chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vitamin B12
Clinical narrative: unable to walk; osteoarthritis; most horrible pain experienced in whole life; swollen lymph nodes of the left arm; severe pain from hip to knee in both legs; severe pain in both shoulders to elbow in both arms; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of GAIT INABILITY (unable to walk), OSTEOARTHRITIS (osteoarthritis), PAIN (most horrible pain experienced in whole life), ARTHRALGIA (severe pain from hip to knee in both legs) and ARTHRALGIA (severe pain in both shoulders to elbow in both arms) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A) and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast cancer. Concurrent medical conditions included Drug allergy (Prednisone), Drug allergy (Dilaudid) and Drug allergy (sulfa drugs). Concomitant products included LETROZOLE (FEMARA) for Breast cancer, ROSUVASTATIN for Cholesterol, OMEPRAZOLE for an unknown indication, METOPROLOL.   On 20-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. On 19-Mar-2021, the patient experienced ARTHRALGIA (severe pain from hip to knee in both legs) and ARTHRALGIA (severe pain in both shoulders to elbow in both arms). On an unknown date, the patient experienced GAIT INABILITY (unable to walk), OSTEOARTHRITIS (osteoarthritis), PAIN (most horrible pain experienced in whole life) and LYMPHADENOPATHY (swollen lymph nodes of the left arm). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form; Physical therapy (HEATING PAD) for Gait inability; Physical therapy (HEATING PAD) for Osteoarthritis; Physical therapy (HEATING PAD) for Pain; Physical therapy (HEATING PAD) for Arthralgia and Physical therapy (HEATING PAD) for Lymphadenopathy. At the time of the report, GAIT INABILITY (unable to walk), OSTEOARTHRITIS (osteoarthritis), PAIN (most horrible pain experienced in whole life), ARTHRALGIA (severe pain from hip to knee in both legs), ARTHRALGIA (severe pain in both shoulders to elbow in both arms) and LYMPHADENOPATHY (swollen lymph nodes of the left arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Vitamin B12: other (Inconclusive) vit B12 levels.         Patient has taken Tylenol but it didn't work well and used heating pad which help her to relieve pain symptoms. She began deep muscle massage. Health care provider advise not to take moderna covid 19 vaccine again. she doesnot have any kind of symptoms for dose 1
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: high fever of one hundred nine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (high fever of one hundred nine) 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 28-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, the patient experienced PYREXIA (high fever of one hundred nine). At the time of the report, PYREXIA (high fever of one hundred nine) outcome was unknown. Not Provided           The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was Not Applicable.  No concomitant medications were reported  Treatment medication for this event was not reported
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Skin reaction
Clinical narrative: SKIN REACTION Delayed reaction rash that is still coming and going after receiving the 1st dose on 21January2021; itcht rash in axillary region after the 2nd dose; Delayed reaction Rash, that is still coming and going after receiving the 1st dose on 21January2021; This spontaneous case was reported by a consumer and describes the occurrence of SKIN REACTION (SKIN REACTION Delayed reaction rash that is still coming and going after receiving the 1st dose on 21January2021), PRURITUS (itcht rash in axillary region after the 2nd dose) and RASH (Delayed reaction Rash, that is still coming and going after receiving the 1st dose on 21January2021) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 032L20A) 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) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SKIN REACTION (SKIN REACTION Delayed reaction rash that is still coming and going after receiving the 1st dose on 21January2021), PRURITUS (itcht rash in axillary region after the 2nd dose) and RASH (Delayed reaction Rash, that is still coming and going after receiving the 1st dose on 21January2021). At the time of the report, SKIN REACTION (SKIN REACTION Delayed reaction rash that is still coming and going after receiving the 1st dose on 21January2021), PRURITUS (itcht rash in axillary region after the 2nd dose) and RASH (Delayed reaction Rash, that is still coming and going after receiving the 1st dose on 21January2021) outcome was unknown.            Treatment information were not provided.  No concomitant medications reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-098115 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 29-May-2021: Email attached on 29-MAY-2021contains significant information. One event updated. On 31-May-2021: Follow up received on 31-MAY-2021 contains Non-significant information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-098115:1st dose
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) 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 30-Dec-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient reported no concomitant medication.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Neck pain, Pain, Vaccination site pain
Clinical narrative: Neck started hurting mainly on her left side; Felt severe pain; Heaviness; sore arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Apr-2021 and was forwarded to Moderna on 29-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Neck started hurting mainly on her left side), PAIN (Felt severe pain), LIMB DISCOMFORT (Heaviness) and VACCINATION SITE PAIN (sore arm) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced NECK PAIN (Neck started hurting mainly on her left side), PAIN (Felt severe pain), LIMB DISCOMFORT (Heaviness) and VACCINATION SITE PAIN (sore arm). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) ongoing since an unknown date for Pain, at a dose of 1 dosage form. At the time of the report, NECK PAIN (Neck started hurting mainly on her left side), PAIN (Felt severe pain), LIMB DISCOMFORT (Heaviness) and VACCINATION SITE PAIN (sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided.
