chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Pain, Pyrexia, Rash
Clinical narrative: SKIN BREAKOUTS; ACHES/PAIN; SERIOUS REACTION AFTER THE FIRST DOSE OF MODERNA COVID VACCINE; FEVER; This spontaneous case was reported by an other and describes the occurrence of RASH (SKIN BREAKOUTS), PAIN (ACHES/PAIN), ADVERSE REACTION (SERIOUS REACTION AFTER THE FIRST DOSE OF MODERNA COVID VACCINE) and PYREXIA (FEVER) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    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 and UPADACITINIB (RINVOQ) (unknown route) at an unspecified dose. On an unknown date, the patient experienced RASH (SKIN BREAKOUTS), PAIN (ACHES/PAIN), ADVERSE REACTION (SERIOUS REACTION AFTER THE FIRST DOSE OF MODERNA COVID VACCINE) and PYREXIA (FEVER). At the time of the report, RASH (SKIN BREAKOUTS), PAIN (ACHES/PAIN) and PYREXIA (FEVER) had resolved and ADVERSE REACTION (SERIOUS REACTION AFTER THE FIRST DOSE OF MODERNA COVID VACCINE) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Musculoskeletal stiffness, Pain, Pollakiuria, Pyrexia
Clinical narrative: bodyache; stiff arm; urinating every hour; low grade fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (bodyache), MUSCULOSKELETAL STIFFNESS (stiff arm), POLLAKIURIA (urinating every hour), PYREXIA (low grade fever) and CHILLS (chills) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042620A and 037K20A) for COVID-19 vaccination.     The patient's past medical history included Postnasal drip from 28-Dec-2020 to 11-Jan-2021.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced PAIN (bodyache), MUSCULOSKELETAL STIFFNESS (stiff arm), POLLAKIURIA (urinating every hour), PYREXIA (low grade fever) and CHILLS (chills). The patient was treated with IBUPROFEN on 28-Jan-2021 for General body pain and Stiffness, at an unspecified dose and frequency. On 29-Jan-2021, PAIN (bodyache), MUSCULOSKELETAL STIFFNESS (stiff arm), POLLAKIURIA (urinating every hour), PYREXIA (low grade fever) and CHILLS (chills) had resolved.            No concomitant medications reported.   This case was linked to MOD-2021-002281 (Patient Link).
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Vaccination site erythema, Vaccination site mass, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Fingers felt stiff; Burning at injection site; Injection site red; Injection site itching; Lump in her arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Lump in her arm), MUSCULOSKELETAL STIFFNESS (Fingers felt stiff), VACCINATION SITE PAIN (Burning at injection site), VACCINATION SITE ERYTHEMA (Injection site red) and VACCINATION SITE PRURITUS (Injection site itching) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included Thyroid disorder. Concurrent medical conditions included Allergy to antibiotic (Amoxicillin) and Sulfonamide allergy. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), AMLODIPINE, METOPROLOL, ATORVASTATIN and ASCORBIC ACID, CALCIUM, MINERALS NOS, RETINOL, TOCOPHERYL ACETATE, VITAMIN B NOS, VITAMINS NOS, ZINC (CENTRUM SILVER [ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS;VITAMINS NOS;ZINC]) for an unknown indication.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced VACCINATION SITE MASS (Lump in her arm). On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (Fingers felt stiff), VACCINATION SITE PAIN (Burning at injection site), VACCINATION SITE ERYTHEMA (Injection site red) and VACCINATION SITE PRURITUS (Injection site itching). At the time of the report, VACCINATION SITE MASS (Lump in her arm) had resolved and MUSCULOSKELETAL STIFFNESS (Fingers felt stiff), VACCINATION SITE PAIN (Burning at injection site), VACCINATION SITE ERYTHEMA (Injection site red) and VACCINATION SITE PRURITUS (Injection site itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitants- Refresh for eyes No treatment was provided.   This case was linked to MOD-2021-281501 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Aug-2021: Significant Follow-Up received on 10-AUG-2021. : Reporter contact information, patient demographics, historical condition, concomitant medicines, events reported and out come of the event lump in arm updated as recovered after 3 weeks.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: cold sore right outside her mouth; This spontaneous case was reported by a consumer and describes the occurrence of ORAL HERPES in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder.   On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced ORAL HERPES. At the time of the report, ORAL HERPES outcome was unknown.            Patient's concomitant medication included unspecified medicine for thyroid.  Treatment medications was not provided by the reporter
