chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site erythema, Vaccination site induration
Clinical narrative: Knot in the injection site; Red mark on the injection site; Feeling tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Red mark on the injection site), VACCINATION SITE INDURATION (Knot in the injection site) and FATIGUE (Feeling tired) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) 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 09-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red mark on the injection site), VACCINATION SITE INDURATION (Knot in the injection site) and FATIGUE (Feeling tired). At the time of the report, VACCINATION SITE ERYTHEMA (Red mark on the injection site), VACCINATION SITE INDURATION (Knot in the injection site) and FATIGUE (Feeling tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the events 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: M
Vaccine: COVID19
Symptoms: Chest discomfort, Ear discomfort, Fatigue, Headache, Heart rate
Clinical narrative: Tired; His ear towards the upper tip felt little warm; Heart palpitations; Odd feeling in chest; Throat discomfort; Headache; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of EAR DISCOMFORT (His ear towards the upper tip felt little warm), PALPITATIONS (Heart palpitations), CHEST DISCOMFORT (Odd feeling in chest), OROPHARYNGEAL DISCOMFORT (Throat discomfort) and HEADACHE (Headache) in a 33-year-old male 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.     The patient's past medical history included No adverse event (No adverse event).    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 EAR DISCOMFORT (His ear towards the upper tip felt little warm), PALPITATIONS (Heart palpitations), CHEST DISCOMFORT (Odd feeling in chest), OROPHARYNGEAL DISCOMFORT (Throat discomfort) and HEADACHE (Headache). On 07-Jan-2021, the patient experienced FATIGUE (Tired). On 08-Jan-2021, EAR DISCOMFORT (His ear towards the upper tip felt little warm), PALPITATIONS (Heart palpitations), CHEST DISCOMFORT (Odd feeling in chest), OROPHARYNGEAL DISCOMFORT (Throat discomfort), HEADACHE (Headache) and FATIGUE (Tired) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jan-2021, Heart rate: The beats per minute were starting at 122 jumped to 133 then 150 then 170 and then to 179. The heart rate decreased to 95 beats per minute. After 5 minutes the bpm was 170 for 1-2 minutes and then dropped to 90 bpm. Then went to 120-130 bpm at ER. Turned to 75bpm after sitting. After getting home HR increased to 122 bpm then lowered to 85-115. At home range went to 75-80 bpm.. On 07-Jan-2021, Heart rate: Resting Heart rate Normal..     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 received at the ER.  Patient was transferred to the ER.  Company Comment: 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. Further information has been requested.; 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. Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal discomfort, Palpitations
Clinical narrative: Tired; His ear towards the upper tip felt little warm; Heart palpitations; Odd feeling in chest; Throat discomfort; Headache; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of EAR DISCOMFORT (His ear towards the upper tip felt little warm), PALPITATIONS (Heart palpitations), CHEST DISCOMFORT (Odd feeling in chest), OROPHARYNGEAL DISCOMFORT (Throat discomfort) and HEADACHE (Headache) in a 33-year-old male 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.     The patient's past medical history included No adverse event (No adverse event).    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 EAR DISCOMFORT (His ear towards the upper tip felt little warm), PALPITATIONS (Heart palpitations), CHEST DISCOMFORT (Odd feeling in chest), OROPHARYNGEAL DISCOMFORT (Throat discomfort) and HEADACHE (Headache). On 07-Jan-2021, the patient experienced FATIGUE (Tired). On 08-Jan-2021, EAR DISCOMFORT (His ear towards the upper tip felt little warm), PALPITATIONS (Heart palpitations), CHEST DISCOMFORT (Odd feeling in chest), OROPHARYNGEAL DISCOMFORT (Throat discomfort), HEADACHE (Headache) and FATIGUE (Tired) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jan-2021, Heart rate: The beats per minute were starting at 122 jumped to 133 then 150 then 170 and then to 179. The heart rate decreased to 95 beats per minute. After 5 minutes the bpm was 170 for 1-2 minutes and then dropped to 90 bpm. Then went to 120-130 bpm at ER. Turned to 75bpm after sitting. After getting home HR increased to 122 bpm then lowered to 85-115. At home range went to 75-80 bpm.. On 07-Jan-2021, Heart rate: Resting Heart rate Normal..     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 received at the ER.  