chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Erythema, Feeling hot, Pain in extremity, Pruritus
Clinical narrative: Red spot on arm tripled in size from shoulder to 6 inches down her arm; Itching on arm; Hot as fire feeling on arm; Bruise; Sore right arm; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (Bruise), ERYTHEMA (Red spot on arm tripled in size from shoulder to 6 inches down her arm), PRURITUS (Itching on arm), FEELING HOT (Hot as fire feeling on arm) and PAIN IN EXTREMITY (Sore right arm) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jun-2021, the patient experienced PAIN IN EXTREMITY (Sore right arm). On 02-Jul-2021, the patient experienced CONTUSION (Bruise). On 05-Jul-2021, the patient experienced ERYTHEMA (Red spot on arm tripled in size from shoulder to 6 inches down her arm), PRURITUS (Itching on arm) and FEELING HOT (Hot as fire feeling on arm). At the time of the report, CONTUSION (Bruise), ERYTHEMA (Red spot on arm tripled in size from shoulder to 6 inches down her arm), PRURITUS (Itching on arm), FEELING HOT (Hot as fire feeling on arm) and PAIN IN EXTREMITY (Sore right arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment medications included unspecified medicated lotion.
Age: 12.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Moderna given to 12 year old; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna given to 12 year old) in a 12-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received 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 (Moderna given to 12 year old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna given to 12 year old) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant medications were not provided by the reporter.  Treatment information was not reported.  The patient has monitored for a week and no adverse reaction was reported by child or parent.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: contain Non significant information.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vial expired but a dose was given to the patient; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vial expired but a dose was given to the patient) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vial expired but a dose was given to the patient). On 07-Jun-2021, EXPIRED PRODUCT ADMINISTERED (vial expired but a dose was given to the patient) 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.   No concomitant medication was reported. No treatment was reported.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 13 years old (deviation from recommended age group); This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13 years old (deviation from recommended age group)) in a 13-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jul-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13 years old (deviation from recommended age group)). On 06-Jul-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13 years old (deviation from recommended age group)) 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.   No medical history reported. Concomitant medications were not provided.  Treatment information was not provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Pain in extremity, Vaccination site movement impairment, Vaccination site pain
Clinical narrative: It has been getting worse; It's at a point where she can't lift left arm/It is very hard to raise her left upper arm down to the elbow; Pain at left arm is internal throbbing pain; Her left shoulder started getting sore at injection site; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (It has been getting worse), VACCINATION SITE MOVEMENT IMPAIRMENT (It's at a point where she can't lift left arm/It is very hard to raise her left upper arm down to the elbow), PAIN IN EXTREMITY (Pain at left arm is internal throbbing pain) and VACCINATION SITE PAIN (Her left shoulder started getting sore at injection site) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. FC031B2RA and 026A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METFORMIN and HYDROCHLOROTHIAZIDE for an unknown indication.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Her left shoulder started getting sore at injection site). On an unknown date, the patient experienced CONDITION AGGRAVATED (It has been getting worse), VACCINATION SITE MOVEMENT IMPAIRMENT (It's at a point where she can't lift left arm/It is very hard to raise her left upper arm down to the elbow) and PAIN IN EXTREMITY (Pain at left arm is internal throbbing pain). The patient was treated with PARACETAMOL (TYLENOL) for Pain in arm, at an unspecified dose and frequency. At the time of the report, CONDITION AGGRAVATED (It has been getting worse), VACCINATION SITE MOVEMENT IMPAIRMENT (It's at a point where she can't lift left arm/It is very hard to raise her left upper arm down to the elbow), PAIN IN EXTREMITY (Pain at left arm is internal throbbing pain) and VACCINATION SITE PAIN (Her left shoulder started getting sore at injection site) had not resolved.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Myalgia, Vaccination site erythema, Vaccination site pain
Clinical narrative: Injection site warm to the touch; Injection site red; Injection site achy; Joint pain; Fatigue; Myalgia; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE WARMTH (Injection site warm to the touch), FATIGUE (Fatigue), MYALGIA (Myalgia), VACCINATION SITE ERYTHEMA (Injection site red) and VACCINATION SITE PAIN (Injection site achy) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jun-2021, the patient experienced FATIGUE (Fatigue) and MYALGIA (Myalgia). On 28-Jun-2021, the patient experienced VACCINATION SITE WARMTH (Injection site warm to the touch), VACCINATION SITE ERYTHEMA (Injection site red), VACCINATION SITE PAIN (Injection site achy) and ARTHRALGIA (Joint pain). On 19-Jun-2021, FATIGUE (Fatigue) and MYALGIA (Myalgia) had resolved. On 05-Jul-2021, VACCINATION SITE WARMTH (Injection site warm to the touch), VACCINATION SITE ERYTHEMA (Injection site red), VACCINATION SITE PAIN (Injection site achy) and ARTHRALGIA (Joint pain) 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.   