chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: it has been too long since my first dose of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (it has been too long since my first dose of the vaccine) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048a21a) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (it has been too long since my first dose of the vaccine). On 03-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (it has been too long since my first dose of the vaccine) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient got 1st dose on 3Mar2021 but vaccination card has 18Mar2021 recorded.  The health department scheduled a 2nd appoint date of 15-Apr-2021, which they called and rescheduled for 18-Apr-2021.  Concomitant product used was not provided by the reporter.  Treatment given is not provided.   This case was linked to MOD-2021-074932 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Dry skin, Vaccination site erythema, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Roughness feeling at site of injection; Starting to itch on red patch; Red patch(circle) at site of injection and below; Red patch(circle) at site of injection and below; This spontaneous case was reported by a consumer and describes the occurrence of DRY SKIN (Roughness feeling at site of injection), VACCINATION SITE PRURITUS (Starting to itch on red patch), VACCINATION SITE RASH (Red patch(circle) at site of injection and below) and VACCINATION SITE ERYTHEMA (Red patch(circle) at site of injection and below) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included LANSOPRAZOLE (PREVACID) and VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced DRY SKIN (Roughness feeling at site of injection), VACCINATION SITE PRURITUS (Starting to itch on red patch), VACCINATION SITE RASH (Red patch(circle) at site of injection and below) and VACCINATION SITE ERYTHEMA (Red patch(circle) at site of injection and below). At the time of the report, DRY SKIN (Roughness feeling at site of injection) outcome was unknown and VACCINATION SITE PRURITUS (Starting to itch on red patch), VACCINATION SITE RASH (Red patch(circle) at site of injection and below) and VACCINATION SITE ERYTHEMA (Red patch(circle) at site of injection and below) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medication included unspecified High Blood Pressure Medications.  No treatment medications were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood count, COVID-19, Chest X-ray, Chills
Clinical narrative: lost appetite; chills; ache/pain; bad cough; fever; aching in joints; headache; This spontaneous case was reported by a physician and describes the occurrence of PAIN (ache/pain), COUGH (bad cough), DECREASED APPETITE (lost appetite), CHILLS (chills) and HEADACHE (headache) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Headache in November 2020, Joint ache in November 2020, Cough in November 2020, Appetite lost in November 2020, Loss of weight in November 2020 and Muscle ache in November 2020. Previously administered products included for an unreported indication: Antibiotic therapy (Patient took Z-pack for 5 days and returned to normal.).    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced PAIN (ache/pain), COUGH (bad cough), CHILLS (chills) and PYREXIA (fever). On 02-Apr-2021, the patient experienced DECREASED APPETITE (lost appetite). In April 2021, the patient experienced HEADACHE (headache) and ARTHRALGIA (aching in joints). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. On 04-Apr-2021, PAIN (ache/pain), COUGH (bad cough), DECREASED APPETITE (lost appetite), CHILLS (chills), HEADACHE (headache) and PYREXIA (fever) had resolved. In April 2021, ARTHRALGIA (aching in joints) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Nov-2020, Body temperature: 102.5 (High) 102.5F. In November 2020, Blood count: normal wbc count (normal) normal WBC count. In November 2020, COVID-19: negative (Negative) Negative. In November 2020, Chest X-ray: cloudiness in the lung (Inconclusive) cloudiness in the lung.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment for the event included fluid.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Follow up information was received and added new events spiked fever of 102,headache,appetite was back,aching in joints, cough. On 12-May-2021: Follow up information was received and Contact information updated
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Decreased appetite, Headache, Pain, Pyrexia
