chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: patients who received a vaccine which was more than 30 days in the refrigerator; patients who received expired vaccine; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients who received expired vaccine) and PRODUCT STORAGE ERROR (patients who received a vaccine which was more than 30 days in the refrigerator) in a 61-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 07-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients who received expired vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (patients who received a vaccine which was more than 30 days in the refrigerator). On 07-Jul-2021, EXPIRED PRODUCT ADMINISTERED (patients who received expired vaccine) had resolved. At the time of the report, PRODUCT STORAGE ERROR (patients who received a vaccine which was more than 30 days in the refrigerator) 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.   No Concomitant medications were reported. No Treatment information was reported.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was reported. The patient got the flu shot after Moderna and then had flu like symptoms, sneezes, coughs, she was having a hard.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash, Rash erythematous, Rash morbilliform
Clinical narrative: morbilliform rash/measles looking; Rash in most of the body/rash; Like a third degree sunburn without protrusion/small erythematous spots/on his neck, trunk, and extremities; Reddish; Itched a little bit towards the end; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 12-Oct-2021. The most recent information was received on 12-Oct-2021 and was forwarded to Moderna on 12-Oct-2021.    This spontaneous case was reported by a consumer and describes the occurrence of RASH MORBILLIFORM (morbilliform rash/measles looking), RASH ERYTHEMATOUS (Like a third degree sunburn without protrusion/small erythematous spots/on his neck, trunk, and extremities), ERYTHEMA (Reddish), PRURITUS (Itched a little bit towards the end) and RASH (Rash in most of the body/rash) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 004M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced RASH MORBILLIFORM (morbilliform rash/measles looking) and RASH (Rash in most of the body/rash). In 2021, the patient experienced RASH ERYTHEMATOUS (Like a third degree sunburn without protrusion/small erythematous spots/on his neck, trunk, and extremities), ERYTHEMA (Reddish) and PRURITUS (Itched a little bit towards the end). On 02-Mar-2021, RASH MORBILLIFORM (morbilliform rash/measles looking) had resolved. In 2021, RASH ERYTHEMATOUS (Like a third degree sunburn without protrusion/small erythematous spots/on his neck, trunk, and extremities), ERYTHEMA (Reddish), PRURITUS (Itched a little bit towards the end) and RASH (Rash in most of the body/rash) 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.   The patient received both doses on the left nondominant arm. The patient experienced events after 36 hours after vaccination and left in 4 days. Patient was not immunocompromised but is thinking on getting 3rd dose.  The patient did not take any treatments and the rash resolved after 1.5 days.  No treatment medications were provided.   This case was linked to MOD-2021-349641 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Oct-2021: Significant Follow Up Appended; Reporter(HCP) Details Updated; Patient DOB Discrepancy
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: either 6 or 8 doses were administered from 2 vials of same lot number that were past expiration; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (either 6 or 8 doses were administered from 2 vials of same lot number that were past expiration) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (either 6 or 8 doses were administered from 2 vials of same lot number that were past expiration). On 29-Sep-2021, EXPIRED PRODUCT ADMINISTERED (either 6 or 8 doses were administered from 2 vials of same lot number that were past expiration) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information was provided. The reporter stated that 6 or 8 doses were administered over 2 different days 29Sep2021 and 30Sep2021 from vials that were past expiration.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Bone pain, Chills, Headache, Mobility decreased
Clinical narrative: Couldn't move the arm; Realized that had a ball on the injection site; Swollen under the arm pit / hard / little bit swollen / still swollen/mild pain still in the arm pit; Head ache; Chills; Bone hurts/bone pain; Felt little stings on the knees; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Bone hurts/bone pain), PAIN (Felt little stings on the knees), MOBILITY DECREASED (Couldn't move the arm), VACCINATION SITE MASS (Realized that had a ball on the injection site) and AXILLARY PAIN (Swollen under the arm pit / hard / little bit swollen / still swollen/mild pain still in the arm pit) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Oct-2021, the patient experienced BONE PAIN (Bone hurts/bone pain) and PAIN (Felt little stings on the knees). On 10-Oct-2021, the patient experienced MOBILITY DECREASED (Couldn't move the arm), VACCINATION SITE MASS (Realized that had a ball on the injection site), AXILLARY PAIN (Swollen under the arm pit / hard / little bit swollen / still swollen/mild pain still in the arm pit), HEADACHE (Head ache) and CHILLS (Chills). The patient was treated with BENZALKONIUM CHLORIDE, SODIUM CHLORIDE (ALIVE) for Adverse event, at an unspecified dose and frequency. At the time of the report, BONE PAIN (Bone hurts/bone pain), PAIN (Felt little stings on the knees), MOBILITY DECREASED (Couldn't move the arm), VACCINATION SITE MASS (Realized that had a ball on the injection site), AXILLARY PAIN (Swollen under the arm pit / hard / little bit swollen / still swollen/mild pain still in the arm pit), HEADACHE (Head ache) and CHILLS (Chills) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Patient had bone pain on 10 Oct 2021.  Treatment medication was cold water cloths for some body temperature.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site mass
