chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Disturbance in attention, Insomnia, SARS-CoV-2 test positive
Clinical narrative: cannot go to work or focus properly; covid-19 positive; insomnia; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INSOMNIA (insomnia), DISTURBANCE IN ATTENTION (cannot go to work or focus properly) and SARS-COV-2 TEST POSITIVE (covid-19 positive) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 10-Jan-2021. Concurrent medical conditions included Hypertension since 03-Mar-1997 and Hyperlipidemia since 03-Mar-1997. Concomitant products included METOPROLOL from 03-Jan-2000 to an unknown date and FENOFIBRATE from 03-Jan-2000 to an unknown date for an unknown indication.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Jan-2021, the patient experienced INSOMNIA (insomnia) and SARS-COV-2 TEST POSITIVE (covid-19 positive). On an unknown date, the patient experienced DISTURBANCE IN ATTENTION (cannot go to work or focus properly). At the time of the report, INSOMNIA (insomnia) and DISTURBANCE IN ATTENTION (cannot go to work or focus properly) had not resolved and SARS-COV-2 TEST POSITIVE (covid-19 positive) outcome was unknown.            More information during hospital admission included, Vipassana meditation for 15 minutes, Art of living meditation for 15 minutes, Walking 2 miles for 45 minutes, sit ups, arms swinging for 15 minutes. Treatment information not provided.  Based on the natural history of COVID-19, and the established information about the mRNA-1273 vaccine, a causal association between the event of Covid-19 positive and the product use is assessed as unlikely.  Event was most-likely pre-existing. The remaining events show temporal association with the use of mRNA-1273 and a causal relationship cannot be excluded.   This case was linked to US-MODERNATX, INC.-MOD-2021-077717 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Follow Up information received on 17-MAY-2021, Medical history added, concomitant medication added, Hospitalization details added.; Sender's Comments: Based on the natural history of COVID-19, and the established information about the mRNA-1273 vaccine, a causal association between the event of Covid-19 positive and the product use is assessed as unlikely.  Event was most-likely pre-existing. The remaining events show temporal association with the use of mRNA-1273 and a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-077717:First dose case
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Bedridden, Chills, Dizziness, Feeling of relaxation, Headache
Clinical narrative: he was better; headache and dizziness; dizziness; chills; was in bed all day; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), BEDRIDDEN (was in bed all day), FEELING OF RELAXATION (he was better), HEADACHE (headache and dizziness) and DIZZINESS (dizziness) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     Concurrent medical conditions included Bone marrow disorder NOS. Concomitant products included OLANZAPINE for an unknown indication.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced CHILLS (chills) and BEDRIDDEN (was in bed all day). On 09-Apr-2021, the patient experienced FEELING OF RELAXATION (he was better), HEADACHE (headache and dizziness) and DIZZINESS (dizziness). At the time of the report, CHILLS (chills), BEDRIDDEN (was in bed all day), FEELING OF RELAXATION (he was better), HEADACHE (headache and dizziness) and DIZZINESS (dizziness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for event include naproxen.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue
Clinical narrative: chills; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and FATIGUE (fatigue) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced CHILLS (chills) and FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) for Chills and Fatigue, at an unspecified dose and frequency. At the time of the report, CHILLS (chills) and FATIGUE (fatigue) outcome was unknown.            No concomitant medications were reported. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. Action taken with mRNA-1273 in response to the event was not applicable.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Feeling abnormal, Hypokinesia, Lip swelling, Musculoskeletal stiffness