Clinical narrative: lost appetite; chills; ache/pain; bad cough; fever; aching in joints; headache; This spontaneous case was reported by a physician and describes the occurrence of PAIN (ache/pain), COUGH (bad cough), DECREASED APPETITE (lost appetite), CHILLS (chills) and HEADACHE (headache) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Headache in November 2020, Joint ache in November 2020, Cough in November 2020, Appetite lost in November 2020, Loss of weight in November 2020 and Muscle ache in November 2020. Previously administered products included for an unreported indication: Antibiotic therapy (Patient took Z-pack for 5 days and returned to normal.).    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced PAIN (ache/pain), COUGH (bad cough), CHILLS (chills) and PYREXIA (fever). On 02-Apr-2021, the patient experienced DECREASED APPETITE (lost appetite). In April 2021, the patient experienced HEADACHE (headache) and ARTHRALGIA (aching in joints). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. On 04-Apr-2021, PAIN (ache/pain), COUGH (bad cough), DECREASED APPETITE (lost appetite), CHILLS (chills), HEADACHE (headache) and PYREXIA (fever) had resolved. In April 2021, ARTHRALGIA (aching in joints) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Nov-2020, Body temperature: 102.5 (High) 102.5F. In November 2020, Blood count: normal wbc count (normal) normal WBC count. In November 2020, COVID-19: negative (Negative) Negative. In November 2020, Chest X-ray: cloudiness in the lung (Inconclusive) cloudiness in the lung.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment for the event included fluid.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Follow up information was received and added new events spiked fever of 102,headache,appetite was back,aching in joints, cough. On 12-May-2021: Follow up information was received and Contact information updated
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Pruritus, Rash macular, Vaccination site inflammation
Clinical narrative: giant blotch (about 6 X 6) on arm; Blotch inflammed; blotch bumpy under skin; blotch itches bad; wrist pain; fatigue; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (giant blotch (about 6 X 6) on arm), VACCINATION SITE INFLAMMATION (Blotch inflammed), VACCINATION SITE MASS (blotch bumpy under skin), PRURITUS (blotch itches bad) and ARTHRALGIA (wrist pain) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy (Allergy to Thimerosal).    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced VACCINATION SITE PAIN (sore arm). On 01-Apr-2021, the patient experienced ARTHRALGIA (wrist pain) and FATIGUE (fatigue). On 11-Apr-2021, the patient experienced RASH MACULAR (giant blotch (about 6 X 6) on arm), VACCINATION SITE INFLAMMATION (Blotch inflammed), VACCINATION SITE MASS (blotch bumpy under skin) and PRURITUS (blotch itches bad). At the time of the report, RASH MACULAR (giant blotch (about 6 X 6) on arm), VACCINATION SITE INFLAMMATION (Blotch inflammed), VACCINATION SITE MASS (blotch bumpy under skin), PRURITUS (blotch itches bad), ARTHRALGIA (wrist pain), VACCINATION SITE PAIN (sore arm) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided Patient treated her symptoms with allergy pill and aspirin which brought blotch down to (4x4)
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site pain
Clinical narrative: giant blotch (about 6 X 6) on arm; Blotch inflammed; blotch bumpy under skin; blotch itches bad; wrist pain; fatigue; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (giant blotch (about 6 X 6) on arm), VACCINATION SITE INFLAMMATION (Blotch inflammed), VACCINATION SITE MASS (blotch bumpy under skin), PRURITUS (blotch itches bad) and ARTHRALGIA (wrist pain) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy (Allergy to Thimerosal).    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced VACCINATION SITE PAIN (sore arm). On 01-Apr-2021, the patient experienced ARTHRALGIA (wrist pain) and FATIGUE (fatigue). On 11-Apr-2021, the patient experienced RASH MACULAR (giant blotch (about 6 X 6) on arm), VACCINATION SITE INFLAMMATION (Blotch inflammed), VACCINATION SITE MASS (blotch bumpy under skin) and PRURITUS (blotch itches bad). At the time of the report, RASH MACULAR (giant blotch (about 6 X 6) on arm), VACCINATION SITE INFLAMMATION (Blotch inflammed), VACCINATION SITE MASS (blotch bumpy under skin), PRURITUS (blotch itches bad), ARTHRALGIA (wrist pain), VACCINATION SITE PAIN (sore arm) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided Patient treated her symptoms with allergy pill and aspirin which brought blotch down to (4x4)
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Oral pain
Clinical narrative: oral pain inside his mouth/bothersome than painful; This spontaneous case was reported by a consumer and describes the occurrence of ORAL PAIN (oral pain inside his mouth/bothersome than painful) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 1003B21A) for COVID-19 vaccination.     The patient's past medical history included Oral surgery NOS. Concomitant products included LEVOTHYROXINE SODIUM (LEVOTHYROXIN) and LOSARTAN for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced ORAL PAIN (oral pain inside his mouth/bothersome than painful). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, ORAL PAIN (oral pain inside his mouth/bothersome than painful) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient had some extensive oral surgery on his right side in his 20's and wondered if that is why he was experiencing this symptom.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Nausea, Nervousness, Pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN (ACHINESS), NERVOUSNESS (FEELS SHAKY LIKE NERVOUS), ASTHENIA (weak), NAUSEA (nauseas) and FATIGUE (tired) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-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 (ACHINESS), NERVOUSNESS (FEELS SHAKY LIKE NERVOUS), ASTHENIA (weak), NAUSEA (nauseas) and FATIGUE (tired). At the time of the report, PAIN (ACHINESS), NERVOUSNESS (FEELS SHAKY LIKE NERVOUS), ASTHENIA (weak), NAUSEA (nauseas) and FATIGUE (tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.  No treatment medication was provided.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Headache, Pain, Pain in extremity
