chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: pregnant and received vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (pregnant and received vaccine) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 027L20A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: COVID-19 VACCINE (first dose received on 30 Dec 2020) on 30-Dec-2020. Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] and OMEPRAZOLE.   On 27-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. The patient's last menstrual period was on 16-Dec-2020 and the estimated date of delivery was 22-Sep-2021. On 27-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (pregnant and received vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  sixth week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (pregnant and received vaccine) had resolved.     No treatment information was reported by reporter.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter considered EXPOSURE DURING PREGNANCY (pregnant and received vaccine) to be not related.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy
Clinical narrative: Neck pain, swollen lymph node; headache where neck meets the head base of the skull right side; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Neck pain, swollen lymph node) and HEADACHE (headache where neck meets the head base of the skull right side) 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 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2020, the patient experienced HEADACHE (headache where neck meets the head base of the skull right side). On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced LYMPHADENOPATHY (Neck pain, swollen lymph node). At the time of the report, LYMPHADENOPATHY (Neck pain, swollen lymph node) was resolving and HEADACHE (headache where neck meets the head base of the skull right side) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.   Treatment information was unknown.   Most recent FOLLOW-UP information incorporated above includes: On 11-Feb-2021: Updated the adverse events.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Ultrasound foetal
Clinical narrative: was pregnant during the first/second dose of Moderna vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (was pregnant during the first/second dose of Moderna vaccine) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 028L20A) for COVID-19 vaccination.     Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy, VITAMIN D3 for Vitamin supplementation.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, 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 in December 2020 and the estimated date of delivery was 08-Sep-2021. On 23-Dec-2020, the patient experienced EXPOSURE DURING PREGNANCY (was pregnant during the first/second dose of Moderna vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  On 20-Jan-2021, EXPOSURE DURING PREGNANCY (was pregnant during the first/second dose of Moderna vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Jan-2021, Ultrasound foetal: normal (normal) normal.         Date of positive pregnancy test: 31-DEC-2020. Estimated date of conception: 16-DEC-2021.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jan-2021: Internal review on 24-Jun-2021 resulted in updates to event coding and pregnancy details.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: heart rate increased; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (heart rate increased) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011l20A) for COVID-19 vaccination.     The patient's past medical history included Hypertension and Asthma. Concomitant products included AMLODIPINE for Hypertension, HCTZ for an unknown indication.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced HEART RATE INCREASED (heart rate increased). At the time of the report, HEART RATE INCREASED (heart rate increased) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the events was unknown.; 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.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Warm to the touch; Redness at the site of injection; Swelling at site of injection; Pain at site of injection; A spontaneous report was received from a other health care professional concerning a 36-years-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pain at site of injection, swelling at site of injection, feeling hot and vaccination site erythema.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 28 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273(lot number: 025J20-2A) intramuscularly for the prophylaxis of COVID-19 infection.  On 28 Dec 2020, she started experiencing pain at site of injection, redness, swelling at site of injection for a while after a day of vaccine, pain then subsided for most part was gone, redness in oval below the site of injection a day after vaccine it now feels warm to the touch.  The action was taken with mRNA-1273 in response to the events was unknown.  The outcome of al events were recovering.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination complication, Vaccination site erythema, Vaccination site pain, Vaccination site rash