Age: 26.0
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Impaired driving ability, Impaired work ability
Clinical narrative: cannot work; trouble driving; severe fatigue; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Apr-2021 and was forwarded to Moderna on 29-Apr-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of IMPAIRED WORK ABILITY (cannot work), IMPAIRED DRIVING ABILITY (trouble driving) and FATIGUE (severe fatigue) in a 26-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMPAIRED WORK ABILITY (cannot work), IMPAIRED DRIVING ABILITY (trouble driving) and FATIGUE (severe fatigue). At the time of the report, IMPAIRED WORK ABILITY (cannot work), IMPAIRED DRIVING ABILITY (trouble driving) and FATIGUE (severe fatigue) 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.   No concomitant medication information was provided. No treatment medication information was provided.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue
Clinical narrative: lightheaded; dizzy; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (lightheaded), DIZZINESS (dizzy) and FATIGUE (fatigue) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVONORGESTREL (KYLEENA) for an unknown indication.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (lightheaded), DIZZINESS (dizzy) and FATIGUE (fatigue). At the time of the report, DIZZINESS (lightheaded), DIZZINESS (dizzy) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: itchy; rash; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy) and RASH (rash) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma, Cholesterol and Acid reflux (esophageal). Concomitant products included FAMOTIDINE for Acid reflux (esophageal), FLUTICASONE PROPIONATE (FLOVENT) for Asthma, PRAVASTATIN for Cholesterol, CETIRIZINE, MONTELUKAST, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), FISH OIL and CALCIUM CARBONATE, ERGOCALCIFEROL (CALCIUM AND VITAMIN D) for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced PRURITUS (itchy) and RASH (rash). On 15-Feb-2021, PRURITUS (itchy) and RASH (rash) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-098863 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pain (body ache) and fatigue in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Apr 27, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced pain (body ache) and fatigue. At the time of the report, pain (body ache) and fatigue outcome: unknown. No concomitant medication or treatment information provided.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 years old; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old). On 25-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old) 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.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: arm was sore where it had been injected; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm was sore where it had been injected) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 VACCINATION SITE PAIN (arm was sore where it had been injected). At the time of the report, VACCINATION SITE PAIN (arm was sore where it had been injected) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported No treatment medications were reported    This case was linked to US-MODERNATX, INC.-MOD-2021-098594 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-098594:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling cold, Headache, Pyrexia, Vaccination site pain
Clinical narrative: Feeling cold or chills; Fever 103.7 degrees fahrenheit; Pain at the injection site; Extremely tired; Mild headache; pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Feeling cold or chills), PYREXIA (Fever 103.7 degrees fahrenheit), VACCINATION SITE PAIN (Pain at the injection site), FATIGUE (Extremely tired) and HEADACHE (Mild headache) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced FEELING COLD (Feeling cold or chills), PYREXIA (Fever 103.7 degrees fahrenheit), VACCINATION SITE PAIN (Pain at the injection site), FATIGUE (Extremely tired), HEADACHE (Mild headache) and VACCINATION SITE PAIN (pain at the injection site). At the time of the report, FEELING COLD (Feeling cold or chills), PYREXIA (Fever 103.7 degrees fahrenheit), VACCINATION SITE PAIN (Pain at the injection site), FATIGUE (Extremely tired), HEADACHE (Mild headache) and VACCINATION SITE PAIN (pain at the injection site) 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.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This spontaneous case was reported by a consumer and 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 vaccination.     No Medical History information was reported.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Urticaria
