chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Hypoaesthesia, Injected limb mobility decreased, Injection site rash, Injection site swelling
Clinical narrative: pain, couldn't lift my arm; my finges would turn colors; my hand and fingers were starting to go numb; it fluctuates between a burning sensation and my skin is being pulled; pain, couldn't lift my arm; tissue damage in that area; rash; pretty extensive swelling, just centrally located where the injection site was; went to bed with an itchy arm at night; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INJECTION SITE SWELLING (pretty extensive swelling, just centrally located where the injection site was), PAIN IN EXTREMITY (pain, couldn't lift my arm) and TISSUE INJURY (tissue damage in that area) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced INJECTION SITE SWELLING (pretty extensive swelling, just centrally located where the injection site was). On 13-Jan-2021, the patient experienced TISSUE INJURY (tissue damage in that area). On an unknown date, the patient experienced PAIN IN EXTREMITY (pain, couldn't lift my arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, INJECTION SITE SWELLING (pretty extensive swelling, just centrally located where the injection site was), PAIN IN EXTREMITY (pain, couldn't lift my arm) and TISSUE INJURY (tissue damage in that area) 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.   Patient went to the emergency room on 05Jan2021 and reported using Benadryl topical cream on 05Jan2021 but stopped using it. On 11Jan2021, patient went to her primary care doctor. On13Jan2021 at urgent care, an x-ray showed that patient experienced tissue damage in that area. Concomitant medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Follow up received on 08JUN-2021 contains of  new Adverse Event  added, reporter information added.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Skin discolouration, Tissue injury
Clinical narrative: pain, couldn't lift my arm; my finges would turn colors; my hand and fingers were starting to go numb; it fluctuates between a burning sensation and my skin is being pulled; pain, couldn't lift my arm; tissue damage in that area; rash; pretty extensive swelling, just centrally located where the injection site was; went to bed with an itchy arm at night; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INJECTION SITE SWELLING (pretty extensive swelling, just centrally located where the injection site was), PAIN IN EXTREMITY (pain, couldn't lift my arm) and TISSUE INJURY (tissue damage in that area) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced INJECTION SITE SWELLING (pretty extensive swelling, just centrally located where the injection site was). On 13-Jan-2021, the patient experienced TISSUE INJURY (tissue damage in that area). On an unknown date, the patient experienced PAIN IN EXTREMITY (pain, couldn't lift my arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, INJECTION SITE SWELLING (pretty extensive swelling, just centrally located where the injection site was), PAIN IN EXTREMITY (pain, couldn't lift my arm) and TISSUE INJURY (tissue damage in that area) 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.   Patient went to the emergency room on 05Jan2021 and reported using Benadryl topical cream on 05Jan2021 but stopped using it. On 11Jan2021, patient went to her primary care doctor. On13Jan2021 at urgent care, an x-ray showed that patient experienced tissue damage in that area. Concomitant medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Follow up received on 08JUN-2021 contains of  new Adverse Event  added, reporter information added.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: body aches; Chills; fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of   in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: No newinformation.; 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: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Skin reaction, Vaccination site pain
Clinical narrative: little cold; it was a delayed hypersensitive reaction (the injection site raised and started to be hot, red, a little itchy and swollen, being 2 inches in diameter.; little tired; Pain on her arm; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Administered in biceps), SKIN REACTION (it was a delayed hypersensitive reaction (the injection site raised and started to be hot, red, a little itchy and swollen, being 2 inches in diameter.), FATIGUE (little tired), CHILLS (little cold) and VACCINATION SITE PAIN (Pain on her arm) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 immunisation.  The patient's past medical history included No adverse event (No reported medical history). Concomitant products included ESCITALOPRAM (LEXAPRO) for an unknown indication.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced FATIGUE (little tired), CHILLS (little cold) and VACCINATION SITE PAIN (Pain on her arm). On 15-Jan-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Administered in biceps) and SKIN REACTION (it was a delayed hypersensitive reaction (the injection site raised and started to be hot, red, a little itchy and swollen, being 2 inches in diameter.). The patient was treated with Wound care (kept the site with ice) for Skin reaction. On 11-Jan-2021, FATIGUE (little tired), CHILLS (little cold) and VACCINATION SITE PAIN (Pain on her arm) had resolved. On 15-Jan-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Administered in biceps) had resolved. At the time of the report, SKIN REACTION (it was a delayed hypersensitive reaction (the injection site raised and started to be hot, red, a little itchy and swollen, being 2 inches in diameter.) outcome was unknown.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  Treatment included, Benadryl + hydrocortisone cream + ibuprofen + ice (For the symptoms that started on 15Jan2021 she took on 16jan2021 Benadryl and a Hydrocortisone cream, and kept the site with ice.  This case was linked to MOD-2021-005636 (E2B Linked Report).  Most recent FOLLOW-UP information incorporated above includes: On 19-Jan-2021: New event and urgent care visit  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. MOD-2021-005636:Cross linked
