chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis allergic, Erythema, Feeling abnormal, Headache, Lip swelling
Clinical narrative: small red spots on my skin; lips swollen; all my body was red; all my body was itchy; skin allergies or allergic reaction; Hives; I was feeling bad; All my body was in pain; Headaches; This spontaneous case was reported by a medical assistant (subsequently medically confirmed) and describes the occurrence of URTICARIA (Hives), RASH MACULAR (small red spots on my skin), LIP SWELLING (lips swollen), ERYTHEMA (all my body was red) and PRURITUS (all my body was itchy) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: HPV VACCINE VLP RL1 9V (YEAST) (HPV-9 vaccine manufacture is Gardasil 9 and given Intramuscular and dose is 3 of 3.) on 03-Dec-2020. Concurrent medical conditions included Hyperthyroidism and Drug allergy (Methimazole). Concomitant products included LEVOTHYROXINE and NORETHINDRONE [NORETHISTERONE] for an unknown indication.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Jan-2021, the patient experienced MYALGIA (All my body was in pain) and HEADACHE (Headaches). On 21-Jan-2021, the patient experienced FEELING ABNORMAL (I was feeling bad). On 22-Jan-2021, the patient experienced URTICARIA (Hives). On an unknown date, the patient experienced RASH MACULAR (small red spots on my skin), LIP SWELLING (lips swollen), ERYTHEMA (all my body was red) and PRURITUS (all my body was itchy). At the time of the report, URTICARIA (Hives), RASH MACULAR (small red spots on my skin), LIP SWELLING (lips swollen), ERYTHEMA (all my body was red), PRURITUS (all my body was itchy), MYALGIA (All my body was in pain) and HEADACHE (Headaches) had not resolved and FEELING ABNORMAL (I was feeling bad) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, White blood cell count: 14.3 (High) 14.3 K/ul.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medications are Medrol 4 mg oral, and stopped on 09 Feb 2021 and after consulting her PCP, the PCP doctor told patient to stop using that medication and start using Prednisone 10 mg. Dermatologist recommended Thamanolone for allergies.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Insignificant follow up received contains NNI.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pruritus, Rash macular, Urticaria, White blood cell count
Clinical narrative: small red spots on my skin; lips swollen; all my body was red; all my body was itchy; skin allergies or allergic reaction; Hives; I was feeling bad; All my body was in pain; Headaches; This spontaneous case was reported by a medical assistant (subsequently medically confirmed) and describes the occurrence of URTICARIA (Hives), RASH MACULAR (small red spots on my skin), LIP SWELLING (lips swollen), ERYTHEMA (all my body was red) and PRURITUS (all my body was itchy) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: HPV VACCINE VLP RL1 9V (YEAST) (HPV-9 vaccine manufacture is Gardasil 9 and given Intramuscular and dose is 3 of 3.) on 03-Dec-2020. Concurrent medical conditions included Hyperthyroidism and Drug allergy (Methimazole). Concomitant products included LEVOTHYROXINE and NORETHINDRONE [NORETHISTERONE] for an unknown indication.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Jan-2021, the patient experienced MYALGIA (All my body was in pain) and HEADACHE (Headaches). On 21-Jan-2021, the patient experienced FEELING ABNORMAL (I was feeling bad). On 22-Jan-2021, the patient experienced URTICARIA (Hives). On an unknown date, the patient experienced RASH MACULAR (small red spots on my skin), LIP SWELLING (lips swollen), ERYTHEMA (all my body was red) and PRURITUS (all my body was itchy). At the time of the report, URTICARIA (Hives), RASH MACULAR (small red spots on my skin), LIP SWELLING (lips swollen), ERYTHEMA (all my body was red), PRURITUS (all my body was itchy), MYALGIA (All my body was in pain) and HEADACHE (Headaches) had not resolved and FEELING ABNORMAL (I was feeling bad) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, White blood cell count: 14.3 (High) 14.3 K/ul.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medications are Medrol 4 mg oral, and stopped on 09 Feb 2021 and after consulting her PCP, the PCP doctor told patient to stop using that medication and start using Prednisone 10 mg. Dermatologist recommended Thamanolone for allergies.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Insignificant follow up received contains NNI.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Arm was sore at injection site after covid-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (Arm was sore at injection site after covid-19 vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Arm was sore at injection site after covid-19 vaccine). At the time of the report, VACCINATION SITE PAIN (Arm was sore at injection site after covid-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported  No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Developed COVID-19 after receiving Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Developed COVID-19 after receiving Moderna vaccine) 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 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Developed COVID-19 after receiving Moderna vaccine). At the time of the report, SARS-COV-2 TEST POSITIVE (Developed COVID-19 after receiving Moderna vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information, if any, was not provided by the reporter.  Treatment information, if any, was not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 31-May-2021: TCR added. Patient declined consent for further follow up and stated "everything is fine".
