chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Profuse night sweat; Neck muscle ache; Sore arm; muscle ache; Fever 102; Headache; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (Profuse night sweat), NECK PAIN (Neck muscle ache), PAIN IN EXTREMITY (Sore arm), MYALGIA (muscle ache) and PYREXIA (Fever 102) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Apr-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 NIGHT SWEATS (Profuse night sweat), NECK PAIN (Neck muscle ache), PAIN IN EXTREMITY (Sore arm), MYALGIA (muscle ache), PYREXIA (Fever 102) and HEADACHE (Headache). At the time of the report, NIGHT SWEATS (Profuse night sweat), NECK PAIN (Neck muscle ache), PAIN IN EXTREMITY (Sore arm), MYALGIA (muscle ache), PYREXIA (Fever 102) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) 102.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided Treatment for the events were not provided
Age: 16.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: invalid dose: pediatric use; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (invalid dose: pediatric use) in a 16-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (invalid dose: pediatric use). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (invalid dose: pediatric use) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Pharmacist called to ask if the patient should receive the second shot and if they can should it still be 0.5ml. No concomitant medications are provided. Treatment to the events not reported.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Inappropriate schedule of product administration, Vaccination site pain
Clinical narrative: second dose's being delayed due to her reported symptoms; sore right arm at the injection site; weirdly tired; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose's being delayed due to her reported symptoms), VACCINATION SITE PAIN (sore right arm at the injection site) and FATIGUE (weirdly tired) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   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) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced VACCINATION SITE PAIN (sore right arm at the injection site) and FATIGUE (weirdly tired). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose's being delayed due to her reported symptoms). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose's being delayed due to her reported symptoms) had resolved, VACCINATION SITE PAIN (sore right arm at the injection site) was resolving and FATIGUE (weirdly tired) outcome was unknown. Not Provided          No treatment medications were provided. No concomitant medications were provided.   This case was linked to MOD-2021-017063 (Patient Link).
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Feeling of body temperature change, Gait disturbance, Headache
Clinical narrative: Bruising around her injection site right arm; Feels hot and cold; Dizziness; Trouble walking because of dizziness; Feel unwell; Redness qround injection site; Tiredness; Occasional headaches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Bruising around her injection site right arm), FEELING OF BODY TEMPERATURE CHANGE (Feels hot and cold), DIZZINESS (Dizziness), GAIT DISTURBANCE (Trouble walking because of dizziness) and MALAISE (Feel unwell) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-May-2021, the patient experienced VACCINATION SITE BRUISING (Bruising around her injection site right arm), FEELING OF BODY TEMPERATURE CHANGE (Feels hot and cold), DIZZINESS (Dizziness), GAIT DISTURBANCE (Trouble walking because of dizziness), MALAISE (Feel unwell), INJECTION SITE ERYTHEMA (Redness qround injection site), FATIGUE (Tiredness) and HEADACHE (Occasional headaches). At the time of the report, VACCINATION SITE BRUISING (Bruising around her injection site right arm), FEELING OF BODY TEMPERATURE CHANGE (Feels hot and cold), DIZZINESS (Dizziness), GAIT DISTURBANCE (Trouble walking because of dizziness), MALAISE (Feel unwell), INJECTION SITE ERYTHEMA (Redness qround injection site), FATIGUE (Tiredness) and HEADACHE (Occasional headaches) had resolved.            No concomitant and treatment medication was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events was not applicable.   This case was linked to MOD-2021-138787 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Added reporter information.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Malaise, Vaccination site bruising
Clinical narrative: Bruising around her injection site right arm; Feels hot and cold; Dizziness; Trouble walking because of dizziness; Feel unwell; Redness qround injection site; Tiredness; Occasional headaches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Bruising around her injection site right arm), FEELING OF BODY TEMPERATURE CHANGE (Feels hot and cold), DIZZINESS (Dizziness), GAIT DISTURBANCE (Trouble walking because of dizziness) and MALAISE (Feel unwell) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-May-2021, the patient experienced VACCINATION SITE BRUISING (Bruising around her injection site right arm), FEELING OF BODY TEMPERATURE CHANGE (Feels hot and cold), DIZZINESS (Dizziness), GAIT DISTURBANCE (Trouble walking because of dizziness), MALAISE (Feel unwell), INJECTION SITE ERYTHEMA (Redness qround injection site), FATIGUE (Tiredness) and HEADACHE (Occasional headaches). At the time of the report, VACCINATION SITE BRUISING (Bruising around her injection site right arm), FEELING OF BODY TEMPERATURE CHANGE (Feels hot and cold), DIZZINESS (Dizziness), GAIT DISTURBANCE (Trouble walking because of dizziness), MALAISE (Feel unwell), INJECTION SITE ERYTHEMA (Redness qround injection site), FATIGUE (Tiredness) and HEADACHE (Occasional headaches) had resolved.            No concomitant and treatment medication was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events was not applicable.   This case was linked to MOD-2021-138787 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Added reporter information.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Sore arm; Felt tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Felt tired) and PAIN IN EXTREMITY (Sore arm) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METOPROLOL TARTRATE (METOPROLOL TARTRATE ACCORD).    On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Felt tired) and PAIN IN EXTREMITY (Sore arm). At the time of the report, FATIGUE (Felt tired) and PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-138731 (Patient Link).
