chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Received an incorrectly stored vaccine; A spontaneous report was received from a consumer concerning a 73-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and reported receiving  an incorrectly stored vaccine.  The patient's medical history, was not reported. Concomitant medications was not reported.   On 01 Mar 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025A21A)for prophylaxis of COVID-19 infection.   On 01 Mar 2021, the patient was informed by the vaccination provider that his vaccine was stored incorrectly.  No laboratory details was provided.No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event, receiving  an incorrectly stored vaccine , was considered resolved .; Reporter's Comments: This report refers to a case of Incorrectly stored vaccine for mRNA-1273, lot # 025A21A with no associated AEs.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: swelling; redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swelling) and VACCINATION SITE ERYTHEMA (redness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE SWELLING (swelling) and VACCINATION SITE ERYTHEMA (redness). At the time of the report, VACCINATION SITE SWELLING (swelling) and VACCINATION SITE ERYTHEMA (redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment products include Couple of pain killers and other medications for health issues.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Bad rash all over the body; Fever; Chills; Muscle pain; Feeling tired; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), RASH (Bad rash all over the body), FATIGUE (Feeling tired), PYREXIA (Fever) and CHILLS (Chills) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and FATIGUE (Feeling tired). On 22-Feb-2021, the patient experienced RASH (Bad rash all over the body), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Muscle pain). The patient was treated with IBUPROFEN at an unspecified dose and frequency and PREDNISONE for Rash, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm), RASH (Bad rash all over the body), FATIGUE (Feeling tired), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Bad rash all over the body; Fever; Chills; Muscle pain; Feeling tired; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), RASH (Bad rash all over the body), FATIGUE (Feeling tired), PYREXIA (Fever) and CHILLS (Chills) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and FATIGUE (Feeling tired). On 22-Feb-2021, the patient experienced RASH (Bad rash all over the body), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Muscle pain). The patient was treated with IBUPROFEN at an unspecified dose and frequency and PREDNISONE for Rash, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm), RASH (Bad rash all over the body), FATIGUE (Feeling tired), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Rash, Urticaria
Clinical narrative: Rash on forearms; Hives; Soreness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN (Soreness), URTICARIA (Hives) and RASH (Rash on forearms) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     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 05-Feb-2021, the patient experienced PAIN (Soreness). On 10-Feb-2021, the patient experienced URTICARIA (Hives). On 14-Feb-2021, the patient experienced RASH (Rash on forearms). The patient was treated with LORATADINE (CLARITIN [LORATADINE]) at an unspecified dose and frequency. On 06-Feb-2021, PAIN (Soreness) had resolved. On 13-Feb-2021, URTICARIA (Hives) had resolved. At the time of the report, RASH (Rash on forearms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Follow up received Added events, treatment medication. Updated reporter contact information ,patient demographics, outcome of event.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: a little bit itchy; skin is red, at the injection site and towards her elbow; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (a little bit itchy) and VACCINATION SITE ERYTHEMA (skin is red, at the injection site and towards her elbow) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 014M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included NAPROXEN for Back pain, HYDROCHLOROTHIAZIDE, PROPRANOLOL, DULOXETINE, POTASSIUM and NYSTATIN (STATIN [NYSTATIN]) for an unknown indication.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2021, the patient experienced VACCINATION SITE PRURITUS (a little bit itchy) and VACCINATION SITE ERYTHEMA (skin is red, at the injection site and towards her elbow). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (a little bit itchy) and VACCINATION SITE ERYTHEMA (skin is red, at the injection site and towards her elbow) outcome was unknown.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Migraine, Pruritus, Vaccination site pain
Clinical narrative: itching; pinkish skin (6 inch long - 2 inch wide); pain at the injection site; terrible headache-migraine for 24 hs; chills; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching), ERYTHEMA (pinkish skin (6 inch long - 2 inch wide)), MIGRAINE (terrible headache-migraine for 24 hs), CHILLS (chills) and VACCINATION SITE PAIN (pain at the injection site) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced MIGRAINE (terrible headache-migraine for 24 hs) and CHILLS (chills). On 01-Mar-2021, the patient experienced PRURITUS (itching), ERYTHEMA (pinkish skin (6 inch long - 2 inch wide)) and VACCINATION SITE PAIN (pain at the injection site). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. On 28-Feb-2021, MIGRAINE (terrible headache-migraine for 24 hs) and CHILLS (chills) outcome was unknown. At the time of the report, PRURITUS (itching), ERYTHEMA (pinkish skin (6 inch long - 2 inch wide)) and VACCINATION SITE PAIN (pain at the injection site) outcome was unknown.            Concomitant medications were not provided.