No concomitant  medication were reported. No treatment information were provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Injection site warm to the touch; Injection site red; Injection site achy; Joint pain; Fatigue; Myalgia; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE WARMTH (Injection site warm to the touch), FATIGUE (Fatigue), MYALGIA (Myalgia), VACCINATION SITE ERYTHEMA (Injection site red) and VACCINATION SITE PAIN (Injection site achy) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jun-2021, the patient experienced FATIGUE (Fatigue) and MYALGIA (Myalgia). On 28-Jun-2021, the patient experienced VACCINATION SITE WARMTH (Injection site warm to the touch), VACCINATION SITE ERYTHEMA (Injection site red), VACCINATION SITE PAIN (Injection site achy) and ARTHRALGIA (Joint pain). On 19-Jun-2021, FATIGUE (Fatigue) and MYALGIA (Myalgia) had resolved. On 05-Jul-2021, VACCINATION SITE WARMTH (Injection site warm to the touch), VACCINATION SITE ERYTHEMA (Injection site red), VACCINATION SITE PAIN (Injection site achy) and ARTHRALGIA (Joint pain) 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.   No concomitant  medication were reported. No treatment information were provided.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: one of the nurse administered the vaccine that was unpunctured, and refrigerated, for more than 12 hours; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (one of the nurse administered the vaccine that was unpunctured, and refrigerated, for more than 12 hours) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (one of the nurse administered the vaccine that was unpunctured, and refrigerated, for more than 12 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (one of the nurse administered the vaccine that was unpunctured, and refrigerated, for more than 12 hours) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported. No treatment medication was reported.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: get the second dose after 65 days since the first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (get the second dose after 65 days since the first dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (get the second dose after 65 days since the first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (get the second dose after 65 days since the first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.  Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Product dose omission issue
Clinical narrative: Vaccine past due; Second dose after 3 months; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Vaccine past due) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose after 3 months) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021C21A and 042C20A) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy (Garlic poison iv).   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Vaccine past due) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose after 3 months). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Vaccine past due) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose after 3 months) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter.  Treatment details was not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Significant follow up appended
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: hot to touch; Injection site size of a golf ball; Arm became very red; Feeling tired; Left arm is sore; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Arm became very red), MYALGIA (Left arm is sore), FATIGUE (Feeling tired) and VACCINATION SITE SWELLING (Injection site size of a golf ball) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jul-2021, the patient experienced MYALGIA (Left arm is sore). On 06-Jul-2021, the patient experienced ERYTHEMA (Arm became very red) and FATIGUE (Feeling tired). On 07-Jul-2021, the patient experienced VACCINATION SITE SWELLING (Injection site size of a golf ball). At the time of the report, ERYTHEMA (Arm became very red), FATIGUE (Feeling tired) and VACCINATION SITE SWELLING (Injection site size of a golf ball) outcome was unknown and MYALGIA (Left arm is sore) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Received the first Moderna vaccine on 5-5-2021; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Received the first Moderna vaccine on 5-5-2021) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Received the first Moderna vaccine on 5-5-2021). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Received the first Moderna vaccine on 5-5-2021) outcome was unknown.        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 medications were not provided.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Product temperature excursion issue
Clinical narrative: First dose of the Moderna COVID-19 vaccine on 11Mar2021 and the second dose on 16 APR 2021; Second dose of vaccine administered after excursion; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Second dose of vaccine administered after excursion) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose of the Moderna COVID-19 vaccine on 11Mar2021 and the second dose on 16 APR 2021) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 031A21A) 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 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Second dose of vaccine administered after excursion). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose of the Moderna COVID-19 vaccine on 11Mar2021 and the second dose on 16 APR 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Second dose of vaccine administered after excursion) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose of the Moderna COVID-19 vaccine on 11Mar2021 and the second dose on 16 APR 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter.  No treatment medication was provided.  The action taken with mRNA-1273 in response to the events were not applicable.   This case was linked to MOD-2021-250456 (Patient Link).