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Vaccination site pain
Clinical narrative: Received Expired Vaccine (>12 hours in room temperature); little sore arm; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Vaccine (>12 hours in room temperature)) and VACCINATION SITE PAIN (little sore arm) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017C21A and 017C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 14-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Vaccine (>12 hours in room temperature)) and VACCINATION SITE PAIN (little sore arm). On 14-May-2021, EXPIRED PRODUCT ADMINISTERED (Received Expired Vaccine (>12 hours in room temperature)) had resolved. At the time of the report, VACCINATION SITE PAIN (little sore arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were reported   This case was linked to US-MODERNATX, INC.-MOD-2021-138841 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Significant Follow Up- 2nd reporter details updated and 2nd dose date; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-138841:
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: itchiness and weals all over body; little weal; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (little weal) and PRURITUS (itchiness and weals all over body) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, the patient experienced URTICARIA (little weal). On 15-May-2021, the patient experienced PRURITUS (itchiness and weals all over body). The patient was treated with CORTISONE (topical) on 14-May-2021 for Urticaria, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 15-May-2021 for Itching all over, at an unspecified dose and frequency. At the time of the report, URTICARIA (little weal) and PRURITUS (itchiness and weals all over body) outcome was unknown.            No concomitant medication information was reported. Patient received her first dose of Moderna Covid-19 vaccine either on 27-Mar-2021 or 27-Apr-2021 (patient got confused and did not make clear which month). Second dose was administered on 14-May-2021. Patient observed a little weal 3 hours after getting the second dose and applied topical cortisone At 3AM of 15-May-2021 patient woke up with itchiness and weal all over her body (arms, legs, stomach). Patient has taken Benadryl to treat symptoms.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: First dose after vaccine was open in refrigerator over 12 hour expiration time; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (First dose after vaccine was open in refrigerator over 12 hour expiration time) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 14-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (First dose after vaccine was open in refrigerator over 12 hour expiration time). On 14-May-2021, EXPIRED PRODUCT ADMINISTERED (First dose after vaccine was open in refrigerator over 12 hour expiration time) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: sore injection site shoulder; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (sore injection site shoulder) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (sore injection site shoulder). At the time of the report, ARTHRALGIA (sore injection site shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not provided.   This case was linked to MOD-2021-138767 (Patient Link).
