chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Injection site swelling, Pain in extremity, Pain of skin
Clinical narrative: back ang leg pain from the shivering; back ang leg pain from the shivering; fever and shivering violently; very tiny bump on the injection site; fever and shivering violently; the skin hurts from the fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN OF SKIN (the skin hurts from the fever), PAIN IN EXTREMITY (back ang leg pain from the shivering), BACK PAIN (back ang leg pain from the shivering), PYREXIA (fever and shivering violently) and INJECTION SITE SWELLING (very tiny bump on the injection site) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0391T20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.  Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Allergy, DESOGESTREL, ETHINYLESTRADIOL (RECLIPSEN) for Birth control.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Jan-2021, the patient experienced PAIN OF SKIN (the skin hurts from the fever), BACK PAIN (back ang leg pain from the shivering), PYREXIA (fever and shivering violently), INJECTION SITE SWELLING (very tiny bump on the injection site) and CHILLS (fever and shivering violently). On an unknown date, the patient experienced PAIN IN EXTREMITY (back ang leg pain from the shivering). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PAIN OF SKIN (the skin hurts from the fever), PAIN IN EXTREMITY (back ang leg pain from the shivering), BACK PAIN (back ang leg pain from the shivering), PYREXIA (fever and shivering violently), INJECTION SITE SWELLING (very tiny bump on the injection site) and CHILLS (fever and shivering violently) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jan-2021, Pyrexia: fever of 102.3°F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: back ang leg pain from the shivering; back ang leg pain from the shivering; fever and shivering violently; very tiny bump on the injection site; fever and shivering violently; the skin hurts from the fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN OF SKIN (the skin hurts from the fever), PAIN IN EXTREMITY (back ang leg pain from the shivering), BACK PAIN (back ang leg pain from the shivering), PYREXIA (fever and shivering violently) and INJECTION SITE SWELLING (very tiny bump on the injection site) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0391T20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.  Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Allergy, DESOGESTREL, ETHINYLESTRADIOL (RECLIPSEN) for Birth control.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Jan-2021, the patient experienced PAIN OF SKIN (the skin hurts from the fever), BACK PAIN (back ang leg pain from the shivering), PYREXIA (fever and shivering violently), INJECTION SITE SWELLING (very tiny bump on the injection site) and CHILLS (fever and shivering violently). On an unknown date, the patient experienced PAIN IN EXTREMITY (back ang leg pain from the shivering). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PAIN OF SKIN (the skin hurts from the fever), PAIN IN EXTREMITY (back ang leg pain from the shivering), BACK PAIN (back ang leg pain from the shivering), PYREXIA (fever and shivering violently), INJECTION SITE SWELLING (very tiny bump on the injection site) and CHILLS (fever and shivering violently) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jan-2021, Pyrexia: fever of 102.3°F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Illness
Clinical narrative: terribly sick; no energy, completely weak; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (terribly sick), ASTHENIA (no energy, completely weak), CHILLS (chills) and HEADACHE (headache) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 23-Feb-2021, the patient experienced ILLNESS (terribly sick), ASTHENIA (no energy, completely weak), CHILLS (chills) and HEADACHE (headache). At the time of the report, ILLNESS (terribly sick), ASTHENIA (no energy, completely weak), CHILLS (chills) and HEADACHE (headache) outcome was unknown.            No laboratory data is provided. No concomitant medications.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Pain, Pyrexia
Clinical narrative: extreme body aches; chills; 101 F. fever; can't get out of bed; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (extreme body aches), CHILLS (chills), PYREXIA (101 F. fever) and FATIGUE (can't get out of bed) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient had a severe case of COVID-19 in December that led to pneumonia) in December 2020 and Pneumonia (Patient had a severe case of COVID-19 in December that led to pneumonia) in December 2020.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced PAIN (extreme body aches), CHILLS (chills), PYREXIA (101 F. fever) and FATIGUE (can't get out of bed). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 18-Feb-2021, PAIN (extreme body aches), CHILLS (chills), PYREXIA (101 F. fever) and FATIGUE (can't get out of bed) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Feb-2021, Body temperature: high 101 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lip pain, Pain in extremity, Paraesthesia, Pruritus
