chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Hot and hurt to touch at the injection site; Tingling feeling at the injection site; Itching at the injection site; Injection site sore; Redness; Swelling at the injection site; Headaches; Tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot and hurt to touch at the injection site), VACCINATION SITE PARAESTHESIA (Tingling feeling at the injection site), VACCINATION SITE PAIN (Injection site sore), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE SWELLING (Swelling at the injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 011N20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 01-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Hot and hurt to touch at the injection site), VACCINATION SITE PARAESTHESIA (Tingling feeling at the injection site), VACCINATION SITE PAIN (Injection site sore), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE SWELLING (Swelling at the injection site), VACCINATION SITE PRURITUS (Itching at the injection site) and HEADACHE (Headaches). In February 2021, the patient experienced FATIGUE (Tired). The patient was treated with PARACETAMOL (TYLENOL) for Vaccination site pain, at a dose of UNK dosage form. At the time of the report, VACCINATION SITE WARMTH (Hot and hurt to touch at the injection site), VACCINATION SITE PARAESTHESIA (Tingling feeling at the injection site), VACCINATION SITE PAIN (Injection site sore), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE SWELLING (Swelling at the injection site), VACCINATION SITE PRURITUS (Itching at the injection site), FATIGUE (Tired) and HEADACHE (Headaches) outcome was unknown.            Concomitant medication was not reported. The patient took some Tylenol for the pain.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain
Clinical narrative: arm pain; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (arm pain) and MYALGIA (Body ache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 09L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced PAIN (arm pain) and MYALGIA (Body ache). At the time of the report, PAIN (arm pain) and MYALGIA (Body ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported Treatment medications was not provided
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pain, Pain in extremity, Vaccination site movement impairment
Clinical narrative: Worse pain in arm, can barely move arm, really painful; Felt like someone is stabbing in my arm; Felt like a shooting every time she moved the arm; Couldn't sleep; Could not lift arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Could not lift arm), PAIN IN EXTREMITY (Worse pain in arm, can barely move arm, really painful), PAIN IN EXTREMITY (Felt like someone is stabbing in my arm), PAIN (Felt like a shooting every time she moved the arm) and INSOMNIA (Couldn't sleep) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced PAIN IN EXTREMITY (Worse pain in arm, can barely move arm, really painful), PAIN IN EXTREMITY (Felt like someone is stabbing in my arm), PAIN (Felt like a shooting every time she moved the arm) and INSOMNIA (Couldn't sleep). On an unknown date, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Could not lift arm). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 400 mg. At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Could not lift arm) and PAIN IN EXTREMITY (Felt like someone is stabbing in my arm) had resolved and PAIN IN EXTREMITY (Worse pain in arm, can barely move arm, really painful), PAIN (Felt like a shooting every time she moved the arm) and INSOMNIA (Couldn't sleep) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-Mar-2021: Follow-up information received on 09-MAR-2021 contains significant information: New event "Stabbing in my arm" which resolved after 6 days. On 10-May-2021: Follow-up information received on 10-MAY-2021 contains significant information: Added lot number of 1st dose of vaccine. The event "Could not lift arm" resolved after 5 days.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site erythema, Injection site joint erythema, Pruritus, Pustule
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE JOINT ERYTHEMA (Huge Red Raised Injection Site (size of orange)), ERYTHEMA (Red Injection Site), PUSTULE (whelk like lesion comes and goes), PRURITUS (The Second time the Injection Site reaction Happened it was Itchy) and PYREXIA (Fever to the touch Injection Site) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Asthma and Hypertension. Concomitant products included CETIRIZINE for Asthma. On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced INJECTION SITE JOINT ERYTHEMA (Huge Red Raised Injection Site (size of orange)), ERYTHEMA (Red Injection Site), PUSTULE (whelk like lesion comes and goes) and PYREXIA (Fever to the touch Injection Site). On 24-Jan-2021, the patient experienced PRURITUS (The Second time the Injection Site reaction Happened it was Itchy). On 02-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (Injection Site Redness still going on). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE, ZINC OXIDE (BENADRYL LOTION N) (topical) for Itching, at a dose of 1 dosage form. At the time of the report, INJECTION SITE JOINT ERYTHEMA (Huge Red Raised Injection Site (size of orange)), ERYTHEMA (Red Injection Site), PUSTULE (whelk like lesion comes and goes), PRURITUS (The Second time the Injection Site reaction Happened it was Itchy), PYREXIA (Fever to the touch Injection Site) and INJECTION SITE ERYTHEMA (Injection Site Redness still going on) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE JOINT ERYTHEMA (Huge Red Raised Injection Site (size of orange)), ERYTHEMA (Red Injection Site), PUSTULE (whelk like lesion comes and goes), PRURITUS (The Second time the Injection Site reaction Happened it was Itchy) and PYREXIA (Fever to the touch Injection Site) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Asthma and Hypertension. Concomitant products included CETIRIZINE for Asthma. On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced INJECTION SITE JOINT ERYTHEMA (Huge Red Raised Injection Site (size of orange)), ERYTHEMA (Red Injection Site), PUSTULE (whelk like lesion comes and goes) and PYREXIA (Fever to the touch Injection Site). On 24-Jan-2021, the patient experienced PRURITUS (The Second time the Injection Site reaction Happened it was Itchy). On 02-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (Injection Site Redness still going on). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE, ZINC OXIDE (BENADRYL LOTION N) (topical) for Itching, at a dose of 1 dosage form. At the time of the report, INJECTION SITE JOINT ERYTHEMA (Huge Red Raised Injection Site (size of orange)), ERYTHEMA (Red Injection Site), PUSTULE (whelk like lesion comes and goes), PRURITUS (The Second time the Injection Site reaction Happened it was Itchy), PYREXIA (Fever to the touch Injection Site) and INJECTION SITE ERYTHEMA (Injection Site Redness still going on) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Vaccination site erythema, Vaccination site rash, Vaccination site reaction, Vaccination site warmth
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE REACTION (Huge amount of reactivity in the arm), VACCINATION SITE WARMTH (Hot and hard), CONDITION AGGRAVATED (Arm blew up and its worse), VACCINATION SITE ERYTHEMA (Described it as red) and VACCINATION SITE RASH (Rash had spread outside the margin) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination.  No Medical History information was reported. On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced VACCINATION SITE REACTION (Huge amount of reactivity in the arm), VACCINATION SITE WARMTH (Hot and hard), CONDITION AGGRAVATED (Arm blew up and its worse) and VACCINATION SITE ERYTHEMA (Described it as red). On 02-Feb-2021, the patient experienced VACCINATION SITE RASH (Rash had spread outside the margin). At the time of the report, VACCINATION SITE REACTION (Huge amount of reactivity in the arm), VACCINATION SITE WARMTH (Hot and hard), CONDITION AGGRAVATED (Arm blew up and its worse), VACCINATION SITE ERYTHEMA (Described it as red) and VACCINATION SITE RASH (Rash had spread outside the margin) 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. Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: NNI; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea, Oedema peripheral, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of OEDEMA PERIPHERAL (my lower legs are swelling), DIARRHOEA (diarrhea), VACCINATION SITE PAIN (arm soreness at the injection site) and NAUSEA (nausea) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Cardiovascular disease, unspecified, COPD and Anxiety. Concomitant products included ALPRAZOLAM (XANAX) for Anxiety, TADALAFIL (CIALIS) for Hypertension, APIXABAN (ELIQUIS) for an unknown indication. On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION SITE PAIN (arm soreness at the injection site). On 01-Feb-2021, the patient experienced OEDEMA PERIPHERAL (my lower legs are swelling), DIARRHOEA (diarrhea) and NAUSEA (nausea). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, OEDEMA PERIPHERAL (my lower legs are swelling), DIARRHOEA (diarrhea), VACCINATION SITE PAIN (arm soreness at the injection site) and NAUSEA (nausea) had not resolved. Diphenhydramine was given 15 minutes before second dose. This case was linked to MOD-2021-074433.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Vaccination site bruising
