chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Myalgia, Nasal congestion, Neck pain, Pain in extremity
Clinical narrative: "real stiff"; like having bronchitis; arms sore; brought him down a little; neck sore; like someone is sitting on his chest/a feeling of pressure on his chest; nose has been "clogged up"; having problems breathing/breathing easier; shoulders sore; "real sore"/whole body is sore/like he has been beat all over; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS ("real stiff"), BRONCHITIS (like having bronchitis), PAIN IN EXTREMITY (arms sore), MALAISE (brought him down a little) and NECK PAIN (neck sore) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053C21A, 017B21A and 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sinusitis and Ragweed allergy.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Dec-2021, the patient experienced MUSCULOSKELETAL STIFFNESS ("real stiff"), BRONCHITIS (like having bronchitis), PAIN IN EXTREMITY (arms sore), MALAISE (brought him down a little), NECK PAIN (neck sore), CHEST DISCOMFORT (like someone is sitting on his chest/a feeling of pressure on his chest), NASAL CONGESTION (nose has been "clogged up"), DYSPNOEA (having problems breathing/breathing easier), ARTHRALGIA (shoulders sore) and MYALGIA ("real sore"/whole body is sore/like he has been beat all over). On 03-Dec-2021, DYSPNOEA (having problems breathing/breathing easier) had resolved. At the time of the report, MUSCULOSKELETAL STIFFNESS ("real stiff"), BRONCHITIS (like having bronchitis), PAIN IN EXTREMITY (arms sore), MALAISE (brought him down a little), NECK PAIN (neck sore), CHEST DISCOMFORT (like someone is sitting on his chest/a feeling of pressure on his chest), NASAL CONGESTION (nose has been "clogged up"), ARTHRALGIA (shoulders sore) and MYALGIA ("real sore"/whole body is sore/like he has been beat all over) outcome was unknown.            Concomitant medication was not provided.  Treatment medication include blood thinner (40 mg daily), inhaler.   This case was linked to MOD-2021-404563 (Patient Link).
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Skin warm
Clinical narrative: Sore arm that was warm; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of SKIN WARM (Sore arm that was warm) and PAIN IN EXTREMITY (Sore arm) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SKIN WARM (Sore arm that was warm) and PAIN IN EXTREMITY (Sore arm). At the time of the report, SKIN WARM (Sore arm that was warm) and PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient stated that he was undiagnosed with health issues and he could have cardiac or intestinal related health issues. No concomitant medications were mentioned. No treatment details were reported.   This case was linked to MOD-2021-404708 (Patient Link).   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: doses given after temperature excursion; Product storage error; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT STORAGE ERROR (Product storage error) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039F21A) 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 EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT STORAGE ERROR (Product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT STORAGE ERROR (Product storage error) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter. No treatment was reported by the reporter.   This case was linked to MOD-2021-403721 (Patient Link).
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: doses given after temperature excursion; Product storage error; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT STORAGE ERROR (Product storage error) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT STORAGE ERROR (Product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT STORAGE ERROR (Product storage error) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Treatment information was not reported.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Malaise, Pyrexia
Clinical narrative: tough time; fever of 99-101 degrees F for 2 days; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (tough time) and PYREXIA (fever of 99-101 degrees F for 2 days) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (tough time) and PYREXIA (fever of 99-101 degrees F for 2 days). At the time of the report, MALAISE (tough time) outcome was unknown and PYREXIA (fever of 99-101 degrees F for 2 days) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99-101 (High) Fever of 99-101 degrees F.         Concomitant medication was not reported. Treatment information was not reported.   This case was linked to MOD-2021-404687 (Patient Link).
