chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: received 2 different brands of vaccine (1st - Moderna, 2nd - Pfizer); This spontaneous case was reported by an other health care professional and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (received 2 different brands of vaccine (1st - Moderna, 2nd - Pfizer)) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 5047B21A) for COVID-19 vaccination.    Co-suspect product included non-company product BNT162B2 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 13-May-2021, the patient started BNT162B2 (unknown route) at an unspecified dose. On 13-May-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (received 2 different brands of vaccine (1st - Moderna, 2nd - Pfizer)). On 13-May-2021, INTERCHANGE OF VACCINE PRODUCTS (received 2 different brands of vaccine (1st - Moderna, 2nd - Pfizer)) 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 and treatment medications were reported.  HCP called in to report that they have administered a Pfizer dose to a patient who was supposed to be getting the 2nd dose of the Moderna vaccine.on 13-May-2021.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Asthenia, Diarrhoea, Erythema, Headache
Clinical narrative: weakness; abdominal cramps; diarrhea; night sweats; BCG scar on the left arm is still red and sensitive; headache; nausea; fever; vaccine in the right arm, the BCG on the left arm turned red; the scar of BCG turned red, few inches below the vaccination site on left, nondominant arm, and states that the redness resolved after about 3 weeks; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (vaccine in the right arm, the BCG on the left arm turned red), ASTHENIA (weakness), ABDOMINAL PAIN (abdominal cramps), DIARRHOEA (diarrhea) and NIGHT SWEATS (night sweats) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced ERYTHEMA (the scar of BCG turned red, few inches below the vaccination site on left, nondominant arm, and states that the redness resolved after about 3 weeks). On 29-Apr-2021, the patient experienced ERYTHEMA (vaccine in the right arm, the BCG on the left arm turned red). On an unknown date, the patient experienced ASTHENIA (weakness), ABDOMINAL PAIN (abdominal cramps), DIARRHOEA (diarrhea), NIGHT SWEATS (night sweats), SENSITIVE SKIN (BCG scar on the left arm is still red and sensitive), HEADACHE (headache), NAUSEA (nausea) and PYREXIA (fever). The patient was treated with PARACETAMOL at an unspecified dose and frequency. At the time of the report, ERYTHEMA (vaccine in the right arm, the BCG on the left arm turned red), ASTHENIA (weakness), ABDOMINAL PAIN (abdominal cramps), DIARRHOEA (diarrhea), NIGHT SWEATS (night sweats), SENSITIVE SKIN (BCG scar on the left arm is still red and sensitive), HEADACHE (headache), NAUSEA (nausea) and PYREXIA (fever) outcome was unknown and ERYTHEMA (the scar of BCG turned red, few inches below the vaccination site on left, nondominant arm, and states that the redness resolved after about 3 weeks) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable.  Concomitant medication include asthma medications.  Patient reports taking paracetamol to treat their symptoms.   This case was linked to MOD-2021-073742 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: No specific follow-up information recorded.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Night sweats, Pyrexia, Sensitive skin
Clinical narrative: weakness; abdominal cramps; diarrhea; night sweats; BCG scar on the left arm is still red and sensitive; headache; nausea; fever; vaccine in the right arm, the BCG on the left arm turned red; the scar of BCG turned red, few inches below the vaccination site on left, nondominant arm, and states that the redness resolved after about 3 weeks; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (vaccine in the right arm, the BCG on the left arm turned red), ASTHENIA (weakness), ABDOMINAL PAIN (abdominal cramps), DIARRHOEA (diarrhea) and NIGHT SWEATS (night sweats) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced ERYTHEMA (the scar of BCG turned red, few inches below the vaccination site on left, nondominant arm, and states that the redness resolved after about 3 weeks). On 29-Apr-2021, the patient experienced ERYTHEMA (vaccine in the right arm, the BCG on the left arm turned red). On an unknown date, the patient experienced ASTHENIA (weakness), ABDOMINAL PAIN (abdominal cramps), DIARRHOEA (diarrhea), NIGHT SWEATS (night sweats), SENSITIVE SKIN (BCG scar on the left arm is still red and sensitive), HEADACHE (headache), NAUSEA (nausea) and PYREXIA (fever). The patient was treated with PARACETAMOL at an unspecified dose and frequency. At the time of the report, ERYTHEMA (vaccine in the right arm, the BCG on the left arm turned red), ASTHENIA (weakness), ABDOMINAL PAIN (abdominal cramps), DIARRHOEA (diarrhea), NIGHT SWEATS (night sweats), SENSITIVE SKIN (BCG scar on the left arm is still red and sensitive), HEADACHE (headache), NAUSEA (nausea) and PYREXIA (fever) outcome was unknown and ERYTHEMA (the scar of BCG turned red, few inches below the vaccination site on left, nondominant arm, and states that the redness resolved after about 3 weeks) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable.  