Clinical narrative: The red area is pretty large, sort of oval, with a redder rim around the outside; m It got extremely red around the vaccine site with a circle around it; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (The red area is pretty large, sort of oval, with a redder rim around the outside) and ERYTHEMA (m It got extremely red around the vaccine site with a circle around it) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced VACCINATION SITE BRUISING (The red area is pretty large, sort of oval, with a redder rim around the outside) and ERYTHEMA (m It got extremely red around the vaccine site with a circle around it). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of half a benadryl and CORTISONE at a dose of 1 dosage form. On 02-Feb-2021, VACCINATION SITE BRUISING (The red area is pretty large, sort of oval, with a redder rim around the outside) and ERYTHEMA (m It got extremely red around the vaccine site with a circle around it) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Urticaria, Vaccination site pain
Clinical narrative: part that is kind of like welted up; is hot to the touch; redness at the site; looks like swelling; it's tender; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (part that is kind of like welted up), INJECTION SITE WARMTH (is hot to the touch), INJECTION SITE ERYTHEMA (redness at the site), INJECTION SITE SWELLING (looks like swelling) and VACCINATION SITE PAIN (it's tender) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced URTICARIA (part that is kind of like welted up), INJECTION SITE WARMTH (is hot to the touch), INJECTION SITE ERYTHEMA (redness at the site), INJECTION SITE SWELLING (looks like swelling) and VACCINATION SITE PAIN (it's tender). The patient was treated with CETIRIZINE HYDROCHLORIDE (BENADRYL ALLERGY [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, URTICARIA (part that is kind of like welted up), INJECTION SITE WARMTH (is hot to the touch), INJECTION SITE ERYTHEMA (redness at the site), INJECTION SITE SWELLING (looks like swelling) and VACCINATION SITE PAIN (it's tender) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator No treatment medications provided by the reporter.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Dental caries
Clinical narrative: Chipped her tooth; This spontaneous case was reported by a consumer and describes the occurrence of DENTAL CARIES (Chipped her tooth) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced DENTAL CARIES (Chipped her tooth). At the time of the report, DENTAL CARIES (Chipped her tooth) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant products were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: stating patient was feeling fine and wanted no further FU. Outcome updated to Resolved
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site rash, Injection site swelling, Limb discomfort
Clinical narrative: Itchy; Bumps from rash on injection arm; Rash; Arm felt heavy; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Arm felt heavy), INJECTION SITE PRURITUS (Itchy), INJECTION SITE SWELLING (Bumps from rash on injection arm) and INJECTION SITE RASH (Rash) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced LIMB DISCOMFORT (Arm felt heavy). On 31-Jan-2021, the patient experienced INJECTION SITE PRURITUS (Itchy), INJECTION SITE SWELLING (Bumps from rash on injection arm) and INJECTION SITE RASH (Rash). On 19-Jan-2021, LIMB DISCOMFORT (Arm felt heavy) had resolved. At the time of the report, INJECTION SITE PRURITUS (Itchy), INJECTION SITE SWELLING (Bumps from rash on injection arm) and INJECTION SITE RASH (Rash) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Peripheral swelling, Pruritus, Vaccination site erythema
Clinical narrative: arm was very sore; arm was swollen; itchy; red around it; can´t scratch since it hurts; Terrible headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was very sore), PERIPHERAL SWELLING (arm was swollen), PRURITUS (itchy), VACCINATION SITE ERYTHEMA (red around it) and VACCINATION SITE PAIN (can´t scratch since it hurts) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm was very sore), PERIPHERAL SWELLING (arm was swollen), PRURITUS (itchy), VACCINATION SITE ERYTHEMA (red around it), VACCINATION SITE PAIN (can´t scratch since it hurts) and HEADACHE (Terrible headache). On 01-Feb-2021, HEADACHE (Terrible headache) had resolved. At the time of the report, PAIN IN EXTREMITY (arm was very sore), PERIPHERAL SWELLING (arm was swollen), PRURITUS (itchy), VACCINATION SITE ERYTHEMA (red around it) and VACCINATION SITE PAIN (can´t scratch since it hurts) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications reported by investigator No treatment medications provided by the reporter.