chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain in extremity
Clinical narrative: Her arm was swollen, red, bumpy and itchy and about a size of orange; Her arm was swollen, red, bumpy and itchy and about a size of orange; neck pain; arm pain; Her arm was swollen, red, bumpy and itchy and about a size of orange; she got an allergic reaction at site; Her arm was swollen, red, bumpy and itchy and about a size of orange; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (Her arm was swollen, red, bumpy and itchy and about a size of orange), INJECTION SITE ERYTHEMA (Her arm was swollen, red, bumpy and itchy and about a size of orange), NECK PAIN (neck pain), PAIN IN EXTREMITY (arm pain) and INJECTION SITE PRURITUS (Her arm was swollen, red, bumpy and itchy and about a size of orange) in a 32-year-old female 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.     No Medical History information was reported.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced INJECTION SITE SWELLING (Her arm was swollen, red, bumpy and itchy and about a size of orange), INJECTION SITE ERYTHEMA (Her arm was swollen, red, bumpy and itchy and about a size of orange), NECK PAIN (neck pain), PAIN IN EXTREMITY (arm pain), INJECTION SITE PRURITUS (Her arm was swollen, red, bumpy and itchy and about a size of orange), INJECTION SITE HYPERSENSITIVITY (she got an allergic reaction at site) and INJECTION SITE PAPULE (Her arm was swollen, red, bumpy and itchy and about a size of orange). At the time of the report, INJECTION SITE SWELLING (Her arm was swollen, red, bumpy and itchy and about a size of orange), INJECTION SITE ERYTHEMA (Her arm was swollen, red, bumpy and itchy and about a size of orange), NECK PAIN (neck pain), PAIN IN EXTREMITY (arm pain), INJECTION SITE PRURITUS (Her arm was swollen, red, bumpy and itchy and about a size of orange), INJECTION SITE HYPERSENSITIVITY (she got an allergic reaction at site) and INJECTION SITE PAPULE (Her arm was swollen, red, bumpy and itchy and about a size of orange) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications included Tylenol, Antihistamines and Hydrocortisone cream.; Sender's Comments: This case concerns a 32-year-old female with a nonserious unexpected event of injection site hypersensitivity, injection site papule, pain in extremity, neck pain and expected injection site pruritus, injection site erythema, injection site swelling. Event onset the same day as first dose mRNA-1273. 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.
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Fatigue, Pain in extremity, Sleep deficit
Clinical narrative: arm is in tremendous pain; confused; tremendous problem sleeping at night; Very tired and fatigued; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm is in tremendous pain), CONFUSIONAL STATE (confused), SLEEP DEFICIT (tremendous problem sleeping at night) and FATIGUE (Very tired and fatigued) in a 66-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 Radiation therapy since an unknown date. Concurrent medical conditions included Breast cancer and Diabetic. Concomitant products included LEVOTHYROXINE, ATORVASTATIN, MELOXICAM (MELICAN), GABAPENTIN and BUPROPION HYDROCHLORIDE (WELLBUTRIN) for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm is in tremendous pain), CONFUSIONAL STATE (confused), SLEEP DEFICIT (tremendous problem sleeping at night) and FATIGUE (Very tired and fatigued). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency; IBUPROFEN for Pain, at an unspecified dose and frequency; NAPROXEN for Pain, at an unspecified dose and frequency; TROLAMINE SALICYLATE (ASPERCREME [TROLAMINE SALICYLATE]) for Pain, at an unspecified dose and frequency and MENTHOL, METHYL SALICYLATE (SALONPAS [MENTHOL;METHYL SALICYLATE]) for Pain, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm is in tremendous pain), CONFUSIONAL STATE (confused), SLEEP DEFICIT (tremendous problem sleeping at night) and FATIGUE (Very tired and fatigued) 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 events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Breast swelling, Rash