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia, Vaccination site pruritus
Clinical narrative: itching every where like chest back and arms; Itchy at the injection site; slight fever; This spontaneous case was reported by an other health care professional and describes the occurrence of PRURITUS (itching every where like chest back and arms), VACCINATION SITE PRURITUS (Itchy at the injection site) and PYREXIA (slight fever) in an 88-year-old male patient 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 PRURITUS (itching every where like chest back and arms), VACCINATION SITE PRURITUS (Itchy at the injection site) and PYREXIA (slight fever). At the time of the report, PRURITUS (itching every where like chest back and arms), VACCINATION SITE PRURITUS (Itchy at the injection site) and PYREXIA (slight fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were provided. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jan-2021: Reporter details, patient details and events were added.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria, Vaccination site pain
Clinical narrative: legs, arm, abs, back and head was itchy, some raised some dots; Full rash on the body, red rash around injection site; little itchy on the back of her neck and back; Sore arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (little itchy on the back of her neck and back), URTICARIA (legs, arm, abs, back and head was itchy, some raised some dots), RASH (Full rash on the body, red rash around injection site) and VACCINATION SITE PAIN (Sore arm) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced VACCINATION SITE PAIN (Sore arm). On 05-Jan-2021, the patient experienced PRURITUS (little itchy on the back of her neck and back). On 06-Jan-2021, the patient experienced URTICARIA (legs, arm, abs, back and head was itchy, some raised some dots) and RASH (Full rash on the body, red rash around injection site). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) on 06-Jan-2021 for Rash all over, at an unspecified dose and frequency. On 07-Jan-2021, RASH (Full rash on the body, red rash around injection site) had resolved. At the time of the report, PRURITUS (little itchy on the back of her neck and back) had not resolved, URTICARIA (legs, arm, abs, back and head was itchy, some raised some dots) outcome was unknown and VACCINATION SITE PAIN (Sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Felt very tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Felt very tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 18-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2021, the patient experienced FATIGUE (Felt very tired). At the time of the report, FATIGUE (Felt very tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment details were not provided; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: Bad headache; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Bad headache) and NAUSEA (Nauseous) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported adverse event).    On 15-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 18-Jan-2021, the patient experienced HEADACHE (Bad headache) and NAUSEA (Nauseous). At the time of the report, HEADACHE (Bad headache) and NAUSEA (Nauseous) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia, Vaccination site erythema, Vaccination site pain
Clinical narrative: Pain on the injection site; A little redness on the injection site; Numbness in the face; Tingling in the face; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PAIN (Pain on the injection site), VACCINATION SITE ERYTHEMA (A little redness on the injection site), HYPOAESTHESIA (Numbness in the face) and PARAESTHESIA (Tingling in the face) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Dec-2020, the patient experienced HYPOAESTHESIA (Numbness in the face) and PARAESTHESIA (Tingling in the face). On 24-Dec-2020, the patient experienced VACCINATION SITE PAIN (Pain on the injection site) and VACCINATION SITE ERYTHEMA (A little redness on the injection site). On 22-Dec-2020, HYPOAESTHESIA (Numbness in the face) and PARAESTHESIA (Tingling in the face) had resolved. On 25-Dec-2020, VACCINATION SITE PAIN (Pain on the injection site) and VACCINATION SITE ERYTHEMA (A little redness on the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site urticaria, Vaccination site warmth
Clinical narrative: Hot; Itchy; Red; Red welt at injection site; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE URTICARIA (Red welt at injection site), VACCINATION SITE WARMTH (Hot), VACCINATION SITE PRURITUS (Itchy) and VACCINATION SITE ERYTHEMA (Red) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced VACCINATION SITE URTICARIA (Red welt at injection site). On an unknown date, the patient experienced VACCINATION SITE WARMTH (Hot), VACCINATION SITE PRURITUS (Itchy) and VACCINATION SITE ERYTHEMA (Red). At the time of the report, VACCINATION SITE URTICARIA (Red welt at injection site), VACCINATION SITE WARMTH (Hot), VACCINATION SITE PRURITUS (Itchy) and VACCINATION SITE ERYTHEMA (Red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.   The patient observed a red welt at injection site but then it went away. Then it suddenly came back, the welt was a one inch circle in diameter. It was hot red itchy and there was no discharge from it. The patient did not take any medications to treat the symptoms.
