chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Laziness
Clinical narrative: felt lazy; felt tired; This spontaneous case was reported by a patient family member or friend and describes the occurrence of LAZINESS (felt lazy) and FATIGUE (felt tired) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LAZINESS (felt lazy) and FATIGUE (felt tired). At the time of the report, LAZINESS (felt lazy) and FATIGUE (felt tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided. Concomitant medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-046313 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-046313:cosslinked
Sex: F
Vaccine: COVID19
Symptoms: Blood count, Blood pressure measurement, Dizziness, Dysstasia, Electrocardiogram
Clinical narrative: Sky high blood pressure; Vertigo; Nauseous; Headache; Could not stand up; Very dizzy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSSTASIA (Could not stand up), DIZZINESS (Very dizzy), HYPERTENSION (Sky high blood pressure), VERTIGO (Vertigo) and NAUSEA (Nauseous) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.     On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced DYSSTASIA (Could not stand up), DIZZINESS (Very dizzy), NAUSEA (Nauseous) and HEADACHE (Headache). On 04-Mar-2021, the patient experienced HYPERTENSION (Sky high blood pressure) and VERTIGO (Vertigo). The patient was treated with METOCLOPRAMIDE on 04-Mar-2021 for Vertigo, at a dose of 25 mg and HYDROCHLOROTHIAZIDE for Blood pressure high, at a dose of 25 mg once a day. At the time of the report, DYSSTASIA (Could not stand up), HYPERTENSION (Sky high blood pressure) and NAUSEA (Nauseous) had resolved and DIZZINESS (Very dizzy), VERTIGO (Vertigo) and HEADACHE (Headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, Blood count: within normal limits (normal) within normal limits. On 04-Mar-2021, Blood pressure measurement: high (High) high. On 04-Mar-2021, Electrocardiogram: normal (normal) normal. On 04-Mar-2021, Magnetic resonance imaging: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   This case was linked to MOD21-054606 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Updated email and fax number of reporter and patient Initials. On 27-Jul-2021: NNI; Sender's Comments:  MOD21-054606:crosslinked
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypertension, Magnetic resonance imaging, Nausea, Vertigo
Clinical narrative: Sky high blood pressure; Vertigo; Nauseous; Headache; Could not stand up; Very dizzy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSSTASIA (Could not stand up), DIZZINESS (Very dizzy), HYPERTENSION (Sky high blood pressure), VERTIGO (Vertigo) and NAUSEA (Nauseous) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.     On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced DYSSTASIA (Could not stand up), DIZZINESS (Very dizzy), NAUSEA (Nauseous) and HEADACHE (Headache). On 04-Mar-2021, the patient experienced HYPERTENSION (Sky high blood pressure) and VERTIGO (Vertigo). The patient was treated with METOCLOPRAMIDE on 04-Mar-2021 for Vertigo, at a dose of 25 mg and HYDROCHLOROTHIAZIDE for Blood pressure high, at a dose of 25 mg once a day. At the time of the report, DYSSTASIA (Could not stand up), HYPERTENSION (Sky high blood pressure) and NAUSEA (Nauseous) had resolved and DIZZINESS (Very dizzy), VERTIGO (Vertigo) and HEADACHE (Headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, Blood count: within normal limits (normal) within normal limits. On 04-Mar-2021, Blood pressure measurement: high (High) high. On 04-Mar-2021, Electrocardiogram: normal (normal) normal. On 04-Mar-2021, Magnetic resonance imaging: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   This case was linked to MOD21-054606 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Updated email and fax number of reporter and patient Initials. On 27-Jul-2021: NNI; Sender's Comments:  MOD21-054606:crosslinked
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Lymphoedema, Vaccination site swelling
Clinical narrative: lymphedema flare up; lymphedema flare up; Right arm swelling/my right arm started to swell again; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHOEDEMA (lymphedema flare up), CONDITION AGGRAVATED (lymphedema flare up) and VACCINATION SITE SWELLING (Right arm swelling/my right arm started to swell again) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 01M20A) for COVID-19 vaccination.     Concurrent medical conditions included Lymphedema, Drug allergy (Prednisone.), Drug allergy (Medrol Pak.), Drug allergy (Tetracycline.), Drug allergy (Avalox.), Drug allergy (Lisinop.), Drug allergy (ACE inhibitors.), Drug allergy (Calcium blocker.), Drug allergy (Triamterene-HCTZ.), Drug allergy (Mucinex-D.), Drug allergy (Erythromycin.), Drug allergy (Phenergan.), Allergy (cats), Allergy (dogs), Allergy (dirt), Dust allergy (dust), Allergy to molds (mold), Allergy (features trees), Allergy to wool, Grass allergy and Cockroach allergy. Concomitant products included COLECALCIFEROL (VITAMIN D 3) for Vitamin D low.   On 02-Feb-2021 at 2:15 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021 at 11:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced VACCINATION SITE SWELLING (Right arm swelling/my right arm started to swell again). On an unknown date, the patient experienced LYMPHOEDEMA (lymphedema flare up) and CONDITION AGGRAVATED (lymphedema flare up). At the time of the report, LYMPHOEDEMA (lymphedema flare up) and CONDITION AGGRAVATED (lymphedema flare up) had not resolved.            Treatment included compression sleeves and chiropractic therapy for 9 months.   This case was linked to MOD-2021-230205 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Followup was received on 22-Jun-2021. Allergies, Concomitant medications and treatment updated. On 23-Jun-2021: Non-significant follow-up appended