Clinical narrative: joint pain; red rash on chest; swelling under breasts; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (joint pain), RASH ERYTHEMATOUS (red rash on chest) and BREAST SWELLING (swelling under breasts) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history provided).    On 09-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 ARTHRALGIA (joint pain), RASH ERYTHEMATOUS (red rash on chest) and BREAST SWELLING (swelling under breasts). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Pain and Swelling, at an unspecified dose and frequency. At the time of the report, ARTHRALGIA (joint pain), RASH ERYTHEMATOUS (red rash on chest) and BREAST SWELLING (swelling under breasts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medication provided; Reporter'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: Mouth haemorrhage, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Itching rash on the injection site; rash on injection  site; Very large bleeding lesion on the roof of her mouth; This spontaneous case was reported by a consumer and describes the occurrence of MOUTH HAEMORRHAGE (Very large bleeding lesion on the roof of her mouth), VACCINATION SITE PRURITUS (Itching rash on the injection site) and VACCINATION SITE RASH (rash on injection  site) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jan-2021, the patient experienced MOUTH HAEMORRHAGE (Very large bleeding lesion on the roof of her mouth). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Itching rash on the injection site) and VACCINATION SITE RASH (rash on injection  site). At the time of the report, MOUTH HAEMORRHAGE (Very large bleeding lesion on the roof of her mouth) had not resolved and VACCINATION SITE PRURITUS (Itching rash on the injection site) and VACCINATION SITE RASH (rash on injection  site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was reported. Treatment details include steroids and antivirals.; Sender's Comments: This case concerns a 63-year-old female with a nonserious unexpected mouth hemorrhage and expected injection site pruritus and injection site rash. Event onset 4 days after first dose mRNA-1273. Event 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.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: shortness of breath; arm was swollen, hot, and red; arm was swollen, hot, and red; arm was swollen, hot, and red; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath), VACCINATION SITE WARMTH (arm was swollen, hot, and red), VACCINATION SITE SWELLING (arm was swollen, hot, and red) and VACCINATION SITE ERYTHEMA (arm was swollen, hot, and red) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced DYSPNOEA (shortness of breath), VACCINATION SITE WARMTH (arm was swollen, hot, and red), VACCINATION SITE SWELLING (arm was swollen, hot, and red) and VACCINATION SITE ERYTHEMA (arm was swollen, hot, and red). On 10-Jan-2021, VACCINATION SITE WARMTH (arm was swollen, hot, and red), VACCINATION SITE SWELLING (arm was swollen, hot, and red) and VACCINATION SITE ERYTHEMA (arm was swollen, hot, and red) had resolved. At the time of the report, DYSPNOEA (shortness of breath) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment information not provided; Reporter's Comments: Based on the information provided which includes a strong temporal association between the reported events and administration of mRNA-1273 vaccine, a causal association cannot be excluded.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Erythema, Lymphadenopathy, Neck pain, Pyrexia
Clinical narrative: redness covering the entire deltoid region; vaccination site was hard; vaccination site was swollen; Painful and swollen lymph nodes; red circle the size of a nickel at injection site; low fever; Swelling under the armpit; pain on the neck; vaccination site was warm; This spontaneous case was reported by a nurse and describes the occurrence of NECK PAIN (pain on the neck), VACCINATION SITE WARMTH (vaccination site was warm), ERYTHEMA (redness covering the entire deltoid region), VACCINATION SITE INDURATION (vaccination site was hard) and VACCINATION SITE SWELLING (vaccination site was swollen) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced NECK PAIN (pain on the neck), VACCINATION SITE WARMTH (vaccination site was warm), VACCINATION SITE INDURATION (vaccination site was hard), VACCINATION SITE SWELLING (vaccination site was swollen), AXILLARY PAIN (Painful and swollen lymph nodes), VACCINATION SITE ERYTHEMA (red circle the size of a nickel at injection site), PYREXIA (low fever) and LYMPHADENOPATHY (Swelling under the armpit). On 08-Jan-2021, the patient experienced ERYTHEMA (redness covering the entire deltoid region). At the time of the report, NECK PAIN (pain on the neck), VACCINATION SITE WARMTH (vaccination site was warm), ERYTHEMA (redness covering the entire deltoid region), VACCINATION SITE INDURATION (vaccination site was hard), VACCINATION SITE SWELLING (vaccination site was swollen), AXILLARY PAIN (Painful and swollen lymph nodes), VACCINATION SITE ERYTHEMA (red circle the size of a nickel at injection site), PYREXIA (low fever) and LYMPHADENOPATHY (Swelling under the armpit) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: All events outcome updated from unknown to recovered/resolved.; 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: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site swelling, Vaccination site warmth