Clinical narrative: patch of red; rash; one red raised hive; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (patch of red), RASH (rash) and URTICARIA (one red raised hive) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On an unknown date, the patient experienced RASH ERYTHEMATOUS (patch of red), RASH (rash) and URTICARIA (one red raised hive). At the time of the report, RASH ERYTHEMATOUS (patch of red), RASH (rash) and URTICARIA (one red raised hive) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reports "not taking or putting anything on the affected area "to relieve symptoms "and will contact doctor if it gets worse". No concomitant medication reported. Upon internal review on 04-Aug-2021, age units was updated to years.   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: NNI
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Hypoaesthesia
Clinical narrative: feels numbness in her whole body and her head; Feels head pain; Feeling very funny; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (feels numbness in her whole body and her head), HEADACHE (Feels head pain) and FEELING ABNORMAL (Feeling very funny) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 046B21A) for COVID-19 vaccination.     The patient's past medical history included Aneurysm in 2008.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (feels numbness in her whole body and her head), HEADACHE (Feels head pain) and FEELING ABNORMAL (Feeling very funny). At the time of the report, HYPOAESTHESIA (feels numbness in her whole body and her head), HEADACHE (Feels head pain) and FEELING ABNORMAL (Feeling very funny) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment or concomitant products reported
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, Product dose omission issue
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of product dose omission issue (second dose of vaccine deferred) and exposure to SARS-CoV-2 (exposure to COVID-19 positive patient) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 037K20A) for COVID-19 immunization. No medical history reported. On Jan 18, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Apr 29, 2021, patient experienced product dose omission issue (second dose of vaccine deferred). On an unknown date, patient experienced exposure to SARS-CoV-2 (exposure to COVID-19 positive patient). At the time of the report, product dose omission issue (second dose of vaccine deferred) outcome: unknown; and exposure to SARS-CoV-2 (exposure to COVID-19 positive patient) resolved. Patient not tested for COVID-19, but still told to quarantine since wife tested positive. No additional information could be obtained regarding patient. Sender's comments: This case linked (cross-linked ID) to MOD21-083977 (E2B linked report).
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: Body Aches; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) 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 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 HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass
Clinical narrative: lump at the injection site; redness and a lump at the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (lump at the injection site) and VACCINATION SITE ERYTHEMA (redness and a lump at the injection) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced VACCINATION SITE MASS (lump at the injection site) and VACCINATION SITE ERYTHEMA (redness and a lump at the injection). On 10-Mar-2021, VACCINATION SITE MASS (lump at the injection site) and VACCINATION SITE ERYTHEMA (redness and a lump at the injection) 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.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Tachycardia, Vaccination site pain
Clinical narrative: rapid heart beat; slight dizziness; soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness at injection site), TACHYCARDIA (rapid heart beat) and DIZZINESS (slight dizziness) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced VACCINATION SITE PAIN (soreness at injection site). On 29-Apr-2021, the patient experienced TACHYCARDIA (rapid heart beat) and DIZZINESS (slight dizziness). At the time of the report, VACCINATION SITE PAIN (soreness at injection site), TACHYCARDIA (rapid heart beat) and DIZZINESS (slight dizziness) 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.   No concomitant medications were provided.  No treatment details were provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-099182 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-099182:Same reporter
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Headache, Musculoskeletal pain
Clinical narrative: left side gluteal muscle pain; back pain like epidural pain; terrible headache; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL PAIN (left side gluteal muscle pain), BACK PAIN (back pain like epidural pain) and HEADACHE (terrible headache) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced MUSCULOSKELETAL PAIN (left side gluteal muscle pain), BACK PAIN (back pain like epidural pain) and HEADACHE (terrible headache). At the time of the report, MUSCULOSKELETAL PAIN (left side gluteal muscle pain), BACK PAIN (back pain like epidural pain) and HEADACHE (terrible headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Bone pain, Headache, Pyrexia, Vaccination site swelling