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: sore arm; Arm a little swollen; Arm is red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm), VACCINATION SITE SWELLING (Arm a little swollen) and VACCINATION SITE ERYTHEMA (Arm is red) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 011L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (THYROXINE) and ESTRADIOL for an unknown indication.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE PAIN (sore arm), VACCINATION SITE SWELLING (Arm a little swollen) and VACCINATION SITE ERYTHEMA (Arm is red). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (sore arm), VACCINATION SITE SWELLING (Arm a little swollen) and VACCINATION SITE ERYTHEMA (Arm is red) outcome was unknown.            This case was linked to MOD-2021-008897, MOD21-06981 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: Reaction on the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Reaction on the vaccine) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (Reaction on the vaccine). At the time of the report, ADVERSE REACTION (Reaction on the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  Treatment medications was not provided by the reporter
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Feeling abnormal, Feeling hot, Gait disturbance, Palpitations
Clinical narrative: 5 steps after receiving the injection, the ptient had to sit down; Felt warmth at the injection site; Armpit warmth; Leg warmth; Chest warmth; Tasted something; Heart raced; Feels hyped; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (5 steps after receiving the injection, the ptient had to sit down), VACCINATION SITE WARMTH (Felt warmth at the injection site), FEELING HOT (Armpit warmth), FEELING HOT (Leg warmth) and CHEST DISCOMFORT (Chest warmth) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced GAIT DISTURBANCE (5 steps after receiving the injection, the ptient had to sit down), VACCINATION SITE WARMTH (Felt warmth at the injection site), FEELING HOT (Armpit warmth), FEELING HOT (Leg warmth), CHEST DISCOMFORT (Chest warmth), TASTE DISORDER (Tasted something), PALPITATIONS (Heart raced) and FEELING ABNORMAL (Feels hyped). On 28-Feb-2021, GAIT DISTURBANCE (5 steps after receiving the injection, the ptient had to sit down), VACCINATION SITE WARMTH (Felt warmth at the injection site), FEELING HOT (Armpit warmth), FEELING HOT (Leg warmth), CHEST DISCOMFORT (Chest warmth), TASTE DISORDER (Tasted something) and PALPITATIONS (Heart raced) had resolved. At the time of the report, FEELING ABNORMAL (Feels hyped) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  Treatment medications was not provided by the reporter
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Taste disorder, Vaccination site warmth
Clinical narrative: 5 steps after receiving the injection, the ptient had to sit down; Felt warmth at the injection site; Armpit warmth; Leg warmth; Chest warmth; Tasted something; Heart raced; Feels hyped; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (5 steps after receiving the injection, the ptient had to sit down), VACCINATION SITE WARMTH (Felt warmth at the injection site), FEELING HOT (Armpit warmth), FEELING HOT (Leg warmth) and CHEST DISCOMFORT (Chest warmth) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced GAIT DISTURBANCE (5 steps after receiving the injection, the ptient had to sit down), VACCINATION SITE WARMTH (Felt warmth at the injection site), FEELING HOT (Armpit warmth), FEELING HOT (Leg warmth), CHEST DISCOMFORT (Chest warmth), TASTE DISORDER (Tasted something), PALPITATIONS (Heart raced) and FEELING ABNORMAL (Feels hyped). On 28-Feb-2021, GAIT DISTURBANCE (5 steps after receiving the injection, the ptient had to sit down), VACCINATION SITE WARMTH (Felt warmth at the injection site), FEELING HOT (Armpit warmth), FEELING HOT (Leg warmth), CHEST DISCOMFORT (Chest warmth), TASTE DISORDER (Tasted something) and PALPITATIONS (Heart raced) had resolved. At the time of the report, FEELING ABNORMAL (Feels hyped) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  Treatment medications was not provided by the reporter
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication, Vaccination site pain, Vaccination site urticaria
