Comments:  MOD21-088917:Same reporter, different patient
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for an unreported indication: FLU VACCINE VII.   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 an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment medications were not provided by the reporter.    This case was linked to MOD21-089331 (E2B Linked Report).; Sender's Comments:  MOD21-089331:cross linked id - husband case
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Extra dose administered, Headache, Inappropriate schedule of product administration, Lethargy
Clinical narrative: could not get out of bed; chills; muscle aches; excruciating headache that lasted 12 to 15 hours; recieved 3rd dose of covid-19 vaccine.; Iappropriate schedule; This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Iappropriate schedule), EXTRA DOSE ADMINISTERED (recieved 3rd dose of covid-19 vaccine.), LETHARGY (could not get out of bed), CHILLS (chills) and MYALGIA (muscle aches) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A, 003C21A and UNK) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included SARS-CoV-2 infection (Patient was positive of covid-19 on 21Jan2021.) and Pneumonia. Concomitant products included SPIRONOLACTONE and PAROXETINE HYDROCHLORIDE (PAXIL CR) for an unknown indication.   On 10-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-May-2021, received third 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 10-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Iappropriate schedule). On 08-May-2021, the patient experienced EXTRA DOSE ADMINISTERED (recieved 3rd dose of covid-19 vaccine.). On an unknown date, the patient experienced LETHARGY (could not get out of bed), CHILLS (chills), MYALGIA (muscle aches) and HEADACHE (excruciating headache that lasted 12 to 15 hours). On 10-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Iappropriate schedule) had resolved. On 08-May-2021, EXTRA DOSE ADMINISTERED (recieved 3rd dose of covid-19 vaccine.) had resolved. At the time of the report, LETHARGY (could not get out of bed), CHILLS (chills), MYALGIA (muscle aches) and HEADACHE (excruciating headache that lasted 12 to 15 hours) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: 20 (High) high antibody number was 20.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient reports experiencing little bit of fever, backache, body ache, and extremely sore arm after receiving the third Moderna Covid-19 vaccine. No treatment was reported. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable, reporter didn't provide causality assessment.   This case was linked to INC.-MOD-2021-118621 (E2B Linked Report).; Sender's Comments:  INC.-MOD-2021-118621:1st Dose
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, SARS-CoV-2 antibody test
Clinical narrative: could not get out of bed; chills; muscle aches; excruciating headache that lasted 12 to 15 hours; recieved 3rd dose of covid-19 vaccine.; Iappropriate schedule; This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Iappropriate schedule), EXTRA DOSE ADMINISTERED (recieved 3rd dose of covid-19 vaccine.), LETHARGY (could not get out of bed), CHILLS (chills) and MYALGIA (muscle aches) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A, 003C21A and UNK) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included SARS-CoV-2 infection (Patient was positive of covid-19 on 21Jan2021.) and Pneumonia. Concomitant products included SPIRONOLACTONE and PAROXETINE HYDROCHLORIDE (PAXIL CR) for an unknown indication.   On 10-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-May-2021, received third 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 10-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Iappropriate schedule). On 08-May-2021, the patient experienced EXTRA DOSE ADMINISTERED (recieved 3rd dose of covid-19 vaccine.). On an unknown date, the patient experienced LETHARGY (could not get out of bed), CHILLS (chills), MYALGIA (muscle aches) and HEADACHE (excruciating headache that lasted 12 to 15 hours). On 10-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Iappropriate schedule) had resolved. On 08-May-2021, EXTRA DOSE ADMINISTERED (recieved 3rd dose of covid-19 vaccine.) had resolved. At the time of the report, LETHARGY (could not get out of bed), CHILLS (chills), MYALGIA (muscle aches) and HEADACHE (excruciating headache that lasted 12 to 15 hours) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: 20 (High) high antibody number was 20.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient reports experiencing little bit of fever, backache, body ache, and extremely sore arm after receiving the third Moderna Covid-19 vaccine. No treatment was reported. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable, reporter didn't provide causality assessment.   This case was linked to INC.-MOD-2021-118621 (E2B Linked Report).; Sender's Comments:  INC.-MOD-2021-118621:1st Dose
