chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Vaccination site pain
Clinical narrative: red; still itching; Arm pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm pain at injection site), PRURITUS (still itching) and ERYTHEMA (red) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041671A) for COVID-19 vaccination.     The patient's past medical history included Childhood asthma. Concurrent medical conditions included Fruit allergy (Oranges) and Food allergy (Tamatoes).    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, the patient experienced VACCINATION SITE PAIN (Arm pain at injection site). On 31-Jan-2021, the patient experienced PRURITUS (still itching). On 04-Feb-2021, the patient experienced ERYTHEMA (red). At the time of the report, VACCINATION SITE PAIN (Arm pain at injection site), PRURITUS (still itching) and ERYTHEMA (red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  No treatment medication was reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Feb-2021 and was forwarded to Moderna on 05-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm pain at injection site), PRURITUS (still itching) and ERYTHEMA (red) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041671A) for COVID-19 vaccination.     The patient's past medical history included Childhood asthma. Concurrent medical conditions included Fruit allergy (Oranges) and Food allergy (Tamatoes).    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, the patient experienced VACCINATION SITE PAIN (Arm pain at injection site). On 31-Jan-2021, the patient experienced PRURITUS (still itching). On 04-Feb-2021, the patient experienced ERYTHEMA (red). At the time of the report, VACCINATION SITE PAIN (Arm pain at injection site), PRURITUS (still itching) and ERYTHEMA (red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  No treatment medication was reported.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (the site of injection was red), VACCINATION SITE SWELLING (swollen injection site), VACCINATION SITE PAIN (ainfull injection site), VACCINATION SITE PRURITUS (intensely itchy) and PAIN (mild body aches). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, VACCINATION SITE ERYTHEMA (the site of injection was red), VACCINATION SITE SWELLING (swollen injection site), VACCINATION SITE PAIN (ainfull injection site), VACCINATION SITE PRURITUS (intensely itchy) and PAIN (mild body aches) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     Concomitant products included VITAMIN D NOS, ASCORBIC ACID (VITAMIN C ACID), CALCIUM and LISINOPRIL for an unknown indication.    On 31-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 DIARRHOEA (diarrhea). At the time of the report, DIARRHOEA (diarrhea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient did not take any treatment medication.   This case was linked to MOD-2021-022461 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea
Clinical narrative: Stomach Pain; Diarrhea; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach Pain) and DIARRHOEA (Diarrhea) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included MACROGOL 3350 (MIRALAX) for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (Stomach Pain) and DIARRHOEA (Diarrhea). At the time of the report, ABDOMINAL PAIN UPPER (Stomach Pain) and DIARRHOEA (Diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medications was not provided   Reporter did not allow further contact
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: hot to touch; arm Itchy; arm  red; swollen down to her elbow; arm hurt for 2 days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot to touch), VACCINATION SITE PRURITUS (arm Itchy), VACCINATION SITE PAIN (arm hurt for 2 days), VACCINATION SITE ERYTHEMA (arm  red) and VACCINATION SITE SWELLING (swollen down to her elbow) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION SITE PAIN (arm hurt for 2 days). On 02-Feb-2021, the patient experienced VACCINATION SITE WARMTH (hot to touch), VACCINATION SITE PRURITUS (arm Itchy), VACCINATION SITE ERYTHEMA (arm  red) and VACCINATION SITE SWELLING (swollen down to her elbow). The patient was treated with HYDROCORTISONE (CORTISONE [HYDROCORTISONE]) for Itching, at a dose of 1 dosage form. On 30-Jan-2021, VACCINATION SITE PAIN (arm hurt for 2 days) had resolved. At the time of the report, VACCINATION SITE WARMTH (hot to touch), VACCINATION SITE ERYTHEMA (arm  red) and VACCINATION SITE SWELLING (swollen down to her elbow) outcome was unknown and VACCINATION SITE PRURITUS (arm Itchy) was resolving.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       As reported by the consumer from the TCR follow up on 6-Jul-21, she used anti-itch cream and cold/warm compresses to treat events from her 1st vaccine and they resolved within 3-4 days. She also reported that she received the second vaccine, date and vaccine info not reported, and had no adverse events.  No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Significant TCR follow-up -outcome of the events
