chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Nausea, Pain
Clinical narrative: sore in every where, like a flu.; sore in every where, like a flu; Having nausea ( very nausea); This spontaneous case was reported by a consumer and describes the occurrence of PAIN (sore in every where, like a flu.), INFLUENZA LIKE ILLNESS (sore in every where, like a flu) and NAUSEA (Having nausea ( very nausea)) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 015M20A) for COVID-19 vaccination.     The patient's medical history was not provided. No relevant concomitant medications were reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced PAIN (sore in every where, like a flu.) and INFLUENZA LIKE ILLNESS (sore in every where, like a flu). 04-Mar-2021, the patient experienced NAUSEA (Having nausea ( very nausea)). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (sore in every where, like a flu.), INFLUENZA LIKE ILLNESS (sore in every where, like a flu) and NAUSEA (Having nausea ( very nausea)) outcome was unknown. The patient received both scheduled doses of mRNA-1273 prior to the events, therefore, the action taken with the drug in response to the events was not applicable.  The outcome of events, having nausea (very nausea), sore in everywhere, like a flu was unknown.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Warm to the touch Injection Site; Hard to the touch Injection Site; Itching Injection Site; Red Injection Site; Swollen Injection Site (Size of grapefruit); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm to the touch Injection Site), VACCINATION SITE INDURATION (Hard to the touch Injection Site), VACCINATION SITE PRURITUS (Itching Injection Site), VACCINATION SITE ERYTHEMA (Red Injection Site) and VACCINATION SITE SWELLING (Swollen Injection Site (Size of grapefruit)) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     The patient's medical history was not provided. No relevant concomitant medications were reported.     On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Warm to the touch Injection Site), VACCINATION SITE INDURATION (Hard to the touch Injection Site), VACCINATION SITE PRURITUS (Itching Injection Site), VACCINATION SITE ERYTHEMA (Red Injection Site) and VACCINATION SITE SWELLING (Swollen Injection Site (Size of grapefruit)). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (ANTI ITCH CREAM [DIPHENHYDRAMINE HYDROCHLORIDE]) (topical) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Warm to the touch Injection Site), VACCINATION SITE INDURATION (Hard to the touch Injection Site), VACCINATION SITE PRURITUS (Itching Injection Site), VACCINATION SITE ERYTHEMA (Red Injection Site) and VACCINATION SITE SWELLING (Swollen Injection Site (Size of grapefruit)) outcome was unknown.     On 3 Mar 2021, the patient experienced the events red injection site, swollen injection site (size of grapefruit), hard to the touch injection site, warm to the touch injection site, itching injection site.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: Left arm pain at the site of the injection; Body aches; Fever; Chills; Nausea; Splitting headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Left arm pain at the site of the injection), MYALGIA (Body aches), PYREXIA (Fever), CHILLS (Chills) and NAUSEA (Nausea) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported.). Concomitant products included IRBESARTAN, ROSUVASTATIN CALCIUM (CRESTOR), LEVOTHYROXINE, XYLOMETAZOLINE HYDROCHLORIDE (NASAL SPRAY ) and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE PAIN (Left arm pain at the site of the injection), MYALGIA (Body aches), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea) and HEADACHE (Splitting headache). At the time of the report, VACCINATION SITE PAIN (Left arm pain at the site of the injection), MYALGIA (Body aches), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea) and HEADACHE (Splitting headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medicines were reported
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Left arm pain at the site of the injection; Body aches; Fever; Chills; Nausea; Splitting headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Left arm pain at the site of the injection), MYALGIA (Body aches), PYREXIA (Fever), CHILLS (Chills) and NAUSEA (Nausea) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported.). Concomitant products included IRBESARTAN, ROSUVASTATIN CALCIUM (CRESTOR), LEVOTHYROXINE, XYLOMETAZOLINE HYDROCHLORIDE (NASAL SPRAY ) and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE PAIN (Left arm pain at the site of the injection), MYALGIA (Body aches), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea) and HEADACHE (Splitting headache). At the time of the report, VACCINATION SITE PAIN (Left arm pain at the site of the injection), MYALGIA (Body aches), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea) and HEADACHE (Splitting headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medicines were reported