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Bursitis, Skin lesion, Tenderness
Clinical narrative: rectangular skin lesion (redness and erythema); rectangular skin lesion (redness, erythema) which is tender to touch on the inner aspect of her left thigh; tenderness on right shoulder jont; bursitis; This spontaneous case was reported by an other health care professional and describes the occurrence of TENDERNESS (tenderness on right shoulder jont), BURSITIS (bursitis), SKIN LESION (rectangular skin lesion (redness and erythema)) and TENDERNESS (rectangular skin lesion (redness, erythema) which is tender to touch on the inner aspect of her left thigh) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced TENDERNESS (tenderness on right shoulder jont) and BURSITIS (bursitis). On 03-May-2021, the patient experienced SKIN LESION (rectangular skin lesion (redness and erythema)) and TENDERNESS (rectangular skin lesion (redness, erythema) which is tender to touch on the inner aspect of her left thigh). The patient was treated with PARACETAMOL (TYLENOL) for Bursitis, at a dose of 1 dosage form. At the time of the report, TENDERNESS (tenderness on right shoulder jont), BURSITIS (bursitis), SKIN LESION (rectangular skin lesion (redness and erythema)) and TENDERNESS (rectangular skin lesion (redness, erythema) which is tender to touch on the inner aspect of her left thigh) 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.   Most recent FOLLOW-UP information incorporated above includes: On 31-May-2021: NNI.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Heart rate increased
Clinical narrative: raoid heartbeat; blood pressure went up; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (raoid heartbeat) and BLOOD PRESSURE INCREASED (blood pressure went up) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, the patient experienced HEART RATE INCREASED (raoid heartbeat) and BLOOD PRESSURE INCREASED (blood pressure went up). At the time of the report, HEART RATE INCREASED (raoid heartbeat) and BLOOD PRESSURE INCREASED (blood pressure went up) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: Increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: interval from the first shot was already 42 days; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (interval from the first shot was already 42 days) 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 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (interval from the first shot was already 42 days). On 16-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (interval from the first shot was already 42 days) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information, if any, was not provided by the reporter.  Treatment information, if any, was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: her arm became swollen; red and itchy; red and itchy; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (her arm became swollen), ERYTHEMA (red and itchy) and PRURITUS (red and itchy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 3001652) for COVID-19 vaccination.     Concomitant products included CLOZAPINE for Sleep disorder.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced PERIPHERAL SWELLING (her arm became swollen), ERYTHEMA (red and itchy) and PRURITUS (red and itchy). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (her arm became swollen), ERYTHEMA (red and itchy) and PRURITUS (red and itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 20-Apr-2021, the patient developed a rash which she describes as white on the inside and red on the outside, similar to a bull's eye and the rash 2.5 inches in diameter.  The patient mentioned she gently cleans her arm everyday with Isopropyl alcohol.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: light headache for 5 days; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (light headache for 5 days) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMINS NOS for an unknown indication.    On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced HEADACHE (light headache for 5 days). On 09-Apr-2021, HEADACHE (light headache for 5 days) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included unspecified thyroid medication (small dose). No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-104091 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: NNI.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-104091:Husband case
