chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Paraesthesia, Pruritus, Rash erythematous
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy), PRURITUS (itching was really bad), RASH ERYTHEMATOUS (big red rash on her upper left arm), PARAESTHESIA (Prickling/Tingling sensation) and FLUSHING (Flushing) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 046A21A) for COVID-19 vaccination. The patient's past medical history included Hives, Rash and Red eye. Concurrent medical conditions included Allergy to chemicals NOS (Allergic to sulphur). Concomitant products included MULTIVITAMIN [VITAMINS NOS] for an unknown indication. On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced PRURITUS (itchy), PARAESTHESIA (Prickling/Tingling sensation) and FLUSHING (Flushing). On 23-Feb-2021, the patient experienced PRURITUS (itching was really bad) and RASH ERYTHEMATOUS (big red rash on her upper left arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and HYDROCORTISONE (topical) for Itching and Redness, at an unspecified dose and frequency. On 23-Feb-2021, PRURITUS (itchy), PRURITUS (itching was really bad), PARAESTHESIA (Prickling/Tingling sensation) and FLUSHING (Flushing) had resolved. At the time of the report, RASH ERYTHEMATOUS (big red rash on her upper left arm) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PRURITUS (itchy) to be possibly related. No further causality assessments were provided for PRURITUS (itching was really bad), RASH ERYTHEMATOUS (big red rash on her upper left arm), PARAESTHESIA (Prickling/Tingling sensation) and FLUSHING (Flushing).  Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow up information was received: Included significant information such as new events, second dose information, Allery status, historical conditions and concomitant were added. Event outcome changed unknown to recovered.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Headache
Clinical narrative: Dizziness; Weakness; Mild headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), ASTHENIA (Weakness), HEADACHE (Mild headache) and FATIGUE (Fatigue) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced DIZZINESS (Dizziness), ASTHENIA (Weakness), HEADACHE (Mild headache) and FATIGUE (Fatigue). At the time of the report, DIZZINESS (Dizziness), ASTHENIA (Weakness), HEADACHE (Mild headache) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: redness around the injection site that went from the inside of the arm down to the elbow; It was also itching; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE ERYTHEMA (redness around the injection site that went from the inside of the arm down to the elbow) and VACCINATION SITE PRURITUS (It was also itching) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness around the injection site that went from the inside of the arm down to the elbow) and VACCINATION SITE PRURITUS (It was also itching). The patient was treated with LEVOCABASTINE HYDROCHLORIDE (ZYRTEC [LEVOCABASTINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE ERYTHEMA (redness around the injection site that went from the inside of the arm down to the elbow) and VACCINATION SITE PRURITUS (It was also itching) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Action taken with mRNA-1273 in response to the event was not applicable.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes in the armpit of the arm of the injection and in her collar bone; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen lymph nodes in the armpit of the arm of the injection and in her collar bone) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 029L20A) for COVID-19 vaccination.     The patient's past medical history included High cholesterol.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes in the armpit of the arm of the injection and in her collar bone). At the time of the report, LYMPHADENOPATHY (Swollen lymph nodes in the armpit of the arm of the injection and in her collar bone) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported were for high cholesterol medication.  No treatment medications provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Non-significant FU - Only contact information updated
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Pain in extremity
Clinical narrative: Arm is really sore; Bruise; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm is really sore) and CONTUSION (Bruise) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm is really sore) and CONTUSION (Bruise). At the time of the report, PAIN IN EXTREMITY (Arm is really sore) and CONTUSION (Bruise) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  No relevant concomitant medications were provided Treatment for the events, were not provided
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Pregnancy test
Clinical narrative: Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 26-year-old female patient (gravida 3, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (Outcome: Live, pre-term birth) from July 2013 to 28-May-2014, Pregnancy (Outcome: Live full-term birth) from January 2017 to 09-Oct-2017 and Alcoholic (1 drink/day) from 22-Feb-2021 to 26-Feb-2021. Previously administered products included for an unreported indication: COVID-19 VACCINE (1ST DOSE) on 19-Jan-2021. Concurrent medical conditions included Penicillin allergy.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021 at 11:43 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 23-Jan-2021 and the estimated date of delivery was 30-Oct-2021. On 16-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  third week of the pregnancy.  On 16-Feb-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Feb-2021, Pregnancy test: positive (Positive) positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.    No treatment and concomitant medications were provided.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Mobility decreased