Clinical narrative: Swelling under left armpit; Short Fever; Achy Bones; Headache; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Achy Bones), HEADACHE (Headache), VACCINATION SITE SWELLING (Swelling under left armpit) and PYREXIA (Short Fever) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for Antiplatelet therapy, ATORVASTATIN CALCIUM (LIPITOR) for Cholesterol.    On 25-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Apr-2021, the patient experienced BONE PAIN (Achy Bones), HEADACHE (Headache) and PYREXIA (Short Fever). On 26-Apr-2021, the patient experienced VACCINATION SITE SWELLING (Swelling under left armpit). At the time of the report, BONE PAIN (Achy Bones), HEADACHE (Headache), VACCINATION SITE SWELLING (Swelling under left armpit) and PYREXIA (Short Fever) outcome was unknown.      Treatment medication included Tylenol, Nyquil, Advil.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hyperhidrosis, Influenza like illness, Malaise, Neck pain
Clinical narrative: sick over a vaccine; neck and shoulder meet is sore to touch; area where neck and shoulder meet is sore to touch and swollen; Very tired; Injection site of arm is sore; Sweats; Aching if she had flu; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweats), INFLUENZA LIKE ILLNESS (Aching if she had flu), MALAISE (sick over a vaccine), NECK PAIN (neck and shoulder meet is sore to touch) and SWELLING (area where neck and shoulder meet is sore to touch and swollen) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 28-Apr-2021, the patient experienced HYPERHIDROSIS (Sweats), INFLUENZA LIKE ILLNESS (Aching if she had flu), NECK PAIN (neck and shoulder meet is sore to touch), SWELLING (area where neck and shoulder meet is sore to touch and swollen), FATIGUE (Very tired) and VACCINATION SITE PAIN (Injection site of arm is sore). On 29-Apr-2021, the patient experienced MALAISE (sick over a vaccine). At the time of the report, HYPERHIDROSIS (Sweats), INFLUENZA LIKE ILLNESS (Aching if she had flu), MALAISE (sick over a vaccine), NECK PAIN (neck and shoulder meet is sore to touch), SWELLING (area where neck and shoulder meet is sore to touch and swollen), FATIGUE (Very tired) and VACCINATION SITE PAIN (Injection site of arm is sore) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided. The patient did not have any pre-existing medical condition apart from taking blood pressure medication.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Vaccination site pain
Clinical narrative: sick over a vaccine; neck and shoulder meet is sore to touch; area where neck and shoulder meet is sore to touch and swollen; Very tired; Injection site of arm is sore; Sweats; Aching if she had flu; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweats), INFLUENZA LIKE ILLNESS (Aching if she had flu), MALAISE (sick over a vaccine), NECK PAIN (neck and shoulder meet is sore to touch) and SWELLING (area where neck and shoulder meet is sore to touch and swollen) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 28-Apr-2021, the patient experienced HYPERHIDROSIS (Sweats), INFLUENZA LIKE ILLNESS (Aching if she had flu), NECK PAIN (neck and shoulder meet is sore to touch), SWELLING (area where neck and shoulder meet is sore to touch and swollen), FATIGUE (Very tired) and VACCINATION SITE PAIN (Injection site of arm is sore). On 29-Apr-2021, the patient experienced MALAISE (sick over a vaccine). At the time of the report, HYPERHIDROSIS (Sweats), INFLUENZA LIKE ILLNESS (Aching if she had flu), MALAISE (sick over a vaccine), NECK PAIN (neck and shoulder meet is sore to touch), SWELLING (area where neck and shoulder meet is sore to touch and swollen), FATIGUE (Very tired) and VACCINATION SITE PAIN (Injection site of arm is sore) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided. The patient did not have any pre-existing medical condition apart from taking blood pressure medication.   Reporter did not allow further contact
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Pain, Vaccination site pain
