chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Hypoaesthesia, Myalgia
Clinical narrative: Sore arm; Diarrhea; Ear numbness; Chills; Muscle aches; Pounding headache; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), HYPOAESTHESIA (Ear numbness), CHILLS (Chills), MYALGIA (Muscle aches) and HEADACHE (Pounding headache) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in April 2020.    On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 19-May-2021, the patient experienced DIARRHOEA (Diarrhea), HYPOAESTHESIA (Ear numbness), CHILLS (Chills), MYALGIA (Muscle aches) and HEADACHE (Pounding headache). On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore arm). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form and NAPROXEN (MOTRIN [NAPROXEN]) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, DIARRHOEA (Diarrhea), HYPOAESTHESIA (Ear numbness), CHILLS (Chills), MYALGIA (Muscle aches), HEADACHE (Pounding headache) and VACCINATION SITE PAIN (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant product was reported.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm; Diarrhea; Ear numbness; Chills; Muscle aches; Pounding headache; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), HYPOAESTHESIA (Ear numbness), CHILLS (Chills), MYALGIA (Muscle aches) and HEADACHE (Pounding headache) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in April 2020.    On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 19-May-2021, the patient experienced DIARRHOEA (Diarrhea), HYPOAESTHESIA (Ear numbness), CHILLS (Chills), MYALGIA (Muscle aches) and HEADACHE (Pounding headache). On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore arm). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form and NAPROXEN (MOTRIN [NAPROXEN]) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, DIARRHOEA (Diarrhea), HYPOAESTHESIA (Ear numbness), CHILLS (Chills), MYALGIA (Muscle aches), HEADACHE (Pounding headache) and VACCINATION SITE PAIN (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant product was reported.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Fatigue, Myalgia
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine from expired vial has been administered), MYALGIA (Sore) and FATIGUE (Tiredness) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine from expired vial has been administered), MYALGIA (Sore) and FATIGUE (Tiredness). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccine from expired vial has been administered), MYALGIA (Sore) and FATIGUE (Tiredness) 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 concomitant medications were provided.  No treatment medications were provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-155542, US-MODERNATX, INC.-MOD-2021-155523 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Updated patient demographics,Vaccine facility, updated events sore(Myalgia), tiredness (fatigue).   This case was linked to US-MODERNATX, INC.-MOD-2021-155542, US-MODERNATX, INC.-MOD-2021-155523 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Updated patient demographics,Vaccine facility, updated events sore(Myalgia), tiredness (fatigue).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-155542: US-MODERNATX, INC.-MOD-2021-155523:
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: First dose given below age of 18 (17 year old patient); This spontaneous case was reported by a physician assistant and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (First dose given below age of 18 (17 year old patient)) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (First dose given below age of 18 (17 year old patient)). On 20-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (First dose given below age of 18 (17 year old patient)) 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 concomitant medications were reported. No treatment medications were reported.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Influenza, Vaccination site pain
Clinical narrative: Contracted the flu; Ear ached; Right arm ached; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Contracted the flu), EAR PAIN (Ear ached) and VACCINATION SITE PAIN (Right arm ached) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced EAR PAIN (Ear ached) and VACCINATION SITE PAIN (Right arm ached). On 10-May-2021, the patient experienced INFLUENZA (Contracted the flu). The patient was treated with GUAIFENESIN, PARACETAMOL, PHENYLEPHRINE HYDROCHLORIDE (THERAFLU [GUAIFENESIN;PARACETAMOL;PHENYLEPHRINE HYDROCHLORIDE]) for Flu, at a dose of three pills. On 26-Apr-2021, EAR PAIN (Ear ached) and VACCINATION SITE PAIN (Right arm ached) had resolved. At the time of the report, INFLUENZA (Contracted the flu) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication list was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Treatment information was updated, new events; right arm ached and ear ached were added.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: punctured vial after its been stored for more than 24 hours; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (punctured vial after its been stored for more than 24 hours) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (punctured vial after its been stored for more than 24 hours). On 19-May-2021, EXPIRED PRODUCT ADMINISTERED (punctured vial after its been stored for more than 24 hours) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information were not provided.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Right knee pain after second dose) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Congestive heart failure, Atrial fibrillation and Gout. Concurrent medical conditions included High cholesterol. On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced ARTHRALGIA (Right knee pain after second dose). At the time of the report, ARTHRALGIA (Right knee pain after second dose) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. No treatment information was provided. This case was linked to US-MODERNATX, INC.-MOD-2021-153684, US-MODERNATX, INC.-MOD-2021-153717 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-153684:Same reporter (1st dose case) US-MODERNATX, INC.-MOD-2021-153717:Same reporter (2nd dose case)
Age: 47.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: syringes of vaccine that were pre-drawn yesterday/They were in the refrigerator overnight/a nurse utilized one of those syringes/. This was the recipient's first dose of the vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (syringes of vaccine that were pre-drawn yesterday/They were in the refrigerator overnight/a nurse utilized one of those syringes/. This was the recipient's first dose of the vaccine) in a 47-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (syringes of vaccine that were pre-drawn yesterday/They were in the refrigerator overnight/a nurse utilized one of those syringes/. This was the recipient's first dose of the vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (syringes of vaccine that were pre-drawn yesterday/They were in the refrigerator overnight/a nurse utilized one of those syringes/. This was the recipient's first dose of the vaccine) 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 concomitant medications are provided. treatment to the events not reported.   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: follow up information received on 20-may-2021, it dose not contain any new information.