Clinical narrative: Couldn't move the arm; Realized that had a ball on the injection site; Swollen under the arm pit / hard / little bit swollen / still swollen/mild pain still in the arm pit; Head ache; Chills; Bone hurts/bone pain; Felt little stings on the knees; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Bone hurts/bone pain), PAIN (Felt little stings on the knees), MOBILITY DECREASED (Couldn't move the arm), VACCINATION SITE MASS (Realized that had a ball on the injection site) and AXILLARY PAIN (Swollen under the arm pit / hard / little bit swollen / still swollen/mild pain still in the arm pit) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Oct-2021, the patient experienced BONE PAIN (Bone hurts/bone pain) and PAIN (Felt little stings on the knees). On 10-Oct-2021, the patient experienced MOBILITY DECREASED (Couldn't move the arm), VACCINATION SITE MASS (Realized that had a ball on the injection site), AXILLARY PAIN (Swollen under the arm pit / hard / little bit swollen / still swollen/mild pain still in the arm pit), HEADACHE (Head ache) and CHILLS (Chills). The patient was treated with BENZALKONIUM CHLORIDE, SODIUM CHLORIDE (ALIVE) for Adverse event, at an unspecified dose and frequency. At the time of the report, BONE PAIN (Bone hurts/bone pain), PAIN (Felt little stings on the knees), MOBILITY DECREASED (Couldn't move the arm), VACCINATION SITE MASS (Realized that had a ball on the injection site), AXILLARY PAIN (Swollen under the arm pit / hard / little bit swollen / still swollen/mild pain still in the arm pit), HEADACHE (Head ache) and CHILLS (Chills) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Patient had bone pain on 10 Oct 2021.  Treatment medication was cold water cloths for some body temperature.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 037B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose). On 12-Oct-2021, EXPIRED PRODUCT ADMINISTERED (expired dose) had resolved.        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.   This case was linked to MOD-2021-350559 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: little soreness in the arm for a day; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (little soreness in the arm for a day) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Sarcoma and Carcinoma.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (little soreness in the arm for a day). At the time of the report, MYALGIA (little soreness in the arm for a day) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was Reported.  No treatment medication was Reported.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Felt a little off; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Felt a little off) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder (Thyroid medication) and Back pain. Concomitant products included GABAPENTIN for Back pain, LEVOTHYROXINE for Thyroid disorder, METOPROLOL, ATORVASTATIN, TIMOLOL MALEATE and LATANOPROST for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced VACCINATION COMPLICATION (Felt a little off). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency; VITAMIN D3 for Adverse event, at a dose of 2000 IU; PROBIOTIC 10 for Adverse event, at an unspecified dose and frequency; CALCIUM CITRATE, COLECALCIFEROL (CITRACAL + D3) for Adverse event, at an unspecified dose and frequency; COD-LIVER OIL (FISH OIL [COD-LIVER OIL]) for Adverse event, at a dose of 1200 mg; VITAMIN B12 (VITAMIN B12 (CYANOCOBALAMIN AND ANALOGUES)) for Adverse event, at a dose of 1200 mcg and UBIDECARENONE (COQ) for Adverse event, at a dose of Coq10  300 mg. At the time of the report, VACCINATION COMPLICATION (Felt a little off) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications used metoprolol for beta-blockers.   This case was linked to MOD-2021-350420 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Oct-2021: Follow-up received contain significant information concomitant and treatment drug updated, On 15-Oct-2021: Follow up contains no new information.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: Arm was sore; slight headaches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm was sore) and HEADACHE (slight headaches) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A, 012M20A and 052E21A) for COVID-19 vaccination.     Concurrent medical conditions included Lymphedema.   On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Arm was sore) and HEADACHE (slight headaches). At the time of the report, VACCINATION SITE PAIN (Arm was sore) and HEADACHE (slight headaches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medication was reported. Treatment information were not provided.      This case was linked to MOD-2021-350345 (Patient Link).
