chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dizziness, Erythema, Hot flush, Rash
Clinical narrative: Cough; dizziness; rash all over my body; face is red; Hot and cold flashes; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), DIZZINESS (dizziness), RASH (rash all over my body), ERYTHEMA (face is red) and HOT FLUSH (Hot and cold flashes) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced COUGH (Cough), DIZZINESS (dizziness), RASH (rash all over my body), ERYTHEMA (face is red) and HOT FLUSH (Hot and cold flashes). At the time of the report, COUGH (Cough), DIZZINESS (dizziness), RASH (rash all over my body), ERYTHEMA (face is red) and HOT FLUSH (Hot and cold flashes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not provided.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain lower, Back pain, Groin pain
Clinical narrative: Left sided groin pain; Left sided lower abdominal pain; muscle pain in his back; This spontaneous case was reported by a patient and describes the occurrence of GROIN PAIN (Left sided groin pain), ABDOMINAL PAIN LOWER (Left sided lower abdominal pain) and BACK PAIN (muscle pain in his back) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 012M20A) for COVID-19 vaccination.    Co-suspect product included non-company product PROPRANOLOL for an unknown indication.    The patient's past medical history included Colitis. Concomitant products included CALCIUM, FOLIC ACID, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), AMLODIPINE, ATORVASTATIN and PLANTAGO OVATA (METAMUCIL [PLANTAGO OVATA]) for an unknown indication.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started PROPRANOLOL (unknown route) at an unspecified dose. On 12-Mar-2021, the patient experienced GROIN PAIN (Left sided groin pain), ABDOMINAL PAIN LOWER (Left sided lower abdominal pain) and BACK PAIN (muscle pain in his back). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, GROIN PAIN (Left sided groin pain), ABDOMINAL PAIN LOWER (Left sided lower abdominal pain) and BACK PAIN (muscle pain in his back) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not Applicable.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Oropharyngeal pain
Clinical narrative: sore throat; Headache; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat) and HEADACHE (Headache) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.   On 14-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 OROPHARYNGEAL PAIN (sore throat) and HEADACHE (Headache). At the time of the report, OROPHARYNGEAL PAIN (sore throat) and HEADACHE (Headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) dosing remained unchanged.       No treatment details were provided. No concomitant medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: initial additional document. Telephone contact report added. 2nd dose details added. Action taken updated.
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia, Influenza like illness, Nausea
Clinical narrative: Hoarseness in throat; flu like symptoms; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHONIA (Hoarseness in throat), INFLUENZA LIKE ILLNESS (flu like symptoms) and NAUSEA (nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) 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 an unknown date, the patient experienced DYSPHONIA (Hoarseness in throat), INFLUENZA LIKE ILLNESS (flu like symptoms) and NAUSEA (nausea). At the time of the report, DYSPHONIA (Hoarseness in throat), INFLUENZA LIKE ILLNESS (flu like symptoms) and NAUSEA (nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medicines were not included.  Treatment medications were not provided   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Significant FU -AE Outcome Provided and FU declined
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Erythema, Pruritus, Vaccination site pain
Clinical narrative: Uncomfortable; Mild itching on trunk and upper backside; Redness; Pain in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Mild itching on trunk and upper backside), ERYTHEMA (Redness), DISCOMFORT (Uncomfortable) and VACCINATION SITE PAIN (Pain in the arm) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain in the arm). On 13-Mar-2021, the patient experienced PRURITUS (Mild itching on trunk and upper backside) and ERYTHEMA (Redness). On an unknown date, the patient experienced DISCOMFORT (Uncomfortable). On 12-Mar-2021, VACCINATION SITE PAIN (Pain in the arm) had resolved. On 15-Mar-2021, PRURITUS (Mild itching on trunk and upper backside) and ERYTHEMA (Redness) had resolved. At the time of the report, DISCOMFORT (Uncomfortable) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Pain in extremity, SARS-CoV-2 test
Clinical narrative: Patient was diagnosed with COVID; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and COVID-19 (Patient was diagnosed with COVID) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-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 13-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 05-Mar-2021, the patient experienced COVID-19 (Patient was diagnosed with COVID). At the time of the report, PAIN IN EXTREMITY (Sore arm) had resolved and COVID-19 (Patient was diagnosed with COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, SARS-CoV-2 test: positive (Positive) He is off qurantine.         No Concomitant medications was reported Treatment information was not provided   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: F/U Received on 06-MAY-2021, Dosage form updated.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Incorrect route of product administration, Myalgia, Nausea, Pain