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: doses given after temperature excursion; Product storage error; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT STORAGE ERROR (Product storage error) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039F21A) 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) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT STORAGE ERROR (Product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT STORAGE ERROR (Product storage error) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: HCP stated they have seen other similar cases after the vaccines; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (HCP stated they have seen other similar cases after the vaccines) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (HCP stated they have seen other similar cases after the vaccines). At the time of the report, VACCINATION COMPLICATION (HCP stated they have seen other similar cases after the vaccines) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment medications were reported.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Rash, Rash erythematous
Clinical narrative: Rash is red and look liked scratches and spread out all over the body; Rash is red and look liked scratches and spread out all over the body; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Rash is red and look liked scratches and spread out all over the body), RASH (Rash is red and look liked scratches and spread out all over the body), PYREXIA (fever) and CHILLS (chills) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH ERYTHEMATOUS (Rash is red and look liked scratches and spread out all over the body), RASH (Rash is red and look liked scratches and spread out all over the body), PYREXIA (fever) and CHILLS (chills). At the time of the report, RASH ERYTHEMATOUS (Rash is red and look liked scratches and spread out all over the body) and RASH (Rash is red and look liked scratches and spread out all over the body) had not resolved and PYREXIA (fever) and CHILLS (chills) outcome was unknown.            Patient had blood work and other test done but so far cause of the rash is unknown. 11 days after receiving the booster dose and experienced a rash all over the body. Patient had the rash for two weeks now and reported the rash is red and looks liked scratches and spread out all over the body. Concomitant medications were not provided. Treatment information was not provided.   This case was linked to MOD-2021-404755, MOD-2021-404744 (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Gingival swelling, Nasal congestion, Rash
Clinical narrative: swelling of gums; swelling of their nasal passages/nasal passages remain the worse; Nasal passages remain the worse; Rash behind the ears and the upper neck; This spontaneous case was reported by a patient and describes the occurrence of GINGIVAL SWELLING (swelling of gums), NASAL CONGESTION (swelling of their nasal passages/nasal passages remain the worse), CONDITION AGGRAVATED (Nasal passages remain the worse) and RASH (Rash behind the ears and the upper neck) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     Concomitant products included VERAPAMIL for Blood pressure high.    On 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced GINGIVAL SWELLING (swelling of gums), NASAL CONGESTION (swelling of their nasal passages/nasal passages remain the worse), CONDITION AGGRAVATED (Nasal passages remain the worse) and RASH (Rash behind the ears and the upper neck). At the time of the report, GINGIVAL SWELLING (swelling of gums) and RASH (Rash behind the ears and the upper neck) had resolved and NASAL CONGESTION (swelling of their nasal passages/nasal passages remain the worse) and CONDITION AGGRAVATED (Nasal passages remain the worse) was resolving.            No treatment information was provided by the reporter.  After the second dose, got worse and also developed swelling of gums and nasal passages, and a rash behind the ears and the upper neck. The symptoms have decreased since March but the nasal passages remain the worse and they are the last thing going away . Patient was concerned because they were thinking of taking the Booster now.   This case was linked to MOD-2021-404752 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dry skin, Eczema, Muscle spasms, Nausea
