chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, Hyperhidrosis, Inappropriate schedule of product administration, Nausea
Clinical narrative: Patient received the first dose on 19Apr2021 and took the second dose today; vomiting profusely; headache; nausea; dizziness; sweating; pale; This spontaneous case was reported by a nurse and describes the occurrence of DIZZINESS (dizziness), HYPERHIDROSIS (sweating), PALLOR (pale), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the first dose on 19Apr2021 and took the second dose today) and VOMITING (vomiting profusely) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Apr-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 10-May-2021, the patient experienced DIZZINESS (dizziness), HYPERHIDROSIS (sweating), PALLOR (pale), VOMITING (vomiting profusely), HEADACHE (headache) and NAUSEA (nausea). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the first dose on 19Apr2021 and took the second dose today). At the time of the report, DIZZINESS (dizziness), HYPERHIDROSIS (sweating), PALLOR (pale), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the first dose on 19Apr2021 and took the second dose today), VOMITING (vomiting profusely), HEADACHE (headache) and NAUSEA (nausea) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   treatment included Advil.  Concomitant product use was not provided by the reporter.  Action taken with mRNA-1273 in response to the event was not applicable.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Pallor, Vomiting
Clinical narrative: Patient received the first dose on 19Apr2021 and took the second dose today; vomiting profusely; headache; nausea; dizziness; sweating; pale; This spontaneous case was reported by a nurse and describes the occurrence of DIZZINESS (dizziness), HYPERHIDROSIS (sweating), PALLOR (pale), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the first dose on 19Apr2021 and took the second dose today) and VOMITING (vomiting profusely) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Apr-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 10-May-2021, the patient experienced DIZZINESS (dizziness), HYPERHIDROSIS (sweating), PALLOR (pale), VOMITING (vomiting profusely), HEADACHE (headache) and NAUSEA (nausea). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the first dose on 19Apr2021 and took the second dose today). At the time of the report, DIZZINESS (dizziness), HYPERHIDROSIS (sweating), PALLOR (pale), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the first dose on 19Apr2021 and took the second dose today), VOMITING (vomiting profusely), HEADACHE (headache) and NAUSEA (nausea) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   treatment included Advil.  Concomitant product use was not provided by the reporter.  Action taken with mRNA-1273 in response to the event was not applicable.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second dose administered 18 days after the first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose administered 18 days after the first dose) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose administered 18 days after the first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose administered 18 days after the first dose) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were provide No concomitant medications were reported.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Adverse event, Blood test, Emotional distress
Clinical narrative: No mental comfort; Not developing any Antibodies; This spontaneous case was reported by a consumer and describes the occurrence of EMOTIONAL DISTRESS (No mental comfort) and ADVERSE EVENT (Not developing any Antibodies) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PREGABALIN (LYRICA), ATORVASTATIN, ASPIRIN [ACETYLSALICYLIC ACID], CYANOCOBALAMIN (VITAMIN B 12 [CYANOCOBALAMIN]), VITAMIN C [ASCORBIC ACID], BACLOFEN, METOPROLOL and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EMOTIONAL DISTRESS (No mental comfort) and ADVERSE EVENT (Not developing any Antibodies). At the time of the report, EMOTIONAL DISTRESS (No mental comfort) and ADVERSE EVENT (Not developing any Antibodies) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: no antibodies (abnormal) No antibodies in system and has an abnormal protein which is called monoclonal protein and it could be a multiple myeloma precursor.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient tested for COVID-19 but no results. No treatment was provided.    Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Contact information updated
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: After receiving the 2nd dose experienced occasional chest tightness, for the last 2 to 3 weeks; When tightness happens has to labor to catch his breath, it wasn't really painful but more debilitating; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CHEST DISCOMFORT (After receiving the 2nd dose experienced occasional chest tightness, for the last 2 to 3 weeks) and DYSPNOEA (When tightness happens has to labor to catch his breath, it wasn't really painful but more debilitating) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 042L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Blood pressure and Glaucoma. Concomitant products included LOSARTAN for Blood pressure management.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced CHEST DISCOMFORT (After receiving the 2nd dose experienced occasional chest tightness, for the last 2 to 3 weeks) and DYSPNOEA (When tightness happens has to labor to catch his breath, it wasn't really painful but more debilitating). At the time of the report, CHEST DISCOMFORT (After receiving the 2nd dose experienced occasional chest tightness, for the last 2 to 3 weeks) and DYSPNOEA (When tightness happens has to labor to catch his breath, it wasn't really painful but more debilitating) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient eye drops for glaucoma.  The action taken with the drug in response to the event(s) was not applicable.    This case was linked to MOD-2021-116578 (Patient Link).
