chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Vaccine Leaked Out.; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Vaccine Leaked Out.) 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 UNDERDOSE (Vaccine Leaked Out.). On 01-Mar-2021, UNDERDOSE (Vaccine Leaked Out.) 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 medication information was provided.  No treatment medication information was provided.   Reporter did not allow further contact
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria, Vaccination site swelling
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itches but not a lot), URTICARIA (Could be hives) and VACCINATION SITE SWELLING (Tennis ball sized area below the site of injection on her right upper arm) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. Concomitant products included GABAPENTIN and MELATONIN for an unknown indication. On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced PRURITUS (Itches but not a lot), URTICARIA (Could be hives) and VACCINATION SITE SWELLING (Tennis ball sized area below the site of injection on her right upper arm). At the time of the report, PRURITUS (Itches but not a lot), URTICARIA (Could be hives) and VACCINATION SITE SWELLING (Tennis ball sized area below the site of injection on her right upper arm) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (shingles) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced HERPES ZOSTER (shingles). At the time of the report, HERPES ZOSTER (shingles) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient received treatment oral unknown medication three times a day. No concomitant medication were provided.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Influenza like illness, Myalgia, Pain in extremity
Clinical narrative: Arm was a little sore; flu-like symptoms; headache; body aches; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was a little sore), INFLUENZA LIKE ILLNESS (flu-like symptoms), HEADACHE (headache), MYALGIA (body aches) and CHILLS (chills) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 044A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm was a little sore), INFLUENZA LIKE ILLNESS (flu-like symptoms), HEADACHE (headache), MYALGIA (body aches) and CHILLS (chills). At the time of the report, PAIN IN EXTREMITY (Arm was a little sore), INFLUENZA LIKE ILLNESS (flu-like symptoms), HEADACHE (headache), MYALGIA (body aches) and CHILLS (chills) outcome was unknown.            Concomitant medication was not provided Treatment information was not provided  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable   This case was linked to MOD-2021-071143 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Insomnia, Nervousness, Pyrexia
Clinical narrative: Not able to sleep for three days; Headache in the back of her head; Having tremors in her hands and arms; Fever; Flu like symptoms; Shaking all over her body; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), TREMOR (Having tremors in her hands and arms), NERVOUSNESS (Shaking all over her body), INSOMNIA (Not able to sleep for three days) and HEADACHE (Headache in the back of her head) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Ear infection. Concomitant products included AMOXICILLIN for Ear infection, VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 15-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 NERVOUSNESS (Shaking all over her body). On 19-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms) and PYREXIA (Fever). On 20-Mar-2021, the patient experienced TREMOR (Having tremors in her hands and arms). On an unknown date, the patient experienced INSOMNIA (Not able to sleep for three days) and HEADACHE (Headache in the back of her head). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form; NAPROXEN SODIUM (ALEVE) at a dose of 1 dosage form and PHENYLEPHRINE HYDROCHLORIDE (AFRIN [PHENYLEPHRINE HYDROCHLORIDE]) at a dose of 1 dosage form. On 24-Mar-2021, INFLUENZA LIKE ILLNESS (Flu like symptoms) and PYREXIA (Fever) had resolved. At the time of the report, TREMOR (Having tremors in her hands and arms), NERVOUSNESS (Shaking all over her body), INSOMNIA (Not able to sleep for three days) and HEADACHE (Headache in the back of her head) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other relevant medication history included Multivitamin.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Not able to sleep for three days; Headache in the back of her head; Having tremors in her hands and arms; Fever; Flu like symptoms; Shaking all over her body; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), TREMOR (Having tremors in her hands and arms), NERVOUSNESS (Shaking all over her body), INSOMNIA (Not able to sleep for three days) and HEADACHE (Headache in the back of her head) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Ear infection. Concomitant products included AMOXICILLIN for Ear infection, VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 15-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 NERVOUSNESS (Shaking all over her body). On 19-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms) and PYREXIA (Fever). On 20-Mar-2021, the patient experienced TREMOR (Having tremors in her hands and arms). On an unknown date, the patient experienced INSOMNIA (Not able to sleep for three days) and HEADACHE (Headache in the back of her head). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form; NAPROXEN SODIUM (ALEVE) at a dose of 1 dosage form and PHENYLEPHRINE HYDROCHLORIDE (AFRIN [PHENYLEPHRINE HYDROCHLORIDE]) at a dose of 1 dosage form. On 24-Mar-2021, INFLUENZA LIKE ILLNESS (Flu like symptoms) and PYREXIA (Fever) had resolved. At the time of the report, TREMOR (Having tremors in her hands and arms), NERVOUSNESS (Shaking all over her body), INSOMNIA (Not able to sleep for three days) and HEADACHE (Headache in the back of her head) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other relevant medication history included Multivitamin.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia
Clinical narrative: unable to swallow after 6 hours of dermal filler injection; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHAGIA (unable to swallow after 6 hours of dermal filler injection) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0116/2/LZ0A and 012L/626A) for COVID-19 vaccination.     The patient's past medical history included Dermal filler injection in 2014.   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 30-Mar-2021, the patient experienced DYSPHAGIA (unable to swallow after 6 hours of dermal filler injection). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form and PREDNISONE at a dose of 1 dosage form. At the time of the report, DYSPHAGIA (unable to swallow after 6 hours of dermal filler injection) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Somnolence, Tenderness, Vaccination site pain
Clinical narrative: Sleepiness; Under injected arm, near left breast is tender and sore; Under injected arm, near left breast is tender and sore; Injected arm is very sore; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Sleepiness), TENDERNESS (Under injected arm, near left breast is tender and sore), PAIN (Under injected arm, near left breast is tender and sore), VACCINATION SITE PAIN (Injected arm is very sore) and FATIGUE (Tiredness) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 013M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included IRON for an unknown indication.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced SOMNOLENCE (Sleepiness), TENDERNESS (Under injected arm, near left breast is tender and sore), PAIN (Under injected arm, near left breast is tender and sore), VACCINATION SITE PAIN (Injected arm is very sore) and FATIGUE (Tiredness). At the time of the report, SOMNOLENCE (Sleepiness), TENDERNESS (Under injected arm, near left breast is tender and sore), PAIN (Under injected arm, near left breast is tender and sore), VACCINATION SITE PAIN (Injected arm is very sore) and FATIGUE (Tiredness) outcome was unknown.            Other relevant medication history included High Blood Pressure Medications. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Blister, Chills, Lethargy, Pain
Clinical narrative: blisters on her mouth, nose and chin  which were white and painful; "they're so dry that they hurt; lethargic; the regular side effects; sore arm; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), LETHARGY (lethargic), ADVERSE REACTION (the regular side effects), BLISTER (blisters on her mouth, nose and chin  which were white and painful) and PAIN ("they're so dry that they hurt) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetic (Insulin dependent diabetic).   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm), ADVERSE REACTION (the regular side effects), CHILLS (chills) and PYREXIA (fever). On 04-Apr-2021, the patient experienced LETHARGY (lethargic). On 06-Apr-2021, the patient experienced BLISTER (blisters on her mouth, nose and chin  which were white and painful) and PAIN ("they're so dry that they hurt). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 04-Apr-2021, PAIN IN EXTREMITY (sore arm) had resolved. On 05-Apr-2021, LETHARGY (lethargic), CHILLS (chills) and PYREXIA (fever) had resolved. At the time of the report, ADVERSE REACTION (the regular side effects) and PAIN ("they're so dry that they hurt) outcome was unknown and BLISTER (blisters on her mouth, nose and chin  which were white and painful) had not resolved.            Other relevant treatment included Cold sore medications. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.   This case was linked to MOD-2021-071139 (Linked Report).; Sender's Comments:  MOD-2021-071139:First Dose
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: blisters on her mouth, nose and chin  which were white and painful; "they're so dry that they hurt; lethargic; the regular side effects; sore arm; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), LETHARGY (lethargic), ADVERSE REACTION (the regular side effects), BLISTER (blisters on her mouth, nose and chin  which were white and painful) and PAIN ("they're so dry that they hurt) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetic (Insulin dependent diabetic).   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm), ADVERSE REACTION (the regular side effects), CHILLS (chills) and PYREXIA (fever). On 04-Apr-2021, the patient experienced LETHARGY (lethargic). On 06-Apr-2021, the patient experienced BLISTER (blisters on her mouth, nose and chin  which were white and painful) and PAIN ("they're so dry that they hurt). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 04-Apr-2021, PAIN IN EXTREMITY (sore arm) had resolved. On 05-Apr-2021, LETHARGY (lethargic), CHILLS (chills) and PYREXIA (fever) had resolved. At the time of the report, ADVERSE REACTION (the regular side effects) and PAIN ("they're so dry that they hurt) outcome was unknown and BLISTER (blisters on her mouth, nose and chin  which were white and painful) had not resolved.            Other relevant treatment included Cold sore medications. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.   This case was linked to MOD-2021-071139 (Linked Report).; Sender's Comments:  MOD-2021-071139:First Dose
