chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Rash
Clinical narrative: Very itchy; A rash on her entire body; A sore arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (A sore arm), PRURITUS (Very itchy) and RASH (A rash on her entire body) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 031L20A) for COVID-19 vaccination.     Concomitant products included VALSARTAN, SIMVASTATIN, LIOTHYRONINE, LEVOTHYROXINE and ALENDRONATE SODIUM (ALENDRONATE) for an unknown indication.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (A sore arm). On 29-Mar-2021, the patient experienced PRURITUS (Very itchy) and RASH (A rash on her entire body). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (A sore arm), PRURITUS (Very itchy) and RASH (A rash on her entire body) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: fatigue; pain in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue) and VACCINATION SITE PAIN (pain in the injection site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced FATIGUE (fatigue) and VACCINATION SITE PAIN (pain in the injection site). On 10-Mar-2021, FATIGUE (fatigue) and VACCINATION SITE PAIN (pain in the injection site) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment details were reported.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain
Clinical narrative: lower back pain; It went from his hip to lower back; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (lower back pain) and ARTHRALGIA (It went from his hip to lower back) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B(or8)21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced BACK PAIN (lower back pain) and ARTHRALGIA (It went from his hip to lower back). At the time of the report, BACK PAIN (lower back pain) and ARTHRALGIA (It went from his hip to lower back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Fatigue, Hyperhidrosis, Pyrexia
Clinical narrative: Sweats; chills; Fever; Fatigued; Difficulty breathing which comes and goes; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficulty breathing which comes and goes), HYPERHIDROSIS (Sweats), CHILLS (chills), PYREXIA (Fever) and FATIGUE (Fatigued) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Difficulty breathing which comes and goes), HYPERHIDROSIS (Sweats), CHILLS (chills), PYREXIA (Fever) and FATIGUE (Fatigued). The patient was treated with GUAIFENESIN (MUCINEX) at an unspecified dose and frequency. At the time of the report, DYSPNOEA (Difficulty breathing which comes and goes), HYPERHIDROSIS (Sweats), CHILLS (chills), PYREXIA (Fever) and FATIGUE (Fatigued) outcome was unknown.            Treatment Medication includes: Steroid Inhaler (Device)  Action taken with mRNA-1273 in response to the event was not applicable.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: Site of injection is red; Pain on site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Site of injection is red) and VACCINATION SITE PAIN (Pain on site of injection) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Site of injection is red) and VACCINATION SITE PAIN (Pain on site of injection). At the time of the report, VACCINATION SITE ERYTHEMA (Site of injection is red) and VACCINATION SITE PAIN (Pain on site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: pains; aches; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pains), PAIN (aches) and HEADACHE (headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS for an unknown indication.    On 13-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 13-Mar-2021, the patient experienced PAIN (pains), PAIN (aches) and HEADACHE (headache). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at a dose of UNK dosage form. At the time of the report, PAIN (pains), PAIN (aches) and HEADACHE (headache) outcome was unknown. Not Provided          Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Influenza, Nasal oedema
Clinical narrative: coming down with the flu; nose swelling (twice the size of it); This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (coming down with the flu) and NASAL OEDEMA (nose swelling (twice the size of it)) 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 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, the patient experienced INFLUENZA (coming down with the flu) and NASAL OEDEMA (nose swelling (twice the size of it)). At the time of the report, INFLUENZA (coming down with the flu) and NASAL OEDEMA (nose swelling (twice the size of it)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Symptoms: Patient reported that she felt like her nose was broken. No treatment medications were reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: Body aches all over; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches all over) and HEADACHE (Headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 028A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Mar-2021, the patient experienced PAIN (Body aches all over) and HEADACHE (Headache). At the time of the report, PAIN (Body aches all over) and HEADACHE (Headache) outcome was unknown.            No treatment medications were provided. No concomitant medication information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Live follow up received on 13-May-2021: Reporter Contact Information Updated On 07-Jul-2021: follow up received on 07-JUL-2021 and contain no new information
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: rash on the injection site 8 days after; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash on the injection site 8 days after) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (rash on the injection site 8 days after). At the time of the report, VACCINATION SITE RASH (rash on the injection site 8 days after) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Cough, Fatigue
Clinical narrative: little bit tired; temperature of 100.5F; headache; joint aches; chills; lethargic; cough; body aches; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (lethargic), COUGH (cough), PAIN (body aches), FATIGUE (little bit tired) and ARTHRALGIA (joint aches) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History Information was reported.  Concomitant products included FAMCICLOVIR, LOSARTAN, ATORVASTATIN, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), MULTIVITAMINS [VITAMINS NOS] and VITAMIN D3 for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced LETHARGY (lethargic), COUGH (cough), PAIN (body aches), ARTHRALGIA (joint aches), CHILLS (chills) and HEADACHE (headache). On 28-Mar-2021, the patient experienced PYREXIA (temperature of 100.5F). On 29-Mar-2021, the patient experienced FATIGUE (little bit tired). The patient was treated with PARACETAMOL (TYLENOL) on 27-Mar-2021 at a dose of 3 dosage form and NAPROXEN on 28-Mar-2021 at a dose of 220 milligram. On 28-Mar-2021, CHILLS (chills) and PYREXIA (temperature of 100.5F) had resolved. On 29-Mar-2021, PAIN (body aches), ARTHRALGIA (joint aches) and HEADACHE (headache) had resolved. At the time of the report, LETHARGY (lethargic), COUGH (cough) and FATIGUE (little bit tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Mar-2021, Body temperature: 100.5f (High) 100.5F Temperature.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-060992 (Patient Link).
