chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, COVID-19, Pyrexia
Clinical narrative: Fever; Tested positive to Covid 19; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Tested positive to Covid 19) and PYREXIA (Fever) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2020, the patient experienced COVID-19 (Tested positive to Covid 19). On 29-Dec-2020, the patient experienced PYREXIA (Fever). At the time of the report, COVID-19 (Tested positive to Covid 19) outcome was unknown and PYREXIA (Fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature increased (102-Unknown degree Celsius): 102 degree Celsius (High) Patient developed fever of 102ºC. On an unknown date, COVID-19: 05-jan-2021 (Positive) Patient tested positive to COVID 19 on 05-JAN-2021.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Heart rate, Heart rate increased, Lymphadenopathy
Clinical narrative: Hives; palpitations; swelling lymphnodes; chills; vomiting; heart beating fast; Nausea; Swelling; Soreness around injection site; Redness around injection site; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling), HEART RATE INCREASED (heart beating fast), URTICARIA (Hives), PALPITATIONS (palpitations) and VOMITING (vomiting) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hives, Penicillin allergy since 1992, Allergy to antibiotic since 2014 and Environmental allergy (Acute hives or rashes all over the body) since 1988. Concomitant products included LORATADINE (CLARITIN HIVES RELIEF) for Hives.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness around injection site) and VACCINATION SITE PAIN (Soreness around injection site). On 06-Jan-2021, the patient experienced SWELLING (Swelling). On 16-Jan-2021, the patient experienced HEART RATE INCREASED (heart beating fast), VOMITING (vomiting) and NAUSEA (Nausea). On an unknown date, the patient experienced URTICARIA (Hives), PALPITATIONS (palpitations), LYMPHADENOPATHY (swelling lymphnodes) and CHILLS (chills). The patient was treated with CAMPHOR, DIPHENHYDRAMINE HYDROCHLORIDE, ZINC OXIDE (BENADRYL SKIN ALLERGY RELIEF) from 06-Jan-2021 to 15-Jan-2021 for Swelling, at a dose of 1 dosage form once a day; CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) (oral) from 29-Jan-2021 to 30-Jan-2021 for Swelling, at a dose of daily and PARACETAMOL (TYLENOL) (oral) from 29-Jan-2021 to 30-Jan-2021 for Adverse event, at a dose of 4 doses within 24 h. On 03-Jan-2021, VACCINATION SITE ERYTHEMA (Redness around injection site) and VACCINATION SITE PAIN (Soreness around injection site) had resolved. On 15-Jan-2021, SWELLING (Swelling) had resolved. On 16-Jan-2021, HEART RATE INCREASED (heart beating fast), VOMITING (vomiting) and NAUSEA (Nausea) had resolved. At the time of the report, URTICARIA (Hives), PALPITATIONS (palpitations), LYMPHADENOPATHY (swelling lymphnodes) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jan-2021, Body temperature: 38.5 degree Celsius (High) 38.5. On 29-Jan-2021, Heart rate: 98 (High) 98. On 30-Jan-2021, Body temperature: 38.5 degree Celsius (High) 38.5. On 30-Jan-2021, Heart rate: 98 (High) 98.         This case was linked to MOD-2021-019963 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Follow-up information received on 04-Jun-2021: Some events were updated, Treatment information added.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Palpitations, Swelling, Urticaria, Vaccination site erythema
Clinical narrative: Hives; palpitations; swelling lymphnodes; chills; vomiting; heart beating fast; Nausea; Swelling; Soreness around injection site; Redness around injection site; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling), HEART RATE INCREASED (heart beating fast), URTICARIA (Hives), PALPITATIONS (palpitations) and VOMITING (vomiting) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hives, Penicillin allergy since 1992, Allergy to antibiotic since 2014 and Environmental allergy (Acute hives or rashes all over the body) since 1988. Concomitant products included LORATADINE (CLARITIN HIVES RELIEF) for Hives.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness around injection site) and VACCINATION SITE PAIN (Soreness around injection site). On 06-Jan-2021, the patient experienced SWELLING (Swelling). On 16-Jan-2021, the patient experienced HEART RATE INCREASED (heart beating fast), VOMITING (vomiting) and NAUSEA (Nausea). On an unknown date, the patient experienced URTICARIA (Hives), PALPITATIONS (palpitations), LYMPHADENOPATHY (swelling lymphnodes) and CHILLS (chills). The patient was treated with CAMPHOR, DIPHENHYDRAMINE HYDROCHLORIDE, ZINC OXIDE (BENADRYL SKIN ALLERGY RELIEF) from 06-Jan-2021 to 15-Jan-2021 for Swelling, at a dose of 1 dosage form once a day; CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) (oral) from 29-Jan-2021 to 30-Jan-2021 for Swelling, at a dose of