Clinical narrative: It was also very red and hot; Swelling around the sight of injection; Strong rash around the sight of the injection; Circle of redness at the injection site of two inches; Felt a little sick; Arm sore; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Felt a little sick), VACCINATION SITE WARMTH (It was also very red and hot), VACCINATION SITE PAIN (Arm sore), VACCINATION SITE ERYTHEMA (Circle of redness at the injection site of two inches) and VACCINATION SITE SWELLING (Swelling around the sight of injection) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included CALCIUM, MAGNESIUM and FISH OIL for an unknown indication.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Jan-2021, the patient experienced VACCINATION COMPLICATION (Felt a little sick), VACCINATION SITE PAIN (Arm sore) and FATIGUE (Fatigue). On 20-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Circle of redness at the injection site of two inches). On an unknown date, the patient experienced VACCINATION SITE WARMTH (It was also very red and hot), VACCINATION SITE SWELLING (Swelling around the sight of injection) and VACCINATION SITE RASH (Strong rash around the sight of the injection). On 12-Jan-2021, FATIGUE (Fatigue) had resolved. On 15-Jan-2021, VACCINATION COMPLICATION (Felt a little sick) and VACCINATION SITE PAIN (Arm sore) had resolved. On 22-Jan-2021, VACCINATION SITE ERYTHEMA (Circle of redness at the injection site of two inches) had resolved. At the time of the report, VACCINATION SITE WARMTH (It was also very red and hot), VACCINATION SITE SWELLING (Swelling around the sight of injection) and VACCINATION SITE RASH (Strong rash around the sight of the injection) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 17-Apr-2021: updated event outcomes, second dose information, concomitant medications, and patient information.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: It was also very red and hot; Swelling around the sight of injection; Strong rash around the sight of the injection; Circle of redness at the injection site of two inches; Felt a little sick; Arm sore; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Felt a little sick), VACCINATION SITE WARMTH (It was also very red and hot), VACCINATION SITE PAIN (Arm sore), VACCINATION SITE ERYTHEMA (Circle of redness at the injection site of two inches) and VACCINATION SITE SWELLING (Swelling around the sight of injection) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included CALCIUM, MAGNESIUM and FISH OIL for an unknown indication.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Jan-2021, the patient experienced VACCINATION COMPLICATION (Felt a little sick), VACCINATION SITE PAIN (Arm sore) and FATIGUE (Fatigue). On 20-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Circle of redness at the injection site of two inches). On an unknown date, the patient experienced VACCINATION SITE WARMTH (It was also very red and hot), VACCINATION SITE SWELLING (Swelling around the sight of injection) and VACCINATION SITE RASH (Strong rash around the sight of the injection). On 12-Jan-2021, FATIGUE (Fatigue) had resolved. On 15-Jan-2021, VACCINATION COMPLICATION (Felt a little sick) and VACCINATION SITE PAIN (Arm sore) had resolved. On 22-Jan-2021, VACCINATION SITE ERYTHEMA (Circle of redness at the injection site of two inches) had resolved. At the time of the report, VACCINATION SITE WARMTH (It was also very red and hot), VACCINATION SITE SWELLING (Swelling around the sight of injection) and VACCINATION SITE RASH (Strong rash around the sight of the injection) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 17-Apr-2021: updated event outcomes, second dose information, concomitant medications, and patient information.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: rash develop around the injection about 3 inches in diameter; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE RASH (rash develop around the injection about 3 inches in diameter) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION SITE RASH (rash develop around the injection about 3 inches in diameter). At the time of the report, VACCINATION SITE RASH (rash develop around the injection about 3 inches in diameter) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant drugs were not reported. Treatment drugs included Anti-biotic and Benadryl topical cream..   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: outcome changed to resolved as per TCR received
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives; A spontaneous report was received from a consumer, concerning a Male of 64 years age, who received Moderna's COVID-19 vaccine and experienced  the hives after taking the vaccine. The patient's medical history was not provided. Concomitant product use was provided by the reporter that metformin has taken and received treatment 10mg steroid orally and then IM On 4jan2021 date, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot number unknown)  to the Left arm via IM route for COVID-19 infection prophylaxis. And later 2 days after vaccination  started getting hives and lasted the whole weeks, big patches from 6 to 12Jan2021 Action taken with mRNA-1273 in response to the event was unknown. The outcome of the event, Hives was considered to be  resolved at the time of this report.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral
Clinical narrative: numbing of the tongue; Case reference number MOD-2021-012274 is a spontaneous case report sent by a Non-Health Professional on 22-JAN-2021 00:00:00 , which refers to a Female aged 52 Years .  The patients past medical history included: No adverse event   . .  On   the patient started taking Moderna COVID-19 Vaccine for COVID-19 vaccination. Some  1 day later,  the patient developed numbing of the tongue. Over a period of the next <ENTER DURATION OF EVENT> days, the patient also developed  . Relevant laboratory results included   and relevant physical signs were <LIST PHYSICAL SYMPTOMS>. The patient experienced the following serious criteria:. The eventual diagnosis made on was Hypoaesthesia oral . .  The patient was treated for the event with   . <ENTER ANY PROCEDURES> The action taken for Moderna COVID-19 Vaccine was  Unknown on  . An autopsy was performed on  . The Non-Health Professional did not declare any relatedness between numbing of the tongue and Moderna COVID-19 Vaccine In their opinion, other possible etiological factors included  <STATE OTHER FACTORS> and the patients age/ history or other factors <LIST OTHER RELEVANT  FACTORS> .  The company believes the following facts are also relevant in this case: <LIST OTHER RELEVANT FACTORS HERE> OR  <THERE IS NO KNOWN PLAUSIBLE MECHANISM BY WHICH THE DRUG WOULD CAUSE THE PRIMARY EVENT>.  The medical reviewer may provide a case evaluation statement, including other possible etiological and confounding factors, e.g. (only limited information has been obtained so far, it is difficult to assess the cause and effect relationship; the co-medications y and x should also be considered causative as the reported event is labeled for both drugs; the company's view is the event is not due to the drug for the following reasons  (probably due to pre existing disease); there is no plausible mechanism to implicate the drug.  .   Terse Narrative (for PSUR narratives and signal review) Brief 3 line summary of above for CIOMS listing: Report Source- Non-Health Professional,  Age- 52 Years,  Sex- Female,  Suspect Drug- Moderna COVID-19 Vaccine,  Treatment-    Diagnosis\Outcome- numbing of the tongue - Not Recovered/Not Resolved.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Itching; Broke out in a rash from head to toe; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching) and RASH (Broke out in a rash from head to toe) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K209) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced PRURITUS (Itching) and RASH (Broke out in a rash from head to toe). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date for Itching, at an unspecified dose and frequency. At the time of the report, PRURITUS (Itching) and RASH (Broke out in a rash from head to toe) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Vaccination site pain
Clinical narrative: weakness; Chills; headache; Sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), CHILLS (Chills), HEADACHE (headache) and VACCINATION SITE PAIN (Sore at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced ASTHENIA (weakness), CHILLS (Chills), HEADACHE (headache) and VACCINATION SITE PAIN (Sore at the injection site). At the time of the report, ASTHENIA (weakness), CHILLS (Chills), HEADACHE (headache) and VACCINATION SITE PAIN (Sore at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information was not provided. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Follow-up received 25-JUN-2021 included no new information. On 12-Jul-2021: Follow-up received on 12-JUL-2021 and reporter contact details updated
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Muscular weakness, Pain in extremity
Clinical narrative: Dizziness; Headache; Weakness of the legs; Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness), DIZZINESS (Dizziness), HEADACHE (Headache) and MUSCULAR WEAKNESS (Weakness of the legs) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     The patient's past medical history included Macular degeneration since an unknown date, Glaucoma since an unknown date, Cholesterol since an unknown date and Hypertension since an unknown date. Concomitant products included ATORVASTATIN for Cholesterol, VALSARTAN for Hypertension, ACETAZOLAMIDE for Macular degeneration and Glaucoma, ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 04-Feb-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness). On 05-Feb-2021, the patient experienced DIZZINESS (Dizziness), HEADACHE (Headache) and MUSCULAR WEAKNESS (Weakness of the legs). On 06-Feb-2021, PAIN IN EXTREMITY (Arm soreness), DIZZINESS (Dizziness), HEADACHE (Headache) and MUSCULAR WEAKNESS (Weakness of the legs) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment details were provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 06-Feb-2021 and was forwarded to Moderna on 08-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness), DIZZINESS (Dizziness), HEADACHE (Headache) and MUSCULAR WEAKNESS (Weakness of the legs) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     The patient's past medical history included Macular degeneration since an unknown date, Glaucoma since an unknown date, Cholesterol since an unknown date and Hypertension since an unknown date. Concomitant products included ATORVASTATIN for Cholesterol, VALSARTAN for Hypertension, ACETAZOLAMIDE for Macular degeneration and Glaucoma, ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 04-Feb-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness). On 05-Feb-2021, the patient experienced DIZZINESS (Dizziness), HEADACHE (Headache) and MUSCULAR WEAKNESS (Weakness of the legs). On 06-Feb-2021, PAIN IN EXTREMITY (Arm soreness), DIZZINESS (Dizziness), HEADACHE (Headache) and MUSCULAR WEAKNESS (Weakness of the legs) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment details were provided.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Headache, Pain in extremity, Vaccination site pain