Clinical narrative: A big red welt with a darker ring around the outside; Localized pain; normal vaccine side effects; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION COMPLICATION (normal vaccine side effects), VACCINATION SITE URTICARIA (A big red welt with a darker ring around the outside) and VACCINATION SITE PAIN (Localized pain) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Pollen allergy, Hay fever and Allergy to animal dander (cat).    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced VACCINATION COMPLICATION (normal vaccine side effects) and VACCINATION SITE PAIN (Localized pain). On 22-Feb-2021, the patient experienced VACCINATION SITE URTICARIA (A big red welt with a darker ring around the outside). In February 2021, VACCINATION COMPLICATION (normal vaccine side effects) and VACCINATION SITE PAIN (Localized pain) had resolved. At the time of the report, VACCINATION SITE URTICARIA (A big red welt with a darker ring around the outside) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  It was reported that the welt did not hurt and the patient has history of getting welts when taking allergy shots.  Patient used little ice on days one and two for the normal side effects of vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Follow up report included no new information
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: side effects; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (side effects) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced ADVERSE EVENT (side effects). At the time of the report, ADVERSE EVENT (side effects) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Decreased appetite, Headache, Pain in extremity
Clinical narrative: Muscle ache right arm; stomach ache; loss of appetite; Headache; A spontaneous report was received from a Consumer concerning herself, 76 years- old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events, muscle ache right arm, stomachache, loss of appetite, and headache, .  No patient's medical history was reported.   The relevant concomitant medications included losartan for hypertension, and paroxetine hydrochloride for depression.  On 02 Mar 2021, prior to the onset of the events, the patient received their second of the two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in right arm for prophylaxis of COVID-19 infection.  On 03 Jan 2021, with onset latency of two days, the patient developed headache, which is getting worse. Moreover, the patient experienced, muscle ache, mild upset stomach, and did not have appetite.  No Laboratory investigations were provided.  No Treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.   At the time of this report, the outcome of the events, Muscle ache right arm, stomachache, loss of appetite, and Headache,  was unknown.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Fatigue; arm soreness; Myalgia; Fever; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), PAIN IN EXTREMITY (arm soreness), MYALGIA (Myalgia) and PYREXIA (Fever) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced FATIGUE (Fatigue), PAIN IN EXTREMITY (arm soreness), MYALGIA (Myalgia) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FATIGUE (Fatigue), PAIN IN EXTREMITY (arm soreness), MYALGIA (Myalgia) and PYREXIA (Fever) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: high (High) 101.3 degrees..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication use was not provided.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough
Clinical narrative: Tested positive for Covid-19; Cough; This spontaneous case was reported by an other and describes the occurrence of COVID-19 (Tested positive for Covid-19) and COUGH (Cough) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00104045) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN, CLOPIDOGREL, CARVEDILOL, ACETYLSALICYLIC ACID (ASPIRIN 81) and FAMOTIDINE (PEPCIDIN) for an unknown indication.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced COVID-19 (Tested positive for Covid-19) and COUGH (Cough). The patient was treated with BAMLANIVIMAB on 02-Mar-2021 at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. On 08-Mar-2021, COVID-19 (Tested positive for Covid-19) outcome was unknown. At the time of the report, COUGH (Cough) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included, Corcidin HBP.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Fatigue, Pain, Pyrexia
Clinical narrative: Fever all day that ranges from 102 Deg. F. - 101.9 Deg F.; body ache; fatigue; slight cough; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever all day that ranges from 102 Deg. F. - 101.9 Deg F.), PAIN (body ache), FATIGUE (fatigue) and COUGH (slight cough) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced PYREXIA (Fever all day that ranges from 102 Deg. F. - 101.9 Deg F.), PAIN (body ache), FATIGUE (fatigue) and COUGH (slight cough). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever all day that ranges from 102 Deg. F. - 101.9 Deg F.), PAIN (body ache), FATIGUE (fatigue) and COUGH (slight cough) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication include, Multivitamins.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Nasal oedema, Nasopharyngitis