Clinical narrative: redness covering the entire deltoid region; vaccination site was hard; vaccination site was swollen; Painful and swollen lymph nodes; red circle the size of a nickel at injection site; low fever; Swelling under the armpit; pain on the neck; vaccination site was warm; This spontaneous case was reported by a nurse and describes the occurrence of NECK PAIN (pain on the neck), VACCINATION SITE WARMTH (vaccination site was warm), ERYTHEMA (redness covering the entire deltoid region), VACCINATION SITE INDURATION (vaccination site was hard) and VACCINATION SITE SWELLING (vaccination site was swollen) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced NECK PAIN (pain on the neck), VACCINATION SITE WARMTH (vaccination site was warm), VACCINATION SITE INDURATION (vaccination site was hard), VACCINATION SITE SWELLING (vaccination site was swollen), AXILLARY PAIN (Painful and swollen lymph nodes), VACCINATION SITE ERYTHEMA (red circle the size of a nickel at injection site), PYREXIA (low fever) and LYMPHADENOPATHY (Swelling under the armpit). On 08-Jan-2021, the patient experienced ERYTHEMA (redness covering the entire deltoid region). At the time of the report, NECK PAIN (pain on the neck), VACCINATION SITE WARMTH (vaccination site was warm), ERYTHEMA (redness covering the entire deltoid region), VACCINATION SITE INDURATION (vaccination site was hard), VACCINATION SITE SWELLING (vaccination site was swollen), AXILLARY PAIN (Painful and swollen lymph nodes), VACCINATION SITE ERYTHEMA (red circle the size of a nickel at injection site), PYREXIA (low fever) and LYMPHADENOPATHY (Swelling under the armpit) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: All events outcome updated from unknown to recovered/resolved.; 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: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site warmth
Clinical narrative: Area of injection was warm to touch; Area of injection was red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Area of injection was warm to touch) and VACCINATION SITE ERYTHEMA (Area of injection was red) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Area of injection was warm to touch) and VACCINATION SITE ERYTHEMA (Area of injection was red). At the time of the report, VACCINATION SITE WARMTH (Area of injection was warm to touch) and VACCINATION SITE ERYTHEMA (Area of injection was red) had not 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.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Additional information added on 07JUN2021 contains no significant information. Patient declines to filling form over a simple reaction.; 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: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site rash, Vaccination site swelling
Clinical narrative: Rash; Swollen at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash) and VACCINATION SITE SWELLING (Swollen at the site of injection) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced VACCINATION SITE RASH (Rash) and VACCINATION SITE SWELLING (Swollen at the site of injection). At the time of the report, VACCINATION SITE RASH (Rash) and VACCINATION SITE SWELLING (Swollen at the site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient did not receive any treatment for the events. Concomitant product use was not provided by the reporter.  Company comment: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: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Hot from the elbow to the shoulder of the vaccinated arm; Itching from the elbow to the shoulder of the vaccinated arm; Redness from the elbow to the shoulder of the vaccinated arm; Swelling from the elbow to the shoulder of the vaccinated arm; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of SKIN WARM (Hot from the elbow to the shoulder of the vaccinated arm), PRURITUS (Itching from the elbow to the shoulder of the vaccinated arm), ERYTHEMA (Redness from the elbow to the shoulder of the vaccinated arm) and PERIPHERAL SWELLING (Swelling from the elbow to the shoulder of the vaccinated arm) in a 64-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 (Medical history not reported.).    