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Slight headache; Itches; Rash under where she got the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itches), VACCINATION SITE RASH (Rash under where she got the injection) and HEADACHE (Slight headache) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itches) and VACCINATION SITE RASH (Rash under where she got the injection). On 10-Feb-2021, the patient experienced HEADACHE (Slight headache). At the time of the report, VACCINATION SITE PRURITUS (Itches), VACCINATION SITE RASH (Rash under where she got the injection) and HEADACHE (Slight headache) 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.   Concomitant medication included: unspecified medication for diabetes, unspecified medication for cholesterol. No treatment medication was provided.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Nasal congestion, Pain in extremity
Clinical narrative: Stuffy nose; Arm hurt; Tired; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (Stuffy nose), PAIN IN EXTREMITY (Arm hurt) and FATIGUE (Tired) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Knee pain and Back pain. Concomitant products included NAPROXEN SODIUM (ALEVE) for Knee pain and Back pain.    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 NASAL CONGESTION (Stuffy nose), PAIN IN EXTREMITY (Arm hurt) and FATIGUE (Tired). At the time of the report, NASAL CONGESTION (Stuffy nose), PAIN IN EXTREMITY (Arm hurt) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not reported.   Reporter did not allow further contact
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Vaccination site erythema, Vaccination site induration, Vaccination site pruritus
Clinical narrative: warm to the touch around the injection site - right arm; itchy near injection site - right arm; little hard near injection site - right arm; red patch near injection site - bout 3 by 4 inches - right arm; rash around the injection site - right arm; headache; sore arm - right arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm to the touch around the injection site - right arm), PAIN IN EXTREMITY (sore arm - right arm), VACCINATION SITE PRURITUS (itchy near injection site - right arm), VACCINATION SITE INDURATION (little hard near injection site - right arm) and HEADACHE (headache) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) for an unknown indication.    On 28-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 IN EXTREMITY (sore arm - right arm) and HEADACHE (headache). On 06-Feb-2021, the patient experienced VACCINATION SITE WARMTH (warm to the touch around the injection site - right arm), VACCINATION SITE PRURITUS (itchy near injection site - right arm), VACCINATION SITE INDURATION (little hard near injection site - right arm), VACCINATION SITE ERYTHEMA (red patch near injection site - bout 3 by 4 inches - right arm) and VACCINATION SITE RASH (rash around the injection site - right arm). At the time of the report, VACCINATION SITE WARMTH (warm to the touch around the injection site - right arm), VACCINATION SITE PRURITUS (itchy near injection site - right arm), VACCINATION SITE INDURATION (little hard near injection site - right arm), VACCINATION SITE ERYTHEMA (red patch near injection site - bout 3 by 4 inches - right arm) and VACCINATION SITE RASH (rash around the injection site - right arm) had not resolved and PAIN IN EXTREMITY (sore arm - right arm) and HEADACHE (headache) had resolved.        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.   Treatment included cool packs.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash, Vaccination site warmth