Clinical narrative: hands and the bottom feel tingling; Lips looks like she had Botox; hives on the back part of the waist/ hives in both cheeks of the butt, and was very itching; Vaccination site hives; hands and the bottom feel itchy; chills; Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PAIN IN EXTREMITY (Sore Arm), URTICARIA (hives on the back part of the waist/ hives in both cheeks of the butt, and was very itching), VACCINATION SITE URTICARIA (Vaccination site hives) and PRURITUS (hands and the bottom feel itchy) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by reporter.  Concomitant products included ATORVASTATIN, PAROXETINE and CENTRUM WOMEN for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, the patient experienced CHILLS (chills) and PAIN IN EXTREMITY (Sore Arm). On 05-Feb-2021, the patient experienced URTICARIA (hives on the back part of the waist/ hives in both cheeks of the butt, and was very itching), VACCINATION SITE URTICARIA (Vaccination site hives), PRURITUS (hands and the bottom feel itchy) and LIP PAIN (Lips looks like she had Botox). On 07-Feb-2021, the patient experienced PARAESTHESIA (hands and the bottom feel tingling). On 27-Jan-2021, CHILLS (chills) had resolved. On 07-Feb-2021, URTICARIA (hives on the back part of the waist/ hives in both cheeks of the butt, and was very itching), VACCINATION SITE URTICARIA (Vaccination site hives), PRURITUS (hands and the bottom feel itchy) and LIP PAIN (Lips looks like she had Botox) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore Arm) and PARAESTHESIA (hands and the bottom feel tingling) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medications included Tylenol, Steroids, and Benadryl.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Vaccination site urticaria
Clinical narrative: hands and the bottom feel tingling; Lips looks like she had Botox; hives on the back part of the waist/ hives in both cheeks of the butt, and was very itching; Vaccination site hives; hands and the bottom feel itchy; chills; Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PAIN IN EXTREMITY (Sore Arm), URTICARIA (hives on the back part of the waist/ hives in both cheeks of the butt, and was very itching), VACCINATION SITE URTICARIA (Vaccination site hives) and PRURITUS (hands and the bottom feel itchy) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by reporter.  Concomitant products included ATORVASTATIN, PAROXETINE and CENTRUM WOMEN for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, the patient experienced CHILLS (chills) and PAIN IN EXTREMITY (Sore Arm). On 05-Feb-2021, the patient experienced URTICARIA (hives on the back part of the waist/ hives in both cheeks of the butt, and was very itching), VACCINATION SITE URTICARIA (Vaccination site hives), PRURITUS (hands and the bottom feel itchy) and LIP PAIN (Lips looks like she had Botox). On 07-Feb-2021, the patient experienced PARAESTHESIA (hands and the bottom feel tingling). On 27-Jan-2021, CHILLS (chills) had resolved. On 07-Feb-2021, URTICARIA (hives on the back part of the waist/ hives in both cheeks of the butt, and was very itching), VACCINATION SITE URTICARIA (Vaccination site hives), PRURITUS (hands and the bottom feel itchy) and LIP PAIN (Lips looks like she had Botox) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore Arm) and PARAESTHESIA (hands and the bottom feel tingling) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medications included Tylenol, Steroids, and Benadryl.
Sex: F
Vaccine: COVID19
Symptoms: Eye symptom, Ocular hyperaemia, Scleral disorder, Vasodilatation
Clinical narrative: One of eye enlarged; One of the eye red; One of the sclera enlarged; One of the vessel enlarged; This spontaneous case was reported by a consumer and describes the occurrence of EYE SYMPTOM (One of eye enlarged), OCULAR HYPERAEMIA (One of the eye red), SCLERAL DISORDER (One of the sclera enlarged) and VASODILATATION (One of the vessel enlarged) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EYE SYMPTOM (One of eye enlarged), OCULAR HYPERAEMIA (One of the eye red), SCLERAL DISORDER (One of the sclera enlarged) and VASODILATATION (One of the vessel enlarged). At the time of the report, EYE SYMPTOM (One of eye enlarged), OCULAR HYPERAEMIA (One of the eye red), SCLERAL DISORDER (One of the sclera enlarged) and VASODILATATION (One of the vessel enlarged) outcome was unknown.            Treatment and concomitant medications were not provided by reporter.   This case was linked to MOD-2021-024826 (E2B Linked Report).; Sender's Comments:  MOD-2021-024826:Husband case
Sex: F
Vaccine: COVID19
Symptoms: Skin reaction
Clinical narrative: I did want to share my reaction. I do have filler. This was my main side effect although I got all of them; This spontaneous case was reported by a health care professional and describes the occurrence of SKIN REACTION (I did want to share my reaction. I do have filler. This was my main side effect although I got all of them) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced SKIN REACTION (I did want to share my reaction. I do have filler. This was my main side effect although I got all of them). At the time of the report, SKIN REACTION (I did want to share my reaction. I do have filler. This was my main side effect although I got all of them) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment and concomitant medications were not provided by reporter.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Soreness of the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness of the arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (The patient's medical history was not provided.).    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 PAIN IN EXTREMITY (Soreness of the arm). At the time of the report, PAIN IN EXTREMITY (Soreness of the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Myalgia, Neck pain, Pain in extremity, Sleep deficit