Sex: M
Vaccine: COVID19
Symptoms: Flatulence, Musculoskeletal stiffness, Pain, Respiration abnormal
Clinical narrative: Achy/ Pain; Stiff leg; Passing Gas; Breathing not normal; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy/ Pain), MUSCULOSKELETAL STIFFNESS (Stiff leg), FLATULENCE (Passing Gas) and RESPIRATION ABNORMAL (Breathing not normal) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03CQOA) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included RIVAROXABAN (XARELTO) for an unknown indication.    On 17-Jan-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 (Achy/ Pain), MUSCULOSKELETAL STIFFNESS (Stiff leg), FLATULENCE (Passing Gas) and RESPIRATION ABNORMAL (Breathing not normal). At the time of the report, PAIN (Achy/ Pain), MUSCULOSKELETAL STIFFNESS (Stiff leg), FLATULENCE (Passing Gas) and RESPIRATION ABNORMAL (Breathing not normal) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Fatigue
Clinical narrative: COVID-19; Loss of Taste; Loss of Smell; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), AGEUSIA (Loss of Taste), ANOSMIA (Loss of Smell) and COVID-19 (COVID-19) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced FATIGUE (Fatigue). On 10-Jan-2021, the patient experienced AGEUSIA (Loss of Taste) and ANOSMIA (Loss of Smell). On 13-Jan-2021, the patient experienced COVID-19 (COVID-19). At the time of the report, FATIGUE (Fatigue), AGEUSIA (Loss of Taste), ANOSMIA (Loss of Smell) and COVID-19 (COVID-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  Treatment of the events were not reported.; Sender's Comments: Although a temporal association exists, based on the current available information, mechanism of action of mRNA-1237 vaccine and the pathogenesis process of Covid-19 infection, the events are assessed as unlikely related.
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: Scratchy throat; This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (Scratchy throat) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced THROAT IRRITATION (Scratchy throat). At the time of the report, THROAT IRRITATION (Scratchy throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: NNI; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Muscular weakness, Myalgia, Paraesthesia, Vaccination site pain
Clinical narrative: injection site was still a little sore; Muscle sore on neck and shoulders; Muscle sore on neck in both sides,scle sore on shoulders; fingers started tingling and weak; all of a sudden neck fot kind of tied and weak; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (fingers started tingling and weak), MUSCULAR WEAKNESS (all of a sudden neck fot kind of tied and weak), VACCINATION SITE PAIN (injection site was still a little sore), ARTHRALGIA (Muscle sore on neck and shoulders) and MYALGIA (Muscle sore on neck in both sides,scle sore on shoulders) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.    Co-suspect product included non-company product LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    Concomitant products included CALCIUM and FISH OIL (OMEGA 3 6 9 [FISH OIL]).   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started LEVOTHYROXINE SODIUM (SYNTHROID) (unknown route) at an unspecified dose. On 18-Jan-2021, the patient experienced PARAESTHESIA (fingers started tingling and weak), MUSCULAR WEAKNESS (all of a sudden neck fot kind of tied and weak), ARTHRALGIA (Muscle sore on neck and shoulders) and MYALGIA (Muscle sore on neck in both sides,scle sore on shoulders). On an unknown date, the patient experienced VACCINATION SITE PAIN (injection site was still a little sore). At the time of the report, PARAESTHESIA (fingers started tingling and weak), MUSCULAR WEAKNESS (all of a sudden neck fot kind of tied and weak), VACCINATION SITE PAIN (injection site was still a little sore), ARTHRALGIA (Muscle sore on neck and shoulders) and MYALGIA (Muscle sore on neck in both sides,scle sore on shoulders) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Dry skin, Feeling abnormal, Lymphadenopathy, Pain in extremity
