chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Bloating; Nausea; Abdominal cramps, it gets worse after she eats or drinks anything; Swelling of Injection site; Redness of injection site; Warmth of Injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warmth of Injection site), ABDOMINAL DISTENSION (Bloating), ABDOMINAL PAIN (Abdominal cramps, it gets worse after she eats or drinks anything), NAUSEA (Nausea) and VACCINATION SITE SWELLING (Swelling of Injection site) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015MZ0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Food allergy (Allergic to food dye) and Glaucoma. Concomitant products included PAROXETINE HYDROCHLORIDE (PAXIL [PAROXETINE HYDROCHLORIDE]) for an unknown indication.   On 19-Feb-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 19-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Warmth of Injection site), VACCINATION SITE SWELLING (Swelling of Injection site) and VACCINATION SITE ERYTHEMA (Redness of injection site). On 01-Mar-2021, the patient experienced ABDOMINAL PAIN (Abdominal cramps, it gets worse after she eats or drinks anything). On 08-Mar-2021, the patient experienced ABDOMINAL DISTENSION (Bloating) and NAUSEA (Nausea). On 21-Feb-2021, VACCINATION SITE WARMTH (Warmth of Injection site), VACCINATION SITE SWELLING (Swelling of Injection site) and VACCINATION SITE ERYTHEMA (Redness of injection site) had resolved. At the time of the report, ABDOMINAL DISTENSION (Bloating), ABDOMINAL PAIN (Abdominal cramps, it gets worse after she eats or drinks anything) and NAUSEA (Nausea) outcome was unknown. Not Provided          Concomitant product included 2 eye drops for glaucoma and over the counter allergy medication..  The side effects redness, swelling and warmth at the injection site only lasted for 48 hours.  No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Musculoskeletal stiffness
Clinical narrative: Can't control the pinky finger due to numbness; Numbness in hand; This spontaneous case was reported by a pharmacist and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Can't control the pinky finger due to numbness) and HYPOAESTHESIA (Numbness in hand) in a 50-year-old male 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (Can't control the pinky finger due to numbness) and HYPOAESTHESIA (Numbness in hand). At the time of the report, MUSCULOSKELETAL STIFFNESS (Can't control the pinky finger due to numbness) and HYPOAESTHESIA (Numbness in hand) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications was not reported. Treatment information were not reported.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dysstasia, Pain in extremity
Clinical narrative: could not put weight on non-surgical knee, could not get up from couch, unable to stand; hand and arm also hurt; had pain in the non-surgical knee, severe joint pain; This spontaneous case was reported by a consumer and describes the occurrence of DYSSTASIA (could not put weight on non-surgical knee, could not get up from couch, unable to stand), PAIN IN EXTREMITY (hand and arm also hurt) and ARTHRALGIA (had pain in the non-surgical knee, severe joint pain) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     The patient's past medical history included Knee replacement on 12-Feb-2021.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced ARTHRALGIA (had pain in the non-surgical knee, severe joint pain). On 04-Mar-2021, the patient experienced DYSSTASIA (could not put weight on non-surgical knee, could not get up from couch, unable to stand) and PAIN IN EXTREMITY (hand and arm also hurt). On 06-Mar-2021, DYSSTASIA (could not put weight on non-surgical knee, could not get up from couch, unable to stand), PAIN IN EXTREMITY (hand and arm also hurt) and ARTHRALGIA (had pain in the non-surgical knee, severe joint pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 04-Mar-2021, the patient had severe joint pain. Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Headache, Lethargy, Mobility decreased
Clinical narrative: Lethargy/feeling comatose; Can't really use his joints; Headache; Hurts all Over; Shakes/ hard shakes; Night sweats; High fever of 103-104F; Joint pain; A spontaneous report, was received from a consumer  (patient), concerning himself, a 51 year-old male patient, unknown race and ethnicity, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced "feeling comatose" (lethargy), shakes/hard shakes (tremor), night sweats, lethargy, can't really use his joint (mobility decreased), high fever of 103-104 Fahrenheit (pyrexia), joint pain (arthralgia), headache, and hurts all over (myalgia).   The patient's medical history was not reported. Concomitant medications reported included losartan, amlodipine, vortioxetine hydrobromide, pregabalin, clonidine, prazosin and ropinirole.  On 10 Mar 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 10 Mar 2021, 30 minutes after the vaccination, the patient experienced bad side effects "like" joint pain, shakes, high fever of 103-104 F, and night sweats. The patient was still experiencing the side effects. On 12 Mar 2021, two days after vaccination, the patient had fever 103 Fahrenheit, hard shakes, headache, lethargy, can't really use his joints, "feeling comatose" and hurts all over. The patient took acetaminophen as treatment medication for the events but hasn't helped. The patient still has a fever at 101 Fahrenheit all day. No other treatment information was provided. Lab details were not provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, "feeling comatose", shakes/hard shakes, night sweats, lethargy, can't really use his joint, high fever of 103-104 Fahrenheit, joint pain, headache, and hurts all over, were considered as not recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Night sweats, Pyrexia, Tremor