daily and PARACETAMOL (TYLENOL) (oral) from 29-Jan-2021 to 30-Jan-2021 for Adverse event, at a dose of 4 doses within 24 h. On 03-Jan-2021, VACCINATION SITE ERYTHEMA (Redness around injection site) and VACCINATION SITE PAIN (Soreness around injection site) had resolved. On 15-Jan-2021, SWELLING (Swelling) had resolved. On 16-Jan-2021, HEART RATE INCREASED (heart beating fast), VOMITING (vomiting) and NAUSEA (Nausea) had resolved. At the time of the report, URTICARIA (Hives), PALPITATIONS (palpitations), LYMPHADENOPATHY (swelling lymphnodes) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jan-2021, Body temperature: 38.5 degree Celsius (High) 38.5. On 29-Jan-2021, Heart rate: 98 (High) 98. On 30-Jan-2021, Body temperature: 38.5 degree Celsius (High) 38.5. On 30-Jan-2021, Heart rate: 98 (High) 98.         This case was linked to MOD-2021-019963 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Follow-up information received on 04-Jun-2021: Some events were updated, Treatment information added.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vomiting
Clinical narrative: Hives; palpitations; swelling lymphnodes; chills; vomiting; heart beating fast; Nausea; Swelling; Soreness around injection site; Redness around injection site; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling), HEART RATE INCREASED (heart beating fast), URTICARIA (Hives), PALPITATIONS (palpitations) and VOMITING (vomiting) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hives, Penicillin allergy since 1992, Allergy to antibiotic since 2014 and Environmental allergy (Acute hives or rashes all over the body) since 1988. Concomitant products included LORATADINE (CLARITIN HIVES RELIEF) for Hives.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness around injection site) and VACCINATION SITE PAIN (Soreness around injection site). On 06-Jan-2021, the patient experienced SWELLING (Swelling). On 16-Jan-2021, the patient experienced HEART RATE INCREASED (heart beating fast), VOMITING (vomiting) and NAUSEA (Nausea). On an unknown date, the patient experienced URTICARIA (Hives), PALPITATIONS (palpitations), LYMPHADENOPATHY (swelling lymphnodes) and CHILLS (chills). The patient was treated with CAMPHOR, DIPHENHYDRAMINE HYDROCHLORIDE, ZINC OXIDE (BENADRYL SKIN ALLERGY RELIEF) from 06-Jan-2021 to 15-Jan-2021 for Swelling, at a dose of 1 dosage form once a day; CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) (oral) from 29-Jan-2021 to 30-Jan-2021 for Swelling, at a dose of daily and PARACETAMOL (TYLENOL) (oral) from 29-Jan-2021 to 30-Jan-2021 for Adverse event, at a dose of 4 doses within 24 h. On 03-Jan-2021, VACCINATION SITE ERYTHEMA (Redness around injection site) and VACCINATION SITE PAIN (Soreness around injection site) had resolved. On 15-Jan-2021, SWELLING (Swelling) had resolved. On 16-Jan-2021, HEART RATE INCREASED (heart beating fast), VOMITING (vomiting) and NAUSEA (Nausea) had resolved. At the time of the report, URTICARIA (Hives), PALPITATIONS (palpitations), LYMPHADENOPATHY (swelling lymphnodes) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jan-2021, Body temperature: 38.5 degree Celsius (High) 38.5. On 29-Jan-2021, Heart rate: 98 (High) 98. On 30-Jan-2021, Body temperature: 38.5 degree Celsius (High) 38.5. On 30-Jan-2021, Heart rate: 98 (High) 98.         This case was linked to MOD-2021-019963 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Follow-up information received on 04-Jun-2021: Some events were updated, Treatment information added.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure abnormal, Dizziness, Heart rate increased, Injection site pain, Vertigo
Clinical narrative: Dizziness; Sporadic increase and decrease in blood pressure; Sporadic rapid heart rate; Vertigo; Arm was sore; A spontaneous report was received from a consumer concerning a 61years old female patient .  The patient got the first Moderna COVID-19 vaccination on Wednesday 13-Jan-2021 in her left deltoid muscle at Hospital. Her arm was sore for the first 24 hours and then went away.   The patient's medical history was not provided  On 16-Jan--2021 she started to experience dizziness, sporadic increase and decrease in blood pressure, sporadic rapid heart rate and vertigo. She has been laying down because when she gets up she cant walk from her vertigo. She has a background in speech and hearing so she did some exercises because she thought it might be an imbalance in her ear but they didn't help so she figured it must be from the Moderna COVID-19 vaccine. Today she noticed a red welt on the injection site that is bigger than a silver dollar. She wanted to know what she should do because the vertigo concerns her.  Consent for safety to follow-up with her- Yes, she prefers cell phone over email.  Consent for safety to follow-up with her healthcare provider- Yes YNS21Jan2021; Reporter's Comments: This case concerns a 61-year old female patient who experienced non-serious events of dizziness, injection site pain, blood pressure abnormal, heart rate increased, and vertigo within 4 days of the mRNA-1273 vaccine administration. 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: Headache, Nausea, Pyrexia