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Pain
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of mild pain, very mild dizziness and balance disorder (trouble of equilibrium) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 039B21A and 048A21A) for COVID-19 immunization. Concurrent medical conditions included heartburn. On Mar 17, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Apr 14, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Apr 15, 2021, after the mRNA-1273 (Moderna COVID-19 vaccine), patient had mild pain. On an unknown date, patient experienced very mild dizziness and balance disorder (trouble of equilibrium). At the time of the report, mild pain, very mild dizziness and balance disorder (trouble of equilibrium) outcome: unknown/not provided. The reporter did not provide any causality assessments, concomitant medications or treatment medications. This case linked to MOD-2021-053448 (patient link).
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Facial pain, Fatigue, Headache, Hypoaesthesia
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CONFUSIONAL STATE (she experienced confusion), FACIAL PAIN (pain and numbness in face), HYPOAESTHESIA (numbness in face), MIGRAINE (She also had pain in her head almost like a migraine) and ILLNESS (just wasn't feeling well) in a 28-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 COVID-19 in March 2021.On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-May-2021, the patient experienced CONFUSIONAL STATE (she experienced confusion), FACIAL PAIN (pain and numbness in face), HYPOAESTHESIA (numbness in face), MIGRAINE (She also had pain in her head almost like a migraine), FATIGUE (extreme fatigue, couldn't keep her eyes open) and HEADACHE (temples felt sore and stuffy). On 10-May-2021, the patient experienced ILLNESS (just wasn't feeling well). The patient was treated with VITAMINS NOS at an unspecified dose and frequency. At the time of the report, CONFUSIONAL STATE (she experienced confusion), FACIAL PAIN (pain and numbness in face), HYPOAESTHESIA (numbness in face), MIGRAINE (She also had pain in her head almost like a migraine), ILLNESS (just wasn't feeling well), FATIGUE (extreme fatigue, couldn't keep her eyes open) and HEADACHE (temples felt sore and stuffy) outcome was unknown. No concomitant medication not provided. No treatment information provided. Action taken with mRNA-1273 in response to the event/s was not applicable. This case was linked to US-MODERNATX, INC.-MOD-2021-116590 (Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2021-116590:dose 1
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Migraine
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CONFUSIONAL STATE (she experienced confusion), FACIAL PAIN (pain and numbness in face), HYPOAESTHESIA (numbness in face), MIGRAINE (She also had pain in her head almost like a migraine) and ILLNESS (just wasn't feeling well) in a 28-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 COVID-19 in March 2021.On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-May-2021, the patient experienced CONFUSIONAL STATE (she experienced confusion), FACIAL PAIN (pain and numbness in face), HYPOAESTHESIA (numbness in face), MIGRAINE (She also had pain in her head almost like a migraine), FATIGUE (extreme fatigue, couldn't keep her eyes open) and HEADACHE (temples felt sore and stuffy). On 10-May-2021, the patient experienced ILLNESS (just wasn't feeling well). The patient was treated with VITAMINS NOS at an unspecified dose and frequency. At the time of the report, CONFUSIONAL STATE (she experienced confusion), FACIAL PAIN (pain and numbness in face), HYPOAESTHESIA (numbness in face), MIGRAINE (She also had pain in her head almost like a migraine), ILLNESS (just wasn't feeling well), FATIGUE (extreme fatigue, couldn't keep her eyes open) and HEADACHE (temples felt sore and stuffy) outcome was unknown. No concomitant medication not provided. No treatment information provided. Action taken with mRNA-1273 in response to the event/s was not applicable. This case was linked to US-MODERNATX, INC.-MOD-2021-116590 (Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2021-116590:dose 1
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Patient received 1st dose of the vaccine and tested positive for covid 5 days later; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Patient received 1st dose of the vaccine and tested positive for covid 5 days later) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, the patient experienced COVID-19 (Patient received 1st dose of the vaccine and tested positive for covid 5 days later). At the time of the report, COVID-19 (Patient received 1st dose of the vaccine and tested positive for covid 5 days later) outcome was unknown. 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.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration
Clinical narrative: got the vaccine back in Jan2021 and had COVID-19 shortly afterwards; second dose is past day 36; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (got the vaccine back in Jan2021 and had COVID-19 shortly afterwards) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose is past day 36) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 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 COVID-19 (got the vaccine back in Jan2021 and had COVID-19 shortly afterwards) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose is past day 36). At the time of the report, COVID-19 (got the vaccine back in Jan2021 and had COVID-19 shortly afterwards) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose is past day 36) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant information provided.  no treatment information provided
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Papilloma viral infection
