chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Muscular weakness, Myalgia, Pain in extremity
Clinical narrative: Muscles hurt and weak; Fatigue; Muscles hurt and weak; Strong chills; Fever; Arm painful; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm painful), MUSCULAR WEAKNESS (Muscles hurt and weak), FATIGUE (Fatigue), PYREXIA (Fever) and MYALGIA (Muscles hurt and weak) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypothyroidism since 1998, Anxiety (worsen) since 1996, Insomnia (worsen) since 1989, High cholesterol, Drug allergy (Codein), Drug allergy (Aspirin) and Drug allergy (Sulfa.). Concomitant products included CLONAZEPAM for Anxiety, ATORVASTATIN CALCIUM (LIPITOR) for High cholesterol, LEVOTHYROXINE for Hypothyroidism.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm painful). 23-Feb-2021, the patient experienced PYREXIA (Fever). On 24-Feb-2021, the patient experienced FATIGUE (Fatigue). On an unknown date, the patient experienced MUSCULAR WEAKNESS (Muscles hurt and weak), MYALGIA (Muscles hurt and weak) and CHILLS (Strong chills). At the time of the report, PAIN IN EXTREMITY (Arm painful), MUSCULAR WEAKNESS (Muscles hurt and weak), PYREXIA (Fever) and MYALGIA (Muscles hurt and weak) outcome was unknown and FATIGUE (Fatigue) and CHILLS (Strong chills) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Platelet count (150-450): 154 (normal) Blood platelets in the low range and other (Borderline) Blood platelets towards the low end of the normal range.         Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: First dose details added, event added, lab data added, concomitant medication added, medical history added, vaccine facility details added,  event details updated
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Platelet count, Pyrexia
Clinical narrative: Muscles hurt and weak; Fatigue; Muscles hurt and weak; Strong chills; Fever; Arm painful; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm painful), MUSCULAR WEAKNESS (Muscles hurt and weak), FATIGUE (Fatigue), PYREXIA (Fever) and MYALGIA (Muscles hurt and weak) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypothyroidism since 1998, Anxiety (worsen) since 1996, Insomnia (worsen) since 1989, High cholesterol, Drug allergy (Codein), Drug allergy (Aspirin) and Drug allergy (Sulfa.). Concomitant products included CLONAZEPAM for Anxiety, ATORVASTATIN CALCIUM (LIPITOR) for High cholesterol, LEVOTHYROXINE for Hypothyroidism.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm painful). 23-Feb-2021, the patient experienced PYREXIA (Fever). On 24-Feb-2021, the patient experienced FATIGUE (Fatigue). On an unknown date, the patient experienced MUSCULAR WEAKNESS (Muscles hurt and weak), MYALGIA (Muscles hurt and weak) and CHILLS (Strong chills). At the time of the report, PAIN IN EXTREMITY (Arm painful), MUSCULAR WEAKNESS (Muscles hurt and weak), PYREXIA (Fever) and MYALGIA (Muscles hurt and weak) outcome was unknown and FATIGUE (Fatigue) and CHILLS (Strong chills) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Platelet count (150-450): 154 (normal) Blood platelets in the low range and other (Borderline) Blood platelets towards the low end of the normal range.         Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: First dose details added, event added, lab data added, concomitant medication added, medical history added, vaccine facility details added,  event details updated
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Insomnia, Pruritus, Rash, Rash pruritic
Clinical narrative: Itchiness that kept her awake all night; Itchiness that kept her awake all night; Rash is warm to the touch; Rash is itchy; Ring-worm bullseye type of rash that is one inch diameter wide/rash is like COVID-arm/ rash is circular; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchiness that kept her awake all night), INSOMNIA (Itchiness that kept her awake all night), FEELING HOT (Rash is warm to the touch), RASH PRURITIC (Rash is itchy) and RASH (Ring-worm bullseye type of rash that is one inch diameter wide/rash is like COVID-arm/ rash is circular) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced PRURITUS (Itchiness that kept her awake all night), INSOMNIA (Itchiness that kept her awake all night), FEELING HOT (Rash is warm to the touch), RASH PRURITIC (Rash is itchy) and RASH (Ring-worm bullseye type of rash that is one inch diameter wide/rash is like COVID-arm/ rash is circular). At the time of the report, PRURITUS (Itchiness that kept her awake all night), INSOMNIA (Itchiness that kept her awake all night), FEELING HOT (Rash is warm to the touch), RASH PRURITIC (Rash is itchy) and RASH (Ring-worm bullseye type of rash that is one inch diameter wide/rash is like COVID-arm/ rash is circular) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product given as birth control pills.  It was described that the itchiness was like a ring-worm bullseye type of rash that was one inch diameter wide. The rash  was circular, itchy, and warm to the touch like the COVID-arm.   Patient also disclosed that  pharmacist said she can take Benadryl (diphenhydramine hydrochloride) or hydrocortisone.   Most recent FOLLOW-UP information incorporated above includes: On 14-Mar-2021: Follow-up information received  contains non-significant information
