chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: itching all over body; rash all over body; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (itching all over body) and RASH (rash all over body) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 030A21A) for COVID-19 vaccination.     Concurrent medical conditions included Shellfish allergy (allergy to oysters ). Concomitant products included DOCUSATE SODIUM (STOOL SOFTENER), VALPROATE SEMISODIUM (DIVALPROEX SODIUM DISPENSING SOLUTIONS), DULOXETINE HYDROCHLORIDE (CYMBALTA), LEVETIRACETAM, VITAMIN D [VITAMIN D NOS], NAPHAZOLINE HYDROCHLORIDE (EYE DROPS [NAPHAZOLINE HYDROCHLORIDE]), ALBUTEROL [SALBUTAMOL], PERAMPANEL (FYCOMPA) and NIFEDIPINE (NICARDIA) for an unknown indication.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced PRURITUS (itching all over body) and RASH (rash all over body). At the time of the report, PRURITUS (itching all over body) and RASH (rash all over body) had not resolved. Not Provided          The concomitant medications also included unspecified Blood Pressure pill 12.5 MG and 10 MG. No laboratory investigations were provided. The Treatment information was included (Diphenhydramine) Benadryl Oatmeal Bath "lotion".  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Missed the second dose of vaccination; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed the second dose of vaccination) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Surgery since an unknown date.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed the second dose of vaccination). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed the second dose of vaccination) outcome was unknown. Not Provided.          No treatment information was provided. No concomitant product use was not provided by the reporter.  Action taken with mRNA-1273 in response to the event was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Intervertebral disc protrusion, Magnetic resonance imaging, Vaccination site pain
Clinical narrative: Diagnosed with a herniated disk; Sore right arm; This spontaneous case was reported by a consumer and describes the occurrence of INTERVERTEBRAL DISC PROTRUSION (Diagnosed with a herniated disk) and VACCINATION SITE PAIN (Sore right arm) 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 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced VACCINATION SITE PAIN (Sore right arm). On 06-Apr-2021, the patient experienced INTERVERTEBRAL DISC PROTRUSION (Diagnosed with a herniated disk). At the time of the report, INTERVERTEBRAL DISC PROTRUSION (Diagnosed with a herniated disk) and VACCINATION SITE PAIN (Sore right arm) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Apr-2021, Magnetic resonance imaging: abnormal (abnormal) Patient had an MRI done and was diagnosed with a herniated disc..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications taken by the patient were not provided.  Treatment information was not provided.  Reporter reported that she does not feel the event herniated disk  had anything to do with the vaccine.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Follow up received on 28 Jun 2021 had outcome of the event updated as recovered.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Over 42 days since the first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Over 42 days since the first dose) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes. Concomitant products included Insulin BASAGLAR and VICTOZA for Diabetes.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Over 42 days since the first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Over 42 days since the first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.   Concomitant product use was not provider by the reporter.    Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Follow-up received on 28-JUN-2021 contains no new information.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Warm to the touch Injection Site; Hard to the touch Injection Site; Itching Injection Site; Sore Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Warm to the touch Injection Site), INJECTION SITE INDURATION (Hard to the touch Injection Site), INJECTION SITE PRURITUS (Itching Injection Site) and INJECTION SITE PAIN (Sore Injection Site) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 14-Apr-2021, the patient experienced INJECTION SITE PAIN (Sore Injection Site). On 23-Apr-2021, the patient experienced INJECTION SITE WARMTH (Warm to the touch Injection Site), INJECTION SITE INDURATION (Hard to the touch Injection Site) and INJECTION SITE PRURITUS (Itching Injection Site). On 16-Apr-2021, INJECTION SITE PAIN (Sore Injection Site) had resolved. At the time of the report, INJECTION SITE WARMTH (Warm to the touch Injection Site), INJECTION SITE INDURATION (Hard to the touch Injection Site) and INJECTION SITE PRURITUS (Itching Injection Site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was given. No laboratory details was given. No treatment information was given.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chest discomfort, Chills, Headache, Off label use