Clinical narrative: injection site pain; pain moved up to muscles on the neck; significant soreness in muscle of injection site; Lingering arm pain; neck pain; Hard to sleep with the pain, wakes him up at night; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of INJECTION SITE PAIN (injection site pain), MYALGIA (pain moved up to muscles on the neck; significant soreness in muscle of injection site), PAIN IN EXTREMITY (Lingering arm pain), NECK PAIN (neck pain) and SLEEP DEFICIT (Hard to sleep with the pain, wakes him up at night) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 25-Jan-2021, the patient experienced INJECTION SITE PAIN (injection site pain), MYALGIA (pain moved up to muscles on the neck; significant soreness in muscle of injection site), PAIN IN EXTREMITY (Lingering arm pain), NECK PAIN (neck pain) and SLEEP DEFICIT (Hard to sleep with the pain, wakes him up at night). At the time of the report, INJECTION SITE PAIN (injection site pain), MYALGIA (pain moved up to muscles on the neck; significant soreness in muscle of injection site), PAIN IN EXTREMITY (Lingering arm pain), NECK PAIN (neck pain) and SLEEP DEFICIT (Hard to sleep with the pain, wakes him up at night) outcome was unknown. Not Provided      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.   Treatment medications included Tylenol and Advil. No concomitant medications were provided by reporter.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pain in extremity
Clinical narrative: Chills; Nausea; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), NAUSEA (Nausea) and PAIN IN EXTREMITY (sore arm) in a 59-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 27-Jan-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 an unknown date, the patient experienced CHILLS (Chills), NAUSEA (Nausea) and PAIN IN EXTREMITY (sore arm). At the time of the report, CHILLS (Chills), NAUSEA (Nausea) and PAIN IN EXTREMITY (sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medications included Advil. Concomitant medications were not reported.   This case was linked to MOD-2021-025115 (Patient Link).
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Asthma, Ear pain
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of asthma (series of asthma attacks) and ear pain (earache) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. January 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced asthma (series of asthma attacks) and ear pain (earache). At the time of the report, asthma (series of asthma attacks) and ear pain (earache) resolved. No concomitant product use provided. The patient treated with unspecified drugs in response to the events. Most recent follow-up information incorporated above included: On Jul 18, 2021: Follow-up received on Jul 18, 2021; no new information added.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Bone pain, Fatigue, Nausea, Pain in extremity
Clinical narrative: stomach pain; hyperpigmentation in the injection site; pain over the core bone; arm sore; pain at the injection site; nausea; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach pain), VACCINATION SITE DISCOLOURATION (hyperpigmentation in the injection site), BONE PAIN (pain over the core bone), PAIN IN EXTREMITY (arm sore) and VACCINATION SITE PAIN (pain at the injection site) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029LCA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach pain), VACCINATION SITE DISCOLOURATION (hyperpigmentation in the injection site), BONE PAIN (pain over the core bone), PAIN IN EXTREMITY (arm sore), VACCINATION SITE PAIN (pain at the injection site), NAUSEA (nausea) and FATIGUE (fatigue). At the time of the report, ABDOMINAL PAIN UPPER (stomach pain), VACCINATION SITE DISCOLOURATION (hyperpigmentation in the injection site), BONE PAIN (pain over the core bone), PAIN IN EXTREMITY (arm sore), VACCINATION SITE PAIN (pain at the injection site), NAUSEA (nausea) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discolouration, Vaccination site pain
Clinical narrative: stomach pain; hyperpigmentation in the injection site; pain over the core bone; arm sore; pain at the injection site; nausea; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach pain), VACCINATION SITE DISCOLOURATION (hyperpigmentation in the injection site), BONE PAIN (pain over the core bone), PAIN IN EXTREMITY (arm sore) and VACCINATION SITE PAIN (pain at the injection site) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029LCA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach pain), VACCINATION SITE DISCOLOURATION (hyperpigmentation in the injection site), BONE PAIN (pain over the core bone), PAIN IN EXTREMITY (arm sore), VACCINATION SITE PAIN (pain at the injection site), NAUSEA (nausea) and FATIGUE (fatigue). At the time of the report, ABDOMINAL PAIN UPPER (stomach pain), VACCINATION SITE DISCOLOURATION (hyperpigmentation in the injection site), BONE PAIN (pain over the core bone), PAIN IN EXTREMITY (arm sore), VACCINATION SITE PAIN (pain at the injection site), NAUSEA (nausea) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Ear haemorrhage, Joint swelling