Sex: M
Vaccine: COVID19
Symptoms: Vertigo, Vertigo positional
Clinical narrative: BPPV; sudden onset of vertigo; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (sudden onset of vertigo) and VERTIGO POSITIONAL (BPPV) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced VERTIGO (sudden onset of vertigo). On an unknown date, the patient experienced VERTIGO POSITIONAL (BPPV). At the time of the report, VERTIGO (sudden onset of vertigo) and VERTIGO POSITIONAL (BPPV) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Lethargy, Neuralgia, Pain
Clinical narrative: Nerve Pain went away for 24 hours; lethargic; weak; achy; A spontaneous report was received from a consumer concerning a 67-years-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events nerve pain went away for 24 hours/neuralgia, lethargic/lethargy, weak/asthenia, achy/pain.  The patient's medical history, as provided by the reporter, previously administered products included Covid-19 VACCINE (Covid -19 vaccine 1st dose) on unknown date. Concurrent medical conditions included Multiple sclerosis (relapsing remitting multiple sclerosis). Concomitant products included GABAPENTIN for Nerve pain.  On 26 Feb 2021, prior to the onset of the events the patient received second of two planned doses of mRNA-1273 (lot/batch: 023M20A) via unknown route on the left arm for prophylaxis of COVID-19 infection. On an unknown date, the patient experienced neuralgia (nerve pain went away for 24 hours), lethargy (lethargic), asthenia (weak) and pain (achy). At the time of the report, neuralgia (nerve pain went away for 24 hours) had resolved and lethargy (lethargic), asthenia (weak) and pain (achy) outcome was unknown.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of events, at the time of the report, neuralgia (nerve pain went away for 24 hours) had resolved and lethargy (lethargic), asthenia (weak) and pain (achy) outcome was unknown.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Musculoskeletal chest pain
Clinical narrative: excruciating pain that was sharp pain in her chest and rib cage; Excruciating pain that was sharp pain in her chest and rib cage; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (excruciating pain that was sharp pain in her chest and rib cage) and MUSCULOSKELETAL CHEST PAIN (Excruciating pain that was sharp pain in her chest and rib cage) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. unknown and unknown) for COVID-19 vaccination.     Concurrent medical conditions included Hyperlipidemia and Arthritis.   On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (excruciating pain that was sharp pain in her chest and rib cage) and MUSCULOSKELETAL CHEST PAIN (Excruciating pain that was sharp pain in her chest and rib cage). At the time of the report, CHEST PAIN (excruciating pain that was sharp pain in her chest and rib cage) and MUSCULOSKELETAL CHEST PAIN (Excruciating pain that was sharp pain in her chest and rib cage) had resolved.            Concomitant medications included medicines for cholesterol and arthritis.  Treatment information were not reported.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphocyte count, Monocyte count, Myalgia, Pyrexia, White blood cell count
Clinical narrative: Abnormal white blood cell count, specifically elevated lymphocytes and monocytes; Fever; Bodyaches; A spontaneous report was received from a consumer concerning a 72-years-old female patient who received second dose of Moderna's COVID-19 vaccine (mRNA-1273) and experienced events abnormal white blood cell count, specifically elevated lymphocytes and monocytes/ white blood cell count abnormal, fever, body aches/myalgia.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 14 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 029L20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.   On 11 Feb 2021, prior to the onset of the events the patient received second of two planned doses of mRNA-1273 (lot/batch: 016M20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.On 11 Feb 2021, the patient experienced fever and body aches.On 25 Feb 2021, the lab test performed included abnormal white blood cell count, specifically elevated lymphocytes and monocytes. Treatment details included paracetamol.  Action taken with mRNA-1273 in response to the events was not applicable.  On 12 Feb 2021 the outcome of events fever and body aches were resolved. The outcome of event, abnormal white blood cell count, specifically elevated lymphocytes and monocytes was unknown.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: White blood cell count abnormal