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Aching of the arm; Hot and swollen at injection site; Hot and swollen at injection site; Arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt), PAIN IN EXTREMITY (Aching of the arm), VACCINATION SITE WARMTH (Hot and swollen at injection site) and VACCINATION SITE SWELLING (Hot and swollen at injection site) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, the patient experienced PAIN IN EXTREMITY (Arm hurt). On 10-May-2021, the patient experienced PAIN IN EXTREMITY (Aching of the arm), VACCINATION SITE WARMTH (Hot and swollen at injection site) and VACCINATION SITE SWELLING (Hot and swollen at injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 04-May-2021, PAIN IN EXTREMITY (Arm hurt) had resolved. At the time of the report, PAIN IN EXTREMITY (Aching of the arm), VACCINATION SITE WARMTH (Hot and swollen at injection site) and VACCINATION SITE SWELLING (Hot and swollen at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Feeling abnormal
Clinical narrative: Things started getting weird; pain in the back; Pain in the joint/Pain on the joint, like on the ankle, on the joint between leg and foot/On the elbowand shoulder; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (Things started getting weird), BACK PAIN (pain in the back) and ARTHRALGIA (Pain in the joint/Pain on the joint, like on the ankle, on the joint between leg and foot/On the elbowand shoulder) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 01-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Things started getting weird), BACK PAIN (pain in the back) and ARTHRALGIA (Pain in the joint/Pain on the joint, like on the ankle, on the joint between leg and foot/On the elbowand shoulder). At the time of the report, FEELING ABNORMAL (Things started getting weird), BACK PAIN (pain in the back) and ARTHRALGIA (Pain in the joint/Pain on the joint, like on the ankle, on the joint between leg and foot/On the elbowand shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment details were provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-118639 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-118639:
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Headache, Myalgia, Pain in extremity
Clinical narrative: muscle aches; fever; backache; extremely sore arm; Excruciating headache that lasted to 12 to 15 hours; chills; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of MYALGIA (muscle aches), PYREXIA (fever), BACK PAIN (backache), PAIN IN EXTREMITY (extremely sore arm) and HEADACHE (Excruciating headache that lasted to 12 to 15 hours) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was given by the reporter.  Concomitant products included SPIRONOLACTONE and PIROXICAM (PAXIL [PIROXICAM]) for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-May-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 MYALGIA (muscle aches), PYREXIA (fever), BACK PAIN (backache), PAIN IN EXTREMITY (extremely sore arm), HEADACHE (Excruciating headache that lasted to 12 to 15 hours) and CHILLS (chills). At the time of the report, MYALGIA (muscle aches), PYREXIA (fever), BACK PAIN (backache), PAIN IN EXTREMITY (extremely sore arm), HEADACHE (Excruciating headache that lasted to 12 to 15 hours) and CHILLS (chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.  Treatment information was not provided.    This case was linked to INC.-MOD-2021-118621 (E2B Linked Report).; Sender's Comments: INC.-MOD-2021-118621:1st Dose.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: muscle aches; fever; backache; extremely sore arm; Excruciating headache that lasted to 12 to 15 hours; chills; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of MYALGIA (muscle aches), PYREXIA (fever), BACK PAIN (backache), PAIN IN EXTREMITY (extremely sore arm) and HEADACHE (Excruciating headache that lasted to 12 to 15 hours) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was given by the reporter.  