Clinical narrative: did not feel that she got the full dose; person who vaccinated her subcutaneously with the vaccine; it came back the feeling of nausea; headache; a little bit of pain; muscle pain; She had nausea; She was headachy; This spontaneous case was reported by a consumer and describes the occurrence of UNDERDOSE (did not feel that she got the full dose), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (person who vaccinated her subcutaneously with the vaccine), PAIN (a little bit of pain), MYALGIA (muscle pain) and NAUSEA (She had nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PAIN (a little bit of pain), MYALGIA (muscle pain), NAUSEA (She had nausea) and HEADACHE (She was headachy). On 12-Mar-2021, the patient experienced NAUSEA (it came back the feeling of nausea) and HEADACHE (headache). On an unknown date, the patient experienced UNDERDOSE (did not feel that she got the full dose) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (person who vaccinated her subcutaneously with the vaccine). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 10-Mar-2021, PAIN (a little bit of pain), MYALGIA (muscle pain), NAUSEA (She had nausea) and HEADACHE (She was headachy) had resolved. On 13-Mar-2021, NAUSEA (it came back the feeling of nausea) and HEADACHE (headache) had resolved. At the time of the report, UNDERDOSE (did not feel that she got the full dose) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (person who vaccinated her subcutaneously with the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant product use was reported.  Treatment medication included Arnica Gel and Advil.   This case was linked to MOD-2021-114479 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Non significant follow up added On 07-May-2021: New events under dose, dose through subcutaneous route
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: did not feel that she got the full dose; person who vaccinated her subcutaneously with the vaccine; it came back the feeling of nausea; headache; a little bit of pain; muscle pain; She had nausea; She was headachy; This spontaneous case was reported by a consumer and describes the occurrence of UNDERDOSE (did not feel that she got the full dose), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (person who vaccinated her subcutaneously with the vaccine), PAIN (a little bit of pain), MYALGIA (muscle pain) and NAUSEA (She had nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PAIN (a little bit of pain), MYALGIA (muscle pain), NAUSEA (She had nausea) and HEADACHE (She was headachy). On 12-Mar-2021, the patient experienced NAUSEA (it came back the feeling of nausea) and HEADACHE (headache). On an unknown date, the patient experienced UNDERDOSE (did not feel that she got the full dose) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (person who vaccinated her subcutaneously with the vaccine). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 10-Mar-2021, PAIN (a little bit of pain), MYALGIA (muscle pain), NAUSEA (She had nausea) and HEADACHE (She was headachy) had resolved. On 13-Mar-2021, NAUSEA (it came back the feeling of nausea) and HEADACHE (headache) had resolved. At the time of the report, UNDERDOSE (did not feel that she got the full dose) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (person who vaccinated her subcutaneously with the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant product use was reported.  Treatment medication included Arnica Gel and Advil.   This case was linked to MOD-2021-114479 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Non significant follow up added On 07-May-2021: New events under dose, dose through subcutaneous route
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: Unknown adverse event; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Unknown adverse event) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 15-Mar-2021, the patient experienced ADVERSE EVENT (Unknown adverse event). At the time of the report, ADVERSE EVENT (Unknown adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Caller sent an email to report an Adverse Event on February 2021, but nobody called back. The caller did not want to provide more information because "is tired to provide the same information all over and over again". Did not provide the names of the adverse events.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Muscle spasms, Nodule, Peripheral swelling
Clinical narrative: Knotted arm; Warm to Touch; Boil or swollen; Left leg muscle cramps; This spontaneous case was reported by a consumer and describes the occurrence of NODULE (Knotted arm), FEELING HOT (Warm to Touch), PERIPHERAL SWELLING (Boil or swollen) and MUSCLE SPASMS (Left leg muscle cramps) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NODULE (Knotted arm), FEELING HOT (Warm to Touch), PERIPHERAL SWELLING (Boil or swollen) and MUSCLE SPASMS (Left leg muscle cramps). At the time of the report, NODULE (Knotted arm), FEELING HOT (Warm to Touch), PERIPHERAL SWELLING (Boil or swollen) and MUSCLE SPASMS (Left leg muscle cramps) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   This case was linked to MOD-2021-108719 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Feeling cold, Influenza like illness, Malaise