Clinical narrative: tears came into her eyes because of the pain.; Pain goes down the collar bone; hard to get dressed; it really hurt when the person gave her the second shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (it really hurt when the person gave her the second shot), PAIN (tears came into her eyes because of the pain.), PAIN (Pain goes down the collar bone) and LIMB DISCOMFORT (hard to get dressed) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 36B21A and 030A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced VACCINATION SITE PAIN (it really hurt when the person gave her the second shot). On an unknown date, the patient experienced PAIN (tears came into her eyes because of the pain.), PAIN (Pain goes down the collar bone) and LIMB DISCOMFORT (hard to get dressed). At the time of the report, VACCINATION SITE PAIN (it really hurt when the person gave her the second shot), PAIN (tears came into her eyes because of the pain.), PAIN (Pain goes down the collar bone) and LIMB DISCOMFORT (hard to get dressed) 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.   No treatment information provided.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Mobility decreased
Clinical narrative: Arm was so sore she couldn't move it at all; dizziness; arm was so sore she couldn't move it at all; Headache; nausea; chills; tiredness; Felt feverish; Whole body soreness, but mostly on left side; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was so sore she couldn't move it at all), DIZZINESS (dizziness), MOBILITY DECREASED (arm was so sore she couldn't move it at all), HEADACHE (Headache) and NAUSEA (nausea) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm was so sore she couldn't move it at all), DIZZINESS (dizziness), MOBILITY DECREASED (arm was so sore she couldn't move it at all), HEADACHE (Headache), NAUSEA (nausea), CHILLS (chills), FATIGUE (tiredness) and PYREXIA (Felt feverish). On an unknown date, the patient experienced MYALGIA (Whole body soreness, but mostly on left side). On 25-Apr-2021, PYREXIA (Felt feverish) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm was so sore she couldn't move it at all), DIZZINESS (dizziness), MOBILITY DECREASED (arm was so sore she couldn't move it at all), HEADACHE (Headache), NAUSEA (nausea), CHILLS (chills), FATIGUE (tiredness) and MYALGIA (Whole body soreness, but mostly on left side) had not resolved. Not Provided
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Arm was so sore she couldn't move it at all; dizziness; arm was so sore she couldn't move it at all; Headache; nausea; chills; tiredness; Felt feverish; Whole body soreness, but mostly on left side; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was so sore she couldn't move it at all), DIZZINESS (dizziness), MOBILITY DECREASED (arm was so sore she couldn't move it at all), HEADACHE (Headache) and NAUSEA (nausea) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm was so sore she couldn't move it at all), DIZZINESS (dizziness), MOBILITY DECREASED (arm was so sore she couldn't move it at all), HEADACHE (Headache), NAUSEA (nausea), CHILLS (chills), FATIGUE (tiredness) and PYREXIA (Felt feverish). On an unknown date, the patient experienced MYALGIA (Whole body soreness, but mostly on left side). On 25-Apr-2021, PYREXIA (Felt feverish) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm was so sore she couldn't move it at all), DIZZINESS (dizziness), MOBILITY DECREASED (arm was so sore she couldn't move it at all), HEADACHE (Headache), NAUSEA (nausea), CHILLS (chills), FATIGUE (tiredness) and MYALGIA (Whole body soreness, but mostly on left side) had not resolved. Not Provided
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Erythema, Fatigue, Headache, Nervousness
Clinical narrative: Covid arm; Little nervousness; Couldn't get out of the bed; Very fatigue; Arm was red and swollen; Arm was red and swollen; Pain in the site of injection; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm was red and swollen), NERVOUSNESS (Little nervousness), ASTHENIA (Couldn't get out of the bed), VACCINATION SITE REACTION (Covid arm) and ERYTHEMA (Arm was red and swollen) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced VACCINATION SITE PAIN (Pain in the site of injection) and HEADACHE (Headache). On 22-Apr-2021, the patient experienced PERIPHERAL SWELLING (Arm was red and swollen) and ERYTHEMA (Arm was red and swollen). On 26-Apr-2021, the patient experienced ASTHENIA (Couldn't get out of the bed) and FATIGUE (Very fatigue). On 29-Apr-2021, the patient experienced NERVOUSNESS (Little nervousness). On an unknown date, the patient experienced VACCINATION SITE REACTION (Covid arm). On 26-Apr-2021, PERIPHERAL SWELLING (Arm was red and swollen) and ERYTHEMA (Arm was red and swollen) had resolved. On 28-Apr-2021, ASTHENIA (Couldn't get out of the bed) and FATIGUE (Very fatigue) had resolved. At the time of the report, NERVOUSNESS (Little nervousness), VACCINATION SITE REACTION (Covid arm), VACCINATION SITE PAIN (Pain in the site of injection) and HEADACHE (Headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was provided
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Vaccination site pain, Vaccination site reaction