Clinical narrative: Lethargy/feeling comatose; Can't really use his joints; Headache; Hurts all Over; Shakes/ hard shakes; Night sweats; High fever of 103-104F; Joint pain; A spontaneous report, was received from a consumer  (patient), concerning himself, a 51 year-old male patient, unknown race and ethnicity, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced "feeling comatose" (lethargy), shakes/hard shakes (tremor), night sweats, lethargy, can't really use his joint (mobility decreased), high fever of 103-104 Fahrenheit (pyrexia), joint pain (arthralgia), headache, and hurts all over (myalgia).   The patient's medical history was not reported. Concomitant medications reported included losartan, amlodipine, vortioxetine hydrobromide, pregabalin, clonidine, prazosin and ropinirole.  On 10 Mar 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 10 Mar 2021, 30 minutes after the vaccination, the patient experienced bad side effects "like" joint pain, shakes, high fever of 103-104 F, and night sweats. The patient was still experiencing the side effects. On 12 Mar 2021, two days after vaccination, the patient had fever 103 Fahrenheit, hard shakes, headache, lethargy, can't really use his joints, "feeling comatose" and hurts all over. The patient took acetaminophen as treatment medication for the events but hasn't helped. The patient still has a fever at 101 Fahrenheit all day. No other treatment information was provided. Lab details were not provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, "feeling comatose", shakes/hard shakes, night sweats, lethargy, can't really use his joint, high fever of 103-104 Fahrenheit, joint pain, headache, and hurts all over, were considered as not recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm a little sore... when stressed in a specific way; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm a little sore... when stressed in a specific way) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm a little sore... when stressed in a specific way). On 15-Feb-2021, PAIN IN EXTREMITY (arm a little sore.. when stressed in a specific way) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling cold, Feeling hot, Headache, Pain, Pain in extremity
Clinical narrative: Achy arm; Very sore; Feeling hot; Feeling cold; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Achy arm), PAIN (Very sore), FEELING HOT (Feeling hot), FEELING COLD (Feeling cold) and HEADACHE (Headache) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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. On 23-Feb-2021, the patient experienced PAIN IN EXTREMITY (Achy arm), PAIN (Very sore), FEELING HOT (Feeling hot), FEELING COLD (Feeling cold) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Achy arm), PAIN (Very sore), FEELING HOT (Feeling hot), FEELING COLD (Feeling cold) and HEADACHE (Headache) outcome was unknown.            No relevant concomitant medications were reported.   No treatment information was provided.   This case was linked to MOD21-051841, MOD21-051914 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site erythema
Clinical narrative: large red spot on their arm, that was very itchy. It has gotten better but still is irritating having any clothes over the area, it is bothersome; itchy reaction that went away after a couple of days; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (large red spot on their arm, that was very itchy. It has gotten better but still is irritating having any clothes over the area, it is bothersome) and VACCINATION SITE ERYTHEMA (itchy reaction that went away after a couple of days) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medication history was provided.     On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PRURITUS (large red spot on their arm, that was very itchy. It has gotten better but still is irritating having any clothes over the area, it is bothersome) and VACCINATION SITE ERYTHEMA (itchy reaction that went away after a couple of days). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and HYDROCORTISONE (CORTISONE [HYDROCORTISONE]) at an unspecified dose and frequency. At the time of the report, PRURITUS (large red spot on their arm, that was very itchy. It has gotten better but still is irritating having any clothes over the area, it is bothersome) and VACCINATION SITE ERYTHEMA (itchy reaction that went away after a couple of days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient provides consent for Safety to follow up with them or their HCP. Patient mentions reading in the computer that some other people had the same itchy reaction that went away after a couple of days. Cases will be crosslinked. This case pertains to the caller. Treated  also with  cold ice pack    Most recent FOLLOW-UP information incorporated above includes: On 12-Mar-2021: No specific follow-up information recorded.