Clinical narrative: Redness; Pain at the injection site; Arm soreness; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness), ERYTHEMA (Redness), HEADACHE (Headache) and VACCINATION SITE PAIN (Pain at the injection site) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Dizziness. Concomitant products included MECLIZINE [MECLOZINE] for Dizziness.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness) and HEADACHE (Headache). On 06-Feb-2021, the patient experienced ERYTHEMA (Redness) and VACCINATION SITE PAIN (Pain at the injection site). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) ongoing since an unknown date for Adverse event, at a dose of UNK dosage form. On 02-Feb-2021, PAIN IN EXTREMITY (Arm soreness) and HEADACHE (Headache) had resolved. At the time of the report, ERYTHEMA (Redness) and VACCINATION SITE PAIN (Pain at the injection site) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reported that her symptoms cleared up after a few days. She had her second dose of vaccine with no adverse events.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Additional information received included event outcome and second dose information.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea
Clinical narrative: Diarrhea; Feels weak; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) and ASTHENIA (Feels weak) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-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 DIARRHOEA (Diarrhea) and ASTHENIA (Feels weak). At the time of the report, DIARRHOEA (Diarrhea) and ASTHENIA (Feels weak) outcome was unknown.            No relevant concomitant medications were provided.  No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea, SARS-CoV-1 test positive
Clinical narrative: Runny nose; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny nose) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced RHINORRHOEA (Runny nose). At the time of the report, RHINORRHOEA (Runny nose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Jan-2021, SARS-CoV-1 test positive: positive (Positive) Positive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant product use was not provided by the reporter.   No treatment details were reported.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Itchy rash came a week after, about 2 inches wide and 3 inches long; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itchy rash came a week after, about 2 inches wide and 3 inches long) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. OL1L20A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included MULTIVITAMIN [VITAMINS NOS], VITAMIN D [VITAMIN D NOS], FISH OIL, MAGNESIUM and MELATONIN for an unknown indication.    On 09-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH PRURITIC (Itchy rash came a week after, about 2 inches wide and 3 inches long). The patient was treated with CALAMINE, ZINC OXIDE (CALADRYL [CALAMINE;ZINC OXIDE]) for Itching, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itching, at a dose of 25 mg, 3 tabs. At the time of the report, RASH PRURITIC (Itchy rash came a week after, about 2 inches wide and 3 inches long) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Itchy rash came a week after vaccination.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dyspnoea, Feeling cold
Clinical narrative: felt cold including her lower back, knees and shoulders; Very short of breath; Her joints hurt badly; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (felt cold including her lower back, knees and shoulders), DYSPNOEA (Very short of breath) and ARTHRALGIA (Her joints hurt badly) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unk) for COVID-19 vaccination.     Concurrent medical conditions included No adverse event (no medical history reported).    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced FEELING COLD (felt cold including her lower back, knees and shoulders), DYSPNOEA (Very short of breath) and ARTHRALGIA (Her joints hurt badly). At the time of the report, FEELING COLD (felt cold including her lower back, knees and shoulders), DYSPNOEA (Very short of breath) and ARTHRALGIA (Her joints hurt badly) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact; Reporter'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: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Pregnancy test