Patient was transferred to the ER.  Company Comment: 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. Further information has been requested.; 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. Further information has been requested.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: soreness of the arm; This spontaneous case was reported by a patient family member or friend and describes the occurrence of INJECTION SITE PAIN (soreness of the arm) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included MAGNESIUM, VITAMIN B COMPLEX (SUPER B COMPL), CINNAMOMUM CASSIA BARK, THIOCTIC ACID (CINNAMON ALPHA LIPOIC ACID), TURMERIC [CURCUMA LONGA RHIZOME], APPLE CIDER VINEGAR, VITAMIN D3, BIOTIN, ORNITHINE ASPARTATE, SELENIUM, SILYBUM MARIANUM, THIOCTIC ACID (LIVERAID [ORNITHINE ASPARTATE;SELENIUM;SILYBUM MARIANUM;THIOCTIC ACID]), CALCIUM CITRATE and GINGER ROOT [ZINGIBER OFFICINALE RHIZOME] for Nutritional supplement, VITAMIN E NOS for Skin disorder NOS, ASCORBIC ACID (VITAMIN C ACID) for Unspecified immunity deficiency.    On 08-Jan-2021 at 3:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021 at 2:30 AM, the patient experienced INJECTION SITE PAIN (soreness of the arm). At the time of the report, INJECTION SITE PAIN (soreness of the 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.   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 start date of the event, a causal relationship cannot be excluded. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Vaccinated while pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccinated while pregnant) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     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) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 08-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccinated while pregnant). On 08-Jan-2021, EXPOSURE DURING PREGNANCY (Vaccinated while pregnant) had resolved.            This is a case of product exposure during pregnancy with no associated AEs for this XX-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for this XX-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Disorientation, Dizziness, Fatigue
Clinical narrative: GI upset; Diarrhea; Loopy; Lightheaded; Tired and exhausted; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (GI upset), DIARRHOEA (Diarrhea), DISORIENTATION (Loopy), DIZZINESS (Lightheaded) and FATIGUE (Tired and exhausted) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0255J202A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included DOCUSATE SODIUM (COLACE) for an unknown indication.    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 ABDOMINAL DISCOMFORT (GI upset), DIARRHOEA (Diarrhea), DISORIENTATION (Loopy), DIZZINESS (Lightheaded) and FATIGUE (Tired and exhausted). At the time of the report, ABDOMINAL DISCOMFORT (GI upset), DIARRHOEA (Diarrhea), DISORIENTATION (Loopy), DIZZINESS (Lightheaded) and FATIGUE (Tired and exhausted) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the events unknown.  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 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 start date of the events, a causal relationship cannot be excluded.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Pain, Pyrexia
Clinical narrative: Flu like symptoms; General body aches; Low graded fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (General body aches) and PYREXIA (Low graded fever) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-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 INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (General body aches) and PYREXIA (Low graded fever). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (General body aches) and PYREXIA (Low graded fever) 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 onset date of the reported events, a causal relationship cannot be excluded.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site inflammation, Vaccination site warmth
Clinical narrative: her arm become red, warm and inflamed; her arm become red, warm and inflamed; her arm become red, warm and inflamed; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE INFLAMMATION (her arm become red, warm and inflamed), VACCINATION SITE WARMTH (her arm become red, warm and inflamed) and VACCINATION SITE ERYTHEMA (her arm become red, warm and inflamed) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J202A) 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 08-Jan-2021, the patient experienced VACCINATION SITE INFLAMMATION (her arm become red, warm and inflamed), VACCINATION SITE WARMTH (her arm become red, warm and inflamed) and VACCINATION SITE ERYTHEMA (her arm become red, warm and inflamed). At the time of the report, VACCINATION SITE INFLAMMATION (her arm become red, warm and inflamed), VACCINATION SITE WARMTH (her arm become red, warm and inflamed) and VACCINATION SITE ERYTHEMA (her arm become red, warm and inflamed) 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.; 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: U