Clinical narrative: Covid arm; Little nervousness; Couldn't get out of the bed; Very fatigue; Arm was red and swollen; Arm was red and swollen; Pain in the site of injection; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm was red and swollen), NERVOUSNESS (Little nervousness), ASTHENIA (Couldn't get out of the bed), VACCINATION SITE REACTION (Covid arm) and ERYTHEMA (Arm was red and swollen) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced VACCINATION SITE PAIN (Pain in the site of injection) and HEADACHE (Headache). On 22-Apr-2021, the patient experienced PERIPHERAL SWELLING (Arm was red and swollen) and ERYTHEMA (Arm was red and swollen). On 26-Apr-2021, the patient experienced ASTHENIA (Couldn't get out of the bed) and FATIGUE (Very fatigue). On 29-Apr-2021, the patient experienced NERVOUSNESS (Little nervousness). On an unknown date, the patient experienced VACCINATION SITE REACTION (Covid arm). On 26-Apr-2021, PERIPHERAL SWELLING (Arm was red and swollen) and ERYTHEMA (Arm was red and swollen) had resolved. On 28-Apr-2021, ASTHENIA (Couldn't get out of the bed) and FATIGUE (Very fatigue) had resolved. At the time of the report, NERVOUSNESS (Little nervousness), VACCINATION SITE REACTION (Covid arm), VACCINATION SITE PAIN (Pain in the site of injection) and HEADACHE (Headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was provided
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Influenza like illness, Malaise, Rhinorrhoea
Clinical narrative: Not feeling well; Like flu; allergy; Runny itchy nose; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Not feeling well), INFLUENZA LIKE ILLNESS (Like flu), HYPERSENSITIVITY (allergy) and RHINORRHOEA (Runny itchy nose) 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 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Not feeling well), INFLUENZA LIKE ILLNESS (Like flu), HYPERSENSITIVITY (allergy) and RHINORRHOEA (Runny itchy nose). At the time of the report, MALAISE (Not feeling well), INFLUENZA LIKE ILLNESS (Like flu), HYPERSENSITIVITY (allergy) and RHINORRHOEA (Runny itchy nose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: vaccine expired by 8 hours was administered; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine expired by 8 hours was administered) and NO ADVERSE EVENT (No adverse event) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine expired by 8 hours was administered) and NO ADVERSE EVENT (No adverse event). On 28-Apr-2021, EXPIRED PRODUCT ADMINISTERED (vaccine expired by 8 hours was administered) and NO ADVERSE EVENT (No adverse event) had resolved. 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.   Concomitant medications were not reported. Patient stated that she did not experience any adverse events after administration of expired vaccine. Patient date of birth was reported as 02-AUG-1974.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: This follow-up was received on 03-JUN-2021 which updated patient demographics, initials, age, route of administration was corrected and facility information was also updated.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Injected limb mobility decreased, Mobility decreased, Pain in extremity, Vaccination site pain, Vaccination site swelling
Clinical narrative: pain and immobility moved down to right leg, then over to left leg, and finally to right arm; difficulty moving; pain and swelling in the right arm and hand; pain and swelling in the right arm and hand; immobility moved down to right leg, then over to left leg, and finally to right arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain and immobility moved down to right leg, then over to left leg, and finally to right arm), INJECTED LIMB MOBILITY DECREASED (difficulty moving), VACCINATION SITE PAIN (pain and swelling in the right arm and hand), VACCINATION SITE SWELLING (pain and swelling in the right arm and hand) and MOBILITY DECREASED (immobility moved down to right leg, then over to left leg, and finally to right arm) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (NO RELEVANT HISTORY PROVIDED.).    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced PAIN IN EXTREMITY (pain and immobility moved down to right leg, then over to left leg, and finally to right arm), INJECTED LIMB MOBILITY DECREASED (difficulty moving), VACCINATION SITE PAIN (pain and swelling in the right arm and hand), VACCINATION SITE SWELLING (pain and swelling in the right arm and hand) and MOBILITY DECREASED (immobility moved down to right leg, then over to left leg, and finally to right arm). At the time of the report, PAIN IN EXTREMITY (pain and immobility moved down to right leg, then over to left leg, and finally to right arm), INJECTED LIMB MOBILITY DECREASED (difficulty moving), VACCINATION SITE PAIN (pain and swelling in the right arm and hand), VACCINATION SITE SWELLING (pain and swelling in the right arm and hand) and MOBILITY DECREASED (immobility moved down to right leg, then over to left leg, and finally to right arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment medications were not provided.