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Ear pain, Erythema, Fatigue, Pain in extremity
Clinical narrative: lump on her arm; face all flush,arms and chest were red; left side ear is aching/ears were bothering her; feeling really tired/had 2 cups coffee and still tired; light headed,woozy or dizzy feeling; warm to touch; arm was sore; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of DIZZINESS (light headed,woozy or dizzy feeling), VACCINATION SITE WARMTH (warm to touch), PAIN IN EXTREMITY (arm was sore), VACCINATION SITE MASS (lump on her arm) and ERYTHEMA (face all flush,arms and chest were red) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter. .  Concomitant products included DULOXETINE HYDROCHLORIDE (CYMBALTA) 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 DIZZINESS (light headed,woozy or dizzy feeling), VACCINATION SITE WARMTH (warm to touch) and PAIN IN EXTREMITY (arm was sore). On 02-Apr-2021, the patient experienced VACCINATION SITE MASS (lump on her arm), ERYTHEMA (face all flush,arms and chest were red), EAR PAIN (left side ear is aching/ears were bothering her) and FATIGUE (feeling really tired/had 2 cups coffee and still tired). At the time of the report, DIZZINESS (light headed,woozy or dizzy feeling), VACCINATION SITE WARMTH (warm to touch), PAIN IN EXTREMITY (arm was sore), VACCINATION SITE MASS (lump on her arm), ERYTHEMA (face all flush,arms and chest were red), EAR PAIN (left side ear is aching/ears were bothering her) and FATIGUE (feeling really tired/had 2 cups coffee and still tired) 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.   Other relevant medication history included cymbalta anxiety depression 90 mg every morning. No treatment information was provided.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site warmth
Clinical narrative: lump on her arm; face all flush,arms and chest were red; left side ear is aching/ears were bothering her; feeling really tired/had 2 cups coffee and still tired; light headed,woozy or dizzy feeling; warm to touch; arm was sore; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of DIZZINESS (light headed,woozy or dizzy feeling), VACCINATION SITE WARMTH (warm to touch), PAIN IN EXTREMITY (arm was sore), VACCINATION SITE MASS (lump on her arm) and ERYTHEMA (face all flush,arms and chest were red) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter. .  Concomitant products included DULOXETINE HYDROCHLORIDE (CYMBALTA) 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 DIZZINESS (light headed,woozy or dizzy feeling), VACCINATION SITE WARMTH (warm to touch) and PAIN IN EXTREMITY (arm was sore). On 02-Apr-2021, the patient experienced VACCINATION SITE MASS (lump on her arm), ERYTHEMA (face all flush,arms and chest were red), EAR PAIN (left side ear is aching/ears were bothering her) and FATIGUE (feeling really tired/had 2 cups coffee and still tired). At the time of the report, DIZZINESS (light headed,woozy or dizzy feeling), VACCINATION SITE WARMTH (warm to touch), PAIN IN EXTREMITY (arm was sore), VACCINATION SITE MASS (lump on her arm), ERYTHEMA (face all flush,arms and chest were red), EAR PAIN (left side ear is aching/ears were bothering her) and FATIGUE (feeling really tired/had 2 cups coffee and still tired) 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.   Other relevant medication history included cymbalta anxiety depression 90 mg every morning. No treatment information was provided.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Vertigo
Clinical narrative: Pregnant; On and off vertigo for about 3 days starting 6 hours after the first dose; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) and VERTIGO (On and off vertigo for about 3 days starting 6 hours after the first dose) in a 33-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) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 22-Feb-2021 and the estimated date of delivery was 29-Nov-2021. On 18-Mar-2021, the patient experienced VERTIGO (On and off vertigo for about 3 days starting 6 hours after the first dose). On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  third week of the pregnancy.  On 21-Mar-2021, VERTIGO (On and off vertigo for about 3 days starting 6 hours after the first dose) had resolved. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information was provided.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Pruritus, Rash, Scar, Swelling