Clinical narrative: Abnormal white blood cell count, specifically elevated lymphocytes and monocytes; Fever; Bodyaches; A spontaneous report was received from a consumer concerning a 72-years-old female patient who received second dose of Moderna's COVID-19 vaccine (mRNA-1273) and experienced events abnormal white blood cell count, specifically elevated lymphocytes and monocytes/ white blood cell count abnormal, fever, body aches/myalgia.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 14 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 029L20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.   On 11 Feb 2021, prior to the onset of the events the patient received second of two planned doses of mRNA-1273 (lot/batch: 016M20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.On 11 Feb 2021, the patient experienced fever and body aches.On 25 Feb 2021, the lab test performed included abnormal white blood cell count, specifically elevated lymphocytes and monocytes. Treatment details included paracetamol.  Action taken with mRNA-1273 in response to the events was not applicable.  On 12 Feb 2021 the outcome of events fever and body aches were resolved. The outcome of event, abnormal white blood cell count, specifically elevated lymphocytes and monocytes was unknown.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Muscle twitching, Paraesthesia
Clinical narrative: tingling and twitching in lips, face, feets, all the body; tingling and twitching in lips, face, feets, all the body; "buzzing inside my body"; This spontaneous case was reported by a dentist (subsequently medically confirmed) and describes the occurrence of PARAESTHESIA (tingling and twitching in lips, face, feets, all the body), MUSCLE TWITCHING (tingling and twitching in lips, face, feets, all the body) and FEELING ABNORMAL ("buzzing inside my body") in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history).    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jan-2021, the patient experienced PARAESTHESIA (tingling and twitching in lips, face, feets, all the body), MUSCLE TWITCHING (tingling and twitching in lips, face, feets, all the body) and FEELING ABNORMAL ("buzzing inside my body"). At the time of the report, PARAESTHESIA (tingling and twitching in lips, face, feets, all the body), MUSCLE TWITCHING (tingling and twitching in lips, face, feets, all the body) and FEELING ABNORMAL ("buzzing inside my body") outcome was unknown. Not Provided      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 relevant concomitant medications were reported. No treatment information was provided.  Company Comment:  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: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Feeding disorder, Headache, Nausea, Pain in extremity
Clinical narrative: vomiting; dry mouth; unable to eat; slight headache; feeling extremely nausea like car sickness; pain on the arm/next day it felt like rocky balboa punched me on my arm that lasted for 48 hours; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain on the arm/next day it felt like rocky balboa punched me on my arm that lasted for 48 hours), DRY MOUTH (dry mouth), FEEDING DISORDER (unable to eat), HEADACHE (slight headache) and NAUSEA (feeling extremely nausea like car sickness) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no reported medical history).    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (pain on the arm/next day it felt like rocky balboa punched me on my arm that lasted for 48 hours). On 01-Mar-2021, the patient experienced DRY MOUTH (dry mouth), FEEDING DISORDER (unable to eat), HEADACHE (slight headache) and NAUSEA (feeling extremely nausea like car sickness). On 02-Mar-2021, the patient experienced VOMITING (vomiting). On 25-Feb-2021, PAIN IN EXTREMITY (pain on the arm/next day it felt like rocky balboa punched me on my arm that lasted for 48 hours) had resolved. At the time of the report, DRY MOUTH (dry mouth), FEEDING DISORDER (unable to eat), HEADACHE (slight headache), NAUSEA (feeling extremely nausea like car sickness) and VOMITING (vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included paracetamol.   This case was linked to MOD-2021-033786 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: vomiting; dry mouth; unable to eat; slight headache; feeling extremely nausea like car sickness; pain on the arm/next day it felt like rocky balboa punched me on my arm that lasted for 48 hours; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain on the arm/next day it felt like rocky balboa punched me on my arm that lasted for 48 hours), DRY MOUTH (dry mouth), FEEDING DISORDER (unable to eat), HEADACHE (slight headache) and NAUSEA (feeling extremely nausea like car sickness) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no reported medical history).    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (pain on the arm/next day it felt like rocky balboa punched me on my arm that lasted for 48 hours). On 01-Mar-2021, the patient experienced DRY MOUTH (dry mouth), FEEDING DISORDER (unable to eat), HEADACHE (slight headache) and NAUSEA (feeling extremely nausea like car sickness). On 02-Mar-2021, the patient experienced VOMITING (vomiting). On 25-Feb-2021, PAIN IN EXTREMITY (pain on the arm/next day it felt like rocky balboa punched me on my arm that lasted for 48 hours) had resolved. At the time of the report, DRY MOUTH (dry mouth), FEEDING DISORDER (unable to eat), HEADACHE (slight headache), NAUSEA (feeling extremely nausea like car sickness) and VOMITING (vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included paracetamol.   This case was linked to MOD-2021-033786 (Patient Link).