Concomitant products included SPIRONOLACTONE and PIROXICAM (PAXIL [PIROXICAM]) for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-May-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 MYALGIA (muscle aches), PYREXIA (fever), BACK PAIN (backache), PAIN IN EXTREMITY (extremely sore arm), HEADACHE (Excruciating headache that lasted to 12 to 15 hours) and CHILLS (chills). At the time of the report, MYALGIA (muscle aches), PYREXIA (fever), BACK PAIN (backache), PAIN IN EXTREMITY (extremely sore arm), HEADACHE (Excruciating headache that lasted to 12 to 15 hours) and CHILLS (chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.  Treatment information was not provided.    This case was linked to INC.-MOD-2021-118621 (E2B Linked Report).; Sender's Comments: INC.-MOD-2021-118621:1st Dose.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Paraesthesia oral, Pharyngeal paraesthesia, Tension
Clinical narrative: Her tongue and throat started tingling; Her tongue and throat started tingling; Dizzy/Lightheaded; Jittery which she described as "like she had too much caffeine"; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (Her tongue and throat started tingling), PHARYNGEAL PARAESTHESIA (Her tongue and throat started tingling), DIZZINESS (Dizzy/Lightheaded) and TENSION (Jittery which she described as "like she had too much caffeine") in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     no medical history information was reported.  Concomitant products included AIRBORNE for an unknown indication.    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, the patient experienced PARAESTHESIA ORAL (Her tongue and throat started tingling), PHARYNGEAL PARAESTHESIA (Her tongue and throat started tingling), DIZZINESS (Dizzy/Lightheaded) and TENSION (Jittery which she described as "like she had too much caffeine"). On 11-May-2021, PARAESTHESIA ORAL (Her tongue and throat started tingling), PHARYNGEAL PARAESTHESIA (Her tongue and throat started tingling), DIZZINESS (Dizzy/Lightheaded) and TENSION (Jittery which she described as "like she had too much caffeine") had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was reported
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea, Headache, Illness, Mobility decreased
Clinical narrative: Body aches; Difficulty breathing; Unable to perform daily activities,do anything,Could not walk; Sore/ache neck; Got sick the same night; Can't work while standing; Could not talk; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficulty breathing), MOBILITY DECREASED (Unable to perform daily activities,do anything,Could not walk), NECK PAIN (Sore/ache neck), ILLNESS (Got sick the same night) and ASTHENIA (Can't work while standing) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 01220A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes.   On 04-Mar-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 04-Mar-2021, the patient experienced DYSPNOEA (Difficulty breathing), MOBILITY DECREASED (Unable to perform daily activities,do anything,Could not walk), NECK PAIN (Sore/ache neck), ILLNESS (Got sick the same night), ASTHENIA (Can't work while standing), SPEECH DISORDER (Could not talk) and HEADACHE (Headache). On an unknown date, the patient experienced MYALGIA (Body aches). The patient was treated with ALBUTEROL [SALBUTAMOL] ongoing since an unknown date for Dyspnea, at an unspecified dose and frequency. At the time of the report, DYSPNOEA (Difficulty breathing) had not resolved, MOBILITY DECREASED (Unable to perform daily activities,do anything,Could not walk) and ASTHENIA (Can't work while standing) outcome was unknown and NECK PAIN (Sore/ache neck), ILLNESS (Got sick the same night), SPEECH DISORDER (Could not talk), HEADACHE (Headache) and MYALGIA (Body aches) had resolved.            Concomitant products includes Diabetes medication Action taken with mRNA-1273 in response to the events is not applicable   Most recent FOLLOW-UP information incorporated above includes: On 12-Jun-2021: Additional information received on 12-JUN-2021. Outcome of the event Difficulty breathing is changed from Unknown to Not recovered
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Neck pain, Speech disorder