Clinical narrative: Human Papilloma Virus; Felt a little sore; This spontaneous case was reported by a consumer and describes the occurrence of PAPILLOMA VIRAL INFECTION (Human Papilloma Virus) and MYALGIA (Felt a little sore) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, the patient experienced MYALGIA (Felt a little sore). On an unknown date, the patient experienced PAPILLOMA VIRAL INFECTION (Human Papilloma Virus). On 14-Apr-2021, PAPILLOMA VIRAL INFECTION (Human Papilloma Virus) and MYALGIA (Felt a little sore) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment medication was reported.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed second dose (more than 3 months since first dose)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second dose (more than 3 months since first dose)). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed second dose (more than 3 months since first dose)) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided.  No treatment information was provided.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Malaise, Migraine, Pain in extremity, Pyrexia
Clinical narrative: arm hurting; migraine; did not feel well for 10 days; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurting), MIGRAINE (migraine), MALAISE (did not feel well for 10 days), CHILLS (Chills) and PYREXIA (Fever) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PARACETAMOL (TYLENOL), IBUPROFEN (ADVIL 12 HOUR) and CAFFEINE, PARACETAMOL (EXCEDRIN ASPIRIN FREE) for an unknown indication.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm hurting), MIGRAINE (migraine), MALAISE (did not feel well for 10 days), CHILLS (Chills) and PYREXIA (Fever). At the time of the report, PAIN IN EXTREMITY (arm hurting), MIGRAINE (migraine), MALAISE (did not feel well for 10 days), CHILLS (Chills) and PYREXIA (Fever) had resolved.            Vitamins were used as concomitant medications. No treatment medications were reported. Action taken with mRNA-1273 in response to the event/s was not applicable.   This case was linked to MOD-2021-117042 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Follow-up information received on 08  JUN  2021 contain information include event outcome updated.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Mixed Covid 19; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Mixed Covid 19) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B212A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    Concurrent medical conditions included Penicillin allergy.   On 27-Mar-2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Mixed Covid 19). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Mixed Covid 19) 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 went over the side effects for Moderna. Reporter scheduled his second shot no knowing until today that he already had received the Pfizer IMZ for his first dose. Reporter called that patient to inform him that according to the CDD he is finished with his COVID IMZs now and he will cancel his second Moder IMZ. He was fine.  No concomitant medication information was provided. No treatment medication were reported.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Follow up received on 14-JUN-2021. Reporter phone number has been updated. Patient details has been updated. Penicillin allergy has been updated. Additional suspect drug Pfizer IMZ has been updated.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second dose was over 42-day window; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose was over 42-day window) in a patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose was over 42-day window). On 08-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose was over 42-day window) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.  No relevant concomitant medications were reported.   Treatment information was not provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort
Clinical narrative: burning of left ear; This spontaneous case was reported by a consumer and describes the occurrence of EAR DISCOMFORT (burning of left ear) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced EAR DISCOMFORT (burning of left ear). At the time of the report, EAR DISCOMFORT (burning of left ear) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included vitamins and OTC allergy medications. Treatment information was not provided.   This case was linked to MOD-2021-116615 (Patient Link).
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Anosmia, Chills, Dry mouth, Feeling abnormal, Muscle fatigue
Clinical narrative: Muscle fatigue; loss of smell; dry mouth; felt wobbly; chills; This spontaneous case was reported by an other health care professional and describes the occurrence of MUSCLE FATIGUE (Muscle fatigue), ANOSMIA (loss of smell), DRY MOUTH (dry mouth), FEELING ABNORMAL (felt wobbly) and CHILLS (chills) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Muscle damage. Concomitant products included MELOXICAM for Muscle damage.    In April 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCLE FATIGUE (Muscle fatigue), ANOSMIA (loss of smell), DRY MOUTH (dry mouth), FEELING ABNORMAL (felt wobbly) and CHILLS (chills). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, MUSCLE FATIGUE (Muscle fatigue), ANOSMIA (loss of smell), DRY MOUTH (dry mouth), FEELING ABNORMAL (felt wobbly) and CHILLS (chills) outcome was unknown. 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.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Pain
Clinical narrative: Redness remained in the arm; hurting; tired; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness remained in the arm), PAIN (hurting) and FATIGUE (tired) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.    On 13-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 ERYTHEMA (Redness remained in the arm), PAIN (hurting) and FATIGUE (tired). At the time of the report, ERYTHEMA (Redness remained in the arm), PAIN (hurting) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details not provided.  Concomitant drug details not provided.