Clinical narrative: Could not move; Joint aches; Freezing; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint aches), CHILLS (Freezing) and MOBILITY DECREASED (Could not move) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-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 ARTHRALGIA (Joint aches), CHILLS (Freezing) and MOBILITY DECREASED (Could not move). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, ARTHRALGIA (Joint aches), CHILLS (Freezing) and MOBILITY DECREASED (Could not move) outcome was unknown.            This case was linked to MOD-2021-031859 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Under my arm my lymph nodes are inflamed; Under my arm my lymph nodes are tender; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Under my arm my lymph nodes are inflamed) and LYMPH NODE PAIN (Under my arm my lymph nodes are tender) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for an unknown indication.     The patient's past medical history included No adverse event.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced LYMPHADENOPATHY (Under my arm my lymph nodes are inflamed) and LYMPH NODE PAIN (Under my arm my lymph nodes are tender). The patient was treated with CHLORHEXIDINE GLUCONATE, THIOMERSAL (SOAK) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, LYMPHADENOPATHY (Under my arm my lymph nodes are inflamed) and LYMPH NODE PAIN (Under my arm my lymph nodes are tender) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Warm compress and Tylenol were recommended by the HCP.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Vaccination site pain
Clinical narrative: Vaccine administered to 17-year-old male patient; arm soreness; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to 17-year-old male patient) and VACCINATION SITE PAIN (arm soreness) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history provided.).    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to 17-year-old male patient) and VACCINATION SITE PAIN (arm soreness). On 15-Feb-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to 17-year-old male patient) had resolved. On 16-Feb-2021, VACCINATION SITE PAIN (arm soreness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.  This report refers to a case of inappropriate age at vaccine administration for mRNA-1273, lot # 015M20A with associated AE vaccination site pain.; Sender's Comments: This report refers to a case of inappropriate age at vaccine administration for mRNA-1273, lot # 015M20A with associated AE vaccination site pain.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pyrexia
Clinical narrative: Fatigue; Chills; Headache; Mild fever; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Mild fever) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 02LA20A and 031L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-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 FATIGUE (Fatigue), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Mild fever). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, FATIGUE (Fatigue), HEADACHE (Headache) and PYREXIA (Mild fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   This case was linked to MOD-2021-033985 (Patient Link).
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Pollakiuria
Clinical narrative: Urinating more; This spontaneous case was reported by a consumer and describes the occurrence of POLLAKIURIA (Urinating more) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced POLLAKIURIA (Urinating more). At the time of the report, POLLAKIURIA (Urinating more) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included were not provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Pyrexia, Tinnitus
Clinical narrative: ringing in the ears - "It's like when you are outside, and crickets are chirping"; lethargic; fever; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (ringing in the ears - "It's like when you are outside, and crickets are chirping"), LETHARGY (lethargic) and PYREXIA (fever) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Feb-2021, the patient experienced TINNITUS (ringing in the ears - "It's like when you are outside, and crickets are chirping"), LETHARGY (lethargic) and PYREXIA (fever). At the time of the report, TINNITUS (ringing in the ears - "It's like when you are outside, and crickets are chirping"), LETHARGY (lethargic) and PYREXIA (fever) outcome was unknown.             Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications provided. No treatment information provided.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Itching; Redness on the Arm; Breaking out with rash; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching), ERYTHEMA (Redness on the Arm) and RASH (Breaking out with rash) 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 19-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itching), ERYTHEMA (Redness on the Arm) and RASH (Breaking out with rash). At the time of the report, PRURITUS (Itching), ERYTHEMA (Redness on the Arm) and RASH (Breaking out with rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant products were reported. No treatments were reported.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow-up received on 21-Jul-2021 contains significant information. The primary reporter contact details were updated. The start date of vaccination was added.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Pyrexia