Clinical narrative: Chest tightness; Upset stomach; patient decided to accept what their doctor advised and to cancel their vaccine appointment today; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Chest tightness), ABDOMINAL DISCOMFORT (Upset stomach), OFF LABEL USE (patient decided to accept what their doctor advised and to cancel their vaccine appointment today), HEADACHE (Headache) and CHILLS (Chills) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-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 CHEST DISCOMFORT (Chest tightness), ABDOMINAL DISCOMFORT (Upset stomach), OFF LABEL USE (patient decided to accept what their doctor advised and to cancel their vaccine appointment today), HEADACHE (Headache) and CHILLS (Chills). At the time of the report, CHEST DISCOMFORT (Chest tightness), ABDOMINAL DISCOMFORT (Upset stomach), OFF LABEL USE (patient decided to accept what their doctor advised and to cancel their vaccine appointment today), HEADACHE (Headache) and CHILLS (Chills) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       no treatment and concomitant medications was reported Patient Stated that her doctor advised her to get Pfizer Vaccine and not to get the second dose of Moderna she was asking about opinion.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: patient did not receive second dose of moderna vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: 2nd dose delayed beyond 36 days; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (2nd dose delayed beyond 36 days) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045a21a) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-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 PRODUCT DOSE OMISSION ISSUE (2nd dose delayed beyond 36 days). At the time of the report, PRODUCT DOSE OMISSION ISSUE (2nd dose delayed beyond 36 days) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Products known to have been used by the patient steroid injections in her back. Concomitant medication use was unknown Treatment information use was unknown
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: A vaccine expired by 8 hours was administered as a first dose to a male patient; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A vaccine expired by 8 hours was administered as a first dose to a male patient) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (A vaccine expired by 8 hours was administered as a first dose to a male patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A vaccine expired by 8 hours was administered as a first dose to a male patient) 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.   Relevant concomitant medications were not reported.  Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Injection site discomfort, Musculoskeletal discomfort, Parasomnia, Vaccination site pain
Clinical narrative: started as a low throb / gradually got bigger over the next few days, annoying; Goes from the collar bone to the shoulder blade; buzzing in his shoulder; circle around the injection site; sometimes wakes him up; soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (buzzing in his shoulder), INJECTION SITE DISCOMFORT (circle around the injection site), PARASOMNIA (sometimes wakes him up), VACCINATION SITE PAIN (soreness at the injection site) and ARTHRALGIA (started as a low throb / gradually got bigger over the next few days, annoying) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced VACCINATION SITE PAIN (soreness at the injection site). On 12-Apr-2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (buzzing in his shoulder), INJECTION SITE DISCOMFORT (circle around the injection site), PARASOMNIA (sometimes wakes him up) and ARTHRALGIA (Goes from the collar bone to the shoulder blade). On an unknown date, the patient experienced ARTHRALGIA (started as a low throb / gradually got bigger over the next few days, annoying). On 10-Apr-2021, VACCINATION SITE PAIN (soreness at the injection site) had resolved. At the time of the report, MUSCULOSKELETAL DISCOMFORT (buzzing in his shoulder), INJECTION SITE DISCOMFORT (circle around the injection site), PARASOMNIA (sometimes wakes him up), ARTHRALGIA (started as a low throb / gradually got bigger over the next few days, annoying) and ARTHRALGIA (Goes from the collar bone to the shoulder blade) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were not provided No treatment medication information were not provided
Sex: F
Vaccine: COVID19
Symptoms: Constipation
Clinical narrative: Five days after the shot, I started getting constipated really bad. I couldn't go to the bathroom for 3-4 days; This spontaneous case was reported by a consumer and describes the occurrence of Five days after the shot, I started getting constipated really bad. I couldn't go to the bathroom for 3-4 days in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 032B21A) for COVID-19 vaccination.     No medical history reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced Five days after the shot, I started getting constipated really bad. I couldn't go to the bathroom for 3-4 days. On 01-Apr-2021, Five days after the shot, I started getting constipated really bad. I couldn't go to the bathroom for 3-4 days had resolved. Not Provided.          No concomitant medications listed.    This case was linked to US-MODERNATX, INC-MOD-2021-098138. Sender's Comments:  US-MODERNATX, INC-MOD-2021-098138.