Clinical narrative: Body aches; Difficulty breathing; Unable to perform daily activities,do anything,Could not walk; Sore/ache neck; Got sick the same night; Can't work while standing; Could not talk; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficulty breathing), MOBILITY DECREASED (Unable to perform daily activities,do anything,Could not walk), NECK PAIN (Sore/ache neck), ILLNESS (Got sick the same night) and ASTHENIA (Can't work while standing) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 01220A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes.   On 04-Mar-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 04-Mar-2021, the patient experienced DYSPNOEA (Difficulty breathing), MOBILITY DECREASED (Unable to perform daily activities,do anything,Could not walk), NECK PAIN (Sore/ache neck), ILLNESS (Got sick the same night), ASTHENIA (Can't work while standing), SPEECH DISORDER (Could not talk) and HEADACHE (Headache). On an unknown date, the patient experienced MYALGIA (Body aches). The patient was treated with ALBUTEROL [SALBUTAMOL] ongoing since an unknown date for Dyspnea, at an unspecified dose and frequency. At the time of the report, DYSPNOEA (Difficulty breathing) had not resolved, MOBILITY DECREASED (Unable to perform daily activities,do anything,Could not walk) and ASTHENIA (Can't work while standing) outcome was unknown and NECK PAIN (Sore/ache neck), ILLNESS (Got sick the same night), SPEECH DISORDER (Could not talk), HEADACHE (Headache) and MYALGIA (Body aches) had resolved.            Concomitant products includes Diabetes medication Action taken with mRNA-1273 in response to the events is not applicable   Most recent FOLLOW-UP information incorporated above includes: On 12-Jun-2021: Additional information received on 12-JUN-2021. Outcome of the event Difficulty breathing is changed from Unknown to Not recovered
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Chest X-ray, Cough, Diarrhoea
Clinical narrative: felt very sick; coughing; diarrhea; lost 10 pounds in weight; felt the pain of the injection; nauseated; Fever; COVID-19 Diagnosis; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19 Diagnosis), MALAISE (felt very sick), COUGH (coughing), DIARRHOEA (diarrhea) and WEIGHT DECREASED (lost 10 pounds in weight) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 012M20A) 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 Multiple sclerosis, Diabetes, Obesity and Drug allergy (Allergic to Sulfa drugs). Concomitant products included VITAMIN D NOS, VITAMIN K NOS and ASCORBIC ACID (VITAMIN C ACID) for an unknown indication.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-May-2021, the patient experienced COVID-19 (COVID-19 Diagnosis). On 12-May-2021, the patient experienced PYREXIA (Fever). On an unknown date, the patient experienced MALAISE (felt very sick), COUGH (coughing), DIARRHOEA (diarrhea), WEIGHT DECREASED (lost 10 pounds in weight), VACCINATION SITE PAIN (felt the pain of the injection) and NAUSEA (nauseated). The patient was treated with VITAMIN D NOS at a dose of 20000 unit once a day; ASCORBIC ACID (VITAMIN C ACID) at a dose of 1000 unit once a day; FAMOTIDINE (PEPCID AC) at a dose of 40 mg twice a day; RIVAROXABAN (XARELTO) at a dose of UNK, qd; MELATONIN at a dose of UNK, qd; IVERMECTIN at a dose of UNK, qd and DOXYCYCLINE at a dose of UNK, qd. At the time of the report, COVID-19 (COVID-19 Diagnosis) had not resolved and MALAISE (felt very sick), COUGH (coughing), DIARRHOEA (diarrhea), WEIGHT DECREASED (lost 10 pounds in weight), VACCINATION SITE PAIN (felt the pain of the injection), NAUSEA (nauseated) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-May-2021, SARS-CoV-2 test: positive positive Positive. On an unknown date, Body temperature: 103.5-104 °f High. On an unknown date, Chest X-ray: abnormal abnormal (abnormal) There was a scar tissue, and it wasn't different from any of her chest x-rays from before. The radiologist thought it could be pneumonia.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nausea, Pyrexia, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: felt very sick; coughing; diarrhea; lost 10 pounds in weight; felt the pain of the injection; nauseated; Fever; COVID-19 Diagnosis; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19 Diagnosis), MALAISE (felt very sick), COUGH (coughing), DIARRHOEA (diarrhea) and WEIGHT DECREASED (lost 10 pounds in weight) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 012M20A) 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 Multiple sclerosis, Diabetes, Obesity and Drug allergy (Allergic to Sulfa drugs). Concomitant products included VITAMIN D NOS, VITAMIN K NOS and ASCORBIC ACID (VITAMIN C ACID) for an unknown indication.