chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia, Visceral pain
Clinical narrative: The patient's past medical history included No adverse effect (no adverse event reported). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 05-Jan-2021 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (Heart palpitations). At the time of the report, PALPITATIONS (Heart palpitations) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Jan-2021, SARS-CoV-2 antibody test positive: positive.     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.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jan-2021: Healthcare professional (HCP) called in to report multiple adverse events and asked if she should receive the second dose. Adverse events included headache, fever, chills, chest pain, heart palpitations.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: Left facial numbness; arm  soreness; A spontaneous report was received from a health care professional concerning a female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm soreness/pain in extremity and left facial numbness/ hypoaesthesia.   The patient's medical history was not provided. Concomitant medications was not reported.  On 08-JAN-2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly at unknown location for prophylaxis of COVID-19 infection.   On 08 Jan 2021, after receiving the mRNA-1273, the patient felt arm soreness.  on 10 Jan 2021, patient felt left facial numbness.   Treatment for the events were unknown.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the  events pain in extremity and hypoaesthesia was unknown.; 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: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Nausea, Pain in extremity, Pyrexia
Clinical narrative: A spontaneous report was received from a consumer who experienced sore arm, low-grade fever, headache, nausea and felt ill. The patient's medical history included anxiety.  Products known to have been used by the patient, within two weeks prior to the event, included vitamin D, ethinylestradiol norethisterone acetate and sertraline. On 31-Dec-2020, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (LOT 039K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  Patient received her vaccine on 31-Dec-2020.  She reported a sore arm that resolved on 02-Jan-2021 (onset date/time not disclosed).   On 09-Jan-2021, approximately ten days after receiving the vaccine, she experienced low-grade fever, headache, nausea and felt ill.  AS of 10-Jan-2021, patient stated that she felt better. Treatment for the event included ibuprofen. Action taken with mRNA-1273 in response to the events, sore arm, low-grade fever, headache, nausea and felt ill, was not provided. The event, sore arm, was considered recovered/resolved on 02-Jan-2021. The events, low-grade fever, headache, nausea and felt ill, were considered recovered/resolved on 10-Jan-2021.; Reporter's Comments: This case concerns a 31-year-old female who experienced NS events of unexpected malaise and expected pain in extremity, headache, pyrexia, nausea.  Event onset occurred the same day as the first dose of mRNA-1273. Treatment with ibuprofen. Events resolved. Based on 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: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (COVID-19) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications and treatment information were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 24-Mar-2021: Follow-up received on 24 Mar 2021 included no new information.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the event a causal relationship is Unlikely. Based on the known causative agent of COVID-19 infection, the event is assessed as unlikely related to mRNA-1273. It is likely that the patient was already infected with the virus but asymptomatic before being administered with the mRNA-1273 vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during breast feeding
Clinical narrative: Breastfeeding; A spontaneous report was received from a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and is breastfeeding.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot: unknown) intramuscularly for prophylaxis of COVID-19.  On an unknown date, the patient stated that she is breastfeeding and inquired about study enrollment. No treatment information provided.   Treatment was not provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome for the event, breastfeeding, was unknown.; Reporter's Comments: This is a case of product exposure during breastfeeding with no associated AEs. Patient will continue to be contacted for further monitoring of AEs.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Hand fracture, Headache, Road traffic accident
Clinical narrative: Broken pinky finger; Car accident; experiencing brain fogginess; Slight headache; Arm soreness; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of ROAD TRAFFIC ACCIDENT (Car accident), FEELING ABNORMAL (experiencing brain fogginess) and VACCINATION SITE PAIN (Arm soreness) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M2OA and 01162OA) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2020. Concomitant products included AMLODIPINE BESILATE (NORVASC) for Blood pressure, ATORVASTATIN for Cholesterol, LINACLOTIDE (LINZESS) for Irritable bowel syndrome, ERGOCALCIFEROL for an unknown indication.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION SITE PAIN (Arm soreness). On 07-Jan-2021, the patient experienced ROAD TRAFFIC ACCIDENT (Car accident) and FEELING ABNORMAL (experiencing brain fogginess). On 09-Jan-2021, VACCINATION SITE PAIN (Arm soreness) had resolved. At the time of the report, ROAD TRAFFIC ACCIDENT (Car accident) and FEELING ABNORMAL (experiencing brain fogginess) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable.   Company comment: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Significant follow up received on 16-Apr-2021: Added concomitant drug amlodipine, atorvastine, ergocalcif, linzess, moderna vaccine second dose, outcome and onset date of event brain fog.; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Broken pinky finger; Car accident; experiencing brain fogginess; Slight headache; Arm soreness; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of ROAD TRAFFIC ACCIDENT (Car accident), FEELING ABNORMAL (experiencing brain fogginess) and VACCINATION SITE PAIN (Arm soreness) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M2OA and 01162OA) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2020. Concomitant products included AMLODIPINE BESILATE (NORVASC) for Blood pressure, ATORVASTATIN for Cholesterol, LINACLOTIDE (LINZESS) for Irritable bowel syndrome, ERGOCALCIFEROL for an unknown indication.