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient received first shot of Moderna COVID-19 vaccine while under the age of 16; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient received first shot of Moderna COVID-19 vaccine while under the age of 16) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient received first shot of Moderna COVID-19 vaccine while under the age of 16). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient received first shot of Moderna COVID-19 vaccine while under the age of 16) had resolved. 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.   Concomitant medication use was unknown Treatment information was unknown
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dizziness, Influenza like illness, Myalgia
Clinical narrative: sore shoulder; "flu-like" symptoms; chills; lightheadedness; extreme body aches; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (sore shoulder), INFLUENZA LIKE ILLNESS ("flu-like" symptoms), CHILLS (chills), DIZZINESS (lightheadedness) and MYALGIA (extreme body aches) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) and DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (DAYQUIL) for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced ARTHRALGIA (sore shoulder), INFLUENZA LIKE ILLNESS ("flu-like" symptoms), CHILLS (chills), DIZZINESS (lightheadedness) and MYALGIA (extreme body aches). At the time of the report, ARTHRALGIA (sore shoulder), INFLUENZA LIKE ILLNESS ("flu-like" symptoms), CHILLS (chills), DIZZINESS (lightheadedness) and MYALGIA (extreme body aches) outcome was unknown. Not Provided    Treatment details include Nyquil, Dayquil  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling hot, Laziness
Clinical narrative: lazy; exteremely hot; tired; This spontaneous case was reported by a consumer and describes the occurrence of LAZINESS (lazy), FEELING HOT (exteremely hot) and FATIGUE (tired) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006LZ1A) for COVID-19 vaccination.     Concomitant products included CARVEDILOL for Hypertension, MELOXICAM for an unknown indication.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced LAZINESS (lazy), FEELING HOT (exteremely hot) and FATIGUE (tired). At the time of the report, LAZINESS (lazy), FEELING HOT (exteremely hot) and FATIGUE (tired) outcome was unknown.        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 information was unknown   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Significant follow up
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pain in extremity
Clinical narrative: Couldn't sleep because of pain; Some pain in the right arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Some pain in the right arm) and INSOMNIA (Couldn't sleep because of pain) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 012L20A) for COVID-19 vaccination.     The patient's past medical history included Knee replacement in March 2021.   On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced PAIN IN EXTREMITY (Some pain in the right arm). On an unknown date, the patient experienced INSOMNIA (Couldn't sleep because of pain). The patient was treated with IBUPROFEN at an unspecified dose and frequency and LIDOCAINE at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Some pain in the right arm) and INSOMNIA (Couldn't sleep because of pain) outcome was unknown. Not Provided          The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.  Relevant concomitant medications included medicine for blood pressure and medicine for diabetes
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pyrexia (fever), chills and myalgia (body aches) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 023C21A) for COVID-19 immunization. No medical history reported. On Apr 28, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19  vaccine), unknown route; 1 dosage form. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19  vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced pyrexia (fever), chills and myalgia (body aches). At the time of the report, pyrexia (fever), chills and myalgia (body aches) outcome: unknown/not provided. No concomitant medication or treatment information reported.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Vaccination site pain