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: feel hotness on the injection site; it was itchy and pinkish; it was itchy and pinkish; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (feel hotness on the injection site), VACCINATION SITE PRURITUS (it was itchy and pinkish) and VACCINATION SITE ERYTHEMA (it was itchy and pinkish) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 010M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced VACCINATION SITE WARMTH (feel hotness on the injection site), VACCINATION SITE PRURITUS (it was itchy and pinkish) and VACCINATION SITE ERYTHEMA (it was itchy and pinkish). At the time of the report, VACCINATION SITE WARMTH (feel hotness on the injection site), VACCINATION SITE PRURITUS (it was itchy and pinkish) and VACCINATION SITE ERYTHEMA (it was itchy and pinkish) outcome was unknown.      No concomitant medications were provided. No treatment was reported for the events.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Lip pruritus, Mouth haemorrhage, Oral mucosal blistering, Oral pain
Clinical narrative: Mouth blisters; Mouth was bleeding from blisters; Mouth is so sore, hard to eat; Mouth is so sore, hard to eat; Lips were itching extremely bad; Face was swollen; UTI; Sore arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Sore arm), URINARY TRACT INFECTION (UTI), LIP PRURITUS (Lips were itching extremely bad), SWELLING FACE (Face was swollen) and ORAL MUCOSAL BLISTERING (Mouth blisters) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Soft tissue sarcoma (Treated with radiation) and Breast cancer (Treated with radiation).    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 06-Mar-2021, the patient experienced URINARY TRACT INFECTION (UTI). On 08-Mar-2021, the patient experienced LIP PRURITUS (Lips were itching extremely bad) and SWELLING FACE (Face was swollen). On 10-Mar-2021, the patient experienced ORAL MUCOSAL BLISTERING (Mouth blisters), MOUTH HAEMORRHAGE (Mouth was bleeding from blisters), ORAL PAIN (Mouth is so sore, hard to eat) and DECREASED APPETITE (Mouth is so sore, hard to eat). The patient was treated with SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM) from 06-Mar-2021 to 08-Mar-2021 for UTI, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm), URINARY TRACT INFECTION (UTI), LIP PRURITUS (Lips were itching extremely bad), SWELLING FACE (Face was swollen), ORAL MUCOSAL BLISTERING (Mouth blisters), MOUTH HAEMORRHAGE (Mouth was bleeding from blisters), ORAL PAIN (Mouth is so sore, hard to eat) and DECREASED APPETITE (Mouth is so sore, hard to eat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications used was not provided by the reporter.  Concomitant therapy administered included radiation treatment  The patient went to see her physician and was prescribed "miracle swish" for the blisters.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Swelling face, Urinary tract infection
Clinical narrative: Mouth blisters; Mouth was bleeding from blisters; Mouth is so sore, hard to eat; Mouth is so sore, hard to eat; Lips were itching extremely bad; Face was swollen; UTI; Sore arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Sore arm), URINARY TRACT INFECTION (UTI), LIP PRURITUS (Lips were itching extremely bad), SWELLING FACE (Face was swollen) and ORAL MUCOSAL BLISTERING (Mouth blisters) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Soft tissue sarcoma (Treated with radiation) and Breast cancer (Treated with radiation).    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 06-Mar-2021, the patient experienced URINARY TRACT INFECTION (UTI). On 08-Mar-2021, the patient experienced LIP PRURITUS (Lips were itching extremely bad) and SWELLING FACE (Face was swollen). On 10-Mar-2021, the patient experienced ORAL MUCOSAL BLISTERING (Mouth blisters), MOUTH HAEMORRHAGE (Mouth was bleeding from blisters), ORAL PAIN (Mouth is so sore, hard to eat) and DECREASED APPETITE (Mouth is so sore, hard to eat). The patient was treated with SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM) from 06-Mar-2021 to 08-Mar-2021 for UTI, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm), URINARY TRACT INFECTION (UTI), LIP PRURITUS (Lips were itching extremely bad), SWELLING FACE (Face was swollen), ORAL MUCOSAL BLISTERING (Mouth blisters), MOUTH HAEMORRHAGE (Mouth was bleeding from blisters), ORAL PAIN (Mouth is so sore, hard to eat) and DECREASED APPETITE (Mouth is so sore, hard to eat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications used was not provided by the reporter.  Concomitant therapy administered included radiation treatment  The patient went to see her physician and was prescribed "miracle swish" for the blisters.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Muscle spasms, Nausea, Pain