Clinical narrative: Blood in ears; Swollen knee; This spontaneous case was reported by a consumer and describes the occurrence of EAR HAEMORRHAGE (Blood in ears) and JOINT SWELLING (Swollen knee) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 042L20A) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for Atrial fibrillation, DUTASTERIDE (AVODART) and TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]) for an unknown indication.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient experienced EAR HAEMORRHAGE (Blood in ears) and JOINT SWELLING (Swollen knee). At the time of the report, EAR HAEMORRHAGE (Blood in ears) and JOINT SWELLING (Swollen knee) outcome was unknown.            No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Follow up received included no new information.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Vaccination site erythema, Vaccination site induration, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: This is a spontaneous case reported by a consumer (subsequently medically confirmed), describing the occurrence of vaccination site warmth (super hot-to-touch), discomfort (little discomfort), vaccination site induration (hardness), vaccination site pruritus (itching) and vaccination site erythema (bright pink) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 015M20A) for COVID-19 immunization. No medical history reported. On Feb 14, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Feb 20, 2021, patient experienced vaccination site induration (hardness). On an unknown date, patient experienced vaccination site warmth (super hot-to-touch), discomfort (little discomfort), vaccination site pruritus (itching) and vaccination site erythema (bright pink). The patient treated with Benadryl 24-D (loratadine/pseudoephedrine hydrochloride) ongoing since an unknown date, 1 dosage form; and Tylenol (paracetamol) ongoing since an unknown date, 1 dosage form. At the time of the report, vaccination site warmth (super hot-to-touch), discomfort (discomfort), vaccination site induration (hardness), vaccination site pruritus (itching) and vaccination site erythema (bright pink): resolving. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication information  provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: reaction to Moderna; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (reaction to Moderna) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction (no reported medical history).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (reaction to Moderna). At the time of the report, VACCINATION COMPLICATION (reaction to Moderna) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided.  No treatment details were provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Headache, Myalgia, Peripheral swelling
Clinical narrative: a ball on the arm; Headache; Body ache; Chills; Redness on the arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (a ball on the arm), HEADACHE (Headache), MYALGIA (Body ache), CHILLS (Chills) and ERYTHEMA (Redness on the arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 029L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (a ball on the arm), HEADACHE (Headache), MYALGIA (Body ache), CHILLS (Chills) and ERYTHEMA (Redness on the arm). At the time of the report, PERIPHERAL SWELLING (a ball on the arm), HEADACHE (Headache), MYALGIA (Body ache), CHILLS (Chills) and ERYTHEMA (Redness on the arm) outcome was unknown.            no concomitant medications reported. no treatment details reported.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pyrexia (fever) in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced pyrexia (fever). At the time of the report, pyrexia (fever) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No treatment medication provided.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test negative
Clinical narrative: IgG test negative after two doses of vaccine; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of SARS-COV-2 ANTIBODY TEST NEGATIVE (IgG test negative after two doses of vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 ANTIBODY TEST NEGATIVE (IgG test negative after two doses of vaccine). At the time of the report, SARS-COV-2 ANTIBODY TEST NEGATIVE (IgG test negative after two doses of vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  No concomitant medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Fever; Soreness in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and PAIN IN EXTREMITY (Soreness in the arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced PAIN IN EXTREMITY (Soreness in the arm). On 27-Jan-2021, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) and PAIN IN EXTREMITY (Soreness in the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient wanted to know if it is okay she took Tylenol.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jan-2021: TCR received- Caller disconnected
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: High heart rate; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEART RATE INCREASED (High heart rate) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced HEART RATE INCREASED (High heart rate). At the time of the report, HEART RATE INCREASED (High heart rate) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hypoaesthesia oral