Clinical narrative: not feeling well; normal flu-like symptoms; couldn't get warm; shooting nerve pain (in Achilles tendon, bottom of feet, top of hands; Pain made her gasp and shocked her each time; pain struck every 5-20 seconds and happened the entire night; Chattering teeth, chills; m it felt like all her organs was hurting so it was possible muscle pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MALAISE (not feeling well), INFLUENZA LIKE ILLNESS (normal flu-like symptoms), FEELING COLD (couldn't get warm), NEURALGIA (shooting nerve pain (in Achilles tendon, bottom of feet, top of hands) and DYSPNOEA (Pain made her gasp and shocked her each time) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.  Concomitant products included MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced MALAISE (not feeling well), INFLUENZA LIKE ILLNESS (normal flu-like symptoms), FEELING COLD (couldn't get warm), NEURALGIA (shooting nerve pain (in Achilles tendon, bottom of feet, top of hands), DYSPNOEA (Pain made her gasp and shocked her each time), PAIN (pain struck every 5-20 seconds and happened the entire night), CHILLS (Chattering teeth, chills) and MYALGIA (m it felt like all her organs was hurting so it was possible muscle pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency. On 13-Mar-2021, MALAISE (not feeling well), INFLUENZA LIKE ILLNESS (normal flu-like symptoms), FEELING COLD (couldn't get warm), NEURALGIA (shooting nerve pain (in Achilles tendon, bottom of feet, top of hands), DYSPNOEA (Pain made her gasp and shocked her each time), PAIN (pain struck every 5-20 seconds and happened the entire night), CHILLS (Chattering teeth, chills) and MYALGIA (m it felt like all her organs was hurting so it was possible muscle pain) had resolved.            This case was linked to MOD-2021-216640, MOD-2021-216640 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Follow-up information received on 06 May 2021 contains updated  outcome as resolved after 2 days
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Neuralgia, Pain
Clinical narrative: not feeling well; normal flu-like symptoms; couldn't get warm; shooting nerve pain (in Achilles tendon, bottom of feet, top of hands; Pain made her gasp and shocked her each time; pain struck every 5-20 seconds and happened the entire night; Chattering teeth, chills; m it felt like all her organs was hurting so it was possible muscle pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MALAISE (not feeling well), INFLUENZA LIKE ILLNESS (normal flu-like symptoms), FEELING COLD (couldn't get warm), NEURALGIA (shooting nerve pain (in Achilles tendon, bottom of feet, top of hands) and DYSPNOEA (Pain made her gasp and shocked her each time) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.  Concomitant products included MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced MALAISE (not feeling well), INFLUENZA LIKE ILLNESS (normal flu-like symptoms), FEELING COLD (couldn't get warm), NEURALGIA (shooting nerve pain (in Achilles tendon, bottom of feet, top of hands), DYSPNOEA (Pain made her gasp and shocked her each time), PAIN (pain struck every 5-20 seconds and happened the entire night), CHILLS (Chattering teeth, chills) and MYALGIA (m it felt like all her organs was hurting so it was possible muscle pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency. On 13-Mar-2021, MALAISE (not feeling well), INFLUENZA LIKE ILLNESS (normal flu-like symptoms), FEELING COLD (couldn't get warm), NEURALGIA (shooting nerve pain (in Achilles tendon, bottom of feet, top of hands), DYSPNOEA (Pain made her gasp and shocked her each time), PAIN (pain struck every 5-20 seconds and happened the entire night), CHILLS (Chattering teeth, chills) and MYALGIA (m it felt like all her organs was hurting so it was possible muscle pain) had resolved.            This case was linked to MOD-2021-216640, MOD-2021-216640 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Follow-up information received on 06 May 2021 contains updated  outcome as resolved after 2 days
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Fatigue, Headache, SARS-CoV-2 antibody test
Clinical narrative: Back Pain; Fatigue; Headache; Knee Pain/Shoulder Pain/Joint Pain; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back Pain), FATIGUE (Fatigue), HEADACHE (Headache) and ARTHRALGIA (Knee Pain/Shoulder Pain/Joint Pain) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Bronchitis (Hospitalized) since an unknown date. Concurrent medical conditions included Thyroid disorder NOS and Blood pressure fluctuation.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced BACK PAIN (Back Pain), FATIGUE (Fatigue), HEADACHE (Headache) and ARTHRALGIA (Knee Pain/Shoulder Pain/Joint Pain). The patient was treated with NAPROXEN SODIUM (ALEVE) for Pain, at an unspecified dose and frequency. At the time of the report, BACK PAIN (Back Pain), FATIGUE (Fatigue), HEADACHE (Headache) and ARTHRALGIA (Knee Pain/Shoulder Pain/Joint Pain) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: negative (Negative) negative.         It was reported that patient was on thyroid and blood pressure medications. Before receiving the vaccination, patient was in a hospital for bronchitis and was on medication for 10 days.  Action taken with mRNA-1273 in response to events was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-108731 (E2B Linked Report).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Second dose vaccine date was added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-108731:second dose case
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Pyrexia