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 years of age received 1st dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years of age received 1st dose) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B212A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years of age received 1st dose). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years of age received 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter. Treatment medication not reported.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: Left shoulder kind of itchy near an older BCG vaccine scar; Left shoulder looks like she got a mosquito bite; Left shoulder redness near an older BCG vaccine scar; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Left shoulder redness near an older BCG vaccine scar), PRURITUS (Left shoulder kind of itchy near an older BCG vaccine scar) and ERYTHEMA (Left shoulder looks like she got a mosquito bite) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: BCG VACCINE AJV.   On 11-May-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 11-May-2021, the patient experienced ERYTHEMA (Left shoulder redness near an older BCG vaccine scar). On 17-May-2021, the patient experienced PRURITUS (Left shoulder kind of itchy near an older BCG vaccine scar) and ERYTHEMA (Left shoulder looks like she got a mosquito bite). At the time of the report, ERYTHEMA (Left shoulder redness near an older BCG vaccine scar), PRURITUS (Left shoulder kind of itchy near an older BCG vaccine scar) and ERYTHEMA (Left shoulder looks like she got a mosquito bite) outcome was unknown.            No concomitant products were reported. No treatment information was provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza, Myalgia, Palpitations
Clinical narrative: Fluish; Felt achy; Heart palpitations/I still have palpitations; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart palpitations/I still have palpitations), INFLUENZA (Fluish) and MYALGIA (Felt achy) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (sulfa, iodine, flagyl, Macrobid, Levaquin, dalandid, cipro, percocet) and Fibromyalgia since 1990. Concomitant products included MONTELUKAST SODIUM (SINGULAIR) for Allergy, PRAVASTATIN for Cholesterol, AMITRIPTYLINE for Fibromyalgia, VITAMIN D NOS for Palpitations, BIFIDOBACTERIUM INFANTIS (ALIGN) for an unknown indication.   On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Jan-2021, the patient experienced PALPITATIONS (Heart palpitations/I still have palpitations). On an unknown date, the patient experienced INFLUENZA (Fluish) and MYALGIA (Felt achy). The patient was treated with METOPROLOL TARTRATE for Palpitations, at a dose of 12.5 mg. At the time of the report, PALPITATIONS (Heart palpitations/I still have palpitations) was resolving and INFLUENZA (Fluish) and MYALGIA (Felt achy) outcome was unknown.            This case was linked to MOD21-091293 (E2B Linked Report). This case was linked to MOD-2021-138697 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jun-2021: Follow-up information received on 19-JUN-2021. Added patient medical history and concomitant medications.; Sender's Comments:  MOD21-091293:Husband's Case
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Rash
Clinical narrative: Burning rash behind the knee on both of her legs; Burning rash behind the knee on both of her legs; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Burning rash behind the knee on both of her legs) and RASH (Burning rash behind the knee on both of her legs) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced RASH (Burning rash behind the knee on both of her legs). On an unknown date, the patient experienced BURNING SENSATION (Burning rash behind the knee on both of her legs). At the time of the report, BURNING SENSATION (Burning rash behind the knee on both of her legs) and RASH (Burning rash behind the knee on both of her legs) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-137607 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-137607:Same reporter
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Dyspepsia, Eructation, Myalgia
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN (Aches), ERUCTATION (Burping), DYSPEPSIA (Indigestion), ABDOMINAL DISCOMFORT (When driving got an upset stomach) and SNEEZING (Sneezing) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Thyroidectomy in 1981. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroidectomy, ESOMEPRAZOLE MAGNESIUM (NEXIUM [ESOMEPRAZOLE MAGNESIUM]) for an unknown indication. On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced PAIN (Aches), ERUCTATION (Burping), DYSPEPSIA (Indigestion), ABDOMINAL DISCOMFORT (When driving got an upset stomach), SNEEZING (Sneezing), PYREXIA (Fever) and CHILLS (Felt chills). On 31-Jan-2021, the patient experienced PRODUCTIVE COUGH (Coughing up stuff). At the time of the report, PAIN (Aches), ERUCTATION (Burping), DYSPEPSIA (Indigestion), ABDOMINAL DISCOMFORT (When driving got an upset stomach), SNEEZING (Sneezing), PRODUCTIVE COUGH (Coughing up stuff), PYREXIA (Fever) and CHILLS (Felt chills) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Other concomitant medication included: 2.5 mg Steroid. It was reported that after the first dose on 27Jan2021, patient had fever, aches that lasted a couple days then felt better, then days later felt crappy and contacted primary care to consult on if she should get the second dose. After both doses she experienced burping, indigestion and when driving got an upset stomach. Then she felt sick to her stomach but was not vomiting and had a fever with a high of 102-103 degrees Fahrenheit and then had a normal low grade fever and stared sneezing. she felt like this for four days then then stared coughing up stuff and felt chills and had to wrap herself in quilt. No treatment information provided. This case was linked to MOD21-091277, US-MODERNATX, INC.-MOD-2021-138791, US-MODERNATX, INC.-MOD-2021-138805 (E2B Linked Report).; Sender's Comments: MOD21-091277: US-MODERNATX, INC.-MOD-2021-138805: US-MODERNATX, INC.-MOD-2021-138791:
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Productive cough, Pyrexia, Sneezing
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN (Aches), ERUCTATION (Burping), DYSPEPSIA (Indigestion), ABDOMINAL DISCOMFORT (When driving got an upset stomach) and SNEEZING (Sneezing) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Thyroidectomy in 1981. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroidectomy, ESOMEPRAZOLE MAGNESIUM (NEXIUM [ESOMEPRAZOLE MAGNESIUM]) for an unknown indication. On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced PAIN (Aches), ERUCTATION (Burping), DYSPEPSIA (Indigestion), ABDOMINAL DISCOMFORT (When driving got an upset stomach), SNEEZING (Sneezing), PYREXIA (Fever) and CHILLS (Felt chills). On 31-Jan-2021, the patient experienced PRODUCTIVE COUGH (Coughing up stuff). At the time of the report, PAIN (Aches), ERUCTATION (Burping), DYSPEPSIA (Indigestion), ABDOMINAL DISCOMFORT (When driving got an upset stomach), SNEEZING (Sneezing), PRODUCTIVE COUGH (Coughing up stuff), PYREXIA (Fever) and CHILLS (Felt chills) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Other concomitant medication included: 2.5 mg Steroid. It was reported that after the first dose on 27Jan2021, patient had fever, aches that lasted a couple days then felt better, then days later felt crappy and contacted primary care to consult on if she should get the second dose. After both doses she experienced burping, indigestion and when driving got an upset stomach. Then she felt sick to her stomach but was not vomiting and had a fever with a high of 102-103 degrees Fahrenheit and then had a normal low grade fever and stared sneezing. she felt like this for four days then then stared coughing up stuff and felt chills and had to wrap herself in quilt. No treatment information provided. This case was linked to MOD21-091277, US-MODERNATX, INC.-MOD-2021-138791, US-MODERNATX, INC.-MOD-2021-138805 (E2B Linked Report).; Sender's Comments: MOD21-091277: US-MODERNATX, INC.-MOD-2021-138805: US-MODERNATX, INC.-MOD-2021-138791:
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Insomnia
Clinical narrative: "felt really bad"; "didn't sleep well that evening"; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL ("felt really bad") and INSOMNIA ("didn't sleep well that evening") in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Psoriasis. Concomitant products included USTEKINUMAB (STELERA) for Psoriasis.   On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-May-2021, the patient experienced FEELING ABNORMAL ("felt really bad") and INSOMNIA ("didn't sleep well that evening"). The patient was treated with IBUPROFEN at a dose of 1 dosage form. On 09-May-2021, FEELING ABNORMAL ("felt really bad") and INSOMNIA ("didn't sleep well that evening") had resolved.            Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: TCR Attached ,Event outcome is updated
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Dizziness, Erythema
Clinical narrative: Fever; Swelling on arm; Redness of arm; Weakness; Light headedness; Night sweats; No quality of life; Chills; Muscle pain; Extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling on arm), ERYTHEMA (Redness of arm), ASTHENIA (Weakness), DIZZINESS (Light headedness) and NIGHT SWEATS (Night sweats) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.  Concomitant products included LEVOTHYROXINE and HYDROCODONE for an unknown indication.   On 25-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 25-Mar-2021, the patient experienced PERIPHERAL SWELLING (Swelling on arm), ERYTHEMA (Redness of arm), ASTHENIA (Weakness), DIZZINESS (Light headedness), NIGHT SWEATS (Night sweats), QUALITY OF LIFE DECREASED (No quality of life), CHILLS (Chills), MYALGIA (Muscle pain) and FATIGUE (Extreme fatigue). On 11-May-2021, the patient experienced PYREXIA (Fever). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (Swelling on arm), ERYTHEMA (Redness of arm), ASTHENIA (Weakness), DIZZINESS (Light headedness), NIGHT SWEATS (Night sweats), QUALITY OF LIFE DECREASED (No quality of life), CHILLS (Chills), MYALGIA (Muscle pain) and FATIGUE (Extreme fatigue) had not resolved and PYREXIA (Fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-May-2021, Body temperature: 100.2 (High) 100.2F. On an unknown date, SARS-CoV-2 test: unknown (Negative) unknown.         Action taken with mRNA-1273 in response to the events was not applicable.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Follow-up information received: No new information
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Night sweats, Peripheral swelling, Pyrexia