Clinical narrative: body aches; my face is stiff and swollen¨; less pain in the left side of the face; my face it is hard to move; my face is stiff and swollen¨; ¨i feel my lips swollen like if i have injected something on them; ¨strange thinks happened on my face¨; pain and swelling on the left side of my face; lower side of my left eye started having like an eye bag; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (pain and swelling on the left side of my face), PERIORBITAL SWELLING (lower side of my left eye started having like an eye bag), EYE PAIN (less pain in the left side of the face), HYPOKINESIA (my face it is hard to move) and MUSCULOSKELETAL STIFFNESS (my face is stiff and swollen¨) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014MZ0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 13-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced SWELLING FACE (pain and swelling on the left side of my face), PERIORBITAL SWELLING (lower side of my left eye started having like an eye bag) and FEELING ABNORMAL (¨strange thinks happened on my face¨). On 15-Apr-2021, the patient experienced EYE PAIN (less pain in the left side of the face), HYPOKINESIA (my face it is hard to move), MUSCULOSKELETAL STIFFNESS (my face is stiff and swollen¨), LIP SWELLING (¨i feel my lips swollen like if i have injected something on them) and SWELLING FACE (my face is stiff and swollen¨). On an unknown date, the patient experienced MYALGIA (body aches). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, SWELLING FACE (pain and swelling on the left side of my face), PERIORBITAL SWELLING (lower side of my left eye started having like an eye bag), HYPOKINESIA (my face it is hard to move), MUSCULOSKELETAL STIFFNESS (my face is stiff and swollen¨), LIP SWELLING (¨i feel my lips swollen like if i have injected something on them), MYALGIA (body aches), SWELLING FACE (my face is stiff and swollen¨) and FEELING ABNORMAL (¨strange thinks happened on my face¨) outcome was unknown and EYE PAIN (less pain in the left side of the face) had not resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication information includes ibuprofen and diphenhydramine on 14Apr2021.  Patient states that she did not have difficulty breathing, and that there were no records of this episode happening in her life.   This case was linked to US-MODERNATX, INC.-MOD-2021-078156 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-078156:husband
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Periorbital swelling, Swelling face
Clinical narrative: body aches; my face is stiff and swollen¨; less pain in the left side of the face; my face it is hard to move; my face is stiff and swollen¨; ¨i feel my lips swollen like if i have injected something on them; ¨strange thinks happened on my face¨; pain and swelling on the left side of my face; lower side of my left eye started having like an eye bag; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (pain and swelling on the left side of my face), PERIORBITAL SWELLING (lower side of my left eye started having like an eye bag), EYE PAIN (less pain in the left side of the face), HYPOKINESIA (my face it is hard to move) and MUSCULOSKELETAL STIFFNESS (my face is stiff and swollen¨) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014MZ0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 13-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced SWELLING FACE (pain and swelling on the left side of my face), PERIORBITAL SWELLING (lower side of my left eye started having like an eye bag) and FEELING ABNORMAL (¨strange thinks happened on my face¨). On 15-Apr-2021, the patient experienced EYE PAIN (less pain in the left side of the face), HYPOKINESIA (my face it is hard to move), MUSCULOSKELETAL STIFFNESS (my face is stiff and swollen¨), LIP SWELLING (¨i feel my lips swollen like if i have injected something on them) and SWELLING FACE (my face is stiff and swollen¨). On an unknown date, the patient experienced MYALGIA (body aches). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, SWELLING FACE (pain and swelling on the left side of my face), PERIORBITAL SWELLING (lower side of my left eye started having like an eye bag), HYPOKINESIA (my face it is hard to move), MUSCULOSKELETAL STIFFNESS (my face is stiff and swollen¨), LIP SWELLING (¨i feel my lips swollen like if i have injected something on them), MYALGIA (body aches), SWELLING FACE (my face is stiff and swollen¨) and FEELING ABNORMAL (¨strange thinks happened on my face¨) outcome was unknown and EYE PAIN (less pain in the left side of the face) had not resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication information includes ibuprofen and diphenhydramine on 14Apr2021.  Patient states that she did not have difficulty breathing, and that there were no records of this episode happening in her life.   This case was linked to US-MODERNATX, INC.-MOD-2021-078156 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-078156:husband
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, Vaccination site erythema