Clinical narrative: Sore throat; Some cold; Sneezing; Face swelling; Swelled eyelids; Swelled area around the nose; Fatigue; Arm sore; Pain on injection site; Headache; Some muscle pain on left leg; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm sore), OROPHARYNGEAL PAIN (Sore throat), NASOPHARYNGITIS (Some cold), SNEEZING (Sneezing) and SWELLING FACE (Face swelling) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Migraine. Concomitant products included RIZATRIPTAN for Migraine.    On 05-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 sore), VACCINATION SITE PAIN (Pain on injection site), HEADACHE (Headache) and MYALGIA (Some muscle pain on left leg). On 06-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat), NASOPHARYNGITIS (Some cold), SNEEZING (Sneezing), SWELLING FACE (Face swelling), SWELLING OF EYELID (Swelled eyelids), NASAL OEDEMA (Swelled area around the nose) and FATIGUE (Fatigue). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) on 06-Mar-2021 for Headache, at a dose of 600 mg. At the time of the report, PAIN IN EXTREMITY (Arm sore), OROPHARYNGEAL PAIN (Sore throat), NASOPHARYNGITIS (Some cold), SNEEZING (Sneezing), SWELLING FACE (Face swelling), SWELLING OF EYELID (Swelled eyelids), NASAL OEDEMA (Swelled area around the nose), VACCINATION SITE PAIN (Pain on injection site), HEADACHE (Headache), MYALGIA (Some muscle pain on left leg) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain in extremity, Sneezing, Swelling face, Swelling of eyelid
Clinical narrative: Sore throat; Some cold; Sneezing; Face swelling; Swelled eyelids; Swelled area around the nose; Fatigue; Arm sore; Pain on injection site; Headache; Some muscle pain on left leg; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm sore), OROPHARYNGEAL PAIN (Sore throat), NASOPHARYNGITIS (Some cold), SNEEZING (Sneezing) and SWELLING FACE (Face swelling) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Migraine. Concomitant products included RIZATRIPTAN for Migraine.    On 05-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 sore), VACCINATION SITE PAIN (Pain on injection site), HEADACHE (Headache) and MYALGIA (Some muscle pain on left leg). On 06-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat), NASOPHARYNGITIS (Some cold), SNEEZING (Sneezing), SWELLING FACE (Face swelling), SWELLING OF EYELID (Swelled eyelids), NASAL OEDEMA (Swelled area around the nose) and FATIGUE (Fatigue). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) on 06-Mar-2021 for Headache, at a dose of 600 mg. At the time of the report, PAIN IN EXTREMITY (Arm sore), OROPHARYNGEAL PAIN (Sore throat), NASOPHARYNGITIS (Some cold), SNEEZING (Sneezing), SWELLING FACE (Face swelling), SWELLING OF EYELID (Swelled eyelids), NASAL OEDEMA (Swelled area around the nose), VACCINATION SITE PAIN (Pain on injection site), HEADACHE (Headache), MYALGIA (Some muscle pain on left leg) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore throat; Some cold; Sneezing; Face swelling; Swelled eyelids; Swelled area around the nose; Fatigue; Arm sore; Pain on injection site; Headache; Some muscle pain on left leg; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm sore), OROPHARYNGEAL PAIN (Sore throat), NASOPHARYNGITIS (Some cold), SNEEZING (Sneezing) and SWELLING FACE (Face swelling) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Migraine. Concomitant products included RIZATRIPTAN for Migraine.    On 05-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 sore), VACCINATION SITE PAIN (Pain on injection site), HEADACHE (Headache) and MYALGIA (Some muscle pain on left leg). On 06-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat), NASOPHARYNGITIS (Some cold), SNEEZING (Sneezing), SWELLING FACE (Face swelling), SWELLING OF EYELID (Swelled eyelids), NASAL OEDEMA (Swelled area around the nose) and FATIGUE (Fatigue). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) on 06-Mar-2021 for Headache, at a dose of 600 mg. At the time of the report, PAIN IN EXTREMITY (Arm sore), OROPHARYNGEAL PAIN (Sore throat), NASOPHARYNGITIS (Some cold), SNEEZING (Sneezing), SWELLING FACE (Face swelling), SWELLING OF EYELID (Swelled eyelids), NASAL OEDEMA (Swelled area around the nose), VACCINATION SITE PAIN (Pain on injection site), HEADACHE (Headache), MYALGIA (Some muscle pain on left leg) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Ligament sprain, Vaccination site discomfort, Vaccination site pain