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: experienced side effects; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (experienced side effects) 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 ADVERSE REACTION (experienced side effects). At the time of the report, ADVERSE REACTION (experienced side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  No treatment information provided.   This case was linked to MOD21-019807 (Patient Link).
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising
Clinical narrative: black and blue mark on her arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (black and blue mark on her arm) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE BRUISING (black and blue mark on her arm). At the time of the report, VACCINATION SITE BRUISING (black and blue mark on her arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided. Upon follow-up on 06-May-2021, the reporter stated that patient received the second dose of Moderna vaccine and had no adverse events.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Additional information received captured event outcome and dose details.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Insomnia, Pyrexia
Clinical narrative: Temperature of 99 degrees; Couldn't sleep; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Couldn't sleep) and PYREXIA (Temperature of 99 degrees) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INSOMNIA (Couldn't sleep). On 16-Mar-2021, the patient experienced PYREXIA (Temperature of 99 degrees). On 16-Mar-2021, INSOMNIA (Couldn't sleep) had resolved. At the time of the report, PYREXIA (Temperature of 99 degrees) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Mar-2021, Body temperature: 99 (High) 99 degrees.         No relevant concomitant medications were reported.  No treatment information was provided. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) is considered as not applicable.   This case was linked to MOD-2021-058176 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: nauseated; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nauseated) 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 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced NAUSEA (nauseated). The patient was treated with ACETAMINOPHEN ongoing since an unknown date for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, NAUSEA (nauseated) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to, INC.-MOD-2021-046626 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments: INC.-MOD-2021-046626:Crosslinked wife case
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: Red rash, brick red; it's painful; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Red rash, brick red) and VACCINATION SITE PAIN (it's painful) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red rash, brick red) and VACCINATION SITE PAIN (it's painful). At the time of the report, VACCINATION SITE ERYTHEMA (Red rash, brick red) and VACCINATION SITE PAIN (it's painful) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Patient did not receive any treatment in response to events.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Hyperhidrosis, Injection site pain, Palpitations, Pruritus
Clinical narrative: injection site started itching really badly; rubbed the itch; found a bunch of small white bumps all over her arm; patient had a period of heart palpitations; shortness of breathe; was sweating; injection hurt her left arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (injection hurt her left arm), PALPITATIONS (patient had a period of heart palpitations), DYSPNOEA (shortness of breathe), HYPERHIDROSIS (was sweating) and VACCINATION SITE PRURITUS (injection site started itching really badly) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for an unknown indication. The occurrence of additional non-serious events is detailed below.     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 INJECTION SITE PAIN (injection hurt her left arm). On 12-Mar-2021, the patient experienced PALPITATIONS (patient had a period of heart palpitations), DYSPNOEA (shortness of breathe) and HYPERHIDROSIS (was sweating). On 16-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (injection site started itching really badly), PRURITUS (rubbed the itch) and VACCINATION SITE REACTION (found a bunch of small white bumps all over her arm). At the time of the report, INJECTION SITE PAIN (injection hurt her left arm), PALPITATIONS (patient had a period of heart palpitations), DYSPNOEA (shortness of breathe), HYPERHIDROSIS (was sweating), VACCINATION SITE PRURITUS (injection site started itching really badly), PRURITUS (rubbed the itch) and VACCINATION SITE REACTION (found a bunch of small white bumps all over her arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported. No treatment was provided.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site reaction