Clinical narrative: Small dry patch; Rash (red, raised, hot); felt like my lymph nodes were inflamed; Armpit tenderness; My arm was sore; Brain fog; A spontaneous report was received from a healthcare professional, a 39 year-old female patient, who received Moderna's COVID-19 Vaccine and experienced arm was sore, brain fog, armpit tenderness, felt like lymph nodes were inflamed, rash (red, raised, hot), and small dry patch.  The patient's medical history was not provided. Concomitant product use was not provided.  On 23 Dec 2020, prior to the onset of events, the patient received the first of two planned doses of mRNA-1273 (batch number not provided) intramuscularly in the right deltoid for COVID-19 infection prophylaxis.   The patient stated that her arm was sore for and that it was not like any other soreness she had after receiving other shots. She reported that 3 hours after the shot she had brain fog.  On 29 Dec 2020, the patient experienced armpit tenderness in the same arm she received the shot that lasted a week or more. She reported that it felt like her lymph nodes were inflamed. The patient stated she had an ultrasound and it was okay.  On 04 Jan 2021, the patient developed a rash that was raised, red and hot. She stated that it was better but she still had a small, dry patch. Treatment for the events included triamcinolone.  Traimcinolone included as treatment drug.  Action taken with mRNA-1273 in response to the events was unknown.   The brain fog, was considered resolved on 23 Dec 2020. The arm was sore, was considered resolved on 28 Dec 2020. The armpit tenderness and felt like my lymph nodes were inflamed, were considered resolved on an unknown date.  The rash was considered resolving. The small dry patch, was considered not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Ultrasound scan normal
Clinical narrative: Small dry patch; Rash (red, raised, hot); felt like my lymph nodes were inflamed; Armpit tenderness; My arm was sore; Brain fog; A spontaneous report was received from a healthcare professional, a 39 year-old female patient, who received Moderna's COVID-19 Vaccine and experienced arm was sore, brain fog, armpit tenderness, felt like lymph nodes were inflamed, rash (red, raised, hot), and small dry patch.  The patient's medical history was not provided. Concomitant product use was not provided.  On 23 Dec 2020, prior to the onset of events, the patient received the first of two planned doses of mRNA-1273 (batch number not provided) intramuscularly in the right deltoid for COVID-19 infection prophylaxis.   The patient stated that her arm was sore for and that it was not like any other soreness she had after receiving other shots. She reported that 3 hours after the shot she had brain fog.  On 29 Dec 2020, the patient experienced armpit tenderness in the same arm she received the shot that lasted a week or more. She reported that it felt like her lymph nodes were inflamed. The patient stated she had an ultrasound and it was okay.  On 04 Jan 2021, the patient developed a rash that was raised, red and hot. She stated that it was better but she still had a small, dry patch. Treatment for the events included triamcinolone.  Traimcinolone included as treatment drug.  Action taken with mRNA-1273 in response to the events was unknown.   The brain fog, was considered resolved on 23 Dec 2020. The arm was sore, was considered resolved on 28 Dec 2020. The armpit tenderness and felt like my lymph nodes were inflamed, were considered resolved on an unknown date.  The rash was considered resolving. The small dry patch, was considered not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Severe amount of fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FATIGUE (Severe amount of fatigue) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1. On an unknown date, the patient experienced FATIGUE (Severe amount of fatigue). At the time of the report, FATIGUE (Severe amount of fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment information provided.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Swelling
Clinical narrative: fever; rigors; swelling; This spontaneous case was reported by an other health care professional and describes the occurrence of   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.        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.   Reporter did not allow further contact
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Fatigue, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Fatigue; itchiness; soreness around the injection site; redness size of a quarter; Nausea; Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant), NAUSEA (nausea), FATIGUE (fatigue), INJECTION SITE PAIN (soreness around the injection site) and INJECTION SITE ERYTHEMA (redness size of a quarter) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.  Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 10-Sep-2020 and the estimated date of delivery was 17-Jun-2021. On 27-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). On 28-Jan-2021, the patient experienced NAUSEA (nausea), FATIGUE (fatigue), INJECTION SITE PAIN (soreness around the injection site) and INJECTION SITE ERYTHEMA (redness size of a quarter). On 02-Feb-2021, the patient experienced INJECTION SITE PRURITUS (itchiness). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the nineteenth week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 27-Jan-2021, EXPOSURE DURING PREGNANCY (Pregnant) had resolved. On 29-Jan-2021, NAUSEA (nausea), FATIGUE (fatigue), INJECTION SITE PAIN (soreness around the injection site) and INJECTION SITE ERYTHEMA (redness size of a quarter) had resolved. At the time of the report, INJECTION SITE PRURITUS (itchiness) outcome was unknown. Not Provided   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    No treatment information was reported.  Most recent FOLLOW-UP information incorporated above includes: On 05-Feb-2021: events were added in the event tab