Concomitant medication include asthma medications.  Patient reports taking paracetamol to treat their symptoms.   This case was linked to MOD-2021-073742 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: No specific follow-up information recorded.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Blood cholesterol increased, Body temperature increased, Chills, Fatigue, Influenza like illness
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms (from first shot lasted for 3 to 4 days)), BODY TEMPERATURE INCREASED (bit of a temperature (from first shot lasted for 3 to 4 days)), PAIN (achiness (from first shot, lasted for 3 to 4 days)), CHILLS (chills) and FATIGUE (fatigue) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 037A21B) for COVID-19 vaccination. Concomitant products included LEVOTHYROXINE and Liosironin for an unknown indication. On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms (from first shot lasted for 3 to 4 days)), BODY TEMPERATURE INCREASED (bit of a temperature (from first shot lasted for 3 to 4 days)), PAIN (achiness (from first shot, lasted for 3 to 4 days)) and CHILLS (chills). On an unknown date, the patient experienced FATIGUE (fatigue). At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms (from first shot lasted for 3 to 4 days)), BODY TEMPERATURE INCREASED (bit of a temperature (from first shot lasted for 3 to 4 days)), PAIN (achiness (from first shot, lasted for 3 to 4 days)), CHILLS (chills) and FATIGUE (fatigue) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Apr-2021, Blood cholesterol increased: high (High) cholesterol high. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. patient was advised to change her diet into Ketogenic Diet  for the inflammation and to get off sugars by doctor. This case was linked to MOD-2021-128621 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms (from first shot lasted for 3 to 4 days)), BODY TEMPERATURE INCREASED (bit of a temperature (from first shot lasted for 3 to 4 days)), PAIN (achiness (from first shot, lasted for 3 to 4 days)), CHILLS (chills) and FATIGUE (fatigue) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 037A21B) for COVID-19 vaccination. Concomitant products included LEVOTHYROXINE and Liosironin for an unknown indication. On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms (from first shot lasted for 3 to 4 days)), BODY TEMPERATURE INCREASED (bit of a temperature (from first shot lasted for 3 to 4 days)), PAIN (achiness (from first shot, lasted for 3 to 4 days)) and CHILLS (chills). On an unknown date, the patient experienced FATIGUE (fatigue). At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms (from first shot lasted for 3 to 4 days)), BODY TEMPERATURE INCREASED (bit of a temperature (from first shot lasted for 3 to 4 days)), PAIN (achiness (from first shot, lasted for 3 to 4 days)), CHILLS (chills) and FATIGUE (fatigue) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Apr-2021, Blood cholesterol increased: high (High) cholesterol high. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. patient was advised to change her diet into Ketogenic Diet  for the inflammation and to get off sugars by doctor. This case was linked to MOD-2021-128621 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Induration, Peripheral swelling
Clinical narrative: Redness; Swelling; Hot; Hard lump; This spontaneous case was reported by a health care professional and describes the occurrence of ERYTHEMA (Redness), PERIPHERAL SWELLING (Swelling), FEELING HOT (Hot) and INDURATION (Hard lump) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Redness), PERIPHERAL SWELLING (Swelling), FEELING HOT (Hot) and INDURATION (Hard lump). At the time of the report, ERYTHEMA (Redness), PERIPHERAL SWELLING (Swelling), FEELING HOT (Hot) and INDURATION (Hard lump) 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 medication was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-128176, US-MODERNATX, INC.-MOD-2021-128305, US-MODERNATX, INC.-MOD-2021-128643, US-MODERNATX, INC.-MOD-2021-128612, US-MODERNATX, INC.-MOD-2021-128689 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-128176: US-MODERNATX, INC.-MOD-2021-128305: US-MODERNATX, INC.-MOD-2021-128689: US-MODERNATX, INC.-MOD-2021-128612: US-MODERNATX, INC.-MOD-2021-128643:
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: "on both arms where I got my injections, there is a big red welt"; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA ("on both arms where I got my injections, there is a big red welt") in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder NOS and Blood pressure fluctuation. Concomitant products included CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]), VITAMIN C [ASCORBIC ACID] and POTASSIUM for an unknown indication.    On 25-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 URTICARIA ("on both arms where I got my injections, there is a big red welt"). At the time of the report, URTICARIA ("on both arms where I got my injections, there is a big red welt") had not resolved.            Additional concomitant product use included thyroid and blood pressure medications.  No medications were taken to help the symptoms.  Patient received both scheduled doses of mRNA-1273; therefore, the action taken in response to the events was not applicable.  Patient gave consent for safety follow up, however, denied consent to follow up with her physician.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature fluctuation, Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: Feel hot and cold; Fever; Headache; feel tired; feel like will vomit; This spontaneous case was reported by a consumer and describes the occurrence of BODY TEMPERATURE FLUCTUATION (Feel hot and cold), PYREXIA (Fever), HEADACHE (Headache), FATIGUE (feel tired) and NAUSEA (feel like will vomit) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, the patient experienced BODY TEMPERATURE FLUCTUATION (Feel hot and cold), PYREXIA (Fever), HEADACHE (Headache), FATIGUE (feel tired) and NAUSEA (feel like will vomit). At the time of the report, BODY TEMPERATURE FLUCTUATION (Feel hot and cold), PYREXIA (Fever), HEADACHE (Headache), FATIGUE (feel tired) and NAUSEA (feel like will vomit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concominant medications were not reported.  Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort, Pain in extremity, Rash erythematous, Vaccination site reaction
Clinical narrative: COVID arm, hard to lift; COVID arm, hard to lift; Feels like a sunburn; Sore arm; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE REACTION (COVID arm, hard to lift), RASH ERYTHEMATOUS (Feels like a sunburn), PAIN IN EXTREMITY (Sore arm) and LIMB DISCOMFORT (COVID arm, hard to lift) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (COVID arm, hard to lift), RASH ERYTHEMATOUS (Feels like a sunburn), PAIN IN EXTREMITY (Sore arm) and LIMB DISCOMFORT (COVID arm, hard to lift). The patient was treated with SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM) at a dose of 1 dosage form. At the time of the report, VACCINATION SITE REACTION (COVID arm, hard to lift), RASH ERYTHEMATOUS (Feels like a sunburn), PAIN IN EXTREMITY (Sore arm) and LIMB DISCOMFORT (COVID arm, hard to lift) 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.    This case was linked to MOD21-090237, US-MODERNATX, INC.-MOD-2021-128176, US-MODERNATX, INC.-MOD-2021-128305, US-MODERNATX, INC.-MOD-2021-128576, US-MODERNATX, INC.-MOD-2021-128643, US-MODERNATX, INC.-MOD-2021-128649, US-MODERNATX, INC.-MOD-2021-128643 (E2B Linked Report).; Sender's Comments:  MOD21-090237: US-MODERNATX, INC.-MOD-2021-128176: US-MODERNATX, INC.-MOD-2021-128305: US-MODERNATX, INC.-MOD-2021-128576: US-MODERNATX, INC.-MOD-2021-128643: US-MODERNATX, INC.-MOD-2021-128649: US-MODERNATX, INC.-MOD-2021-128643:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Blood cholesterol, Blood test, Fatigue, Inflammation