Vaccine: COVID19
Symptoms: Paraesthesia oral, Rash
Clinical narrative: This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of RASH (Rash) and PARAESTHESIA ORAL (Tingling on the lip) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced RASH (Rash) and PARAESTHESIA ORAL (Tingling on the lip). At the time of the report, RASH (Rash) and PARAESTHESIA ORAL (Tingling on the lip) 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 relevant concomitant medications were provided.     No treatment information was provided.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Insomnia, Vaccination site bruising, Vaccination site erythema, Vaccination site induration
Clinical narrative: Injection site hot to touch; There was a knot at injection site; Injection site redness; Injection site bruising; Injection site bruising; Freezing; Soreness from the injection/painfully sore; Unable to sleep; A spontaneous report was received from a 75 year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced soreness from the injection site,  bruising,  knot, redness, hot to touch and unable to sleep.   The patient's medical history was not provided. There were no concomitant medications provided.    On 06 Jan 2021, the patient received the first of two planned doses of mRNA-1273 (Lot # 011J20A) intramuscularly, in her left arm, for prophylaxis of COVID-19 infection.   On 06 Jan 2021, the patient experienced the non-serious event of soreness from the injection site, immediately following. On 07 Jan 2021, the injection site was painfully sore and bruised and she was unable to sleep. On 08 Jan 2021 there was a knot at injection site,hot to touch. The patient experienced freezing from the night of vaccination until 08 Jan 2021. There was no treatment information provided.  Action taken with mRNA-1273 in response to the reported events was not reported.  The event of freezing was resolved after on 08 Jan 20201. The outcome for the reported events of soreness from the injection site, injection site bruising, unable to sleep, there was a knot at injection site, injection site redness, and injection site hot to touch, was unknown at the time of this report.; 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: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site warmth
Clinical narrative: Injection site hot to touch; There was a knot at injection site; Injection site redness; Injection site bruising; Injection site bruising; Freezing; Soreness from the injection/painfully sore; Unable to sleep; A spontaneous report was received from a 75 year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced soreness from the injection site,  bruising,  knot, redness, hot to touch and unable to sleep.   The patient's medical history was not provided. There were no concomitant medications provided.    On 06 Jan 2021, the patient received the first of two planned doses of mRNA-1273 (Lot # 011J20A) intramuscularly, in her left arm, for prophylaxis of COVID-19 infection.   On 06 Jan 2021, the patient experienced the non-serious event of soreness from the injection site, immediately following. On 07 Jan 2021, the injection site was painfully sore and bruised and she was unable to sleep. On 08 Jan 2021 there was a knot at injection site,hot to touch. The patient experienced freezing from the night of vaccination until 08 Jan 2021. There was no treatment information provided.  Action taken with mRNA-1273 in response to the reported events was not reported.  The event of freezing was resolved after on 08 Jan 20201. The outcome for the reported events of soreness from the injection site, injection site bruising, unable to sleep, there was a knot at injection site, injection site redness, and injection site hot to touch, was unknown at the time of this report.; 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: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bone pain, Chest discomfort, Chills, Cough