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Fatigue; itchiness; soreness around the injection site; redness size of a quarter; Nausea; Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant), NAUSEA (nausea), FATIGUE (fatigue), INJECTION SITE PAIN (soreness around the injection site) and INJECTION SITE ERYTHEMA (redness size of a quarter) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.  Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 10-Sep-2020 and the estimated date of delivery was 17-Jun-2021. On 27-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). On 28-Jan-2021, the patient experienced NAUSEA (nausea), FATIGUE (fatigue), INJECTION SITE PAIN (soreness around the injection site) and INJECTION SITE ERYTHEMA (redness size of a quarter). On 02-Feb-2021, the patient experienced INJECTION SITE PRURITUS (itchiness). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the nineteenth week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 27-Jan-2021, EXPOSURE DURING PREGNANCY (Pregnant) had resolved. On 29-Jan-2021, NAUSEA (nausea), FATIGUE (fatigue), INJECTION SITE PAIN (soreness around the injection site) and INJECTION SITE ERYTHEMA (redness size of a quarter) had resolved. At the time of the report, INJECTION SITE PRURITUS (itchiness) outcome was unknown. Not Provided   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    No treatment information was reported.  Most recent FOLLOW-UP information incorporated above includes: On 05-Feb-2021: events were added in the event tab
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle twitching, Pain
Clinical narrative: twitching; pain; A spontaneous report was received from a non healthcare professional who was 70 years old male patient who received Moderna's COVID-19 vaccine. Caller reported adverse event following Moderna vaccine on 16JAN2021. Symptoms included twitching and pain.   Patients medical history was not available. His concomitant medication included simvastatin for cholesterol,Tamsulosin for prostate and hydrochlorothiazide for water retention. The start date or stop date of these medications were not provided. Treatment provided was unknown.  Action taken with mRNA -1273 was not available.  The outcome of events ,twitching and pain are unknown.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Pregnancy test
Clinical narrative: Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnancy) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (sulfa drugs) and Allergy (mild environmental allergies). Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for an unknown indication.    On 27-Jan-2021 at 2:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 06-Nov-2020 and the estimated date of delivery was 13-Aug-2021. On 27-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  eleventh week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. At the time of the report, EXPOSURE DURING PREGNANCY (Pregnancy) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, Pregnancy test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information  was reported.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 37-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sex: U
Vaccine: COVID19
Symptoms: Hypoglycaemia
Clinical narrative: Hypoglycaemia; This spontaneous case was reported by a consumer and describes the occurrence of HYPOGLYCAEMIA (Hypoglycaemia) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes mellitus insulin-dependent, Addison's disease, Pernicious anemia and Hashimoto's disease.    On 15-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 15-Jan-2021, the patient experienced HYPOGLYCAEMIA (Hypoglycaemia). At the time of the report, HYPOGLYCAEMIA (Hypoglycaemia) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 19-Jan-2021: some of the medical history is added On 02-Feb-2021: No specific follow-up information recorded.; Sender's Comments: Although a temporal association exists, based on the current available information, mechanism of action of mRNA-1237 vaccine and the patient's concurrent condition of autoimmune polyendocrine syndrome, the event hypoglycemia is assessed as unlikely related.