Clinical narrative: lips and tongue started to get numb; Tired; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (lips and tongue started to get numb), FATIGUE (Tired) and CHILLS (Chills) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     The patient's past medical history included Allergic reaction (a year or two ago had injection in knee and had a very bad reaction). Concomitant products included NORTRIPTYLINE, OMEPRAZOLE, LEVOTHYROXINE and LISINOPRIL for an unknown indication.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced FATIGUE (Tired) and CHILLS (Chills). On 25-Jan-2021, the patient experienced HYPOAESTHESIA ORAL (lips and tongue started to get numb). On 25-Jan-2021, HYPOAESTHESIA ORAL (lips and tongue started to get numb) had resolved. At the time of the report, FATIGUE (Tired) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Carpal tunnel syndrome, Condition aggravated, Hypoaesthesia, Pain in extremity
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (arm was sore), hypoaesthesia (didn't have feeling on the arm), carpal tunnel syndrome (thinks the vaccine aggravated her carpal tunnel syndrome) and condition aggravated (thinks the vaccine aggravated her carpal tunnel syndrome) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. Concurrent medical conditions included carpal tunnel syndrome. On Feb 24, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced pain in extremity (arm was sore), hypoaesthesia (didn't have feeling on the arm), carpal tunnel syndrome (thinks the vaccine aggravated her carpal tunnel syndrome) and condition aggravated (thinks the vaccine aggravated her carpal tunnel syndrome). At the time of the report, pain in extremity (arm was sore), hypoaesthesia (didn't have feeling on the arm), carpal tunnel syndrome (thinks the vaccine aggravated her carpal tunnel syndrome) and condition aggravated (thinks the vaccine aggravated her carpal tunnel syndrome) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medication or treatment information provided.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives popped up on face, Hives popped in some other parts of body; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of URTICARIA (hives popped up on face, Hives popped in some other parts of body) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URTICARIA (hives popped up on face, Hives popped in some other parts of body). At the time of the report, URTICARIA (hives popped up on face, Hives popped in some other parts of body) outcome was unknown.        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 treatment information was provided.  No concomitant medication was provided.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pruritus, Pyrexia, Rash
Clinical narrative: This spontaneous case reported by a nurse (subsequently medically confirmed), describes the occurrence of pruritus (deep itching), rash (generalized rash) and pyrexia (temperature got up 102°F) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 02SL209) for COVID-19 immunization. The patient's past medical history included eczema and psoriasis. On Dec 30, 2020, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced pruritus (deep itching), rash (generalized rash) and pyrexia (temperature got up 102°F). The patient treated with Cipro 1A Pharma (ciprofloxacin hydrochloride) at an unspecified dose and frequency. At the time of the report, pruritus (deep itching), rash (generalized rash) and pyrexia (temperature got up 102°F): resolved. Diagnostic results: On an unknown date, body temperature: 101°F (high). The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. The reporter did not provide any causality assessments or concomitant medications.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Mild tenderness to the touch at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Mild tenderness to the touch at the injection site) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNKNOWN) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced INJECTION SITE PAIN (Mild tenderness to the touch at the injection site). At the time of the report, INJECTION SITE PAIN (Mild tenderness to the touch at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Treatment medications were unknown.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain, Pain in extremity
Clinical narrative: Arm Pain; Body Aches for 10 hour; Chills; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm Pain), PAIN (Body Aches for 10 hour), CHILLS (Chills), HEADACHE (Headache) and NAUSEA (Nausea) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm Pain), PAIN (Body Aches for 10 hour), CHILLS (Chills), HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, PAIN IN EXTREMITY (Arm Pain), PAIN (Body Aches for 10 hour), CHILLS (Chills), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment medications were provided.   Reporter did not allow further contact