Clinical narrative: Difficulty catching her breath; Her heart was pounding out of her chest; Cramping in calf behind the knees; Fever; Nausea; Chills; Arm soreness; Aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness), PAIN (Aches), DYSPNOEA (Difficulty catching her breath), PALPITATIONS (Her heart was pounding out of her chest) and MUSCLE SPASMS (Cramping in calf behind the knees) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information reported .  Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness), PAIN (Aches), MUSCLE SPASMS (Cramping in calf behind the knees), PYREXIA (Fever), NAUSEA (Nausea) and CHILLS (Chills). On 09-Mar-2021, the patient experienced DYSPNOEA (Difficulty catching her breath) and PALPITATIONS (Her heart was pounding out of her chest). The patient was treated with PARACETAMOL (TYLENOL) for Cramps calf, at an unspecified dose and frequency and MAGNESIUM for Cramps calf, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm soreness), PAIN (Aches), DYSPNOEA (Difficulty catching her breath), PALPITATIONS (Her heart was pounding out of her chest), MUSCLE SPASMS (Cramping in calf behind the knees), PYREXIA (Fever), NAUSEA (Nausea) and CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 09-Mar-2021, the patient felt like her heart was pounding out of her chest and difficulty catching her breath. This happened about 3-4 times thought the next couple of days.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Palpitations, Pyrexia
Clinical narrative: Difficulty catching her breath; Her heart was pounding out of her chest; Cramping in calf behind the knees; Fever; Nausea; Chills; Arm soreness; Aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness), PAIN (Aches), DYSPNOEA (Difficulty catching her breath), PALPITATIONS (Her heart was pounding out of her chest) and MUSCLE SPASMS (Cramping in calf behind the knees) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information reported .  Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness), PAIN (Aches), MUSCLE SPASMS (Cramping in calf behind the knees), PYREXIA (Fever), NAUSEA (Nausea) and CHILLS (Chills). On 09-Mar-2021, the patient experienced DYSPNOEA (Difficulty catching her breath) and PALPITATIONS (Her heart was pounding out of her chest). The patient was treated with PARACETAMOL (TYLENOL) for Cramps calf, at an unspecified dose and frequency and MAGNESIUM for Cramps calf, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm soreness), PAIN (Aches), DYSPNOEA (Difficulty catching her breath), PALPITATIONS (Her heart was pounding out of her chest), MUSCLE SPASMS (Cramping in calf behind the knees), PYREXIA (Fever), NAUSEA (Nausea) and CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 09-Mar-2021, the patient felt like her heart was pounding out of her chest and difficulty catching her breath. This happened about 3-4 times thought the next couple of days.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Headache
Clinical narrative: having trouble breathing; chest tightness; headache; A spontaneous report (United States) was received from a consumer concerning a 58-years-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events having trouble breathing/dyspnoea, chest tightness/chest discomfort, and headache.  The patient's medical history included Type 2 Diabetes. Concomitant product use was not provided by the reporter  On 10 Mar 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (Batch: 030A21A) in the left non-dominant arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the events trouble breathing, chest tightness, headache. Treatment for the event included Tylenol.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of events, having trouble breathing, chest tightness, and headache was not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, COVID-19, Chills, Pain, Pain in extremity
Clinical narrative: positive for COVID-19; sore arm; threw up; fever 102°F; no taste at all; achy; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), PAIN (achy), AGEUSIA (no taste at all), COVID-19 (positive for COVID-19) and CHILLS (chills) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.  Concomitant products included VENLAFAXINE for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced PAIN (achy) and CHILLS (chills). On 09-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm), AGEUSIA (no taste at all), VOMITING (threw up) and PYREXIA (fever 102°F). On 10-Mar-2021, the patient experienced COVID-19 (positive for COVID-19). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), PAIN (achy), AGEUSIA (no taste at all), COVID-19 (positive for COVID-19), CHILLS (chills), VOMITING (threw up) and PYREXIA (fever 102°F) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: positive for COVID-19; sore arm; threw up; fever 102°F; no taste at all; achy; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), PAIN (achy), AGEUSIA (no taste at all), COVID-19 (positive for COVID-19) and CHILLS (chills) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.  Concomitant products included VENLAFAXINE for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced PAIN (achy) and CHILLS (chills). On 09-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm), AGEUSIA (no taste at all), VOMITING (threw up) and PYREXIA (fever 102°F). On 10-Mar-2021, the patient experienced COVID-19 (positive for COVID-19). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), PAIN (achy), AGEUSIA (no taste at all), COVID-19 (positive for COVID-19), CHILLS (chills), VOMITING (threw up) and PYREXIA (fever 102°F) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Insomnia, Therapeutic response unexpected