Clinical narrative: Hands feeling rough to the touch; Her hands started itching; Nausea; A lump; Eczema; Arm cramped all the way down into her hand; No energy; Arm pain her arm hurting, but moving it; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Arm cramped all the way down into her hand), ASTHENIA (No energy), PAIN IN EXTREMITY (Arm pain her arm hurting, but moving it), DRY SKIN (Hands feeling rough to the touch) and ECZEMA (Eczema) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030H21B, 002C21A and 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Flu (Flu several years ago with absolutely no energy). Concurrent medical conditions included Heart disorder (Heart condition).   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced MUSCLE SPASMS (Arm cramped all the way down into her hand), ASTHENIA (No energy), PAIN IN EXTREMITY (Arm pain her arm hurting, but moving it), ECZEMA (Eczema) and VACCINATION SITE MASS (A lump). On 01-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced NAUSEA (Nausea). On 02-Dec-2021, the patient experienced DRY SKIN (Hands feeling rough to the touch) and PRURITUS (Her hands started itching). At the time of the report, MUSCLE SPASMS (Arm cramped all the way down into her hand), ASTHENIA (No energy), DRY SKIN (Hands feeling rough to the touch), ECZEMA (Eczema), PRURITUS (Her hands started itching), VACCINATION SITE MASS (A lump) and NAUSEA (Nausea) outcome was unknown and PAIN IN EXTREMITY (Arm pain her arm hurting, but moving it) had resolved.            No concomitant medications were mentioned. Treatment medication reported included Organic cream for eczema. Patient stated that she has been using hand sanitizer more regularly.   This case was linked to MOD-2021-404769 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Vaccination site mass
Clinical narrative: Hands feeling rough to the touch; Her hands started itching; Nausea; A lump; Eczema; Arm cramped all the way down into her hand; No energy; Arm pain her arm hurting, but moving it; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Arm cramped all the way down into her hand), ASTHENIA (No energy), PAIN IN EXTREMITY (Arm pain her arm hurting, but moving it), DRY SKIN (Hands feeling rough to the touch) and ECZEMA (Eczema) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030H21B, 002C21A and 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Flu (Flu several years ago with absolutely no energy). Concurrent medical conditions included Heart disorder (Heart condition).   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced MUSCLE SPASMS (Arm cramped all the way down into her hand), ASTHENIA (No energy), PAIN IN EXTREMITY (Arm pain her arm hurting, but moving it), ECZEMA (Eczema) and VACCINATION SITE MASS (A lump). On 01-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced NAUSEA (Nausea). On 02-Dec-2021, the patient experienced DRY SKIN (Hands feeling rough to the touch) and PRURITUS (Her hands started itching). At the time of the report, MUSCLE SPASMS (Arm cramped all the way down into her hand), ASTHENIA (No energy), DRY SKIN (Hands feeling rough to the touch), ECZEMA (Eczema), PRURITUS (Her hands started itching), VACCINATION SITE MASS (A lump) and NAUSEA (Nausea) outcome was unknown and PAIN IN EXTREMITY (Arm pain her arm hurting, but moving it) had resolved.            No concomitant medications were mentioned. Treatment medication reported included Organic cream for eczema. Patient stated that she has been using hand sanitizer more regularly.   This case was linked to MOD-2021-404769 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Nasopharyngitis, Pain in extremity, Sneezing
Clinical narrative: I sneezed a lot; It sounded like a cold was coming/Sounds like it might be a head cold...I don't know.; a little bit of congestion; I had a sore arm; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (I had a sore arm), NASAL CONGESTION (a little bit of congestion), SNEEZING (I sneezed a lot) and NASOPHARYNGITIS (It sounded like a cold was coming/Sounds like it might be a head cold...I don't know.) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, the patient experienced PAIN IN EXTREMITY (I had a sore arm). On 02-Dec-2021, the patient experienced NASAL CONGESTION (a little bit of congestion). On 03-Dec-2021, the patient experienced SNEEZING (I sneezed a lot) and NASOPHARYNGITIS (It sounded like a cold was coming/Sounds like it might be a head cold...I don't know.). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (I had a sore arm), NASAL CONGESTION (a little bit of congestion), SNEEZING (I sneezed a lot) and NASOPHARYNGITIS (It sounded like a cold was coming/Sounds like it might be a head cold..I don't know.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter.   This case was linked to MOD-2021-404802 (Patient Link).
Age: 55.0
Sex: M
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 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016C21A, 031A21A and 031A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Blood pressure high.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Dec-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) had not resolved.            No treatment was reported by the reporter.   This case was linked to MOD-2021-404776, MOD-2021-404786 (Patient Link).