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION SITE PAIN (Arm soreness). On 07-Jan-2021, the patient experienced ROAD TRAFFIC ACCIDENT (Car accident) and FEELING ABNORMAL (experiencing brain fogginess). On 09-Jan-2021, VACCINATION SITE PAIN (Arm soreness) had resolved. At the time of the report, ROAD TRAFFIC ACCIDENT (Car accident) and FEELING ABNORMAL (experiencing brain fogginess) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable.   Company comment: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Significant follow up received on 16-Apr-2021: Added concomitant drug amlodipine, atorvastine, ergocalcif, linzess, moderna vaccine second dose, outcome and onset date of event brain fog.; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test, Ultrasound scan
Clinical narrative: got vaccine while pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (got vaccine while pregnant) in a 37-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     Concurrent medical conditions included Depression, Type 1 diabetes mellitus (no dates provided), Drug allergy (Azithromycin) and Infertility NOS (Could not get pregnant right away.). Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for Depression, IRON DEXTRAN (IRON [IRON DEXTRAN]) for Vitamin supplementation, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 16-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 01-Aug-2020 and the estimated date of delivery was 12-May-2021. On 16-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (got vaccine while pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-fourth week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 16-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (got vaccine while pregnant) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Aug-2020, Pregnancy test: positive (Positive) Positive. On 23-Sep-2020, Ultrasound scan: normal (normal) normal. On 23-Oct-2020, Ultrasound scan: normal (normal) normal. On 30-Oct-2020, Ultrasound scan: normal (normal) normal. On 23-Dec-2020, Ultrasound scan: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient previous pregnancy details -delivered live full term baby . Treatment details was not reported by the reporter.  This is a case of product exposure during pregnancy with no associated AEs for this 37-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 37-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: developed a UTI; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (developed a UTI) in an 82-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 07-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jan-2021, the patient experienced URINARY TRACT INFECTION (developed a UTI). At the time of the report, URINARY TRACT INFECTION (developed a UTI) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.  Although a temporal association exist, there is still limited information regarding the reported event at this time. Patient's medical history, list of concomitant medications, clinical details any laboratory test for UTI are lacking.  Urinary tract infection is of an infective etiology and the risk increases with advanced age above 65 years hence assessed as unlikely related to product use.; Reporter's Comments: Although a temporal association exist, there is still limited information regarding the reported event at this time. Patient's medical history, list of concomitant medications, clinical details any laboratory test for UTI are lacking.  Urinary tract infection is of an infective etiology and the risk increases with advanced age above 65 years hence assessed as unlikely related to product use.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) had resolved.            No Concomitant medications was provided by the reporter.  No Treatment medications was provided by the reporter.  This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Pregnancy test, Ultrasound foetal
Clinical narrative: I am calling to register because I am pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (I am calling to register because I am pregnant) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to chemicals (Patient have allergy towards hair dyied.), Endometriosis in May 2019, Diabetic, Cyst of ovary and Blood pressure increased. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 11-Jul-2020 and the estimated date of delivery was 16-Apr-2021. On 29-Dec-2020, the patient experienced EXPOSURE DURING PREGNANCY (I am calling to register because I am pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-fourth week of the pregnancy.  On 29-Dec-2020, EXPOSURE DURING PREGNANCY (I am calling to register because I am pregnant) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jul-2020, Pregnancy test: positive (Positive) Positive. On 30-Nov-2020, Ultrasound foetal: unknown unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication details was reported.  Company comment: This is a case of product exposure during pregnancy with no associated AEs for this 30-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 30-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: some redness at the injection; some itchiness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (some redness at the injection) and VACCINATION SITE PRURITUS (some itchiness at the injection site) in a 43-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 (No medical history reported.).    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (some redness at the injection) and VACCINATION SITE PRURITUS (some itchiness at the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (some redness at the injection) and VACCINATION SITE PRURITUS (some itchiness at the injection site) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.    Most recent FOLLOW-UP information incorporated above includes: On 16-Jan-2021: No specific follow-up information recorded.; Sender'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.