Clinical narrative: warm to the touch around the injection site - right arm; itchy near injection site - right arm; little hard near injection site - right arm; red patch near injection site - bout 3 by 4 inches - right arm; rash around the injection site - right arm; headache; sore arm - right arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm to the touch around the injection site - right arm), PAIN IN EXTREMITY (sore arm - right arm), VACCINATION SITE PRURITUS (itchy near injection site - right arm), VACCINATION SITE INDURATION (little hard near injection site - right arm) and HEADACHE (headache) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) for an unknown indication.    On 28-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 IN EXTREMITY (sore arm - right arm) and HEADACHE (headache). On 06-Feb-2021, the patient experienced VACCINATION SITE WARMTH (warm to the touch around the injection site - right arm), VACCINATION SITE PRURITUS (itchy near injection site - right arm), VACCINATION SITE INDURATION (little hard near injection site - right arm), VACCINATION SITE ERYTHEMA (red patch near injection site - bout 3 by 4 inches - right arm) and VACCINATION SITE RASH (rash around the injection site - right arm). At the time of the report, VACCINATION SITE WARMTH (warm to the touch around the injection site - right arm), VACCINATION SITE PRURITUS (itchy near injection site - right arm), VACCINATION SITE INDURATION (little hard near injection site - right arm), VACCINATION SITE ERYTHEMA (red patch near injection site - bout 3 by 4 inches - right arm) and VACCINATION SITE RASH (rash around the injection site - right arm) had not resolved and PAIN IN EXTREMITY (sore arm - right arm) and HEADACHE (headache) had resolved.        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.   Treatment included cool packs.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Pain, Pyrexia, Vaccination site erythema
Clinical narrative: body aches; felt weird all of the next day; knot at the injection site; severe itching at the injection site; fever; chills; Redness at the injection site; This spontaneous case was reported by a dietician and describes the occurrence of PYREXIA (fever), PAIN (body aches), CHILLS (chills), FEELING ABNORMAL (felt weird all of the next day) and VACCINATION SITE INDURATION (knot at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 21-Dec-2020, Fever on 21-Dec-2020 and Headache on 21-Dec-2020. Concomitant products included LEVOTHYROXINE, ATORVASTATIN, GLUCOSAMINE, MULTIVITAMIN [VITAMINS NOS] and OSPEMIFENE (OSPHENA) for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced PYREXIA (fever), PAIN (body aches), CHILLS (chills), FEELING ABNORMAL (felt weird all of the next day), VACCINATION SITE INDURATION (knot at the injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE PRURITUS (severe itching at the injection site). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. In February 2021, PYREXIA (fever), PAIN (body aches), CHILLS (chills), FEELING ABNORMAL (felt weird all of the next day) and VACCINATION SITE INDURATION (knot at the injection site) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE PRURITUS (severe itching at the injection site) was resolving. 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.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site pruritus
Clinical narrative: body aches; felt weird all of the next day; knot at the injection site; severe itching at the injection site; fever; chills; Redness at the injection site; This spontaneous case was reported by a dietician and describes the occurrence of PYREXIA (fever), PAIN (body aches), CHILLS (chills), FEELING ABNORMAL (felt weird all of the next day) and VACCINATION SITE INDURATION (knot at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 21-Dec-2020, Fever on 21-Dec-2020 and Headache on 21-Dec-2020. Concomitant products included LEVOTHYROXINE, ATORVASTATIN, GLUCOSAMINE, MULTIVITAMIN [VITAMINS NOS] and OSPEMIFENE (OSPHENA) for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced PYREXIA (fever), PAIN (body aches), CHILLS (chills), FEELING ABNORMAL (felt weird all of the next day), VACCINATION SITE INDURATION (knot at the injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE PRURITUS (severe itching at the injection site). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. In February 2021, PYREXIA (fever), PAIN (body aches), CHILLS (chills), FEELING ABNORMAL (felt weird all of the next day) and VACCINATION SITE INDURATION (knot at the injection site) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE PRURITUS (severe itching at the injection site) was resolving. 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.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Muscle twitching
Clinical narrative: Nerves in my face were jumping; Teeth occasionally chatter; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TWITCHING (Nerves in my face were jumping) and CHILLS (Teeth occasionally chatter) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and ROSUVASTATIN for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced MUSCLE TWITCHING (Nerves in my face were jumping) and CHILLS (Teeth occasionally chatter). On 28-Jan-2021, MUSCLE TWITCHING (Nerves in my face were jumping) had resolved. At the time of the report, CHILLS (Teeth occasionally chatter) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was reported.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Erythema, Fatigue, Immune system disorder
