chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Limb discomfort, Somnolence
Clinical narrative: Sore right arm; Sleepiness; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Sore right arm), SOMNOLENCE (Sleepiness) and FATIGUE (Fatigue) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in January 2021.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, the patient experienced LIMB DISCOMFORT (Sore right arm), SOMNOLENCE (Sleepiness) and FATIGUE (Fatigue). At the time of the report, LIMB DISCOMFORT (Sore right arm), SOMNOLENCE (Sleepiness) and FATIGUE (Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.   No treatment medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Follow-up information included no new information. On 03-Aug-2021: Event outcome updated.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: solid whole neck rash that was confined to neck and shoulder; This spontaneous case was reported by a consumer and describes the occurrence of RASH (solid whole neck rash that was confined to neck and shoulder) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     The patient's past medical history included Rash from 14-Feb-2021 to 15-Feb-2021.  On 01-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 24-Apr-2021, the patient experienced RASH (solid whole neck rash that was confined to neck and shoulder).   At the time of the report, RASH (solid whole neck rash that was confined to neck and shoulder) outcome was unknown.     This case was linked to US-MODERNATX, INC.-MOD-2021-029248 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes:  On 31-May-2021: No specific follow-up information recorded.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever of 99 degrees; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 99 degrees) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 011A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced PYREXIA (Fever of 99 degrees). At the time of the report, PYREXIA (Fever of 99 degrees) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-090264, US-MODERNATX, INC.-MOD-2021-090279 (E2B Linked Report). This case was linked to MOD-2021-090387 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-090264:Husband dose 1 case US-MODERNATX, INC.-MOD-2021-090279:Husband dose 2 case
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Malaise, Pyrexia
Clinical narrative: Felt ill; Low grade fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Felt ill), PYREXIA (Low grade fever) and CHILLS (Chills) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced MALAISE (Felt ill), PYREXIA (Low grade fever) and CHILLS (Chills). At the time of the report, MALAISE (Felt ill), PYREXIA (Low grade fever) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provider by the reporter.  Treatment information was not provided.    This case was linked to MOD-2021-090192.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Hypoaesthesia, Spinal pain
Clinical narrative: Pain in the spine; Numbness on the left of the spine; Sore shoulder; This spontaneous case was reported by a consumer and describes the occurrence of SPINAL PAIN (Pain in the spine), HYPOAESTHESIA (Numbness on the left of the spine) and ARTHRALGIA (Sore shoulder) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Apr-2021, the patient experienced SPINAL PAIN (Pain in the spine), HYPOAESTHESIA (Numbness on the left of the spine) and ARTHRALGIA (Sore shoulder). At the time of the report, SPINAL PAIN (Pain in the spine), HYPOAESTHESIA (Numbness on the left of the spine) and ARTHRALGIA (Sore shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment information was not provided.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray, Chest discomfort, Feeling hot, Peripheral swelling
Clinical narrative: Experienced chest tightness; Right arm swelled up to the size of a baseball; Really warm to the touch; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Experienced chest tightness), PERIPHERAL SWELLING (Right arm swelled up to the size of a baseball) and FEELING HOT (Really warm to the touch) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     The patient's past medical history included Traumatic injury (brain damage from a traumatic injury she had 14 years ago). Concurrent medical conditions included Penicillin allergy, Drug allergy, Drug allergy, Sulfonamide allergy, Blood pressure high, Food allergy and Handicap.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced CHEST DISCOMFORT (Experienced chest tightness), PERIPHERAL SWELLING (Right arm swelled up to the size of a baseball) and FEELING HOT (Really warm to the touch). The patient was treated with METOPROLOL ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, CHEST DISCOMFORT (Experienced chest tightness), PERIPHERAL SWELLING (Right arm swelled up to the size of a baseball) and FEELING HOT (Really warm to the touch) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: negative (Negative) Negative. On an unknown date, Chest X-ray: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other relevant lab investigations included looked at heart and was found to be normal. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Significant follow up added. New events,History added.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Hypoaesthesia, Pruritus, Skin warm, Swelling