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Vaccination site induration, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: arm got hard (feels like solid) to touch on her injection site; arm got itchy on her injection site; arm got swelling on her injection site; arm got tenderness on her injection site; arm got hot on her injection site; arm was bad; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (arm was bad), VACCINATION SITE WARMTH (arm got hot on her injection site), VACCINATION SITE INDURATION (arm got hard (feels like solid) to touch on her injection site), VACCINATION SITE PRURITUS (arm got itchy on her injection site) and VACCINATION SITE SWELLING (arm got swelling on her injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter. .     On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced LIMB DISCOMFORT (arm was bad). On 10-Jan-2021, the patient experienced VACCINATION SITE WARMTH (arm got hot on her injection site), VACCINATION SITE PRURITUS (arm got itchy on her injection site), VACCINATION SITE SWELLING (arm got swelling on her injection site) and VACCINATION SITE PAIN (arm got tenderness on her injection site). On 11-Jan-2021, the patient experienced VACCINATION SITE INDURATION (arm got hard (feels like solid) to touch on her injection site). The patient was treated with HYDROCORTISONE for Itching, at an unspecified dose and frequency. At the time of the report, LIMB DISCOMFORT (arm was bad), VACCINATION SITE WARMTH (arm got hot on her injection site), VACCINATION SITE INDURATION (arm got hard (feels like solid) to touch on her injection site), VACCINATION SITE PRURITUS (arm got itchy on her injection site), VACCINATION SITE SWELLING (arm got swelling on her injection site) and VACCINATION SITE PAIN (arm got tenderness on her injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.; 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.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: arm got hard (feels like solid) to touch on her injection site; arm got itchy on her injection site; arm got swelling on her injection site; arm got tenderness on her injection site; arm got hot on her injection site; arm was bad; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (arm was bad), VACCINATION SITE WARMTH (arm got hot on her injection site), VACCINATION SITE INDURATION (arm got hard (feels like solid) to touch on her injection site), VACCINATION SITE PRURITUS (arm got itchy on her injection site) and VACCINATION SITE SWELLING (arm got swelling on her injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter. .     On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced LIMB DISCOMFORT (arm was bad). On 10-Jan-2021, the patient experienced VACCINATION SITE WARMTH (arm got hot on her injection site), VACCINATION SITE PRURITUS (arm got itchy on her injection site), VACCINATION SITE SWELLING (arm got swelling on her injection site) and VACCINATION SITE PAIN (arm got tenderness on her injection site). On 11-Jan-2021, the patient experienced VACCINATION SITE INDURATION (arm got hard (feels like solid) to touch on her injection site). The patient was treated with HYDROCORTISONE for Itching, at an unspecified dose and frequency. At the time of the report, LIMB DISCOMFORT (arm was bad), VACCINATION SITE WARMTH (arm got hot on her injection site), VACCINATION SITE INDURATION (arm got hard (feels like solid) to touch on her injection site), VACCINATION SITE PRURITUS (arm got itchy on her injection site), VACCINATION SITE SWELLING (arm got swelling on her injection site) and VACCINATION SITE PAIN (arm got tenderness on her injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.; 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: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Vaccination site pain, Vaccination site rash, Vaccination site urticaria
Clinical narrative: Hives; Itchy arm; Rash; soreness at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (Itchy arm), VACCINATION SITE RASH (Rash), VACCINATION SITE URTICARIA (Hives) and VACCINATION SITE PAIN (soreness at the site of injection) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced VACCINATION SITE PAIN (soreness at the site of injection). On 11-Jan-2021, the patient experienced INJECTION SITE PRURITUS (Itchy arm) and VACCINATION SITE RASH (Rash). On 12-Jan-2021, the patient experienced VACCINATION SITE URTICARIA (Hives). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, INJECTION SITE PRURITUS (Itchy arm), VACCINATION SITE RASH (Rash), VACCINATION SITE URTICARIA (Hives) and VACCINATION SITE PAIN (soreness at the site of injection) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.; Sender'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.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Condition aggravated, Vertigo