Clinical narrative: Lot of pain in arm the shot was given - right arm; Pain is a little bit above the elbow; Cannot lift the arm up - right arm; Joint pain but only in elbows - both; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Lot of pain in arm the shot was given - right arm), LIGAMENT SPRAIN (Pain is a little bit above the elbow), VACCINATION SITE DISCOMFORT (Cannot lift the arm up - right arm) and ARTHRALGIA (Joint pain but only in elbows - both) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).  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 VACCINATION SITE PAIN (Lot of pain in arm the shot was given - right arm), LIGAMENT SPRAIN (Pain is a little bit above the elbow), VACCINATION SITE DISCOMFORT (Cannot lift the arm up - right arm) and ARTHRALGIA (Joint pain but only in elbows - both).   At the time of the report, VACCINATION SITE PAIN (Lot of pain in arm the shot was given - right arm), LIGAMENT SPRAIN (Pain is a little bit above the elbow), VACCINATION SITE DISCOMFORT (Cannot lift the arm up - right arm) and ARTHRALGIA (Joint pain but only in elbows - both) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Concomitant drug was not reported.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Headache, Heart rate
Clinical narrative: Dizziness; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and HEADACHE (Headache) 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 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced HEADACHE (Headache). On 08-Mar-2021, the patient experienced DIZZINESS (Dizziness). The patient was treated with IBUPROFEN for Headache, at a dose of 1 dosage form. At the time of the report, DIZZINESS (Dizziness) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Mar-2021, Blood pressure measurement: 128 (Inconclusive) 128. On 08-Mar-2021, Heart rate: elevated (High) Elevated.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Achy arm on arm of injection.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Achy arm on arm of injection.) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VIT D [VITAMIN D NOS] and CHONDROITIN SULFATE, GLUCOSAMINE (GLUCOSAMINE/CHONDROITIN [CHONDROITIN SULFATE;GLUCOSAMINE]) for an unknown indication.   On 08-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. On 08-Mar-2021, the patient experienced VACCINATION SITE PAIN (Achy arm on arm of injection.). The patient was treated with IBUPROFEN for Pain in arm, at a dose of 1 dosage form. At the time of the report, VACCINATION SITE PAIN (Achy arm on arm of injection.) outcome was unknown. Not Provided          Concomitant medications included High Blood Pressure Medications, Antihyperlipidemic, Multivitamin. Action taken with mRNA-1273 in response to the events was not applicable.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain) in a 69-year-old male 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm pain). At the time of the report, PAIN IN EXTREMITY (Arm pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Treatment medications were unknown.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Blister, Paraesthesia oral, Pruritus, Rash
Clinical narrative: Mouth began tingling; Cheek began to itch; Yellow centered blisters; Rash formed on cheek; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (Mouth began tingling), PRURITUS (Cheek began to itch), BLISTER (Yellow centered blisters) and RASH (Rash formed on cheek) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 007M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Feb-2021, the patient experienced PARAESTHESIA ORAL (Mouth began tingling), PRURITUS (Cheek began to itch), BLISTER (Yellow centered blisters) and RASH (Rash formed on cheek). At the time of the report, PARAESTHESIA ORAL (Mouth began tingling), PRURITUS (Cheek began to itch) and RASH (Rash formed on cheek) outcome was unknown and BLISTER (Yellow centered blisters) had resolved. Not Provided          No concomitant medications were provided. Treatment medications were unknown.    Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow-up information received on 10-MAY-2021 contains non-significant information: Contact information updated.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Sore arm; Head was tingling every once in a while; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and PARAESTHESIA (Head was tingling every once in a while) in an 84-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 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and PARAESTHESIA (Head was tingling every once in a while). At the time of the report, PAIN IN EXTREMITY (Sore arm) and PARAESTHESIA (Head was tingling every once in a while) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment medications were unknown.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Feeling hot, Rash, Rash pruritic, Skin warm