Clinical narrative: Dry Cough; Chills; bone and joint pain in hip and shoulder area; bone and joint pain in hip and shoulder area; Fatigue; Headache; Chest heaviness; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Chest heaviness), COUGH (Dry Cough), CHILLS (Chills), BONE PAIN (bone and joint pain in hip and shoulder area) and ARTHRALGIA (bone and joint pain in hip and shoulder area) in a 39-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 event (No adverse event).    On 04-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced CHEST DISCOMFORT (Chest heaviness), CHILLS (Chills), BONE PAIN (bone and joint pain in hip and shoulder area), ARTHRALGIA (bone and joint pain in hip and shoulder area), FATIGUE (Fatigue) and HEADACHE (Headache). On 07-Jan-2021, the patient experienced COUGH (Dry Cough). At the time of the report, CHEST DISCOMFORT (Chest heaviness), COUGH (Dry Cough), CHILLS (Chills), BONE PAIN (bone and joint pain in hip and shoulder area), ARTHRALGIA (bone and joint pain in hip and shoulder area), FATIGUE (Fatigue) and HEADACHE (Headache) 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.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Dry Cough; Chills; bone and joint pain in hip and shoulder area; bone and joint pain in hip and shoulder area; Fatigue; Headache; Chest heaviness; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Chest heaviness), COUGH (Dry Cough), CHILLS (Chills), BONE PAIN (bone and joint pain in hip and shoulder area) and ARTHRALGIA (bone and joint pain in hip and shoulder area) in a 39-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 event (No adverse event).    On 04-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced CHEST DISCOMFORT (Chest heaviness), CHILLS (Chills), BONE PAIN (bone and joint pain in hip and shoulder area), ARTHRALGIA (bone and joint pain in hip and shoulder area), FATIGUE (Fatigue) and HEADACHE (Headache). On 07-Jan-2021, the patient experienced COUGH (Dry Cough). At the time of the report, CHEST DISCOMFORT (Chest heaviness), COUGH (Dry Cough), CHILLS (Chills), BONE PAIN (bone and joint pain in hip and shoulder area), ARTHRALGIA (bone and joint pain in hip and shoulder area), FATIGUE (Fatigue) and HEADACHE (Headache) 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.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia, Vaccination site pain
Clinical narrative: Fatigue; Fever; Injection site soreness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), PYREXIA (Fever) and VACCINATION SITE PAIN (Injection site soreness) in a 63-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). Concomitant products included LOSARTAN POTASSIUM for Blood pressure fluctuation.    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 FATIGUE (Fatigue), PYREXIA (Fever) and VACCINATION SITE PAIN (Injection site soreness). On 08-Jan-2021, VACCINATION SITE PAIN (Injection site soreness) had resolved. On 09-Jan-2021, FATIGUE (Fatigue) and PYREXIA (Fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Fatigue and fever that subside after taking a fresh air outside. No treatment information was provided.  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.
Sex: U
Vaccine: COVID19
Symptoms: Hyperhidrosis, Nasopharyngitis, Nausea
Clinical narrative: Diaphoretic; Nauseated; Cold; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of HYPERHIDROSIS (Diaphoretic), NAUSEA (Nauseated) and NASOPHARYNGITIS (Cold) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced HYPERHIDROSIS (Diaphoretic), NAUSEA (Nauseated) and NASOPHARYNGITIS (Cold). At the time of the report, HYPERHIDROSIS (Diaphoretic), NAUSEA (Nauseated) and NASOPHARYNGITIS (Cold) 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.; Sender's Comments: Case is invalid as there is no patient identifier reported
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: Allergic reaction; A spontaneous report was received from a nurse practitioner concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced an allergic reaction.  The patient's medical history was not reported.  Concomitant medication use was not provided.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced an allergic reaction to the vaccine.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, allergic reaction, was not reported.; Reporter's Comments: This case concerns a patient who received their first of two planned doses of mRNA-1273 (Lot unknown), and who experienced the non-serious unlisted event of allergic reaction.  Very limited information regarding this event has been provided at this time. Based on the current available information and temporal association between the use of the product and the onset of the event following vaccination, a causal relationship cannot be excluded and the event is considered possibly related to the vaccine.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Aphthous ulcer, Candida infection, Facial pain, Headache, Influenza like illness