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: itchiness; swelling; Redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itchiness), VACCINATION SITE SWELLING (swelling) and VACCINATION SITE ERYTHEMA (Redness) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (itchiness), VACCINATION SITE SWELLING (swelling) and VACCINATION SITE ERYTHEMA (Redness). At the time of the report, VACCINATION SITE PRURITUS (itchiness), VACCINATION SITE SWELLING (swelling) and VACCINATION SITE ERYTHEMA (Redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information, if any, was not provided by the reporter.  Treatment information, if any, was not provided.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash erythematous
Clinical narrative: Red rash all over body; red rash which is itchy; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red rash all over body) and PRURITUS (red rash which is itchy) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) 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) 1 dosage form. On 03-May-2021, the patient experienced RASH ERYTHEMATOUS (Red rash all over body) and PRURITUS (red rash which is itchy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, RASH ERYTHEMATOUS (Red rash all over body) and PRURITUS (red rash which is itchy) outcome was unknown.            Concomitant product information as not provided by the reporter. Action taken with MRNA-1273 in response to the events was not applicable   Most recent FOLLOW-UP information incorporated above includes: On 31-May-2021: NNI.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Heart rate irregular, Tenderness
Clinical narrative: Heavy, irregular heartbeat after the 1st dose; tenderness in left arm; Chest pain after the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE IRREGULAR (Heavy, irregular heartbeat after the 1st dose), CHEST PAIN (Chest pain after the 1st dose) and TENDERNESS (tenderness in left arm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     Concurrent medical conditions included Atrial fibrillation.   On 30-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 HEART RATE IRREGULAR (Heavy, irregular heartbeat after the 1st dose), CHEST PAIN (Chest pain after the 1st dose) and TENDERNESS (tenderness in left arm). At the time of the report, HEART RATE IRREGULAR (Heavy, irregular heartbeat after the 1st dose), CHEST PAIN (Chest pain after the 1st dose) and TENDERNESS (tenderness in left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No treatment information was provided. No relevant concomitant medications reported.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chills, Pyrexia
Clinical narrative: back pain; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back pain), PYREXIA (fever) and CHILLS (chills) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMINS NOS for an unknown indication.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Apr-2021, the patient experienced BACK PAIN (back pain), PYREXIA (fever) and CHILLS (chills). At the time of the report, BACK PAIN (back pain), PYREXIA (fever) and CHILLS (chills) outcome was unknown.            Concomitant medication also include unspecified Blood pressure medication. Treatment medication was not reported.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient is past 42 days since 1st dose which was administered 16Mar2021; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient is past 42 days since 1st dose which was administered 16Mar2021) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient is past 42 days since 1st dose which was administered 16Mar2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient is past 42 days since 1st dose which was administered 16Mar2021) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was reported.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Electric shock sensation, Feeling abnormal, Pain, Pyrexia
Clinical narrative: Felt not myself 100%; Trembling on whole arm; A shock in the arm, like an electric thing; Felt "hot", had a temperature about 100.6F; Warm sensation on vaccination site; Stinging sensation on wrist; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt not myself 100%), PAIN (Stinging sensation on wrist), TREMOR (Trembling on whole arm), ELECTRIC SHOCK SENSATION (A shock in the arm, like an electric thing) and VACCINATION SITE WARMTH (Warm sensation on vaccination site) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concurrent medical conditions included Mental disorder NOS (mental health condition).   On 01-Apr-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 29-Apr-2021, the patient experienced PAIN (Stinging sensation on wrist) and VACCINATION SITE WARMTH (Warm sensation on vaccination site). On 30-Apr-2021, the patient experienced FEELING ABNORMAL (Felt not myself 100%), TREMOR (Trembling on whole arm), ELECTRIC SHOCK SENSATION (A shock in the arm, like an electric thing) and PYREXIA (Felt "hot", had a temperature about 100.6F). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. On 30-Apr-2021, FEELING ABNORMAL (Felt not myself 100%), TREMOR (Trembling on whole arm), ELECTRIC SHOCK SENSATION (A shock in the arm, like an electric thing) and PYREXIA (Felt "hot", had a temperature about 100.6F) had resolved, PAIN (Stinging sensation on wrist) outcome was unknown. At the time of the report, VACCINATION SITE WARMTH (Warm sensation on vaccination site) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Apr-2021, Body temperature: 100.6 (High) 100.6F.         Concomitant medication reported included a product for mental health condition (unspecified).   This case was linked to MOD-2021-101567 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor, Vaccination site warmth
Clinical narrative: Felt not myself 100%; Trembling on whole arm; A shock in the arm, like an electric thing; Felt "hot", had a temperature about 100.6F; Warm sensation on vaccination site; Stinging sensation on wrist; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt not myself 100%), PAIN (Stinging sensation on wrist), TREMOR (Trembling on whole arm), ELECTRIC SHOCK SENSATION (A shock in the arm, like an electric thing) and VACCINATION SITE WARMTH (Warm sensation on vaccination site) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concurrent medical conditions included Mental disorder NOS (mental health condition).   On 01-Apr-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 29-Apr-2021, the patient experienced PAIN (Stinging sensation on wrist) and VACCINATION SITE WARMTH (Warm sensation on vaccination site). On 30-Apr-2021, the patient experienced FEELING ABNORMAL (Felt not myself 100%), TREMOR (Trembling on whole arm), ELECTRIC SHOCK SENSATION (A shock in the arm, like an electric thing) and PYREXIA (Felt "hot", had a temperature about 100.6F). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. On 30-Apr-2021, FEELING ABNORMAL (Felt not myself 100%), TREMOR (Trembling on whole arm), ELECTRIC SHOCK SENSATION (A shock in the arm, like an electric thing) and PYREXIA (Felt "hot", had a temperature about 100.6F) had resolved, PAIN (Stinging sensation on wrist) outcome was unknown. At the time of the report, VACCINATION SITE WARMTH (Warm sensation on vaccination site) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Apr-2021, Body temperature: 100.6 (High) 100.6F.         Concomitant medication reported included a product for mental health condition (unspecified).   This case was linked to MOD-2021-101567 (Patient Link).
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Contusion, Diarrhoea, Dyspnoea, Headache
Clinical narrative: Leg pain; Calf Pain; Facial swelling; facial bruising; L side of the body started to swell/ swelling neck; left side of her neck (swelling); left jaw joint hurt so bad; shortness of breath; like her jaw was locked; not feeling well; diarrhea; sweating; headache/head was pounding; vomiting; chills; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Facial swelling), CONTUSION (facial bruising), DIARRHOEA (diarrhea), HYPERHIDROSIS (sweating) and SWELLING (L side of the body started to swell/ swelling neck) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (In spring 2020.) in 2020 and Bronchitis in January 2021.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, the patient experienced DIARRHOEA (diarrhea), HYPERHIDROSIS (sweating), MALAISE (not feeling well), HEADACHE (headache/head was pounding), VOMITING (vomiting) and CHILLS (chills). On an unknown date, the patient experienced SWELLING FACE (Facial swelling), CONTUSION (facial bruising), SWELLING (L side of the body started to swell/ swelling neck), SWELLING (left side of her neck (swelling)), PAIN IN JAW (left jaw joint hurt so bad), DYSPNOEA (shortness of breath), TRISMUS (like her jaw was locked), PAIN IN EXTREMITY (Calf Pain) and PAIN IN EXTREMITY (Leg pain). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, SWELLING FACE (Facial swelling), CONTUSION (facial bruising), DIARRHOEA (diarrhea), HYPERHIDROSIS (sweating), SWELLING (L side of the body started to swell/ swelling neck), SWELLING (left side of her neck (swelling)), PAIN IN JAW (left jaw joint hurt so bad), DYSPNOEA (shortness of breath), TRISMUS (like her jaw was locked), MALAISE (not feeling well), PAIN IN EXTREMITY (Calf Pain), PAIN IN EXTREMITY (Leg pain), VOMITING (vomiting) and CHILLS (chills) was resolving and HEADACHE (headache/head was pounding) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, SARS-CoV-2 antibody test positive: positive (Positive) positive.     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   This case was linked to MOD21-085334 (E2B Linked Report).; Sender's Comments:  MOD21-085334:
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Malaise, Pain in extremity, Pain in jaw, SARS-CoV-2 antibody test positive
Clinical narrative: Leg pain; Calf Pain; Facial swelling; facial bruising; L side of the body started to swell/ swelling neck; left side of her neck (swelling); left jaw joint hurt so bad; shortness of breath; like her jaw was locked; not feeling well; diarrhea; sweating; headache/head was pounding; vomiting; chills; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Facial swelling), CONTUSION (facial bruising), DIARRHOEA (diarrhea), HYPERHIDROSIS (sweating) and SWELLING (L side of the body started to swell/ swelling neck) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (In spring 2020.) in 2020 and Bronchitis in January 2021.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, the patient experienced DIARRHOEA (diarrhea), HYPERHIDROSIS (sweating), MALAISE (not feeling well), HEADACHE (headache/head was pounding), VOMITING (vomiting) and CHILLS (chills). On an unknown date, the patient experienced SWELLING FACE (Facial swelling), CONTUSION (facial bruising), SWELLING (L side of the body started to swell/ swelling neck), SWELLING (left side of her neck (swelling)), PAIN IN JAW (left jaw joint hurt so bad), DYSPNOEA (shortness of breath), TRISMUS (like her jaw was locked), PAIN IN EXTREMITY (Calf Pain) and PAIN IN EXTREMITY (Leg pain). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, SWELLING FACE (Facial swelling), CONTUSION (facial bruising), DIARRHOEA (diarrhea), HYPERHIDROSIS (sweating), SWELLING (L side of the body started to swell/ swelling neck), SWELLING (left side of her neck (swelling)), PAIN IN JAW (left jaw joint hurt so bad), DYSPNOEA (shortness of breath), TRISMUS (like her jaw was locked), MALAISE (not feeling well), PAIN IN EXTREMITY (Calf Pain), PAIN IN EXTREMITY (Leg pain), VOMITING (vomiting) and CHILLS (chills) was resolving and HEADACHE (headache/head was pounding) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, SARS-CoV-2 antibody test positive: positive (Positive) positive.     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   This case was linked to MOD21-085334 (E2B Linked Report).; Sender's Comments:  MOD21-085334:
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Swelling face, Trismus, Vomiting
Clinical narrative: Leg pain; Calf Pain; Facial swelling; facial bruising; L side of the body started to swell/ swelling neck; left side of her neck (swelling); left jaw joint hurt so bad; shortness of breath; like her jaw was locked; not feeling well; diarrhea; sweating; headache/head was pounding; vomiting; chills; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Facial swelling), CONTUSION (facial bruising), DIARRHOEA (diarrhea), HYPERHIDROSIS (sweating) and SWELLING (L side of the body started to swell/ swelling neck) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (In spring 2020.) in 2020 and Bronchitis in January 2021.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, the patient experienced DIARRHOEA (diarrhea), HYPERHIDROSIS (sweating), MALAISE (not feeling well), HEADACHE (headache/head was pounding), VOMITING (vomiting) and CHILLS (chills). On an unknown date, the patient experienced SWELLING FACE (Facial swelling), CONTUSION (facial bruising), SWELLING (L side of the body started to swell/ swelling neck), SWELLING (left side of her neck (swelling)), PAIN IN JAW (left jaw joint hurt so bad), DYSPNOEA (shortness of breath), TRISMUS (like her jaw was locked), PAIN IN EXTREMITY (Calf Pain) and PAIN IN EXTREMITY (Leg pain). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, SWELLING FACE (Facial swelling), CONTUSION (facial bruising), DIARRHOEA (diarrhea), HYPERHIDROSIS (sweating), SWELLING (L side of the body started to swell/ swelling neck), SWELLING (left side of her neck (swelling)), PAIN IN JAW (left jaw joint hurt so bad), DYSPNOEA (shortness of breath), TRISMUS (like her jaw was locked), MALAISE (not feeling well), PAIN IN EXTREMITY (Calf Pain), PAIN IN EXTREMITY (Leg pain), VOMITING (vomiting) and CHILLS (chills) was resolving and HEADACHE (headache/head was pounding) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, SARS-CoV-2 antibody test positive: positive (Positive) positive.     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   This case was linked to MOD21-085334 (E2B Linked Report).; Sender's Comments:  MOD21-085334:
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Rash erythematous