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: GI issues (upset stomach); in the area where she received the vaccine it felt hot to the touch; in the area where she received the vaccine it felt itchy; in the area where she received the vaccine it felt swollen; in the area where she received the vaccine it felt red; a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (GI issues (upset stomach)), VACCINATION SITE WARMTH (in the area where she received the vaccine it felt hot to the touch), VACCINATION SITE PRURITUS (in the area where she received the vaccine it felt itchy), VACCINATION SITE PAIN (a sore arm) and VACCINATION SITE SWELLING (in the area where she received the vaccine it felt swollen) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     no specific medical history was reported.  Concomitant products included GABAPENTIN and CYCLOBENZAPRINE for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE PAIN (a sore arm). On 27-Jan-2021, the patient experienced ABDOMINAL DISCOMFORT (GI issues (upset stomach)), VACCINATION SITE WARMTH (in the area where she received the vaccine it felt hot to the touch), VACCINATION SITE PRURITUS (in the area where she received the vaccine it felt itchy), VACCINATION SITE SWELLING (in the area where she received the vaccine it felt swollen) and VACCINATION SITE ERYTHEMA (in the area where she received the vaccine it felt red). On 22-Jan-2021, VACCINATION SITE PAIN (a sore arm) had resolved. At the time of the report, ABDOMINAL DISCOMFORT (GI issues (upset stomach)), VACCINATION SITE WARMTH (in the area where she received the vaccine it felt hot to the touch), VACCINATION SITE PRURITUS (in the area where she received the vaccine it felt itchy), VACCINATION SITE SWELLING (in the area where she received the vaccine it felt swollen) and VACCINATION SITE ERYTHEMA (in the area where she received the vaccine it felt red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: GI issues (upset stomach); in the area where she received the vaccine it felt hot to the touch; in the area where she received the vaccine it felt itchy; in the area where she received the vaccine it felt swollen; in the area where she received the vaccine it felt red; a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (GI issues (upset stomach)), VACCINATION SITE WARMTH (in the area where she received the vaccine it felt hot to the touch), VACCINATION SITE PRURITUS (in the area where she received the vaccine it felt itchy), VACCINATION SITE PAIN (a sore arm) and VACCINATION SITE SWELLING (in the area where she received the vaccine it felt swollen) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     no specific medical history was reported.  Concomitant products included GABAPENTIN and CYCLOBENZAPRINE for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE PAIN (a sore arm). On 27-Jan-2021, the patient experienced ABDOMINAL DISCOMFORT (GI issues (upset stomach)), VACCINATION SITE WARMTH (in the area where she received the vaccine it felt hot to the touch), VACCINATION SITE PRURITUS (in the area where she received the vaccine it felt itchy), VACCINATION SITE SWELLING (in the area where she received the vaccine it felt swollen) and VACCINATION SITE ERYTHEMA (in the area where she received the vaccine it felt red). On 22-Jan-2021, VACCINATION SITE PAIN (a sore arm) had resolved. At the time of the report, ABDOMINAL DISCOMFORT (GI issues (upset stomach)), VACCINATION SITE WARMTH (in the area where she received the vaccine it felt hot to the touch), VACCINATION SITE PRURITUS (in the area where she received the vaccine it felt itchy), VACCINATION SITE SWELLING (in the area where she received the vaccine it felt swollen) and VACCINATION SITE ERYTHEMA (in the area where she received the vaccine it felt red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Feeling hot, Pain in extremity
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (very sore arm), feeling hot (heat emanating) and contusion (bruising) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine, batch#  unknown) for COVID-19 immunization. No medical history reported. On Jan 22, 2021, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced pain in extremity (very sore arm), feeling hot (heat emanating) and contusion (bruising). At the time of the report, pain in extremity (very sore arm), feeling hot (heat emanating) and contusion (bruising) outcome: unknown/not provided. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medications or treatment information reported. Sender's comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Headache, Pyrexia, Tremor
Clinical narrative: feeling cold; shaking; fever; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (feeling cold), TREMOR (shaking), PYREXIA (fever), CHILLS (chills) and HEADACHE (headache) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M2DA) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING COLD (feeling cold), TREMOR (shaking), PYREXIA (fever), CHILLS (chills) and HEADACHE (headache). At the time of the report, FEELING COLD (feeling cold), TREMOR (shaking), PYREXIA (fever), CHILLS (chills) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pruritus
Clinical narrative: Itching all over the body; Aches and pain all over body; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN (Aches and pain all over body) and PRURITUS (Itching all over the body) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced PAIN (Aches and pain all over body). On 21-Jan-2021, the patient experienced PRURITUS (Itching all over the body). At the time of the report, PAIN (Aches and pain all over body) and PRURITUS (Itching all over the body) 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.; Reporter's Comments: Based on the current available information which shows a  strong temporal association between the use of the product and the start date of the reported event, a causal relationship with the event cannot be excluded.  Rash is consistent with the known safety profile of the mRNA-1273.