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: First vaccine, he only had chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (First vaccine, he only had chills) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 022M20A) for COVID-19 vaccination.     The patient's past medical history included Surgery (Cataract surgery). Concurrent medical conditions included Drug allergy (Allergic to Versed Anastacia).   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-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 CHILLS (First vaccine, he only had chills). At the time of the report, CHILLS (First vaccine, he only had chills) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-036258 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-036258:Dose 2
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Nervousness, Vaccination site warmth
Clinical narrative: both of his arm are red; shaky; Warm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (both of his arm are red), NERVOUSNESS (shaky) and VACCINATION SITE WARMTH (Warm) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.  The patient's medical history was not provided. No relevant concomitant medications were reported.     On 05-Mar-2021 at 9:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced ERYTHEMA (both of his arm are red), NERVOUSNESS (shaky) and VACCINATION SITE WARMTH (Warm). At the time of the report, ERYTHEMA (both of his arm are red), NERVOUSNESS (shaky) and VACCINATION SITE WARMTH (Warm) outcome was unknown.       No treatment information was provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Action taken with mRNA-1273 in response to the events was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Pain, Pruritus
Clinical narrative: Red Bumps; Itching; Soreness; A spontaneous report was received from a consumer concerning a female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pain (soreness), injection site erythema (red bumps) and pruritus (itching).  On 25 Feb 2021, approximately 9 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20A) through an unknown route for prophylaxis of COVID-19 infection.   On 25 Feb 2021, after vaccination, the patient experienced soreness. On 6 Mar 2021, the patient stated experiencing injection site itchy and had red bumps.  No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event, soreness was resolved on 26 Feb 2021. The outcome of other events was unknown.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Myalgia, Pain in extremity
Clinical narrative: Legs aching terribly; Difficulty walking; Severe muscle pain; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Legs aching terribly), GAIT DISTURBANCE (Difficulty walking) and MYALGIA (Severe muscle pain) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Solitary kidney.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced PAIN IN EXTREMITY (Legs aching terribly), GAIT DISTURBANCE (Difficulty walking) and MYALGIA (Severe muscle pain). At the time of the report, PAIN IN EXTREMITY (Legs aching terribly), GAIT DISTURBANCE (Difficulty walking) and MYALGIA (Severe muscle pain) outcome was unknown. patient reported adverse events after receiving first dose of Moderna Vaccine.      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported. No concomitant medication were reported. Patient also received second dose of Moderna Vaccine on unknown date, and did not experience any side effects.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Additional details provided regarding second dose of Moderna Vaccine and reporter details updated
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Pain in jaw, Temporomandibular joint syndrome
Clinical narrative: right side up to my ear; TMJ; pain in the joint of my jaw; This spontaneous case was reported by a consumer and describes the occurrence of EAR PAIN (right side up to my ear), PAIN IN JAW (pain in the joint of my jaw) and TEMPOROMANDIBULAR JOINT SYNDROME (TMJ) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced PAIN IN JAW (pain in the joint of my jaw). On an unknown date, the patient experienced EAR PAIN (right side up to my ear) and TEMPOROMANDIBULAR JOINT SYNDROME (TMJ). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, EAR PAIN (right side up to my ear), PAIN IN JAW (pain in the joint of my jaw) and TEMPOROMANDIBULAR JOINT SYNDROME (TMJ) outcome was unknown.       On 16 Feb 2021, the patient experienced the pain in the joint of her jaw. On an unknown date, the patient experienced TMJ, yawning triggers and she can't put her teeth together and had pain on right side up to her ear.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.The outcome of events was unknown   No medical history and concomitant medications was provided by the reporter.  Patient stated that she tried Ibuprofen, but she said she is limited to how much she can take it, because she has reflux.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid twice; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for Covid twice) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure inadequately controlled (patient is on high Blood Pressure medication). Concomitant products included METFORMIN for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, the patient experienced COVID-19 (Tested positive for Covid twice). At the time of the report, COVID-19 (Tested positive for Covid twice) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive. On 04-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication also included blood pressure medication. No treatment information was provided. Patient provided spouse's Moderna Vaccine lot No. 016M20A who was also vaccinated at the same time as her. Patient reported that her HCP recommended to reschedule her second dose.