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Gout, Pain
Clinical narrative: Gout Flared up; It been hurting badly Saturday and Sunday; This spontaneous case was reported by a consumer and describes the occurrence of GOUT (Gout Flared up) and PAIN (It been hurting badly Saturday and Sunday) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     Concurrent medical conditions included Gout.    On 25-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 GOUT (Gout Flared up) and PAIN (It been hurting badly Saturday and Sunday). At the time of the report, GOUT (Gout Flared up) and PAIN (It been hurting badly Saturday and Sunday) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment medication included Colchicine.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.  Patient's underlying gout is considered a risk factor.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Inflammation, Injection site swelling, Pruritus, Stress
Clinical narrative: Stress; swelling of the injection site; Redness and inflammation is growing (right) arm to elbow; Right arm to elbow is hot to the touch; Redness and inflammation is growing (right) arm to elbow; Itching of right arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INFLAMMATION (Redness and inflammation is growing (right) arm to elbow), VACCINATION SITE WARMTH (Right arm to elbow is hot to the touch), STRESS (Stress), INJECTION SITE SWELLING (swelling of the injection site) and ERYTHEMA (Redness and inflammation is growing (right) arm to elbow) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported.).   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced INFLAMMATION (Redness and inflammation is growing (right) arm to elbow) and PRURITUS (Itching of right arm). On 27-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Right arm to elbow is hot to the touch), INJECTION SITE SWELLING (swelling of the injection site) and ERYTHEMA (Redness and inflammation is growing (right) arm to elbow). On an unknown date, the patient experienced STRESS (Stress). At the time of the report, INFLAMMATION (Redness and inflammation is growing (right) arm to elbow), VACCINATION SITE WARMTH (Right arm to elbow is hot to the touch), STRESS (Stress), INJECTION SITE SWELLING (swelling of the injection site), ERYTHEMA (Redness and inflammation is growing (right) arm to elbow) and PRURITUS (Itching of right arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 03-Mar-2021: No specific follow-up information recorded.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Stress; swelling of the injection site; Redness and inflammation is growing (right) arm to elbow; Right arm to elbow is hot to the touch; Redness and inflammation is growing (right) arm to elbow; Itching of right arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INFLAMMATION (Redness and inflammation is growing (right) arm to elbow), VACCINATION SITE WARMTH (Right arm to elbow is hot to the touch), STRESS (Stress), INJECTION SITE SWELLING (swelling of the injection site) and ERYTHEMA (Redness and inflammation is growing (right) arm to elbow) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported.).   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced INFLAMMATION (Redness and inflammation is growing (right) arm to elbow) and PRURITUS (Itching of right arm). On 27-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Right arm to elbow is hot to the touch), INJECTION SITE SWELLING (swelling of the injection site) and ERYTHEMA (Redness and inflammation is growing (right) arm to elbow). On an unknown date, the patient experienced STRESS (Stress). At the time of the report, INFLAMMATION (Redness and inflammation is growing (right) arm to elbow), VACCINATION SITE WARMTH (Right arm to elbow is hot to the touch), STRESS (Stress), INJECTION SITE SWELLING (swelling of the injection site), ERYTHEMA (Redness and inflammation is growing (right) arm to elbow) and PRURITUS (Itching of right arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 03-Mar-2021: No specific follow-up information recorded.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test
Clinical narrative: Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 32-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     The patient's past medical history included Rosacea in July 2016. Concomitant products included VITAMIN D3 for COVID-19, NAPROXEN for Cramps, VITAMIN B6 for Nausea, PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] and CALCIUM CARBONATE (CALTRATE [CALCIUM CARBONATE]) for Pregnancy.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 23-Nov-2020 and the estimated date of delivery was 05-Sep-2021. On 28-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fourteenth week of the pregnancy.  At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, Pregnancy test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Headache, Tremor