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SOMNOLENCE (sleeping 12 to 16 hours a day), INFLAMMATION (high inflammation in her body), FATIGUE (fatigue) and NAUSEA (debilitating nausea) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 046A21A) for COVID-19 vaccination. Concurrent medical conditions included Hypothyroidism. Concomitant products included LEVOTHYROXINE and LIOTHYRONINE for Hypothyroidism.On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced SOMNOLENCE (sleeping 12 to 16 hours a day), INFLAMMATION (high inflammation in her body), FATIGUE (fatigue) and NAUSEA (debilitating nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, SOMNOLENCE (sleeping 12 to 16 hours a day), INFLAMMATION (high inflammation in her body), FATIGUE (fatigue) and NAUSEA (debilitating nausea) had not resolved.  DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Apr-2021, Blood cholesterol: high (High) High Cholesterol. On 13-Apr-2021, Blood test: high (Inconclusive) High inflammation. On an unknown date, Antibody test: negative (Negative) Negative. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.Patient advised to change diet into Ketogenic diet for the inflammation and to get off sugars. This case was linked to MOD-2021-128551 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Follow-up information received on 26-MAY-2021 contains significant information - Treatment information, lab data added.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Somnolence
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SOMNOLENCE (sleeping 12 to 16 hours a day), INFLAMMATION (high inflammation in her body), FATIGUE (fatigue) and NAUSEA (debilitating nausea) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 046A21A) for COVID-19 vaccination. Concurrent medical conditions included Hypothyroidism. Concomitant products included LEVOTHYROXINE and LIOTHYRONINE for Hypothyroidism.On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced SOMNOLENCE (sleeping 12 to 16 hours a day), INFLAMMATION (high inflammation in her body), FATIGUE (fatigue) and NAUSEA (debilitating nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, SOMNOLENCE (sleeping 12 to 16 hours a day), INFLAMMATION (high inflammation in her body), FATIGUE (fatigue) and NAUSEA (debilitating nausea) had not resolved.  DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Apr-2021, Blood cholesterol: high (High) High Cholesterol. On 13-Apr-2021, Blood test: high (Inconclusive) High inflammation. On an unknown date, Antibody test: negative (Negative) Negative. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.Patient advised to change diet into Ketogenic diet for the inflammation and to get off sugars. This case was linked to MOD-2021-128551 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Follow-up information received on 26-MAY-2021 contains significant information - Treatment information, lab data added.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Headache, Illness, Tremor
Clinical narrative: Very sick; Shaking; His body was cold; Shivering; Headache; Throwing up even though there's no food in his stomach over night.; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ILLNESS (Very sick), TREMOR (Shaking), FEELING COLD (His body was cold), CHILLS (Shivering) and HEADACHE (Headache) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027CZ1A and 044BZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to animal.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2021, the patient experienced ILLNESS (Very sick), TREMOR (Shaking), CHILLS (Shivering) and HEADACHE (Headache). 11-May-2021, the patient experienced FEELING COLD (His body was cold) and VOMITING (Throwing up even though there's no food in his stomach over night.). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 11-May-2021, ILLNESS (Very sick), TREMOR (Shaking), FEELING COLD (His body was cold), CHILLS (Shivering) and VOMITING (Throwing up even though there's no food in his stomach over night.) had resolved. At the time of the report, HEADACHE (Headache) outcome was unknown.            Treatment and Concomitant medicines were not provided,     This case was linked to US-MODERNATX, INC.-MOD-2021-128524 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-128524:
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Very sick; Shaking; His body was cold; Shivering; Headache; Throwing up even though there's no food in his stomach over night.; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ILLNESS (Very sick), TREMOR (Shaking), FEELING COLD (His body was cold), CHILLS (Shivering) and HEADACHE (Headache) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027CZ1A and 044BZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to animal.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2021, the patient experienced ILLNESS (Very sick), TREMOR (Shaking), CHILLS (Shivering) and HEADACHE (Headache). 11-May-2021, the patient experienced FEELING COLD (His body was cold) and VOMITING (Throwing up even though there's no food in his stomach over night.). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 11-May-2021, ILLNESS (Very sick), TREMOR (Shaking), FEELING COLD (His body was cold), CHILLS (Shivering) and VOMITING (Throwing up even though there's no food in his stomach over night.) had resolved. At the time of the report, HEADACHE (Headache) outcome was unknown.            Treatment and Concomitant medicines were not provided,     This case was linked to US-MODERNATX, INC.-MOD-2021-128524 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-128524:
Sex: F
Vaccine: COVID19
Symptoms: Drainage, Erythema, Feeling hot, Peripheral swelling, Skin induration
Clinical narrative: redness and swelling in the arm; redness and swelling in the arm; hot; hard; some drainage of the arm because it was smelly; This spontaneous case was reported by a health care professional and describes the occurrence of ERYTHEMA (redness and swelling in the arm), PERIPHERAL SWELLING (redness and swelling in the arm), FEELING HOT (hot), SKIN INDURATION (hard) and DRAINAGE (some drainage of the arm because it was smelly) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (redness and swelling in the arm), PERIPHERAL SWELLING (redness and swelling in the arm), FEELING HOT (hot), SKIN INDURATION (hard) and DRAINAGE (some drainage of the arm because it was smelly). At the time of the report, ERYTHEMA (redness and swelling in the arm), PERIPHERAL SWELLING (redness and swelling in the arm), FEELING HOT (hot), SKIN INDURATION (hard) and DRAINAGE (some drainage of the arm because it was smelly) 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 medication was not reported. No treatment medication was reported.    This case was linked to US-MODERNATX, INC.-MOD-2021-128176, US-MODERNATX, INC.-MOD-2021-128305, US-MODERNATX, INC.-MOD-2021-128576, US-MODERNATX, INC.-MOD-2021-128612, US-MODERNATX, INC.-MOD-2021-128612, US-MODERNATX, INC.-MOD-2021-128649, US-MODERNATX, INC.-MOD-2021-128689 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-128176: US-MODERNATX, INC.-MOD-2021-128305: US-MODERNATX, INC.-MOD-2021-128576: US-MODERNATX, INC.-MOD-2021-128612: US-MODERNATX, INC.-MOD-2021-128649: US-MODERNATX, INC.-MOD-2021-128689: US-MODERNATX, INC.-MOD-2021-128612:
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Injection site nodule, Injection site pain, Malaise, Vaccination site pain
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of MALAISE (Feeling sick), INJECTION SITE NODULE (Nodule injection site), FEELING COLD (Coldness general), VACCINATION SITE PAIN (Vaccination site pain) and INJECTION SITE PAIN (Injection site pain) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported.  On 29-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) (Intramuscular) 1 dosage form. In April 2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). On 29-Apr-2021, the patient experienced MALAISE (Feeling sick). On an unknown date, the patient experienced INJECTION SITE NODULE (Nodule injection site), FEELING COLD (Coldness general) and INJECTION SITE PAIN (Injection site pain). The patient was treated with ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa, at a dose of prefilled syringe and IBUPROFEN for Pain NOS, at an unspecified dose and frequency. At the time of the report, MALAISE (Feeling sick), FEELING COLD (Coldness general), VACCINATION SITE PAIN (Vaccination site pain) and INJECTION SITE PAIN (Injection site pain) outcome was unknown and INJECTION SITE NODULE (Nodule injection site) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. A solicited report from the USA by a consumer. Reporter did not allow further contact.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Induration, Peripheral swelling
Clinical narrative: Redness in arm; Swelling in arm; Hot; Hard; This spontaneous case was reported by a nurse and describes the occurrence of ERYTHEMA (Redness in arm), PERIPHERAL SWELLING (Swelling in arm), FEELING HOT (Hot) and INDURATION (Hard) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 05-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Redness in arm), PERIPHERAL SWELLING (Swelling in arm), FEELING HOT (Hot) and INDURATION (Hard). The patient was treated with CLINDAMYCIN for Adverse event, at an unspecified dose and frequency. At the time of the report, ERYTHEMA (Redness in arm), PERIPHERAL SWELLING (Swelling in arm), FEELING HOT (Hot) and INDURATION (Hard) 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 medication was not reported.   This case was linked to MOD-2021-128176, MOD-2021-128305, MOD-2021-128649, MOD-2021-128612, MOD-2021-128689, MOD-2021-128643 (Patient Link).