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood test, Feeling abnormal, Gait disturbance, Malaise
Clinical narrative: woke up feeling horrible; had difficulty walking; felt weak; felt awful; nauseous; three episodes of very light vomiting; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (woke up feeling horrible), GAIT DISTURBANCE (had difficulty walking), ASTHENIA (felt weak), FEELING ABNORMAL (felt awful) and NAUSEA (nauseous) in an 82-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.     Concurrent medical conditions included Diabetes (for 26years.). Concomitant products included INSULIN for Diabetes.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Aug-2021, the patient experienced MALAISE (woke up feeling horrible), GAIT DISTURBANCE (had difficulty walking), ASTHENIA (felt weak), FEELING ABNORMAL (felt awful), NAUSEA (nauseous) and VOMITING (three episodes of very light vomiting). At the time of the report, MALAISE (woke up feeling horrible), GAIT DISTURBANCE (had difficulty walking), ASTHENIA (felt weak), FEELING ABNORMAL (felt awful), NAUSEA (nauseous) and VOMITING (three episodes of very light vomiting) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: mid to high 200s (High) High.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.  Patient checked his blood sugar level before he ate and was mid to high 200s, which is too high for him. He stated that lasted for 14 days, no matter how much insulin he used. The blood sugar level returned to normal after 14 days but then is high again, mid to high 200s. He saw his endocrinologist who did not know what could have caused it. He stated that his diet and insulin regimen had not changed
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: woke up feeling horrible; had difficulty walking; felt weak; felt awful; nauseous; three episodes of very light vomiting; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (woke up feeling horrible), GAIT DISTURBANCE (had difficulty walking), ASTHENIA (felt weak), FEELING ABNORMAL (felt awful) and NAUSEA (nauseous) in an 82-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.     Concurrent medical conditions included Diabetes (for 26years.). Concomitant products included INSULIN for Diabetes.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Aug-2021, the patient experienced MALAISE (woke up feeling horrible), GAIT DISTURBANCE (had difficulty walking), ASTHENIA (felt weak), FEELING ABNORMAL (felt awful), NAUSEA (nauseous) and VOMITING (three episodes of very light vomiting). At the time of the report, MALAISE (woke up feeling horrible), GAIT DISTURBANCE (had difficulty walking), ASTHENIA (felt weak), FEELING ABNORMAL (felt awful), NAUSEA (nauseous) and VOMITING (three episodes of very light vomiting) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: mid to high 200s (High) High.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.  Patient checked his blood sugar level before he ate and was mid to high 200s, which is too high for him. He stated that lasted for 14 days, no matter how much insulin he used. The blood sugar level returned to normal after 14 days but then is high again, mid to high 200s. He saw his endocrinologist who did not know what could have caused it. He stated that his diet and insulin regimen had not changed
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: received a third dose of the Moderna COVID-19 vaccine and is not immunocompromised; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (received a third dose of the Moderna COVID-19 vaccine and is not immunocompromised) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol and Blood pressure high.    On 11-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2021, the patient experienced EXTRA DOSE ADMINISTERED (received a third dose of the Moderna COVID-19 vaccine and is not immunocompromised). On 11-Oct-2021, EXTRA DOSE ADMINISTERED (received a third dose of the Moderna COVID-19 vaccine and is not immunocompromised) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details were provided.  The patient came in for a flu shot and was given Moderna COVID-19 vaccine instead. This patient had already received 2 doses of the Moderna COVID-19 vaccine earlier this year, so this was a third dose for her. The patient iwas not immunocompromised.  No treatment medication details were reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 042L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced PYREXIA (fever). At the time of the report, PYREXIA (fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drugs were reported. The patient had a fever on the first day. No treatment drugs were reported.   This case was linked to MOD-2021-350423 (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Given a vaccine that expired yesterday; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Given a vaccine that expired yesterday) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Given a vaccine that expired yesterday). On 12-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Given a vaccine that expired yesterday) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product was provided.  No treatment information was provided.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Anger, Chills, Fatigue, Intentional product use issue, Miliaria