Clinical narrative: arm was sore and radiating to my back and neck; radiating to her back and neck.; not able to move easily; headaches that got worse over time; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN IN EXTREMITY (arm was sore and radiating to my back and neck), PAIN (radiating to her back and neck.), GAIT DISTURBANCE (not able to move easily) and HEADACHE (headaches that got worse over time) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     Concomitant products included MAGNESIUM and GALCANEZUMAB GNLM (EMGALITY [GALCANEZUMAB GNLM]) for an unknown indication.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm was sore and radiating to my back and neck), PAIN (radiating to her back and neck.), GAIT DISTURBANCE (not able to move easily) and HEADACHE (headaches that got worse over time). The patient was treated with RIZATRIPTAN at an unspecified dose and frequency; IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and CAFFEINE, PARACETAMOL (EXCEDRIN [CAFFEINE;PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm was sore and radiating to my back and neck), PAIN (radiating to her back and neck.), GAIT DISTURBANCE (not able to move easily) and HEADACHE (headaches that got worse over time) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient also used physical therapy and massage therapy as treatment for the events.   This case was linked to MOD-2021-075055 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain, Skin burning sensation, Vaccination site induration, Vaccination site pain
Clinical narrative: red area is burning; red area is more painful; redarea is spreading from actual site; hot, hard swollen area of redness,1/2 to 1 inch below the vaccination spot; red area is itching; hard, swollen area of redness 1/2 to 1 inch below the vaccination spot spreading from actual site; pain at the injection arm; hot, hard swollen area of redness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SKIN BURNING SENSATION (red area is burning), PAIN (red area is more painful), ERYTHEMA (redarea is spreading from actual site), VACCINATION SITE WARMTH (hot, hard swollen area of redness,1/2 to 1 inch below the vaccination spot) and VACCINATION SITE PRURITUS (red area is itching) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced SKIN BURNING SENSATION (red area is burning), PAIN (red area is more painful), ERYTHEMA (redarea is spreading from actual site), VACCINATION SITE WARMTH (hot, hard swollen area of redness,1/2 to 1 inch below the vaccination spot), VACCINATION SITE PRURITUS (red area is itching), VACCINATION SITE INDURATION (hard, swollen area of redness 1/2 to 1 inch below the vaccination spot spreading from actual site), VACCINATION SITE PAIN (pain at the injection arm) and VACCINATION SITE SWELLING (hot, hard swollen area of redness). At the time of the report, SKIN BURNING SENSATION (red area is burning), PAIN (red area is more painful), ERYTHEMA (redarea is spreading from actual site), VACCINATION SITE WARMTH (hot, hard swollen area of redness,1/2 to 1 inch below the vaccination spot), VACCINATION SITE PRURITUS (red area is itching), VACCINATION SITE INDURATION (hard, swollen area of redness 1/2 to 1 inch below the vaccination spot spreading from actual site), VACCINATION SITE PAIN (pain at the injection arm) and VACCINATION SITE SWELLING (hot, hard swollen area of redness) outcome was unknown.            patient developed no symptoms after receiving the first shot. No concomitant medications were provided. Patient consulted Nurse practitioner and treated her symptoms with acetaminophen, applied ice, applied warm clot and took allergy medications as advised. Nurse Practitioner also prescribed Sulfa drug medication and suggested to start taking if , if the redness is not getting better, but according to the patient rash improved although the redness persist, has no symptoms of itching or burning pain.