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Skin haemorrhage
Clinical narrative: he puts a bandage on his skin and take it off it pulls layer of  his skin and it bleeds; This spontaneous case was reported by a consumer and describes the occurrence of SKIN HAEMORRHAGE (he puts a bandage on his skin and take it off it pulls layer of  his skin and it bleeds) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0321321a) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SKIN HAEMORRHAGE (he puts a bandage on his skin and take it off it pulls layer of  his skin and it bleeds). At the time of the report, SKIN HAEMORRHAGE (he puts a bandage on his skin and take it off it pulls layer of  his skin and it bleeds) outcome was unknown.            Concomitant medication was not reported.No treatment information was provided.Action taken with mRNA-1273 in response to the events was not applicable.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Condition aggravated, Dysstasia, Muscular weakness, Nausea
Clinical narrative: end of March when she felt weakness on her legs; not able to get up without pulling herself up resting her hands on the table; After the second shot, her condition worsen she can hardly walk without any assistance; nauseated and really weak (first shot); pain in her arm (first shot); nauseated and really weak (first shot); This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (pain in her arm (first shot)), ASTHENIA (nauseated and really weak (first shot)), MUSCULAR WEAKNESS (end of March when she felt weakness on her legs), DYSSTASIA (not able to get up without pulling herself up resting her hands on the table) and CONDITION AGGRAVATED (After the second shot, her condition worsen she can hardly walk without any assistance) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no medical history reported).   On 02-Mar-2021, the patient received second 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-Mar-2021, the patient experienced PAIN IN EXTREMITY (pain in her arm (first shot)), ASTHENIA (nauseated and really weak (first shot)) and NAUSEA (nauseated and really weak (first shot)). On 02-Apr-2021, the patient experienced CONDITION AGGRAVATED (After the second shot, her condition worsen she can hardly walk without any assistance). On an unknown date, the patient experienced MUSCULAR WEAKNESS (end of March when she felt weakness on her legs) and DYSSTASIA (not able to get up without pulling herself up resting her hands on the table). On 03-Mar-2021, PAIN IN EXTREMITY (pain in her arm (first shot)), ASTHENIA (nauseated and really weak (first shot)) and NAUSEA (nauseated and really weak (first shot)) outcome was unknown. At the time of the report, MUSCULAR WEAKNESS (end of March when she felt weakness on her legs), DYSSTASIA (not able to get up without pulling herself up resting her hands on the table) and CONDITION AGGRAVATED (After the second shot, her condition worsen she can hardly walk without any assistance) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-May-2021, Physical examination: to confirm Guillain Barre Syndrome coming from the Moderna Vaccine. On an unknown date, Nerve conduction studies: to confirm Guillain Barre Syndrome coming from the Moderna Vaccine.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Nerve conduction studies, Pain in extremity, Physical examination
Clinical narrative: end of March when she felt weakness on her legs; not able to get up without pulling herself up resting her hands on the table; After the second shot, her condition worsen she can hardly walk without any assistance; nauseated and really weak (first shot); pain in her arm (first shot); nauseated and really weak (first shot); This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (pain in her arm (first shot)), ASTHENIA (nauseated and really weak (first shot)), MUSCULAR WEAKNESS (end of March when she felt weakness on her legs), DYSSTASIA (not able to get up without pulling herself up resting her hands on the table) and CONDITION AGGRAVATED (After the second shot, her condition worsen she can hardly walk without any assistance) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no medical history reported).   