Clinical narrative: very sore arm; red rash on arm; hot; angry; painful to the touch; told by their HCP to wait 2 weeks before and 2 weeks after surgery until they received their second dose; body aches; fatigued; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (very sore arm), RASH ERYTHEMATOUS (red rash on arm), MILIARIA (hot), ANGER (angry) and RASH (painful to the touch) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (had COVID prior to getting the vaccine,feeling okay now.) and Surgery on 17-Sep-2021.    On 02-Sep-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 PAIN IN EXTREMITY (very sore arm), RASH ERYTHEMATOUS (red rash on arm), MILIARIA (hot), ANGER (angry), RASH (painful to the touch), INTENTIONAL PRODUCT USE ISSUE (told by their HCP to wait 2 weeks before and 2 weeks after surgery until they received their second dose), MYALGIA (body aches), FATIGUE (fatigued) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (very sore arm), RASH ERYTHEMATOUS (red rash on arm), MILIARIA (hot), ANGER (angry), RASH (painful to the touch), INTENTIONAL PRODUCT USE ISSUE (told by their HCP to wait 2 weeks before and 2 weeks after surgery until they received their second dose), MYALGIA (body aches), FATIGUE (fatigued) and CHILLS (chills) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Rash, Rash erythematous
Clinical narrative: very sore arm; red rash on arm; hot; angry; painful to the touch; told by their HCP to wait 2 weeks before and 2 weeks after surgery until they received their second dose; body aches; fatigued; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (very sore arm), RASH ERYTHEMATOUS (red rash on arm), MILIARIA (hot), ANGER (angry) and RASH (painful to the touch) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (had COVID prior to getting the vaccine,feeling okay now.) and Surgery on 17-Sep-2021.    On 02-Sep-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 PAIN IN EXTREMITY (very sore arm), RASH ERYTHEMATOUS (red rash on arm), MILIARIA (hot), ANGER (angry), RASH (painful to the touch), INTENTIONAL PRODUCT USE ISSUE (told by their HCP to wait 2 weeks before and 2 weeks after surgery until they received their second dose), MYALGIA (body aches), FATIGUE (fatigued) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (very sore arm), RASH ERYTHEMATOUS (red rash on arm), MILIARIA (hot), ANGER (angry), RASH (painful to the touch), INTENTIONAL PRODUCT USE ISSUE (told by their HCP to wait 2 weeks before and 2 weeks after surgery until they received their second dose), MYALGIA (body aches), FATIGUE (fatigued) and CHILLS (chills) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of EPISTAXIS (Couple of nosebleeds 3 days postvaccination) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Oct-2021, the patient experienced EPISTAXIS (Couple of nosebleeds 3 days postvaccination). At the time of the report, EPISTAXIS (Couple of nosebleeds 3 days postvaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. Patient experienced the event 3 days post vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pyrexia, Rash erythematous, Rash pruritic, Swollen tongue
Clinical narrative: Swelling of the tongue without difficulty breathing; Malaise; Generalized raised red itchy rash; Generalized raised red itchy rash/Itchiness persisted for 2 days after the redness subsided; Fever; This spontaneous case was reported by a physician and describes the occurrence of SWOLLEN TONGUE (Swelling of the tongue without difficulty breathing), MALAISE (Malaise), RASH PRURITIC (Generalized raised red itchy rash), RASH ERYTHEMATOUS (Generalized raised red itchy rash/Itchiness persisted for 2 days after the redness subsided) and PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 04-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWOLLEN TONGUE (Swelling of the tongue without difficulty breathing), MALAISE (Malaise), RASH PRURITIC (Generalized raised red itchy rash), RASH ERYTHEMATOUS (Generalized raised red itchy rash/Itchiness persisted for 2 days after the redness subsided) and PYREXIA (Fever). At the time of the report, SWOLLEN TONGUE (Swelling of the tongue without difficulty breathing), MALAISE (Malaise), RASH PRURITIC (Generalized raised red itchy rash), RASH ERYTHEMATOUS (Generalized raised red itchy rash/Itchiness persisted for 2 days after the redness subsided) and PYREXIA (Fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication listed.   No treatment information provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 037B21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included LOSARTAN, TROMANTADINE and DILTIAZEM (CARDIAZEM [DILTIAZEM]) for an unknown indication.   On 14-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose). On 12-Oct-2021, EXPIRED PRODUCT ADMINISTERED (expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications reported.   This case was linked to MOD-2021-350559 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Oct-2021: Follow up received on 12-Oct-2021, additional reporter details and product dosage details updated, event verbatim updated.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Extra dose administered, Pain in extremity, Pruritus