Clinical narrative: feels off with no energy; could not sleep well; pain in left hip before the vaccination is gone after the first vaccination; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (feels off with no energy), INSOMNIA (could not sleep well) and THERAPEUTIC RESPONSE UNEXPECTED (pain in left hip before the vaccination is gone after the first vaccination) 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 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-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 ASTHENIA (feels off with no energy), INSOMNIA (could not sleep well) and THERAPEUTIC RESPONSE UNEXPECTED (pain in left hip before the vaccination is gone after the first vaccination). At the time of the report, ASTHENIA (feels off with no energy), INSOMNIA (could not sleep well) and THERAPEUTIC RESPONSE UNEXPECTED (pain in left hip before the vaccination is gone after the first vaccination) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: injection site hot; nausea; headache; injection site swollen; injection site hurts; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection site hot), NAUSEA (nausea), HEADACHE (headache), VACCINATION SITE SWELLING (injection site swollen) and VACCINATION SITE PAIN (injection site hurts) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced VACCINATION SITE WARMTH (injection site hot), NAUSEA (nausea), HEADACHE (headache), VACCINATION SITE SWELLING (injection site swollen) and VACCINATION SITE PAIN (injection site hurts). At the time of the report, VACCINATION SITE WARMTH (injection site hot), VACCINATION SITE SWELLING (injection site swollen) and VACCINATION SITE PAIN (injection site hurts) had not resolved and NAUSEA (nausea) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Flushing, Headache, Pruritus, Vaccination site mass
Clinical narrative: Hardened bump two inches below injection site; Red; Itchy; Headache; Flushed Face; This spontaneous case was reported by a patient and describes the occurrence of FLUSHING (Flushed Face), VACCINATION SITE MASS (Hardened bump two inches below injection site), ERYTHEMA (Red), PRURITUS (Itchy) and HEADACHE (Headache) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011AZ1A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (allergic to sulfa) and Drug allergy (thimerosal).    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced FLUSHING (Flushed Face) and HEADACHE (Headache). On 12-Mar-2021, the patient experienced VACCINATION SITE MASS (Hardened bump two inches below injection site), ERYTHEMA (Red) and PRURITUS (Itchy). At the time of the report, FLUSHING (Flushed Face) and HEADACHE (Headache) had resolved and VACCINATION SITE MASS (Hardened bump two inches below injection site), ERYTHEMA (Red) and PRURITUS (Itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided  No Treatment medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Non-Significant Follow-up Information received on 23-JUN-2021; Reporter contact details are updated.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Nasopharyngitis
Clinical narrative: Cold; Clammy; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold) and COLD SWEAT (Clammy) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 012M20A) for COVID-19 vaccination.     The patient's past medical history was not reported .  Concomitant products included ATENOLOL, ROSUVASTATIN CALCIUM (CRESTOR), AMLODIPINE, CALCIUM CARBONATE (GAVISCON ACID BREAKTHROUGH FORMULA) and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced NASOPHARYNGITIS (Cold) and COLD SWEAT (Clammy). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, NASOPHARYNGITIS (Cold) and COLD SWEAT (Clammy) outcome was unknown.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: red arm; itchy arm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red arm) and PRURITUS (itchy arm) in a 70-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 ERYTHEMA (red arm) and PRURITUS (itchy arm). At the time of the report, ERYTHEMA (red arm) and PRURITUS (itchy arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant Medications were not provided by the reporter. Treatment Information was not provided by the reporter.   This case was linked to MOD21-052042 (Patient Link).   Reporter did not allow further contact
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Insomnia, Myalgia, Nausea
Clinical narrative: sore arm; couldn't sleep at night; severe chills; fever; muscle soreness,bodyaches; headache; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), INSOMNIA (couldn't sleep at night), CHILLS (severe chills), PYREXIA (fever) and MYALGIA (muscle soreness,bodyaches) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE SODIUM for Thyroid disorder.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm), INSOMNIA (couldn't sleep at night), CHILLS (severe chills), PYREXIA (fever), MYALGIA (muscle soreness,bodyaches), HEADACHE (headache) and NAUSEA (nauseous). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), INSOMNIA (couldn't sleep at night), CHILLS (severe chills), PYREXIA (fever), MYALGIA (muscle soreness,bodyaches), HEADACHE (headache) and NAUSEA (nauseous) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, Body temperature: 100 (High) 100 degree.