Clinical narrative: Severe headache; Nausea; High fever; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of HEADACHE (Severe headache), NAUSEA (Nausea) and PYREXIA (High fever) 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 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced HEADACHE (Severe headache), NAUSEA (Nausea) and PYREXIA (High fever). At the time of the report, HEADACHE (Severe headache), NAUSEA (Nausea) and PYREXIA (High fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not 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.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: 16 years old received 1 dose; A spontaneous report () was received from a healthcare professional, concerning a 16-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) first dose inadvertently at 16 year old.  The patient medical history was not provided, no concomitant medications were reported.  On 4 Jan 2021 the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  It was reported the parents want their 16-year-old female daughter to received their second dose of the vaccine dose, but nobody is willing to give her the second shot. The reporter reported her patient is doing fine.   No treatment medication was reported.  Action taken with mRNA-1273 in response to the events was not reported.  The event patient 16 years old received 1 dose was considered resolved on 4 Jan 2021.; Reporter's Comments: This report refers to a case of intentional administration of vaccine to a 16-year-old female patient with no associated adverse events. Causality for the event is not applicable.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pain, Palpitations
Clinical narrative: A spontaneous report was received from a consumer concerning a 30-year-old, female patient who experienced dizziness, pain and palpiations.   Patient's medical history was not provided. Concomitant medications known to have been used by the patient, within two weeks prior to the event, included vitamins.  On 05 JAN 2021, prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 (lot number: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 6th JAN 2021, the patient reported dizziness, body pain with high palpitations.  Treatments of the events were not provided.  Action taken with mRNA-1273 was not reported.  The outcome of the events, dizziness and body pain with high palpitation was resolving.; 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: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Muscle twitching, Vaccination site erythema, Vaccination site induration, Vaccination site pain
Clinical narrative: Warm to touch; Hard shaped; Big red spot at injection site; Muscle shaking from knee t upper head; Felt weaken; Muscle soreness that extended trough left arm; This spontaneous case was reported by an other health care professional and describes the occurrence of MUSCLE TWITCHING (Muscle shaking from knee t upper head), ASTHENIA (Felt weaken), VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE INDURATION (Hard shaped) and VACCINATION SITE PAIN (Muscle soreness that extended trough left arm) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011320A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Anal dilation procedure. Concurrent medical conditions included Allergy to nuts, Drug allergy (allergic to cipro, morphine and ibuprofen products.) and Ulcerative colitis. Concomitant products included LORATADINE (ALLERCLEAR) for Allergy, RAMIPRIL for Blood pressure management, VITAMIN D NOS for an unknown indication.   On 06-Jan-2021 at 12:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION SITE PAIN (Muscle soreness that extended trough left arm). On 09-Jan-2021, the patient experienced MUSCLE TWITCHING (Muscle shaking from knee t upper head) and ASTHENIA (Felt weaken). On 14-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE INDURATION (Hard shaped) and VACCINATION SITE ERYTHEMA (Big red spot at injection site). On 08-Jan-2021, VACCINATION SITE PAIN (Muscle soreness that extended trough left arm) had resolved. On 10-Jan-2021, MUSCLE TWITCHING (Muscle shaking from knee t upper head) and ASTHENIA (Felt weaken) had resolved. At the time of the report, VACCINATION SITE WARMTH (Warm to touch) and VACCINATION SITE INDURATION (Hard shaped) had resolved and VACCINATION SITE ERYTHEMA (Big red spot at injection site) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MUSCLE TWITCHING (Muscle shaking from knee t upper head), ASTHENIA (Felt weaken), VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE INDURATION (Hard shaped), VACCINATION SITE PAIN (Muscle soreness that extended trough left arm) and VACCINATION SITE ERYTHEMA (Big red spot at injection site) to be possibly related.    This case was linked to MOD-2021-075517 (E2B Linked Report). This case was linked to MOD-2021-075536, MOD-2021-075536 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: Medical history, concomitant medications, suspect product details, event details and reporter causality was updated.; Sender's Comments:  MOD-2021-075517:Reporter's mother case