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: red area is burning; red area is more painful; redarea is spreading from actual site; hot, hard swollen area of redness,1/2 to 1 inch below the vaccination spot; red area is itching; hard, swollen area of redness 1/2 to 1 inch below the vaccination spot spreading from actual site; pain at the injection arm; hot, hard swollen area of redness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SKIN BURNING SENSATION (red area is burning), PAIN (red area is more painful), ERYTHEMA (redarea is spreading from actual site), VACCINATION SITE WARMTH (hot, hard swollen area of redness,1/2 to 1 inch below the vaccination spot) and VACCINATION SITE PRURITUS (red area is itching) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced SKIN BURNING SENSATION (red area is burning), PAIN (red area is more painful), ERYTHEMA (redarea is spreading from actual site), VACCINATION SITE WARMTH (hot, hard swollen area of redness,1/2 to 1 inch below the vaccination spot), VACCINATION SITE PRURITUS (red area is itching), VACCINATION SITE INDURATION (hard, swollen area of redness 1/2 to 1 inch below the vaccination spot spreading from actual site), VACCINATION SITE PAIN (pain at the injection arm) and VACCINATION SITE SWELLING (hot, hard swollen area of redness). At the time of the report, SKIN BURNING SENSATION (red area is burning), PAIN (red area is more painful), ERYTHEMA (redarea is spreading from actual site), VACCINATION SITE WARMTH (hot, hard swollen area of redness,1/2 to 1 inch below the vaccination spot), VACCINATION SITE PRURITUS (red area is itching), VACCINATION SITE INDURATION (hard, swollen area of redness 1/2 to 1 inch below the vaccination spot spreading from actual site), VACCINATION SITE PAIN (pain at the injection arm) and VACCINATION SITE SWELLING (hot, hard swollen area of redness) outcome was unknown.            patient developed no symptoms after receiving the first shot. No concomitant medications were provided. Patient consulted Nurse practitioner and treated her symptoms with acetaminophen, applied ice, applied warm clot and took allergy medications as advised. Nurse Practitioner also prescribed Sulfa drug medication and suggested to start taking if , if the redness is not getting better, but according to the patient rash improved although the redness persist, has no symptoms of itching or burning pain.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Lightheadedness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Lightheadedness) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced DIZZINESS (Lightheadedness). At the time of the report, DIZZINESS (Lightheadedness) had not resolved. Not Provided          No Concomitant product was reported.   No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous case was reported by an other (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (shingles) 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 reporter.  No concomitant medication reported.    On 17-Feb-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 HERPES ZOSTER (shingles). At the time of the report, HERPES ZOSTER (shingles) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication was reported.  Treatment information was not provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    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 (sore arm). On 12-Mar-2021, VACCINATION SITE PAIN (sore arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were provided patient took acetaminophen to treat her symptoms
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Could not get up from bed; Fatigue; body aches; Fever; Arm pain; Could not get up from bed; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain), the first episode of ASTHENIA (Could not get up from bed), the second episode of ASTHENIA (Could not get up from bed), MYALGIA (body aches) and PYREXIA (Fever) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Fibromyalgia. Concomitant products included HYDROXYZINE HCL, GABAPENTIN, VITAMIN D [VITAMIN D NOS], TRAZODONE, CYCLOBENZAPRINE and IBUPROFEN (EXCEDRIN IB) for an unknown indication.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm pain), the first episode of ASTHENIA (Could not get up from bed), MYALGIA (body aches) and PYREXIA (Fever). On 08-Apr-2021, the patient experienced the second episode of ASTHENIA (Could not get up from bed) and FATIGUE (Fatigue). On 28-Mar-2021, PAIN IN EXTREMITY (Arm pain), MYALGIA (body aches) and PYREXIA (Fever) had resolved. On 09-Apr-2021, last episode of ASTHENIA (Could not get up from bed) and FATIGUE (Fatigue) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.        No treatment was provided for the symptoms.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Product dose omission issue
Clinical narrative: did not receive the second dose; Had COVID end of january; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Had COVID end of january) and PRODUCT DOSE OMISSION ISSUE (did not receive the second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced COVID-19 (Had COVID end of january). In February 2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (did not receive the second dose). In February 2021, PRODUCT DOSE OMISSION ISSUE (did not receive the second dose) had resolved. At the time of the report, COVID-19 (Had COVID end of january) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was temporarily withheld on an unknown date.       No concomitant medications were reported Patient was not given any treatment for COVID
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at the injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Pain at the injection site). At the time of the report, VACCINATION SITE PAIN (Pain at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided.  No treatment information was given.   This case was linked to MOD-2021-075367 (Patient Link).