Clinical narrative: dark red scars now; Itchy; red, raised spots along my waist and shoulder area; painful lump under TB injection area; TB injection scar swelled up; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY MASS (painful lump under TB injection area), SWELLING (TB injection scar swelled up), SCAR (dark red scars now), PRURITUS (Itchy) and RASH (red, raised spots along my waist and shoulder area) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038K20A and 039K20A) for COVID-19 vaccination.     The patient's past medical history included Chickenpox (Patient had chickenpox as a child.). Previously administered products included for an unreported indication: TUBERCULOSIS VACCINES (Patient received a tuberculosis vaccine as a child.). Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for an unknown indication.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced AXILLARY MASS (painful lump under TB injection area) and SWELLING (TB injection scar swelled up). On 08-Feb-2021, the patient experienced PRURITUS (Itchy) and RASH (red, raised spots along my waist and shoulder area). On 08-Apr-2021, the patient experienced SCAR (dark red scars now). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 1 dosage form. On 05-Feb-2021, AXILLARY MASS (painful lump under TB injection area) and SWELLING (TB injection scar swelled up) had resolved. At the time of the report, SCAR (dark red scars now) had not resolved and PRURITUS (Itchy) and RASH (red, raised spots along my waist and shoulder area) had resolved.            Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.   This case was linked to MOD-2021-071135 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received the 2nd dose 6 days after the 1st dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the 2nd dose 6 days after the 1st dose) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0007B21A) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the 2nd dose 6 days after the 1st dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the 2nd dose 6 days after the 1st dose) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment was unknown. Action taken with mRNA-1273 in response to the event was not applicable. List of concomitant medication were not given.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Rash, Vaccination site reaction
Clinical narrative: Rash on left shoulder/Little rash on her back; shingles; covid arm develop in lower arm and at the injection site/had COVID arm which lasted almost until her second injection; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (shingles), VACCINATION SITE REACTION (covid arm develop in lower arm and at the injection site/had COVID arm which lasted almost until her second injection) and RASH (Rash on left shoulder/Little rash on her back) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 06B21A and 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder (She took medication though she's not taking it at that time because she was  waiting to feel better.).   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 23-Mar-2021, the patient experienced VACCINATION SITE REACTION (covid arm develop in lower arm and at the injection site/had COVID arm which lasted almost until her second injection). On 30-Mar-2021, the patient experienced HERPES ZOSTER (shingles). On an unknown date, the patient experienced RASH (Rash on left shoulder/Little rash on her back). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALTREX) for Shingles, at an unspecified dose and frequency. In April 2021, VACCINATION SITE REACTION (covid arm develop in lower arm and at the injection site/had COVID arm which lasted almost until her second injection) had resolved. At the time of the report, HERPES ZOSTER (shingles) had resolved with sequelae and RASH (Rash on left shoulder/Little rash on her back) had not resolved.            List of concomitant medication were not given. 7 to 8 days after her second shot, the patient had first shingles episode. The patient went to the doctor and was prescribed with Valtrex. It seemed to work, but then shingles came back. However the patient recovered, but has a rash where she used to have shingles (on her left shoulder, above the injection site). She also has a little rash on her back.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow-Up received-NNI On 06-Aug-2021: Significant Follow-Up received - Added patient details, medical history, event and treatment drug.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: This spontaneous case reported by a nurse, describes the occurrence of inappropriate schedule of product administration (42 days between 2 doses) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Feb 24, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced inappropriate schedule of product administration (42 days between 2 doses). At the time of the report, inappropriate schedule of product administration (42 days between 2 doses) resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. The reporter did not provide any causality assessments, concomitant medications or treatment information. Most recent follow-up information incorporated: On May 10, 2021: Follow-up received on May 10, 2021 contains no significant information.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Product dose omission issue
Clinical narrative: unable to get their 2nd dose of Moderna COVID19 vaccine within the 42 day window; COVID-19; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (unable to get their 2nd dose of Moderna COVID19 vaccine within the 42 day window) and COVID-19 (COVID-19) 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 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (unable to get their 2nd dose of Moderna COVID19 vaccine within the 42 day window) and COVID-19 (COVID-19). At the time of the report, PRODUCT DOSE OMISSION ISSUE (unable to get their 2nd dose of Moderna COVID19 vaccine within the 42 day window) had resolved and COVID-19 (COVID-19) 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 and treatment medications were provided by reporter.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pyrexia, Vomiting