Sex: U
Vaccine: COVID19
Symptoms: Syringe issue, Underdose
Clinical narrative: Lower than authorized dose volume was administered; Syringe was loose/cracked; A spontaneous report was received from a nurse concerning a patient (age and gender unspecified) who received Moderna's COVID-19 vaccine (mRNA-1273). It was observed that the syringe was loose/cracked and a lower than authorized dose volume was administered.  The patient's medical history and concomitant medications were not reported.  On 05 Mar 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011A21A) intramuscularly for prophylaxis of COVID-19 infection.   On 05 Mar 2021, while vaccine administration to a particular patient the syringe was loose/cracked and a lower than authorized dose volume was administered.  Treatment information were not provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of events, were considered resolved on 05 Mar 2021.; Reporter's Comments: This report refers to a case of underdose and device connection issue for mRNA-1273 (lot # 011A21A) with no associated AEs reported.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Pain, Pyrexia
Clinical narrative: hurt all over; felt terrible; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (hurt all over), FEELING ABNORMAL (felt terrible) and PYREXIA (Fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.       On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 (hurt all over), FEELING ABNORMAL (felt terrible) and PYREXIA (Fever). At the time of the report, PAIN (hurt all over), FEELING ABNORMAL (felt terrible) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No medical history was provided by the reporter. No concomitant medications was provided by the reporter Treatment was not included by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Feeling abnormal, Headache, Influenza, Lethargy
Clinical narrative: Lethargy; Brain fog; Joint pain; Headache; Muscle pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LETHARGY (Lethargy), FEELING ABNORMAL (Brain fog), ARTHRALGIA (Joint pain), HEADACHE (Headache) and MYALGIA (Muscle pain) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event since an unknown date.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LETHARGY (Lethargy), FEELING ABNORMAL (Brain fog), ARTHRALGIA (Joint pain), HEADACHE (Headache) and MYALGIA (Muscle pain). At the time of the report, LETHARGY (Lethargy), FEELING ABNORMAL (Brain fog), ARTHRALGIA (Joint pain), HEADACHE (Headache) and MYALGIA (Muscle pain) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Influenza: Negative. On an unknown date, SARS-CoV-2 test: Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, SARS-CoV-2 test
Clinical narrative: Lethargy; Brain fog; Joint pain; Headache; Muscle pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LETHARGY (Lethargy), FEELING ABNORMAL (Brain fog), ARTHRALGIA (Joint pain), HEADACHE (Headache) and MYALGIA (Muscle pain) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event since an unknown date.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LETHARGY (Lethargy), FEELING ABNORMAL (Brain fog), ARTHRALGIA (Joint pain), HEADACHE (Headache) and MYALGIA (Muscle pain). At the time of the report, LETHARGY (Lethargy), FEELING ABNORMAL (Brain fog), ARTHRALGIA (Joint pain), HEADACHE (Headache) and MYALGIA (Muscle pain) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Influenza: Negative. On an unknown date, SARS-CoV-2 test: Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: SHINGLES; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (SHINGLES) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (SHINGLES). At the time of the report, HERPES ZOSTER (SHINGLES) outcome was unknown. Reporter did not allow further contact
Age: 87.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Asthenia, Fatigue, Injection site pruritus, Skin irritation
Clinical narrative: periods of fatigue and weakness, itchiness in the area and some irritation; periods of fatigue and weakness, itchiness in the area and some irritation; periods of fatigue and weakness, itchiness in the area and some irritation; itchiness on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of SKIN IRRITATION (periods of fatigue and weakness, itchiness in the area and some irritation) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011m20a) for COVID-19 vaccination.    Co-suspect product included non-company product MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    Concurrent medical conditions included Hypertension. Concomitant products included ALPRAZOLAM (AZOR [ALPRAZOLAM]) and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and MULTIVITAMINS [VITAMINS NOS] (unknown route) at an unspecified dose. On 22-Feb-2021, the patient experienced SKIN IRRITATION (periods of fatigue and weakness, itchiness in the area and some irritation). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, SKIN IRRITATION (periods of fatigue and weakness, itchiness in the area and some irritation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patients medical history was not provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: muscle ache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of MYALGIA (muscle ache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (muscle ache). At the time of the report, MYALGIA (muscle ache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided. Lab details were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-035118, US-MODERNATX, INC.-MOD-2021-035118 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-035118:Cross link case for Reporter's mother neighbor (unknown gender, no patient identifer) US-MODERNATX, INC.-MOD-2021-035118:Reporter's husband case (male patient)
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pyrexia
Clinical narrative: got a little sick; low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (low grade fever) and MALAISE (got a little sick) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.      On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (low grade fever) and MALAISE (got a little sick). At the time of the report, PYREXIA (low grade fever) and MALAISE (got a little sick) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-036367 (Patient Link).