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: arm was very sore; arm was swollen; itchy; red around it; can´t scratch since it hurts; Terrible headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was very sore), PERIPHERAL SWELLING (arm was swollen), PRURITUS (itchy), VACCINATION SITE ERYTHEMA (red around it) and VACCINATION SITE PAIN (can´t scratch since it hurts) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm was very sore), PERIPHERAL SWELLING (arm was swollen), PRURITUS (itchy), VACCINATION SITE ERYTHEMA (red around it), VACCINATION SITE PAIN (can´t scratch since it hurts) and HEADACHE (Terrible headache). On 01-Feb-2021, HEADACHE (Terrible headache) had resolved. At the time of the report, PAIN IN EXTREMITY (arm was very sore), PERIPHERAL SWELLING (arm was swollen), PRURITUS (itchy), VACCINATION SITE ERYTHEMA (red around it) and VACCINATION SITE PAIN (can´t scratch since it hurts) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications reported by investigator No treatment medications provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph node in left arm that is growing in size each day; A spontaneous report was received from a pharmacist concerning a patient of unknown age and gender, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events swollen lymph node in left arm pit that's growing in size each day/lymphadenopathy.   The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date in 2021, prior to the onset of the events the patient received their unknown dose of two planned doses of mRNA-1273 (lot batch: unknown) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date in 2021, the pharmacist reported that a patient whom she administered the vaccine experienced the event swollen lymph node in left arm that is growing in size each day. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   At the time of this report, the outcome of the event swollen lymph node in left arm pit that is growing in size each day was not resolved.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-122691:dose 1
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Pain, Peripheral swelling, Pruritus, Rash macular
Clinical narrative: hot to touch; swollen; a red mark the size of a quarter was visible; arm hurt really bad and it itched; arm hurt really bad and it itched; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (a red mark the size of a quarter was visible), FEELING HOT (hot to touch), PERIPHERAL SWELLING (swollen), PRURITUS (arm hurt really bad and it itched) and PAIN (arm hurt really bad and it itched) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L02A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included LEVOTHYROXINE, PEPSIN, LOSARTAN, UBIDECARENONE (COQ) and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced PRURITUS (arm hurt really bad and it itched) and PAIN (arm hurt really bad and it itched). On 23-Jan-2021, the patient experienced RASH MACULAR (a red mark the size of a quarter was visible). On 02-Feb-2021, the patient experienced FEELING HOT (hot to touch) and PERIPHERAL SWELLING (swollen). At the time of the report, RASH MACULAR (a red mark the size of a quarter was visible), FEELING HOT (hot to touch), PERIPHERAL SWELLING (swollen), PRURITUS (arm hurt really bad and it itched) and PAIN (arm hurt really bad and it itched) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: No specific follow-up information recorded.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Headache, Pruritus, Swelling
Clinical narrative: The area was red and itchy and swollen for about a week; The area was red and itchy and swollen for about a week -; itchy and sensitive to touch; the site of the shot got very pink; a tiny bit of redness; headache; tired; This spontaneous case was reported by a health care professional and describes the occurrence of ERYTHEMA (a tiny bit of redness), VACCINATION SITE PRURITUS (itchy and sensitive to touch), HEADACHE (headache), FATIGUE (tired) and VACCINATION SITE ERYTHEMA (the site of the shot got very pink) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concurrent medical conditions included Pollen allergy (Mild to moderate.) and Allergy to molds (Mild to moderate). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), LORATADINE (CLARITIN [LORATADINE]), SPIRONOLACTONE, HYDROCHLOROTHIAZIDE, FAMOTIDINE, FLUVOXAMINE MALEATE, GABAPENTIN, MIRABEGRON (MYRBETRIQ), OLOPATADINE HYDROCHLORIDE (PATADAY) and OLOPATADINE HYDROCHLORIDE (PATANASE) for an unknown indication.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced ERYTHEMA (a tiny bit of redness), HEADACHE (headache) and FATIGUE (tired). On 30-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (itchy and sensitive to touch) and VACCINATION SITE ERYTHEMA (the site of the shot got very pink). On an unknown date, the patient experienced SWELLING (The area was red and itchy and swollen for about a week -) and PRURITUS (The area was red and itchy and swollen for about a week). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency; CORTISONE for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. On 25-Jan-2021, HEADACHE (headache) had resolved. On 26-Jan-2021, ERYTHEMA (a tiny bit of redness) had resolved. On 30-Jan-2021, FATIGUE (tired) had resolved. At the time of the report, VACCINATION SITE PRURITUS (itchy and sensitive to touch), VACCINATION SITE ERYTHEMA (the site of the shot got very pink), SWELLING (The area was red and itchy and swollen for about a week -) and PRURITUS (The area was red and itchy and swollen for about a week) 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.   