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Lethargy, Pain, Pyrexia
Clinical narrative: little bit tired; temperature of 100.5F; headache; joint aches; chills; lethargic; cough; body aches; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (lethargic), COUGH (cough), PAIN (body aches), FATIGUE (little bit tired) and ARTHRALGIA (joint aches) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History Information was reported.  Concomitant products included FAMCICLOVIR, LOSARTAN, ATORVASTATIN, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), MULTIVITAMINS [VITAMINS NOS] and VITAMIN D3 for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced LETHARGY (lethargic), COUGH (cough), PAIN (body aches), ARTHRALGIA (joint aches), CHILLS (chills) and HEADACHE (headache). On 28-Mar-2021, the patient experienced PYREXIA (temperature of 100.5F). On 29-Mar-2021, the patient experienced FATIGUE (little bit tired). The patient was treated with PARACETAMOL (TYLENOL) on 27-Mar-2021 at a dose of 3 dosage form and NAPROXEN on 28-Mar-2021 at a dose of 220 milligram. On 28-Mar-2021, CHILLS (chills) and PYREXIA (temperature of 100.5F) had resolved. On 29-Mar-2021, PAIN (body aches), ARTHRALGIA (joint aches) and HEADACHE (headache) had resolved. At the time of the report, LETHARGY (lethargic), COUGH (cough) and FATIGUE (little bit tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Mar-2021, Body temperature: 100.5f (High) 100.5F Temperature.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-060992 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Limb injury
Clinical narrative: Finger Injury; This spontaneous case was reported by a consumer and describes the occurrence of LIMB INJURY (Finger Injury) 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 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced LIMB INJURY (Finger Injury). At the time of the report, LIMB INJURY (Finger Injury) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment drugs were not provided concomitant drugs were not provided
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pruritus, Vaccination site rash, Varicose vein
Clinical narrative: Rash this time the size of a soft ball; varicose vein like discoloration; Slightly more pain; Itch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash this time the size of a soft ball), PRURITUS (Itch), VARICOSE VEIN (varicose vein like discoloration) and PAIN (Slightly more pain) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cardiac disorder NOS (Since 10-NOV ) and Unspecified functional disorder of stomach since 01-Jun-2021. Concomitant products included METOPROLOL for Heart disorder, SACUBITRIL VALSARTAN SODIUM HYDRATE (ENTRESTO), LEVOTHYROXINE SODIUM (SYNTHROID), SPIRONOLACTONE (ALDACTONE [SPIRONOLACTONE]) and FAMOTIDINE (PEPCID [FAMOTIDINE]) for an unknown indication.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (Rash this time the size of a soft ball), PRURITUS (Itch), VARICOSE VEIN (varicose vein like discoloration) and PAIN (Slightly more pain). At the time of the report, VACCINATION SITE RASH (Rash this time the size of a soft ball), PRURITUS (Itch) and VARICOSE VEIN (varicose vein like discoloration) had not resolved and PAIN (Slightly more pain) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered PRURITUS (Itch) to be possibly related. No further causality assessments were provided for VACCINATION SITE RASH (Rash this time the size of a soft ball), VARICOSE VEIN (varicose vein like discoloration) and PAIN (Slightly more pain).    Patient reported history of back and knees. Concomitant medication was provided as Blood thinners. No treatment information is provided.   This case was linked to MOD-2021-067280 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow up received on 15-Jul-2021 contains Patient demographics, Concomitant drugs, New events, duration and outcome were added. Reporter causality and event outcomes were updated
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Exposure to SARS-CoV-2
Clinical narrative: tested positive; exposed to covid; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE TO SARS-COV-2 (exposed to covid) and COVID-19 (tested positive) 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 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced EXPOSURE TO SARS-COV-2 (exposed to covid). On 22-Mar-2021, the patient experienced COVID-19 (tested positive). At the time of the report, EXPOSURE TO SARS-COV-2 (exposed to covid) and COVID-19 (tested positive) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue
Clinical narrative: Chills without fever; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills without fever) and FATIGUE (Tiredness) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 011A21A) for COVID-19 vaccination.     No Medical History Information was reported.  Concomitant products included FAMOTIDINE, AMLODIPINE, HYDROCHLOROTHIAZIDE, LISINOPRIL, ATENOLOL, VITAMIN B3, SIMVASTATIN and MIRTAZAPINE for an unknown indication.   On 25-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced CHILLS (Chills without fever) and FATIGUE (Tiredness). At the time of the report, CHILLS (Chills without fever) and FATIGUE (Tiredness) was resolving.            No treatment medications were reported.  Action taken with mRNA-1273 in response to the event was not applicable.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Feeling hot, Nasopharyngitis, SARS-CoV-2 test