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: lots of itching; hives all over her body except for her face; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (lots of itching) and URTICARIA (hives all over her body except for her face) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced PRURITUS (lots of itching) and URTICARIA (hives all over her body except for her face). At the time of the report, PRURITUS (lots of itching) and URTICARIA (hives all over her body except for her face) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details included 5 day unspecified  steroid. No relevant concomitant medications were reported.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm at the injection site) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  No relevant concomitant medications were reported.   On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, the patient experienced VACCINATION SITE PAIN (Sore arm at the injection site). At the time of the report, VACCINATION SITE PAIN (Sore arm at the injection site) outcome was unknown.       On 21 Feb 2021, the patient experienced the event sore arm at the injection site.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of event, sore arm at the injection site was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Flushing
Clinical narrative: Flush; temperature; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (Flush) and BODY TEMPERATURE INCREASED (temperature) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Jan-2021, the patient experienced FLUSHING (Flush) and BODY TEMPERATURE INCREASED (temperature). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FLUSHING (Flush) and BODY TEMPERATURE INCREASED (temperature) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.5 (High) High.         treatment includes paracetamol (Tylenol).   This case was linked to MOD-2021-036290 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: cold/flu like symptoms; This spontaneous case was reported by a physician and describes the occurrence of INFLUENZA LIKE ILLNESS (cold/flu like symptoms) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (cold/flu like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (cold/flu like symptoms) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.   Reporter did not allow further contact
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Rhinorrhoea
Clinical narrative: Runny nose; Dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy) and RHINORRHOEA (Runny nose) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     Concurrent medical conditions included Parkinson's disease. Concomitant products included CARBIDOPA for Parkinson's disease, CLONAZEPAM, GABAPENTIN, TAMSULOSIN and NORTRIPTYLINE HYDROCHLORIDE (PAMELOR) for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced DIZZINESS (Dizzy). On 07-Mar-2021, the patient experienced RHINORRHOEA (Runny nose). At the time of the report, DIZZINESS (Dizzy) and RHINORRHOEA (Runny nose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No treatment information was reported.   This case was linked to MOD-2021-036713 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Outcome of the events were updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure decreased, Blood pressure measurement, Chills, Headache, Influenza like illness
Clinical narrative: Flu like symptoms; Blood pressure decreased; Chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), BLOOD PRESSURE DECREASED (Blood pressure decreased), CHILLS (Chills) and HEADACHE (headache) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-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 an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), BLOOD PRESSURE DECREASED (Blood pressure decreased), CHILLS (Chills) and HEADACHE (headache). The patient was treated with ASCORBIC ACID, CYANOCOBALAMIN, FERRIC PYROPHOSPHATE, FOLIC ACID (SEDEROM) at a dose of 500 milligram. At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), BLOOD PRESSURE DECREASED (Blood pressure decreased), CHILLS (Chills) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: decreased (Low) decreased.         No concomitant medications reported. Action taken for Moderna COVID-19 Vaccine was not applicable.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pain, Pyrexia
Clinical narrative: Had an ache all over; Been feeling a little tired; 100-degree temperature; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Had an ache all over), FATIGUE (Been feeling a little tired) and PYREXIA (100-degree temperature) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced PAIN (Had an ache all over), FATIGUE (Been feeling a little tired) and PYREXIA (100-degree temperature). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 06-Mar-2021, PYREXIA (100-degree temperature) had resolved. At the time of the report, PAIN (Had an ache all over) and FATIGUE (Been feeling a little tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, Pyrexia: 100 degree (plane angle) 100-degree temperature.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 57.0