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jan-2021, the patient experienced SKIN WARM (Hot from the elbow to the shoulder of the vaccinated arm), PRURITUS (Itching from the elbow to the shoulder of the vaccinated arm), ERYTHEMA (Redness from the elbow to the shoulder of the vaccinated arm) and PERIPHERAL SWELLING (Swelling from the elbow to the shoulder of the vaccinated arm). At the time of the report, SKIN WARM (Hot from the elbow to the shoulder of the vaccinated arm), PRURITUS (Itching from the elbow to the shoulder of the vaccinated arm), ERYTHEMA (Redness from the elbow to the shoulder of the vaccinated arm) and PERIPHERAL SWELLING (Swelling from the elbow to the shoulder of the vaccinated arm) had not 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.   Concomitant and treatment information not provided; Reporter'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: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Influenza like illness, Pain in extremity, Pyrexia
Clinical narrative: Chest tightness; Fever; Pain in the left arm; Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in the left arm), INFLUENZA LIKE ILLNESS (Flu like symptoms), CHEST DISCOMFORT (Chest tightness) and PYREXIA (Fever) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Drug allergy (Allergy to Erythromycin), Drug allergy (Allergy to Clindamycin), Sulfonamide allergy (Allergy to Sulfa), Drug allergy (Allergy to Flonase), Allergy to molds, Allergic to cats (Allergy to cats), Grass allergy, Allergy and Cockroach allergy (Allergy to cockroaches). Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) and DENOSUMAB (PROLIA) for an unknown indication, DIPHENHYDRAMINE.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced PAIN IN EXTREMITY (Pain in the left arm), INFLUENZA LIKE ILLNESS (Flu like symptoms) and PYREXIA (Fever). On 09-Jan-2021, the patient experienced CHEST DISCOMFORT (Chest tightness). At the time of the report, PAIN IN EXTREMITY (Pain in the left arm), INFLUENZA LIKE ILLNESS (Flu like symptoms) and PYREXIA (Fever) had resolved and CHEST DISCOMFORT (Chest tightness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication includes Allergy shot received on 04-jan-2021 due to allergies. No treatment information was provided. Patient reported that chest tightness was from Benadryl which she took before vaccination.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Follow-up received, updated event outcome and reporter's causality.; 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: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nasal congestion
Clinical narrative: Stuffy nose; Slight headache; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (Stuffy nose) and HEADACHE (Slight headache) in a 23-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 (No medical history reported).    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 HEADACHE (Slight headache). On 07-Jan-2021, the patient experienced NASAL CONGESTION (Stuffy nose). On 07-Jan-2021, HEADACHE (Slight headache) had resolved. At the time of the report, NASAL CONGESTION (Stuffy nose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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.; Reporter'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: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Positive covid test after the vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of SARS-COV-2 TEST POSITIVE (Positive covid test after the vaccine) 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 02-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SARS-COV-2 TEST POSITIVE (Positive covid test after the vaccine). At the time of the report, SARS-COV-2 TEST POSITIVE (Positive covid test after the vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided. No concomitant medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Non-Significant follow up Email and  updated.; Sender's Comments: Based on the current available information, the mRNA-1273 does not contain a virus capable of causing infection and with the occurrence of SAR-COV-2 test positive after vaccination, the event is assessed as unlikely related to mRNA-1273.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Flushing, Nausea, Pruritus, Urticaria