Clinical narrative: Blood patches; Red black rash; sore arm; fever; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Blood patches), RASH (Red black rash), VACCINATION SITE PAIN (sore arm) and PYREXIA (fever) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced RASH (Blood patches), RASH (Red black rash), VACCINATION SITE PAIN (sore arm) and PYREXIA (fever). At the time of the report, RASH (Blood patches), RASH (Red black rash), VACCINATION SITE PAIN (sore arm) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included Ciprofloxacin, Prednisone and Doxycycline.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria, Vaccination site urticaria
Clinical narrative: hives further down the injected arm and wrist area.; hives 6 hours after the first dose; . This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE URTICARIA (hives further down the injected arm and wrist area.) and URTICARIA (hives 6 hours after the first dose) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    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 VACCINATION SITE URTICARIA (hives further down the injected arm and wrist area.) and URTICARIA (hives 6 hours after the first dose). At the time of the report, VACCINATION SITE URTICARIA (hives further down the injected arm and wrist area.) and URTICARIA (hives 6 hours after the first dose) outcome was unknown.        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. no treatment medications reported.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Blepharospasm
Clinical narrative: Loss of about 40 to 45% of hair progressively beginning 2 days after second vaccine shot; Twitching in the right upper eye lid; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Loss of about 40 to 45% of hair progressively beginning 2 days after second vaccine shot) and BLEPHAROSPASM (Twitching in the right upper eye lid) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 031M20H) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METFORMIN, GLIPIZIDE, ATORVASTATIN, LOSARTAN, SPIRONOLACTONE, CARVEDILOL, AMITRIPTYLINE, FUROSEMIDE, PARACETAMOL (TYLENOL), ACICLOVIR SODIUM (ACYCLOVIR ABBOTT VIAL), DICLOFENAC, PENTOSAN POLYSULFATE, GABAPENTIN, MELOXICAM, OMEPRAZOLE, BUSPIRONE, TOLTERODINE, ASCORBIC ACID, VITAMIN D NOS and VITAMIN C [ASCORBIC ACID] for an unknown indication.   On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced ALOPECIA (Loss of about 40 to 45% of hair progressively beginning 2 days after second vaccine shot) and BLEPHAROSPASM (Twitching in the right upper eye lid). At the time of the report, ALOPECIA (Loss of about 40 to 45% of hair progressively beginning 2 days after second vaccine shot) and BLEPHAROSPASM (Twitching in the right upper eye lid) outcome was unknown. Not Provided          Treatment medications were not reported
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: first dose administered to a 17yr old; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (first dose administered to a 17yr old) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (first dose administered to a 17yr old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (first dose administered to a 17yr old) had resolved. 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.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate increased, Heavy menstrual bleeding, Palpitations
Clinical narrative: menstruation prolonged; headache; her heart was racing. It's on and off. Sometimesit's in the 80s, but it even goes up to 110.; her heart was racing; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PALPITATIONS (her heart was racing. It's on and off. Sometimesit's in the 80s, but it even goes up to 110.), HEART RATE INCREASED (her heart was racing), HEAVY MENSTRUAL BLEEDING (menstruation prolonged) and HEADACHE (headache) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 003B21A) for COVID-19 vaccination.     Concomitant products included ETHINYLESTRADIOL, LEVONORGESTREL (LARISSIA) for Birth control.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced PALPITATIONS (her heart was racing. It's on and off. Sometimesit's in the 80s, but it even goes up to 110.) and HEART RATE INCREASED (her heart was racing). On 29-Apr-2021, the patient experienced HEADACHE (headache). On 01-May-2021, the patient experienced HEAVY MENSTRUAL BLEEDING (menstruation prolonged). The patient was treated with ACETAMINOPHEN on 29-Apr-2021 at an unspecified dose and frequency. At the time of the report, PALPITATIONS (her heart was racing. It's on and off. Sometimesit's in the 80s, but it even goes up to 110.), HEART RATE INCREASED (her heart was racing), HEAVY MENSTRUAL BLEEDING (menstruation prolonged) and HEADACHE (headache) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: ADR form added