On 02-Mar-2021, the patient received second 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-Mar-2021, the patient experienced PAIN IN EXTREMITY (pain in her arm (first shot)), ASTHENIA (nauseated and really weak (first shot)) and NAUSEA (nauseated and really weak (first shot)). On 02-Apr-2021, the patient experienced CONDITION AGGRAVATED (After the second shot, her condition worsen she can hardly walk without any assistance). On an unknown date, the patient experienced MUSCULAR WEAKNESS (end of March when she felt weakness on her legs) and DYSSTASIA (not able to get up without pulling herself up resting her hands on the table). On 03-Mar-2021, PAIN IN EXTREMITY (pain in her arm (first shot)), ASTHENIA (nauseated and really weak (first shot)) and NAUSEA (nauseated and really weak (first shot)) outcome was unknown. At the time of the report, MUSCULAR WEAKNESS (end of March when she felt weakness on her legs), DYSSTASIA (not able to get up without pulling herself up resting her hands on the table) and CONDITION AGGRAVATED (After the second shot, her condition worsen she can hardly walk without any assistance) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-May-2021, Physical examination: to confirm Guillain Barre Syndrome coming from the Moderna Vaccine. On an unknown date, Nerve conduction studies: to confirm Guillain Barre Syndrome coming from the Moderna Vaccine.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Induration, Mass, Swelling
Clinical narrative: Redness; Swelling; Hot; Hard lump; Hard lump; This spontaneous case was reported by a health care professional and describes the occurrence of ERYTHEMA (Redness), SWELLING (Swelling), FEELING HOT (Hot), MASS (Hard lump) and INDURATION (Hard lump) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Redness), SWELLING (Swelling), FEELING HOT (Hot), MASS (Hard lump) and INDURATION (Hard lump). At the time of the report, ERYTHEMA (Redness), SWELLING (Swelling), FEELING HOT (Hot), MASS (Hard lump) and INDURATION (Hard lump) 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 medication was not reported.   This case was linked to MOD-2021-128176, MOD-2021-128305, MOD-2021-128576, MOD-2021-128649,  INC.-MOD-2021-128643 (E2B Linked Report).; Sender's Comments:  INC.-MOD-2021-128176: MOD-2021-128305: MOD-2021-128576: MOD-2021-128649: INC.-MOD-2021-128643:
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Eczema, Gastritis, Influenza, Pyrexia
Clinical narrative: Vaccine minimal side effects; Eczema; Gastritis; flu; Pain; Tenderness; Fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Vaccine minimal side effects), ECZEMA (Eczema), GASTRITIS (Gastritis), INFLUENZA (flu) and ABDOMINAL PAIN (Pain) in a female patient of an unknown age 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 was reported.     On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Vaccine minimal side effects), ECZEMA (Eczema), GASTRITIS (Gastritis), INFLUENZA (flu), ABDOMINAL PAIN (Pain), TENDERNESS (Tenderness) and PYREXIA (Fever ). At the time of the report, VACCINATION COMPLICATION (Vaccine minimal side effects), ECZEMA (Eczema), GASTRITIS (Gastritis), INFLUENZA (flu), ABDOMINAL PAIN (Pain), TENDERNESS (Tenderness) and PYREXIA (Fever ) outcome was unknown.            No concomitant and treatment drugs are provided.   This case was linked to MOD-2021-025385 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Tenderness, Vaccination complication