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: sore arm; couldn't sleep at night; severe chills; fever; muscle soreness,bodyaches; headache; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), INSOMNIA (couldn't sleep at night), CHILLS (severe chills), PYREXIA (fever) and MYALGIA (muscle soreness,bodyaches) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE SODIUM for Thyroid disorder.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm), INSOMNIA (couldn't sleep at night), CHILLS (severe chills), PYREXIA (fever), MYALGIA (muscle soreness,bodyaches), HEADACHE (headache) and NAUSEA (nauseous). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), INSOMNIA (couldn't sleep at night), CHILLS (severe chills), PYREXIA (fever), MYALGIA (muscle soreness,bodyaches), HEADACHE (headache) and NAUSEA (nauseous) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, Body temperature: 100 (High) 100 degree.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Neuralgia
Clinical narrative: neuralgia; sunburn feeling; This spontaneous case was reported by a consumer and describes the occurrence of NEURALGIA (neuralgia) and BURNING SENSATION (sunburn feeling) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 00A2117 and 012M20A) 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-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NEURALGIA (neuralgia) and BURNING SENSATION (sunburn feeling). At the time of the report, NEURALGIA (neuralgia) and BURNING SENSATION (sunburn feeling) outcome was unknown.            No Concomitant medications were provided No Treatment information provided
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Soreness in injection arm; Stiffness in injection arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in injection arm) and MUSCULOSKELETAL STIFFNESS (Stiffness in injection arm) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced PAIN IN EXTREMITY (Soreness in injection arm) and MUSCULOSKELETAL STIFFNESS (Stiffness in injection arm). At the time of the report, PAIN IN EXTREMITY (Soreness in injection arm) and MUSCULOSKELETAL STIFFNESS (Stiffness in injection arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided Treatment information provided as heat, pain relievers
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Chills, Dry mouth, Dysuria
Clinical narrative: Problem urination; Fever; Chills; Dry mouth; Loss of taste; Loss of smell; This spontaneous case was reported by a consumer and describes the occurrence of DRY MOUTH (Dry mouth), AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), DYSURIA (Problem urination) and PYREXIA (Fever) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced DRY MOUTH (Dry mouth), AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), PYREXIA (Fever) and CHILLS (Chills). On 09-Mar-2021, the patient experienced DYSURIA (Problem urination). At the time of the report, DRY MOUTH (Dry mouth) had not resolved and AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), DYSURIA (Problem urination), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: Problem urination; Fever; Chills; Dry mouth; Loss of taste; Loss of smell; This spontaneous case was reported by a consumer and describes the occurrence of DRY MOUTH (Dry mouth), AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), DYSURIA (Problem urination) and PYREXIA (Fever) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced DRY MOUTH (Dry mouth), AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), PYREXIA (Fever) and CHILLS (Chills). On 09-Mar-2021, the patient experienced DYSURIA (Problem urination). At the time of the report, DRY MOUTH (Dry mouth) had not resolved and AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), DYSURIA (Problem urination), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Oropharyngeal pain
Clinical narrative: Dry Mouth; Sore throat; This spontaneous case was reported by a patient and describes the occurrence of DRY MOUTH (Dry Mouth) and OROPHARYNGEAL PAIN (Sore throat) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Breast cancer.   On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced DRY MOUTH (Dry Mouth) and OROPHARYNGEAL PAIN (Sore throat). The patient was treated with BIOTENE DRY MOUTH ORAL RINSE for Dry mouth, at an unspecified dose and frequency. At the time of the report, DRY MOUTH (Dry Mouth) and OROPHARYNGEAL PAIN (Sore throat) outcome was unknown.            For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.No concomitant medications were reported.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: pain and swelling at injection site; pain and swelling at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain and swelling at injection site) and VACCINATION SITE SWELLING (pain and swelling at injection site) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for an unknown indication.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced VACCINATION SITE PAIN (pain and swelling at injection site) and VACCINATION SITE SWELLING (pain and swelling at injection site). On 08-Mar-2021, VACCINATION SITE PAIN (pain and swelling at injection site) and VACCINATION SITE SWELLING (pain and swelling at injection site) 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.   No treatment information was provided. No relevant concomitant medications reported.  This case was linked to MOD-2021-042819 (Patient Link).