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-May-2021, the patient experienced COVID-19 (COVID-19 Diagnosis). On 12-May-2021, the patient experienced PYREXIA (Fever). On an unknown date, the patient experienced MALAISE (felt very sick), COUGH (coughing), DIARRHOEA (diarrhea), WEIGHT DECREASED (lost 10 pounds in weight), VACCINATION SITE PAIN (felt the pain of the injection) and NAUSEA (nauseated). The patient was treated with VITAMIN D NOS at a dose of 20000 unit once a day; ASCORBIC ACID (VITAMIN C ACID) at a dose of 1000 unit once a day; FAMOTIDINE (PEPCID AC) at a dose of 40 mg twice a day; RIVAROXABAN (XARELTO) at a dose of UNK, qd; MELATONIN at a dose of UNK, qd; IVERMECTIN at a dose of UNK, qd and DOXYCYCLINE at a dose of UNK, qd. At the time of the report, COVID-19 (COVID-19 Diagnosis) had not resolved and MALAISE (felt very sick), COUGH (coughing), DIARRHOEA (diarrhea), WEIGHT DECREASED (lost 10 pounds in weight), VACCINATION SITE PAIN (felt the pain of the injection), NAUSEA (nauseated) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-May-2021, SARS-CoV-2 test: positive positive Positive. On an unknown date, Body temperature: 103.5-104 °f High. On an unknown date, Chest X-ray: abnormal abnormal (abnormal) There was a scar tissue, and it wasn't different from any of her chest x-rays from before. The radiologist thought it could be pneumonia.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: felt very sick; coughing; diarrhea; lost 10 pounds in weight; felt the pain of the injection; nauseated; Fever; COVID-19 Diagnosis; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19 Diagnosis), MALAISE (felt very sick), COUGH (coughing), DIARRHOEA (diarrhea) and WEIGHT DECREASED (lost 10 pounds in weight) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 012M20A) 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 Multiple sclerosis, Diabetes, Obesity and Drug allergy (Allergic to Sulfa drugs). Concomitant products included VITAMIN D NOS, VITAMIN K NOS and ASCORBIC ACID (VITAMIN C ACID) for an unknown indication.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-May-2021, the patient experienced COVID-19 (COVID-19 Diagnosis). On 12-May-2021, the patient experienced PYREXIA (Fever). On an unknown date, the patient experienced MALAISE (felt very sick), COUGH (coughing), DIARRHOEA (diarrhea), WEIGHT DECREASED (lost 10 pounds in weight), VACCINATION SITE PAIN (felt the pain of the injection) and NAUSEA (nauseated). The patient was treated with VITAMIN D NOS at a dose of 20000 unit once a day; ASCORBIC ACID (VITAMIN C ACID) at a dose of 1000 unit once a day; FAMOTIDINE (PEPCID AC) at a dose of 40 mg twice a day; RIVAROXABAN (XARELTO) at a dose of UNK, qd; MELATONIN at a dose of UNK, qd; IVERMECTIN at a dose of UNK, qd and DOXYCYCLINE at a dose of UNK, qd. At the time of the report, COVID-19 (COVID-19 Diagnosis) had not resolved and MALAISE (felt very sick), COUGH (coughing), DIARRHOEA (diarrhea), WEIGHT DECREASED (lost 10 pounds in weight), VACCINATION SITE PAIN (felt the pain of the injection), NAUSEA (nauseated) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-May-2021, SARS-CoV-2 test: positive positive Positive. On an unknown date, Body temperature: 103.5-104 °f High. On an unknown date, Chest X-ray: abnormal abnormal (abnormal) There was a scar tissue, and it wasn't different from any of her chest x-rays from before. The radiologist thought it could be pneumonia.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: severe pain in her arm that she can't even to put her jacket after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (severe pain in her arm that she can't even to put her jacket after 2nd dose) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 036B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included Birth Control and BUPROPION HYDROCHLORIDE (WELLBUTRIN) for an unknown indication.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced MYALGIA (severe pain in her arm that she can't even to put her jacket after 2nd dose). At the time of the report, MYALGIA (severe pain in her arm that she can't even to put her jacket after 2nd dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient Tylenol medication and applied cold compress, to relieve the symptoms. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine was not applicable.   This case was linked to MOD-2021-118642 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: cold sores; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of ORAL HERPES (cold sores) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. unknown and unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 07-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, the patient experienced ORAL HERPES (cold sores). At the time of the report, ORAL HERPES (cold sores) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.