chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Gait disturbance, Insomnia
Clinical narrative: Trouble sleeping; Noticed balancing problem; Not feeling steady during walking; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Trouble sleeping), BALANCE DISORDER (Noticed balancing problem) and GAIT DISTURBANCE (Not feeling steady during walking) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 01SL20A and 012M02A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jan-2021, the patient experienced INSOMNIA (Trouble sleeping), BALANCE DISORDER (Noticed balancing problem) and GAIT DISTURBANCE (Not feeling steady during walking). At the time of the report, INSOMNIA (Trouble sleeping), BALANCE DISORDER (Noticed balancing problem) and GAIT DISTURBANCE (Not feeling steady during walking) outcome was unknown.            Concomitant product use was not provided by the reporter. No treatment information was provided. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Reporter's contact information email id  was added.Events like noticed balancing problem,not feeling steady during walking was added.Date of second dose vaccine was added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Rash, Rash pruritic, Rash pustular
Clinical narrative: one rash was itchy; rashes were big and blotchy and elongated with "white things (pus) in the middle; rash on his arms and chest; fatigue; his arm also hurt and was sore; dizziness / lightheadedness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness / lightheadedness), FATIGUE (fatigue), VACCINATION SITE PAIN (his arm also hurt and was sore), RASH (rash on his arms and chest) and RASH PRURITIC (one rash was itchy) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Idiopathic pulmonary fibrosis.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced DIZZINESS (dizziness / lightheadedness), FATIGUE (fatigue) and VACCINATION SITE PAIN (his arm also hurt and was sore). On 10-Jan-2021, the patient experienced RASH (rash on his arms and chest), RASH PRURITIC (one rash was itchy) and RASH PUSTULAR (rashes were big and blotchy and elongated with "white things (pus) in the middle). On 09-Jan-2021, DIZZINESS (dizziness / lightheadedness), FATIGUE (fatigue) and VACCINATION SITE PAIN (his arm also hurt and was sore) had resolved. At the time of the report, RASH (rash on his arms and chest), RASH PRURITIC (one rash was itchy) and RASH PUSTULAR (rashes were big and blotchy and elongated with "white things (pus) in the middle) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment medication was not reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: one rash was itchy; rashes were big and blotchy and elongated with "white things (pus) in the middle; rash on his arms and chest; fatigue; his arm also hurt and was sore; dizziness / lightheadedness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness / lightheadedness), FATIGUE (fatigue), VACCINATION SITE PAIN (his arm also hurt and was sore), RASH (rash on his arms and chest) and RASH PRURITIC (one rash was itchy) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Idiopathic pulmonary fibrosis.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced DIZZINESS (dizziness / lightheadedness), FATIGUE (fatigue) and VACCINATION SITE PAIN (his arm also hurt and was sore). On 10-Jan-2021, the patient experienced RASH (rash on his arms and chest), RASH PRURITIC (one rash was itchy) and RASH PUSTULAR (rashes were big and blotchy and elongated with "white things (pus) in the middle). On 09-Jan-2021, DIZZINESS (dizziness / lightheadedness), FATIGUE (fatigue) and VACCINATION SITE PAIN (his arm also hurt and was sore) had resolved. At the time of the report, RASH (rash on his arms and chest), RASH PRURITIC (one rash was itchy) and RASH PUSTULAR (rashes were big and blotchy and elongated with "white things (pus) in the middle) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment medication was not reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Vaccination site pain, Vaccination site swelling
Clinical narrative: Joint pain in arm; Swelling near the injection site on her upper arm; Pain near the injection site on her upper arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swelling near the injection site on her upper arm), VACCINATION SITE PAIN (Pain near the injection site on her upper arm) and ARTHRALGIA (Joint pain in arm) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02FL20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Swelling near the injection site on her upper arm) and VACCINATION SITE PAIN (Pain near the injection site on her upper arm). On 07-Jan-2021, the patient experienced ARTHRALGIA (Joint pain in arm). At the time of the report, VACCINATION SITE SWELLING (Swelling near the injection site on her upper arm) was resolving and VACCINATION SITE PAIN (Pain near the injection site on her upper arm) and ARTHRALGIA (Joint pain in arm) 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.   Concomitant product use was not provided by the reporter. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Allergic reaction symptoms like hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Allergic reaction symptoms like hives) in a female 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 (No reported medical history).    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced URTICARIA (Allergic reaction symptoms like hives). At the time of the report, URTICARIA (Allergic reaction symptoms like hives) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.     Concomitant product use was not provided by the reporter. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event of urticaria, a causal relationship cannot be excluded.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Myalgia, Pain, Peripheral swelling, Skin warm
Clinical narrative: arm very swollen, very warm and a redness appeared on it; arm very swollen, very warm and a redness appeared on it; arm very swollen, very warm and a redness appeared on it; a little bit of muscle pain; body aches; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Jan-2021 and was forwarded to Moderna on 12-Jan-2021.    This spontaneous case was reported by a nurse and describes the occurrence of MYALGIA (a little bit of muscle pain), PAIN (body aches), PERIPHERAL SWELLING (arm very swollen, very warm and a redness appeared on it), ERYTHEMA (arm very swollen, very warm and a redness appeared on it) and SKIN WARM (arm very swollen, very warm and a redness appeared on it) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011j20a) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2020, the patient experienced MYALGIA (a little bit of muscle pain) and PAIN (body aches). On 08-Jan-2021, the patient experienced PERIPHERAL SWELLING (arm very swollen, very warm and a redness appeared on it), ERYTHEMA (arm very swollen, very warm and a redness appeared on it) and SKIN WARM (arm very swollen, very warm and a redness appeared on it). At the time of the report, MYALGIA (a little bit of muscle pain), PAIN (body aches), PERIPHERAL SWELLING (arm very swollen, very warm and a redness appeared on it), ERYTHEMA (arm very swollen, very warm and a redness appeared on it) and SKIN WARM (arm very swollen, very warm and a redness appeared on it) 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.   Concomitant medication includes Colesterol Meds and Antibiotics A doctor marked her arm to see and to measure how the condition of her arm evolved, and prescribed antibiotics; 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.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site haemorrhage, Vaccination site swelling
Clinical narrative: bleeding at injection site; injection site red; injection site swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMORRHAGE (bleeding at injection site), VACCINATION SITE ERYTHEMA (injection site red) and VACCINATION SITE SWELLING (injection site swelling) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE HAEMORRHAGE (bleeding at injection site), VACCINATION SITE ERYTHEMA (injection site red) and VACCINATION SITE SWELLING (injection site swelling). At the time of the report, VACCINATION SITE HAEMORRHAGE (bleeding at injection site) had resolved and VACCINATION SITE ERYTHEMA (injection site red) and VACCINATION SITE SWELLING (injection site swelling) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's medical history was not provided.  No relevant concomitant medications were reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: NNI: consumer declines further FU; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: Feeling body aches; Feeling fatigue; This spontaneous case was reported by a physician assistant (subsequently medically confirmed) and describes the occurrence of PAIN (Feeling body aches) and FATIGUE (Feeling fatigue) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse effect (No medical history provided).    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jan-2021, the patient experienced PAIN (Feeling body aches) and FATIGUE (Feeling fatigue). At the time of the report, PAIN (Feeling body aches) and FATIGUE (Feeling fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment medication included Paracetamol.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Hyperhidrosis, Limb discomfort, Throat irritation