Clinical narrative: "rash" (red area) around the triceps on the right arm.; chills; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), RASH ERYTHEMATOUS ("rash" (red area) around the triceps on the right arm.) and CHILLS (chills) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIZZINESS (Dizziness). On 03-May-2021, the patient experienced RASH ERYTHEMATOUS ("rash" (red area) around the triceps on the right arm.) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and ACETYLSALICYLIC ACID (BABY ASPIRIN) for Adverse event, at an unspecified dose and frequency. At the time of the report, DIZZINESS (Dizziness) and CHILLS (chills) outcome was unknown and RASH ERYTHEMATOUS ("rash" (red area) around the triceps on the right arm.) had not resolved.            Concomitant product information, if any, was not provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-101553 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-101553:First Dose Case
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dysphonia, Eye swelling, Myalgia, Swelling face
Clinical narrative: left face was swollen; left eye was swollen; was hoarse; chills; body aches; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (left face was swollen), EYE SWELLING (left eye was swollen), DYSPHONIA (was hoarse), CHILLS (chills) and MYALGIA (body aches) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy NOS (Patient reported she has 27 allergies and her body chemistry's just crazy) and Vascular disorder (left leg vascular problems).    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced SWELLING FACE (left face was swollen), EYE SWELLING (left eye was swollen), DYSPHONIA (was hoarse), CHILLS (chills) and MYALGIA (body aches). At the time of the report, SWELLING FACE (left face was swollen), EYE SWELLING (left eye was swollen), DYSPHONIA (was hoarse), CHILLS (chills) and MYALGIA (body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information, if any, was not provided by the reporter.  Treatment information, if any, was not provided.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: UTI; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (UTI) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced URINARY TRACT INFECTION (UTI). At the time of the report, URINARY TRACT INFECTION (UTI) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information, if any, was not provided by the reporter.  Patient was prescribed 2 types of antibiotics (unspecified) by a physician for the UTI but not known if patient has begun taking them.
Age: 16.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 16yr old patient was administered the vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16yr old patient was administered the vaccine) in a 16-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16yr old patient was administered the vaccine). On 30-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16yr old patient was administered the vaccine) 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 relevant concomitant medications were reported.  Treatment information was not provided.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dark circles under eyes, Decreased appetite, Dyspnoea, Fatigue
Clinical narrative: Dark circle around eyes; Loss of appetite; Out of breath on exertion; Loss of weight; Nausea; Tired; Muscle ache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DARK CIRCLES UNDER EYES (Dark circle around eyes), DECREASED APPETITE (Loss of appetite), DYSPNOEA (Out of breath on exertion), WEIGHT DECREASED (Loss of weight) and NAUSEA (Nausea) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-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 22-Apr-2021, the patient experienced DARK CIRCLES UNDER EYES (Dark circle around eyes), DECREASED APPETITE (Loss of appetite), DYSPNOEA (Out of breath on exertion), WEIGHT DECREASED (Loss of weight), NAUSEA (Nausea), FATIGUE (Tired), MYALGIA (Muscle ache) and CHILLS (Chills). At the time of the report, DARK CIRCLES UNDER EYES (Dark circle around eyes), DECREASED APPETITE (Loss of appetite), DYSPNOEA (Out of breath on exertion), WEIGHT DECREASED (Loss of weight), NAUSEA (Nausea), FATIGUE (Tired), MYALGIA (Muscle ache) and CHILLS (Chills) had not resolved.            Concomitant product information, if any, was not provided by the reporter.  Treatment information, if any, was not provided.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Weight decreased