Clinical narrative: injection site started itching really badly; rubbed the itch; found a bunch of small white bumps all over her arm; patient had a period of heart palpitations; shortness of breathe; was sweating; injection hurt her left arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (injection hurt her left arm), PALPITATIONS (patient had a period of heart palpitations), DYSPNOEA (shortness of breathe), HYPERHIDROSIS (was sweating) and VACCINATION SITE PRURITUS (injection site started itching really badly) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for an unknown indication. The occurrence of additional non-serious events is detailed below.     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 INJECTION SITE PAIN (injection hurt her left arm). On 12-Mar-2021, the patient experienced PALPITATIONS (patient had a period of heart palpitations), DYSPNOEA (shortness of breathe) and HYPERHIDROSIS (was sweating). On 16-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (injection site started itching really badly), PRURITUS (rubbed the itch) and VACCINATION SITE REACTION (found a bunch of small white bumps all over her arm). At the time of the report, INJECTION SITE PAIN (injection hurt her left arm), PALPITATIONS (patient had a period of heart palpitations), DYSPNOEA (shortness of breathe), HYPERHIDROSIS (was sweating), VACCINATION SITE PRURITUS (injection site started itching really badly), PRURITUS (rubbed the itch) and VACCINATION SITE REACTION (found a bunch of small white bumps all over her arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported. No treatment was provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema
Clinical narrative: Red rectangle around injection site; This spontaneous case was reported by a patient and describes the occurrence of INJECTION SITE ERYTHEMA (Red rectangle around injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced INJECTION SITE ERYTHEMA (Red rectangle around injection site). At the time of the report, INJECTION SITE ERYTHEMA (Red rectangle around injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment information in response to events was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Vaccination complication, Vaccination site mass
Clinical narrative: Mild symptoms; Red on arm; Itchy on arm; Bump like a protrusion on her arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Mild symptoms), ERYTHEMA (Red on arm), PRURITUS (Itchy on arm) and VACCINATION SITE MASS (Bump like a protrusion on her arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure and Diabetic (Type 2).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced VACCINATION COMPLICATION (Mild symptoms), ERYTHEMA (Red on arm), PRURITUS (Itchy on arm) and VACCINATION SITE MASS (Bump like a protrusion on her arm). At the time of the report, VACCINATION COMPLICATION (Mild symptoms), ERYTHEMA (Red on arm), PRURITUS (Itchy on arm) and VACCINATION SITE MASS (Bump like a protrusion on her arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The reporter stated that the patient's second dose was scheduled on 21-MAR-2021. Blood pressure and  type 2 diabetic medications are the concomitant medications reported. Treatment information in response to events was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Follow up TCR received on 22-Jul-2021 contains Updated outcome of the event.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received Moderna COVID-19 injection past the 6-hour time expiration; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received Moderna COVID-19 injection past the 6-hour time expiration) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 15-Mar-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received Moderna COVID-19 injection past the 6-hour time expiration). On 15-Mar-2021, EXPIRED PRODUCT ADMINISTERED (received Moderna COVID-19 injection past the 6-hour time expiration) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-046684, MOD-2021-046516, MOD-2021-046415, MOD-2021-046260, MOD-2021-046182 (Patient Link).; Sender's Comments: This report refers to a case of Expired Product Administered for mRNA-1273 (Lot #: 014M20A)  with no associated AEs.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash over entire body; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash over entire body) in an 18-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 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced RASH (Rash over entire body). The patient was treated with LORATADINE at an unspecified dose and frequency. On 14-Mar-2021, RASH (Rash over entire body) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was reported No treatment information was provided
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever after 2nd dose) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032m20a) for COVID-19 vaccination.     No Medical History information was reported.   On 15-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 15-Mar-2021, the patient experienced PYREXIA (Fever after 2nd dose). The patient was treated with IBUPROFEN for Fever, at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever after 2nd dose) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.6 (Inconclusive) slight fever of 99.6.         Action taken with mRNA-1273 in response to the events was not Applicable.  Concomitant product use was not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Approx 4 to 5 patient were administered expired vaccinations; A spontaneous report was received from a physician concerning some unspecified patients, who received Moderna's COVID-19 vaccine (mRNA-1273) and were administered expired vaccinations/expired product administered.   The patient's medical history, was not provided by the reporter.  No concomitant medications were reported.  On 15 Mar 2021, the patients received their doses of mRNA-1273 (Lot number: 014M20A) intramuscularly for prophylaxis of COVID-19 infection.  The reporter states that, on 15 Mar 2021 one vial was punctured at 10:45am. Therefore, the pre-filled syringes expired at 4:45pm.  The reporter also states there were approximately four to five patients that received the expired doses between 4:45pm to 5:15pm on 15 Mar 2021.   Treatment for the events were not reported. Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event administered expired vaccinations were considered to be recovered.; Reporter's Comments: This report refers to a case of expired product administered for mRNA-1273 with no associated AEs lot # 014M20A with no associated AEs.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Influenza B virus test, Influenza like illness, Pyrexia