Clinical narrative: Vaccine minimal side effects; Eczema; Gastritis; flu; Pain; Tenderness; Fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Vaccine minimal side effects), ECZEMA (Eczema), GASTRITIS (Gastritis), INFLUENZA (flu) and ABDOMINAL PAIN (Pain) in a female patient of an unknown age 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 was reported.     On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Vaccine minimal side effects), ECZEMA (Eczema), GASTRITIS (Gastritis), INFLUENZA (flu), ABDOMINAL PAIN (Pain), TENDERNESS (Tenderness) and PYREXIA (Fever ). At the time of the report, VACCINATION COMPLICATION (Vaccine minimal side effects), ECZEMA (Eczema), GASTRITIS (Gastritis), INFLUENZA (flu), ABDOMINAL PAIN (Pain), TENDERNESS (Tenderness) and PYREXIA (Fever ) outcome was unknown.            No concomitant and treatment drugs are provided.   This case was linked to MOD-2021-025385 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Exposure via breast milk
Clinical narrative: Vaccine exposure via breast milk; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-May-2021 and was forwarded to Moderna on 03-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (Vaccine exposure via breast milk) in a female patient of an unknown age exposed to mRNA-1273 (Moderna COVID-19 Vaccine) , while the mother received the product for COVID-19 vaccination.    MEDICAL HISTORY (Parent): The mother's past medical history included Maternal exposure during breast feeding.    No Medical History information was reported.    On an unknown date, the mother received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient was diagnosed with EXPOSURE VIA BREAST MILK (Vaccine exposure via breast milk). At the time of the report, EXPOSURE VIA BREAST MILK (Vaccine exposure via breast milk) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.   This case was linked to MOD-2021-037076 (E2B Linked Report). This case was linked to MOD-2021-037076 (Patient Link).; Sender's Comments:  MOD-2021-037076:
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (Shingles). At the time of the report, HERPES ZOSTER (Shingles) outcome was unknown.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Sleep disorder
Clinical narrative: Sleep disturbed; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP DISORDER (Sleep disturbed) and ARTHRALGIA (Joint pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SLEEP DISORDER (Sleep disturbed) and ARTHRALGIA (Joint pain). The patient was treated with ADALIMUMAB (HUMIRA) (subcutaneous) for Psoriatic arthritis, at an unspecified dose and frequency. At the time of the report, SLEEP DISORDER (Sleep disturbed) outcome was unknown and ARTHRALGIA (Joint pain) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.    No concomitant medications were reported.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Bone densitometry, Muscular weakness, Urticaria
Clinical narrative: feel weak that I cannot stand up; feel weakness in both my knees, from ankles to legs feels also weak, buckling under my knees; big red welt; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (big red welt), ASTHENIA (feel weak that I cannot stand up) and MUSCULAR WEAKNESS (feel weakness in both my knees, from ankles to legs feels also weak, buckling under my knees) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included VITAMIN C [ASCORBIC ACID], CYANOCOBALAMIN (B12 [CYANOCOBALAMIN]) and POTASSIUM for an unknown indication.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced URTICARIA (big red welt). On 22-Apr-2021, the patient experienced ASTHENIA (feel weak that I cannot stand up) and MUSCULAR WEAKNESS (feel weakness in both my knees, from ankles to legs feels also weak, buckling under my knees). At the time of the report, ASTHENIA (feel weak that I cannot stand up) and MUSCULAR WEAKNESS (feel weakness in both my knees, from ankles to legs feels also weak, buckling under my knees) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-May-2021, Bone densitometry: not reported (Inconclusive) Not reported.         Concomitant medication include blood pressure medications and thyroid medications.  No medications were taken for the symptoms.   This case was linked to MOD-2021-128578 (Patient Link).