Clinical narrative: Felt asthmatic; Inflammation inside the throat; Sore arm immediately after receiving the first dose of moderna vaccine; A little sweating immediately after receiving the first dose of moderna vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of ASTHMA (Felt asthmatic), HYPERHIDROSIS (A little sweating immediately after receiving the first dose of moderna vaccine), THROAT IRRITATION (Inflammation inside the throat) and LIMB DISCOMFORT (Sore arm immediately after receiving the first dose of moderna vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced HYPERHIDROSIS (A little sweating immediately after receiving the first dose of moderna vaccine) and LIMB DISCOMFORT (Sore arm immediately after receiving the first dose of moderna vaccine). On 07-Jan-2021, the patient experienced ASTHMA (Felt asthmatic) and THROAT IRRITATION (Inflammation inside the throat). On 06-Jan-2021, HYPERHIDROSIS (A little sweating immediately after receiving the first dose of moderna vaccine) had resolved, LIMB DISCOMFORT (Sore arm immediately after receiving the first dose of moderna vaccine) outcome was unknown. At the time of the report, ASTHMA (Felt asthmatic) and THROAT IRRITATION (Inflammation inside the throat) 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 medications included Inhaler. No concomitant medications were provided by reporter.   Reporter did not allow further contact; Sender's Comments: This case concerns an adult female with a nonserious unexpected event of asthma, hyperhidrosis, throat irritation and expected limb discomfort. Event onset 2 days after first dose mRNA-1273. Treated with prednisone. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes, Vaccination site pain
Clinical narrative: Cold sores appeared all over her mouth and lips; slight pain in the arm after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of ORAL HERPES (Cold sores appeared all over her mouth and lips) and VACCINATION SITE PAIN (slight pain in the arm after vaccination) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included Cold sores (stated she is susceptible to cold sores in the winter with cold dry air) and No adverse event (Medical history not provided). Concomitant products included ACYCLOVIR [ACICLOVIR].    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 09-Jan-2021, the patient experienced VACCINATION SITE PAIN (slight pain in the arm after vaccination). On 11-Jan-2021, the patient experienced ORAL HERPES (Cold sores appeared all over her mouth and lips). In January 2021, VACCINATION SITE PAIN (slight pain in the arm after vaccination) had resolved. At the time of the report, ORAL HERPES (Cold sores appeared all over her mouth and lips) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided. Patient is susceptible to cold sores in the winter with the cold, dry air.; 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.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: Itching at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching at the injection site) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event). Concomitant products included AZILSARTAN KAMEDOXOMIL (EDARBI), METFORMIN, DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE (FARXIGA) and SITAGLIPTIN (JANUVIA [SITAGLIPTIN]) for an unknown indication.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 09-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itching at the injection site). At the time of the report, VACCINATION SITE PRURITUS (Itching at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Headache, Illness, Injection site erythema
Clinical narrative: like a pressure on her head, like sinusitis; felt sick; wanted to vomit; chills; fever; felt pain in the arm of the injection; redness; headache; This spontaneous case was reported by a consumer and describes the occurrence of PARANASAL SINUS DISCOMFORT (like a pressure on her head, like sinusitis), INJECTION SITE PAIN (felt pain in the arm of the injection), INJECTION SITE ERYTHEMA (redness), HEADACHE (headache) and CHILLS (chills) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for an unknown indication. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: HEPATITIS B VACCINE (last dose of the Hepatitis B vaccine) on 31-Dec-2020. Concurrent medical conditions included Type 2 diabetes mellitus, Cholesterol blood excessive and Blood pressure high. Concomitant products included BIOTIN for Hair loss, OMEPRAZOLE for Skin disorder, EMPAGLIFLOZIN (JARDIANCE) for Type 2 diabetes mellitus, ATORVASTATIN, TELMISARTAN, ACETYLSALICYLIC ACID (ASPIRIN 81), VITAMIN D3 and VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 04-Jan-2021, the patient experienced INJECTION SITE PAIN (felt pain in the arm of the injection), INJECTION SITE ERYTHEMA (redness) and HEADACHE (headache). On 05-Jan-2021, the patient experienced CHILLS (chills) and PYREXIA (fever). On 06-Jan-2021, the patient experienced ILLNESS (felt sick) and NAUSEA (wanted to vomit). On 07-Jan-2021, the patient experienced PARANASAL SINUS DISCOMFORT (like a pressure on her head, like sinusitis). On 05-Jan-2021, HEADACHE (headache) had resolved. At the time of the report, PARANASAL SINUS DISCOMFORT (like a pressure on her head, like sinusitis), INJECTION SITE ERYTHEMA (redness), CHILLS (chills), ILLNESS (felt sick) and NAUSEA (wanted to vomit) had resolved and INJECTION SITE PAIN (felt pain in the arm of the injection) and PYREXIA (fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, COVID-19: positive absent (Positive) Positive twice..     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 included Tylenol.; Sender's Comments: This case concerns an adult with PMH of COVID-19 had nonserious unexpected events of paranasal sinus discomfort, illness and expected pyrexia, chills, headache, nausea, injection site pain, injection site erythema. Event onset 3 days after first dose mRNA-1273. Events ongoing. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Nausea, Paranasal sinus discomfort, Pyrexia