Clinical narrative: exhausted; chills; headache; shakes; felt lousy/ still feel lousy; felt awful; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (felt awful), TREMOR (shakes), FEELING ABNORMAL (felt lousy/ still feel lousy), FATIGUE (exhausted) and CHILLS (chills) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced VACCINATION COMPLICATION (felt awful). On 25-Feb-2021, the patient experienced TREMOR (shakes), FEELING ABNORMAL (felt lousy/ still feel lousy), CHILLS (chills) and HEADACHE (headache). On 01-Mar-2021, the patient experienced FATIGUE (exhausted). At the time of the report, VACCINATION COMPLICATION (felt awful), TREMOR (shakes), FATIGUE (exhausted), CHILLS (chills) and HEADACHE (headache) outcome was unknown and FEELING ABNORMAL (felt lousy/ still feel lousy) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications and treatment medication were reported. The reporter causality was not provided.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: exhausted; chills; headache; shakes; felt lousy/ still feel lousy; felt awful; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (felt awful), TREMOR (shakes), FEELING ABNORMAL (felt lousy/ still feel lousy), FATIGUE (exhausted) and CHILLS (chills) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced VACCINATION COMPLICATION (felt awful). On 25-Feb-2021, the patient experienced TREMOR (shakes), FEELING ABNORMAL (felt lousy/ still feel lousy), CHILLS (chills) and HEADACHE (headache). On 01-Mar-2021, the patient experienced FATIGUE (exhausted). At the time of the report, VACCINATION COMPLICATION (felt awful), TREMOR (shakes), FATIGUE (exhausted), CHILLS (chills) and HEADACHE (headache) outcome was unknown and FEELING ABNORMAL (felt lousy/ still feel lousy) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications and treatment medication were reported. The reporter causality was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Injection site erythema, Injection site swelling, Myalgia, Pyrexia
Clinical narrative: Body ache; chills; little bit fever; redness under the injection site that is spreaded upto his elbow; swelling under the injection site that is spreaded upto his elbow; swelling has move down from the elbow to the arm area; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body ache), CHILLS (chills), PYREXIA (little bit fever), INJECTION SITE ERYTHEMA (redness under the injection site that is spreaded upto his elbow) and INJECTION SITE SWELLING (swelling under the injection site that is spreaded upto his elbow) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Body ache), CHILLS (chills), PYREXIA (little bit fever), INJECTION SITE ERYTHEMA (redness under the injection site that is spreaded upto his elbow), INJECTION SITE SWELLING (swelling under the injection site that is spreaded upto his elbow) and SWELLING (swelling has move down from the elbow to the arm area). At the time of the report, MYALGIA (Body ache), CHILLS (chills), PYREXIA (little bit fever), INJECTION SITE ERYTHEMA (redness under the injection site that is spreaded upto his elbow), INJECTION SITE SWELLING (swelling under the injection site that is spreaded upto his elbow) and SWELLING (swelling has move down from the elbow to the arm area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Body ache; chills; little bit fever; redness under the injection site that is spreaded upto his elbow; swelling under the injection site that is spreaded upto his elbow; swelling has move down from the elbow to the arm area; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body ache), CHILLS (chills), PYREXIA (little bit fever), INJECTION SITE ERYTHEMA (redness under the injection site that is spreaded upto his elbow) and INJECTION SITE SWELLING (swelling under the injection site that is spreaded upto his elbow) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Body ache), CHILLS (chills), PYREXIA (little bit fever), INJECTION SITE ERYTHEMA (redness under the injection site that is spreaded upto his elbow), INJECTION SITE SWELLING (swelling under the injection site that is spreaded upto his elbow) and SWELLING (swelling has move down from the elbow to the arm area). At the time of the report, MYALGIA (Body ache), CHILLS (chills), PYREXIA (little bit fever), INJECTION SITE ERYTHEMA (redness under the injection site that is spreaded upto his elbow), INJECTION SITE SWELLING (swelling under the injection site that is spreaded upto his elbow) and SWELLING (swelling has move down from the elbow to the arm area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: all or part of their dose was administered subcutaneously; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (all or part of their dose was administered subcutaneously) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 015M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021 at 10:55 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021 at 10:40 AM, 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 INCORRECT ROUTE OF PRODUCT ADMINISTRATION (all or part of their dose was administered subcutaneously). At the time of the report, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (all or part of their dose was administered subcutaneously) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 09-Apr-2021: Patient Identifiers updated