Clinical narrative: diarrhea; neck has been very itchy, numb, hot and swollen; neck has been very itchy, numb, hot and swollen; neck has been very itchy, numb, hot and swollen; neck has been very itchy, numb, hot and swollen; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (neck has been very itchy, numb, hot and swollen), HYPOAESTHESIA (neck has been very itchy, numb, hot and swollen), SKIN WARM (neck has been very itchy, numb, hot and swollen), SWELLING (neck has been very itchy, numb, hot and swollen) and DIARRHOEA (diarrhea) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027321A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, the patient experienced PRURITUS (neck has been very itchy, numb, hot and swollen), HYPOAESTHESIA (neck has been very itchy, numb, hot and swollen), SKIN WARM (neck has been very itchy, numb, hot and swollen) and SWELLING (neck has been very itchy, numb, hot and swollen). On an unknown date, the patient experienced DIARRHOEA (diarrhea). At the time of the report, PRURITUS (neck has been very itchy, numb, hot and swollen), HYPOAESTHESIA (neck has been very itchy, numb, hot and swollen), SKIN WARM (neck has been very itchy, numb, hot and swollen) and SWELLING (neck has been very itchy, numb, hot and swollen) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was unknown by the reporter. Treatment medication included some antibiotics.   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Follow up received on 27-may-2021 added health care professional  details.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Myalgia, Pruritus
Clinical narrative: itchy from top of chest and neck; it's warm but not rash; she had little bit soreness; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy from top of chest and neck), FEELING HOT (it's warm but not rash) and MYALGIA (she had little bit soreness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced MYALGIA (she had little bit soreness). On an unknown date, the patient experienced PRURITUS (itchy from top of chest and neck) and FEELING HOT (it's warm but not rash). On 04-Mar-2021, MYALGIA (she had little bit soreness) had resolved. At the time of the report, PRURITUS (itchy from top of chest and neck) and FEELING HOT (it's warm but not rash) outcome was unknown.            No concomitant medication was reported.Treatment medication was not provided.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Feeling hot
Clinical narrative: felt hot; weird feeling of standing inside the body leaning onto herself; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (felt hot) and FEELING ABNORMAL (weird feeling of standing inside the body leaning onto herself) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Previously administered products included for an unreported indication: FLU (fibromyalgia). Concurrent medical conditions included Drug allergy (Thimerosal).    On 01-Apr-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 FEELING HOT (felt hot) and FEELING ABNORMAL (weird feeling of standing inside the body leaning onto herself). At the time of the report, FEELING HOT (felt hot) and FEELING ABNORMAL (weird feeling of standing inside the body leaning onto herself) 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.   This case was linked to US-MODERNATX, INC.-MOD-2021-090430 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-090430:dose 2
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Feeling hot, Hypoaesthesia, Maternal exposure during breast feeding
Clinical narrative: Congestion; She is breastfeeding; Itching; Redness; Red itchy eyes; Numbness; Feeling hot; Rash; Hives all over her body but primarily on forearms, elbows and hairline; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives all over her body but primarily on forearms, elbows and hairline), NASAL CONGESTION (Congestion), MATERNAL EXPOSURE DURING BREAST FEEDING (She is breastfeeding), PRURITUS (Itching) and ERYTHEMA (Redness) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 008B12A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hay fever. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 08-Jan-2018 to an unknown date for an unknown indication.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced FATIGUE (Fatigue). On 23-Apr-2021, the patient experienced URTICARIA (Hives all over her body but primarily on forearms, elbows and hairline). On an unknown date, the patient experienced NASAL CONGESTION (Congestion), MATERNAL EXPOSURE DURING BREAST FEEDING (She is breastfeeding), PRURITUS (Itching), ERYTHEMA (Redness), OCULAR HYPERAEMIA (Red itchy eyes), HYPOAESTHESIA (Numbness), FEELING HOT (Feeling hot) and RASH (Rash). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) from 04-May-2021 to 2021 for Hives, at a dose of 1 dosage form; OATMEAL for Hives, at a dose of 1 UNK and ASCORBIC ACID (VITAMIN C CITRUS) at a dose of 1 dosage form. On 26-Apr-2021, URTICARIA (Hives all over her body but primarily on forearms, elbows and hairline) had resolved. At the time of the report, NASAL CONGESTION (Congestion), MATERNAL EXPOSURE DURING BREAST FEEDING (She is breastfeeding), PRURITUS (Itching), ERYTHEMA (Redness), OCULAR HYPERAEMIA (Red itchy eyes), HYPOAESTHESIA (Numbness), FEELING HOT (Feeling hot), RASH (Rash) and FATIGUE (Fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.    This case was linked to MOD-2021-271601 (Parent-Child Link).   See case MOD-2021-271601 for details regarding the child case.  Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: FU received: Added events, outcome updated, con med added, patient demographics.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Ocular hyperaemia, Pruritus, Rash, SARS-CoV-2 test