Clinical narrative: Dark circle around eyes; Loss of appetite; Out of breath on exertion; Loss of weight; Nausea; Tired; Muscle ache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DARK CIRCLES UNDER EYES (Dark circle around eyes), DECREASED APPETITE (Loss of appetite), DYSPNOEA (Out of breath on exertion), WEIGHT DECREASED (Loss of weight) and NAUSEA (Nausea) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-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 22-Apr-2021, the patient experienced DARK CIRCLES UNDER EYES (Dark circle around eyes), DECREASED APPETITE (Loss of appetite), DYSPNOEA (Out of breath on exertion), WEIGHT DECREASED (Loss of weight), NAUSEA (Nausea), FATIGUE (Tired), MYALGIA (Muscle ache) and CHILLS (Chills). At the time of the report, DARK CIRCLES UNDER EYES (Dark circle around eyes), DECREASED APPETITE (Loss of appetite), DYSPNOEA (Out of breath on exertion), WEIGHT DECREASED (Loss of weight), NAUSEA (Nausea), FATIGUE (Tired), MYALGIA (Muscle ache) and CHILLS (Chills) had not resolved.            Concomitant product information, if any, was not provided by the reporter.  Treatment information, if any, was not provided.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: not feeling well; This spontaneous case was reported by a pharmacist and describes the occurrence of MALAISE (not feeling well) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MALAISE (not feeling well). At the time of the report, MALAISE (not feeling well) 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.  Action taken with mRNA-1273 in response to the event was unknown
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Disorientation, Dizziness, Fall, Feeling abnormal
Clinical narrative: fell down; Back pain; Disoriented; Extremely sick; Felt like pulling brain out/felt like going to die; Dizzy; Back pain; could not get up; memory was gone; This spontaneous case was reported by a consumer and describes the occurrence of DISORIENTATION (Disoriented), ILLNESS (Extremely sick), FEELING ABNORMAL (Felt like pulling brain out/felt like going to die), DIZZINESS (Dizzy) and the first episode of BACK PAIN (Back pain) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Lyme's disease, Bartonellosis (part of Lyme's disease) and Relapsing fever. Concurrent medical conditions included Allergy to antibiotic and Drug allergy (Codeine).    On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced DISORIENTATION (Disoriented), ILLNESS (Extremely sick), FEELING ABNORMAL (Felt like pulling brain out/felt like going to die), DIZZINESS (Dizzy), the first episode of BACK PAIN (Back pain), HYPOKINESIA (could not get up), MEMORY IMPAIRMENT (memory was gone) and the second episode of BACK PAIN (Back pain). On 03-May-2021, the patient experienced FALL (fell down). The patient was treated with LORATADINE ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, DISORIENTATION (Disoriented) and DIZZINESS (Dizzy) had not resolved and ILLNESS (Extremely sick), FEELING ABNORMAL (Felt like pulling brain out/felt like going to die), HYPOKINESIA (could not get up), MEMORY IMPAIRMENT (memory was gone), FALL (fell down) and the last episode of BACK PAIN (Back pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  Treatment medicine include Loratadine  Action taken with mRNA-1273 in response to the event was unknown
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Hypokinesia, Illness, Memory impairment
Clinical narrative: fell down; Back pain; Disoriented; Extremely sick; Felt like pulling brain out/felt like going to die; Dizzy; Back pain; could not get up; memory was gone; This spontaneous case was reported by a consumer and describes the occurrence of DISORIENTATION (Disoriented), ILLNESS (Extremely sick), FEELING ABNORMAL (Felt like pulling brain out/felt like going to die), DIZZINESS (Dizzy) and the first episode of BACK PAIN (Back pain) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Lyme's disease, Bartonellosis (part of Lyme's disease) and Relapsing fever. Concurrent medical conditions included Allergy to antibiotic and Drug allergy (Codeine).    On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced DISORIENTATION (Disoriented), ILLNESS (Extremely sick), FEELING ABNORMAL (Felt like pulling brain out/felt like going to die), DIZZINESS (Dizzy), the first episode of BACK PAIN (Back pain), HYPOKINESIA (could not get up), MEMORY IMPAIRMENT (memory was gone) and the second episode of BACK PAIN (Back pain). On 03-May-2021, the patient experienced FALL (fell down). The patient was treated with LORATADINE ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, DISORIENTATION (Disoriented) and DIZZINESS (Dizzy) had not resolved and ILLNESS (Extremely sick), FEELING ABNORMAL (Felt like pulling brain out/felt like going to die), HYPOKINESIA (could not get up), MEMORY IMPAIRMENT (memory was gone), FALL (fell down) and the last episode of BACK PAIN (Back pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  Treatment medicine include Loratadine  Action taken with mRNA-1273 in response to the event was unknown