Clinical narrative: Feeling flushed; Feeling warm; hives on chest, arm, face, and thigh; Itchiness of the skin; Nauseous; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of FLUSHING (Feeling flushed), FEELING HOT (Feeling warm), URTICARIA (hives on chest, arm, face, and thigh), PRURITUS (Itchiness of the skin) and NAUSEA (Nauseous) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced FLUSHING (Feeling flushed), FEELING HOT (Feeling warm), URTICARIA (hives on chest, arm, face, and thigh), PRURITUS (Itchiness of the skin) and NAUSEA (Nauseous). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of 25 milligram; FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Adverse event, at a dose of UNK dosage form; METHYLPREDNISOLONE (MEDROL DOSEPAK) for Adverse event, at a dose of UNK dosage form and FAMOTIDINE for Adverse event, at a dose of UNK dosage form. At the time of the report, FLUSHING (Feeling flushed), FEELING HOT (Feeling warm), URTICARIA (hives on chest, arm, face, and thigh), PRURITUS (Itchiness of the skin) and NAUSEA (Nauseous) 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.   No concomitant medication reported.      Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: follow up information received, stating that Patient is fine, has not presented any sequalae's, everything is fine, and all previous symptoms have resolved and there are no ongoing symptoms.; Sender's Comments:
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Oxygen saturation, Pain in extremity, Pruritus, Pyrexia
Clinical narrative: Felt really weak; Shaking; Itchy; Wheezing; Had to be on bed for 2 days and a half; Fever; Sore arm for 3 days; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Sore arm for 3 days), ASTHENIA (Felt really weak), TREMOR (Shaking), PRURITUS (Itchy) and PYREXIA (Fever) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma. Concomitant products included SALBUTAMOL SULFATE (VENTOLINE [SALBUTAMOL SULFATE]) for Asthma.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced PAIN IN EXTREMITY (Sore arm for 3 days). On 01-Jan-2021, the patient experienced ASTHENIA (Felt really weak), TREMOR (Shaking), PRURITUS (Itchy), PYREXIA (Fever) and WHEEZING (Wheezing; Had to be on bed for 2 days and a half). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of UNK dosage form and IBUPROFEN (ADVIL [IBUPROFEN]) for Fever, at a dose of UNK dosage form. On 01-Jan-2021, PAIN IN EXTREMITY (Sore arm for 3 days) had resolved. On 06-Jan-2021, TREMOR (Shaking), PRURITUS (Itchy), PYREXIA (Fever) and WHEEZING (Wheezing; Had to be on bed for 2 days and a half) had resolved. At the time of the report, ASTHENIA (Felt really weak) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jan-2021, Oxygen saturation: 91 % (Low) went down to 91%. On 02-Jan-2021, SARS-CoV-2 test: negative (Negative) Negative.     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 included few medicines(inhaler), steroids, blood pressure and cholesterol medicine. It was reported that the patient had skipped steroids, blood pressure and cholesterol medicine since he thought he had COVID-19. The patient got "barely" a sore arm for 3 days. It was reported that the patient felt better on 06-Jan-2021 but was still  a little weak at the time of report. The severity of the events were reported as 9/10.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Tremor, Wheezing
Clinical narrative: Felt really weak; Shaking; Itchy; Wheezing; Had to be on bed for 2 days and a half; Fever; Sore arm for 3 days; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Sore arm for 3 days), ASTHENIA (Felt really weak), TREMOR (Shaking), PRURITUS (Itchy) and PYREXIA (Fever) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma. Concomitant products included SALBUTAMOL SULFATE (VENTOLINE [SALBUTAMOL SULFATE]) for Asthma.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced PAIN IN EXTREMITY (Sore arm for 3 days). On 01-Jan-2021, the patient experienced ASTHENIA (Felt really weak), TREMOR (Shaking), PRURITUS (Itchy), PYREXIA (Fever) and WHEEZING (Wheezing; Had to be on bed for 2 days and a half). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of UNK dosage form and IBUPROFEN (ADVIL [IBUPROFEN]) for Fever, at a dose of UNK dosage form. On 01-Jan-2021, PAIN IN EXTREMITY (Sore arm for 3 days) had resolved. On 06-Jan-2021, TREMOR (Shaking), PRURITUS (Itchy), PYREXIA (Fever) and WHEEZING (Wheezing; Had to be on bed for 2 days and a half) had resolved. At the time of the report, ASTHENIA (Felt really weak) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jan-2021, Oxygen saturation: 91 % (Low) went down to 91%. On 02-Jan-2021, SARS-CoV-2 test: negative (Negative) Negative.     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 included few medicines(inhaler), steroids, blood pressure and cholesterol medicine. It was reported that the patient had skipped steroids, blood pressure and cholesterol medicine since he thought he had COVID-19. The patient got "barely" a sore arm for 3 days. It was reported that the patient felt better on 06-Jan-2021 but was still  a little weak at the time of report. The severity of the events were reported as 9/10.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site warmth