Clinical narrative: Congestion; She is breastfeeding; Itching; Redness; Red itchy eyes; Numbness; Feeling hot; Rash; Hives all over her body but primarily on forearms, elbows and hairline; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives all over her body but primarily on forearms, elbows and hairline), NASAL CONGESTION (Congestion), MATERNAL EXPOSURE DURING BREAST FEEDING (She is breastfeeding), PRURITUS (Itching) and ERYTHEMA (Redness) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 008B12A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hay fever. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 08-Jan-2018 to an unknown date for an unknown indication.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced FATIGUE (Fatigue). On 23-Apr-2021, the patient experienced URTICARIA (Hives all over her body but primarily on forearms, elbows and hairline). On an unknown date, the patient experienced NASAL CONGESTION (Congestion), MATERNAL EXPOSURE DURING BREAST FEEDING (She is breastfeeding), PRURITUS (Itching), ERYTHEMA (Redness), OCULAR HYPERAEMIA (Red itchy eyes), HYPOAESTHESIA (Numbness), FEELING HOT (Feeling hot) and RASH (Rash). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) from 04-May-2021 to 2021 for Hives, at a dose of 1 dosage form; OATMEAL for Hives, at a dose of 1 UNK and ASCORBIC ACID (VITAMIN C CITRUS) at a dose of 1 dosage form. On 26-Apr-2021, URTICARIA (Hives all over her body but primarily on forearms, elbows and hairline) had resolved. At the time of the report, NASAL CONGESTION (Congestion), MATERNAL EXPOSURE DURING BREAST FEEDING (She is breastfeeding), PRURITUS (Itching), ERYTHEMA (Redness), OCULAR HYPERAEMIA (Red itchy eyes), HYPOAESTHESIA (Numbness), FEELING HOT (Feeling hot), RASH (Rash) and FATIGUE (Fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.    This case was linked to MOD-2021-271601 (Parent-Child Link).   See case MOD-2021-271601 for details regarding the child case.  Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: FU received: Added events, outcome updated, con med added, patient demographics.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Congestion; She is breastfeeding; Itching; Redness; Red itchy eyes; Numbness; Feeling hot; Rash; Hives all over her body but primarily on forearms, elbows and hairline; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives all over her body but primarily on forearms, elbows and hairline), NASAL CONGESTION (Congestion), MATERNAL EXPOSURE DURING BREAST FEEDING (She is breastfeeding), PRURITUS (Itching) and ERYTHEMA (Redness) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 008B12A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hay fever. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 08-Jan-2018 to an unknown date for an unknown indication.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced FATIGUE (Fatigue). On 23-Apr-2021, the patient experienced URTICARIA (Hives all over her body but primarily on forearms, elbows and hairline). On an unknown date, the patient experienced NASAL CONGESTION (Congestion), MATERNAL EXPOSURE DURING BREAST FEEDING (She is breastfeeding), PRURITUS (Itching), ERYTHEMA (Redness), OCULAR HYPERAEMIA (Red itchy eyes), HYPOAESTHESIA (Numbness), FEELING HOT (Feeling hot) and RASH (Rash). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) from 04-May-2021 to 2021 for Hives, at a dose of 1 dosage form; OATMEAL for Hives, at a dose of 1 UNK and ASCORBIC ACID (VITAMIN C CITRUS) at a dose of 1 dosage form. On 26-Apr-2021, URTICARIA (Hives all over her body but primarily on forearms, elbows and hairline) had resolved. At the time of the report, NASAL CONGESTION (Congestion), MATERNAL EXPOSURE DURING BREAST FEEDING (She is breastfeeding), PRURITUS (Itching), ERYTHEMA (Redness), OCULAR HYPERAEMIA (Red itchy eyes), HYPOAESTHESIA (Numbness), FEELING HOT (Feeling hot), RASH (Rash) and FATIGUE (Fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.    This case was linked to MOD-2021-271601 (Parent-Child Link).   See case MOD-2021-271601 for details regarding the child case.  Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: FU received: Added events, outcome updated, con med added, patient demographics.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administered vaccine to a 12 year old; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered vaccine to a 12 year old) in a 12-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered vaccine to a 12 year old). On 24-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered vaccine to a 12 year old) had resolved. 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.   No concomitant medications were provided. No treatment drugs were reported.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in ears; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Ringing in ears) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TINNITUS (Ringing in ears). The patient was treated with PREDNISONE for Ringing in ears, at a dose of UNK 6 days. At the time of the report, TINNITUS (Ringing in ears) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash, Vaccination site swelling