Clinical narrative: Arm hurting me; Caller states she received a third dose of the Moderna vaccine but is not immuno-compromised; Itchy; Whole arm turned red from where he gave me the shot all the way down to the elbow.; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy), ERYTHEMA (Whole arm turned red from where he gave me the shot all the way down to the elbow.), PAIN IN EXTREMITY (Arm hurting me) and EXTRA DOSE ADMINISTERED (Caller states she received a third dose of the Moderna vaccine but is not immuno-compromised) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037F21A, 029K20A and 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Aug-2021, the patient experienced PRURITUS (Itchy) and ERYTHEMA (Whole arm turned red from where he gave me the shot all the way down to the elbow.). 30-Aug-2021, the patient experienced EXTRA DOSE ADMINISTERED (Caller states she received a third dose of the Moderna vaccine but is not immuno-compromised). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm hurting me). The patient was treated with Physical therapy for Pain in extremity. On 30-Aug-2021, EXTRA DOSE ADMINISTERED (Caller states she received a third dose of the Moderna vaccine but is not immuno-compromised) had resolved. At the time of the report, PRURITUS (Itchy), ERYTHEMA (Whole arm turned red from where he gave me the shot all the way down to the elbow.) and PAIN IN EXTREMITY (Arm hurting me) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.  Patient was not immunocompromised. Patient's physician was sending her for physical therapy.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Vaccination site pain
Clinical narrative: sore left injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore left injection site arm) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METFORMIN, CARVEDILOL, OMEPRAZOLE, TELMISARTAN (MICARDIS), ATORVASTATIN, CELECOXIB (CELEBREX), ACETYLSALICYLIC ACID (ASPIRIN 81), IRON, MAGNESIUM, VITAMIN C [ASCORBIC ACID], INSULIN GLARGINE (LANTUS) and CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) for an unknown indication.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced VACCINATION SITE PAIN (sore left injection site arm). At the time of the report, VACCINATION SITE PAIN (sore left injection site arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) normal.     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 medication include Novolog Insulin No treatment medication use was reported.   This case was linked to MOD-2021-350530 (Patient Link).; Sender's Comments: This case concerns a 72 year-old male patient with no reported medical history, who experienced the expected non-serious event of Vaccination site pain. The event occurred on the same day as the first dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The spontaneous report indicated Medically significant seriousness criteria, but based on medical judgement and review of source document that did not include information supporting the seriousness criteria manual override was done to remove seriousness criteria.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Illness, Vaccination site pain
Clinical narrative: sick 3-4 days; arm hurt; chills; This spontaneous case was reported by a health care professional and describes the occurrence of ILLNESS (sick 3-4 days), VACCINATION SITE PAIN (arm hurt) and CHILLS (chills) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     Concurrent medical conditions included Adhesive tape allergy (allergic to 3M Tegaderm transparent dressing.). Concomitant products included METOPROLOL SUCCINATE (TOPROL XL), HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (COZAAR COMP), FUROSEMIDE, GABAPENTIN (GABAPENTIN 2K), ALLOPURINOL (ALLOPURINOL BP), OMEPRAZOLE, EZETIMIBE (EZETIMIBE CF), FENOFIBRATE (FENOFIBRATE (II)), IPRATROPIUM, TESTOSTERONE CIPIONATE (TESTOSTERONE CYPIONATE), FLUTICASONE PROPIONATE (FLUTICASONE CIPLA), AZELASTINE HYDROCHLORIDE (ASTEPRO), CLONAZEPAM (KLONOPIN), FISH OIL (OMEGA 3 AGE DEFENCE), INSULIN HUMAN, INSULIN HUMAN INJECTION, ISOPHANE (HUMULINE), MONTELUKAST SODIUM (SINGULAIR BABY), ANASTROZOLE (ANASTROZOLE AN), LEVOTHYROXINE SODIUM (SYNTHROID), CARISOPRODOL (CARISOPRODOL ACTAVIS), CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), PARACETAMOL (TYLENOL A), IBUPROFEN (IBUPROFEN 2CARE4), VITAMIN C [ASCORBIC ACID], MULTIVITAMINS [VITAMINS NOS], CINNAMOMUM CASSIA (CINNAMON [CINNAMOMUM CASSIA]), UBIDECARENONE (COQ 10), VITAMIN B COMPLEX (B COMPLEX (B50)), VITAMIN D3 and THIAMINE (VITAMIN B1 [THIAMINE]) for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On an unknown date, the patient experienced ILLNESS (sick 3-4 days), VACCINATION SITE PAIN (arm hurt) and CHILLS (chills). At the time of the report, ILLNESS (sick 3-4 days), VACCINATION SITE PAIN (arm hurt) and CHILLS (chills) 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 drugs also included 17gram of polyethylene glycol 3350 powder, MagniLlife muscle cramp pain reliever.  As per source document, patient had a broken back, gout arthritis, hands did not work very good and not allergic to any medicines.   This case was linked to MOD-2021-350577 (Patient Link).