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Warm to touch; Hard shaped; Big red spot at injection site; Muscle shaking from knee t upper head; Felt weaken; Muscle soreness that extended trough left arm; This spontaneous case was reported by an other health care professional and describes the occurrence of MUSCLE TWITCHING (Muscle shaking from knee t upper head), ASTHENIA (Felt weaken), VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE INDURATION (Hard shaped) and VACCINATION SITE PAIN (Muscle soreness that extended trough left arm) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011320A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Anal dilation procedure. Concurrent medical conditions included Allergy to nuts, Drug allergy (allergic to cipro, morphine and ibuprofen products.) and Ulcerative colitis. Concomitant products included LORATADINE (ALLERCLEAR) for Allergy, RAMIPRIL for Blood pressure management, VITAMIN D NOS for an unknown indication.   On 06-Jan-2021 at 12:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION SITE PAIN (Muscle soreness that extended trough left arm). On 09-Jan-2021, the patient experienced MUSCLE TWITCHING (Muscle shaking from knee t upper head) and ASTHENIA (Felt weaken). On 14-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE INDURATION (Hard shaped) and VACCINATION SITE ERYTHEMA (Big red spot at injection site). On 08-Jan-2021, VACCINATION SITE PAIN (Muscle soreness that extended trough left arm) had resolved. On 10-Jan-2021, MUSCLE TWITCHING (Muscle shaking from knee t upper head) and ASTHENIA (Felt weaken) had resolved. At the time of the report, VACCINATION SITE WARMTH (Warm to touch) and VACCINATION SITE INDURATION (Hard shaped) had resolved and VACCINATION SITE ERYTHEMA (Big red spot at injection site) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MUSCLE TWITCHING (Muscle shaking from knee t upper head), ASTHENIA (Felt weaken), VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE INDURATION (Hard shaped), VACCINATION SITE PAIN (Muscle soreness that extended trough left arm) and VACCINATION SITE ERYTHEMA (Big red spot at injection site) to be possibly related.    This case was linked to MOD-2021-075517 (E2B Linked Report). This case was linked to MOD-2021-075536, MOD-2021-075536 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: Medical history, concomitant medications, suspect product details, event details and reporter causality was updated.; Sender's Comments:  MOD-2021-075517:Reporter's mother case
Age: 33.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Exposure via breast milk
Clinical narrative: Vaccine exposure during breastfeeding; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of EXPOSURE VIA BREAST MILK (Vaccine exposure during breastfeeding) in a 34-year-old female adult exposed to mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) , while the mother received the product for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the mother received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the adult was diagnosed with EXPOSURE VIA BREAST MILK (Vaccine exposure during breastfeeding). The Adult was exposed to mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.         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 was not reported. The treatment medication was included Prenatal vitamins.; Sender's Comments: This is a case of product exposure during breastfeeding with no associated AEs. Patient will continue to be contacted for further monitoring of AEs.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: positive test for COVID-19; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of COVID-19 (positive test for COVID-19) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 immunisation.     Concomitant products included ESTRADIOL (ESTROGEN), CITALOPRAM, MONTELUKAST SODIUM (SINGULAIR), SALBUTAMOL (ALBUTEROL HFA) and BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2021, the patient experienced COVID-19 (positive test for COVID-19). At the time of the report, COVID-19 (positive test for COVID-19) outcome was unknown. Not Provided      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: Based on reporter's causality the event is assessed as unlikely related to mRNA-1273.