Clinical narrative: rash swelled slightly; rash on top half of her left arm where she was vaccinated/ rash on upper arm where vaccinated/rash responds to heat and gets red again; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash on top half of her left arm where she was vaccinated/ rash on upper arm where vaccinated/rash responds to heat and gets red again) and VACCINATION SITE SWELLING (rash swelled slightly) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     Concurrent medical conditions included Rubella (she had shot in 30's when planning to get pregnant - got Rubella for the full 3 days over full body).   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced VACCINATION SITE RASH (rash on top half of her left arm where she was vaccinated/ rash on upper arm where vaccinated/rash responds to heat and gets red again). On an unknown date, the patient experienced VACCINATION SITE SWELLING (rash swelled slightly). The patient was treated with HYDROCORTISONE (BACTINE [HYDROCORTISONE]) at a dose of 1 dosage form. On 12-May-2021, VACCINATION SITE RASH (rash on top half of her left arm where she was vaccinated/ rash on upper arm where vaccinated/rash responds to heat and gets red again) had resolved. At the time of the report, VACCINATION SITE SWELLING (rash swelled slightly) had resolved. Not Provided          NO Concomitant products were provided.  treatment medications were provided   This case was linked to MOD-2021-185872 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: events updated; second dose information updated, patient demographic details updated, outcome updated
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Vaccination site swelling
Clinical narrative: A little stiff; injection site is swollen; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (A little stiff) and VACCINATION SITE SWELLING (injection site is swollen) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 10-Apr-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 MUSCULOSKELETAL STIFFNESS (A little stiff) and VACCINATION SITE SWELLING (injection site is swollen). At the time of the report, MUSCULOSKELETAL STIFFNESS (A little stiff) and VACCINATION SITE SWELLING (injection site is swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient took thyroid, cholesterol and antidepressant medication (unspecified).   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Report received contains no significant information.; 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: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain, Vaccination site swelling
Clinical narrative: Swelling at the injection site; Pain at the injection site; Tired for a day; The injection site on the left arm started swelling; Tender to touch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swelling at the injection site), VACCINATION SITE PAIN (Pain at the injection site), FATIGUE (Tired for a day), VACCINATION SITE SWELLING (The injection site on the left arm started swelling) and VACCINATION SITE PAIN (Tender to touch) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-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 VACCINATION SITE SWELLING (Swelling at the injection site), VACCINATION SITE PAIN (Pain at the injection site), FATIGUE (Tired for a day), VACCINATION SITE SWELLING (The injection site on the left arm started swelling) and VACCINATION SITE PAIN (Tender to touch). At the time of the report, VACCINATION SITE SWELLING (Swelling at the injection site), VACCINATION SITE PAIN (Pain at the injection site) and FATIGUE (Tired for a day) had resolved and VACCINATION SITE SWELLING (The injection site on the left arm started swelling) and VACCINATION SITE PAIN (Tender to touch) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   Treatment information was not provided.  After vaccination Patient was tired and experienced swelling and pain at the injection site, after 2-3 days the patient felt fine and arm became normal. She reported that again after 10 days of vaccination, the injection site on the left arm started swelling and it is tender to touch.   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: No new information. Patient declined the consent for follow-up.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Neck pain, Pain in extremity, Swelling