Clinical narrative: like a pressure on her head, like sinusitis; felt sick; wanted to vomit; chills; fever; felt pain in the arm of the injection; redness; headache; This spontaneous case was reported by a consumer and describes the occurrence of PARANASAL SINUS DISCOMFORT (like a pressure on her head, like sinusitis), INJECTION SITE PAIN (felt pain in the arm of the injection), INJECTION SITE ERYTHEMA (redness), HEADACHE (headache) and CHILLS (chills) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for an unknown indication. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: HEPATITIS B VACCINE (last dose of the Hepatitis B vaccine) on 31-Dec-2020. Concurrent medical conditions included Type 2 diabetes mellitus, Cholesterol blood excessive and Blood pressure high. Concomitant products included BIOTIN for Hair loss, OMEPRAZOLE for Skin disorder, EMPAGLIFLOZIN (JARDIANCE) for Type 2 diabetes mellitus, ATORVASTATIN, TELMISARTAN, ACETYLSALICYLIC ACID (ASPIRIN 81), VITAMIN D3 and VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 04-Jan-2021, the patient experienced INJECTION SITE PAIN (felt pain in the arm of the injection), INJECTION SITE ERYTHEMA (redness) and HEADACHE (headache). On 05-Jan-2021, the patient experienced CHILLS (chills) and PYREXIA (fever). On 06-Jan-2021, the patient experienced ILLNESS (felt sick) and NAUSEA (wanted to vomit). On 07-Jan-2021, the patient experienced PARANASAL SINUS DISCOMFORT (like a pressure on her head, like sinusitis). On 05-Jan-2021, HEADACHE (headache) had resolved. At the time of the report, PARANASAL SINUS DISCOMFORT (like a pressure on her head, like sinusitis), INJECTION SITE ERYTHEMA (redness), CHILLS (chills), ILLNESS (felt sick) and NAUSEA (wanted to vomit) had resolved and INJECTION SITE PAIN (felt pain in the arm of the injection) and PYREXIA (fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, COVID-19: positive absent (Positive) Positive twice..     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 included Tylenol.; Sender's Comments: This case concerns an adult with PMH of COVID-19 had nonserious unexpected events of paranasal sinus discomfort, illness and expected pyrexia, chills, headache, nausea, injection site pain, injection site erythema. Event onset 3 days after first dose mRNA-1273. Events ongoing. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Urinary tract infection
Clinical narrative: Urinary Tract Infection (UTI); A Little Injection Site Swelling; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of URINARY TRACT INFECTION (Urinary Tract Infection (UTI)) and INJECTION SITE SWELLING (A Little Injection Site Swelling) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Dec-2020, the patient experienced INJECTION SITE SWELLING (A Little Injection Site Swelling). On 11-Jan-2021, the patient experienced URINARY TRACT INFECTION (Urinary Tract Infection (UTI)). On 25-Dec-2020, INJECTION SITE SWELLING (A Little Injection Site Swelling) had resolved. At the time of the report, URINARY TRACT INFECTION (Urinary Tract Infection (UTI)) 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.   Concomitant product use was not provided by the reporter. Treatment information was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Rash papular
Clinical narrative: Rash appeared on his chest on the right side down, like big puff like dots; Felt dizzy and light headed; Chills; This spontaneous case was reported by a consumer and describes the occurrence of RASH PAPULAR (Rash appeared on his chest on the right side down, like big puff like dots), DIZZINESS (Felt dizzy and light headed) and CHILLS (Chills) 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 (No recorded medical history.).    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2021, the patient experienced DIZZINESS (Felt dizzy and light headed) and CHILLS (Chills). On 10-Jan-2021, the patient experienced RASH PAPULAR (Rash appeared on his chest on the right side down, like big puff like dots). At the time of the report, RASH PAPULAR (Rash appeared on his chest on the right side down, like big puff like dots), DIZZINESS (Felt dizzy and light headed) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.; Sender's Comments: Based on the current available information and the temporal association between the product sue and the start date of the events a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: Their entire left arm up to the elbow became red; 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 ERYTHEMA (Their entire left arm up to the elbow became red) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced ERYTHEMA (Their entire left arm up to the elbow became red). At the time of the report, ERYTHEMA (Their entire left arm up to the elbow became red) 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.   