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Alcohol test, Alcohol test negative
Clinical narrative: tested positive for alcohol; This spontaneous case was reported by a consumer and describes the occurrence of ALCOHOL TEST NEGATIVE (tested positive for alcohol) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 078BNAS and 022B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METHADONE and DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL (TYLENOL PM) for an unknown indication.   On 07-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jul-2021 at 1:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jul-2021 at 5:30 AM, the patient experienced ALCOHOL TEST NEGATIVE (tested positive for alcohol). At the time of the report, ALCOHOL TEST NEGATIVE (tested positive for alcohol) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jul-2021, Alcohol test: positive (Positive) Alcohol test positive.         Treatment information was unknown.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Hyperhidrosis, Night sweats, Pain in extremity, Pyrexia
Clinical narrative: Sweats; in my left arm a warm itchy rash was noted; Cough / dry hacking cough; Arm pain; Night sweats; Arm rash; Light fever 2nd time around; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweats), NIGHT SWEATS (Night sweats), COUGH (Cough / dry hacking cough), PAIN IN EXTREMITY (Arm pain) and RASH PRURITIC (in my left arm a warm itchy rash was noted) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A and 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma since October 1979, Allergic reaction to drug (Vicodin), Drug allergy (Percocet), Allergic reaction to drug (Naprosyn), Allergic reaction to drug (Sulfur) and Tetracycline (Tetracycline). Concomitant products included FLUTICASONE FUROATE, VILANTEROL TRIFENATATE (BREO ELLIPTA), DUPILUMAB (DUPIXENT) and MAGNESIUM for Asthma, ROSUVASTATIN for Cholesterol, DENOSUMAB (PROLIA) for Osteopenia, VITAMIN D NOS, CALCIUM and UBIDECARENONE (COQ-10) for an unknown indication.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced NIGHT SWEATS (Night sweats), PAIN IN EXTREMITY (Arm pain), RASH (Arm rash) and PYREXIA (Light fever 2nd time around). On 28-Mar-2021, the patient experienced COUGH (Cough / dry hacking cough). On an unknown date, the patient experienced HYPERHIDROSIS (Sweats) and RASH PRURITIC (in my left arm a warm itchy rash was noted). On 28-Mar-2021, NIGHT SWEATS (Night sweats) and PYREXIA (Light fever 2nd time around) had resolved. On 30-Mar-2021, PAIN IN EXTREMITY (Arm pain) and RASH (Arm rash) had resolved. At the time of the report, HYPERHIDROSIS (Sweats) and RASH PRURITIC (in my left arm a warm itchy rash was noted) outcome was unknown and COUGH (Cough / dry hacking cough) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered HYPERHIDROSIS (Sweats), NIGHT SWEATS (Night sweats), COUGH (Cough / dry hacking cough), PAIN IN EXTREMITY (Arm pain), RASH PRURITIC (in my left arm a warm itchy rash was noted), RASH (Arm rash) and PYREXIA (Light fever 2nd time around) to be possibly related.    Vitamin-D and Calcium indicated for Bones. Treatment information not provided for Dose 2 events.    This case was linked to MOD-2021-037257 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow up received on 14 Jul 2021- Vaccine adverse event  reporting form added.Patient demographics and medical history was updated.Batch no. of the suspect drug added and concomitant drug details was added.Events added.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: Sweats; in my left arm a warm itchy rash was noted; Cough / dry hacking cough; Arm pain; Night sweats; Arm rash; Light fever 2nd time around; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweats), NIGHT SWEATS (Night sweats), COUGH (Cough / dry hacking cough), PAIN IN EXTREMITY (Arm pain) and RASH PRURITIC (in my left arm a warm itchy rash was noted) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A and 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma since October 1979, Allergic reaction to drug (Vicodin), Drug allergy (Percocet), Allergic reaction to drug (Naprosyn), Allergic reaction to drug (Sulfur) and Tetracycline (Tetracycline). Concomitant products included FLUTICASONE FUROATE, VILANTEROL TRIFENATATE (BREO ELLIPTA), DUPILUMAB (DUPIXENT) and MAGNESIUM for Asthma, ROSUVASTATIN for Cholesterol, DENOSUMAB (PROLIA) for Osteopenia, VITAMIN D NOS, CALCIUM and UBIDECARENONE (COQ-10) for an unknown indication.