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Feeling abnormal, Pain in extremity, Vaccination site erythema
Clinical narrative: red circle at injection side; had diarrhea; feeling a little funny; arm ached; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (had diarrhea), FEELING ABNORMAL (feeling a little funny), PAIN IN EXTREMITY (arm ached) and VACCINATION SITE ERYTHEMA (red circle at injection side) in a 79-year-old male patient 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) at an unspecified dose. On 16-Apr-2021, the patient experienced DIARRHOEA (had diarrhea), FEELING ABNORMAL (feeling a little funny) and PAIN IN EXTREMITY (arm ached). On 28-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (red circle at injection side). At the time of the report, DIARRHOEA (had diarrhea), FEELING ABNORMAL (feeling a little funny), PAIN IN EXTREMITY (arm ached) and VACCINATION SITE ERYTHEMA (red circle at injection side) outcome was unknown. Unknown          No concomitant medication details were provided. No treatment medication details were provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-May-2021: Follow-up received on 29-May-21 and contains no new information.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Vertigo has been non-stop, Vertigo started the day of vaccine and has not stop since; This spontaneous case was reported by a physician and describes the occurrence of VERTIGO (Vertigo has been non-stop, Vertigo started the day of vaccine and has not stop since) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 014M20A) for COVID-19 vaccination.     Concurrent medical conditions included Vertigo, Chronic kidney disease stage 4 since 19-Dec-2018, Anaemia since 18-May-2020, Hypertension since 2008, Restless legs since 2014 and Drug allergy (Allergy to nitroglycerin patch). Concomitant products included MECLIZINE [MECLOZINE] for Vertigo.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced VERTIGO (Vertigo has been non-stop, Vertigo started the day of vaccine and has not stop since). At the time of the report, VERTIGO (Vertigo has been non-stop, Vertigo started the day of vaccine and has not stop since) had not resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The reporter mentioned that mRNA vaccine has been added as an allergy to the patient list as she thought vertigo was probably due to a derivative in the vaccine. Patient taking Meclizine for treating Vertigo.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Follow up information includes Patient demographics and Medical History On 19-Jul-2021: Follow up information contains No New Information On 19-Jul-2021: Significant Follow up information includes Event details , Vaccination Record, and Correspondence information
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Nausea, Vaccination site pain
Clinical narrative: "Pain at injection site"; "Nausea"; "Abdominal pain"; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN ("Pain at injection site"), NAUSEA ("Nausea") and ABDOMINAL PAIN ("Abdominal pain") in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced NAUSEA ("Nausea") and ABDOMINAL PAIN ("Abdominal pain"). On 29-Apr-2021, the patient experienced VACCINATION SITE PAIN ("Pain at injection site"). On 28-Apr-2021, NAUSEA ("Nausea") and ABDOMINAL PAIN ("Abdominal pain") had resolved. On 29-Apr-2021, VACCINATION SITE PAIN ("Pain at injection site") had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication and treatment medication was provided.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products, Overdose
Clinical narrative: First two doses of pfizer vaccine, 3rd dose of moderna vaccine; First two doses of pfizer vaccine, 3rd dose of moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of OVERDOSE (First two doses of pfizer vaccine, 3rd dose of moderna vaccine) and INTERCHANGE OF VACCINE PRODUCTS (First two doses of pfizer vaccine, 3rd dose of moderna vaccine) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced OVERDOSE (First two doses of pfizer vaccine, 3rd dose of moderna vaccine) and INTERCHANGE OF VACCINE PRODUCTS (First two doses of pfizer vaccine, 3rd dose of moderna vaccine). At the time of the report, OVERDOSE (First two doses of pfizer vaccine, 3rd dose of moderna vaccine) and INTERCHANGE OF VACCINE PRODUCTS (First two doses of pfizer vaccine, 3rd dose of moderna vaccine) 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.   No concomitant medications were reported. No treatment medication was reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 29-May-2021: TCR added-NNI. Reporter stated that all of the forms have already been completed and sent in. There is no need for further follow-up.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Headache, Mobility decreased