Age: 95.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Warmness about 2/3 above and below injection site; Dots and redness about 2/3 above and below injection site; Swelling about 2/3 above and below injection site; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (Warmness about 2/3 above and below injection site), VACCINATION SITE ERYTHEMA (Dots and redness about 2/3 above and below injection site) and VACCINATION SITE SWELLING (Swelling about 2/3 above and below injection site) in a 95-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Shingles (Got vaccinated).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Warmness about 2/3 above and below injection site), VACCINATION SITE ERYTHEMA (Dots and redness about 2/3 above and below injection site) and VACCINATION SITE SWELLING (Swelling about 2/3 above and below injection site). At the time of the report, VACCINATION SITE WARMTH (Warmness about 2/3 above and below injection site), VACCINATION SITE ERYTHEMA (Dots and redness about 2/3 above and below injection site) and VACCINATION SITE SWELLING (Swelling about 2/3 above and below injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment information was unknown
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Peripheral swelling, Pruritus, Tenderness
Clinical narrative: swollen; warm; itchy; arm was tender; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (arm was tender), PERIPHERAL SWELLING (swollen), FEELING HOT (warm) and PRURITUS (itchy) 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 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced TENDERNESS (arm was tender). On 11-Mar-2021, the patient experienced PERIPHERAL SWELLING (swollen), FEELING HOT (warm) and PRURITUS (itchy). At the time of the report, TENDERNESS (arm was tender) had not resolved and PERIPHERAL SWELLING (swollen), FEELING HOT (warm) and PRURITUS (itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications taken by the patient were not provided. Treatment information was not provided.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Vomiting
Clinical narrative: Vomiting; Flushed bright red; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (Flushed bright red) and VOMITING (Vomiting) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Surgery (Half of thyroid gland being removed surgically) on 28-Oct-2020. Concurrent medical conditions included Blood pressure, Thyroid cancer and Immunocompromised.    On 11-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced FLUSHING (Flushed bright red). On 12-Mar-2021, the patient experienced VOMITING (Vomiting). On 11-Mar-2021, FLUSHING (Flushed bright red) had resolved. At the time of the report, VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included blood pressure and anticancer drug.  No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain in arm, sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in arm, sore arm) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (pain in arm, sore arm). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Pain, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (pain in arm, sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reported that pain in arm stopped for 10 days and reappeared in worst state 3 days ago. Concomitant product use was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 12-Mar-2021: Event details updated
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Reading disorder, Speech disorder
Clinical narrative: Difficulty speaking; Difficulty reading; This spontaneous case was reported by a consumer and describes the occurrence of SPEECH DISORDER (Difficulty speaking) and READING DISORDER (Difficulty reading) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Diabetes.    On 03-Mar-2021 at 6:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced SPEECH DISORDER (Difficulty speaking) and READING DISORDER (Difficulty reading). At the time of the report, SPEECH DISORDER (Difficulty speaking) outcome was unknown and READING DISORDER (Difficulty reading) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Myalgia
Clinical narrative: Chills; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and MYALGIA (Body aches) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     Concomitant products included AMLODIPINE, HYDRALAZINE, ATORVASTATIN CALCIUM (LIPITOR) and ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced CHILLS (Chills). 12-Mar-2021, the patient experienced MYALGIA (Body aches). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 2 dosage form. At the time of the report, CHILLS (Chills) and MYALGIA (Body aches) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pyrexia, Vaccination site rash, Vaccination site reaction
Clinical narrative: she had "covid arm"; a rash around the injection site; it's feverish; her face went red for several hours; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (her face went red for several hours), VACCINATION SITE REACTION (she had "covid arm"), VACCINATION SITE RASH (a rash around the injection site) and PYREXIA (it's feverish) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included INSULIN, LEVOTHYROXINE and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced ERYTHEMA (her face went red for several hours). On 11-Mar-2021, the patient experienced VACCINATION SITE REACTION (she had "covid arm"), VACCINATION SITE RASH (a rash around the injection site) and PYREXIA (it's feverish). On 02-Mar-2021, ERYTHEMA (her face went red for several hours) had resolved. At the time of the report, VACCINATION SITE REACTION (she had "covid arm"), VACCINATION SITE RASH (a rash around the injection site) and PYREXIA (it's feverish) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Another concomitant medication was cholesterol medicine.  Treatment information in response to events was not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: TCR - Event outcome was updated