Clinical narrative: Injection site achiness; High fever of 102 F; Chills; Headache; Felt drained; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection site achiness), PYREXIA (High fever of 102 F), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Felt drained) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     The patient's past medical history included Plasma donor (She donated plasma for antibodies, after recovering from Covid-19.).    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced VACCINATION SITE PAIN (Injection site achiness), PYREXIA (High fever of 102 F), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Felt drained). At the time of the report, VACCINATION SITE PAIN (Injection site achiness), PYREXIA (High fever of 102 F), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Felt drained) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Body temperature: 102 f (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment and concomitant medications were reported.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection site achiness; High fever of 102 F; Chills; Headache; Felt drained; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection site achiness), PYREXIA (High fever of 102 F), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Felt drained) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     The patient's past medical history included Plasma donor (She donated plasma for antibodies, after recovering from Covid-19.).    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced VACCINATION SITE PAIN (Injection site achiness), PYREXIA (High fever of 102 F), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Felt drained). At the time of the report, VACCINATION SITE PAIN (Injection site achiness), PYREXIA (High fever of 102 F), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Felt drained) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Body temperature: 102 f (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment and concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Feeling hot, Peripheral swelling, Pyrexia, Rash
Clinical narrative: Swollen arm; Warm to touch; Rash; Low grade fever of 99.8F; Joints pain; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen arm), FEELING HOT (Warm to touch), RASH (Rash), PYREXIA (Low grade fever of 99.8F) and ARTHRALGIA (Joints pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history information was reported.     On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced ARTHRALGIA (Joints pain). On an unknown date, the patient experienced PERIPHERAL SWELLING (Swollen arm), FEELING HOT (Warm to touch), RASH (Rash) and PYREXIA (Low grade fever of 99.8F). The patient was treated with IBUPROFEN at an unspecified dose and frequency and BISMUTH SUBSALICYLATE (PEPTO-BISMOL) at an unspecified dose and frequency. On 25-Feb-2021, PERIPHERAL SWELLING (Swollen arm), FEELING HOT (Warm to touch), RASH (Rash), PYREXIA (Low grade fever of 99.8F) and ARTHRALGIA (Joints pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.   Reporter did not allow further contact.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Sore arm; Tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and FATIGUE (Tired) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and FATIGUE (Tired). At the time of the report, PAIN IN EXTREMITY (Sore arm) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment and concomitant medications were reported.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Fatigue, Feeling cold, Headache
Clinical narrative: sore arm; not feeling good; cold; lips and face twiching; Diarrhea; dizzy; fever; nausea; headache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), MALAISE (not feeling good), FEELING COLD (cold), MUSCLE TWITCHING (lips and face twiching) and DIARRHOEA (Diarrhea) in a 63-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 was provided by the reporter.     On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm), MALAISE (not feeling good), FEELING COLD (cold), MUSCLE TWITCHING (lips and face twiching), DIARRHOEA (Diarrhea), DIZZINESS (dizzy), PYREXIA (fever), NAUSEA (nausea), HEADACHE (headache) and FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 28-Feb-2021, PAIN IN EXTREMITY (sore arm), MALAISE (not feeling good), FEELING COLD (cold), MUSCLE TWITCHING (lips and face twiching), DIARRHOEA (Diarrhea), DIZZINESS (dizzy), PYREXIA (fever), NAUSEA (nausea) and HEADACHE (headache) had resolved. At the time of the report, FATIGUE (fatigue) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Muscle twitching, Nausea, Pain in extremity, Pyrexia
Clinical narrative: sore arm; not feeling good; cold; lips and face twiching; Diarrhea; dizzy; fever; nausea; headache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), MALAISE (not feeling good), FEELING COLD (cold), MUSCLE TWITCHING (lips and face twiching) and DIARRHOEA (Diarrhea) in a 63-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 was provided by the reporter.     On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm), MALAISE (not feeling good), FEELING COLD (cold), MUSCLE TWITCHING (lips and face twiching), DIARRHOEA (Diarrhea), DIZZINESS (dizzy), PYREXIA (fever), NAUSEA (nausea), HEADACHE (headache) and FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 28-Feb-2021, PAIN IN EXTREMITY (sore arm), MALAISE (not feeling good), FEELING COLD (cold), MUSCLE TWITCHING (lips and face twiching), DIARRHOEA (Diarrhea), DIZZINESS (dizzy), PYREXIA (fever), NAUSEA (nausea) and HEADACHE (headache) had resolved. At the time of the report, FATIGUE (fatigue) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hyperhidrosis, Myalgia, Nausea
Clinical narrative: Myalgia; Fatigue; Chills; Nausea; Sweating; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Myalgia), FATIGUE (Fatigue), CHILLS (Chills), NAUSEA (Nausea) and HYPERHIDROSIS (Sweating) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Myalgia), FATIGUE (Fatigue), CHILLS (Chills), NAUSEA (Nausea) and HYPERHIDROSIS (Sweating). The patient was treated with PARACETAMOL (TYLENOL) for Myalgia, Fatigue, Chills, Nausea and Sweating, at an unspecified dose and frequency. At the time of the report, MYALGIA (Myalgia), FATIGUE (Fatigue), CHILLS (Chills), NAUSEA (Nausea) and HYPERHIDROSIS (Sweating) outcome was unknown.            No concomitant medication provided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Eye disorder, Headache, Pyrexia, Urticaria