Concomitant product use was not provided by the reporter. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event of erythema, a causal relationship cannot be excluded.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027LV0A) for COVID-19 vaccination.     The patient's past medical history included No adverse drug effect.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 11-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 11-Jan-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the event a causal relationship cannot be excluded.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Pyrexia, Somnolence
Clinical narrative: Slept all day long; Body aches; Chills; Low grade fever; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Slept all day long), MYALGIA (Body aches), CHILLS (Chills), PYREXIA (Low grade fever) and FATIGUE (Fatigue) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Cancer and Blood pressure.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2021, the patient experienced SOMNOLENCE (Slept all day long), MYALGIA (Body aches), CHILLS (Chills), PYREXIA (Low grade fever) and FATIGUE (Fatigue). At the time of the report, SOMNOLENCE (Slept all day long), MYALGIA (Body aches), CHILLS (Chills), PYREXIA (Low grade fever) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.  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.; 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.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Headache, Palpitations
Clinical narrative: blood pressure shot up; I could feel my heart beating; insides feeling as if racing; Headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BLOOD PRESSURE INCREASED (blood pressure shot up), PALPITATIONS (I could feel my heart beating; insides feeling as if racing) and HEADACHE (Headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Drug allergy (Allergic to erythromycin), Chronic back pain (2 major back surgeries), Drug allergy (Allergic to Compazine), Thyroid disorder NOS, Scleroderma (autoimmune disease), Pustular psoriasis (autoimmune disease), Drug allergy (Allergic to Darvocet) and Drug allergy (Allergic to Breo). Concomitant products included LEVOTHYROXINE, MORPHINE SULFATE (MORPHINE SULPHATE), PREGABALIN, VITAMIN C [ASCORBIC ACID], MULTIVITAMIN [VITAMINS NOS], CALCIUM, LATANOPROST and DORZOLAMIDE HYDROCHLORIDE, TIMOLOL MALEATE (TIMOLOL + DORZOLAMIDA ACTAVIS) for an unknown indication.    On 07-Jan-2021 at 1:15 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021 at 2:15 PM, the patient experienced BLOOD PRESSURE INCREASED (blood pressure shot up), PALPITATIONS (I could feel my heart beating; insides feeling as if racing) and HEADACHE (Headache). The patient was treated with AMLODIPINE BESILATE for Increased blood pressure, at a dose of 2.5 milligram. At the time of the report, BLOOD PRESSURE INCREASED (blood pressure shot up) was resolving and PALPITATIONS (I could feel my heart beating; insides feeling as if racing) and HEADACHE (Headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jan-2021, Blood pressure measurement: 145/93 mmHg (High) 145/93 in both arms.         The patient stated all other symptoms stopped after taking the very first blood pressure pill.  The patient stated the last 2 weeks without "blood pressure pill in me yet" her blood pressure seemed to be returning to normal levels, with readings of 111/72 and 104/70.   This case was linked to US-MODERNATX, INC.-MOD-2021-077712 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: linked number was added for Dose 2 case On 24-May-2021: Completed ADR form; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-077712:DOSE 2
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection Site Soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection Site Soreness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Injection Site Soreness). At the time of the report, VACCINATION SITE PAIN (Injection Site Soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Cough, Fatigue, Headache
Clinical narrative: Paresthesia; Cough; Photophobia; General body aches; Increased fatigue; Headache; Left temporal temperature of 99.3; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of PARAESTHESIA (Paresthesia), COUGH (Cough), PHOTOPHOBIA (Photophobia), PAIN (General body aches) and FATIGUE (Increased fatigue) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse effect (no medical history provided).    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jan-2021, the patient experienced COUGH (Cough), PHOTOPHOBIA (Photophobia), PAIN (General body aches), FATIGUE (Increased fatigue), HEADACHE (Headache) and BODY TEMPERATURE INCREASED (Left temporal temperature of 99.3). On an unknown date, the patient experienced PARAESTHESIA (Paresthesia). At the time of the report, PARAESTHESIA (Paresthesia), COUGH (Cough), PHOTOPHOBIA (Photophobia), PAIN (General body aches), FATIGUE (Increased fatigue), HEADACHE (Headache) and BODY TEMPERATURE INCREASED (Left temporal temperature of 99.3) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Jan-2021, Body temperature (97-99): 99.3 (Borderline) degrees. On 10-Jan-2021, White blood cell count (4,500-11,000): 4 (Borderline) no left shift.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.; Sender's Comments: Based on the current information available and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Paraesthesia, Photophobia, White blood cell count