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: runny nose; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (runny nose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2021, the patient experienced RHINORRHOEA (runny nose). At the time of the report, RHINORRHOEA (runny nose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling
Clinical narrative: swollen; extremely itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swollen) and VACCINATION SITE PRURITUS (extremely itchy) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     Concurrent medical conditions included No adverse event (No reported medical history).    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 22-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE SWELLING (swollen) and VACCINATION SITE PRURITUS (extremely itchy). At the time of the report, VACCINATION SITE SWELLING (swollen) and VACCINATION SITE PRURITUS (extremely itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.  Based on the current available information and the temporal association between the product use and the start date of the evens a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the evens a causal relationship cannot be excluded.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Maternal exposure during pregnancy, Myalgia, Pregnancy test, Ultrasound scan
Clinical narrative: Pregnant; Sore arm; Tiredness; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant), MYALGIA (Sore arm) and FATIGUE (Tiredness) in a 35-year-old female patient (gravida 3, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     The patient's past medical history included Live birth on 18-Aug-2018 and Miscarriage in May 2020. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 08-Feb-2021 to an unknown date and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 01-Sep-2020 and the estimated date of delivery was 01-Jun-2021. On 08-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant), MYALGIA (Sore arm) and FATIGUE (Tiredness). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-third week of the pregnancy.  On 08-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved. On 10-Feb-2021, MYALGIA (Sore arm) and FATIGUE (Tiredness) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Sep-2020, Pregnancy test: positive (Positive) Positive. On 28-Sep-2020, Ultrasound scan:. On 14-Jan-2021, Ultrasound scan: normal (normal) 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.   Since, an unknown date in 2003, Factor V laiden was also reported as maternal concurrent condition. No treatment information provided. Estimated date of conception was on 11-SEP-2020 The patient did not have any complications or acute illnesses during this pregnancy to date DIAGNOSTIC RESULTS  On 30OCT-2020: Prenatal panel screen: Normal On 31-DEC-2020: (ACOG) Prenatal genetic screen for 2nd trimester: Normal
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm pain; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (arm pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 23-Jan-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. In January 2021, the patient experienced PAIN IN EXTREMITY (arm pain). At the time of the report, PAIN IN EXTREMITY (arm pain) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: arm is very red; is very raised in a circle about maybe a 3 inch by 4 inch area; itchy; This spontaneous case was reported by a  and describes the occurrence of VACCINATION SITE ERYTHEMA (arm is very red), VACCINATION SITE SWELLING (is very raised in a circle about maybe a 3 inch by 4 inch area) and VACCINATION SITE PRURITUS (itchy) 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 13-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 22-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (arm is very red), VACCINATION SITE SWELLING (is very raised in a circle about maybe a 3 inch by 4 inch area) and VACCINATION SITE PRURITUS (itchy). The patient was treated with CORTISONE at a dose of unknown. At the time of the report, VACCINATION SITE ERYTHEMA (arm is very red) and VACCINATION SITE SWELLING (is very raised in a circle about maybe a 3 inch by 4 inch area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain
Clinical narrative: Sore Arm- same side of injection site; This spontaneous case was reported by a physician and describes the occurrence of AXILLARY PAIN (Sore Arm- same side of injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced AXILLARY PAIN (Sore Arm- same side of injection site). At the time of the report, AXILLARY PAIN (Sore Arm- same side of injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: developed shingles after vaccination; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (developed shingles after vaccination) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced HERPES ZOSTER (developed shingles after vaccination). At the time of the report, HERPES ZOSTER (developed shingles after vaccination) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore on her left arm at site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore on her left arm at site of injection) in a 79-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 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore on her left arm at site of injection). At the time of the report, VACCINATION SITE PAIN (sore on her left arm at site of injection) 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 information was provided. No treatment medication information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: NNI: Fax number of HCP updated.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Injection site erythema, Injection site inflammation, Injection site pain, Injection site swelling