Clinical narrative: Painful to touch; Shoulder inflamed; Nerve pain; Vertigo; Dizziness; Joint pain; Fatigue; Arm redness; Muscle pain; Fare up in her immune systems; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Painful to touch), INFLAMMATION (Shoulder inflamed), NEURALGIA (Nerve pain), VERTIGO (Vertigo) and DIZZINESS (Dizziness) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Painful to touch), INFLAMMATION (Shoulder inflamed), NEURALGIA (Nerve pain), VERTIGO (Vertigo), DIZZINESS (Dizziness), ARTHRALGIA (Joint pain), FATIGUE (Fatigue), ERYTHEMA (Arm redness), MYALGIA (Muscle pain) and IMMUNE SYSTEM DISORDER (Fare up in her immune systems). At the time of the report, PAIN (Painful to touch), INFLAMMATION (Shoulder inflamed), NEURALGIA (Nerve pain), ARTHRALGIA (Joint pain), ERYTHEMA (Arm redness), MYALGIA (Muscle pain) and IMMUNE SYSTEM DISORDER (Fare up in her immune systems) had resolved and VERTIGO (Vertigo), DIZZINESS (Dizziness) and FATIGUE (Fatigue) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant and treatment information were not provided.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Myalgia, Neuralgia, Pain, Vertigo
Clinical narrative: Painful to touch; Shoulder inflamed; Nerve pain; Vertigo; Dizziness; Joint pain; Fatigue; Arm redness; Muscle pain; Fare up in her immune systems; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Painful to touch), INFLAMMATION (Shoulder inflamed), NEURALGIA (Nerve pain), VERTIGO (Vertigo) and DIZZINESS (Dizziness) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Painful to touch), INFLAMMATION (Shoulder inflamed), NEURALGIA (Nerve pain), VERTIGO (Vertigo), DIZZINESS (Dizziness), ARTHRALGIA (Joint pain), FATIGUE (Fatigue), ERYTHEMA (Arm redness), MYALGIA (Muscle pain) and IMMUNE SYSTEM DISORDER (Fare up in her immune systems). At the time of the report, PAIN (Painful to touch), INFLAMMATION (Shoulder inflamed), NEURALGIA (Nerve pain), ARTHRALGIA (Joint pain), ERYTHEMA (Arm redness), MYALGIA (Muscle pain) and IMMUNE SYSTEM DISORDER (Fare up in her immune systems) had resolved and VERTIGO (Vertigo), DIZZINESS (Dizziness) and FATIGUE (Fatigue) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant and treatment information were not provided.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin sensitisation
Clinical narrative: Itching arm; Swollen down to elbow; Arm sensitive to touch; Red down to the elbow; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching arm), PERIPHERAL SWELLING (Swollen down to elbow), SKIN SENSITISATION (Arm sensitive to touch) and ERYTHEMA (Red down to the elbow) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itching arm), PERIPHERAL SWELLING (Swollen down to elbow), SKIN SENSITISATION (Arm sensitive to touch) and ERYTHEMA (Red down to the elbow). At the time of the report, PRURITUS (Itching arm), PERIPHERAL SWELLING (Swollen down to elbow), SKIN SENSITISATION (Arm sensitive to touch) and ERYTHEMA (Red down to the elbow) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment medication was not reported.   Reporter did not allow further contact
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache
Clinical narrative: I still don't feel good; Headache; Fatigue; Felt like crap again; Started feeling like a shit for 4 days; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (I still don't feel good), FEELING ABNORMAL (Started feeling bad for 4 days), FEELING ABNORMAL (Felt bad again), HEADACHE (Headache) and FATIGUE (Fatigue) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder.    On 29-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced FEELING ABNORMAL (Started feeling like a shit for 4 days). On 08-Feb-2021, the patient experienced FEELING ABNORMAL (Felt bad again). On an unknown date, the patient experienced FEELING ABNORMAL (I still don't feel good), HEADACHE (Headache) and FATIGUE (Fatigue). On 03-Feb-2021, FEELING ABNORMAL (Started feeling bad for 4 days) had resolved. At the time of the report, FEELING ABNORMAL (I still don't feel good), FEELING ABNORMAL (Felt bad again), HEADACHE (Headache) and FATIGUE (Fatigue) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-086720 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: NNI regarding Outcome: Not recovered