Clinical narrative: Missed the 37 day mark to get the second dose; arm got a little bit red; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Apr-2021 and was forwarded to Moderna on 15-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (arm got a little bit red) and PRODUCT DOSE OMISSION ISSUE (Missed the 37 day mark to get the second dose) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (arm got a little bit red). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed the 37 day mark to get the second dose). At the time of the report, VACCINATION SITE ERYTHEMA (arm got a little bit red) and PRODUCT DOSE OMISSION ISSUE (Missed the 37 day mark to get the second dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that patient had an appointment for 11Apr2021 for the second dose, but since the vaccine was not available, she was rescheduled for 13 May2021.  No Concomitant medications were reported.  No Treatment information was reported.   This case was linked to MOD21-076028, US-MODERNATX, INC.-MOD-2021-077864 (E2B Linked Report).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: AE Outcome updated and FU declined; Sender's Comments:  MOD21-076028: US-MODERNATX, INC.-MOD-2021-077864:Husband's case
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Chills, Injection site erythema, Injection site swelling, Nasal congestion
Clinical narrative: she is having itchiness; hardening on the arm of the injection; has an internal ball on the arm of the injection; Rosette on the arm of the injection; chills; she had congestion; lost her voice; This spontaneous case was reported by a patient and describes the occurrence of NASAL CONGESTION (she had congestion), APHONIA (lost her voice), PRURITUS (she is having itchiness), VACCINATION SITE INDURATION (hardening on the arm of the injection) and CHILLS (chills) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced CHILLS (chills). On 14-Apr-2021, the patient experienced PRURITUS (she is having itchiness), VACCINATION SITE INDURATION (hardening on the arm of the injection), INJECTION SITE SWELLING (has an internal ball on the arm of the injection) and INJECTION SITE ERYTHEMA (Rosette on the arm of the injection). In April 2021, the patient experienced NASAL CONGESTION (she had congestion) and APHONIA (lost her voice). On 08-Apr-2021, CHILLS (chills) had resolved. At the time of the report, NASAL CONGESTION (she had congestion), APHONIA (lost her voice), PRURITUS (she is having itchiness), VACCINATION SITE INDURATION (hardening on the arm of the injection), INJECTION SITE SWELLING (has an internal ball on the arm of the injection) and INJECTION SITE ERYTHEMA (Rosette on the arm of the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient does not have concomitant medication. No treatment medication details were reported.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site induration
Clinical narrative: she is having itchiness; hardening on the arm of the injection; has an internal ball on the arm of the injection; Rosette on the arm of the injection; chills; she had congestion; lost her voice; This spontaneous case was reported by a patient and describes the occurrence of NASAL CONGESTION (she had congestion), APHONIA (lost her voice), PRURITUS (she is having itchiness), VACCINATION SITE INDURATION (hardening on the arm of the injection) and CHILLS (chills) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced CHILLS (chills). On 14-Apr-2021, the patient experienced PRURITUS (she is having itchiness), VACCINATION SITE INDURATION (hardening on the arm of the injection), INJECTION SITE SWELLING (has an internal ball on the arm of the injection) and INJECTION SITE ERYTHEMA (Rosette on the arm of the injection). In April 2021, the patient experienced NASAL CONGESTION (she had congestion) and APHONIA (lost her voice). On 08-Apr-2021, CHILLS (chills) had resolved. At the time of the report, NASAL CONGESTION (she had congestion), APHONIA (lost her voice), PRURITUS (she is having itchiness), VACCINATION SITE INDURATION (hardening on the arm of the injection), INJECTION SITE SWELLING (has an internal ball on the arm of the injection) and INJECTION SITE ERYTHEMA (Rosette on the arm of the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient does not have concomitant medication. No treatment medication details were reported.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Swelling face
Clinical narrative: face is swollen; entire left arm is in a lot of pain; fever; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (face is swollen), PAIN IN EXTREMITY (entire left arm is in a lot of pain) and PYREXIA (fever) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 15-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 SWELLING FACE (face is swollen), PAIN IN EXTREMITY (entire left arm is in a lot of pain) and PYREXIA (fever). At the time of the report, SWELLING FACE (face is swollen), PAIN IN EXTREMITY (entire left arm is in a lot of pain) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported.  No treatment was provided.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: bruising all through his left leg and calf; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (bruising all through his left leg and calf) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced CONTUSION (bruising all through his left leg and calf). At the time of the report, CONTUSION (bruising all through his left leg and calf) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness, Lethargy, Pain, Pruritus