Clinical narrative: fever; headache; flu like symptom; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptom), PYREXIA (fever) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L2A) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL), ACETYLSALICYLIC ACID (ASPRIN), ROSUVASTATIN and PROGESTERONE for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptom). On an unknown date, the patient experienced PYREXIA (fever) and HEADACHE (headache). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptom), PYREXIA (fever) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99 (Inconclusive) 99. On an unknown date, Influenza B virus test: positive (Positive) Positive. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative and positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication were provided. Patient was tested positive for flu B and COVID-19. Patient was taking low dose blood pressure medication and thyroid medication as concomitant medication.; 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.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: fever; headache; flu like symptom; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptom), PYREXIA (fever) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L2A) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL), ACETYLSALICYLIC ACID (ASPRIN), ROSUVASTATIN and PROGESTERONE for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptom). On an unknown date, the patient experienced PYREXIA (fever) and HEADACHE (headache). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptom), PYREXIA (fever) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99 (Inconclusive) 99. On an unknown date, Influenza B virus test: positive (Positive) Positive. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative and positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication were provided. Patient was tested positive for flu B and COVID-19. Patient was taking low dose blood pressure medication and thyroid medication as concomitant medication.; 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.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Limb discomfort, Vaccination site erythema, Vaccination site induration, Vaccination site pain
Clinical narrative: soreness right arm; right arm swelling; right arm hardness; right arm redness; right arm itchiness; hot to touch; right arm has pressure; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (soreness right arm), VACCINATION SITE SWELLING (right arm swelling), VACCINATION SITE INDURATION (right arm hardness), VACCINATION SITE ERYTHEMA (right arm redness) and VACCINATION SITE PRURITUS (right arm itchiness) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No relevant medical history).    On 08-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 VACCINATION SITE PAIN (soreness right arm), VACCINATION SITE SWELLING (right arm swelling), VACCINATION SITE INDURATION (right arm hardness), VACCINATION SITE ERYTHEMA (right arm redness), VACCINATION SITE PRURITUS (right arm itchiness), FEELING HOT (hot to touch) and LIMB DISCOMFORT (right arm has pressure). At the time of the report, VACCINATION SITE PAIN (soreness right arm), VACCINATION SITE SWELLING (right arm swelling), VACCINATION SITE INDURATION (right arm hardness), VACCINATION SITE ERYTHEMA (right arm redness), VACCINATION SITE PRURITUS (right arm itchiness), FEELING HOT (hot to touch) and LIMB DISCOMFORT (right arm has pressure) outcome was unknown. 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.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling
Clinical narrative: soreness right arm; right arm swelling; right arm hardness; right arm redness; right arm itchiness; hot to touch; right arm has pressure; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (soreness right arm), VACCINATION SITE SWELLING (right arm swelling), VACCINATION SITE INDURATION (right arm hardness), VACCINATION SITE ERYTHEMA (right arm redness) and VACCINATION SITE PRURITUS (right arm itchiness) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No relevant medical history).    On 08-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 VACCINATION SITE PAIN (soreness right arm), VACCINATION SITE SWELLING (right arm swelling), VACCINATION SITE INDURATION (right arm hardness), VACCINATION SITE ERYTHEMA (right arm redness), VACCINATION SITE PRURITUS (right arm itchiness), FEELING HOT (hot to touch) and LIMB DISCOMFORT (right arm has pressure). At the time of the report, VACCINATION SITE PAIN (soreness right arm), VACCINATION SITE SWELLING (right arm swelling), VACCINATION SITE INDURATION (right arm hardness), VACCINATION SITE ERYTHEMA (right arm redness), VACCINATION SITE PRURITUS (right arm itchiness), FEELING HOT (hot to touch) and LIMB DISCOMFORT (right arm has pressure) outcome was unknown. 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.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Myalgia, Vaccination site pain