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain, Pyrexia
Clinical narrative: Really stiff neck from ear down to collar bone; Slight fever; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), MUSCULOSKELETAL STIFFNESS (Really stiff neck from ear down to collar bone) and PYREXIA (Slight fever) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032b21a) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Apr-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) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced PAIN (Body aches) and PYREXIA (Slight fever). On 12-Apr-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Really stiff neck from ear down to collar bone). At the time of the report, PAIN (Body aches), MUSCULOSKELETAL STIFFNESS (Really stiff neck from ear down to collar bone) and PYREXIA (Slight fever) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable  Concomitant medication includes allergy medicine.  Treatment medication was not provided.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Bone pain, Chest pain, Decreased appetite, Dyspnoea
Clinical narrative: couldn't hold head up; no appetite; every bone in body hurt; chest hurt; hard to breathe; hair hurt; nauseated; migraine; low grade fever of 99 degrees, high grade fever of 102.5 degrees that lasted 9 day; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MIGRAINE (migraine), HEAD DISCOMFORT (couldn't hold head up), DECREASED APPETITE (no appetite), BONE PAIN (every bone in body hurt) and CHEST PAIN (chest hurt) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B27A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to antibiotic (Keflex), Allergy to antibiotic (erythromycin), Drug allergy (statins) and Drug allergy (steroid injection in joints). Concomitant products included ZOLPIDEM TARTRATE (AMBIEN), BUPROPION HYDROCHLORIDE (WELLBUTRIN), SERTRALINE HYDROCHLORIDE (ZOLOFT), METOPROLOL, TOPIRAMATE (TOPAMAX) and CLONAZEPAM (KLONOPIN) for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced MIGRAINE (migraine) and PYREXIA (low grade fever of 99 degrees, high grade fever of 102.5 degrees that lasted 9 day). On 22-Mar-2021, the patient experienced HEAD DISCOMFORT (couldn't hold head up), DECREASED APPETITE (no appetite), BONE PAIN (every bone in body hurt), CHEST PAIN (chest hurt), DYSPNOEA (hard to breathe), PAIN OF SKIN (hair hurt) and NAUSEA (nauseated). The patient was treated with KETOROLAC TROMETHAMINE (TORADOL) on 03-Apr-2021 at an unspecified dose and frequency and PROCHLORPERAZINE EDISYLATE (COMPAZINE [PROCHLORPERAZINE EDISYLATE]) on 03-Apr-2021 at an unspecified dose and frequency. At the time of the report, MIGRAINE (migraine), HEAD DISCOMFORT (couldn't hold head up), DECREASED APPETITE (no appetite), BONE PAIN (every bone in body hurt), CHEST PAIN (chest hurt), DYSPNOEA (hard to breathe), PAIN OF SKIN (hair hurt), PYREXIA (low grade fever of 99 degrees, high grade fever of 102.5 degrees that lasted 9 day) and NAUSEA (nauseated) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Mar-2021, Body temperature: 99 (High) 99. On 22-Mar-2021, Body temperature: 102.5 (High) 102.5.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       0n 03-Apr-2021 the patient went to the emergency department and treatment included intravenous fluids.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Migraine, Nausea, Pain of skin, Pyrexia
Clinical narrative: couldn't hold head up; no appetite; every bone in body hurt; chest hurt; hard to breathe; hair hurt; nauseated; migraine; low grade fever of 99 degrees, high grade fever of 102.5 degrees that lasted 9 day; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MIGRAINE (migraine), HEAD DISCOMFORT (couldn't hold head up), DECREASED APPETITE (no appetite), BONE PAIN (every bone in body hurt) and CHEST PAIN (chest hurt) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B27A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to antibiotic (Keflex), Allergy to antibiotic (erythromycin), Drug allergy (statins) and Drug allergy (steroid injection in joints). Concomitant products included ZOLPIDEM TARTRATE (AMBIEN), BUPROPION HYDROCHLORIDE (WELLBUTRIN), SERTRALINE HYDROCHLORIDE (ZOLOFT), METOPROLOL, TOPIRAMATE (TOPAMAX) and CLONAZEPAM (KLONOPIN) for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced MIGRAINE (migraine) and PYREXIA (low grade fever of 99 degrees, high grade fever of 102.5 degrees that lasted 9 day). On 22-Mar-2021, the patient experienced HEAD DISCOMFORT (couldn't hold head up), DECREASED APPETITE (no appetite), BONE PAIN (every bone in body hurt), CHEST PAIN (chest hurt), DYSPNOEA (hard to breathe), PAIN OF SKIN (hair hurt) and NAUSEA (nauseated). The patient was treated with KETOROLAC TROMETHAMINE (TORADOL) on 03-Apr-2021 at an unspecified dose and frequency and PROCHLORPERAZINE EDISYLATE (COMPAZINE [PROCHLORPERAZINE EDISYLATE]) on 03-Apr-2021 at an unspecified dose and frequency. At the time of the report, MIGRAINE (migraine), HEAD DISCOMFORT (couldn't hold head up), DECREASED APPETITE (no appetite), BONE PAIN (every bone in body hurt), CHEST PAIN (chest hurt), DYSPNOEA (hard to breathe), PAIN OF SKIN (hair hurt), PYREXIA (low grade fever of 99 degrees, high grade fever of 102.5 degrees that lasted 9 day) and NAUSEA (nauseated) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Mar-2021, Body temperature: 99 (High) 99. On 22-Mar-2021, Body temperature: 102.5 (High) 102.5.