This case was linked to MOD-2021-260913 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Significant follow up appended.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: The area was red and itchy and swollen for about a week; The area was red and itchy and swollen for about a week -; itchy and sensitive to touch; the site of the shot got very pink; a tiny bit of redness; headache; tired; This spontaneous case was reported by a health care professional and describes the occurrence of ERYTHEMA (a tiny bit of redness), VACCINATION SITE PRURITUS (itchy and sensitive to touch), HEADACHE (headache), FATIGUE (tired) and VACCINATION SITE ERYTHEMA (the site of the shot got very pink) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concurrent medical conditions included Pollen allergy (Mild to moderate.) and Allergy to molds (Mild to moderate). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), LORATADINE (CLARITIN [LORATADINE]), SPIRONOLACTONE, HYDROCHLOROTHIAZIDE, FAMOTIDINE, FLUVOXAMINE MALEATE, GABAPENTIN, MIRABEGRON (MYRBETRIQ), OLOPATADINE HYDROCHLORIDE (PATADAY) and OLOPATADINE HYDROCHLORIDE (PATANASE) for an unknown indication.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced ERYTHEMA (a tiny bit of redness), HEADACHE (headache) and FATIGUE (tired). On 30-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (itchy and sensitive to touch) and VACCINATION SITE ERYTHEMA (the site of the shot got very pink). On an unknown date, the patient experienced SWELLING (The area was red and itchy and swollen for about a week -) and PRURITUS (The area was red and itchy and swollen for about a week). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency; CORTISONE for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. On 25-Jan-2021, HEADACHE (headache) had resolved. On 26-Jan-2021, ERYTHEMA (a tiny bit of redness) had resolved. On 30-Jan-2021, FATIGUE (tired) had resolved. At the time of the report, VACCINATION SITE PRURITUS (itchy and sensitive to touch), VACCINATION SITE ERYTHEMA (the site of the shot got very pink), SWELLING (The area was red and itchy and swollen for about a week -) and PRURITUS (The area was red and itchy and swollen for about a week) 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.   This case was linked to MOD-2021-260913 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Significant follow up appended.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain in upper right leg; arm hurt a little; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt a little) and PAIN IN EXTREMITY (pain in upper right leg) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included VITAMINS NOS for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm hurt a little). On 01-Feb-2021, the patient experienced PAIN IN EXTREMITY (pain in upper right leg). On 28-Jan-2021, PAIN IN EXTREMITY (arm hurt a little) had resolved. In February 2021, PAIN IN EXTREMITY (pain in upper right leg) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant products also included an unspecified medication to treat high blood pressure.  The patient did not use treatment for the events.   This case was linked to MOD-2021-234292 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Outcome recovered.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pain, Pain in extremity
Clinical narrative: worse worse is she have like a shot that goes and came again in her leg.; everything on her body is hurting; join pain; muscle pain; headache; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (worse worse is she have like a shot that goes and came again in her leg.), PAIN (everything on her body is hurting), PAIN IN EXTREMITY (join pain), MYALGIA (muscle pain) and HEADACHE (headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension.   On 26-Jan-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 26-Jan-2021, the patient experienced PAIN IN EXTREMITY (worse worse is she have like a shot that goes and came again in her leg.), PAIN (everything on her body is hurting), PAIN IN EXTREMITY (join pain), MYALGIA (muscle pain), HEADACHE (headache), PYREXIA (fever) and CHILLS (chills). At the time of the report, PAIN IN EXTREMITY (worse worse is she have like a shot that goes and came again in her leg.), PAIN (everything on her body is hurting), PAIN IN EXTREMITY (join pain), MYALGIA (muscle pain), HEADACHE (headache), PYREXIA (fever) and CHILLS (chills) had not resolved.            Tylenol Used as a Treatment Medication. No Concomitant Medication was provided by reporter.