Clinical narrative: Vertigo; condition aggravated; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo) and CONDITION AGGRAVATED (condition aggravated) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included Benign positional vertigo in 2020. Concurrent medical conditions included Hypertension (mild blood pressure). Concomitant products included METOPROLOL SUCCINATE for Hypertension.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced VERTIGO (Vertigo) and CONDITION AGGRAVATED (condition aggravated). At the time of the report, VERTIGO (Vertigo) and CONDITION AGGRAVATED (condition aggravated) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Jan-2021, Blood pressure measurement: 167 167.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment information not provided.  Company comment: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.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: reporter's email was updated to the case; Sender'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: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia
Clinical narrative: Chills; Fever 100F; Soreness; A spontaneous report was received from a 49-years old, female patient (health care professional) concerning herself who experienced the events soreness/pain, chills and fever of 100F.   The patient's medical history was not provided.  Concomitant product use includes multivitamins for immunity.  On 04 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route at unknown anatomical location for prophylaxis of COVID-19 infection.    On 04 Jan 2021, the patient experienced soreness.   On 09 Jan 2021, the patient had chills and fever of 100F up until at the time of this report.   Treatment details included Paracetamol and Naproxen for pain.   Action taken with mRNA-1273 in response to the events  was not provided.  The outcome of the events soreness was unknown, chills and fever was not recovered/resolved.; 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: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Headache, Hypersomnia
Clinical narrative: lack of appetite (eating way less than usual); sleeps more than usual; fatigue; muscle pain; chills; headache; arm swollen; pain and tenderness on arm; nausea when trying to eat; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm swollen), DECREASED APPETITE (lack of appetite (eating way less than usual)), HYPERSOMNIA (sleeps more than usual), PAIN IN EXTREMITY (pain and tenderness on arm) and NAUSEA (nausea when trying to eat) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) 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 medical history reported).    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced PERIPHERAL SWELLING (arm swollen), PAIN IN EXTREMITY (pain and tenderness on arm) and NAUSEA (nausea when trying to eat). On 30-Dec-2020, the patient experienced HEADACHE (headache). On an unknown date, the patient experienced DECREASED APPETITE (lack of appetite (eating way less than usual)), HYPERSOMNIA (sleeps more than usual), FATIGUE (fatigue), MYALGIA (muscle pain) and CHILLS (chills). On 30-Dec-2020, NAUSEA (nausea when trying to eat) had resolved. At the time of the report, PERIPHERAL SWELLING (arm swollen) and PAIN IN EXTREMITY (pain and tenderness on arm) outcome was unknown, DECREASED APPETITE (lack of appetite (eating way less than usual)), HYPERSOMNIA (sleeps more than usual), FATIGUE (fatigue), MYALGIA (muscle pain) and CHILLS (chills) had not resolved and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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.; Sender'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: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain in extremity, Peripheral swelling
Clinical narrative: lack of appetite (eating way less than usual); sleeps more than usual; fatigue; muscle pain; chills; headache; arm swollen; pain and tenderness on arm; nausea when trying to eat; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm swollen), DECREASED APPETITE (lack of appetite (eating way less than usual)), HYPERSOMNIA (sleeps more than usual), PAIN IN EXTREMITY (pain and tenderness on arm) and NAUSEA (nausea when trying to eat) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) 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 medical history reported).    