Age: 72.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Blister, Burning sensation, Ear discomfort, Erythema
Clinical narrative: burns on ears, face, scalp; burns on ears, face, scalp; red and bubbling of skin on ears, face, scalp; blistering; burns from inside out; This spontaneous case was reported by a consumer and describes the occurrence of EAR DISCOMFORT (burns on ears, face, scalp), BURNING SENSATION (burns on ears, face, scalp), ERYTHEMA (red and bubbling of skin on ears, face, scalp), BLISTER (blistering) and BURNING SENSATION (burns from inside out) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 029A21A) for COVID-19 vaccination.    Co-suspect product included non-company product CEFALEXIN (KEFLEX [CEFALEXIN]) for an unknown indication.    No medical history was provided by the reporter.  Concomitant products included VITAMINS NOS for an unknown indication.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient started CEFALEXIN (KEFLEX [CEFALEXIN]) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced EAR DISCOMFORT (burns on ears, face, scalp), BURNING SENSATION (burns on ears, face, scalp), ERYTHEMA (red and bubbling of skin on ears, face, scalp), BLISTER (blistering) and BURNING SENSATION (burns from inside out). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALTREX) at a dose of 1 dosage form. At the time of the report, EAR DISCOMFORT (burns on ears, face, scalp), BURNING SENSATION (burns on ears, face, scalp), ERYTHEMA (red and bubbling of skin on ears, face, scalp) and BLISTER (blistering) was resolving and BURNING SENSATION (burns from inside out) outcome was unknown. Not Provided          Concomitant medication included OTC allergy medication.  Action taken with mRNA-1273 in response to the event was not applicable.  Patient was received treatment of Valtrex, Keflex, ointment.  Patient has been to 3 doctors who has prescribed medications but no diagnosis.It was first thought to be shingles but all physicians involved were unsure. Symptoms was calmed down and burns were continuing to dry out.   This case was linked to US-MODERNATX, INC.-MOD-2021-116609 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-116609:
Sex: F
Vaccine: COVID19
Symptoms: Spinal pain
Clinical narrative: Spinal pain; This spontaneous case was reported by a consumer and describes the occurrence of SPINAL PAIN (Spinal pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SPINAL PAIN (Spinal pain). At the time of the report, SPINAL PAIN (Spinal pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported No treatment drugs were reported   This case was linked to US-MODERNATX, INC.-MOD-2021-116619, US-MODERNATX, INC.-MOD-2021-116654, US-MODERNATX, INC.-MOD-2021-116661 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-116619:Crosslinked with cluster case US-MODERNATX, INC.-MOD-2021-116654:Case for daughter US-MODERNATX, INC.-MOD-2021-116661:case daughter
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discharge
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE DISCHARGE (dot of liquid on top of band-aid was seen) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination. No Medical History information was reported. On 08-May-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 VACCINATION SITE DISCHARGE (dot of liquid on top of band-aid was seen). At the time of the report, VACCINATION SITE DISCHARGE (dot of liquid on top of band-aid was seen) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications was reported. No treatment information was provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Chest pain, Crying, Discomfort, Dysphonia
Clinical narrative: sciatica; Burning sensation; walking with difficulty; Discomfort; chest pain; screaming; crying; tooth ache; Voice disturbance; Pain in extremity; Numbness in feet; headache; This spontaneous case was reported by a consumer and describes the occurrence of SCIATICA (sciatica), BURNING SENSATION (Burning sensation), GAIT DISTURBANCE (walking with difficulty), DISCOMFORT (Discomfort ) and CHEST PAIN (chest pain) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Tachycardia and Cholesterol. Concomitant products included SIMVASTATIN for Cholesterol, METOPROLOL for Tachycardia, VITAMINS NOS for an unknown indication.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SCIATICA (sciatica), BURNING SENSATION (Burning sensation), GAIT DISTURBANCE (walking with difficulty), DISCOMFORT (Discomfort ), CHEST PAIN (chest pain), SCREAMING (screaming), CRYING (crying), TOOTHACHE (tooth ache), DYSPHONIA (Voice disturbance), PAIN IN EXTREMITY (Pain in extremity), HYPOAESTHESIA (Numbness in feet) and HEADACHE (headache). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, SCIATICA (sciatica), BURNING SENSATION (Burning sensation), GAIT DISTURBANCE (walking with difficulty), DISCOMFORT (Discomfort ), CHEST PAIN (chest pain), SCREAMING (screaming), CRYING (crying), TOOTHACHE (tooth ache), DYSPHONIA (Voice disturbance), PAIN IN EXTREMITY (Pain in extremity) and HYPOAESTHESIA (Numbness in feet) outcome was unknown and HEADACHE (headache) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: increased (High) increased.         Action taken for Moderna COVID-19 Vaccine was not applicable.   This case was linked to MOD-2021-072476 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: New event was added.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Headache, Heart rate, Hypoaesthesia, Pain in extremity
Clinical narrative: sciatica; Burning sensation; walking with difficulty; Discomfort; chest pain; screaming; crying; tooth ache; Voice disturbance; Pain in extremity; Numbness in feet; headache; This spontaneous case was reported by a consumer and describes the occurrence of SCIATICA (sciatica), BURNING SENSATION (Burning sensation), GAIT DISTURBANCE (walking with difficulty), DISCOMFORT (Discomfort ) and CHEST PAIN (chest pain) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Tachycardia and Cholesterol. Concomitant products included SIMVASTATIN for Cholesterol, METOPROLOL for Tachycardia, VITAMINS NOS for an unknown indication.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SCIATICA (sciatica), BURNING SENSATION (Burning sensation), GAIT DISTURBANCE (walking with difficulty), DISCOMFORT (Discomfort ), CHEST PAIN (chest pain), SCREAMING (screaming), CRYING (crying), TOOTHACHE (tooth ache), DYSPHONIA (Voice disturbance), PAIN IN EXTREMITY (Pain in extremity), HYPOAESTHESIA (Numbness in feet) and HEADACHE (headache). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, SCIATICA (sciatica), BURNING SENSATION (Burning sensation), GAIT DISTURBANCE (walking with difficulty), DISCOMFORT (Discomfort ), CHEST PAIN (chest pain), SCREAMING (screaming), CRYING (crying), TOOTHACHE (tooth ache), DYSPHONIA (Voice disturbance), PAIN IN EXTREMITY (Pain in extremity) and HYPOAESTHESIA (Numbness in feet) outcome was unknown and HEADACHE (headache) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: increased (High) increased.         Action taken for Moderna COVID-19 Vaccine was not applicable.   This case was linked to MOD-2021-072476 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: New event was added.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Sciatica, Screaming, Toothache
Clinical narrative: sciatica; Burning sensation; walking with difficulty; Discomfort; chest pain; screaming; crying; tooth ache; Voice disturbance; Pain in extremity; Numbness in feet; headache; This spontaneous case was reported by a consumer and describes the occurrence of SCIATICA (sciatica), BURNING SENSATION (Burning sensation), GAIT DISTURBANCE (walking with difficulty), DISCOMFORT (Discomfort ) and CHEST PAIN (chest pain) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Tachycardia and Cholesterol. Concomitant products included SIMVASTATIN for Cholesterol, METOPROLOL for Tachycardia, VITAMINS NOS for an unknown indication.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SCIATICA (sciatica), BURNING SENSATION (Burning sensation), GAIT DISTURBANCE (walking with difficulty), DISCOMFORT (Discomfort ), CHEST PAIN (chest pain), SCREAMING (screaming), CRYING (crying), TOOTHACHE (tooth ache), DYSPHONIA (Voice disturbance), PAIN IN EXTREMITY (Pain in extremity), HYPOAESTHESIA (Numbness in feet) and HEADACHE (headache). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, SCIATICA (sciatica), BURNING SENSATION (Burning sensation), GAIT DISTURBANCE (walking with difficulty), DISCOMFORT (Discomfort ), CHEST PAIN (chest pain), SCREAMING (screaming), CRYING (crying), TOOTHACHE (tooth ache), DYSPHONIA (Voice disturbance), PAIN IN EXTREMITY (Pain in extremity) and HYPOAESTHESIA (Numbness in feet) outcome was unknown and HEADACHE (headache) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: increased (High) increased.         Action taken for Moderna COVID-19 Vaccine was not applicable.   This case was linked to MOD-2021-072476 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: New event was added.