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea
Clinical narrative: Horrible stomach pains; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Horrible stomach pains) and DIARRHOEA (Diarrhea) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) 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 ABDOMINAL PAIN UPPER (Horrible stomach pains) and DIARRHOEA (Diarrhea). At the time of the report, ABDOMINAL PAIN UPPER (Horrible stomach pains) and DIARRHOEA (Diarrhea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Lymphadenopathy, Pyrexia
Clinical narrative: Swelling in the left arm pit; Fever; Hot flashes; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (Hot flashes), LYMPHADENOPATHY (Swelling in the left arm pit) and PYREXIA (Fever) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included INSULIN HUMAN, INSULIN HUMAN INJECTION, ISOPHANE (NOVOLIN 70/30), METFORMIN, METOPROLOL TARTRATE (METPROLOL), LOSARTAN, AMLODIPINE, HYDRALAZINE and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced HOT FLUSH (Hot flashes) and PYREXIA (Fever). On 08-Mar-2021, the patient experienced LYMPHADENOPATHY (Swelling in the left arm pit). At the time of the report, HOT FLUSH (Hot flashes), LYMPHADENOPATHY (Swelling in the left arm pit) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications also included emergency pill when BP > 180 0.1mg on emergency.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash
Clinical narrative: 4-5 inches big rash at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (4-5 inches big rash at the site of injection) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy and Latex allergy.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced INJECTION SITE RASH (4-5 inches big rash at the site of injection). At the time of the report, INJECTION SITE RASH (4-5 inches big rash at the site of injection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medicines were reported. No treatment information were reported.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Vaccination site pruritus
Clinical narrative: Weakness; Chills; Injection site itchiness; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), CHILLS (Chills) and VACCINATION SITE PRURITUS (Injection site itchiness) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (Weakness), CHILLS (Chills) and VACCINATION SITE PRURITUS (Injection site itchiness). At the time of the report, ASTHENIA (Weakness), CHILLS (Chills) and VACCINATION SITE PRURITUS (Injection site itchiness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.    No treatment information was provided.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Vaccination site rash
Clinical narrative: Rash spread to legs, vagina and around buttocks; Rash on injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash spread to legs, vagina and around buttocks) and VACCINATION SITE RASH (Rash on injection site) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Rash spread to legs, vagina and around buttocks) and VACCINATION SITE RASH (Rash on injection site). The patient was treated with TERBINAFINE HYDROCHLORIDE (LAMISIL [TERBINAFINE HYDROCHLORIDE]) for Rash, at an unspecified dose and frequency and KETOCONAZOLE for Adverse event, at an unspecified dose and frequency. At the time of the report, RASH (Rash spread to legs, vagina and around buttocks) outcome was unknown and VACCINATION SITE RASH (Rash on injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  No concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: Chills; Fever; Muscle aches; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CHILLS (Chills), PYREXIA (Fever) and MYALGIA (Muscle aches) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills), PYREXIA (Fever) and MYALGIA (Muscle aches). At the time of the report, CHILLS (Chills), PYREXIA (Fever) and MYALGIA (Muscle aches) 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 and treatment medications were reported.   This case was linked to MOD-2021-042557 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria, Vaccination site pain, Vaccination site warmth
Clinical narrative: itchy; really hot; big welt at the injection site and to the elbow; burning was the worse, terrific/ little sore arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (itchy), VACCINATION SITE WARMTH (really hot), URTICARIA (big welt at the injection site and to the elbow) and VACCINATION SITE PAIN (burning was the worse, terrific/ little sore arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced PRURITUS (itchy), VACCINATION SITE WARMTH (really hot), URTICARIA (big welt at the injection site and to the elbow) and VACCINATION SITE PAIN (burning was the worse, terrific/ little sore arm). The patient was treated with CORTISONE at a dose of 1 dosage form. On 06-Mar-2021, PRURITUS (itchy), VACCINATION SITE WARMTH (really hot), URTICARIA (big welt at the injection site and to the elbow) and VACCINATION SITE PAIN (burning was the worse, terrific/ little sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's have prior experience of same event when she took pneumonia vaccine was provided. Products known to have been used by the patient, within two weeks prior to the event, included blood pressure and thyroids by reporter