Clinical narrative: Arm hurts at the injection site; Glands are swelling; Whole body hurts; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm hurts at the injection site), LYMPHADENOPATHY (Glands are swelling) and MYALGIA (Whole body hurts) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE PAIN (Arm hurts at the injection site), LYMPHADENOPATHY (Glands are swelling) and MYALGIA (Whole body hurts). The patient was treated with PREDNISONE on 15-Mar-2021 at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Arm hurts at the injection site), LYMPHADENOPATHY (Glands are swelling) and MYALGIA (Whole body hurts) outcome was unknown.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypersensitivity, Rash
Clinical narrative: Allergy; rashes; feeling funny; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feeling funny), HYPERSENSITIVITY (Allergy) and RASH (rashes) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. D20JL4U) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included IRBESARTAN for Blood pressure management.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, the patient experienced FEELING ABNORMAL (feeling funny). On 28-Feb-2021, the patient experienced HYPERSENSITIVITY (Allergy) and RASH (rashes). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Allergy, at an unspecified dose and frequency; CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Allergy, at an unspecified dose and frequency and FAMOTIDINE (PEPCID [FAMOTIDINE]) for Allergy, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (feeling funny), HYPERSENSITIVITY (Allergy) and RASH (rashes) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Follow up information received included events outcome were updated to resolved.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Depression, Headache, Myalgia
Clinical narrative: depression; headache; arthritic pain in entire body/muscle, joint pain, body aches; muscle, joint pain, body aches; This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSION (depression), HEADACHE (headache), ARTHRALGIA (arthritic pain in entire body/muscle, joint pain, body aches) and MYALGIA (muscle, joint pain, body aches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced DEPRESSION (depression), HEADACHE (headache), ARTHRALGIA (arthritic pain in entire body/muscle, joint pain, body aches) and MYALGIA (muscle, joint pain, body aches). At the time of the report, DEPRESSION (depression), HEADACHE (headache), ARTHRALGIA (arthritic pain in entire body/muscle, joint pain, body aches) and MYALGIA (muscle, joint pain, body aches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medication were reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: updated events tab - outcome (resolved), event duration, declined for further follow up.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Headache
Clinical narrative: dry cough; Headache; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (dry cough) and HEADACHE (Headache) in a 65-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 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced COUGH (dry cough) and HEADACHE (Headache). At the time of the report, COUGH (dry cough) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment information in response to events was not provided.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: felt little achy; arm was pretty sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (felt little achy) and PAIN IN EXTREMITY (arm was pretty sore) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02BA21A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic obstructive pulmonary disease (she has COPD and she uses oxygen 24/7). Concomitant products included HYDROCODONE, CLONAZEPAM, FLUOXETINE HYDROCHLORIDE (PROZAC), DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]), TOLTERODINE and ROFLUMILAST (DALIRESP) for an unknown indication, PROPRANOLOL.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, the patient experienced PAIN (felt little achy) and PAIN IN EXTREMITY (arm was pretty sore). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 13-Apr-2021, PAIN (felt little achy) and PAIN IN EXTREMITY (arm was pretty sore) 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.   Treatment included - patient drank a lot of water.       Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Significant follow-up appended
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itching on my back; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (Itching on my back) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ETHAMBUTOL, AZITHROMYCIN, RIFAMPIN, METOPROLOL and ALPRAZOLAM for an unknown indication.   On 12-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. In March 2021, the patient experienced PRURITUS (Itching on my back). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itch, at an unspecified dose and frequency. At the time of the report, PRURITUS (Itching on my back) was resolving.            No treatment medications were reported.    Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Follow up source document contains no new information
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Sleep deficit
Clinical narrative: He could not sleep/ his body was awake; When he gets up he gets dizzy; Strong headache; His body is very tired; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP DEFICIT (He could not sleep/ his body was awake), DIZZINESS (When he gets up he gets dizzy), HEADACHE (Strong headache) and FATIGUE (His body is very tired) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced SLEEP DEFICIT (He could not sleep/ his body was awake), DIZZINESS (When he gets up he gets dizzy), HEADACHE (Strong headache) and FATIGUE (His body is very tired). At the time of the report, SLEEP DEFICIT (He could not sleep/ his body was awake), DIZZINESS (When he gets up he gets dizzy), HEADACHE (Strong headache) and FATIGUE (His body is very tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided. No treatment information provided.