Sex: U
Vaccine: COVID19
Symptoms: Spinal pain
Clinical narrative: spinal pain; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of SPINAL PAIN (spinal pain) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SPINAL PAIN (spinal pain). At the time of the report, SPINAL PAIN (spinal pain) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications provided. No treatment information provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-116616, US-MODERNATX, INC.-MOD-2021-116654, US-MODERNATX, INC.-MOD-2021-116661 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-116616:Crosslinked with daughter case US-MODERNATX, INC.-MOD-2021-116654:Cluster case for other people having spinal pain US-MODERNATX, INC.-MOD-2021-116661:Cluster case for other people having spinal pain
Age: 17.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 year-old patient received vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year-old patient received vaccine) in a 17-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year-old patient received vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year-old patient received vaccine) 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.   No concomitant medications reported by investigator No treatment medications provided by the reporter.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Gait disturbance, Musculoskeletal stiffness, Pain in extremity, Peripheral swelling
Clinical narrative: calf of right leg was swollen; hardly walk certain times of the day; really sore on the back of the calf / moved to the below my knee; gets really stiff; slight chills; This spontaneous case was reported by a patient and describes the occurrence of PERIPHERAL SWELLING (calf of right leg was swollen), GAIT DISTURBANCE (hardly walk certain times of the day), PAIN IN EXTREMITY (really sore on the back of the calf / moved to the below my knee), MUSCULOSKELETAL STIFFNESS (gets really stiff) and CHILLS (slight chills) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (calf of right leg was swollen), GAIT DISTURBANCE (hardly walk certain times of the day), PAIN IN EXTREMITY (really sore on the back of the calf / moved to the below my knee), MUSCULOSKELETAL STIFFNESS (gets really stiff) and CHILLS (slight chills). At the time of the report, PERIPHERAL SWELLING (calf of right leg was swollen), GAIT DISTURBANCE (hardly walk certain times of the day), PAIN IN EXTREMITY (really sore on the back of the calf / moved to the below my knee), MUSCULOSKELETAL STIFFNESS (gets really stiff) and CHILLS (slight chills) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No Concomitant medications were reported. Treatment taken was Ultrasound but did not find anything.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Vaccination site pain
Clinical narrative: A little bit of headache; A little muscle aches; Pain at the injection site; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (A little bit of headache), MYALGIA (A little muscle aches) and VACCINATION SITE PAIN (Pain at the injection site) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A and 019821A or 0198Z1A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL, SILODOSIN (RAPAFLO), BUPRENORPHINE, OXYCODONE HYDROCHLORIDE, PARACETAMOL (OXYCODONE AND ACETAMINOPHEN), OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]) and TESTOSTERONE (TESTIM) for an unknown indication.   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-May-2021, the patient experienced HEADACHE (A little bit of headache), MYALGIA (A little muscle aches) and VACCINATION SITE PAIN (Pain at the injection site). At the time of the report, HEADACHE (A little bit of headache), MYALGIA (A little muscle aches) and VACCINATION SITE PAIN (Pain at the injection site) outcome was unknown.            The patient is not currently taking anything to treat adverse effects, but would like to take Tylenol.  Action taken with mRNA-1273 in response to the event was not applicable   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: The patient stated that he was feeling fine.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: More than 36 days after the first dose without receiving the second dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 36 days after the first dose without receiving the second dose) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026-A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 36 days after the first dose without receiving the second dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 36 days after the first dose without receiving the second dose) outcome was unknown.        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: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection area hurting; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection area hurting) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes. Concomitant products included METFORMIN and INSULIN GLARGINE (TOUJEO MAX SOLOSTAR) for Diabetes, LOSARTAN, MELOXICAM, GABAPENTIN, CLONIDINE, METOPROLOL, OXYBUTYNIN, TRAZODONE and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced VACCINATION SITE PAIN (Injection area hurting). At the time of the report, VACCINATION SITE PAIN (Injection area hurting) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications also include Victo. No treatment information was provided.   This case was linked to MOD-2021-116637 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Follow up information was received and contain no new information.