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives), PYREXIA (Fever), HEADACHE (Headache), EYE DISORDER (Eye abnormality) and DIARRHOEA (diarrhea) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. No Medical History information was reported. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced URTICARIA (Hives), PYREXIA (Fever), HEADACHE (Headache), EYE DISORDER (Eye abnormality) and DIARRHOEA (diarrhea). At the time of the report, URTICARIA (Hives), PYREXIA (Fever), HEADACHE (Headache), EYE DISORDER (Eye abnormality) and DIARRHOEA (diarrhea) 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 medication use was not provided. Treatment information was not provided.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain
Clinical narrative: aches; chills; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aches), CHILLS (chills) and FATIGUE (tiredness) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 130M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (aches), CHILLS (chills) and FATIGUE (tiredness). At the time of the report, PAIN (aches), CHILLS (chills) and FATIGUE (tiredness) outcome was unknown.            No concomitant medications were reported. No treatment related information has been reported.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash on stomach and back; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on stomach and back) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042120A) for COVID-19 vaccination.     Concurrent medical conditions included Lung disorder NOS (lung problems). Concomitant products included TAMSULOSIN, CLOPIDOGREL, LOSARTAN, SENNA, BUDESONIDE and MORPHINE for an unknown indication.    On 16-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 RASH (rash on stomach and back). The patient was treated with CORTISONE for Rash, at an unspecified dose and frequency. At the time of the report, RASH (rash on stomach and back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitantly, patient was taking perosomad and aderid.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Pounding headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Pounding headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Migraine (Medical history reported as patient has normal migraine).   On 11-Feb-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Pounding headache). At the time of the report, HEADACHE (Pounding headache) outcome was unknown. Not Provided          Concomitant product use was not provided. No treatment was reported. Action taken in response to mRNA-1273 was not applicable.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Limb discomfort, Pain, Pyrexia, Swelling
Clinical narrative: bedridden; cant pick up her arm; her neck is swelling like there is 2 balls growing on her neck; soreness; fever; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (bedridden), LIMB DISCOMFORT (cant pick up her arm), SWELLING (her neck is swelling like there is 2 balls growing on her neck), PAIN (soreness) and PYREXIA (fever) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced BEDRIDDEN (bedridden), LIMB DISCOMFORT (cant pick up her arm), SWELLING (her neck is swelling like there is 2 balls growing on her neck), PAIN (soreness) and PYREXIA (fever). At the time of the report, BEDRIDDEN (bedridden), LIMB DISCOMFORT (cant pick up her arm), SWELLING (her neck is swelling like there is 2 balls growing on her neck), PAIN (soreness) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  No treatment medications were provided
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dizziness postural
Clinical narrative: became dizzy; went to his knees; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (became dizzy) and DIZZINESS POSTURAL (went to his knees) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (became dizzy) and DIZZINESS POSTURAL (went to his knees). At the time of the report, DIZZINESS (became dizzy) and DIZZINESS POSTURAL (went to his knees) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: persistent headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (persistent headache) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced HEADACHE (persistent headache). At the time of the report, HEADACHE (persistent headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment details were not provided.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: really tired; exhausted; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (exhausted) and FATIGUE (really tired) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unk) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 22-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced FATIGUE (exhausted). On 02-Mar-2021, the patient experienced FATIGUE (really tired). At the time of the report, FATIGUE (exhausted) and FATIGUE (really tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: right ear was numb/right side of head was numb; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (right ear was numb/right side of head was numb) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (right ear was numb/right side of head was numb). At the time of the report, HYPOAESTHESIA (right ear was numb/right side of head was numb) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Throat irritation, Urticaria