Clinical narrative: headache; sweaty; Feverish; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweaty), PYREXIA (Feverish) and HEADACHE (headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced HYPERHIDROSIS (sweaty) and PYREXIA (Feverish). On 14-Mar-2021, the patient experienced HEADACHE (headache). At the time of the report, HYPERHIDROSIS (sweaty), PYREXIA (Feverish) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   Treatment information was not provided.   Reporter did not allow further contact
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Night sweats, Vaccination site pain
Clinical narrative: Night sweat; Injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (Night sweat) and VACCINATION SITE PAIN (Injection site pain) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038K20A and 010M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Jan-2021, the patient experienced VACCINATION SITE PAIN (Injection site pain). On 25-Jan-2021, the patient experienced NIGHT SWEATS (Night sweat). On 25-Jan-2021, NIGHT SWEATS (Night sweat) and VACCINATION SITE PAIN (Injection site pain) had resolved.            No concomitant medications were provided. Treatment information provided mentioned Tylenol, Zyrtec, and hydrocortisone 2.5%.  Action taken with mRNA-1273 in response to the event was not applicable as patient received both doses of the vaccine.   This case was linked to MOD-2021-058663 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Induration
Clinical narrative: Red area in arm; Hard area in arm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red area in arm) and INDURATION (Hard area in arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced ERYTHEMA (Red area in arm) and INDURATION (Hard area in arm). At the time of the report, ERYTHEMA (Red area in arm) and INDURATION (Hard area in arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant Medication were provided. No Treatment Medications were provided.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: shortness of breath for about 30 minutes; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath for about 30 minutes) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 20-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 DYSPNOEA (shortness of breath for about 30 minutes). On 28-Feb-2021, DYSPNOEA (shortness of breath for about 30 minutes) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: Received a dose of the Moderna COVID19 vaccine from a vial that went through a temperature; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Received a dose of the Moderna COVID19 vaccine from a vial that went through a temperature) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (Received a dose of the Moderna COVID19 vaccine from a vial that went through a temperature). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Received a dose of the Moderna COVID19 vaccine from a vial that went through a temperature) 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 provided by the reporter.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Heart rate, Heart rate increased
Clinical narrative: Increased Heart rates; A spontaneous report was received from a consumer (patient) concerning a 43-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced increased heart rate.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 5 Mar 2021, 14 hours prior to the onset of the events the patient received second of two planned doses of mRNA-1273 (batch: 032M20A) Intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 5 Mar 2021, experienced increased heart rate. Her baseline heart rate is usually 60-80 bpm, it went up 120-130 bpm. On 9 Mar 2021, she went to an urgent care. On the same day, electrocardiogram (EKG) was normal. On 15 Mar 2021, the patient followed-up with her doctor and was asked to get some lab work done which she planned to do on 16 Mar 2021.  No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.   The outcome of event of increased heart rate was unknown.   The reporter did not provide assessment for the event of increased heart rate.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Myalgia, Rash erythematous, Vaccination site pain
Clinical narrative: red splotchy rash; CHILLS; soreness at the injection site; body aches or feeling horrible; joint aches or feeling horrible; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (red splotchy rash), CHILLS (CHILLS), VACCINATION SITE PAIN (soreness at the injection site), MYALGIA (body aches or feeling horrible) and ARTHRALGIA (joint aches or feeling horrible) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030LZOA?) for COVID-19 vaccination.    Co-suspect product included non-company product IBUPROFEN for Symptomatic treatment.    No medical history reported by the reporter.  Concomitant products included METOPROLOL SUCCINATE for an unknown indication.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started IBUPROFEN (unknown route) 1 dosage form(s). On 10-Mar-2021, the patient experienced RASH ERYTHEMATOUS (red splotchy rash). In March 2021, the patient experienced CHILLS (CHILLS), VACCINATION SITE PAIN (soreness at the injection site), MYALGIA (body aches or feeling horrible) and ARTHRALGIA (joint aches or feeling horrible). At the time of the report, RASH ERYTHEMATOUS (red splotchy rash), CHILLS (CHILLS), VACCINATION SITE PAIN (soreness at the injection site), MYALGIA (body aches or feeling horrible) and ARTHRALGIA (joint aches or feeling horrible) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        Reporter did not allow further contact