Clinical narrative: Feeling Hot; Had fever in arm; Itching on arm; My arm developed a big red ring; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Feeling Hot), SKIN WARM (Had fever in arm), RASH PRURITIC (Itching on arm) and RASH (My arm developed a big red ring) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for an unreported indication: INFLUENZA VACCINE. Concurrent medical conditions included Autoimmune disorder and Drug allergy (Allergic to sulfa drug (Broke down inti rash)). Concomitant products included MELOXICAM (MOBIC), BUPROPION HYDROCHLORIDE (WELLBUTRIN XL), HYDROCODONE BITARTRATE, PARACETAMOL (NORCO), CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and HYDROCHLOROTHIAZIDE, VALSARTAN (DIOVAN HCT) 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 05-Mar-2021, the patient experienced SKIN WARM (Had fever in arm), RASH PRURITIC (Itching on arm) and RASH (My arm developed a big red ring). On an unknown date, the patient experienced FEELING HOT (Feeling Hot). The patient was treated with PREDNISONE at a dose of 1 dosage form. At the time of the report, FEELING HOT (Feeling Hot), SKIN WARM (Had fever in arm), RASH PRURITIC (Itching on arm) and RASH (My arm developed a big red ring) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (High) 101.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: new event and event outcome updated.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: Upper lip swelling; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of LIP SWELLING (Upper lip swelling) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Perioral dermatitis and Dermal filler injection (Patient had Volbella to upper lip) in February 2020. Previously administered products included for Product used for unknown indication: Restylane (Patient was injected with Restylane Kysse 1ml to upper and lower lips.) on 18-Sep-2020. Concomitant products included DOXYCYCLINE (ORACEA [DOXYCYCLINE]) and SERTRALINE for an unknown indication.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.   On 29-Jan-2021, the patient experienced LIP SWELLING (Upper lip swelling). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 50 milligram and TRAMADOL at a dose of 10 milligram.   On 30-Jan-2021, LIP SWELLING (Upper lip swelling) had resolved. Not Provided    For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Migraine, Myalgia
Clinical narrative: Migraine/Pain in the left side of the head; Pain in the left side of the body; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine/Pain in the left side of the head) and MYALGIA (Pain in the left side of the body) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Stroke (Suffered Ictus in the past that affected the left side of his body.).    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced MIGRAINE (Migraine/Pain in the left side of the head) and MYALGIA (Pain in the left side of the body). At the time of the report, MIGRAINE (Migraine/Pain in the left side of the head) and MYALGIA (Pain in the left side of the body) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment medications were unknown.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Mass, Pain, Pruritus
Clinical narrative: Had a big lump; Red; Very sore; Very warm to the touch; It is starting to get itchy; Looks like a rash; This spontaneous case was reported by a consumer and describes the occurrence of MASS (Had a big lump), ERYTHEMA (Red), PAIN (Very sore), FEELING HOT (Very warm to the touch) and PRURITUS (It is starting to get itchy) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   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. On 06-Mar-2021, the patient experienced MASS (Had a big lump), ERYTHEMA (Red), PAIN (Very sore), FEELING HOT (Very warm to the touch), PRURITUS (It is starting to get itchy) and RASH (Looks like a rash). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, MASS (Had a big lump), ERYTHEMA (Red), PAIN (Very sore), FEELING HOT (Very warm to the touch), PRURITUS (It is starting to get itchy) and RASH (Looks like a rash) outcome was unknown.            No concomitant medications were provided. Action taken with mRNA-1273 in response to the events was not applicable.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Had a big lump; Red; Very sore; Very warm to the touch; It is starting to get itchy; Looks like a rash; This spontaneous case was reported by a consumer and describes the occurrence of MASS (Had a big lump), ERYTHEMA (Red), PAIN (Very sore), FEELING HOT (Very warm to the touch) and PRURITUS (It is starting to get itchy) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   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. On 06-Mar-2021, the patient experienced MASS (Had a big lump), ERYTHEMA (Red), PAIN (Very sore), FEELING HOT (Very warm to the touch), PRURITUS (It is starting to get itchy) and RASH (Looks like a rash). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, MASS (Had a big lump), ERYTHEMA (Red), PAIN (Very sore), FEELING HOT (Very warm to the touch), PRURITUS (It is starting to get itchy) and RASH (Looks like a rash) outcome was unknown.            No concomitant medications were provided. Action taken with mRNA-1273 in response to the events was not applicable.