Clinical narrative: Barely Walk; Slight Headache; severe pain in right knee; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (Barely Walk), HEADACHE (Slight Headache) and ARTHRALGIA (severe pain in right knee) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 036A21A) for COVID-19 vaccination.     The patient's past medical history included Pulmonary osteoarthropathy hypertrophic on 11-Aug-2020 and Total knee replacement on 15-Jan-2021. Concurrent medical conditions included Drug allergy (Amlodipine, Nifedipine, tramadol , oxazepane,azetimide), Hypertension, Migraine, Obesity, Obstructive sleep apnea syndrome and Type 2 diabetes mellitus. Concomitant products included VITAMINS NOS, LEVOTHYROXINE SODIUM (SYNTHROID), ASCORBIC ACID, BIOTIN, CHOLECALCIFEROL, CYANOCOBALAMIN, LEVOTHYROXINE, VITAMINS NOS (MVI [VITAMINS NOS]), OMEPRAZOLE and MACROGOL 3350 (MIRALAX) for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-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 ARTHRALGIA (severe pain in right knee). On 12-Apr-2021, the patient experienced HEADACHE (Slight Headache). On an unknown date, the patient experienced MOBILITY DECREASED (Barely Walk). The patient was treated with PREDNISONE at an unspecified dose and frequency; CELECOXIB (CELEBREX) at an unspecified dose and frequency; LIDOCAINE at a dose of 5% patch and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 27-May-2021, ARTHRALGIA (severe pain in right knee) had resolved. At the time of the report, MOBILITY DECREASED (Barely Walk) and HEADACHE (Slight Headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Apr-2021, Blood test: normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The pain resolved after receiving an  intra-articular corticosteroid injection on 14-MAY-2021. Fulminant response to the injection would support intra-articular soft tissue inflammation as the source of pain. The source of the intra-articular soft tissue inflammation was not clear.   This case was linked to MOD-2021-097825 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: ADR received on 07-JUN-2021 contains Allergies, past medical history updated. additional concomitant medications updated. Outcome for event of right knee pain updated.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising
Clinical narrative: Bruising; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Bruising) in a 30-year-old female patient 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 BRUISING (Bruising). At the time of the report, VACCINATION SITE BRUISING (Bruising) 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.   No concomitant and treatment information was reported.   This case was linked to MOD-2021-097880 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Dizziness, Feeling abnormal, Headache
Clinical narrative: getting dizzy; nauseous; chills; weren't as bad; Headache is what gets me. Headache is at my temple and behind it, real severe; feeling horrible; neck ache; her temperature went up slightly; felt real crappy; Headache; had chills; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (neck ache), DIZZINESS (getting dizzy), BODY TEMPERATURE INCREASED (her temperature went up slightly), FEELING ABNORMAL (felt real crappy) and FEELING ABNORMAL (feeling horrible) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History Information was reported.  Concomitant products included DULOXETINE HYDROCHLORIDE (CYMBALTA), RIVAROXABAN (XARELTO), TOPIRAMATE (TOPAMAX), MULTIVITAMIN [VITAMINS NOS], VITAMIN B NOS and MAGNESIUM for an unknown indication.   On 15-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) (Intramuscular) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced NECK PAIN (neck ache), BODY TEMPERATURE INCREASED (her temperature went up slightly), FEELING ABNORMAL (felt real crappy), HEADACHE (Headache) and CHILLS (had chills). On 27-Apr-2021, the patient experienced FEELING ABNORMAL (feeling horrible) and HEADACHE (Headache is what gets me. Headache is at my temple and behind it, real severe). On 28-Apr-2021, the patient experienced DIZZINESS (getting dizzy), NAUSEA (nauseous) and CHILLS (chills; weren't as bad). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. On 15-Apr-2021, NECK PAIN (neck ache), BODY TEMPERATURE INCREASED (her temperature went up slightly), FEELING ABNORMAL (felt real crappy), HEADACHE (Headache) and CHILLS (had chills) had resolved. At the time of the report, DIZZINESS (getting dizzy), FEELING ABNORMAL (feeling horrible), NAUSEA (nauseous), HEADACHE (Headache is what gets me. Headache is at my temple and behind it, real severe) and CHILLS (chills; weren't as bad) outcome was unknown.            Concomitant medication also included blood thinners.   This case was linked to MOD-2021-060943 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Neck pain