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bedridden, Fibromyalgia, Myalgia, Photophobia
Clinical narrative: Enflamed her fibromyalgia; Injection site pain; Aversion to light; Excruciating muscle pain from head to toe; Joints were really bad; Ended up in bed for three days; This spontaneous case was reported by a consumer and describes the occurrence of FIBROMYALGIA (Enflamed her fibromyalgia), PHOTOPHOBIA (Aversion to light), BEDRIDDEN (Ended up in bed for three days), MYALGIA (Excruciating muscle pain from head to toe) and ARTHRALGIA (Joints were really bad) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010AZIA and 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Fibromyalgia.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced PHOTOPHOBIA (Aversion to light), MYALGIA (Excruciating muscle pain from head to toe) and ARTHRALGIA (Joints were really bad). On an unknown date, the patient experienced FIBROMYALGIA (Enflamed her fibromyalgia), BEDRIDDEN (Ended up in bed for three days) and VACCINATION SITE PAIN (Injection site pain). The patient was treated with CELECOXIB (CELEBREX) at an unspecified dose and frequency. At the time of the report, FIBROMYALGIA (Enflamed her fibromyalgia) and ARTHRALGIA (Joints were really bad) was resolving, PHOTOPHOBIA (Aversion to light) and VACCINATION SITE PAIN (Injection site pain) outcome was unknown and BEDRIDDEN (Ended up in bed for three days) and MYALGIA (Excruciating muscle pain from head to toe) had resolved.            No concomitant medications were provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Enflamed her fibromyalgia; Injection site pain; Aversion to light; Excruciating muscle pain from head to toe; Joints were really bad; Ended up in bed for three days; This spontaneous case was reported by a consumer and describes the occurrence of FIBROMYALGIA (Enflamed her fibromyalgia), PHOTOPHOBIA (Aversion to light), BEDRIDDEN (Ended up in bed for three days), MYALGIA (Excruciating muscle pain from head to toe) and ARTHRALGIA (Joints were really bad) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010AZIA and 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Fibromyalgia.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced PHOTOPHOBIA (Aversion to light), MYALGIA (Excruciating muscle pain from head to toe) and ARTHRALGIA (Joints were really bad). On an unknown date, the patient experienced FIBROMYALGIA (Enflamed her fibromyalgia), BEDRIDDEN (Ended up in bed for three days) and VACCINATION SITE PAIN (Injection site pain). The patient was treated with CELECOXIB (CELEBREX) at an unspecified dose and frequency. At the time of the report, FIBROMYALGIA (Enflamed her fibromyalgia) and ARTHRALGIA (Joints were really bad) was resolving, PHOTOPHOBIA (Aversion to light) and VACCINATION SITE PAIN (Injection site pain) outcome was unknown and BEDRIDDEN (Ended up in bed for three days) and MYALGIA (Excruciating muscle pain from head to toe) had resolved.            No concomitant medications were provided.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Exposure during pregnancy, Gestational diabetes, Pregnancy test, Ultrasound scan
Clinical narrative: pregnant; the most gnarly bruise, started at the injection site, it was really large, dark and purple; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of CONTUSION (the most gnarly bruise, started at the injection site, it was really large, dark and purple) and EXPOSURE DURING PREGNANCY (pregnant) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     The patient's past medical history included Fertilization (Genetically normal embryo prior to transfer for IVF). Previously administered products included for In vitro fertilization: Estrogen from 04-Sep-2020 to 20-Nov-2020 and Progesterone since 04-Sep-2020. Concomitant products included LEVOTHYROXINE and MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 13-Feb-2021 at 3:55 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 29-May-2021. On 14-Feb-2021, the patient experienced CONTUSION (the most gnarly bruise, started at the injection site, it was really large, dark and purple). On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (pregnant). On 05-Mar-2021, CONTUSION (the most gnarly bruise, started at the injection site, it was really large, dark and purple) had resolved. At the time of the report, EXPOSURE DURING PREGNANCY (pregnant) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Sep-2020, Pregnancy test: positive (Positive) Positive. On 28-Oct-2020, Ultrasound scan: (normal) Patient's ultrasound results were normal.. On 04-Mar-2021, Gestational diabetes: (Negative) Patient's gestational diabetes results were negative..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was tested positive for pregnancy on 14-Sep-2020 and estimated date of conception was 10-Sep-2020. Patient had two anatomy scans on 06-Jan2021 and 20-Jan-2021, results were not reported and scheduled for another scan on 01-Apr-2021. No treatment information was reported.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Soreness of the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness of the arm) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03A21A) 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 PAIN IN EXTREMITY (Soreness of the arm). At the time of the report, PAIN IN EXTREMITY (Soreness of the arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Injection site, hot to touch; Swelling at the injection site; Blotchy red near the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site, hot to touch), VACCINATION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE ERYTHEMA (Blotchy red near the injection site) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 immunisation.     