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Skin swelling, Vaccination site pain, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: injection site warmth; puffy; vaccine site swelling; it turned in a red big spot; itchiness; it hurts/ it is sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection site warmth), SKIN SWELLING (puffy), VACCINATION SITE SWELLING (vaccine site swelling), VACCINATION SITE RASH (it turned in a red big spot) and VACCINATION SITE PRURITUS (itchiness) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in November 2020 and Pneumonia. Concurrent medical conditions included Allergy, Asthma and Hypertension. Concomitant products included HYDROCHLOROTHIAZIDE for Blood pressure, VENLAFAXINE HYDROCHLORIDE (EFFEXOR), CETIRIZINE HYDROCHLORIDE (CETRIZINE) and FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE WARMTH (injection site warmth), SKIN SWELLING (puffy), VACCINATION SITE SWELLING (vaccine site swelling), VACCINATION SITE RASH (it turned in a red big spot), VACCINATION SITE PRURITUS (itchiness) and VACCINATION SITE PAIN (it hurts/ it is sore). At the time of the report, VACCINATION SITE WARMTH (injection site warmth), SKIN SWELLING (puffy), VACCINATION SITE SWELLING (vaccine site swelling), VACCINATION SITE RASH (it turned in a red big spot), VACCINATION SITE PRURITUS (itchiness) and VACCINATION SITE PAIN (it hurts/ it is sore) 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 treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: NNI Case
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: injection site warmth; puffy; vaccine site swelling; it turned in a red big spot; itchiness; it hurts/ it is sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection site warmth), SKIN SWELLING (puffy), VACCINATION SITE SWELLING (vaccine site swelling), VACCINATION SITE RASH (it turned in a red big spot) and VACCINATION SITE PRURITUS (itchiness) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in November 2020 and Pneumonia. Concurrent medical conditions included Allergy, Asthma and Hypertension. Concomitant products included HYDROCHLOROTHIAZIDE for Blood pressure, VENLAFAXINE HYDROCHLORIDE (EFFEXOR), CETIRIZINE HYDROCHLORIDE (CETRIZINE) and FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE WARMTH (injection site warmth), SKIN SWELLING (puffy), VACCINATION SITE SWELLING (vaccine site swelling), VACCINATION SITE RASH (it turned in a red big spot), VACCINATION SITE PRURITUS (itchiness) and VACCINATION SITE PAIN (it hurts/ it is sore). At the time of the report, VACCINATION SITE WARMTH (injection site warmth), SKIN SWELLING (puffy), VACCINATION SITE SWELLING (vaccine site swelling), VACCINATION SITE RASH (it turned in a red big spot), VACCINATION SITE PRURITUS (itchiness) and VACCINATION SITE PAIN (it hurts/ it is sore) 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 treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: NNI Case
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: pain in arm; fatigue; severe headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in arm), HEADACHE (severe headache) and FATIGUE (fatigue) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in arm), HEADACHE (severe headache) and FATIGUE (fatigue). At the time of the report, PAIN IN EXTREMITY (pain in arm), HEADACHE (severe headache) and FATIGUE (fatigue) had resolved.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Vaccination site erythema, Vaccination site pruritus, Vaccination site rash, Vaccination site reaction
Clinical narrative: covid arm; Itchy swelling at injection site; very hot; enormous rash 3 inches; burning; bright red; terrible itch at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (very hot), VACCINATION SITE REACTION (covid arm), VACCINATION SITE PRURITUS (terrible itch at injection site), VACCINATION SITE RASH (enormous rash 3 inches) and INJECTION SITE PAIN (burning) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 17-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (terrible itch at injection site). On 18-Feb-2021, the patient experienced VACCINATION SITE WARMTH (very hot), VACCINATION SITE RASH (enormous rash 3 inches), INJECTION SITE PAIN (burning) and VACCINATION SITE ERYTHEMA (bright red). On an unknown date, the patient experienced VACCINATION SITE REACTION (covid arm) and VACCINATION SITE SWELLING (Itchy swelling at injection site). At the time of the report, VACCINATION SITE WARMTH (very hot), VACCINATION SITE REACTION (covid arm), VACCINATION SITE PRURITUS (terrible itch at injection site), VACCINATION SITE RASH (enormous rash 3 inches), INJECTION SITE PAIN (burning) and VACCINATION SITE ERYTHEMA (bright red) had resolved and VACCINATION SITE SWELLING (Itchy swelling at injection site) 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 product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2021-261489 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Follow up received included event outcome COVID arm was updated from unknown to recovered. On 20-Jul-2021: Follow up received included patient demographics, additional event(Itchy swelling at injection site) were updated.