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Soreness of arm; Tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness of arm) and FATIGUE (Tired) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced PAIN IN EXTREMITY (Soreness of arm) and FATIGUE (Tired). At the time of the report, PAIN IN EXTREMITY (Soreness of arm) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment information in response to events was not provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pain, Pain in extremity, Pyrexia
Clinical narrative: Aches; Sore arm; Fever (101.8°F); This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches), PAIN IN EXTREMITY (Sore arm) and PYREXIA (Fever (101.8°F)) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced PAIN (Aches), PAIN IN EXTREMITY (Sore arm) and PYREXIA (Fever (101.8°F)). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PAIN (Aches), PAIN IN EXTREMITY (Sore arm) and PYREXIA (Fever (101.8°F)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, Body temperature: 101.8 (High) (101.8°F).         No Concomitant product use was reported. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Follow up received on 05-may-2021 and updated that patient was feeling better now and requested not to follow up again
Age: 92.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pyrexia, Rash
Clinical narrative: rash with little stripes on his lower left leg calf; His fever was >97.1 this morning; Husband started feeling tired on same day after receiving 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash with little stripes on his lower left leg calf), FATIGUE (Husband started feeling tired on same day after receiving 1st dose) and PYREXIA (His fever was >97.1 this morning) in a 92-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No medical History was provided by the reporter.  Concomitant products included QUETIAPINE, PRAVASTATIN, ATENOLOL, MEMANTINE HYDROCHLORIDE (NAMENDA), NORTRIPTYLINE, ACETYLSALICYLIC ACID (BABY ASPIRIN), PARACETAMOL (TYLENOL EXTRA STRENGTH), VITAMINS NOS, MAGNESIUM and ASCORBIC ACID, BETACAROTENE, CUPRIC OXIDE, TOCOPHERYL ACETATE, ZINC OXIDE (PRESERVISION) for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 09-Mar-2021, the patient experienced FATIGUE (Husband started feeling tired on same day after receiving 1st dose). On 12-Mar-2021, the patient experienced RASH (rash with little stripes on his lower left leg calf) and PYREXIA (His fever was >97.1 this morning). The patient was treated with CORTISONE at an unspecified dose and frequency. At the time of the report, RASH (rash with little stripes on his lower left leg calf), FATIGUE (Husband started feeling tired on same day after receiving 1st dose) and PYREXIA (His fever was >97.1 this morning) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, Body temperature: >97.1 (Inconclusive) fever was >97.1.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: feverish; chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (feverish) and CHILLS (chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included SARS-CoV-2 infection in October 2020.    On 11-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 CHILLS (chills). On 12-Mar-2021, the patient experienced PYREXIA (feverish). At the time of the report, PYREXIA (feverish) and CHILLS (chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not provided. Concomitant medications were not provided.
Age: 67.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: warm, feels warm; arm is little swollen; redness; pain; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (warm, feels warm), INJECTION SITE SWELLING (arm is little swollen), INJECTION SITE ERYTHEMA (redness) and INJECTION SITE PAIN (pain) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product PARACETAMOL (TYLENOL) for an unknown indication.    No Medical History information was reported.   On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started PARACETAMOL (TYLENOL) (unknown route) at an unspecified dose. On 12-Mar-2021, the patient experienced INJECTION SITE WARMTH (warm, feels warm), INJECTION SITE SWELLING (arm is little swollen), INJECTION SITE ERYTHEMA (redness) and INJECTION SITE PAIN (pain). At the time of the report, INJECTION SITE WARMTH (warm, feels warm), INJECTION SITE SWELLING (arm is little swollen), INJECTION SITE ERYTHEMA (redness) and INJECTION SITE PAIN (pain) had not resolved.; 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: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Peripheral swelling