Clinical narrative: little red bumps like mosquito bites; throat is little itchy; itchy again on her bra line and on her back; welting on her inner arm a little bit on the bottom and the top; itching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching), URTICARIA (little red bumps like mosquito bites), PRURITUS (itchy again on her bra line and on her back), URTICARIA (welting on her inner arm a little bit on the bottom and the top) and THROAT IRRITATION (throat is little itchy) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced PRURITUS (itching). On 02-Mar-2021, the patient experienced PRURITUS (itchy again on her bra line and on her back) and URTICARIA (welting on her inner arm a little bit on the bottom and the top). On 03-Mar-2021, the patient experienced THROAT IRRITATION (throat is little itchy). On an unknown date, the patient experienced URTICARIA (little red bumps like mosquito bites). At the time of the report, PRURITUS (itching), URTICARIA (little red bumps like mosquito bites), PRURITUS (itchy again on her bra line and on her back), URTICARIA (welting on her inner arm a little bit on the bottom and the top) and THROAT IRRITATION (throat is little itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was treated with Trampemine ointment.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Swollen (Injection); Redness (Injection SIte); Itchiness (Injection Site); A spontaneous report was received from a consumer concerning a 66-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events swollen (injection), redness (injection site), itchiness (injection site).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 17 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 038K20A) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) Swollen (Injection), Redness (Injection SIte), Itchiness (Injection Site).  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), swollen (injection), redness (injection site), itchiness (injection site) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: body ache; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body ache), PYREXIA (fever) and CHILLS (chills) 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 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced PAIN (body ache), PYREXIA (fever) and CHILLS (chills). At the time of the report, PAIN (body ache), PYREXIA (fever) and CHILLS (chills) outcome was unknown.            No treatment information was provided.  Patient wanted to know if she can take Tylenol.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Balance disorder, Headache, Myalgia, Pyrexia
Clinical narrative: lost balance; Every joint in my body aches; Terrible headaches; Body Aches; Fever; Throwing up; This spontaneous case was reported by a health care professional and describes the occurrence of BALANCE DISORDER (lost balance), PYREXIA (Fever), VOMITING (Throwing up), MYALGIA (Body Aches) and ARTHRALGIA (Every joint in my body aches) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 042L208) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Arthritis. Concomitant products included LOSARTAN, OMEPRAZOLE, ACETYLSALICYLIC ACID (ASPIRIN LOW), METOPROLOL, ATORVASTATIN, AMITRIPTYLINE, INSULIN and INSULIN DEGLUDEC (TRESIBA) for an unknown indication.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced PYREXIA (Fever) and VOMITING (Throwing up). On 03-Mar-2021, the patient experienced MYALGIA (Body Aches). On an unknown date, the patient experienced BALANCE DISORDER (lost balance), ARTHRALGIA (Every joint in my body aches) and HEADACHE (Terrible headaches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; ACETAMINOPHEN at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, BALANCE DISORDER (lost balance), PYREXIA (Fever), VOMITING (Throwing up), MYALGIA (Body Aches), ARTHRALGIA (Every joint in my body aches) and HEADACHE (Terrible headaches) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: lost balance; Every joint in my body aches; Terrible headaches; Body Aches; Fever; Throwing up; This spontaneous case was reported by a health care professional and describes the occurrence of BALANCE DISORDER (lost balance), PYREXIA (Fever), VOMITING (Throwing up), MYALGIA (Body Aches) and ARTHRALGIA (Every joint in my body aches) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 042L208) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Arthritis. Concomitant products included LOSARTAN, OMEPRAZOLE, ACETYLSALICYLIC ACID (ASPIRIN LOW), METOPROLOL, ATORVASTATIN, AMITRIPTYLINE, INSULIN and INSULIN DEGLUDEC (TRESIBA) for an unknown indication.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced PYREXIA (Fever) and VOMITING (Throwing up). On 03-Mar-2021, the patient experienced MYALGIA (Body Aches). On an unknown date, the patient experienced BALANCE DISORDER (lost balance), ARTHRALGIA (Every joint in my body aches) and HEADACHE (Terrible headaches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; ACETAMINOPHEN at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, BALANCE DISORDER (lost balance), PYREXIA (Fever), VOMITING (Throwing up), MYALGIA (Body Aches), ARTHRALGIA (Every joint in my body aches) and HEADACHE (Terrible headaches) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: did not get full dose as vaccine split on her arm; A spontaneous report was received from a consumer concerning her daughter, a 26-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced didn't get the full dose and the vaccine split on their arm during administration (accidental underdose).  The patient's medical history was not provided by the reporter. Concomitant medication was not provided by the reporter.  On 02-Mar-2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. The reporter stated that the patient didn't get the full dose and the vaccine split on her arm during administration.  No laboratory details were provided.  Treatment information for the event was not provided by the reporter.  Action taken with mRNA-1273 in response to the event was unknown.   On 02-Mar-2021, the outcome of the event, didn't get the full dose and the vaccine split on their arm during administration, was considered recovered/resolved.; Reporter's Comments: This report refers to a case of 26-year-old female with Accidental underdose for the first dose of mRNA-1273 (lot #: Unknown) with no associated adverse events. Event considered resolved.