Clinical narrative: warm to the touch all day; redness about the size of a half dollar; bump; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (bump), VACCINATION SITE WARMTH (warm to the touch all day) and VACCINATION SITE ERYTHEMA (redness about the size of a half dollar) in a 50-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 event (No medical history reported).    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jan-2021, the patient experienced VACCINATION SITE MASS (bump) and VACCINATION SITE ERYTHEMA (redness about the size of a half dollar). On 11-Jan-2021, the patient experienced VACCINATION SITE WARMTH (warm to the touch all day). On 11-Jan-2021, VACCINATION SITE MASS (bump) had resolved. At the time of the report, VACCINATION SITE WARMTH (warm to the touch all day) and VACCINATION SITE ERYTHEMA (redness about the size of a half dollar) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment was taken for the symptoms.  Company comment: 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.; 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.
Sex: F
Vaccine: COVID19
Symptoms: Tenderness, Vaccination site cellulitis
Clinical narrative: Cellulitis at the injection site; Tenderness in the Left Armpit; This spontaneous case was reported by a physical therapist (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE CELLULITIS (Cellulitis at the injection site) and TENDERNESS (Tenderness in the Left Armpit) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder.    On 07-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 TENDERNESS (Tenderness in the Left Armpit). On 15-Jan-2021, the patient experienced VACCINATION SITE CELLULITIS (Cellulitis at the injection site). At the time of the report, VACCINATION SITE CELLULITIS (Cellulitis at the injection site) and TENDERNESS (Tenderness in the Left Armpit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment details was provided.; Sender's Comments: Very limited information regarding this event of cellulitis has been provided at this time.  Further information has been requested
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: itching at the injection site; redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itching at the injection site) and VACCINATION SITE ERYTHEMA (redness at injection site) 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.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (itching at the injection site). In January 2021, the patient experienced VACCINATION SITE ERYTHEMA (redness at injection site). At the time of the report, VACCINATION SITE PRURITUS (itching at the injection site) had resolved and VACCINATION SITE ERYTHEMA (redness at injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.     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: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Pain in extremity, Vaccination site movement impairment
Clinical narrative: knees issues which gives her trouble walking up the steps; Arm was hurting and has trouble lifting up; Arm was hurting and has trouble lifting up; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (knees issues which gives her trouble walking up the steps), PAIN IN EXTREMITY (Arm was hurting and has trouble lifting up) and VACCINATION SITE MOVEMENT IMPAIRMENT (Arm was hurting and has trouble lifting up) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced GAIT DISTURBANCE (knees issues which gives her trouble walking up the steps), PAIN IN EXTREMITY (Arm was hurting and has trouble lifting up) and VACCINATION SITE MOVEMENT IMPAIRMENT (Arm was hurting and has trouble lifting up). At the time of the report, GAIT DISTURBANCE (knees issues which gives her trouble walking up the steps), PAIN IN EXTREMITY (Arm was hurting and has trouble lifting up) and VACCINATION SITE MOVEMENT IMPAIRMENT (Arm was hurting and has trouble lifting up) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details were not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 11-Jan-2021: Patient demographic updated, new adverse events updated.; 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: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Blood urine present, Fungal infection, Rash, Urinary tract disorder