Age: 54.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine from punctured vial stored more than 12hours.; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine from punctured vial stored more than 12hours.) in a 54-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine from punctured vial stored more than 12hours.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine from punctured vial stored more than 12hours.) 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.   Concomitant medication history not provided. Treatment information was unknown.   This case was linked to US-MODERNATX, INC.-MOD-2021-154927 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-154927:Crosslink
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash
Clinical narrative: Itchy; Rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy) and VACCINATION SITE RASH (Rash) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     Concurrent medical conditions included Acid reflux (esophageal).    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Itchy) and VACCINATION SITE RASH (Rash). At the time of the report, VACCINATION SITE PRURITUS (Itchy) and VACCINATION SITE RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant included acid reflux medication. No treatment provided
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: He has hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (He has hives) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2021, the patient experienced URTICARIA (He has hives). At the time of the report, URTICARIA (He has hives) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drugs and treatment information was reported.   This case was linked to MOD21-092206 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  MOD21-092206:
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Dizziness, Fatigue, Headache, Myalgia
Clinical narrative: right arm was a little achy; Stomach Upset; Dizziness when arising from bed; Headache; Fatigue; Body Aches; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (Dizziness when arising from bed), ABDOMINAL DISCOMFORT (Stomach Upset), VACCINATION SITE PAIN (right arm was a little achy), MYALGIA (Body Aches) and HEADACHE (Headache) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: flu vaccine (she had an immune reaction which included a Headache, Dizziness, Sore Upper Arm and Low sugar for 1 month. The neurologist told her to never get vaccinated again.) in 2014. Past adverse reactions to the above products included Immune complex reaction with flu vaccine.    On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced MYALGIA (Body Aches). On 13-May-2021, the patient experienced DIZZINESS (Dizziness when arising from bed), HEADACHE (Headache) and FATIGUE (Fatigue). On 20-May-2021, the patient experienced ABDOMINAL DISCOMFORT (Stomach Upset). On an unknown date, the patient experienced VACCINATION SITE PAIN (right arm was a little achy). At the time of the report, DIZZINESS (Dizziness when arising from bed), ABDOMINAL DISCOMFORT (Stomach Upset), VACCINATION SITE PAIN (right arm was a little achy), MYALGIA (Body Aches), HEADACHE (Headache) and FATIGUE (Fatigue) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided. No treatment information is provided.  Patient stated that considering the risk of having COVID-19 Disease she consulted with her Primary doctor and they both agreed that she should receive the COVID-19 Vaccine and after receiving the vaccine, at first her right arm was a little achy. As days went by, she had more side effects (on and off). On 20MAY2021, she has a Stomach upset in addition to the other side effects.  She is scheduled to receive the Second dose on 03June2021. Patient stated that she does not want to receive the second dose until these symptoms go away.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: right arm was a little achy; Stomach Upset; Dizziness when arising from bed; Headache; Fatigue; Body Aches; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (Dizziness when arising from bed), ABDOMINAL DISCOMFORT (Stomach Upset), VACCINATION SITE PAIN (right arm was a little achy), MYALGIA (Body Aches) and HEADACHE (Headache) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: flu vaccine (she had an immune reaction which included a Headache, Dizziness, Sore Upper Arm and Low sugar for 1 month. The neurologist told her to never get vaccinated again.) in 2014. Past adverse reactions to the above products included Immune complex reaction with flu vaccine.    On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced MYALGIA (Body Aches). On 13-May-2021, the patient experienced DIZZINESS (Dizziness when arising from bed), HEADACHE (Headache) and FATIGUE (Fatigue). On 20-May-2021, the patient experienced ABDOMINAL DISCOMFORT (Stomach Upset). On an unknown date, the patient experienced VACCINATION SITE PAIN (right arm was a little achy). At the time of the report, DIZZINESS (Dizziness when arising from bed), ABDOMINAL DISCOMFORT (Stomach Upset), VACCINATION SITE PAIN (right arm was a little achy), MYALGIA (Body Aches), HEADACHE (Headache) and FATIGUE (Fatigue) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided. No treatment information is provided.  