Clinical narrative: arm was itching like crazy; tired; flu-like symptoms; lethargic; achy; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), LETHARGY (lethargic), PAIN (achy), PRURITUS (arm was itching like crazy) and FATIGUE (tired) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     Concomitant products included DENOSUMAB (PROLIA), DIPHENHYDRAMINE and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication.   On 05-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), LETHARGY (lethargic), PAIN (achy) and FATIGUE (tired). On 08-Feb-2021, the patient experienced PRURITUS (arm was itching like crazy). On 07-Feb-2021, INFLUENZA LIKE ILLNESS (flu-like symptoms), LETHARGY (lethargic), PAIN (achy) and FATIGUE (tired) had resolved. On 09-Feb-2021, PRURITUS (arm was itching like crazy) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Additional concomitant drug was mentioned as Allergy shots.  No treatment medication was reported.  Action taken with the mRNA-1273 vaccine in response to the events was not applicable.   This case was linked to MOD21-03671 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Follow up received and contain non significant information. On 21-Jul-2021: Follow up received and patient stated that she was fine, had no problem.; Sender's Comments:  MOD21-03671:1st dose
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site paraesthesia, Paraesthesia
Clinical narrative: Tingling in her finger tips on the same side of inj; Tingling on her left hand at her finger tips; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PARAESTHESIA (Tingling in her finger tips on the same side of inj) and PARAESTHESIA (Tingling on her left hand at her finger tips) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced INJECTION SITE PARAESTHESIA (Tingling in her finger tips on the same side of inj) and PARAESTHESIA (Tingling on her left hand at her finger tips). At the time of the report, INJECTION SITE PARAESTHESIA (Tingling in her finger tips on the same side of inj) and PARAESTHESIA (Tingling on her left hand at her finger tips) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medication was reported.  Treatment medication was not provided by the reporter.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Hypokinesia, Pain in extremity
Clinical narrative: arm hurt where she couldn't lay or roll over on her arm; arm hurt where she couldn't lay or roll over on her arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt where she couldn't lay or roll over on her arm) and HYPOKINESIA (arm hurt where she couldn't lay or roll over on her arm) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 032L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm hurt where she couldn't lay or roll over on her arm) and HYPOKINESIA (arm hurt where she couldn't lay or roll over on her arm). At the time of the report, PAIN IN EXTREMITY (arm hurt where she couldn't lay or roll over on her arm) and HYPOKINESIA (arm hurt where she couldn't lay or roll over on her arm) outcome was unknown. Not Provided
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity
Clinical narrative: pain on legs; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain on legs) and NAUSEA (Nausea) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included OLANZAPINE, ROSUVASTATIN, VENLAFAXINE, GABAPENTIN and CICLOSPORIN (RESTASIS) for an unknown indication.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced PAIN IN EXTREMITY (pain on legs) and NAUSEA (Nausea). At the time of the report, PAIN IN EXTREMITY (pain on legs) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD21-076433, US-MODERNATX, INC.-MOD-2021-077818 (E2B Linked Report).; Sender's Comments:  MOD21-076433: US-MODERNATX, INC.-MOD-2021-077818:daughter
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Movement disorder, Myalgia, Nasopharyngitis, Nausea
Clinical narrative: IN AND OUT OF BED FOR TWO DAYS; COLD; HOT; RASH ON ARM AT INJECTION SITE; NAUSEAS; MUSCLE ACHE; This spontaneous case was reported by a consumer and describes the occurrence of MOVEMENT DISORDER (IN AND OUT OF BED FOR TWO DAYS), NASOPHARYNGITIS (COLD), FEELING HOT (HOT), VACCINATION SITE RASH (RASH ON ARM AT INJECTION SITE) and NAUSEA (NAUSEAS) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MOVEMENT DISORDER (IN AND OUT OF BED FOR TWO DAYS), NASOPHARYNGITIS (COLD), FEELING HOT (HOT), VACCINATION SITE RASH (RASH ON ARM AT INJECTION SITE), NAUSEA (NAUSEAS) and MYALGIA (MUSCLE ACHE). At the time of the report, MOVEMENT DISORDER (IN AND OUT OF BED FOR TWO DAYS), NASOPHARYNGITIS (COLD), FEELING HOT (HOT), VACCINATION SITE RASH (RASH ON ARM AT INJECTION SITE), NAUSEA (NAUSEAS) and MYALGIA (MUSCLE ACHE) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported.  No treatment information was provided.