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: Allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Allergic reaction) in a 66-year-old female patient 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (Allergic reaction). At the time of the report, HYPERSENSITIVITY (Allergic reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported. No treatment was provided.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pain in extremity, Somnolence
Clinical narrative: Fell asleep during day; very sore arm; Fatigue; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Fell asleep during day), PAIN IN EXTREMITY (very sore arm), FATIGUE (Fatigue) and NAUSEA (Nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced SOMNOLENCE (Fell asleep during day), PAIN IN EXTREMITY (very sore arm), FATIGUE (Fatigue) and NAUSEA (Nausea). At the time of the report, SOMNOLENCE (Fell asleep during day), PAIN IN EXTREMITY (very sore arm), FATIGUE (Fatigue) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment medication was not reported.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: reaction to moderna vaccine due to allergy to shelfish; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (reaction to moderna vaccine due to allergy to shelfish) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Kidney disorder.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (reaction to moderna vaccine due to allergy to shelfish). At the time of the report, HYPERSENSITIVITY (reaction to moderna vaccine due to allergy to shelfish) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant as well as treatment information was provided.  Patient was also received Pfizer covid vaccine on an unknown date.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Ear discomfort, Headache
Clinical narrative: clogged ear; vertigo; tinnitus; Muscle fatigue; Unable to unplug hair dryer/ debiliatting enough to disable from walking, sitting upright, or even eating; vomitting; dizziness; injection site swelling; weakness; giant bump on injection site; Fever; chills/ shivering; muscle aches; headache on top of the head; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), VACCINATION SITE MASS (giant bump on injection site), DIZZINESS (dizziness), EAR DISCOMFORT (clogged ear) and VERTIGO (vertigo) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History Information was given by the reporter.  Concomitant products included VITAMIN D3 and CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) for an unknown indication.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced ASTHENIA (weakness), VACCINATION SITE MASS (giant bump on injection site), PYREXIA (Fever), CHILLS (chills/ shivering), MYALGIA (muscle aches), HEADACHE (headache on top of the head) and VACCINATION SITE SWELLING (injection site swelling). On 27-Mar-2021, the patient experienced DIZZINESS (dizziness). On an unknown date, the patient experienced EAR DISCOMFORT (clogged ear), VERTIGO (vertigo), TINNITUS (tinnitus), MUSCLE FATIGUE (Muscle fatigue), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Unable to unplug hair dryer/ debiliatting enough to disable from walking, sitting upright, or even eating) and VOMITING (vomitting). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PARACETAMOL, PHENYLEPHRINE HYDROCHLORIDE (TYLENOL COLD + FLU SEVERE) at an unspecified dose and frequency. On 08-Feb-2021, ASTHENIA (weakness), VACCINATION SITE MASS (giant bump on injection site), PYREXIA (Fever), CHILLS (chills/ shivering) and MYALGIA (muscle aches) had resolved. At the time of the report, DIZZINESS (dizziness), EAR DISCOMFORT (clogged ear), VERTIGO (vertigo), TINNITUS (tinnitus), MUSCLE FATIGUE (Muscle fatigue), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Unable to unplug hair dryer/ debiliatting enough to disable from walking, sitting upright, or even eating), HEADACHE (headache on top of the head), VOMITING (vomitting) and VACCINATION SITE SWELLING (injection site swelling) had not resolved.            This case was linked to mod-2021-090644 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: The Significant Follow up Information was received on 22-APR-2021.Events are updated. Patient demographics are added.  First dose information was added.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site swelling, Vertigo, Vomiting