Patient stated that considering the risk of having COVID-19 Disease she consulted with her Primary doctor and they both agreed that she should receive the COVID-19 Vaccine and after receiving the vaccine, at first her right arm was a little achy. As days went by, she had more side effects (on and off). On 20MAY2021, she has a Stomach upset in addition to the other side effects.  She is scheduled to receive the Second dose on 03June2021. Patient stated that she does not want to receive the second dose until these symptoms go away.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: Lower lip is very swollen; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Lower lip is very swollen) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 18-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2021, the patient experienced LIP SWELLING (Lower lip is very swollen). At the time of the report, LIP SWELLING (Lower lip is very swollen) outcome was unknown.            No concomitant medications were provided. Treatment medications were unknown. Action taken with mRNA-1273 in response to the event was not applicable.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives,Hives are on stomach,Great big red welts; Itching; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives,Hives are on stomach,Great big red welts) and PRURITUS (Itching) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014m20a) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-May-2021, the patient experienced URTICARIA (Hives,Hives are on stomach,Great big red welts) and PRURITUS (Itching). At the time of the report, URTICARIA (Hives,Hives are on stomach,Great big red welts) and PRURITUS (Itching) outcome was unknown.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Have not received second dose; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Have not received second dose) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Have not received second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Have not received second dose) 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 concomitant medication was reported. No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-155187 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-155187:same reporter case
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Chills, Formication, Rash vesicular, Skin burning sensation
Clinical narrative: Chills; feels like animals are crawling on her; blisters; scratches the blisters, they start to burn; scratches the blisters, they start to burn; This spontaneous case was reported by a consumer and describes the occurrence of FORMICATION (feels like animals are crawling on her), BLISTER (blisters), SKIN BURNING SENSATION (scratches the blisters, they start to burn), RASH VESICULAR (scratches the blisters, they start to burn) and CHILLS (Chills) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced FORMICATION (feels like animals are crawling on her), BLISTER (blisters), SKIN BURNING SENSATION (scratches the blisters, they start to burn) and RASH VESICULAR (scratches the blisters, they start to burn). On 16-Feb-2021, the patient experienced CHILLS (Chills). The patient was treated with PREDNISONE at a dose of 1 dosage form and HYDROCORTISONE (topical) at a dose of 2.5 %. At the time of the report, FORMICATION (feels like animals are crawling on her), BLISTER (blisters), SKIN BURNING SENSATION (scratches the blisters, they start to burn), RASH VESICULAR (scratches the blisters, they start to burn) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was provided.   This case was linked to MOD-2021-155006 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) and PRURITUS (Itching on left arm/ progressed to both arms, leg, stomach, face.) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination. Concurrent medical conditions included Acid reflux (oesophageal). On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH (Rash) and PRURITUS (Itching on left arm/ progressed to both arms, leg, stomach, face.). The patient was treated with HYDROCORTISONE for Itching and Rash, at an unspecified dose and frequency. At the time of the report, RASH (Rash) and PRURITUS (Itching on left arm/ progressed to both arms, leg, stomach, face.) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.This case was linked to MOD-2021-154555 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Skin discolouration, Vaccination site induration