Age: 77.0
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Glassy eyes, Pain, Pyrexia, Vaccination site pain
Clinical narrative: Eyes were glassy; Weakness; Body ache; Fever; Pain at injection (left) arm; This spontaneous case was reported by a consumer and describes the occurrence of GLASSY EYES (Eyes were glassy), ASTHENIA (Weakness), PAIN (Body ache), PYREXIA (Fever) and VACCINATION SITE PAIN (Pain at injection (left) arm) in a 77-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Hospitalized.) in January 2021.    On 04-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 GLASSY EYES (Eyes were glassy), ASTHENIA (Weakness), PAIN (Body ache), PYREXIA (Fever) and VACCINATION SITE PAIN (Pain at injection (left) arm). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 2 dosage form and HYDROCODONE BITARTRATE, PARACETAMOL (VICODIN) at an unspecified dose and frequency. At the time of the report, GLASSY EYES (Eyes were glassy), ASTHENIA (Weakness), PAIN (Body ache), PYREXIA (Fever) and VACCINATION SITE PAIN (Pain at injection (left) arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Other treatment information included cold wash cloth.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort
Clinical narrative: Having back problems; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (Having back problems) in a 67-year-old male patient 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL DISCOMFORT (Having back problems). The patient was treated with PREDNISONE for Back discomfort, at an unspecified dose and frequency and HYDROCODONE for Back discomfort, at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL DISCOMFORT (Having back problems) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular, Skin tightness, Swelling
Clinical narrative: Blotchy skin around her wrist; Skin tightening; Swelling; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Blotchy skin around her wrist), SKIN TIGHTNESS (Skin tightening) and SWELLING (Swelling) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-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 RASH MACULAR (Blotchy skin around her wrist), SKIN TIGHTNESS (Skin tightening) and SWELLING (Swelling). At the time of the report, RASH MACULAR (Blotchy skin around her wrist), SKIN TIGHTNESS (Skin tightening) and SWELLING (Swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Pain in extremity
Clinical narrative: Had pain in the arm/pain when touching it; Hardness; Redness at the injection site; A 2 inches bulge; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Had pain in the arm/pain when touching it), INJECTION SITE INDURATION (Hardness), INJECTION SITE ERYTHEMA (Redness at the injection site) and INJECTION SITE SWELLING (A 2 inches bulge) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-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 PAIN IN EXTREMITY (Had pain in the arm/pain when touching it), INJECTION SITE INDURATION (Hardness), INJECTION SITE ERYTHEMA (Redness at the injection site) and INJECTION SITE SWELLING (A 2 inches bulge). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Had pain in the arm/pain when touching it), INJECTION SITE INDURATION (Hardness), INJECTION SITE ERYTHEMA (Redness at the injection site) and INJECTION SITE SWELLING (A 2 inches bulge) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Other treatment medication included application of ice.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Pain in extremity, Vaccination site erythema, Vaccination site reaction, Vaccination site swelling
Clinical narrative: COVID arm; Red patch,  at injection site; Slightly raised, at injection site; Her arm hurt very bad, she wanted to cut it off; Arm felt a little heavy; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT, VACCINATION SITE REACTION, PAIN IN EXTREMITY, VACCINATION SITE ERYTHEMA, and VACCINATION SITE SWELLING in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     The patient's past medical history included Mastectomy in 1995 and Mastectomy in 1997. Concurrent medical conditions included Neuroma and Dizziness.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced LIMB DISCOMFORT and PAIN IN EXTREMITY. On 20-Feb-2021, the patient experienced VACCINATION SITE REACTION, VACCINATION SITE ERYTHEMA, and VACCINATION SITE SWELLING. On 13-Feb-2021, LIMB DISCOMFORT had resolved. On 14-Feb-2021, PAIN IN EXTREMITY had resolved. On 26-Feb-2021, VACCINATION SITE REACTION, VACCINATION SITE ERYTHEMA, and VACCINATION SITE SWELLING had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not provided.