Clinical narrative: lost her taste; she felt cold inside; got really hot while in bed; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (lost her taste), NASOPHARYNGITIS (she felt cold inside) and FEELING HOT (got really hot while in bed) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006A21A and 014M20A) 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-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced NASOPHARYNGITIS (she felt cold inside) and FEELING HOT (got really hot while in bed). On an unknown date, the patient experienced AGEUSIA (lost her taste). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and IBUPROFEN at a dose of 1 dosage form. On 26-Mar-2021, NASOPHARYNGITIS (she felt cold inside) and FEELING HOT (got really hot while in bed) had resolved. At the time of the report, AGEUSIA (lost her taste) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, SARS-CoV-2 test: positive (Positive) Positive.         No relevant concomitant medications were reported.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.   This case was linked to MOD-2021-060880 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Heart rate, Influenza like illness, Oxygen saturation, Tinnitus
Clinical narrative: ringing in her ears; flu-like symptoms; tired; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (ringing in her ears), INFLUENZA LIKE ILLNESS (flu-like symptoms) and FATIGUE (tired) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 016M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced TINNITUS (ringing in her ears), INFLUENZA LIKE ILLNESS (flu-like symptoms) and FATIGUE (tired). On 12-Mar-2021, INFLUENZA LIKE ILLNESS (flu-like symptoms) had resolved. At the time of the report, TINNITUS (ringing in her ears) and FATIGUE (tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, Heart rate: 117 bpm (Inconclusive) 117 bpm for 24 Hours. On 10-Mar-2021, Oxygen saturation: 93 % (Low) 93%.         For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.  No concomitant medications were reported. No treatment medications were reported.  Action taken with mRNA-1273 in response to the event was not applicable.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pain, Pain in extremity
Clinical narrative: Body aches; Injected arm became sore; Chills; Headache; Fever to 101.7 F; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), PAIN IN EXTREMITY (Injected arm became sore), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever to 101.7 F) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History Information was reported.  Concomitant products included DOXYCYCLINE for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN (Body aches), PAIN IN EXTREMITY (Injected arm became sore), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever to 101.7 F). At the time of the report, PAIN (Body aches), PAIN IN EXTREMITY (Injected arm became sore), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever to 101.7 F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Mar-2021, Body temperature: 101.7 f (High) 101.7 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.  No treatment medications were reported.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Body aches; Injected arm became sore; Chills; Headache; Fever to 101.7 F; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), PAIN IN EXTREMITY (Injected arm became sore), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever to 101.7 F) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History Information was reported.  Concomitant products included DOXYCYCLINE for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN (Body aches), PAIN IN EXTREMITY (Injected arm became sore), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever to 101.7 F). At the time of the report, PAIN (Body aches), PAIN IN EXTREMITY (Injected arm became sore), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever to 101.7 F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Mar-2021, Body temperature: 101.7 f (High) 101.7 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.  No treatment medications were reported.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Dyskinesia, Nausea, Pyrexia