Clinical narrative: nauseous; Random pains in right arm too (not injection site arm); injection site redness; body aches; arm was super itchy; thrush; mouth felt funny; Canker sores; pain in cheeks; pain in legs; swollen arm; arm was super sore; felt fluish; Feeling off; headache; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of CANDIDA INFECTION (thrush), PARAESTHESIA ORAL (mouth felt funny), APHTHOUS ULCER (Canker sores), FACIAL PAIN (pain in cheeks) and PAIN IN EXTREMITY (pain in legs) in a 40-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.     The patient's past medical history included No adverse effect.    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 LIMB DISCOMFORT (arm was super sore), INFLUENZA LIKE ILLNESS (felt fluish), MALAISE (Feeling off) and HEADACHE (headache). On 06-Jan-2021, the patient experienced CANDIDA INFECTION (thrush), PARAESTHESIA ORAL (mouth felt funny), APHTHOUS ULCER (Canker sores), FACIAL PAIN (pain in cheeks), PAIN IN EXTREMITY (pain in legs), PERIPHERAL SWELLING (swollen arm), PRURITUS (arm was super itchy), VACCINATION SITE ERYTHEMA (injection site redness) and MYALGIA (body aches). On 07-Jan-2021, the patient experienced PAIN IN EXTREMITY (Random pains in right arm too (not injection site arm)). On 08-Jan-2021, the patient experienced NAUSEA (nauseous). At the time of the report, CANDIDA INFECTION (thrush), PARAESTHESIA ORAL (mouth felt funny), APHTHOUS ULCER (Canker sores), FACIAL PAIN (pain in cheeks), PAIN IN EXTREMITY (pain in legs), PERIPHERAL SWELLING (swollen arm), LIMB DISCOMFORT (arm was super sore), INFLUENZA LIKE ILLNESS (felt fluish), MALAISE (Feeling off), PRURITUS (arm was super itchy), PAIN IN EXTREMITY (Random pains in right arm too (not injection site arm)), HEADACHE (headache), NAUSEA (nauseous), VACCINATION SITE ERYTHEMA (injection site redness) and MYALGIA (body aches) outcome was unknown. ER visit 07-Jan-2021 details not provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.; 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: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Malaise, Myalgia, Nausea, Pain in extremity
Clinical narrative: nauseous; Random pains in right arm too (not injection site arm); injection site redness; body aches; arm was super itchy; thrush; mouth felt funny; Canker sores; pain in cheeks; pain in legs; swollen arm; arm was super sore; felt fluish; Feeling off; headache; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of CANDIDA INFECTION (thrush), PARAESTHESIA ORAL (mouth felt funny), APHTHOUS ULCER (Canker sores), FACIAL PAIN (pain in cheeks) and PAIN IN EXTREMITY (pain in legs) in a 40-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.     The patient's past medical history included No adverse effect.    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 LIMB DISCOMFORT (arm was super sore), INFLUENZA LIKE ILLNESS (felt fluish), MALAISE (Feeling off) and HEADACHE (headache). On 06-Jan-2021, the patient experienced CANDIDA INFECTION (thrush), PARAESTHESIA ORAL (mouth felt funny), APHTHOUS ULCER (Canker sores), FACIAL PAIN (pain in cheeks), PAIN IN EXTREMITY (pain in legs), PERIPHERAL SWELLING (swollen arm), PRURITUS (arm was super itchy), VACCINATION SITE ERYTHEMA (injection site redness) and MYALGIA (body aches). On 07-Jan-2021, the patient experienced PAIN IN EXTREMITY (Random pains in right arm too (not injection site arm)). On 08-Jan-2021, the patient experienced NAUSEA (nauseous). At the time of the report, CANDIDA INFECTION (thrush), PARAESTHESIA ORAL (mouth felt funny), APHTHOUS ULCER (Canker sores), FACIAL PAIN (pain in cheeks), PAIN IN EXTREMITY (pain in legs), PERIPHERAL SWELLING (swollen arm), LIMB DISCOMFORT (arm was super sore), INFLUENZA LIKE ILLNESS (felt fluish), MALAISE (Feeling off), PRURITUS (arm was super itchy), PAIN IN EXTREMITY (Random pains in right arm too (not injection site arm)), HEADACHE (headache), NAUSEA (nauseous), VACCINATION SITE ERYTHEMA (injection site redness) and MYALGIA (body aches) outcome was unknown. ER visit 07-Jan-2021 details not provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.; 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: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Peripheral swelling, Pruritus, Vaccination site erythema