Clinical narrative: swelling in my hands and lips; swelling in my hands and lips; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (swelling in my hands and lips) and PERIPHERAL SWELLING (swelling in my hands and lips) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 024M20A or 026M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ACYCLOVIR [ACICLOVIR] for an unknown indication.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1. On 12-Mar-2021, the patient experienced LIP SWELLING (swelling in my hands and lips) and PERIPHERAL SWELLING (swelling in my hands and lips). The patient was treated with IBUPROFEN for Swollen lips and Hand swelling, at an unspecified dose and frequency. At the time of the report, LIP SWELLING (swelling in my hands and lips) and PERIPHERAL SWELLING (swelling in my hands and lips) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: salty taste in my mouth and I can't get rid of it/metallic taste; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (salty taste in my mouth and I can't get rid of it/metallic taste) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02UM20A) for COVID-19 vaccination.     The patient's past medical history included Smoker (He is a smoker(1.5 packs/day)).    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced DYSGEUSIA (salty taste in my mouth and I can't get rid of it/metallic taste). At the time of the report, DYSGEUSIA (salty taste in my mouth and I can't get rid of it/metallic taste) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: Body Ache; Head ache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body Ache) and HEADACHE (Head ache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-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 experienced MYALGIA (Body Ache) and HEADACHE (Head ache). At the time of the report, MYALGIA (Body Ache) and HEADACHE (Head ache) outcome was unknown.            No concomitant medication was reported. No treatment was given. Action taken with mRNA-1273 in response to the event was not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: 11 doses were administered today to 11 patients from one vial after excursion; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (11 doses were administered today to 11 patients from one vial after excursion) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (11 doses were administered today to 11 patients from one vial after excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (11 doses were administered today to 11 patients from one vial after excursion) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications was reported Treatment information was not provided
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Lymphadenopathy, Pyrexia
Clinical narrative: was tire; fever and chill; he had swollen glands; short of breath.; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (short of breath.), PYREXIA (fever and chill), LYMPHADENOPATHY (he had swollen glands) and FATIGUE (was tire) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     The patient's past medical history included Heart attack and Stent placement.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced DYSPNOEA (short of breath.). On 05-Feb-2021, the patient experienced LYMPHADENOPATHY (he had swollen glands). On 07-Feb-2021, the patient experienced PYREXIA (fever and chill). On an unknown date, the patient experienced FATIGUE (was tire). At the time of the report, DYSPNOEA (short of breath.), PYREXIA (fever and chill), LYMPHADENOPATHY (he had swollen glands) and FATIGUE (was tire) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment product included steroids  no concomitant product was reported
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Diarrhoea, Dizziness, Heart rate increased, Hot flush
Clinical narrative: Fast heart beat; Dizziness; Off balance; Hot flashes; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (Hot flashes), DIARRHOEA (Diarrhea), HEART RATE INCREASED (Fast heart beat), DIZZINESS (Dizziness) and BALANCE DISORDER (Off balance) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced HOT FLUSH (Hot flashes) and DIARRHOEA (Diarrhea). On 05-Mar-2021, the patient experienced HEART RATE INCREASED (Fast heart beat) and DIZZINESS (Dizziness). On an unknown date, the patient experienced BALANCE DISORDER (Off balance). On 04-Mar-2021, HOT FLUSH (Hot flashes) and DIARRHOEA (Diarrhea) had resolved. On 07-Mar-2021, HEART RATE INCREASED (Fast heart beat) had resolved. At the time of the report, DIZZINESS (Dizziness) was resolving and BALANCE DISORDER (Off balance) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Pain in extremity, Vomiting
Clinical narrative: dizziness; nausea; vomiting; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), NAUSEA (nausea), VOMITING (vomiting) and PAIN IN EXTREMITY (sore arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concomitant products included NAPROXEN SODIUM (ALEVE) for an unknown indication.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced DIZZINESS (dizziness), NAUSEA (nausea), VOMITING (vomiting) and PAIN IN EXTREMITY (sore arm). At the time of the report, DIZZINESS (dizziness), NAUSEA (nausea), VOMITING (vomiting) and PAIN IN EXTREMITY (sore arm) outcome was unknown.            No concomitant medication was reported. treatment to the events given as Aleve.  Treatment medication include, Aleve for sore arm and unknown for other events.      Action taken with mRNA-1273 in response to the events was not Applicable.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling of body temperature change, Insomnia, Nasopharyngitis, Pain