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: IN AND OUT OF BED FOR TWO DAYS; COLD; HOT; RASH ON ARM AT INJECTION SITE; NAUSEAS; MUSCLE ACHE; This spontaneous case was reported by a consumer and describes the occurrence of MOVEMENT DISORDER (IN AND OUT OF BED FOR TWO DAYS), NASOPHARYNGITIS (COLD), FEELING HOT (HOT), VACCINATION SITE RASH (RASH ON ARM AT INJECTION SITE) and NAUSEA (NAUSEAS) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MOVEMENT DISORDER (IN AND OUT OF BED FOR TWO DAYS), NASOPHARYNGITIS (COLD), FEELING HOT (HOT), VACCINATION SITE RASH (RASH ON ARM AT INJECTION SITE), NAUSEA (NAUSEAS) and MYALGIA (MUSCLE ACHE). At the time of the report, MOVEMENT DISORDER (IN AND OUT OF BED FOR TWO DAYS), NASOPHARYNGITIS (COLD), FEELING HOT (HOT), VACCINATION SITE RASH (RASH ON ARM AT INJECTION SITE), NAUSEA (NAUSEAS) and MYALGIA (MUSCLE ACHE) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported.  No treatment information was provided.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Candida infection
Clinical narrative: Thrush; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CANDIDA INFECTION (Thrush) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced CANDIDA INFECTION (Thrush). At the time of the report, CANDIDA INFECTION (Thrush) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were provided by the reporter.   This case was linked to MOD-2021-075307, MOD21-074672 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow-up information received on 21 JUL 2021 contains significant information updated that the doctor earlier misdiagnosed with thrush patient has no adverse event.; Sender's Comments:  MOD-2021-075307:Wife case MOD21-074672:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypersomnia, Lethargy, Nausea
Clinical narrative: lethargic; sleeping a lot; headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (lethargic), HYPERSOMNIA (sleeping a lot), HEADACHE (headache) and NAUSEA (nausea) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2021, the patient experienced LETHARGY (lethargic), HYPERSOMNIA (sleeping a lot), HEADACHE (headache) and NAUSEA (nausea). The patient was treated with ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL, SALICYLAMIDE (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL;SALICYLAMIDE]) at an unspecified dose and frequency. At the time of the report, LETHARGY (lethargic), HYPERSOMNIA (sleeping a lot), HEADACHE (headache) and NAUSEA (nausea) outcome was unknown.            No concomitant medications were reported.  No treatment information was reported.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Heart rate increased, Pain, Pyrexia
Clinical narrative: Chills; headache; fever; Bodyache; soreness of left arm; High pulse rate 105-115 /min; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), HEADACHE (headache), PYREXIA (fever), PAIN (Bodyache) and VACCINATION SITE PAIN (soreness of left arm) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 036B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced CHILLS (Chills), HEADACHE (headache), PYREXIA (fever), PAIN (Bodyache), VACCINATION SITE PAIN (soreness of left arm) and HEART RATE INCREASED (High pulse rate 105-115 /min). The patient was treated with IBUPROFEN SODIUM (IBUPROFEN [IBUPROFEN SODIUM]) at an unspecified dose and frequency. At the time of the report, CHILLS (Chills), HEADACHE (headache), PYREXIA (fever), PAIN (Bodyache), VACCINATION SITE PAIN (soreness of left arm) and HEART RATE INCREASED (High pulse rate 105-115 /min) outcome was unknown.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Chills; headache; fever; Bodyache; soreness of left arm; High pulse rate 105-115 /min; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), HEADACHE (headache), PYREXIA (fever), PAIN (Bodyache) and VACCINATION SITE PAIN (soreness of left arm) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 036B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced CHILLS (Chills), HEADACHE (headache), PYREXIA (fever), PAIN (Bodyache), VACCINATION SITE PAIN (soreness of left arm) and HEART RATE INCREASED (High pulse rate 105-115 /min). The patient was treated with IBUPROFEN SODIUM (IBUPROFEN [IBUPROFEN SODIUM]) at an unspecified dose and frequency. At the time of the report, CHILLS (Chills), HEADACHE (headache), PYREXIA (fever), PAIN (Bodyache), VACCINATION SITE PAIN (soreness of left arm) and HEART RATE INCREASED (High pulse rate 105-115 /min) outcome was unknown.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Itchy; Hard; Red; Swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE INDURATION (Hard), VACCINATION SITE ERYTHEMA (Red) and VACCINATION SITE SWELLING (Swollen) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE INDURATION (Hard), VACCINATION SITE ERYTHEMA (Red) and VACCINATION SITE SWELLING (Swollen). At the time of the report, VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE INDURATION (Hard), VACCINATION SITE ERYTHEMA (Red) and VACCINATION SITE SWELLING (Swollen) 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.  Treatment information was not provided.   This case was linked to MOD-2021-077805 (Patient Link).