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced NIGHT SWEATS (Night sweats), PAIN IN EXTREMITY (Arm pain), RASH (Arm rash) and PYREXIA (Light fever 2nd time around). On 28-Mar-2021, the patient experienced COUGH (Cough / dry hacking cough). On an unknown date, the patient experienced HYPERHIDROSIS (Sweats) and RASH PRURITIC (in my left arm a warm itchy rash was noted). On 28-Mar-2021, NIGHT SWEATS (Night sweats) and PYREXIA (Light fever 2nd time around) had resolved. On 30-Mar-2021, PAIN IN EXTREMITY (Arm pain) and RASH (Arm rash) had resolved. At the time of the report, HYPERHIDROSIS (Sweats) and RASH PRURITIC (in my left arm a warm itchy rash was noted) outcome was unknown and COUGH (Cough / dry hacking cough) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered HYPERHIDROSIS (Sweats), NIGHT SWEATS (Night sweats), COUGH (Cough / dry hacking cough), PAIN IN EXTREMITY (Arm pain), RASH PRURITIC (in my left arm a warm itchy rash was noted), RASH (Arm rash) and PYREXIA (Light fever 2nd time around) to be possibly related.    Vitamin-D and Calcium indicated for Bones. Treatment information not provided for Dose 2 events.    This case was linked to MOD-2021-037257 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow up received on 14 Jul 2021- Vaccine adverse event  reporting form added.Patient demographics and medical history was updated.Batch no. of the suspect drug added and concomitant drug details was added.Events added.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: Product temperature excursion issue; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (First dose of vaccine administered after excursion) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (First dose of vaccine administered after excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (First dose of vaccine administered after excursion) 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 were provided. No treatment medications were provided.   This case was linked to MOD-2021-250486 (Patient Link).
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: diagnosed with ACIP; This spontaneous case was reported by a consumer and describes the occurrence of UNEVALUABLE EVENT (diagnosed with ACIP) in an 81-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced UNEVALUABLE EVENT (diagnosed with ACIP). At the time of the report, UNEVALUABLE EVENT (diagnosed with ACIP) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment and concomitant medications were reported.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test negative
Clinical narrative: Tested negative for SARS-CoV-2 antibodies after receiving two doses of the vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of SARS-COV-2 TEST NEGATIVE (Tested negative for SARS-CoV-2 antibodies after receiving two doses of the vaccine) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-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 SARS-COV-2 TEST NEGATIVE (Tested negative for SARS-CoV-2 antibodies after receiving two doses of the vaccine). At the time of the report, SARS-COV-2 TEST NEGATIVE (Tested negative for SARS-CoV-2 antibodies after receiving two doses of the vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     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 medication reported by reporter.  No treatment medication reported by reporter.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Bone pain, Product temperature excursion issue
Clinical narrative: first dose of vaccine administered after excursion; bone pain,bone ache; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (first dose of vaccine administered after excursion) and BONE PAIN (bone pain,bone ache) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (first dose of vaccine administered after excursion) and BONE PAIN (bone pain,bone ache). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (first dose of vaccine administered after excursion) and BONE PAIN (bone pain,bone ache) 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.   Concomitant medications were not provided.  Treatment information was not provided.   This case was linked to MOD-2021-250491 (Patient Link).