Clinical narrative: Sore arm; Fever 101; Chills; Shivering; A bit nauseous; Shaking; kid of jerking; Stomachache; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaking), ABDOMINAL PAIN UPPER (Stomachache), DYSKINESIA (kid of jerking), VACCINATION SITE PAIN (Sore arm) and PYREXIA (Fever 101) in a 71-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 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomachache). On 29-Mar-2021, the patient experienced TREMOR (Shaking), DYSKINESIA (kid of jerking), PYREXIA (Fever 101), CHILLS (Chills), CHILLS (Shivering) and NAUSEA (A bit nauseous). On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore arm). At the time of the report, TREMOR (Shaking), ABDOMINAL PAIN UPPER (Stomachache), DYSKINESIA (kid of jerking), VACCINATION SITE PAIN (Sore arm), PYREXIA (Fever 101), CHILLS (Chills), CHILLS (Shivering) and NAUSEA (A bit nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter Treatment information was not provided by the reporter   Most recent FOLLOW-UP information incorporated above includes: On 26-Jun-2021: Follow-up information received on 26-JUN-2021.Updated new AE sore arm.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor, Vaccination site pain
Clinical narrative: Sore arm; Fever 101; Chills; Shivering; A bit nauseous; Shaking; kid of jerking; Stomachache; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaking), ABDOMINAL PAIN UPPER (Stomachache), DYSKINESIA (kid of jerking), VACCINATION SITE PAIN (Sore arm) and PYREXIA (Fever 101) in a 71-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 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomachache). On 29-Mar-2021, the patient experienced TREMOR (Shaking), DYSKINESIA (kid of jerking), PYREXIA (Fever 101), CHILLS (Chills), CHILLS (Shivering) and NAUSEA (A bit nauseous). On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore arm). At the time of the report, TREMOR (Shaking), ABDOMINAL PAIN UPPER (Stomachache), DYSKINESIA (kid of jerking), VACCINATION SITE PAIN (Sore arm), PYREXIA (Fever 101), CHILLS (Chills), CHILLS (Shivering) and NAUSEA (A bit nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter Treatment information was not provided by the reporter   Most recent FOLLOW-UP information incorporated above includes: On 26-Jun-2021: Follow-up information received on 26-JUN-2021.Updated new AE sore arm.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: little sore arm for first dose//couldn't even raise arm, could not use arm for 1 to 2 weeks; little headache for first dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (little sore arm for first dose//couldn't even raise arm, could not use arm for 1 to 2 weeks) and HEADACHE (little headache for first dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006821A) for COVID-19 vaccination.     Concurrent medical conditions included Breast cancer.   On 26-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (little sore arm for first dose//couldn't even raise arm, could not use arm for 1 to 2 weeks) and HEADACHE (little headache for first dose). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, PAIN IN EXTREMITY (little sore arm for first dose//couldn't even raise arm, could not use arm for 1 to 2 weeks) and HEADACHE (little headache for first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications was provided by the reporter.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Feeling abnormal, Headache, Incoherent
Clinical narrative: Headache; incoherent; shaking from head to toe; lightheaded; She was totally out of it; nausea; Fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of INCOHERENT (incoherent), TREMOR (shaking from head to toe), DIZZINESS (lightheaded), FEELING ABNORMAL (She was totally out of it) and NAUSEA (nausea) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (No symptoms.) on 07-Apr-2020. Concurrent medical conditions included Chronic back pain since 1985 and High cholesterol since 2016. Concomitant products included OXYCODONE and GABAPENTIN for Back pain, SERTRALINE for Depression, SIMVASTATIN for High cholesterol, VITAMIN D3, FISH OIL and IRON for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced INCOHERENT (incoherent), TREMOR (shaking from head to toe), DIZZINESS (lightheaded), FEELING ABNORMAL (She was totally out of it), NAUSEA (nausea), PYREXIA (Fever) and CHILLS (chills). On an unknown date, the patient experienced HEADACHE (Headache). On 03-Mar-2021, INCOHERENT (incoherent), TREMOR (shaking from head to toe), DIZZINESS (lightheaded) and HEADACHE (Headache) had resolved. At the time of the report, FEELING ABNORMAL (She was totally out of it), NAUSEA (nausea), PYREXIA (Fever) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No treatment medications were provided. COVID-19 Test- Q-TIP up nose (No symptoms);Tested Positive.   This case was linked to MOD-2021-262720 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow-up information contains new event  information- Headache. New event outcome-Recovered for-Dizzy, Headache, Shaking, Incoherent.New medical history- COVID-19, Chronic back pain,  High cholesterol.Contains new product information-2nd dose information, Concomitant drugs, Contains updated patient demographics.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Tremor