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       0n 03-Apr-2021 the patient went to the emergency department and treatment included intravenous fluids.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Face oedema, Fatigue, Headache, Myalgia
Clinical narrative: Face swollen; Chills; Body aches; Tiredness; Headache; Fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FACE OEDEMA (Face swollen), CHILLS (Chills), MYALGIA (Body aches), FATIGUE (Tiredness) and HEADACHE (Headache) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to antibiotic (Augmentin), Irritable bowel syndrome since 09-Feb-2016 and Asthma (Mild) since 01-Feb-1980. Concomitant products included VITAMIN D [VITAMIN D NOS] from 15-Feb-2017 to an unknown date, VITAMIN B NOS and TIMOLOL for an unknown indication.   On 22-Jan-2021 at 4:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021 at 4:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced CHILLS (Chills), MYALGIA (Body aches), FATIGUE (Tiredness), HEADACHE (Headache) and PYREXIA (Fever). On 20-Feb-2021 at 5:00 AM, the patient experienced FACE OEDEMA (Face swollen). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) for Myalgia, at a dose of 1 dosage form; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) on 21-Feb-2021 for Facial swelling, at a dose of 1 dosage form; FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Facial swelling, at a dose of 1 dosage form and PARACETAMOL (TYLENOL) ongoing since an unknown date for Fever, at a dose of 1 dosage form. On 23-Feb-2021, CHILLS (Chills), MYALGIA (Body aches), FATIGUE (Tiredness), HEADACHE (Headache) and PYREXIA (Fever) had resolved. On 03-Mar-2021, FACE OEDEMA (Face swollen) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient stated that Diphenhydramine and Fexofenadine did not helped in facial swelling, it was subsided by itself.   This case was linked to INC.-MOD-2021-072797 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Additional VAER form was received on 19-MAY-2021 contains patient's medical history and treatment medications.; Sender's Comments: INC.-MOD-2021-072797:First dose vaccination
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Face swollen; Chills; Body aches; Tiredness; Headache; Fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FACE OEDEMA (Face swollen), CHILLS (Chills), MYALGIA (Body aches), FATIGUE (Tiredness) and HEADACHE (Headache) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to antibiotic (Augmentin), Irritable bowel syndrome since 09-Feb-2016 and Asthma (Mild) since 01-Feb-1980. Concomitant products included VITAMIN D [VITAMIN D NOS] from 15-Feb-2017 to an unknown date, VITAMIN B NOS and TIMOLOL for an unknown indication.   On 22-Jan-2021 at 4:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021 at 4:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced CHILLS (Chills), MYALGIA (Body aches), FATIGUE (Tiredness), HEADACHE (Headache) and PYREXIA (Fever). On 20-Feb-2021 at 5:00 AM, the patient experienced FACE OEDEMA (Face swollen). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) for Myalgia, at a dose of 1 dosage form; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) on 21-Feb-2021 for Facial swelling, at a dose of 1 dosage form; FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Facial swelling, at a dose of 1 dosage form and PARACETAMOL (TYLENOL) ongoing since an unknown date for Fever, at a dose of 1 dosage form. On 23-Feb-2021, CHILLS (Chills), MYALGIA (Body aches), FATIGUE (Tiredness), HEADACHE (Headache) and PYREXIA (Fever) had resolved. On 03-Mar-2021, FACE OEDEMA (Face swollen) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient stated that Diphenhydramine and Fexofenadine did not helped in facial swelling, it was subsided by itself.   This case was linked to INC.-MOD-2021-072797 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Additional VAER form was received on 19-MAY-2021 contains patient's medical history and treatment medications.; Sender's Comments: INC.-MOD-2021-072797:First dose vaccination