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Hot; Pain at injection site (right); Swelling; Redness; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Mar-2021 and was forwarded to Moderna on 08-Mar-2021.    A spontaneous report was received from a consumer concerning a 57-years-old patient of unknown gender who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events pain at injection site (right)/ vaccination site pain, swelling/ vaccination site swelling, redness/ vaccination site erythema, hot/ vaccination site warmth.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 4 Mar 2021, approximately one day prior to the onset of the events the patient received their dose of mRNA-1273 (lot/batch: 014M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 4 Mar 2021, the patient experienced the events pain at injection site (right), swelling, redness, hot.  Treatment details included Motrin one dose, ice, heat.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, pain at injection site (right), swelling, redness, hot was unknown.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Constipation, Feeling abnormal, Lethargy
Clinical narrative: Lethargy; Constipation; brain fog; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Lethargy), CONSTIPATION (Constipation) and FEELING ABNORMAL (brain fog) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 042L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced LETHARGY (Lethargy), CONSTIPATION (Constipation) and FEELING ABNORMAL (brain fog). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Post vaccination syndrome, at a dose of 2 doses. On 28-Feb-2021, LETHARGY (Lethargy), CONSTIPATION (Constipation) and FEELING ABNORMAL (brain fog) had resolved.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Cough, Dizziness, Feeling of body temperature change
Clinical narrative: Felt "wonky and lightheaded"; Felt weak and lacked energy.; Itchy all over her body.; Cold cold chills then got hot hot hot; hot, itchy, cold all the time, and sick to the stomach.; As "having the flu."; Coughing a lot; Also has a running nose; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Felt "wonky and lightheaded"), ASTHENIA (Felt weak and lacked energy.), PRURITUS (Itchy all over her body.), FEELING OF BODY TEMPERATURE CHANGE (Cold cold chills then got hot hot hot) and ABDOMINAL DISCOMFORT (hot, itchy, cold all the time, and sick to the stomach.) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced DIZZINESS (Felt "wonky and lightheaded"), ASTHENIA (Felt weak and lacked energy.), PRURITUS (Itchy all over her body.), FEELING OF BODY TEMPERATURE CHANGE (Cold cold chills then got hot hot hot), ABDOMINAL DISCOMFORT (hot, itchy, cold all the time, and sick to the stomach.), INFLUENZA LIKE ILLNESS (As "having the flu."), COUGH (Coughing a lot) and RHINORRHOEA (Also has a running nose). At the time of the report, DIZZINESS (Felt "wonky and lightheaded"), ASTHENIA (Felt weak and lacked energy.), PRURITUS (Itchy all over her body.), FEELING OF BODY TEMPERATURE CHANGE (Cold cold chills then got hot hot hot), ABDOMINAL DISCOMFORT (hot, itchy, cold all the time, and sick to the stomach.), INFLUENZA LIKE ILLNESS (As "having the flu."), COUGH (Coughing a lot) and RHINORRHOEA (Also has a running nose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Pruritus, Rhinorrhoea
Clinical narrative: Felt "wonky and lightheaded"; Felt weak and lacked energy.; Itchy all over her body.; Cold cold chills then got hot hot hot; hot, itchy, cold all the time, and sick to the stomach.; As "having the flu."; Coughing a lot; Also has a running nose; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Felt "wonky and lightheaded"), ASTHENIA (Felt weak and lacked energy.), PRURITUS (Itchy all over her body.), FEELING OF BODY TEMPERATURE CHANGE (Cold cold chills then got hot hot hot) and ABDOMINAL DISCOMFORT (hot, itchy, cold all the time, and sick to the stomach.) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced DIZZINESS (Felt "wonky and lightheaded"), ASTHENIA (Felt weak and lacked energy.), PRURITUS (Itchy all over her body.), FEELING OF BODY TEMPERATURE CHANGE (Cold cold chills then got hot hot hot), ABDOMINAL DISCOMFORT (hot, itchy, cold all the time, and sick to the stomach.), INFLUENZA LIKE ILLNESS (As "having the flu."), COUGH (Coughing a lot) and RHINORRHOEA (Also has a running nose). At the time of the report, DIZZINESS (Felt "wonky and lightheaded"), ASTHENIA (Felt weak and lacked energy.), PRURITUS (Itchy all over her body.), FEELING OF BODY TEMPERATURE CHANGE (Cold cold chills then got hot hot hot), ABDOMINAL DISCOMFORT (hot, itchy, cold all the time, and sick to the stomach.), INFLUENZA LIKE ILLNESS (As "having the flu."), COUGH (Coughing a lot) and RHINORRHOEA (Also has a running nose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 31.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Body temperature, Chills, Dermatitis, Fatigue
Clinical narrative: Sweating; Chills; Fever; A little tired; Skin inflammation; Joint pain; This spontaneous case was reported by a physician and describes the occurrence of HYPERHIDROSIS (Sweating), DERMATITIS (Skin inflammation), CHILLS (Chills), FATIGUE (A little tired) and PYREXIA (Fever) in a 31-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.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis and Plaque psoriasis.    Concurrent medical conditions included Ankylosing spondylitis (Moderate to severe chronic plaque psoriasis) and Plaque psoriasis.   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 an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On 20-Jan-2021, the patient experienced FATIGUE (A little tired). On 21-Jan-2021, the patient experienced HYPERHIDROSIS (Sweating), CHILLS (Chills) and PYREXIA (Fever). In 2021, the patient experienced DERMATITIS (Skin inflammation) and ARTHRALGIA (Joint pain). At the time of the report, HYPERHIDROSIS (Sweating), DERMATITIS (Skin inflammation), CHILLS (Chills), FATIGUE (A little tired), PYREXIA (Fever) and ARTHRALGIA (Joint pain) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jan-2021, Body temperature: 105 (High) 105.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.   No corrective treatment was provided.