Clinical narrative: clogged ear; vertigo; tinnitus; Muscle fatigue; Unable to unplug hair dryer/ debiliatting enough to disable from walking, sitting upright, or even eating; vomitting; dizziness; injection site swelling; weakness; giant bump on injection site; Fever; chills/ shivering; muscle aches; headache on top of the head; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), VACCINATION SITE MASS (giant bump on injection site), DIZZINESS (dizziness), EAR DISCOMFORT (clogged ear) and VERTIGO (vertigo) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History Information was given by the reporter.  Concomitant products included VITAMIN D3 and CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) for an unknown indication.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced ASTHENIA (weakness), VACCINATION SITE MASS (giant bump on injection site), PYREXIA (Fever), CHILLS (chills/ shivering), MYALGIA (muscle aches), HEADACHE (headache on top of the head) and VACCINATION SITE SWELLING (injection site swelling). On 27-Mar-2021, the patient experienced DIZZINESS (dizziness). On an unknown date, the patient experienced EAR DISCOMFORT (clogged ear), VERTIGO (vertigo), TINNITUS (tinnitus), MUSCLE FATIGUE (Muscle fatigue), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Unable to unplug hair dryer/ debiliatting enough to disable from walking, sitting upright, or even eating) and VOMITING (vomitting). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PARACETAMOL, PHENYLEPHRINE HYDROCHLORIDE (TYLENOL COLD + FLU SEVERE) at an unspecified dose and frequency. On 08-Feb-2021, ASTHENIA (weakness), VACCINATION SITE MASS (giant bump on injection site), PYREXIA (Fever), CHILLS (chills/ shivering) and MYALGIA (muscle aches) had resolved. At the time of the report, DIZZINESS (dizziness), EAR DISCOMFORT (clogged ear), VERTIGO (vertigo), TINNITUS (tinnitus), MUSCLE FATIGUE (Muscle fatigue), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Unable to unplug hair dryer/ debiliatting enough to disable from walking, sitting upright, or even eating), HEADACHE (headache on top of the head), VOMITING (vomitting) and VACCINATION SITE SWELLING (injection site swelling) had not resolved.            This case was linked to mod-2021-090644 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: The Significant Follow up Information was received on 22-APR-2021.Events are updated. Patient demographics are added.  First dose information was added.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: ran fever around 24 hrs; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (ran fever around 24 hrs) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 1. On an unknown date, the patient experienced PYREXIA (ran fever around 24 hrs). At the time of the report, PYREXIA (ran fever around 24 hrs) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not reported. Treatment medication was not reported.   Reporter did not allow further contact
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Nausea, Pyrexia
Clinical narrative: nauseous; 100°F fever; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nauseous) and PYREXIA (100°F fever) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced NAUSEA (nauseous) and PYREXIA (100°F fever). At the time of the report, NAUSEA (nauseous) and PYREXIA (100°F fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Body temperature: 100 °F High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not reported. Treatment medication was not reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Headache, Influenza like illness, Nausea
Clinical narrative: Mild dizziness; Nausea; Mild flu like symptoms; Heightened temperature; Headache; This spontaneous case was reported by an other and describes the occurrence of INFLUENZA LIKE ILLNESS (Mild flu like symptoms), DIZZINESS (Mild dizziness), PYREXIA (Heightened temperature), HEADACHE (Headache) and NAUSEA (Nausea) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 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) (unknown route) 1 dosage form. On 01-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Mild flu like symptoms), PYREXIA (Heightened temperature) and HEADACHE (Headache). On 02-Feb-2021, the patient experienced DIZZINESS (Mild dizziness) and NAUSEA (Nausea). On 03-Feb-2021, INFLUENZA LIKE ILLNESS (Mild flu like symptoms), DIZZINESS (Mild dizziness), PYREXIA (Heightened temperature), HEADACHE (Headache) and NAUSEA (Nausea) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Feb-2021, Body temperature: high (High) heightened temperature.         Action taken with mRNA-1273 in response to the events was not Applicable.  Concomitant product use was not provided by the reporter.  Patient was treated with standard OTC medication.