Clinical narrative: Enroll in registry for being pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Enroll in registry for being pregnant) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 29A21A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use from 22-Sep-2014 to 01-Dec-2020. Concurrent medical conditions included Trauma (Trauma due to racism, patient went to therapy and is still working through it.) since March 2020. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 2021 to an unknown date for Pregnancy, DIPHENHYDRAMINE for Sleep disorder, MULTIVITAMINS [VITAMINS NOS], ZINC and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 11-Dec-2020 and the estimated date of delivery was 17-Sep-2021. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Enroll in registry for being pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  eighth week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (Enroll in registry for being pregnant) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jan-2021, Pregnancy test: positive (Positive) Pregnancy test positive.         The action taken with mRNA-1273(Moderna COVID-19 vaccine) was not applicable.  No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 24-Apr-2021: Patient demographics updated, Medical history information updated,  pregnancy  test updated, Concomitant medications added, second dose added,
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Pain in extremity, Pyrexia
Clinical narrative: Arm is sore; did not feel to hot and face was hot; Slight fever; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Arm is sore), FLUSHING (did not feel to hot and face was hot) and PYREXIA (Slight fever) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety (Anxiety under control with medications.).   On 05-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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm is sore), FLUSHING (did not feel to hot and face was hot) and PYREXIA (Slight fever). At the time of the report, PAIN IN EXTREMITY (Arm is sore) and PYREXIA (Slight fever) outcome was unknown and FLUSHING (did not feel to hot and face was hot) had resolved. Not Provided          Concomitant medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-Feb-2021: TCR was attached. The patient was received treatment medication and second dose of vaccine was received.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Patient is pregnant; This spontaneous retrospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EXPOSURE DURING PREGNANCY (Patient is pregnant) in a 34-year-old female patient (gravida 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (Previous Pregnancy).    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 15-Jul-2021. On 22-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Patient is pregnant). At the time of the report, EXPOSURE DURING PREGNANCY (Patient is pregnant) 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 product use was not provided.  No treatment details were reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Feb-2021 and was forwarded to Moderna on 09-Feb-2021.    This spontaneous retrospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EXPOSURE DURING PREGNANCY (Patient is pregnant) in a 34-year-old female patient (gravida 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (Previous Pregnancy).    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 15-Jul-2021. On 22-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Patient is pregnant). At the time of the report, EXPOSURE DURING PREGNANCY (Patient is pregnant) 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 product use was not provided.  No treatment details were reported.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. M2L20A) for COVID-19 vaccination.     NO medical history information was reported.     On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 18-Jan-2021, PAIN IN EXTREMITY (sore arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  No treatment details were reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Jan-2021 and was forwarded to Moderna on 22-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. M2L20A) for COVID-19 vaccination.     NO medical history information was reported.     On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 18-Jan-2021, PAIN IN EXTREMITY (sore arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  No treatment details were reported.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema
Clinical narrative: Redness on injection arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Redness on injection arm) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history information was reported.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE ERYTHEMA (Redness on injection arm). At the time of the report, INJECTION SITE ERYTHEMA (Redness on injection arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  No treatment details were reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Jan-2021 and was forwarded to Moderna on 22-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Redness on injection arm) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history information was reported.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE ERYTHEMA (Redness on injection arm). At the time of the report, INJECTION SITE ERYTHEMA (Redness on injection arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  No treatment details were reported.