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Fatigue, Heart rate increased
Clinical narrative: if she just walks her dog her heart rate goes up to 203BPM; She has chest pains / She also woke up in the night with severe chest pains; She has been feeling very tired since; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (if she just walks her dog her heart rate goes up to 203BPM), CHEST PAIN (She has chest pains / She also woke up in the night with severe chest pains) and FATIGUE (She has been feeling very tired since) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jun-2021, the patient experienced HEART RATE INCREASED (if she just walks her dog her heart rate goes up to 203BPM), CHEST PAIN (She has chest pains / She also woke up in the night with severe chest pains) and FATIGUE (She has been feeling very tired since). At the time of the report, HEART RATE INCREASED (if she just walks her dog her heart rate goes up to 203BPM), CHEST PAIN (She has chest pains / She also woke up in the night with severe chest pains) and FATIGUE (She has been feeling very tired since) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  No treatment details were provided.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: First dose of vaccine administered after excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (First dose of vaccine administered after excursion) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (First dose of vaccine administered after excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (First dose of vaccine administered after excursion) 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.   Concomitant drug was not reported. Treatment medication was not reported.  it was reported that vaccine was administered to people with fluctuating temperature.   This case was linked to MOD-2021-250505 (Patient Link).
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Bone pain, Inappropriate schedule of product administration, Product temperature excursion issue
Clinical narrative: First dose administered 11Mar2021,Second dose administered 16Apr2021; bone pain; second dose of vaccine administered after excursion; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (second dose of vaccine administered after excursion), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose administered 11Mar2021,Second dose administered 16Apr2021) and BONE PAIN (bone pain) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No medical history was provided by reporter.  No concomitant medication reported.     On 16-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (second dose of vaccine administered after excursion). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose administered 11Mar2021,Second dose administered 16Apr2021) and BONE PAIN (bone pain). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (second dose of vaccine administered after excursion), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose administered 11Mar2021,Second dose administered 16Apr2021) and BONE PAIN (bone pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.    Concomitant medication use was unknown No treatment medication reported.   This case was linked to MOD-2021-250480 (Patient Link).
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: First dose of vaccine administered after excursion; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (First dose of vaccine administered after excursion) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (First dose of vaccine administered after excursion). On 11-Mar-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (First dose of vaccine administered after excursion) 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.   No concomitant medication reported by reporter.  No treatment medication reported by reporter.   This case was linked to MOD-2021-250758 (Patient Link).
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling hot, Myalgia, Peripheral swelling, Vaccination site urticaria
Clinical narrative: that was hot to the touch; swollen arm; hives around the injection site; minor muscle aches; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (that was hot to the touch), PERIPHERAL SWELLING (swollen arm), VACCINATION SITE URTICARIA (hives around the injection site), MYALGIA (minor muscle aches) and FATIGUE (tiredness) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041321A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN) for an unknown indication.    On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING HOT (that was hot to the touch), PERIPHERAL SWELLING (swollen arm), VACCINATION SITE URTICARIA (hives around the injection site), MYALGIA (minor muscle aches) and FATIGUE (tiredness). The patient was treated with CYANOCOBALAMIN (B-12) ongoing since an unknown date at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency; IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency; NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and GABAPENTIN at an unspecified dose and frequency. At the time of the report, FEELING HOT (that was hot to the touch), PERIPHERAL SWELLING (swollen arm), VACCINATION SITE URTICARIA (hives around the injection site), MYALGIA (minor muscle aches) and FATIGUE (tiredness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information also included Ice packs, heat packs, rest exercise and Perkiest.   This case was linked to MOD-2021-250506 (Patient Link).