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Mild dizziness; Nausea; Mild flu like symptoms; Heightened temperature; Headache; This spontaneous case was reported by an other and describes the occurrence of INFLUENZA LIKE ILLNESS (Mild flu like symptoms), DIZZINESS (Mild dizziness), PYREXIA (Heightened temperature), HEADACHE (Headache) and NAUSEA (Nausea) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 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) (unknown route) 1 dosage form. On 01-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Mild flu like symptoms), PYREXIA (Heightened temperature) and HEADACHE (Headache). On 02-Feb-2021, the patient experienced DIZZINESS (Mild dizziness) and NAUSEA (Nausea). On 03-Feb-2021, INFLUENZA LIKE ILLNESS (Mild flu like symptoms), DIZZINESS (Mild dizziness), PYREXIA (Heightened temperature), HEADACHE (Headache) and NAUSEA (Nausea) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Feb-2021, Body temperature: high (High) heightened temperature.         Action taken with mRNA-1273 in response to the events was not Applicable.  Concomitant product use was not provided by the reporter.  Patient was treated with standard OTC medication.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dyspnoea, Fatigue, Nausea, Oxygen saturation
Clinical narrative: nauseous; fatigue; stomach pain; can not breathe; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach pain), DYSPNOEA (can not breathe), NAUSEA (nauseous) and FATIGUE (fatigue) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02G(?)L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach pain) and DYSPNOEA (can not breathe). On 02-Feb-2021, the patient experienced FATIGUE (fatigue). On an unknown date, the patient experienced NAUSEA (nauseous). At the time of the report, ABDOMINAL PAIN UPPER (stomach pain), DYSPNOEA (can not breathe) and FATIGUE (fatigue) had not resolved and NAUSEA (nauseous) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Oxygen saturation: normal (normal) normal.     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 medication details were provided. No treatment medication details were provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm is hurting; Arm ache for a few days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm ache for a few days) and PAIN IN EXTREMITY (Arm is hurting) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. NDC number 99) for COVID-19 vaccination.     No medical history was provided by the reporter. .     On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm ache for a few days). On 04-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm is hurting). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm ache for a few days) had resolved and PAIN IN EXTREMITY (Arm is hurting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration
Clinical narrative: arm is hard; arm is red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (arm is hard) and VACCINATION SITE ERYTHEMA (arm is red) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE INDURATION (arm is hard) and VACCINATION SITE ERYTHEMA (arm is red). At the time of the report, VACCINATION SITE INDURATION (arm is hard) and VACCINATION SITE ERYTHEMA (arm is red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not reported. Treatment medication was not reported.   Reporter did not allow further contact
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Palpitations; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Palpitations) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced PALPITATIONS (Palpitations). On 16-Jan-2021, PALPITATIONS (Palpitations) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment medication was reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: A red, swollen and tender area around the injection site; A red, swollen and tender area around the injection site; A red, swollen and tender area around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (A red, swollen and tender area around the injection site), VACCINATION SITE ERYTHEMA (A red, swollen and tender area around the injection site) and VACCINATION SITE SWELLING (A red, swollen and tender area around the injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN and IBANDRONATE SODIUM (BONIVA) for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced VACCINATION SITE PAIN (A red, swollen and tender area around the injection site), VACCINATION SITE ERYTHEMA (A red, swollen and tender area around the injection site) and VACCINATION SITE SWELLING (A red, swollen and tender area around the injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (A red, swollen and tender area around the injection site), VACCINATION SITE ERYTHEMA (A red, swollen and tender area around the injection site) and VACCINATION SITE SWELLING (A red, swollen and tender area around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Additional event treatment included ice.