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Discomfort, Head discomfort, Influenza, Pyrexia
Clinical narrative: I have episodes of severe chills, shaking, fever, whole head and body.; I have episodes of severe chills, shaking, fever, whole head and body.; I have episodes of severe chills, shaking, fever, whole head and body.; I have episodes of severe chills, shaking, fever, whole head and body.; I have episodes of severe chills, shaking, fever, whole head and body.; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (I have episodes of severe chills, shaking, fever, whole head and body.), HEAD DISCOMFORT (I have episodes of severe chills, shaking, fever, whole head and body.), DISCOMFORT (I have episodes of severe chills, shaking, fever, whole head and body.), CHILLS (I have episodes of severe chills, shaking, fever, whole head and body.) and PYREXIA (I have episodes of severe chills, shaking, fever, whole head and body.) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033F21A, 012M20A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-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 TREMOR (I have episodes of severe chills, shaking, fever, whole head and body.), HEAD DISCOMFORT (I have episodes of severe chills, shaking, fever, whole head and body.), DISCOMFORT (I have episodes of severe chills, shaking, fever, whole head and body.), CHILLS (I have episodes of severe chills, shaking, fever, whole head and body.) and PYREXIA (I have episodes of severe chills, shaking, fever, whole head and body.). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, TREMOR (I have episodes of severe chills, shaking, fever, whole head and body.), HEAD DISCOMFORT (I have episodes of severe chills, shaking, fever, whole head and body.), DISCOMFORT (I have episodes of severe chills, shaking, fever, whole head and body.), CHILLS (I have episodes of severe chills, shaking, fever, whole head and body.) and PYREXIA (I have episodes of severe chills, shaking, fever, whole head and body.) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Influenza: negative (Negative) Patient tested flu negative.. On an unknown date, SARS-CoV-2 test: negative (Negative) Patient tested COVID-19 negative..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Tremor
Clinical narrative: I have episodes of severe chills, shaking, fever, whole head and body.; I have episodes of severe chills, shaking, fever, whole head and body.; I have episodes of severe chills, shaking, fever, whole head and body.; I have episodes of severe chills, shaking, fever, whole head and body.; I have episodes of severe chills, shaking, fever, whole head and body.; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (I have episodes of severe chills, shaking, fever, whole head and body.), HEAD DISCOMFORT (I have episodes of severe chills, shaking, fever, whole head and body.), DISCOMFORT (I have episodes of severe chills, shaking, fever, whole head and body.), CHILLS (I have episodes of severe chills, shaking, fever, whole head and body.) and PYREXIA (I have episodes of severe chills, shaking, fever, whole head and body.) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033F21A, 012M20A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-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 TREMOR (I have episodes of severe chills, shaking, fever, whole head and body.), HEAD DISCOMFORT (I have episodes of severe chills, shaking, fever, whole head and body.), DISCOMFORT (I have episodes of severe chills, shaking, fever, whole head and body.), CHILLS (I have episodes of severe chills, shaking, fever, whole head and body.) and PYREXIA (I have episodes of severe chills, shaking, fever, whole head and body.). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, TREMOR (I have episodes of severe chills, shaking, fever, whole head and body.), HEAD DISCOMFORT (I have episodes of severe chills, shaking, fever, whole head and body.), DISCOMFORT (I have episodes of severe chills, shaking, fever, whole head and body.), CHILLS (I have episodes of severe chills, shaking, fever, whole head and body.) and PYREXIA (I have episodes of severe chills, shaking, fever, whole head and body.) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Influenza: negative (Negative) Patient tested flu negative.. On an unknown date, SARS-CoV-2 test: negative (Negative) Patient tested COVID-19 negative..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Tongue disorder
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of TONGUE DISORDER (spots forming on her tongue within 2 days of the shot, for a couple of days) and MYALGIA (achy feeling for about a day) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced TONGUE DISORDER (spots forming on her tongue within 2 days of the shot, for a couple of days). On an unknown date, the patient experienced MYALGIA (achy feeling for about a day). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA [FEXOFENADINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, TONGUE DISORDER (spots forming on her tongue within 2 days of the shot, for a couple of days) and MYALGIA (achy feeling for about a day) outcome was unknown.            No concomitant medication details were reported.   This case was linked to MOD-2021-404738, MOD-2021-404817 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: sinus infection; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (sinus infection) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SINUSITIS (sinus infection). At the time of the report, SINUSITIS (sinus infection) had resolved.       