Clinical narrative: bump on arm; bump on arm and it was hurting; arm hot; arm hurting-same side of injection; left arm - Vaccination site sore; Red at injection site; swollen at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE INFLAMMATION (bump on arm and it was hurting), VACCINATION SITE WARMTH (arm hot), VACCINATION SITE INDURATION (bump on arm), INJECTION SITE PAIN (left arm - Vaccination site sore) and INJECTION SITE ERYTHEMA (Red at injection site) in a 70-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.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced INJECTION SITE PAIN (left arm - Vaccination site sore), INJECTION SITE ERYTHEMA (Red at injection site) and INJECTION SITE SWELLING (swollen at injection site). On 17-Jan-2021, the patient experienced VACCINATION SITE WARMTH (arm hot) and AXILLARY PAIN (arm hurting-same side of injection). On 23-Jan-2021, the patient experienced INJECTION SITE INFLAMMATION (bump on arm and it was hurting) and VACCINATION SITE INDURATION (bump on arm). On 25-Jan-2021, INJECTION SITE INFLAMMATION (bump on arm and it was hurting), VACCINATION SITE WARMTH (arm hot), VACCINATION SITE INDURATION (bump on arm), INJECTION SITE PAIN (left arm - Vaccination site sore), INJECTION SITE ERYTHEMA (Red at injection site), INJECTION SITE SWELLING (swollen at injection site) and AXILLARY PAIN (arm hurting-same side of injection) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.; Sender's Comments: Based on the current available information and 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: F
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site warmth
Clinical narrative: bump on arm; bump on arm and it was hurting; arm hot; arm hurting-same side of injection; left arm - Vaccination site sore; Red at injection site; swollen at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE INFLAMMATION (bump on arm and it was hurting), VACCINATION SITE WARMTH (arm hot), VACCINATION SITE INDURATION (bump on arm), INJECTION SITE PAIN (left arm - Vaccination site sore) and INJECTION SITE ERYTHEMA (Red at injection site) in a 70-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.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced INJECTION SITE PAIN (left arm - Vaccination site sore), INJECTION SITE ERYTHEMA (Red at injection site) and INJECTION SITE SWELLING (swollen at injection site). On 17-Jan-2021, the patient experienced VACCINATION SITE WARMTH (arm hot) and AXILLARY PAIN (arm hurting-same side of injection). On 23-Jan-2021, the patient experienced INJECTION SITE INFLAMMATION (bump on arm and it was hurting) and VACCINATION SITE INDURATION (bump on arm). On 25-Jan-2021, INJECTION SITE INFLAMMATION (bump on arm and it was hurting), VACCINATION SITE WARMTH (arm hot), VACCINATION SITE INDURATION (bump on arm), INJECTION SITE PAIN (left arm - Vaccination site sore), INJECTION SITE ERYTHEMA (Red at injection site), INJECTION SITE SWELLING (swollen at injection site) and AXILLARY PAIN (arm hurting-same side of injection) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Headache, Pain in extremity, Pyrexia, Vaccination site erythema
Clinical narrative: low fever; headache; redness at injection site; large hard bump underneath armpit; Pain the arm; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY MASS (large hard bump underneath armpit), PAIN IN EXTREMITY (Pain the arm), PYREXIA (low fever), HEADACHE (headache) and VACCINATION SITE ERYTHEMA (redness at injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 01-Jan-2021, the patient experienced AXILLARY MASS (large hard bump underneath armpit), PAIN IN EXTREMITY (Pain the arm) and VACCINATION SITE ERYTHEMA (redness at injection site).   On 06-Jan-2021, the patient experienced PYREXIA (low fever) and HEADACHE (headache). At the time of the report, AXILLARY MASS (large hard bump underneath armpit), PAIN IN EXTREMITY (Pain the arm), PYREXIA (low fever), HEADACHE (headache) and VACCINATION SITE ERYTHEMA (redness at injection site) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperaesthesia, Injection site pruritus, Myalgia, Pain in extremity, Vaccination site erythema