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Patient received vaccine after allowed expiry time; Patient received vaccine after allowed expiry time; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after allowed expiry time) and PRODUCT STORAGE ERROR (Patient received vaccine after allowed expiry time) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after allowed expiry time) and PRODUCT STORAGE ERROR (Patient received vaccine after allowed expiry time). On 07-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after allowed expiry time) and PRODUCT STORAGE ERROR (Patient received vaccine after allowed expiry time) 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.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Punctured vial was stored at room temperature for over 12 hours; Patient received vaccine after allowed expiry time; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after allowed expiry time) and PRODUCT STORAGE ERROR (Punctured vial was stored at room temperature for over 12 hours) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jul-2021 at 11:44 AM, 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 07-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after allowed expiry time). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Punctured vial was stored at room temperature for over 12 hours). On 07-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after allowed expiry time) had resolved. At the time of the report, PRODUCT STORAGE ERROR (Punctured vial was stored at room temperature for over 12 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD21-118547, MOD21-118561, MOD21-118564, MOD21-118565, MOD21-118567, MOD21-118570 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Non-Significant FU received on 27-jul-2021
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Hypertension, Impaired healing, Pain in extremity
Clinical narrative: Vaccination related malaise; Pain in arm; Healing delayed; Hypertension; Dizziness; crust; Vaccination site pruritus; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION COMPLICATION (Vaccination related malaise), PAIN IN EXTREMITY (Pain in arm), IMPAIRED HEALING (Healing delayed), HYPERTENSION (Hypertension) and DIZZINESS (Dizziness) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21-2A and 032B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Allergic to Statins), Allergy (Allergic to super glue), Allergy to plants (Allergic to fresh cut grass), Allergy to antibiotic (Allergic to Erythromycin) and Disorder thyroid (Low thyroid). Concomitant products included LEVOTHYROXINE for an unknown indication.   On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Vaccination related malaise), PAIN IN EXTREMITY (Pain in arm), IMPAIRED HEALING (Healing delayed), HYPERTENSION (Hypertension), DIZZINESS (Dizziness), SCAB (crust) and VACCINATION SITE PRURITUS (Vaccination site pruritus). At the time of the report, VACCINATION COMPLICATION (Vaccination related malaise), PAIN IN EXTREMITY (Pain in arm), IMPAIRED HEALING (Healing delayed), HYPERTENSION (Hypertension), DIZZINESS (Dizziness), SCAB (crust) and VACCINATION SITE PRURITUS (Vaccination site pruritus) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 180/79 High.         For mRNA-1273 (COVID-19 Vaccine Moderna) , the reporter did not provide any causality assessments.  Treatment information was not provided.   This case was linked to MOD-2021-148855 (Patient Link).
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Scab, Vaccination complication, Vaccination site pruritus
Clinical narrative: Vaccination related malaise; Pain in arm; Healing delayed; Hypertension; Dizziness; crust; Vaccination site pruritus; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION COMPLICATION (Vaccination related malaise), PAIN IN EXTREMITY (Pain in arm), IMPAIRED HEALING (Healing delayed), HYPERTENSION (Hypertension) and DIZZINESS (Dizziness) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21-2A and 032B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Allergic to Statins), Allergy (Allergic to super glue), Allergy to plants (Allergic to fresh cut grass), Allergy to antibiotic (Allergic to Erythromycin) and Disorder thyroid (Low thyroid). Concomitant products included LEVOTHYROXINE for an unknown indication.   On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Vaccination related malaise), PAIN IN EXTREMITY (Pain in arm), IMPAIRED HEALING (Healing delayed), HYPERTENSION (Hypertension), DIZZINESS (Dizziness), SCAB (crust) and VACCINATION SITE PRURITUS (Vaccination site pruritus). At the time of the report, VACCINATION COMPLICATION (Vaccination related malaise), PAIN IN EXTREMITY (Pain in arm), IMPAIRED HEALING (Healing delayed), HYPERTENSION (Hypertension), DIZZINESS (Dizziness), SCAB (crust) and VACCINATION SITE PRURITUS (Vaccination site pruritus) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 180/79 High.         For mRNA-1273 (COVID-19 Vaccine Moderna) , the reporter did not provide any causality assessments.  Treatment information was not provided.   This case was linked to MOD-2021-148855 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) 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. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medications are provided. treatment to the events not reported.