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swelling under armpits; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swelling under armpits) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (Swelling under armpits). At the time of the report, LYMPHADENOPATHY (Swelling under armpits) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Injection site urticaria
Clinical narrative: Developed Urticaria; This spontaneous case was reported by an other health care professional and describes the occurrence of INJECTION SITE URTICARIA (Developed Urticaria) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   No Medical History was provided by the reporter. Concurrent medical conditions included Penicillin allergy.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced INJECTION SITE URTICARIA (Developed Urticaria). At the time of the report, INJECTION SITE URTICARIA (Developed Urticaria) 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.   Concomitant product use was not provided by the reporter. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Diarrhoea, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: itching, red; itching, red; arm is swollen; Abdominal cramps; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (Abdominal cramps), DIARRHOEA (Diarrhea), VACCINATION SITE PRURITUS (itching, red), VACCINATION SITE ERYTHEMA (itching, red) and VACCINATION SITE SWELLING (arm is swollen) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced ABDOMINAL PAIN (Abdominal cramps), DIARRHOEA (Diarrhea) and VACCINATION SITE SWELLING (arm is swollen). On 14-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (itching, red) and VACCINATION SITE ERYTHEMA (itching, red). At the time of the report, ABDOMINAL PAIN (Abdominal cramps), DIARRHOEA (Diarrhea), VACCINATION SITE PRURITUS (itching, red), VACCINATION SITE ERYTHEMA (itching, red) and VACCINATION SITE SWELLING (arm is swollen) 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. Treatment information was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Erythema, Fatigue, Feeling hot, Headache
Clinical narrative: hives; fatigue; arm is hot; arm swollen and later csame in the news as Moderna Arm; Redness in the arm (dime-sized); Headache; Earache; Pain in arm; This spontaneous case was reported by a physician and describes the occurrence of MYALGIA (Pain in arm) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Soy allergy, Shellfish allergy and Egg allergy.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced MYALGIA (Pain in arm). At the time of the report, MYALGIA (Pain in arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided.    Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2021: No specific follow-up information recorded. On 23-Jun-2021: Non-Significant follow-up Appended
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Urticaria
Clinical narrative: hives; fatigue; arm is hot; arm swollen and later csame in the news as Moderna Arm; Redness in the arm (dime-sized); Headache; Earache; Pain in arm; This spontaneous case was reported by a physician and describes the occurrence of MYALGIA (Pain in arm) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Soy allergy, Shellfish allergy and Egg allergy.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced MYALGIA (Pain in arm). At the time of the report, MYALGIA (Pain in arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided.    Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2021: No specific follow-up information recorded. On 23-Jun-2021: Non-Significant follow-up Appended
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Injection site was warm; Red circle around the injection site; Injection site perhaps a little bit raised; injection wite like a mosquito bite, wanted to scratch because it was itchy; Injection site a little sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site was warm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypercholesteraemia. Concomitant products included IBUPROFEN (ADVIL [IBUPROFEN]) for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Injection site was warm). At the time of the report, VACCINATION SITE WARMTH (Injection site was warm) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant drug included cholesterol medicine. Treatment medication was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Follow-up information received on 04-JUN-2021 contains non-significant information.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Pyrexia, Vaccination site swelling
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (arm was swollen a little bit), PYREXIA (fever), AGEUSIA (No sense of taste) and ANOSMIA (No sense of smell) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced VACCINATION SITE SWELLING (arm was swollen a little bit) and PYREXIA (fever). On 16-Jan-2021, the patient experienced AGEUSIA (No sense of taste) and ANOSMIA (No sense of smell). On 15-Jan-2021, VACCINATION SITE SWELLING (arm was swollen a little bit) and PYREXIA (fever) had resolved. At the time of the report, AGEUSIA (No sense of taste) and ANOSMIA (No sense of smell) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information provided.