Clinical narrative: purple knot on her arm; purple knot on her arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE INDURATION (purple knot on her arm) and SKIN DISCOLOURATION (purple knot on her arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE INDURATION (purple knot on her arm) and SKIN DISCOLOURATION (purple knot on her arm). At the time of the report, VACCINATION SITE INDURATION (purple knot on her arm) and SKIN DISCOLOURATION (purple knot on her arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 001B21A) for COVID-19 vaccination. Concurrent medical conditions included Idiopathic urticaria (Controlled - No changes) since 2019. Concomitant products included LISDEXAMFETAMINE MESILATE (VYVANSE) for ADD, OMALIZUMAB (XOLAIR) for Idiopathic urticaria, OMALIZUMAB for Urticaria. On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced HEADACHE (Headache). The patient was treated with ACETAMINOPHEN for Headache, at a dose of 1 dosage form twice a day. On 07-Apr-2021, HEADACHE (Headache) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The patient reported symptoms started about 1-2 hours after second dosage of Covid 19 vaccine and lasted until evening, Patient took Acetaminophen twice during the headache according to label.  Patient was not concerned as he knew the reported side effects.  Patient did not experience any side effects with the first dosage. Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: On 21-May-2021, follow up document was received: Reporter requested to remove DOB of the patient. On 06-Jul-2021: Significant follow up information received contains events stop date. Medical history, concomitant medication and corrective treatment added. Patient details (Race and Ethnicity) added.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swelling in her lymph node in injection arms/swollen lymph node in neck; This spontaneous case was reported by a patient and describes the occurrence of LYMPHADENOPATHY (swelling in her lymph node in injection arms/swollen lymph node in neck) 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 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (swelling in her lymph node in injection arms/swollen lymph node in neck). At the time of the report, LYMPHADENOPATHY (swelling in her lymph node in injection arms/swollen lymph node in neck) outcome was unknown.            No concomitant medication included.  No treatment medication included.   This case was linked to MOD-2021-154946 (Patient Link).   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Condition aggravated, Diarrhoea, Feeling abnormal, Pyrexia
Clinical narrative: Felling the same symptoms; Fever; Diarrhea; Bellyache; Feeling bad; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 20-May-2021 and was forwarded to Moderna on 21-May-2021.    This spontaneous case was reported by an other and describes the occurrence of DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Bellyache), PYREXIA (Fever), FEELING ABNORMAL (Feeling bad) and CONDITION AGGRAVATED (Felling the same symptoms) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 10-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-May-2021, the patient experienced DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Bellyache), PYREXIA (Fever) and FEELING ABNORMAL (Feeling bad). On 20-May-2021, the patient experienced CONDITION AGGRAVATED (Felling the same symptoms). At the time of the report, DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Bellyache), PYREXIA (Fever), FEELING ABNORMAL (Feeling bad) and CONDITION AGGRAVATED (Felling the same symptoms) outcome was unknown.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Gait disturbance, Headache, Injection site erythema, Limb discomfort
Clinical narrative: Can't walk; Veins varicose in legs; Too much pressure in my legs; Swelling of the legs; Redness from site of injection to the elbow; Redness from site of injection to the elbow; Swelling of the arm; Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Redness from site of injection to the elbow), GAIT DISTURBANCE (Can't walk), VARICOSE VEIN (Veins varicose in legs), LIMB DISCOMFORT (Too much pressure in my legs) and PERIPHERAL SWELLING (Swelling of the arm) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     No medical history provided.  Concomitant products included LEVOTHYROXINE and FLUCONAZOLE (FLUCONAZOL) for an unknown indication.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced PYREXIA (Fever). On 06-May-2021, the patient experienced HEADACHE (Headache). On 08-May-2021, the patient experienced INJECTION SITE ERYTHEMA (Redness from site of injection to the elbow), PERIPHERAL SWELLING (Swelling of the arm) and ERYTHEMA (Redness from site of injection to the elbow). On 14-May-2021, the patient experienced GAIT DISTURBANCE (Can't walk), VARICOSE VEIN (Veins varicose in legs), LIMB DISCOMFORT (Too much pressure in my legs) and PERIPHERAL SWELLING (Swelling of the legs). The patient was treated with IBUPROFEN on 06-May-2021 for Fever, at an unspecified dose and frequency. On 06-May-2021, PYREXIA (Fever) and HEADACHE (Headache) had resolved. At the time of the report, INJECTION SITE ERYTHEMA (Redness from site of injection to the elbow), GAIT DISTURBANCE (Can't walk), VARICOSE VEIN (Veins varicose in legs), LIMB DISCOMFORT (Too much pressure in my legs), PERIPHERAL SWELLING (Swelling of the arm), PERIPHERAL SWELLING (Swelling of the legs) and ERYTHEMA (Redness from site of injection to the elbow) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       patient gave consent to follow-up by safety.   Reporter did not allow further contact