Concomitant medication information was not provided by the reporter.                            Treatment information was not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Inappropriate schedule of product administration, Joint swelling, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: SUDDEN ARM PAIN/ It hurt very much when person received the shot,remained in constant pain,pain in arm; STIFFNESS; ENLARGED LEFT SHOULDER; SHOULDER PAIN; the patient received additional  vaccine mRNA 1273 .Dose number in the series was 2; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (SUDDEN ARM PAIN/ It hurt very much when person received the shot,remained in constant pain,pain in arm), MUSCULOSKELETAL STIFFNESS (STIFFNESS), JOINT SWELLING (ENLARGED LEFT SHOULDER), ARTHRALGIA (SHOULDER PAIN) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (the patient received additional  vaccine mRNA 1273 .Dose number in the series was 2) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for Prophylactic vaccination.     Previously administered products included for Prophylactic vaccination: Janssen COVID-19 Vaccine from 05-Apr-2021 to July 2021, Janssen COVID-19 Vaccine from 05-Apr-2021 to July 2021 and Janssen COVID-19 Vaccine from 05-Apr-2021 to July 2021. Past adverse reactions to the above products included Leg pain with Janssen COVID-19 Vaccine; Numbness with Janssen COVID-19 Vaccine; and Tingling with Janssen COVID-19 Vaccine.    On 22-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, the patient experienced PAIN IN EXTREMITY (SUDDEN ARM PAIN/ It hurt very much when person received the shot,remained in constant pain,pain in arm), MUSCULOSKELETAL STIFFNESS (STIFFNESS), JOINT SWELLING (ENLARGED LEFT SHOULDER), ARTHRALGIA (SHOULDER PAIN) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (the patient received additional  vaccine mRNA 1273 .Dose number in the series was 2). On 22-Oct-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (the patient received additional  vaccine mRNA 1273 .Dose number in the series was 2) had resolved. At the time of the report, PAIN IN EXTREMITY (SUDDEN ARM PAIN/ It hurt very much when person received the shot,remained in constant pain,pain in arm), JOINT SWELLING (ENLARGED LEFT SHOULDER) and ARTHRALGIA (SHOULDER PAIN) had not resolved and MUSCULOSKELETAL STIFFNESS (STIFFNESS) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2021, X-ray: results not reported Results not reported.         No Concomitant medications were reported. No Treatment mediations were reported.   Events related to historical Janssen COVID-19 vaccine severe leg pain, tingling in feel, legs, arms, hands and numbness  for at least 3 months had The patient  recovered from severe leg  pain, tingling in feet, legs, arms, hands, and numbness on an unspecified date in JUL-2021.
Sex: U
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: SUDDEN ARM PAIN/ It hurt very much when person received the shot,remained in constant pain,pain in arm; STIFFNESS; ENLARGED LEFT SHOULDER; SHOULDER PAIN; the patient received additional  vaccine mRNA 1273 .Dose number in the series was 2; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (SUDDEN ARM PAIN/ It hurt very much when person received the shot,remained in constant pain,pain in arm), MUSCULOSKELETAL STIFFNESS (STIFFNESS), JOINT SWELLING (ENLARGED LEFT SHOULDER), ARTHRALGIA (SHOULDER PAIN) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (the patient received additional  vaccine mRNA 1273 .Dose number in the series was 2) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for Prophylactic vaccination.     Previously administered products included for Prophylactic vaccination: Janssen COVID-19 Vaccine from 05-Apr-2021 to July 2021, Janssen COVID-19 Vaccine from 05-Apr-2021 to July 2021 and Janssen COVID-19 Vaccine from 05-Apr-2021 to July 2021. Past adverse reactions to the above products included Leg pain with Janssen COVID-19 Vaccine; Numbness with Janssen COVID-19 Vaccine; and Tingling with Janssen COVID-19 Vaccine.    On 22-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, the patient experienced PAIN IN EXTREMITY (SUDDEN ARM PAIN/ It hurt very much when person received the shot,remained in constant pain,pain in arm), MUSCULOSKELETAL STIFFNESS (STIFFNESS), JOINT SWELLING (ENLARGED LEFT SHOULDER), ARTHRALGIA (SHOULDER PAIN) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (the patient received additional  vaccine mRNA 1273 .Dose number in the series was 2). On 22-Oct-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (the patient received additional  vaccine mRNA 1273 .Dose number in the series was 2) had resolved. At the time of the report, PAIN IN EXTREMITY (SUDDEN ARM PAIN/ It hurt very much when person received the shot,remained in constant pain,pain in arm), JOINT SWELLING (ENLARGED LEFT SHOULDER) and ARTHRALGIA (SHOULDER PAIN) had not resolved and MUSCULOSKELETAL STIFFNESS (STIFFNESS) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2021, X-ray: results not reported Results not reported.         No Concomitant medications were reported. No Treatment mediations were reported.   Events related to historical Janssen COVID-19 vaccine severe leg pain, tingling in feel, legs, arms, hands and numbness  for at least 3 months had The patient  recovered from severe leg  pain, tingling in feet, legs, arms, hands, and numbness on an unspecified date in JUL-2021.