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Product dose omission issue
Clinical narrative: girl's father wanted her daughter to receive the vaccine, but the pharmacist called Moderna and did not; Received moderna vaccine underage; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received moderna vaccine underage) and PRODUCT DOSE OMISSION ISSUE (girl's father wanted her daughter to receive the vaccine, but the pharmacist called Moderna and did not) in a 15-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received moderna vaccine underage). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (girl's father wanted her daughter to receive the vaccine, but the pharmacist called Moderna and did not). On 03-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received moderna vaccine underage) outcome was unknown. At the time of the report, PRODUCT DOSE OMISSION ISSUE (girl's father wanted her daughter to receive the vaccine, but the pharmacist called Moderna and did not) 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.   No concomitant medication were reported. No treatment information was Reported.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: No specific follow-up information recorded. On 08-Jul-2021: Additional information received on 08-JUL-2021 updated reporter details, patient initials and event.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second dose given on day 21 after first dose; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose given on day 21 after first dose) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 038B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose given on day 21 after first dose). On 14-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose given on day 21 after first dose) had resolved. Unknown      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications were reported. Treatment information was unknown.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Coronavirus test
Clinical narrative: does not have taste; does not have smell; Contracted covid; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (does not have taste), ANOSMIA (does not have smell) and COVID-19 (Contracted covid) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced AGEUSIA (does not have taste), ANOSMIA (does not have smell) and COVID-19 (Contracted covid). At the time of the report, AGEUSIA (does not have taste), ANOSMIA (does not have smell) and COVID-19 (Contracted covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2021, Coronavirus test: Positive. On an unknown date, Coronavirus test: (Negative) Retested on unknown date an tested negative..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was reported No treatment information was provided   This case was linked to MOD21-076101,MOD-2021-078210 (E2B Linked Report).; Sender's Comments:  MOD21-076101:crosslink
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Right arm keeps itching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Right arm keeps itching) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008821-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-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 PRURITUS (Right arm keeps itching). At the time of the report, PRURITUS (Right arm keeps itching) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported. No treatment was reported.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising, Vaccination site discolouration
Clinical narrative: Injection site bruising; It as visibly a different color for 3 weeks; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Injection site bruising) and VACCINATION SITE DISCOLOURATION (It as visibly a different color for 3 weeks) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 040B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE BRUISING (Injection site bruising) and VACCINATION SITE DISCOLOURATION (It as visibly a different color for 3 weeks). At the time of the report, VACCINATION SITE BRUISING (Injection site bruising) and VACCINATION SITE DISCOLOURATION (It as visibly a different color for 3 weeks) outcome was unknown. Not Provided          No concomitant medication were reported.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-077799 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-077799:
Sex: M
Vaccine: COVID19
Symptoms: Cough, Influenza like illness, Nasopharyngitis, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: Flu like symptoms; Sore throat; Runny nose; Cough; Cold; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (Runny nose), COUGH (Cough) and NASOPHARYNGITIS (Cold) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included COPD.   On 13-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms) and NASOPHARYNGITIS (Cold). 13-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (Runny nose) and COUGH (Cough). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (Runny nose), COUGH (Cough) and NASOPHARYNGITIS (Cold) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Coronavirus infection, SARS-CoV-2 test
Clinical narrative: Diagnosed with coronavirus; This spontaneous case was reported by a consumer and describes the occurrence of CORONAVIRUS INFECTION (Diagnosed with coronavirus) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced CORONAVIRUS INFECTION (Diagnosed with coronavirus). At the time of the report, CORONAVIRUS INFECTION (Diagnosed with coronavirus) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, SARS-CoV-2 test: positive (Positive) she got diagnosed with corona virus.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Swelling at Injection site 8 days after first dose of Vaccine; Itching at the injection site 8 days after first dose of Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swelling at Injection site 8 days after first dose of Vaccine) and VACCINATION SITE PRURITUS (Itching at the injection site 8 days after first dose of Vaccine) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma, Hypertension and Anemia. Concomitant products included IRON for Anemia, SALBUTAMOL (VENTOLINE [SALBUTAMOL]) and BECLOMETASONE DIPROPIONATE (QVAR) for Asthma, TRIAMTERENE for Blood pressure high.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced VACCINATION SITE SWELLING (Swelling at Injection site 8 days after first dose of Vaccine) and VACCINATION SITE PRURITUS (Itching at the injection site 8 days after first dose of Vaccine). The patient was treated with LORATADINE (CLARITIN [LORATADINE]) for Vaccination site pruritus, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE SWELLING (Swelling at Injection site 8 days after first dose of Vaccine) and VACCINATION SITE PRURITUS (Itching at the injection site 8 days after first dose of Vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: Lower Back pain; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Lower Back pain) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history was reported).    On 14-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced BACK PAIN (Lower Back pain). At the time of the report, BACK PAIN (Lower Back pain) outcome was unknown. Not Provided          Treatment received in response to the event was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache
Clinical narrative: Headache; Chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), CHILLS (Chills) and FATIGUE (Fatigue) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was provided).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache), CHILLS (Chills) and FATIGUE (Fatigue). At the time of the report, HEADACHE (Headache), CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications and medical history were not reported. Treatment taken in response to the events was not reported.   Reporter did not allow further contact