Clinical narrative: getting dizzy; nauseous; chills; weren't as bad; Headache is what gets me. Headache is at my temple and behind it, real severe; feeling horrible; neck ache; her temperature went up slightly; felt real crappy; Headache; had chills; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (neck ache), DIZZINESS (getting dizzy), BODY TEMPERATURE INCREASED (her temperature went up slightly), FEELING ABNORMAL (felt real crappy) and FEELING ABNORMAL (feeling horrible) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History Information was reported.  Concomitant products included DULOXETINE HYDROCHLORIDE (CYMBALTA), RIVAROXABAN (XARELTO), TOPIRAMATE (TOPAMAX), MULTIVITAMIN [VITAMINS NOS], VITAMIN B NOS and MAGNESIUM for an unknown indication.   On 15-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) (Intramuscular) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced NECK PAIN (neck ache), BODY TEMPERATURE INCREASED (her temperature went up slightly), FEELING ABNORMAL (felt real crappy), HEADACHE (Headache) and CHILLS (had chills). On 27-Apr-2021, the patient experienced FEELING ABNORMAL (feeling horrible) and HEADACHE (Headache is what gets me. Headache is at my temple and behind it, real severe). On 28-Apr-2021, the patient experienced DIZZINESS (getting dizzy), NAUSEA (nauseous) and CHILLS (chills; weren't as bad). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. On 15-Apr-2021, NECK PAIN (neck ache), BODY TEMPERATURE INCREASED (her temperature went up slightly), FEELING ABNORMAL (felt real crappy), HEADACHE (Headache) and CHILLS (had chills) had resolved. At the time of the report, DIZZINESS (getting dizzy), FEELING ABNORMAL (feeling horrible), NAUSEA (nauseous), HEADACHE (Headache is what gets me. Headache is at my temple and behind it, real severe) and CHILLS (chills; weren't as bad) outcome was unknown.            Concomitant medication also included blood thinners.   This case was linked to MOD-2021-060943 (Patient Link).
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: when pushing the dose in the vaccine seeped out of the syringe at the hub; when pushing the dose in the vaccine seeped out of the syringe at the hub; This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE CONNECTION ISSUE (when pushing the dose in the vaccine seeped out of the syringe at the hub) and UNDERDOSE (when pushing the dose in the vaccine seeped out of the syringe at the hub) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, the patient experienced DEVICE CONNECTION ISSUE (when pushing the dose in the vaccine seeped out of the syringe at the hub) and UNDERDOSE (when pushing the dose in the vaccine seeped out of the syringe at the hub). At the time of the report, DEVICE CONNECTION ISSUE (when pushing the dose in the vaccine seeped out of the syringe at the hub) and UNDERDOSE (when pushing the dose in the vaccine seeped out of the syringe at the hub) 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 and treatment medication information was reported.    This case was linked to MOD-2021-098598 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Rash at the injection site; Rash at the injection site and it is also itchy; Second dose received outside of window; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash at the injection site), VACCINATION SITE PRURITUS (Rash at the injection site and it is also itchy) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose received outside of window) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose received outside of window). On 27-Apr-2021, the patient experienced VACCINATION SITE RASH (Rash at the injection site) and VACCINATION SITE PRURITUS (Rash at the injection site and it is also itchy). On 21-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose received outside of window) had resolved. At the time of the report, VACCINATION SITE RASH (Rash at the injection site) and VACCINATION SITE PRURITUS (Rash at the injection site and it is also itchy) had not resolved. Not Provided