Clinical narrative: Fever chills; Headache; Chills; Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever chills), HEADACHE (Headache), CHILLS (Chills), NAUSEA (Nausea ) and VOMITING (Vomiting) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Drug allergy (allergy to Remerol) and Latex allergy. Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Allergy, FISH OIL, MULTIVITAMIN [VITAMINS NOS] and CALCIUM for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced CHILLS (Chills), NAUSEA (Nausea ) and VOMITING (Vomiting). On an unknown date, the patient experienced PYREXIA (Fever chills). an unknown date, the patient experienced HEADACHE (Headache). The patient was treated with NAPROXEN for Fever, Chills and Nausea, at a dose of 220 mg. On 07-Mar-2021, NAUSEA (Nausea ) and VOMITING (Vomiting) had resolved. At the time of the report, PYREXIA (Fever chills), HEADACHE (Headache) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-071167 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow-up information received on 11 May 2021.Added patient demographic information, medical history, concomitant medication, treatment medication and new events
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feeling a little off) and FATIGUE (tired) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. Concurrent medical conditions included Liver failure (Stage 4 Liver failure). On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced FEELING ABNORMAL (feeling a little off) and FATIGUE (tired). The patient was treated with TRAMADOL at a dose of 1 dosage form. On 08-Mar-2021, FEELING ABNORMAL (feeling a little off) and FATIGUE (tired) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. No treatment information was provided. This case was linked to US-MODERNATX, INC.-MOD-2021-071172 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2021-071172:Second Dose
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Fatigue, Feeling abnormal, Headache
Clinical narrative: Kept feeling bad; Was sick like a cold; Congestion; Cough; Tiredness; Had a very bad and strange headache; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Kept feeling bad), NASOPHARYNGITIS (Was sick like a cold), NASAL CONGESTION (Congestion), COUGH (Cough) and COVID-19 (COVID-19) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced COVID-19 (COVID-19). On 30-Mar-2021, the patient experienced FEELING ABNORMAL (Kept feeling bad), NASOPHARYNGITIS (Was sick like a cold), NASAL CONGESTION (Congestion), COUGH (Cough), FATIGUE (Tiredness) and HEADACHE (Had a very bad and strange headache). At the time of the report, FEELING ABNORMAL (Kept feeling bad), NASOPHARYNGITIS (Was sick like a cold), NASAL CONGESTION (Congestion), COUGH (Cough), COVID-19 (COVID-19), FATIGUE (Tiredness) and HEADACHE (Had a very bad and strange headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Nasopharyngitis
Clinical narrative: Kept feeling bad; Was sick like a cold; Congestion; Cough; Tiredness; Had a very bad and strange headache; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Kept feeling bad), NASOPHARYNGITIS (Was sick like a cold), NASAL CONGESTION (Congestion), COUGH (Cough) and COVID-19 (COVID-19) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced COVID-19 (COVID-19). On 30-Mar-2021, the patient experienced FEELING ABNORMAL (Kept feeling bad), NASOPHARYNGITIS (Was sick like a cold), NASAL CONGESTION (Congestion), COUGH (Cough), FATIGUE (Tiredness) and HEADACHE (Had a very bad and strange headache). At the time of the report, FEELING ABNORMAL (Kept feeling bad), NASOPHARYNGITIS (Was sick like a cold), NASAL CONGESTION (Congestion), COUGH (Cough), COVID-19 (COVID-19), FATIGUE (Tiredness) and HEADACHE (Had a very bad and strange headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia, Vaccination site pain
Clinical narrative: Bodyache; Temperature is 98.6 ° F but she feels hot inside; Chills; Injection site swelling; Injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Bodyache), PYREXIA (Temperature is 98.6 ° F but she feels hot inside), CHILLS (Chills), VACCINATION SITE SWELLING (Injection site swelling) and VACCINATION SITE PAIN (Injection site pain) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced VACCINATION SITE SWELLING (Injection site swelling) and VACCINATION SITE PAIN (Injection site pain). On 08-Apr-2021, the patient experienced PAIN (Bodyache), PYREXIA (Temperature is 98.6 ° F but she feels hot inside) and CHILLS (Chills). The patient was treated with IBUPROFEN at an unspecified dose and frequency and DICYCLOMINE [DICYCLOVERINE] at an unspecified dose and frequency. At the time of the report, PAIN (Bodyache), PYREXIA (Temperature is 98.6 ° F but she feels hot inside), CHILLS (Chills), VACCINATION SITE SWELLING (Injection site swelling) and VACCINATION SITE PAIN (Injection site pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Apr-2021, Body temperature: 98.6 (High) 98.6 ° F.     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 not provided.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Bodyache; Temperature is 98.6 ° F but she feels hot inside; Chills; Injection site swelling; Injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Bodyache), PYREXIA (Temperature is 98.6 ° F but she feels hot inside), CHILLS (Chills), VACCINATION SITE SWELLING (Injection site swelling) and VACCINATION SITE PAIN (Injection site pain) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced VACCINATION SITE SWELLING (Injection site swelling) and VACCINATION SITE PAIN (Injection site pain). On 08-Apr-2021, the patient experienced PAIN (Bodyache), PYREXIA (Temperature is 98.6 ° F but she feels hot inside) and CHILLS (Chills). The patient was treated with IBUPROFEN at an unspecified dose and frequency and DICYCLOMINE [DICYCLOVERINE] at an unspecified dose and frequency. At the time of the report, PAIN (Bodyache), PYREXIA (Temperature is 98.6 ° F but she feels hot inside), CHILLS (Chills), VACCINATION SITE SWELLING (Injection site swelling) and VACCINATION SITE PAIN (Injection site pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Apr-2021, Body temperature: 98.6 (High) 98.6 ° F.     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 not provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pain