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Migraine, Pyrexia, Tremor
Clinical narrative: diarrhea for 48 hours; migraines on left side for 36 hours; vomiting every hour for 24 hours; night chills; fever more 100.1 degrees Fahrenheit; uncontrollable shaking for 36 hours; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea for 48 hours), TREMOR (uncontrollable shaking for 36 hours), MIGRAINE (migraines on left side for 36 hours), CHILLS (night chills) and PYREXIA (fever more 100.1 degrees Fahrenheit) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced TREMOR (uncontrollable shaking for 36 hours), CHILLS (night chills) and PYREXIA (fever more 100.1 degrees Fahrenheit). On 09-Apr-2021, the patient experienced DIARRHOEA (diarrhea for 48 hours), MIGRAINE (migraines on left side for 36 hours) and VOMITING (vomiting every hour for 24 hours). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 09-Apr-2021, CHILLS (night chills) had resolved. On 10-Apr-2021, TREMOR (uncontrollable shaking for 36 hours) and VOMITING (vomiting every hour for 24 hours) had resolved. On 11-Apr-2021, DIARRHOEA (diarrhea for 48 hours) and MIGRAINE (migraines on left side for 36 hours) had resolved. At the time of the report, PYREXIA (fever more 100.1 degrees Fahrenheit) outcome was unknown.            No concomitant medications were provided Action taken with mRNA-1273 in response to the events were Not Applicable   This case was linked to US-MODERNATX, INC.-MOD-2021-075044 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-075044:MOD-2021-075044
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: diarrhea for 48 hours; migraines on left side for 36 hours; vomiting every hour for 24 hours; night chills; fever more 100.1 degrees Fahrenheit; uncontrollable shaking for 36 hours; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea for 48 hours), TREMOR (uncontrollable shaking for 36 hours), MIGRAINE (migraines on left side for 36 hours), CHILLS (night chills) and PYREXIA (fever more 100.1 degrees Fahrenheit) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced TREMOR (uncontrollable shaking for 36 hours), CHILLS (night chills) and PYREXIA (fever more 100.1 degrees Fahrenheit). On 09-Apr-2021, the patient experienced DIARRHOEA (diarrhea for 48 hours), MIGRAINE (migraines on left side for 36 hours) and VOMITING (vomiting every hour for 24 hours). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 09-Apr-2021, CHILLS (night chills) had resolved. On 10-Apr-2021, TREMOR (uncontrollable shaking for 36 hours) and VOMITING (vomiting every hour for 24 hours) had resolved. On 11-Apr-2021, DIARRHOEA (diarrhea for 48 hours) and MIGRAINE (migraines on left side for 36 hours) had resolved. At the time of the report, PYREXIA (fever more 100.1 degrees Fahrenheit) outcome was unknown.            No concomitant medications were provided Action taken with mRNA-1273 in response to the events were Not Applicable   This case was linked to US-MODERNATX, INC.-MOD-2021-075044 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-075044:MOD-2021-075044
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: past due for his second dose of vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (past due for his second dose of vaccine.) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (past due for his second dose of vaccine.). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (past due for his second dose of vaccine.) outcome was unknown. Not Provided          No concomitant medications were provided by the reported. No Treatment History was provided by the reporter   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: TCR - No new information
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Nausea, Vomiting
Clinical narrative: dizziness; continuing headache; vomiting; nausea; shivering; This spontaneous case was reported by a pharmacist and describes the occurrence of DIZZINESS (dizziness), HEADACHE (continuing headache), VOMITING (vomiting), NAUSEA (nausea) and CHILLS (shivering) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 037K20A) for COVID-19 vaccination.     No medical history was reported.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced DIZZINESS (dizziness), HEADACHE (continuing headache), VOMITING (vomiting), NAUSEA (nausea) and CHILLS (shivering). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 15-Feb-2021, DIZZINESS (dizziness), VOMITING (vomiting), NAUSEA (nausea) and CHILLS (shivering) had resolved. At the time of the report, HEADACHE (continuing headache) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported   This case was linked to US-MODERNATX, INC.-MOD-2021-075039, MOD-2021-075081, MOD-2021-075123 (Patient Link).