Sex: F
Vaccine: COVID19
Symptoms: Eye pain
Clinical narrative: Shooting pain around the eyes; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 16-Mar-2021. The most recent information was received on 12-May-2021 and was forwarded to Moderna on 12-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN (Shooting pain around the eyes) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Trigeminal neuralgia. Concomitant products included CARBAMAZEPINE and ASPIRIN [ACETYLSALICYLIC ACID] for Trigeminal neuralgia.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EYE PAIN (Shooting pain around the eyes). At the time of the report, EYE PAIN (Shooting pain around the eyes) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Med Info Agent: Caller returned call from Safety, updated on her state of health and updated contact information.   Patient reported that she feels fine now, her symptoms have calmed down now. She will be seeing a neurologist and has to take very high doses of medications to keep her pain under control. She reported that it took her a month to recover from the second vaccine. This case was linked to INC.-MOD-2021-077579 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Outcome of event updated.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Paraesthesia
Clinical narrative: tingling all over; muscles set on fire; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling all over) and MYALGIA (muscles set on fire) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis. Concomitant products included PREDNISONE (PREDNISON) for Arthritis, DICLOFENAC DIETHYLAMINE (ANTI INFLAMMATORY) for an unknown indication.    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 PARAESTHESIA (tingling all over) and MYALGIA (muscles set on fire). At the time of the report, PARAESTHESIA (tingling all over) and MYALGIA (muscles set on fire) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Coordination abnormal, Vaccination complication
Clinical narrative: Moderate reaction to first dose; Some loss of muscular coordination; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Moderate reaction to first dose) and COORDINATION ABNORMAL (Some loss of muscular coordination) 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 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION COMPLICATION (Moderate reaction to first dose) and COORDINATION ABNORMAL (Some loss of muscular coordination). At the time of the report, VACCINATION COMPLICATION (Moderate reaction to first dose) and COORDINATION ABNORMAL (Some loss of muscular coordination) had resolved.            No concomitant medications were reported  Treatment information was not provided. The patient had to stay at the vaccination location for about 2 hours while her symptoms abated.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Urticaria, Vaccination site pain
Clinical narrative: Hives; Red Rash all over her body, Red when Scratching. When not scratching it looks Lumpy; Sore Left Arm Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives), RASH ERYTHEMATOUS (Red Rash all over her body, Red when Scratching. When not scratching it looks Lumpy) and VACCINATION SITE PAIN (Sore Left Arm Injection Site) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-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 URTICARIA (Hives), RASH ERYTHEMATOUS (Red Rash all over her body, Red when Scratching. When not scratching it looks Lumpy) and VACCINATION SITE PAIN (Sore Left Arm Injection Site). At the time of the report, URTICARIA (Hives), RASH ERYTHEMATOUS (Red Rash all over her body, Red when Scratching. When not scratching it looks Lumpy) and VACCINATION SITE PAIN (Sore Left Arm Injection Site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported No treatment medications were reported. Patient said that she is doing fine.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Follow-up received on 22-jul-2021 contains significant information-Updated  Event outcome ;recovered.
Sex: M
Vaccine: COVID19
Symptoms: Cough, SARS-CoV-2 test
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of cough (lingering cough) in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunisation. No medical history reported. On Feb 25, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced cough (lingering cough). At the time of the report, cough (lingering cough) outcome: unknown. Diagnostic results: On Mar 6, 2021, SARS-CoV-2 test: positive. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. Concomitant medication and treatment information not provided. This case linked to MOD-2021-044179 (patient link). Most recent follow-up information incorporated above includes: On May 21, 2021: Reporter denied consent to follow-up.