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: worse worse is she have like a shot that goes and came again in her leg.; everything on her body is hurting; join pain; muscle pain; headache; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (worse worse is she have like a shot that goes and came again in her leg.), PAIN (everything on her body is hurting), PAIN IN EXTREMITY (join pain), MYALGIA (muscle pain) and HEADACHE (headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension.   On 26-Jan-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 26-Jan-2021, the patient experienced PAIN IN EXTREMITY (worse worse is she have like a shot that goes and came again in her leg.), PAIN (everything on her body is hurting), PAIN IN EXTREMITY (join pain), MYALGIA (muscle pain), HEADACHE (headache), PYREXIA (fever) and CHILLS (chills). At the time of the report, PAIN IN EXTREMITY (worse worse is she have like a shot that goes and came again in her leg.), PAIN (everything on her body is hurting), PAIN IN EXTREMITY (join pain), MYALGIA (muscle pain), HEADACHE (headache), PYREXIA (fever) and CHILLS (chills) had not resolved.            Tylenol Used as a Treatment Medication. No Concomitant Medication was provided by reporter.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fall, Gait disturbance, Muscular weakness, Pain in extremity
Clinical narrative: right leg in sever pain; fell a couple of times getting out of bed; Weakness from lower spine down his foot; Wakness down right leg; Right leg unusable / right leg gives out when walking; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (right leg in sever pain), FALL (fell a couple of times getting out of bed), ASTHENIA (Weakness from lower spine down his foot), MUSCULAR WEAKNESS (Wakness down right leg) and GAIT DISTURBANCE (Right leg unusable / right leg gives out when walking) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Unknown and 015M204) for COVID-19 vaccination.     Concomitant products included LEUPRORELIN ACETATE (LUPRON) and ENZALUTAMIDE (XTANDI) for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (right leg in sever pain), FALL (fell a couple of times getting out of bed), ASTHENIA (Weakness from lower spine down his foot), MUSCULAR WEAKNESS (Wakness down right leg) and GAIT DISTURBANCE (Right leg unusable / right leg gives out when walking). At the time of the report, PAIN IN EXTREMITY (right leg in sever pain), FALL (fell a couple of times getting out of bed), ASTHENIA (Weakness from lower spine down his foot), MUSCULAR WEAKNESS (Wakness down right leg) and GAIT DISTURBANCE (Right leg unusable / right leg gives out when walking) outcome was unknown.            Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Follow-up information  received on 13 May 2021 and updated patient's date of birth. On 14-May-2021: Follow-up information  received on 14 May 2021 and  additional events provided and date of initial dose of vaccine was updated.; Sender's Comments: Very limited information regarding the events has been provided at this time and is insufficient for causality assessment. Further information has been requested.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Erythema, Injection site erythema, Pruritus
Clinical narrative: light pink at injection site; woke up with itching so bad; red on arm where I got the vaccine - sunburn red. Redness was 2 inch wide by 4 inches long; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (woke up with itching so bad), ERYTHEMA (red on arm where I got the vaccine - sunburn red. Redness was 2 inch wide by 4 inches long), INJECTION SITE ERYTHEMA (light pink at injection site) and ARTHRALGIA (sore arm) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included TAMOXIFEN for an unknown indication.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced ARTHRALGIA (sore arm). On 28-Jan-2021, the patient experienced PRURITUS (woke up with itching so bad) and ERYTHEMA (red on arm where I got the vaccine - sunburn red. Redness was 2 inch wide by 4 inches long). On 01-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (light pink at injection site). On 20-Jan-2021, ARTHRALGIA (sore arm) had resolved. On 01-Feb-2021, ERYTHEMA (red on arm where I got the vaccine - sunburn red. Redness was 2 inch wide by 4 inches long) had resolved. At the time of the report, PRURITUS (woke up with itching so bad) and INJECTION SITE ERYTHEMA (light pink at injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Ice used as a Treatment.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: severe nausea; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (severe nausea) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No medical history was provided by the reporter. .  Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), ATORVASTATIN, LEVOTHYROXINE SODIUM (SYNTHROID) and CLOPIDOGREL for an unknown indication.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced NAUSEA (severe nausea). At the time of the report, NAUSEA (severe nausea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Used ondansetron for the nausea treatment.