Clinical narrative: Pain all over the body; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain all over the body) and HEADACHE (Headache) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 032M20A) for COVID-19 vaccination.     The patient's past medical history included Bursitis and Allergic reaction to analgesics since an unknown date. Concurrent medical conditions included Arthritis. Concomitant products included LEVOTHYROXINE for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced PAIN (Pain all over the body) and HEADACHE (Headache). At the time of the report, PAIN (Pain all over the body) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Apr-2021, Body temperature: 99.8 (High) 99.8.         No treatment information was provided. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: head cold; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (head cold) 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 04-Apr-2021, the patient experienced NASOPHARYNGITIS (head cold). The patient was treated with GUAIFENESIN (MUCINEX) at an unspecified dose and frequency. At the time of the report, NASOPHARYNGITIS (head cold) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD21-072032, MOD21-072083 (E2B Linked Report).; Sender's Comments:  MOD21-072032: MOD21-072083:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Urticaria, Vomiting
Clinical narrative: Headache; 12 hours after vaccination she broke out in hives everywhere/she could fell them down in her esophaus(hives)/ hives on the scalp/ hives on neck, eyes, inside throatand  shoulders, back,legs, hands, feet/ hives on the inside of eyelids, mouth; Nausea; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (12 hours after vaccination she broke out in hives everywhere/she could fell them down in her esophaus(hives)/ hives on the scalp/ hives on neck, eyes, inside throatand  shoulders, back,legs, hands, feet/ hives on the inside of eyelids, mouth), NAUSEA (Nausea), VOMITING (vomiting) and HEADACHE (Headache) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 029A21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Latex allergy and Drug allergy (demerol). Concomitant products included FISH OIL, MULTIVITAMIN [VITAMINS NOS] and CALCIUM for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced URTICARIA (12 hours after vaccination she broke out in hives everywhere/she could fell them down in her esophaus(hives)/ hives on the scalp/ hives on neck, eyes, inside throatand  shoulders, back,legs, hands, feet/ hives on the inside of eyelids, mouth) and VOMITING (vomiting). 05-Apr-2021, the patient experienced NAUSEA (Nausea). On 11-May-2021, the patient experienced HEADACHE (Headache). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) (oral) ongoing since an unknown date for Allergy, at an unspecified dose and frequency; MONTELUKAST (oral) at a dose of 10 mg once a day and FAMOTIDINE (PEPCID AC) (oral) at an unspecified dose and frequency. On 07-Apr-2021, NAUSEA (Nausea) and VOMITING (vomiting) had resolved. At the time of the report, URTICARIA (12 hours after vaccination she broke out in hives everywhere/she could fell them down in her esophaus(hives)/ hives on the scalp/ hives on neck, eyes, inside throatand  shoulders, back,legs, hands, feet/ hives on the inside of eyelids, mouth) and HEADACHE (Headache) had not resolved.            Treatment activities for event was also done with steroid for 5 days and allegra. The action taken for mRNA-1273 was not applicable.   This case was linked to MOD-2021-071161.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow up information was received and the reporter information, patient demographics, concomitant medication, treatment medication and new event were updated.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Inappropriate schedule of product administration, Product dose omission issue
Clinical narrative: Late for second dose; missed dose; health issue   not related to COVID; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed dose), ILLNESS (health issue   not related to COVID) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Late for second 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 26-Jan-2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 26-Jan-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed dose) and ILLNESS (health issue   not related to COVID). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Late for second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed dose), ILLNESS (health issue   not related to COVID) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Late for second dose) had not resolved. Not Provided          Upon in internal review on 21 May 2021, the age was corrected to unknown age.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 09-Apr-2021: Patient received second dose of vaccine outside of time period