Clinical narrative: Swelling up at the base of my neck on the left side; Neck pain; Don't feel good; Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain), SWELLING (Swelling up at the base of my neck on the left side), NECK PAIN (Neck pain) and FEELING ABNORMAL (Don't feel good) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm pain) and FEELING ABNORMAL (Don't feel good). On 26-Apr-2021, the patient experienced SWELLING (Swelling up at the base of my neck on the left side) and NECK PAIN (Neck pain). The patient was treated with ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL, SALICYLAMIDE (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL;SALICYLAMIDE]) on 25-Apr-2021 for Adverse event, at a dose of 2 dosage form. At the time of the report, PAIN IN EXTREMITY (Arm pain), SWELLING (Swelling up at the base of my neck on the left side), NECK PAIN (Neck pain) and FEELING ABNORMAL (Don't feel good) outcome was unknown. Not Provided          No relevant concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) 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 FATIGUE (Fatigue). At the time of the report, FATIGUE (Fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Relevant concomitant medications was reported.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: received first dose in 11March2021; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (received first dose in 11March2021) 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 11-Mar-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 PRODUCT DOSE OMISSION ISSUE (received first dose in 11March2021). At the time of the report, PRODUCT DOSE OMISSION ISSUE (received first dose in 11March2021) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Pain in extremity, Somnolence
Clinical narrative: Arm Pain; Tingling/Numbness; sleepy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm Pain), HYPOAESTHESIA ORAL (Tingling/Numbness) and SOMNOLENCE (sleepy) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm Pain), HYPOAESTHESIA ORAL (Tingling/Numbness) and SOMNOLENCE (sleepy). At the time of the report, PAIN IN EXTREMITY (Arm Pain), HYPOAESTHESIA ORAL (Tingling/Numbness) and SOMNOLENCE (sleepy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included Vitamins.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Inappropriate schedule of product administration
Clinical narrative: patient got sick; passed the 42 days window; This spontaneous case was reported by a physician and describes the occurrence of ILLNESS (patient got sick) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (passed the 42 days window) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (passed the 42 days window). On an unknown date, the patient experienced ILLNESS (patient got sick). At the time of the report, ILLNESS (patient got sick) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (passed the 42 days window) 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.   This case was linked to MOD21-081725 (E2B Linked Report).; Sender's Comments:  MOD21-081725:
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Myalgia, Pain in extremity, Tendon injury
Clinical narrative: right arm pain; deep muscle ache (right arm); feelings of "pulled tendon" (right arm); difficulty lifting right arm/inability to lift right arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (right arm pain), MYALGIA (deep muscle ache (right arm)), TENDON INJURY (feelings of "pulled tendon" (right arm)) and LIMB DISCOMFORT (difficulty lifting right arm/inability to lift right arm) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 011B21A) for COVID-19 vaccination.     Concomitant products included AZITHROMYCIN (AZO) for an unknown indication.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced PAIN IN EXTREMITY (right arm pain), MYALGIA (deep muscle ache (right arm)), TENDON INJURY (feelings of "pulled tendon" (right arm)) and LIMB DISCOMFORT (difficulty lifting right arm/inability to lift right arm). At the time of the report, PAIN IN EXTREMITY (right arm pain), MYALGIA (deep muscle ache (right arm)), TENDON INJURY (feelings of "pulled tendon" (right arm)) and LIMB DISCOMFORT (difficulty lifting right arm/inability to lift right arm) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable. Treatment information was not provided.   This case was linked to MOD21-082172 (E2B Linked Report).; Sender's Comments:  MOD21-082172:Case for dose 1
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia
Clinical narrative: loses the strength on her right hand; loses the strength on her whole body; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (loses the strength on her right hand) and ASTHENIA (loses the strength on her whole body) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0391321A and 037A2113) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 16-Apr-2021, the patient experienced ASTHENIA (loses the strength on her right hand) and ASTHENIA (loses the strength on her whole body). At the time of the report, ASTHENIA (loses the strength on her right hand) and ASTHENIA (loses the strength on her whole body) outcome was unknown. Not Provided          No concomitant medications reported. No treatment information provided.   This case was linked to MOD-2021-090355, MOD-2021-090355 (Patient Link).