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia, Varicose vein
Clinical narrative: Can't walk; Veins varicose in legs; Too much pressure in my legs; Swelling of the legs; Redness from site of injection to the elbow; Redness from site of injection to the elbow; Swelling of the arm; Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Redness from site of injection to the elbow), GAIT DISTURBANCE (Can't walk), VARICOSE VEIN (Veins varicose in legs), LIMB DISCOMFORT (Too much pressure in my legs) and PERIPHERAL SWELLING (Swelling of the arm) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     No medical history provided.  Concomitant products included LEVOTHYROXINE and FLUCONAZOLE (FLUCONAZOL) for an unknown indication.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced PYREXIA (Fever). On 06-May-2021, the patient experienced HEADACHE (Headache). On 08-May-2021, the patient experienced INJECTION SITE ERYTHEMA (Redness from site of injection to the elbow), PERIPHERAL SWELLING (Swelling of the arm) and ERYTHEMA (Redness from site of injection to the elbow). On 14-May-2021, the patient experienced GAIT DISTURBANCE (Can't walk), VARICOSE VEIN (Veins varicose in legs), LIMB DISCOMFORT (Too much pressure in my legs) and PERIPHERAL SWELLING (Swelling of the legs). The patient was treated with IBUPROFEN on 06-May-2021 for Fever, at an unspecified dose and frequency. On 06-May-2021, PYREXIA (Fever) and HEADACHE (Headache) had resolved. At the time of the report, INJECTION SITE ERYTHEMA (Redness from site of injection to the elbow), GAIT DISTURBANCE (Can't walk), VARICOSE VEIN (Veins varicose in legs), LIMB DISCOMFORT (Too much pressure in my legs), PERIPHERAL SWELLING (Swelling of the arm), PERIPHERAL SWELLING (Swelling of the legs) and ERYTHEMA (Redness from site of injection to the elbow) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       patient gave consent to follow-up by safety.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient have not received second dose of Moderna Covid 19 vaccice 49 days after first.; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient have not received second dose of Moderna Covid 19 vaccice 49 days after first.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient have not received second dose of Moderna Covid 19 vaccice 49 days after first.). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient have not received second dose of Moderna Covid 19 vaccice 49 days after first.) 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 Concomitant Medication was provided. No treatment  was provided.  Reporter  called on 20May2021 and reported that a male patient was currently at their clinic to receive the second dose of Moderna Covid -19 vaccine, but it has been 49 days since patient  got the first dose. . First dose was received on 1April2021.  It was unspecified if the patient was given the 2nd dose.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Gait disturbance, Influenza like illness, Tendonitis, Vaccination site pain
Clinical narrative: severe bilateral Achilles tendinitis; could barely walk down the steps; pain in arm; tired; felt flu-ish; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (felt flu-ish), TENDONITIS (severe bilateral Achilles tendinitis), GAIT DISTURBANCE (could barely walk down the steps), VACCINATION SITE PAIN (pain in arm) and FATIGUE (tired) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (felt flu-ish), VACCINATION SITE PAIN (pain in arm) and FATIGUE (tired). On 20-Apr-2021, the patient experienced TENDONITIS (severe bilateral Achilles tendinitis) and GAIT DISTURBANCE (could barely walk down the steps). On 10-Apr-2021, INFLUENZA LIKE ILLNESS (felt flu-ish), VACCINATION SITE PAIN (pain in arm) and FATIGUE (tired) had resolved. At the time of the report, TENDONITIS (severe bilateral Achilles tendinitis) and GAIT DISTURBANCE (could barely walk down the steps) outcome was unknown.            Concomitant medication included Birth control pills. No treatment medications were provided.  Patient reported on 20-May-2021 she received first dose of Moderna vaccine on 8-Apr-2021 in left arm from a local county health department, patient did not know the name. Patient reported she had for approximately 2 nights, pain in arm, tired and felt flu-ish. Patient stated on 20-Apr-2021, she had severe bilateral Achilles tendinitis, she states she could barely walk down the steps. Patient states she did receive the second dose. Patient stated her tendinitis has improved, but has not been completely resolved. Patient has treated symptoms with Ibuprofen. Patient consent to Safety follow via email.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Pain in extremity, Rash pruritic