Clinical narrative: nauseous; Random pains in right arm too (not injection site arm); injection site redness; body aches; arm was super itchy; thrush; mouth felt funny; Canker sores; pain in cheeks; pain in legs; swollen arm; arm was super sore; felt fluish; Feeling off; headache; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of CANDIDA INFECTION (thrush), PARAESTHESIA ORAL (mouth felt funny), APHTHOUS ULCER (Canker sores), FACIAL PAIN (pain in cheeks) and PAIN IN EXTREMITY (pain in legs) in a 40-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.     The patient's past medical history included No adverse effect.    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 LIMB DISCOMFORT (arm was super sore), INFLUENZA LIKE ILLNESS (felt fluish), MALAISE (Feeling off) and HEADACHE (headache). On 06-Jan-2021, the patient experienced CANDIDA INFECTION (thrush), PARAESTHESIA ORAL (mouth felt funny), APHTHOUS ULCER (Canker sores), FACIAL PAIN (pain in cheeks), PAIN IN EXTREMITY (pain in legs), PERIPHERAL SWELLING (swollen arm), PRURITUS (arm was super itchy), VACCINATION SITE ERYTHEMA (injection site redness) and MYALGIA (body aches). On 07-Jan-2021, the patient experienced PAIN IN EXTREMITY (Random pains in right arm too (not injection site arm)). On 08-Jan-2021, the patient experienced NAUSEA (nauseous). At the time of the report, CANDIDA INFECTION (thrush), PARAESTHESIA ORAL (mouth felt funny), APHTHOUS ULCER (Canker sores), FACIAL PAIN (pain in cheeks), PAIN IN EXTREMITY (pain in legs), PERIPHERAL SWELLING (swollen arm), LIMB DISCOMFORT (arm was super sore), INFLUENZA LIKE ILLNESS (felt fluish), MALAISE (Feeling off), PRURITUS (arm was super itchy), PAIN IN EXTREMITY (Random pains in right arm too (not injection site arm)), HEADACHE (headache), NAUSEA (nauseous), VACCINATION SITE ERYTHEMA (injection site redness) and MYALGIA (body aches) outcome was unknown. ER visit 07-Jan-2021 details not provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.; 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: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Nodule, Pruritus
Clinical narrative: Small knots all over the body; Very itchy knots; This spontaneous case was reported by a consumer and describes the occurrence of NODULE (Small knots all over the body) and PRURITUS (Very itchy knots) in a 70-year-old male 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.    On 07-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jan-2021, the patient experienced NODULE (Small knots all over the body) and PRURITUS (Very itchy knots). At the time of the report, NODULE (Small knots all over the body) and PRURITUS (Very itchy knots) 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 for the event included diphenhydramine.; 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: M
Vaccine: COVID19
Symptoms: Allergy to vaccine
Clinical narrative: Experienced a really bad allergic reaction after the vaccination; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (Experienced a really bad allergic reaction after the vaccination) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Shellfish allergy.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ALLERGY TO VACCINE (Experienced a really bad allergic reaction after the vaccination). At the time of the report, ALLERGY TO VACCINE (Experienced a really bad allergic reaction after the vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment details were not 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 event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Tested positive for covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for covid) in a 95-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included Bypass surgery (quadruple bypass surgery). Concurrent medical conditions included Diabetes.    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 COVID-19 (Tested positive for covid). At the time of the report, COVID-19 (Tested positive for covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test positive: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details include he reported that is scheduled to receive the infusion of drug.  Concomitant product use was not provided.; Sender's Comments: This case concerns a 95-year-old male who experienced nonserious unexpected event of COVID-19 based on SARS-CoV-2 test positive.  Event onset occurred with unknown latency after the first dose of mRNA-1273. Planned treatment with infusion of drug. 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: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Anosmia
Clinical narrative: This spontaneous case was reported by a dentist and describes the occurrence of ANOSMIA (Loss of smell) in a 48-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 reported medical history).    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced ANOSMIA (Loss of smell). At the time of the report, ANOSMIA (Loss of smell) 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 relevant concomitant medications were reported.; Reporter's Comments: Based on the information provided, a temporal association between the reported events and administration of mRNA-1273 vaccine, and excluding any other etiology, a causal association cannot be excluded
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Peripheral swelling, Pyrexia, Vaccination site rash