Clinical narrative: Achy all over; Hard right at the site and around it; Itchy - at injection site; Sore arm - hurt to move my arm; lymph system was affected, my breast and even my nipples I could not; Redness - injection site arm was red - injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm - hurt to move my arm), HYPERAESTHESIA (lymph system was affected, my breast and even my nipples I could not), VACCINATION SITE INDURATION (Hard right at the site and around it), INJECTION SITE PRURITUS (Itchy - at injection site) and MYALGIA (Achy all over) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy, Drug allergy, Allergy to antibiotic, Drug allergy and Oil allergy. Concomitant products included CLONAZEPAM (KLONOPIN), GABAPENTIN, LEVOTHYROXINE, ESTRADIOL (CLIMARA [ESTRADIOL]), MIRTAZAPINE and VITAMINS NOS for an unknown indication.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm - hurt to move my arm), HYPERAESTHESIA (lymph system was affected, my breast and even my nipples I could not) and VACCINATION SITE ERYTHEMA (Redness - injection site arm was red - injection site). On 07-Feb-2021, the patient experienced VACCINATION SITE INDURATION (Hard right at the site and around it) and INJECTION SITE PRURITUS (Itchy - at injection site). On an unknown date, the patient experienced MYALGIA (Achy all over). On 01-Feb-2021, PAIN IN EXTREMITY (Sore arm - hurt to move my arm), HYPERAESTHESIA (lymph system was affected, my breast and even my nipples I could not) and VACCINATION SITE ERYTHEMA (Redness - injection site arm was red - injection site) had resolved. At the time of the report, VACCINATION SITE INDURATION (Hard right at the site and around it), INJECTION SITE PRURITUS (Itchy - at injection site) and MYALGIA (Achy all over) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient 's doctor recommended to not receive 2nd vaccine .  No treatment information was reported.    Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Follow up information was received and an additional event  was added.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration
Clinical narrative: Achy all over; Hard right at the site and around it; Itchy - at injection site; Sore arm - hurt to move my arm; lymph system was affected, my breast and even my nipples I could not; Redness - injection site arm was red - injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm - hurt to move my arm), HYPERAESTHESIA (lymph system was affected, my breast and even my nipples I could not), VACCINATION SITE INDURATION (Hard right at the site and around it), INJECTION SITE PRURITUS (Itchy - at injection site) and MYALGIA (Achy all over) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy, Drug allergy, Allergy to antibiotic, Drug allergy and Oil allergy. Concomitant products included CLONAZEPAM (KLONOPIN), GABAPENTIN, LEVOTHYROXINE, ESTRADIOL (CLIMARA [ESTRADIOL]), MIRTAZAPINE and VITAMINS NOS for an unknown indication.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm - hurt to move my arm), HYPERAESTHESIA (lymph system was affected, my breast and even my nipples I could not) and VACCINATION SITE ERYTHEMA (Redness - injection site arm was red - injection site). On 07-Feb-2021, the patient experienced VACCINATION SITE INDURATION (Hard right at the site and around it) and INJECTION SITE PRURITUS (Itchy - at injection site). On an unknown date, the patient experienced MYALGIA (Achy all over). On 01-Feb-2021, PAIN IN EXTREMITY (Sore arm - hurt to move my arm), HYPERAESTHESIA (lymph system was affected, my breast and even my nipples I could not) and VACCINATION SITE ERYTHEMA (Redness - injection site arm was red - injection site) had resolved. At the time of the report, VACCINATION SITE INDURATION (Hard right at the site and around it), INJECTION SITE PRURITUS (Itchy - at injection site) and MYALGIA (Achy all over) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient 's doctor recommended to not receive 2nd vaccine .  No treatment information was reported.    Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Follow up information was received and an additional event  was added.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Haematoma, Headache, Nausea, Pain
Clinical narrative: ache; SORENESS; HAEMATOMA; nausea; headache; This spontaneous case was reported by a patient and describes the occurrence of PAIN (ache), ARTHRALGIA (SORENESS), HAEMATOMA (HAEMATOMA), HEADACHE (headache) and NAUSEA (nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A / 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced HEADACHE (headache). On 15-Feb-2021, the patient experienced NAUSEA (nausea). On 16-Feb-2021, the patient experienced PAIN (ache), ARTHRALGIA (SORENESS) and HAEMATOMA (HAEMATOMA). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. At the time of the report, PAIN (ache), ARTHRALGIA (SORENESS), HAEMATOMA (HAEMATOMA), HEADACHE (headache) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by investigator.    The patient is on blood thinner.   Most recent FOLLOW-UP information incorporated above includes: On 25-Apr-2021: Email response from  the consumer.