Sex: M
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: Experienced an adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Experienced an adverse reaction) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (Experienced an adverse reaction). At the time of the report, ADVERSE REACTION (Experienced an adverse reaction) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Relevant concomitant medication was not reported.  Treatment information was not provided.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Neuralgia, Vaccination site erythema, Vaccination site mass, Vaccination site pain, Vaccination site pruritus
Clinical narrative: its like all the nerve endings are going crazy; tender to touch; Where the inoculation was, I got a red hard lump there; it was itchy; I have a big red thing down my arm at least 2 inches wide and 4-5 inches long/it didnt come until a week later; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Where the inoculation was, I got a red hard lump there), VACCINATION SITE PRURITUS (it was itchy), VACCINATION SITE ERYTHEMA (I have a big red thing down my arm at least 2 inches wide and 4-5 inches long/it didnt come until a week later), VACCINATION SITE PAIN (tender to touch) and NEURALGIA (its like all the nerve endings are going crazy) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced VACCINATION SITE MASS (Where the inoculation was, I got a red hard lump there), VACCINATION SITE PRURITUS (it was itchy) and VACCINATION SITE ERYTHEMA (I have a big red thing down my arm at least 2 inches wide and 4-5 inches long/it didnt come until a week later). On 02-Feb-2021, the patient experienced VACCINATION SITE PAIN (tender to touch). On an unknown date, the patient experienced NEURALGIA (its like all the nerve endings are going crazy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MASS (Where the inoculation was, I got a red hard lump there), VACCINATION SITE PRURITUS (it was itchy) and VACCINATION SITE ERYTHEMA (I have a big red thing down my arm at least 2 inches wide and 4-5 inches long/it didnt come until a week later) had not resolved and VACCINATION SITE PAIN (tender to touch) and NEURALGIA (its like all the nerve endings are going crazy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator  Treatment includes hot/wet cold packs on it.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Muscle spasms
Clinical narrative: Loose stool, runs; Diarrhea; Cramps; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Loose stool, runs), DIARRHOEA (Diarrhea) and MUSCLE SPASMS (Cramps) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (LEVOXYL) and IBUPROFEN (ADVIL [IBUPROFEN]) for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced DIARRHOEA (Loose stool, runs), DIARRHOEA (Diarrhea) and MUSCLE SPASMS (Cramps). At the time of the report, DIARRHOEA (Loose stool, runs), DIARRHOEA (Diarrhea) and MUSCLE SPASMS (Cramps) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported her bowel condition was due to eating too many nuts and it was not related to the vaccine. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Follow-up was received on -1-FEB-2021 and causality is updated by patient
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ear ringing/felt like ringing was in the middle of her head; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Ear ringing/felt like ringing was in the middle of her head) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced TINNITUS (Ear ringing/felt like ringing was in the middle of her head). On 02-Feb-2021, TINNITUS (Ear ringing/felt like ringing was in the middle of her head) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Follow- up received on 19 Apr 2021: included contact information( Email address)
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Malaise, Nausea, Palpitations, Vaccination site reaction
Clinical narrative: No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced VACCINATION SITE REACTION (experienced a side effect within the first 7 minutes, it did subside within the hour). On an unknown date, the patient experienced MALAISE (Fealt so exhausted), PALPITATIONS (Heart racing), DIZZINESS (Dizzy as if being put under) and NAUSEA (Nauseous). At the time of the report, MALAISE (Fealt so exhausted), PALPITATIONS (Heart racing), DIZZINESS (Dizzy as if being put under) and NAUSEA (Nauseous) outcome was unknown and VACCINATION SITE REACTION (experienced a side effect within the first 7 minutes, it did subside within the hour) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided by reporter. No treatment medications provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Follow up received; Reporter email address, Patient demographics, Drug information and event outcome was updated.