Clinical narrative: Fever; Swelling on arm; Redness of arm; Weakness; Light headedness; Night sweats; No quality of life; Chills; Muscle pain; Extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling on arm), ERYTHEMA (Redness of arm), ASTHENIA (Weakness), DIZZINESS (Light headedness) and NIGHT SWEATS (Night sweats) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.  Concomitant products included LEVOTHYROXINE and HYDROCODONE for an unknown indication.   On 25-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 25-Mar-2021, the patient experienced PERIPHERAL SWELLING (Swelling on arm), ERYTHEMA (Redness of arm), ASTHENIA (Weakness), DIZZINESS (Light headedness), NIGHT SWEATS (Night sweats), QUALITY OF LIFE DECREASED (No quality of life), CHILLS (Chills), MYALGIA (Muscle pain) and FATIGUE (Extreme fatigue). On 11-May-2021, the patient experienced PYREXIA (Fever). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (Swelling on arm), ERYTHEMA (Redness of arm), ASTHENIA (Weakness), DIZZINESS (Light headedness), NIGHT SWEATS (Night sweats), QUALITY OF LIFE DECREASED (No quality of life), CHILLS (Chills), MYALGIA (Muscle pain) and FATIGUE (Extreme fatigue) had not resolved and PYREXIA (Fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-May-2021, Body temperature: 100.2 (High) 100.2F. On an unknown date, SARS-CoV-2 test: unknown (Negative) unknown.         Action taken with mRNA-1273 in response to the events was not applicable.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Follow-up information received: No new information
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Quality of life decreased, SARS-CoV-2 test
Clinical narrative: Fever; Swelling on arm; Redness of arm; Weakness; Light headedness; Night sweats; No quality of life; Chills; Muscle pain; Extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling on arm), ERYTHEMA (Redness of arm), ASTHENIA (Weakness), DIZZINESS (Light headedness) and NIGHT SWEATS (Night sweats) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.  Concomitant products included LEVOTHYROXINE and HYDROCODONE for an unknown indication.   On 25-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 25-Mar-2021, the patient experienced PERIPHERAL SWELLING (Swelling on arm), ERYTHEMA (Redness of arm), ASTHENIA (Weakness), DIZZINESS (Light headedness), NIGHT SWEATS (Night sweats), QUALITY OF LIFE DECREASED (No quality of life), CHILLS (Chills), MYALGIA (Muscle pain) and FATIGUE (Extreme fatigue). On 11-May-2021, the patient experienced PYREXIA (Fever). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (Swelling on arm), ERYTHEMA (Redness of arm), ASTHENIA (Weakness), DIZZINESS (Light headedness), NIGHT SWEATS (Night sweats), QUALITY OF LIFE DECREASED (No quality of life), CHILLS (Chills), MYALGIA (Muscle pain) and FATIGUE (Extreme fatigue) had not resolved and PYREXIA (Fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-May-2021, Body temperature: 100.2 (High) 100.2F. On an unknown date, SARS-CoV-2 test: unknown (Negative) unknown.         Action taken with mRNA-1273 in response to the events was not applicable.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Follow-up information received: No new information
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Product dose omission issue
Clinical narrative: a stiff arm; 53 days has pasted since his first dose; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (a stiff arm) and PRODUCT DOSE OMISSION ISSUE (53 days has pasted since his first dose) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-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 MUSCULOSKELETAL STIFFNESS (a stiff arm) and PRODUCT DOSE OMISSION ISSUE (53 days has pasted since his first dose). At the time of the report, MUSCULOSKELETAL STIFFNESS (a stiff arm) had not resolved and PRODUCT DOSE OMISSION ISSUE (53 days has pasted since his first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. No treatment information was provided. Patient was supposed to get vaccinated on 16-APR-2021 but 53 days has pasted since his first dose
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Pyrexia, Somnolence, Vaccination complication
Clinical narrative: all types of things started happening to him; chills; fever; got into bed and slept for 24 hours straight/woke up and slept for another 48 hours; he woke up he felt very weird; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (got into bed and slept for 24 hours straight/woke up and slept for another 48 hours), FEELING ABNORMAL (he woke up he felt very weird), VACCINATION COMPLICATION (all types of things started happening to him), CHILLS (chills) and PYREXIA (fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    In March 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. In March 2021, the patient experienced SOMNOLENCE (got into bed and slept for 24 hours straight/woke up and slept for another 48 hours), FEELING ABNORMAL (he woke up he felt very weird), CHILLS (chills) and PYREXIA (fever). On an unknown date, the patient experienced VACCINATION COMPLICATION (all types of things started happening to him). At the time of the report, SOMNOLENCE (got into bed and slept for 24 hours straight/woke up and slept for another 48 hours), FEELING ABNORMAL (he woke up he felt very weird), VACCINATION COMPLICATION (all types of things started happening to him), CHILLS (chills) and PYREXIA (fever) outcome was unknown.            Treatment, Lab data and other concomitant medications were not reported.   This case was linked to MOD-2021-138784 (Patient Link).   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore injection site shoulder; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore injection site shoulder) 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 VACCINATION SITE PAIN (sore injection site shoulder). At the time of the report, VACCINATION SITE PAIN (sore injection site shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use and treatment information not provided.   This case was linked to MOD-2021-138721 (Patient Link).