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Loss of consciousness, Myalgia, Pyrexia
Clinical narrative: passed out; Fever; Headache; body aches; Dizzy; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2021, the patient experienced PYREXIA (Fever). On 12-Oct-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant). In October 2021, the patient experienced DIZZINESS (Dizzy), HEADACHE (Headache) and MYALGIA (body aches). At the time of the report, LOSS OF CONSCIOUSNESS (passed out), DIZZINESS (Dizzy), PYREXIA (Fever), HEADACHE (Headache) and MYALGIA (body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications were not reported. Treatment included injection for her dizziness.  Patient was scheduled to take her second dose on 13Nov2021.  This case concerns a 42-year-old female patient with no relevant medical history, who experienced the serious unexpected event of Loss of consciousness. The event occurred approximately 4 days after the first dose of Moderna COVID-19 Vaccine. The event seriousness assessed as serious per IME list although information in the source document does not suggest seriousness criteria fulfilling the medically significant criteria. The rechallenge was not applicable as the event occurred after the first dose. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.; Sender's Comments: This case concerns a 42-year-old female patient with no relevant medical history, who experienced the serious unexpected event of Loss of consciousness. The event occurred approximately 4 days after the first dose of Moderna COVID-19 Vaccine. The event seriousness assessed as serious per IME list although information in the source document does not suggest seriousness criteria fulfilling the medically significant criteria. The rechallenge was not applicable as the event occurred after the first dose. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: experienced trouble with her menstruation cycle; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (experienced trouble with her menstruation cycle) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 experienced MENSTRUAL DISORDER (experienced trouble with her menstruation cycle). At the time of the report, MENSTRUAL DISORDER (experienced trouble with her menstruation cycle) outcome was unknown.            No concomitant medications reported No Treatment medications reported   Most recent FOLLOW-UP information incorporated above includes: On 12-Oct-2021: Follow up received contains No New Information
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Mu COVID after 2 doses of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Mu COVID after 2 doses of vaccine) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 experienced COVID-19 (Mu COVID after 2 doses of vaccine). At the time of the report, COVID-19 (Mu COVID after 2 doses of vaccine) outcome was unknown.            No concomitant medication were reported.  No treatment information was provided by the reporter.; Sender's Comments: This case concerns a male patient with no relevant medical history, who experienced the non-serious event of COVID-19.The date of onset was not reported, neither vaccination date.The rechallenge was not applicable as no additional dose is expected to be given, and no details were provided about the doses. The benefit-risk relationship of Spikevax is not affected by this report.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: pain; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain) and CHILLS (chills) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 028A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (pain) and CHILLS (chills). At the time of the report, PAIN (pain) and CHILLS (chills) outcome was unknown.            No concomitant medications were reported.  No treatment information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received dose after more than 30 days refrigerated; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received dose after more than 30 days refrigerated) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received dose after more than 30 days refrigerated). On 11-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received dose after more than 30 days refrigerated) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment medications were provided.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE PAIN (burning sensation from his arm to his neck ~ 45 minutes after getting the vaccine) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Oct-2021, the patient experienced VACCINATION SITE PAIN (burning sensation from his arm to his neck ~ 45 minutes after getting the vaccine). At the time of the report, VACCINATION SITE PAIN (burning sensation from his arm to his neck ~ 45 minutes after getting the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   Treatment information was not provided.  The vaccine was given at the Pharmacist's clinic.