Age: 31.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Hyperhidrosis, Pyrexia
Clinical narrative: Sweating; Chills; Fever; A little tired; Skin inflammation; Joint pain; This spontaneous case was reported by a physician and describes the occurrence of HYPERHIDROSIS (Sweating), DERMATITIS (Skin inflammation), CHILLS (Chills), FATIGUE (A little tired) and PYREXIA (Fever) in a 31-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.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis and Plaque psoriasis.    Concurrent medical conditions included Ankylosing spondylitis (Moderate to severe chronic plaque psoriasis) and Plaque psoriasis.   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 an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On 20-Jan-2021, the patient experienced FATIGUE (A little tired). On 21-Jan-2021, the patient experienced HYPERHIDROSIS (Sweating), CHILLS (Chills) and PYREXIA (Fever). In 2021, the patient experienced DERMATITIS (Skin inflammation) and ARTHRALGIA (Joint pain). At the time of the report, HYPERHIDROSIS (Sweating), DERMATITIS (Skin inflammation), CHILLS (Chills), FATIGUE (A little tired), PYREXIA (Fever) and ARTHRALGIA (Joint pain) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jan-2021, Body temperature: 105 (High) 105.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.   No corrective treatment was provided.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Pyrexia, Vomiting
Clinical narrative: Diarrhea; Chills; Fatigue; Slight fever; Sever vomiting; A spontaneous report was received from a consumer concerning a 78-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chills, diarrhea, fatigue (very tired), pyrexia(slight fever) and vomiting( severe vomiting).  On 20 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 030L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 17 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 010M20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 21 Feb 2021, 6 days after vaccination, the patient experienced  sever vomiting, chills, slight fever, diarrhea and she was feeling very tired.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Limb discomfort, Pain
Clinical narrative: it feels like a "booster shoot"; the whole arm is useless; feeling very very sore; the pain was all night; headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (it feels like a "booster shoot"), LIMB DISCOMFORT (the whole arm is useless), PAIN (feeling very very sore), PAIN (the pain was all night) and HEADACHE (headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Multiple sclerosis.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced FEELING ABNORMAL (it feels like a "booster shoot"), LIMB DISCOMFORT (the whole arm is useless), PAIN (feeling very very sore), PAIN (the pain was all night) and HEADACHE (headache). On 04-Mar-2021, HEADACHE (headache) had resolved. At the time of the report, FEELING ABNORMAL (it feels like a "booster shoot"), LIMB DISCOMFORT (the whole arm is useless), PAIN (feeling very very sore) and PAIN (the pain was all night) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's medical history included Multiple Sclerosis (MS). Concomitant medications reported were blood pressure medication and MS medications.  Treatment details included MOTRIN® (Ibuprofen) and Tylenol.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Non Significant follow up
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: tested positive for covid; A spontaneous report was received from a consumer concerning a 83-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events tested positive for covid.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 8 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 031L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 18 Feb 2021, the patient experienced the event(s) tested positive for covid.. she is feeling good feeling and would like to know if she can take her second shot.  Treatment details included Robitussin.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), tested positive for covid was unknown.