Sex: U
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: found report of spontaneous urticaria; This spontaneous case was reported by a nurse and describes the occurrence of URTICARIA (found report of spontaneous urticaria) 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 URTICARIA (found report of spontaneous urticaria). At the time of the report, URTICARIA (found report of spontaneous urticaria) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Vertigo
Clinical narrative: vertigo; Brain fog; Extreme Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (vertigo), FEELING ABNORMAL (Brain fog) and FATIGUE (Extreme Tiredness) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     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, 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 VERTIGO (vertigo), FEELING ABNORMAL (Brain fog) and FATIGUE (Extreme Tiredness). At the time of the report, VERTIGO (vertigo), FEELING ABNORMAL (Brain fog) and FATIGUE (Extreme Tiredness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant information was reported. No treatment information was reported.   This case was linked to MOD-2021-404863 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Therapeutic response unexpected
Clinical narrative: Expressed thanks to Moderna that her breathing has been easier; she just had some allergies growing up; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Expressed thanks to Moderna that her breathing has been easier) and HYPERSENSITIVITY (she just had some allergies growing up) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Expressed thanks to Moderna that her breathing has been easier) and HYPERSENSITIVITY (she just had some allergies growing up). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Expressed thanks to Moderna that her breathing has been easier) had resolved and HYPERSENSITIVITY (she just had some allergies growing up) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided.   This case was linked to MOD-2021-404870, MOD-2021-404866 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Impaired quality of life, Vertigo
Clinical narrative: vertigo/side effect got worse; Extreme brain fog / side effect got worse; Ruined day to day life with no signs of improvement; Extreme Tiredness / side effect got worse; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (vertigo/side effect got worse), FEELING ABNORMAL (Extreme brain fog / side effect got worse), IMPAIRED QUALITY OF LIFE (Ruined day to day life with no signs of improvement) and FATIGUE (Extreme Tiredness / side effect got worse) 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 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 VERTIGO (vertigo/side effect got worse), FEELING ABNORMAL (Extreme brain fog / side effect got worse), IMPAIRED QUALITY OF LIFE (Ruined day to day life with no signs of improvement) and FATIGUE (Extreme Tiredness / side effect got worse). At the time of the report, VERTIGO (vertigo/side effect got worse), FEELING ABNORMAL (Extreme brain fog / side effect got worse), IMPAIRED QUALITY OF LIFE (Ruined day to day life with no signs of improvement) and FATIGUE (Extreme Tiredness / side effect got worse) had not resolved. Not Provided          No concomitant medication was reported. No treatment information was provided.   This case was linked to MOD-2021-404859 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Feeling abnormal, Feeling cold, Pain in extremity
Clinical narrative: get cold, bone cold on the inside and soon rest of body started to get cold/oldness was horrible/she was turning into a block of ice; brain fog/brain fog never went away; hands & feet started to hurt; fingers started to swell especially the middle joints and fingers/Swell; extreme fatigue; joints started to hurt; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (get cold, bone cold on the inside and soon rest of body started to get cold/oldness was horrible/she was turning into a block of ice), FEELING ABNORMAL (brain fog/brain fog never went away), PAIN IN EXTREMITY (hands & feet started to hurt), PERIPHERAL SWELLING (fingers started to swell especially the middle joints and fingers/Swell) and FATIGUE (extreme fatigue) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced FEELING COLD (get cold, bone cold on the inside and soon rest of body started to get cold/oldness was horrible/she was turning into a block of ice), FEELING ABNORMAL (brain fog/brain fog never