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue
Clinical narrative: shortness of breath; fatigue; This spontaneous case was reported by a health care professional and describes the occurrence of DYSPNOEA (shortness of breath) and FATIGUE (fatigue) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METHOTREXATE, ALLOPURINOL, FOLIC ACID, GABAPENTIN, IBUPROFEN, MAGNESIUM, IPRATROPIUM BROMIDE (ATROVENT), ALBUTEROL [SALBUTAMOL], METFORMIN, METOPROLOL, VITAMIN D [VITAMIN D NOS] and IRON for an unknown indication.    On 15-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 DYSPNOEA (shortness of breath) and FATIGUE (fatigue). At the time of the report, DYSPNOEA (shortness of breath) and FATIGUE (fatigue) 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 medication include steroid cream and immunomodulator methotrexate. No treatment medication details was reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Dizziness, Neck pain, Pain in extremity
Clinical narrative: neck pain; dizziness; weakness; Right Arm Pain; shoulder pain; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (neck pain), DIZZINESS (dizziness), ASTHENIA (weakness), PAIN IN EXTREMITY (Right Arm Pain) and ARTHRALGIA (shoulder pain) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METOPROLOL for an unknown indication.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced NECK PAIN (neck pain), DIZZINESS (dizziness), ASTHENIA (weakness), PAIN IN EXTREMITY (Right Arm Pain) and ARTHRALGIA (shoulder pain). The patient was treated with PARACETAMOL (TYLENOL) for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, NECK PAIN (neck pain), DIZZINESS (dizziness), ASTHENIA (weakness), PAIN IN EXTREMITY (Right Arm Pain) and ARTHRALGIA (shoulder pain) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication also included Lapanodrost for an unknown indication.  Patient reported neck, shoulder and right arm pain chronic but worst after vaccine.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: covid-19 positive; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid-19 positive) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044BUA) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced COVID-19 (covid-19 positive). At the time of the report, COVID-19 (covid-19 positive) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information provided.  No treatment information provided.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose, Incorrect dose administered
Clinical narrative: Inappropriate dose of vaccine administered; Accidental overdose; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of INCORRECT DOSE ADMINISTERED (Inappropriate dose of vaccine administered) and ACCIDENTAL OVERDOSE (Accidental overdose) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 ml. On 26-Apr-2021, the patient experienced INCORRECT DOSE ADMINISTERED (Inappropriate dose of vaccine administered) and ACCIDENTAL OVERDOSE (Accidental overdose). At the time of the report, INCORRECT DOSE ADMINISTERED (Inappropriate dose of vaccine administered) and ACCIDENTAL OVERDOSE (Accidental overdose) outcome was unknown. Not Provided      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 medication were provided. No treatment medication were provided. Reporter informed that 1 ml of vaccine was administered to 4 patients.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: My son contracted covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (My son contracted covid) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-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 COVID-19 (My son contracted covid). At the time of the report, COVID-19 (My son contracted covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Apr-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided. Treatment information was not provided.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Lymphadenopathy
Clinical narrative: Noticed red blotches and rash on arm going from shoulder to elbow; Its painful under the arm, and painful behind arm; Site is swollen and hard; Site is swollen and hard; Lymph node is swollen; Had Headaches; Fever; Had Chills; Had Muscle pain; Felt tired; Had joint pain; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Noticed red blotches and rash on arm going from shoulder to elbow), PAIN IN EXTREMITY (Its painful under the arm, and painful behind arm), VACCINATION SITE INDURATION (Site is swollen and hard), HEADACHE (Had Headaches) and PYREXIA (Fever) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 24-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 25-Apr-2021, the patient experienced HEADACHE (Had Headaches), PYREXIA (Fever), CHILLS (Had Chills), MYALGIA (Had Muscle pain), FATIGUE (Felt tired) and ARTHRALGIA (Had joint pain). On 26-Apr-2021, the patient experienced RASH MACULAR (Noticed red blotches and rash on arm going from shoulder to elbow), PAIN IN EXTREMITY (Its painful under the arm, and painful behind arm), VACCINATION SITE INDURATION (Site is swollen and hard), VACCINATION SITE SWELLING (Site is swollen and hard) and LYMPHADENOPATHY (Lymph node is swollen). The patient was treated with IBUPROFEN on 25-Apr-2021 for Adverse event, at an unspecified dose and frequency. On 26-Apr-2021, HEADACHE (Had Headaches), PYREXIA (Fever), CHILLS (Had Chills), MYALGIA (Had Muscle pain), FATIGUE (Felt tired) and ARTHRALGIA (Had joint pain) had resolved. At the time of the report, RASH MACULAR (Noticed red blotches and rash on arm going from shoulder to elbow), PAIN IN EXTREMITY (Its painful under the arm, and painful behind arm), VACCINATION SITE INDURATION (Site is swollen and hard), VACCINATION SITE SWELLING (Site is swollen and hard) and LYMPHADENOPATHY (Lymph node is swollen) outcome was unknown.            No concomitant Medications were reported.