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Cough, Fatigue
Clinical narrative: weakness; cough; tired/fatigued; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), COUGH (cough) and FATIGUE (tired/fatigued) in a 62-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.  The patient's past medical history included No adverse event. Concomitant products included OMEPRAZOLE for Acid reflux (esophageal), ALPRAZOLAM for Anxiety, LITHIUM for Depression.   On 12-May-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 16-May-2021, the patient experienced ASTHENIA (weakness), COUGH (cough) and FATIGUE (tired/fatigued). At the time of the report, ASTHENIA (weakness), COUGH (cough) and FATIGUE (tired/fatigued) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-May-2021, Body temperature: 96 degree fahrenheit (High) 96 degree Fahrenheit.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second dose scheduled beyond 42 days; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose scheduled beyond 42 days) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose scheduled beyond 42 days). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose scheduled beyond 42 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not  mentioned. Treatment medications were not mentioned
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine past beyond use date administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine past beyond use date administered) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy and Drug allergy.    On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine past beyond use date administered). On 17-May-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine past beyond use date administered) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant information was not provided. Treatment information was not provided.   This case was linked to MOD21-091070 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Patient medical history was updated. Allergies to medication, food and others.; Sender's Comments:  MOD21-091070:same reporter different patient
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Rash
Clinical narrative: This spontaneous case reported by an other caregiver, describes the occurrence of rash and insomnia (could not sleep) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 001C21A and 041B21A) for COVID-19 immunization. No medical history reported. On Apr 16, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On May 14, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. May 2021, patient experienced rash. On an unknown date, patient experienced insomnia (could not sleep). Treatment with cortisone ongoing from May 2021, at an unspecified dose and frequency; and Nyquil (dextromethorphan hydrobromide, doxylamine succinate, ephedrine sulfate, ethanol, paracetamol) ongoing from May 2021, at an unspecified dose and frequency; both for rash. At the time of the report, rash: not resolved; and insomnia (could not sleep) outcome: unknown.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pyrexia, Swelling, Vaccination site pain
Clinical narrative: Arm was Sore; Swelling; Redness; Fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm was Sore), SWELLING (Swelling), ERYTHEMA (Redness) and PYREXIA (Fever) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, the patient experienced VACCINATION SITE PAIN (Arm was Sore), SWELLING (Swelling), ERYTHEMA (Redness) and PYREXIA (Fever). At the time of the report, VACCINATION SITE PAIN (Arm was Sore), SWELLING (Swelling), ERYTHEMA (Redness) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment and concomitant medications were provided   This case was linked to MODERNATX, INC.-MOD-2021-138400 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2021-138400:Patient who called - their case
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Blepharospasm, Pain in extremity
Clinical narrative: eyes twitching mainly the right eye sporadically; soreness in the left arm; This spontaneous case was reported by a consumer and describes the occurrence of BLEPHAROSPASM (eyes twitching mainly the right eye sporadically) and PAIN IN EXTREMITY (soreness in the left arm) in a 45-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 PROGESTERONE for an unknown indication.    On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced BLEPHAROSPASM (eyes twitching mainly the right eye sporadically) and PAIN IN EXTREMITY (soreness in the left arm). On 10-May-2021, PAIN IN EXTREMITY (soreness in the left arm) had resolved. At the time of the report, BLEPHAROSPASM (eyes twitching mainly the right eye sporadically) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, Device connection issue
Clinical narrative: patient did not receive the full dose administered because of "issues with the needle"; Accidental underdose; This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE CONNECTION ISSUE (patient did not receive the full dose administered because of "issues with the needle") and ACCIDENTAL UNDERDOSE (Accidental underdose) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 17-May-2021, the patient experienced DEVICE CONNECTION ISSUE (patient did not receive the full dose administered because of "issues with the needle") and ACCIDENTAL UNDERDOSE (Accidental underdose). On 17-May-2021, DEVICE CONNECTION ISSUE (patient did not receive the full dose administered because of "issues with the needle") and ACCIDENTAL UNDERDOSE (Accidental underdose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported by investigator. No treatment medications provided by the reporter.