went away), PAIN IN EXTREMITY (hands & feet started to hurt), PERIPHERAL SWELLING (fingers started to swell especially the middle joints and fingers/Swell), FATIGUE (extreme fatigue) and ARTHRALGIA (joints started to hurt). At the time of the report, FEELING COLD (get cold, bone cold on the inside and soon rest of body started to get cold/oldness was horrible/she was turning into a block of ice) and FEELING ABNORMAL (brain fog/brain fog never went away) had not resolved and PAIN IN EXTREMITY (hands & feet started to hurt), PERIPHERAL SWELLING (fingers started to swell especially the middle joints and fingers/Swell), FATIGUE (extreme fatigue) and ARTHRALGIA (joints started to hurt) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.  The patient stated that no shivers yet but stated that it was an immune response. The coldness was horrible and was turning into a block of ice. Coldness sensitivity never went away completely.  Patient had no side effects until 9 hours later after 2nd dose. Patient kept on covering himself and was drinking warm fluids, but it had no effect, and this lasted for 4 days.   This case was linked to MOD-2021-404879 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: get cold, bone cold on the inside and soon rest of body started to get cold/oldness was horrible/she was turning into a block of ice; brain fog/brain fog never went away; hands & feet started to hurt; fingers started to swell especially the middle joints and fingers/Swell; extreme fatigue; joints started to hurt; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (get cold, bone cold on the inside and soon rest of body started to get cold/oldness was horrible/she was turning into a block of ice), FEELING ABNORMAL (brain fog/brain fog never went away), PAIN IN EXTREMITY (hands & feet started to hurt), PERIPHERAL SWELLING (fingers started to swell especially the middle joints and fingers/Swell) and FATIGUE (extreme fatigue) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced FEELING COLD (get cold, bone cold on the inside and soon rest of body started to get cold/oldness was horrible/she was turning into a block of ice), FEELING ABNORMAL (brain fog/brain fog never went away), PAIN IN EXTREMITY (hands & feet started to hurt), PERIPHERAL SWELLING (fingers started to swell especially the middle joints and fingers/Swell), FATIGUE (extreme fatigue) and ARTHRALGIA (joints started to hurt). At the time of the report, FEELING COLD (get cold, bone cold on the inside and soon rest of body started to get cold/oldness was horrible/she was turning into a block of ice) and FEELING ABNORMAL (brain fog/brain fog never went away) had not resolved and PAIN IN EXTREMITY (hands & feet started to hurt), PERIPHERAL SWELLING (fingers started to swell especially the middle joints and fingers/Swell), FATIGUE (extreme fatigue) and ARTHRALGIA (joints started to hurt) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.  The patient stated that no shivers yet but stated that it was an immune response. The coldness was horrible and was turning into a block of ice. Coldness sensitivity never went away completely.  Patient had no side effects until 9 hours later after 2nd dose. Patient kept on covering himself and was drinking warm fluids, but it had no effect, and this lasted for 4 days.   This case was linked to MOD-2021-404879 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Therapeutic response unexpected
Clinical narrative: Expressed thanks to Moderna that her breathing has been easier; she just had some allergies growing up; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Expressed thanks to Moderna that her breathing has been easier) and HYPERSENSITIVITY (she just had some allergies growing up) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 07F21A) for COVID-19 vaccination.     The patient's past medical history included Respiratory disorder NOS.    On 02-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Expressed thanks to Moderna that her breathing has been easier) and HYPERSENSITIVITY (she just had some allergies growing up). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Expressed thanks to Moderna that her breathing has been easier) had resolved and HYPERSENSITIVITY (she just had some allergies growing up) outcome was unknown.            No concomitant drug details were reported. No treatment details were reported.   This case was linked to MOD-2021-404862, MOD-2021-404866 (Patient Link).