Clinical narrative: Low grade fever; Fatigued; Arm swollen; Rash at the injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Jan-2021 and was forwarded to Moderna on 10-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigued) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. unknown and unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 29-Dec-2020, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (Fatigued). The patient was treated with IBUPROFEN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Low grade fever, at an unspecified dose and frequency. At the time of the report, FATIGUE (Fatigued) outcome was unknown.      Most recent FOLLOW-UP information incorporated above includes: On 05-Feb-2021: Valid information received; 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 pruritus, Vaccination site reaction
Clinical narrative: upper arm started itching; Hard; Injection site red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (upper arm started itching), VACCINATION SITE REACTION (Hard) and VACCINATION SITE ERYTHEMA (Injection site red) in a 64-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. Concomitant products included CEFALEXIN (KEFLEXIN) for an unknown indication.    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 VACCINATION SITE PRURITUS (upper arm started itching), VACCINATION SITE REACTION (Hard) and VACCINATION SITE ERYTHEMA (Injection site red). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) on 08-Jan-2021 for Rash, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (upper arm started itching), VACCINATION SITE REACTION (Hard) and VACCINATION SITE ERYTHEMA (Injection site red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: This case concerns a 64-year-old female who experienced nonserious events of unexpected injection site reaction, injection site pruritus and expected injection site erythema.  Event onset occurred 8 days after the first dose of mRNA-1273. Treated with Keflex. 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: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Vaccination site pain
Clinical narrative: Soreness; Normal pain; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (Soreness) and VACCINATION SITE PAIN (Normal pain) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history was not reported .     On 07-Jan-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced DISCOMFORT (Soreness) and VACCINATION SITE PAIN (Normal pain). At the time of the report, DISCOMFORT (Soreness) and VACCINATION SITE PAIN (Normal pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information 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 event, a causal relationship cannot be excluded.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Limb discomfort, Throat irritation, Vaccination site pain
Clinical narrative: nerve shock sensation on her left arm; numbness on the palm; itchness of the throat; painful left arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LIMB DISCOMFORT (nerve shock sensation on her left arm), HYPOAESTHESIA (numbness on the palm), THROAT IRRITATION (itchness of the throat) and VACCINATION SITE PAIN (painful left arm) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K70A and 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Latex allergy. Concomitant products included OMEPRAZOLE for Gastrointestinal disorder, TRAZODONE for Sleep disorder.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Jan-2021, the patient experienced LIMB DISCOMFORT (nerve shock sensation on her left arm), HYPOAESTHESIA (numbness on the palm), THROAT IRRITATION (itchness of the throat) and VACCINATION SITE PAIN (painful left arm). On 29-Jan-2021, LIMB DISCOMFORT (nerve shock sensation on her left arm), HYPOAESTHESIA (numbness on the palm), THROAT IRRITATION (itchness of the throat) and VACCINATION SITE PAIN (painful left arm) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   treatment include Tylenol 1000mg. Action taken with mRNA-1273 in response to the event was not applicable.    Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: the follow up were received on 15-APR-2021 and include below updated information:-address and occupation were updated.reporter-2(HCP) details were updated.patient weight, height and ethnicity were updated.patient allergic condition were updated.second dose details of moderna vaccine were updated.concomitant medication updated.outcome result updated.; Sender's Comments: This case concerns a 41-year-old female who experienced the nonserious unexpected events of pain in extremity, limb discomfort, hypoesthesia, and throat irritation.  Event onset the same day as the first dose of mRNA-1273. Treatment with acetaminophen. 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.