Clinical narrative: Headache; incoherent; shaking from head to toe; lightheaded; She was totally out of it; nausea; Fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of INCOHERENT (incoherent), TREMOR (shaking from head to toe), DIZZINESS (lightheaded), FEELING ABNORMAL (She was totally out of it) and NAUSEA (nausea) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (No symptoms.) on 07-Apr-2020. Concurrent medical conditions included Chronic back pain since 1985 and High cholesterol since 2016. Concomitant products included OXYCODONE and GABAPENTIN for Back pain, SERTRALINE for Depression, SIMVASTATIN for High cholesterol, VITAMIN D3, FISH OIL and IRON for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced INCOHERENT (incoherent), TREMOR (shaking from head to toe), DIZZINESS (lightheaded), FEELING ABNORMAL (She was totally out of it), NAUSEA (nausea), PYREXIA (Fever) and CHILLS (chills). On an unknown date, the patient experienced HEADACHE (Headache). On 03-Mar-2021, INCOHERENT (incoherent), TREMOR (shaking from head to toe), DIZZINESS (lightheaded) and HEADACHE (Headache) had resolved. At the time of the report, FEELING ABNORMAL (She was totally out of it), NAUSEA (nausea), PYREXIA (Fever) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No treatment medications were provided. COVID-19 Test- Q-TIP up nose (No symptoms);Tested Positive.   This case was linked to MOD-2021-262720 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow-up information contains new event  information- Headache. New event outcome-Recovered for-Dizzy, Headache, Shaking, Incoherent.New medical history- COVID-19, Chronic back pain,  High cholesterol.Contains new product information-2nd dose information, Concomitant drugs, Contains updated patient demographics.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Rash
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of peripheral swelling  (swollen arm) and rash (rash across arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 044A21A) for COVID-19 immunization. No medical history reported. On Mar 12, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 12, 2021, patient experienced peripheral swelling (swollen arm) and rash (rash across arm). At the time of the report, peripheral swelling (swollen arm) and rash (rash across arm) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. Concomitant products included thyroid medication. Treatment medications included itch cream.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Sore arm; Tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and FATIGUE (Tired) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     Concomitant products included DILTIAZEM HYDROCHLORIDE (CARDIZEM CD) for an unknown indication.    On 19-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and FATIGUE (Tired). At the time of the report, PAIN IN EXTREMITY (Sore arm) and FATIGUE (Tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment details were not provided.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Scab
Clinical narrative: Major itching/ horrific itching -left arm, feet and arm pit - worse on her head; Scabs on her head because of the itching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Major itching/ horrific itching -left arm, feet and arm pit - worse on her head) and SCAB (Scabs on her head because of the itching) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 03M20A and 018A21A) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 24-Feb-2021, the patient experienced PRURITUS (Major itching/ horrific itching -left arm, feet and arm pit - worse on her head) and SCAB (Scabs on her head because of the itching). At the time of the report, PRURITUS (Major itching/ horrific itching -left arm, feet and arm pit - worse on her head) and SCAB (Scabs on her head because of the itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment details were not provided.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Pyrexia
Clinical narrative: thinks she has covid/experiencing covid symptoms; may have fever; couldn't taste mint; couldn't smell Vicks; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (thinks she has covid/experiencing covid symptoms), AGEUSIA (couldn't taste mint), ANOSMIA (couldn't smell Vicks) and PYREXIA (may have fever) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     Concurrent medical conditions included Breast cancer (On her right side), Sinus disorder NOS (sinus drainage), Cough, Allergy (The patient had bad allergies) and Runny nose.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced AGEUSIA (couldn't taste mint) and ANOSMIA (couldn't smell Vicks). On an unknown date, the patient experienced COVID-19 (thinks she has covid/experiencing covid symptoms) and PYREXIA (may have fever). At the time of the report, COVID-19 (thinks she has covid/experiencing covid symptoms), AGEUSIA (couldn't taste mint), ANOSMIA (couldn't smell Vicks) and PYREXIA (may have fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment details were not provided.   The patient did not get tested for Covid-19
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature decreased, Dyspnoea, Insomnia, Limb discomfort