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FUNGAL INFECTION (recurring yeast infections), URINARY TRACT DISORDER (urinary problems), BLOOD URINE PRESENT (blood in urine) and RASH (rash expanding to stomach, legs, back and arms; rash was so bad the only place she did not get it were on her head and feet) in a 75-year-old female patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced FUNGAL INFECTION (recurring yeast infections) and BLOOD URINE PRESENT (blood in urine). On 01-Jan-2021, the patient experienced RASH (rash expanding to stomach, legs, back and arms; rash was so bad the only place she did not get it were on her head and feet). On an unknown date, the patient experienced URINARY TRACT DISORDER (urinary problems). The patient was treated with PREDNISONE for Rash, at a dose of 1 dosage form. At the time of the report, FUNGAL INFECTION (recurring yeast infections), URINARY TRACT DISORDER (urinary problems) and BLOOD URINE PRESENT (blood in urine) outcome was unknown and RASH (rash expanding to stomach, legs, back and arms; rash was so bad the only place she did not get it were on her head and feet) had resolved.            Concomitant medications were not provided by the reporter.   The patient reported taking numerous oral and topical medications for the event including prednisone shots.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: TCR provided additional event and treatment details On 03-Jun-2021: New events added after 1st dose, 2nd dose details provided
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Broken out in a rash on the torso; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Broken out in a rash on the torso) in a 62-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 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 RASH (Broken out in a rash on the torso). At the time of the report, RASH (Broken out in a rash on the torso) 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.  Company comment:Based on the current available information and temporal association between the use of the product and the onset date of the reported event, 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 onset date of the reported event, a causal relationship cannot be excluded.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling hot, Headache, Pyrexia
Clinical narrative: hotness; light fever; headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (hotness), PYREXIA (light fever), HEADACHE (headache) and CHILLS (Chills) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 13-Jan-2021, the patient experienced FEELING HOT (hotness), PYREXIA (light fever), HEADACHE (headache) and CHILLS (Chills). At the time of the report, FEELING HOT (hotness), PYREXIA (light fever), HEADACHE (headache) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information provided included paracetamol to treat symptoms.  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: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Cough, Fatigue, Hyperhidrosis
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of COUGH (bad cough this morning), HYPERHIDROSIS (sweat), FATIGUE (Felt tired,fatigue), MYALGIA (Woke up with aches) and CHILLS (chills) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LOSARTAN POTASSIUM (LOSARTAN POTASSSIUM) and OMEPRAZOLE (OMEPRAZOLE ABBOTT) for an unknown indication.    On 11-Jan-2021 at 8:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced FATIGUE (Felt tired,fatigue), MYALGIA (Woke up with aches), CHILLS (chills) and PYREXIA (fever). On 13-Jan-2021, the patient experienced COUGH (bad cough this morning). On an unknown date, the patient experienced HYPERHIDROSIS (sweat). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at a dose of UNK dosage form. At the time of the report, COUGH (bad cough this morning) outcome was unknown and HYPERHIDROSIS (sweat), FATIGUE (Felt tired,fatigue), MYALGIA (Woke up with aches), CHILLS (chills) and PYREXIA (fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Jan-2021, Body temperature: 101.4 (High) high.         The patient reported taking an unspecified nasal spray concomitantly.  In the afternoon of 11JAN2021, the patient felt tired and took a nap. He woke up with aches, chills , fever and fatigue. (which lasted for about 48 hours).  The patient self-treated with ibuprofen, which helped the fever. On 13JAN2021, the patient developed a "bad cough" which was concerning. The patient experienced fatigue for 4 or 5 days.   This case was linked to MOD-2021-075444 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Jan-2021: Reporter address and Lot # provided, additional events and event details reported On 12-Apr-2021: Completed ADR Form: includes patient demographic information and medical history, event outcomes updated; 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.