Clinical narrative: her symptoms were so bad that it kept her awake and couldn't sleep at all; aching so badly; could not get warm; possible fever; feel woozy, dizzy; extremely cold that fluctuates to extreme hot spells; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (feel woozy, dizzy), FEELING OF BODY TEMPERATURE CHANGE (extremely cold that fluctuates to extreme hot spells), INSOMNIA (her symptoms were so bad that it kept her awake and couldn't sleep at all), PAIN (aching so badly) and NASOPHARYNGITIS (could not get warm) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced DIZZINESS (feel woozy, dizzy), FEELING OF BODY TEMPERATURE CHANGE (extremely cold that fluctuates to extreme hot spells), NASOPHARYNGITIS (could not get warm) and PYREXIA (possible fever). On 13-Mar-2021, the patient experienced INSOMNIA (her symptoms were so bad that it kept her awake and couldn't sleep at all) and PAIN (aching so badly). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] on 13-Mar-2021 for Ache, at an unspecified dose and frequency. At the time of the report, DIZZINESS (feel woozy, dizzy), FEELING OF BODY TEMPERATURE CHANGE (extremely cold that fluctuates to extreme hot spells), INSOMNIA (her symptoms were so bad that it kept her awake and couldn't sleep at all), PAIN (aching so badly), NASOPHARYNGITIS (could not get warm) and PYREXIA (possible fever) had not resolved.            Concomitant medications were not provided.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: her symptoms were so bad that it kept her awake and couldn't sleep at all; aching so badly; could not get warm; possible fever; feel woozy, dizzy; extremely cold that fluctuates to extreme hot spells; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (feel woozy, dizzy), FEELING OF BODY TEMPERATURE CHANGE (extremely cold that fluctuates to extreme hot spells), INSOMNIA (her symptoms were so bad that it kept her awake and couldn't sleep at all), PAIN (aching so badly) and NASOPHARYNGITIS (could not get warm) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced DIZZINESS (feel woozy, dizzy), FEELING OF BODY TEMPERATURE CHANGE (extremely cold that fluctuates to extreme hot spells), NASOPHARYNGITIS (could not get warm) and PYREXIA (possible fever). On 13-Mar-2021, the patient experienced INSOMNIA (her symptoms were so bad that it kept her awake and couldn't sleep at all) and PAIN (aching so badly). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] on 13-Mar-2021 for Ache, at an unspecified dose and frequency. At the time of the report, DIZZINESS (feel woozy, dizzy), FEELING OF BODY TEMPERATURE CHANGE (extremely cold that fluctuates to extreme hot spells), INSOMNIA (her symptoms were so bad that it kept her awake and couldn't sleep at all), PAIN (aching so badly), NASOPHARYNGITIS (could not get warm) and PYREXIA (possible fever) had not resolved.            Concomitant medications were not provided.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and PYREXIA (fever) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-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 12-Mar-2021, the patient experienced CHILLS (Chills) and PYREXIA (fever). At the time of the report, CHILLS (Chills) and PYREXIA (fever) outcome was unknown.            No concomitant medications was reported Treatment information was not provided
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Pruritus, Swelling
Clinical narrative: itchiness and redness; itchiness and redness; swelling & soreness on her arm; swelling & soreness on her arm; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swelling & soreness on her arm), PAIN IN EXTREMITY (swelling & soreness on her arm), PRURITUS (itchiness and redness) and ERYTHEMA (itchiness and redness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced SWELLING (swelling & soreness on her arm) and PAIN IN EXTREMITY (swelling & soreness on her arm). On 09-Mar-2021, the patient experienced PRURITUS (itchiness and redness) and ERYTHEMA (itchiness and redness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) at an unspecified dose and frequency. On 26-Feb-2021, SWELLING (swelling & soreness on her arm) and PAIN IN EXTREMITY (swelling & soreness on her arm) had resolved. At the time of the report, PRURITUS (itchiness and redness) and ERYTHEMA (itchiness and redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was reported Treatment information alo included  ice.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Blood pressure measurement, Chills, Myalgia, Pain in jaw
Clinical narrative: pain expanded to the fingers of his left arm; "horrible pain" in arm; "horrible pain" going to the jaw; experienced chills; body aches; fever at night time; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN JAW ("horrible pain" going to the jaw), CHILLS (experienced chills), MYALGIA (body aches), PYREXIA (fever at night time) and VACCINATION SITE PAIN ("horrible pain" in arm) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032N20A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced CHILLS (experienced chills), MYALGIA (body aches) and PYREXIA (fever at night time). On 10-Mar-2021, the patient experienced PAIN IN JAW ("horrible pain" going to the jaw) and VACCINATION SITE PAIN ("horrible pain" in arm). On 11-Mar-2021, the patient experienced ARTHRALGIA (pain expanded to the fingers of his left arm). At the time of the report, PAIN IN JAW ("horrible pain" going to the jaw), CHILLS (experienced chills), MYALGIA (body aches), PYREXIA (fever at night time), VACCINATION SITE PAIN ("horrible pain" in arm) and ARTHRALGIA (pain expanded to the fingers of his left arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Mar-2021, Blood pressure measurement: 166/112 (High) blood pressure increased.         Concomitant product use was not provided by the reporter.   ? No treatment information was provided. ? The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events was not applicable. ? Action taken with mRNA-1273 in response to the event was not applicable.