Clinical narrative: unable to sleep; severe decrease of body temperature; Shortness of breath and difficulty breathing; heart was racing; could not move arm, felt like it was broken; Legs wobbly; no strength in legs for three days/ weak legs; This spontaneous case was reported by an other health care professional and describes the occurrence of DYSPNOEA (Shortness of breath and difficulty breathing), PALPITATIONS (heart was racing), INSOMNIA (unable to sleep), BODY TEMPERATURE DECREASED (severe decrease of body temperature) and TREMOR (Legs wobbly) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Nodule on extremity. Concurrent medical conditions included Blood pressure increased (high blood pressure) and Nasal cavity mass. Concomitant products included VITAMIN D3 for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced DYSPNOEA (Shortness of breath and difficulty breathing), PALPITATIONS (heart was racing) and LIMB DISCOMFORT (could not move arm, felt like it was broken). On an unknown date, the patient experienced INSOMNIA (unable to sleep), BODY TEMPERATURE DECREASED (severe decrease of body temperature), TREMOR (Legs wobbly) and MUSCULAR WEAKNESS (no strength in legs for three days/ weak legs). At the time of the report, DYSPNOEA (Shortness of breath and difficulty breathing), INSOMNIA (unable to sleep), BODY TEMPERATURE DECREASED (severe decrease of body temperature) and LIMB DISCOMFORT (could not move arm, felt like it was broken) outcome was unknown and PALPITATIONS (heart was racing), TREMOR (Legs wobbly) and MUSCULAR WEAKNESS (no strength in legs for three days/ weak legs) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: decreased (Low) decreased.     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.   Concomitant medications were not provided. No treatment information was provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Palpitations, Tremor
Clinical narrative: unable to sleep; severe decrease of body temperature; Shortness of breath and difficulty breathing; heart was racing; could not move arm, felt like it was broken; Legs wobbly; no strength in legs for three days/ weak legs; This spontaneous case was reported by an other health care professional and describes the occurrence of DYSPNOEA (Shortness of breath and difficulty breathing), PALPITATIONS (heart was racing), INSOMNIA (unable to sleep), BODY TEMPERATURE DECREASED (severe decrease of body temperature) and TREMOR (Legs wobbly) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Nodule on extremity. Concurrent medical conditions included Blood pressure increased (high blood pressure) and Nasal cavity mass. Concomitant products included VITAMIN D3 for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced DYSPNOEA (Shortness of breath and difficulty breathing), PALPITATIONS (heart was racing) and LIMB DISCOMFORT (could not move arm, felt like it was broken). On an unknown date, the patient experienced INSOMNIA (unable to sleep), BODY TEMPERATURE DECREASED (severe decrease of body temperature), TREMOR (Legs wobbly) and MUSCULAR WEAKNESS (no strength in legs for three days/ weak legs). At the time of the report, DYSPNOEA (Shortness of breath and difficulty breathing), INSOMNIA (unable to sleep), BODY TEMPERATURE DECREASED (severe decrease of body temperature) and LIMB DISCOMFORT (could not move arm, felt like it was broken) outcome was unknown and PALPITATIONS (heart was racing), TREMOR (Legs wobbly) and MUSCULAR WEAKNESS (no strength in legs for three days/ weak legs) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: decreased (Low) decreased.     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.   Concomitant medications were not provided. No treatment information was provided.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: Needle disconnected from syringe and 0.1-0.15 ml dripped down patient arm; Needle disconnected from syringe and 0.1-0.15 ml dripped down patient arm; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Needle disconnected from syringe and 0.1-0.15 ml dripped down patient arm) and DEVICE CONNECTION ISSUE (Needle disconnected from syringe and 0.1-0.15 ml dripped down patient arm) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced UNDERDOSE (Needle disconnected from syringe and 0.1-0.15 ml dripped down patient arm) and DEVICE CONNECTION ISSUE (Needle disconnected from syringe and 0.1-0.15 ml dripped down patient arm). On 28-Mar-2021, UNDERDOSE (Needle disconnected from syringe and 0.1-0.15 ml dripped down patient arm) and DEVICE CONNECTION ISSUE (Needle disconnected from syringe and 0.1-0.15 ml dripped down patient arm) 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.   Concomitant product use was not provided. No treatment information was provided.   This case was linked to MOD-2021-060889 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swollen lymph node on top of her clavicle; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (swollen lymph node on top of her clavicle) 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 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced LYMPHADENOPATHY (swollen lymph node on top of her clavicle). At the time of the report, LYMPHADENOPATHY (swollen lymph node on top of her clavicle) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications are not provided.  No treatment information was provided.