No Medical History information was reported.   On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Injection site, hot to touch). 13-Mar-2021, the patient experienced VACCINATION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE ERYTHEMA (Blotchy red near the injection site). The patient was treated with NAPROXEN at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Injection site, hot to touch), VACCINATION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE ERYTHEMA (Blotchy red near the injection site) outcome was unknown.            Concomitant medications was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Follow-up information received  contains non-significant information
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Severe persistent arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Severe persistent arm pain) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Mar-2021 at 2:00 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Severe persistent arm pain). The patient was treated with PARACETAMOL (TYLENOL) for Pain in arm, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Pain in arm, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Severe persistent arm pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Heart rate, Hypersensitivity
Clinical narrative: he felt his face warm; his face was red; he thinks he had allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (he felt his face warm), ERYTHEMA (his face was red) and HYPERSENSITIVITY (he thinks he had allergic reaction) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No relevant medical history was reported.  Concomitant products included PRAVASTATIN, METFORMIN and ACETYLSALICYLIC ACID (ASPIRIN) for an unknown indication.    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 FEELING HOT (he felt his face warm). 09-Mar-2021, the patient experienced ERYTHEMA (his face was red) and HYPERSENSITIVITY (he thinks he had allergic reaction). On 09-Mar-2021, FEELING HOT (he felt his face warm), ERYTHEMA (his face was red) and HYPERSENSITIVITY (he thinks he had allergic reaction) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2021, Heart rate: 75-185 (Inconclusive) 75-185.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient also reported his "RPM from 75 to 185.... he felt okay all the time."  No treatment medications provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-046377 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: the patient stated he took 2nd dose of Moderna and he felt fine with no issues. Denied additional follow-up; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-046377:Husband case
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Patient got 3rd dose of vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (Patient got 3rd dose of vaccine) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012a21a, 011m20a and 037k20a) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Mar-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced EXTRA DOSE ADMINISTERED (Patient got 3rd dose of vaccine). On 15-Mar-2021, EXTRA DOSE ADMINISTERED (Patient got 3rd dose of vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-044862, MOD-2021-044851 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2021: Non significant follow up received on 06-APR-2021, no new information
Sex: F
Vaccine: COVID19
Symptoms: Arthritis
Clinical narrative: hurting arthritis pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (hurting arthritis pain) 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 for an unknown indication.    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 ARTHRITIS (hurting arthritis pain). The patient was treated with ACETYLSALICYLIC ACID for Adverse event, at an unspecified dose and frequency. At the time of the report, ARTHRITIS (hurting arthritis pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Infection, Vaccination site pain
Clinical narrative: surgery due to infection; Injection site shoulder pain; headache; This spontaneous case was reported by a consumer and describes the occurrence of INFECTION (surgery due to infection), VACCINATION SITE PAIN (Injection site shoulder pain) and HEADACHE (headache) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     Concomitant products included FENTANYL, HYDROCODONE, PROMETHAZINE, MOMETASONE FUROATE (NASONEX), FLUTICASONE, SODIUM PROPIONATE (PROPIONATE), INSULIN, TRAVOPROST, DIAZEPAM, VITAMIN C [ASCORBIC ACID], METFORMIN, PREDNISONE, ACETYLSALICYLIC ACID (BABY ASPIRIN), HYDROCHLOROTHIAZIDE, MIRABEGRON (MYRBETRIQ), ATORVASTATIN, LISINOPRIL, VITAMIN D [VITAMIN D NOS], MULTIVITAMIN [VITAMINS NOS], MAGNESIUM, Co-Q10, SITAGLIPTIN PHOSPHATE (JANUVIA [SITAGLIPTIN PHOSPHATE]) and CURCUMA LONGA (TURMERIC [CURCUMA LONGA]) for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced VACCINATION SITE PAIN (Injection site shoulder pain) and HEADACHE (headache). On an unknown date, the patient experienced INFECTION (surgery due to infection). At the time of the report, INFECTION (surgery due to infection), VACCINATION SITE PAIN (Injection site shoulder pain) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication also included PreserVision Areds 2 Eye Vitamin Mineral  No information about treatment was given.