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site warmth, Pruritus, Swelling
Clinical narrative: redness; swelling; itching at injection site; site is warm to touch; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (redness), SWELLING (swelling), PRURITUS (itching at injection site) and INJECTION SITE WARMTH (site is warm to touch) 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 15-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (redness), SWELLING (swelling), PRURITUS (itching at injection site) and INJECTION SITE WARMTH (site is warm to touch). At the time of the report, INJECTION SITE ERYTHEMA (redness), SWELLING (swelling), PRURITUS (itching at injection site) and INJECTION SITE WARMTH (site is warm to touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  No treatment details were reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Jan-2021 and was forwarded to Moderna on 24-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (redness), SWELLING (swelling), PRURITUS (itching at injection site) and INJECTION SITE WARMTH (site is warm to touch) 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 15-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (redness), SWELLING (swelling), PRURITUS (itching at injection site) and INJECTION SITE WARMTH (site is warm to touch). At the time of the report, INJECTION SITE ERYTHEMA (redness), SWELLING (swelling), PRURITUS (itching at injection site) and INJECTION SITE WARMTH (site is warm to touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  No treatment details were reported.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site erythema, Injection site mass, Injection site pruritus
Clinical narrative: headaches; itch; red; lump; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headaches), INJECTION SITE PRURITUS (itch), INJECTION SITE ERYTHEMA (red) and INJECTION SITE MASS (lump) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037KZOA) for COVID-19 vaccination.     NO medical history information was reported.     On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headaches), INJECTION SITE PRURITUS (itch), INJECTION SITE ERYTHEMA (red) and INJECTION SITE MASS (lump). At the time of the report, HEADACHE (headaches), INJECTION SITE PRURITUS (itch), INJECTION SITE ERYTHEMA (red) and INJECTION SITE MASS (lump) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  Treatment medication was not reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Jan-2021 and was forwarded to Moderna on 22-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headaches), INJECTION SITE PRURITUS (itch), INJECTION SITE ERYTHEMA (red) and INJECTION SITE MASS (lump) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037KZOA) for COVID-19 vaccination.     NO medical history information was reported.     On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headaches), INJECTION SITE PRURITUS (itch), INJECTION SITE ERYTHEMA (red) and INJECTION SITE MASS (lump). At the time of the report, HEADACHE (headaches), INJECTION SITE PRURITUS (itch), INJECTION SITE ERYTHEMA (red) and INJECTION SITE MASS (lump) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  Treatment medication was not reported.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Lethargy, Pain in extremity
Clinical narrative: little soreness in my arm; little lethargic; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (little soreness in my arm) and LETHARGY (little lethargic) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced PAIN IN EXTREMITY (little soreness in my arm) and LETHARGY (little lethargic). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 17-Jan-2021, PAIN IN EXTREMITY (little soreness in my arm) and LETHARGY (little lethargic) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021:  This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Jan-2021 and was forwarded to Moderna on 22-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (little soreness in my arm) and LETHARGY (little lethargic) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced PAIN IN EXTREMITY (little soreness in my arm) and LETHARGY (little lethargic). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 17-Jan-2021, PAIN IN EXTREMITY (little soreness in my arm) and LETHARGY (little lethargic) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Fatigue, Headache, Lethargy
Clinical narrative: slight cough; headache; body aches; lethargy; chills; fever; could not get out of bed next two days; sore throat; congestion; arm was really sore; This spontaneous case was reported by a nurse and describes the occurrence of COUGH (slight cough), HEADACHE (headache), MYALGIA (body aches), LETHARGY (lethargy) and CHILLS (chills) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included Dental surgery NOS. Concurrent medical conditions included Allergy to antibiotic and Hypothyroidism since 2019. Concomitant products included LORATADINE for Allergy, AMOXICILLIN, CLAVULANIC ACID (AUGMENTIN BAMBINI) for Dental treatment NOS, LEVOTHYROXINE for Hypothyroidism, ASA for Prevention, MULTIVITAMIN & MINERAL for an unknown indication.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COUGH (slight cough), HEADACHE (headache), MYALGIA (body aches), LETHARGY (lethargy) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL A) for Fever, at an unspecified dose and frequency and IBUPROFEN (ADVIL 12 HOUR) for Fever, at an unspecified dose and frequency. At the time of the report, COUGH (slight cough), HEADACHE (headache), MYALGIA (body aches), LETHARGY (lethargy) and CHILLS (chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jan-2021, SARS-CoV-1 test: positive (Positive) Nasopharyngeal swab.     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.   This case was linked to MOD-2021-080866 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Follow up received and contains : Concomitant medications, second dose detail was updated .