Clinical narrative: Itchy rash on hand, stomach, and leg which lasted for about an hour; Patient did not receive second dose; Pain in extremity; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itchy rash on hand, stomach, and leg which lasted for about an hour.), OFF LABEL USE (Patient did not receive second dose) and VACCINATION SITE PAIN (sorearm) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to vaccine.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH PRURITIC (Itchy rash on hand, stomach, and leg which lasted for about an hour.), OFF LABEL USE (Patient did not receive second dose) and VACCINATION SITE PAIN (sorearm). At the time of the report, RASH PRURITIC (Itchy rash on hand, stomach, and leg which lasted for about an hour.), OFF LABEL USE (Patient did not receive second dose) and VACCINATION SITE PAIN (sorearm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided No treatment was reported  The consumer reported that, had not received the second vaccine because the company advised to do so.   Most recent FOLLOW-UP information incorporated above includes: On 17-Jul-2021: Non significant FU, narrative updated
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Injection site erythema, Pain in extremity
Clinical narrative: Sore arm; Redness at injection site that lasted for a while; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and INJECTION SITE ERYTHEMA (Redness at injection site that lasted for a while) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     Concurrent medical conditions included Cancer (Cancer Remission). Concomitant products included APIXABAN (ELIQUIS), DILTIAZEM, FEXOFENADINE HYDROCHLORIDE (ALLEGRA), ASCORBIC ACID, BETACAROTENE, CUPRIC OXIDE, TOCOPHERYL ACETATE, ZINC OXIDE (PRESERVISION) and TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA) for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and INJECTION SITE ERYTHEMA (Redness at injection site that lasted for a while). At the time of the report, PAIN IN EXTREMITY (Sore arm) and INJECTION SITE ERYTHEMA (Redness at injection site that lasted for a while) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: negative (Negative) negative.         Concomitant : Nasal Spray   This case was linked to MOD21-092635, MOD21-092634 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Oral discomfort
Clinical narrative: Hardening of lip filler after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of ORAL DISCOMFORT (Hardening of lip filler after 2nd dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 ORAL DISCOMFORT (Hardening of lip filler after 2nd dose). At the time of the report, ORAL DISCOMFORT (Hardening of lip filler after 2nd dose) outcome was unknown.            Concomitant product use was not provided by the reporter.  Action taken with mRNA-1273 in response to the events was not applicable.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: tested positive to Covid virus after 1st shot of the Moderna Covid-19 Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive to Covid virus after 1st shot of the Moderna Covid-19 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 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 SARS-COV-2 TEST POSITIVE (tested positive to Covid virus after 1st shot of the Moderna Covid-19 Vaccine). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive to Covid virus after 1st shot of the Moderna Covid-19 Vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment information was provided by the reporter
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site haemorrhage, Vaccination site swelling, Vision blurred
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE HAEMORRHAGE (While administering the vaccine,little blood came out within a minute), VISION BLURRED (eyes got blurry) and VACCINATION SITE SWELLING (arm started swelling up immediately/ swelling is smaller than a golf ball but about the size of a jumbo lemon) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036C21A and 002C21A) for COVID-19 vaccination. No Medical History information was reported. On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-May-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (While administering the vaccine,little blood came out within a minute), VISION BLURRED (eyes got blurry) and VACCINATION SITE SWELLING (arm started swelling up immediately/ swelling is smaller than a golf ball but about the size of a jumbo lemon). At the time of the report, VACCINATION SITE HAEMORRHAGE (While administering the vaccine,little blood came out within a minute), VISION BLURRED (eyes got blurry) and VACCINATION SITE SWELLING (arm started swelling up immediately/ swelling is smaller than a golf ball but about the size of a jumbo lemon) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.