Clinical narrative: Paresthesia; Cough; Photophobia; General body aches; Increased fatigue; Headache; Left temporal temperature of 99.3; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of PARAESTHESIA (Paresthesia), COUGH (Cough), PHOTOPHOBIA (Photophobia), PAIN (General body aches) and FATIGUE (Increased fatigue) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse effect (no medical history provided).    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jan-2021, the patient experienced COUGH (Cough), PHOTOPHOBIA (Photophobia), PAIN (General body aches), FATIGUE (Increased fatigue), HEADACHE (Headache) and BODY TEMPERATURE INCREASED (Left temporal temperature of 99.3). On an unknown date, the patient experienced PARAESTHESIA (Paresthesia). At the time of the report, PARAESTHESIA (Paresthesia), COUGH (Cough), PHOTOPHOBIA (Photophobia), PAIN (General body aches), FATIGUE (Increased fatigue), HEADACHE (Headache) and BODY TEMPERATURE INCREASED (Left temporal temperature of 99.3) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Jan-2021, Body temperature (97-99): 99.3 (Borderline) degrees. On 10-Jan-2021, White blood cell count (4,500-11,000): 4 (Borderline) no left shift.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.; Sender's Comments: Based on the current information available and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Vaccination site pain
Clinical narrative: Vaccination site pain; Runny nose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain) and RHINORRHOEA (Runny nose) in a female 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 (No adverse event 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 SITE PAIN (Vaccination site pain) and RHINORRHOEA (Runny nose). At the time of the report, VACCINATION SITE PAIN (Vaccination site pain) and RHINORRHOEA (Runny nose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.; 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.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site movement impairment, Vaccination site pain, Vaccination site warmth
Clinical narrative: vaccination site movement impairment; Felt warm; Severe pain above the injection site (left arm), around shoulder; Redness; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (vaccination site movement impairment), VACCINATION SITE WARMTH (Felt warm), VACCINATION SITE PAIN (Severe pain above the injection site (left arm), around shoulder) and VACCINATION SITE ERYTHEMA (Redness) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (vaccination site movement impairment), VACCINATION SITE WARMTH (Felt warm), VACCINATION SITE PAIN (Severe pain above the injection site (left arm), around shoulder) and VACCINATION SITE ERYTHEMA (Redness). In January 2021, VACCINATION SITE ERYTHEMA (Redness) had resolved. At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (vaccination site movement impairment) had not resolved and VACCINATION SITE WARMTH (Felt warm) and VACCINATION SITE PAIN (Severe pain above the injection site (left arm), around shoulder) was resolving.        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 product use was not provided by the reporter. Treatment medications included ibuprofen and diclofenac prescribed by her doctor. Patient also had ice for the pain.    Based on the current information and the temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current information and the temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain
Clinical narrative: left axillary lymph node pain; Lymph node pain in her neck; This spontaneous case was reported by a consumer and describes the occurrence of LYMPH NODE PAIN (left axillary lymph node pain) and LYMPH NODE PAIN (Lymph node pain in her neck) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced LYMPH NODE PAIN (Lymph node pain in her neck). On 10-Jan-2021, the patient experienced LYMPH NODE PAIN (left axillary lymph node pain). On 06-Jan-2021, LYMPH NODE PAIN (Lymph node pain in her neck) outcome was unknown. On 12-Jan-2021, LYMPH NODE PAIN (left axillary lymph node pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was included. Treatment included unknown.   Reporter did not allow further contact; Sender's Comments: This case concerns a 42-year-old female with a nonserious unexpected event of Lymph node pain.  Event onset the same day as first dose mRNA-1273. Event resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.