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced PERIPHERAL SWELLING (arm swollen), PAIN IN EXTREMITY (pain and tenderness on arm) and NAUSEA (nausea when trying to eat). On 30-Dec-2020, the patient experienced HEADACHE (headache). On an unknown date, the patient experienced DECREASED APPETITE (lack of appetite (eating way less than usual)), HYPERSOMNIA (sleeps more than usual), FATIGUE (fatigue), MYALGIA (muscle pain) and CHILLS (chills). On 30-Dec-2020, NAUSEA (nausea when trying to eat) had resolved. At the time of the report, PERIPHERAL SWELLING (arm swollen) and PAIN IN EXTREMITY (pain and tenderness on arm) outcome was unknown, DECREASED APPETITE (lack of appetite (eating way less than usual)), HYPERSOMNIA (sleeps more than usual), FATIGUE (fatigue), MYALGIA (muscle pain) and CHILLS (chills) had not resolved and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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.; Sender'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: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Vaccination site pain
Clinical narrative: Fatigue; Aches on his lower back, hip and ankles; Pain on the injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (Pain on the injection site), FATIGUE (Fatigue) and MYALGIA (Aches on his lower back, hip and ankles) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic. Concomitant products included METFORMIN for an unknown indication.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2020, the patient experienced VACCINATION SITE PAIN (Pain on the injection site). On 08-Jan-2021, the patient experienced FATIGUE (Fatigue) and MYALGIA (Aches on his lower back, hip and ankles). On 30-Dec-2020, VACCINATION SITE PAIN (Pain on the injection site) had resolved. At the time of the report, FATIGUE (Fatigue) and MYALGIA (Aches on his lower back, hip and ankles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided  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.; 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: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Slightly itchy; Red circle where the shot was given, redness kind of spread, getting bigger; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE PRURITUS (Slightly itchy) and VACCINATION SITE ERYTHEMA (Red circle where the shot was given, redness kind of spread, getting bigger) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), LEVOTHYROXINE SODIUM (LEVOTHYROX), CETIRIZINE, LEVOTHYROXINE, OMEPRAZOLE, FLUVASTATIN, FLUOXETINE and ZOLPIDEM for an unknown indication.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Slightly itchy) and VACCINATION SITE ERYTHEMA (Red circle where the shot was given, redness kind of spread, getting bigger). On 07-Jan-2021, VACCINATION SITE PRURITUS (Slightly itchy) and VACCINATION SITE ERYTHEMA (Red circle where the shot was given, redness kind of spread, getting bigger) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.; 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: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Red knots under the skin on both hands, knees, elbow and foot.; itchy knots under the skin on both hands, knees elbow and foot.; Swollen knot under the skin on both hands, knees, elbow and foot; This spontaneous case was reported by an other health care professional and describes the occurrence of   in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 30-Dec-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.; Reporter's Comments: This case concerns a 34-year-old male who experienced nonserious unexpected events of urticaria, erythema, and pruritus.  Event onset occurred 10 days after the first dose of mRNA-1273. Treatment with Diphenhydramine. Events ongoing. Based on 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: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Headache, Influenza like illness, Nausea
Clinical narrative: Feels like when she had Covid 19; Feeling tired; Feels like sleeping or resting all the time; Dry cough; Arm is sore; Headache; Sick to stomach; Feeling tired; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Feels like when she had Covid 19), the first episode of FATIGUE (Feeling tired), SOMNOLENCE (Feels like sleeping or resting all the time), COUGH (Dry cough) and PAIN IN EXTREMITY (Arm is sore) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01ZLZA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Recovery date not provided) from March 2020 to 2020. Concomitant products included SIMVASTATIN, PANTOPRAZOLE and TRIAMTERENE for an unknown indication.    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (Feels like when she had Covid 19), the first episode of FATIGUE (Feeling tired), SOMNOLENCE (Feels like sleeping or resting all the time), COUGH (Dry cough), PAIN IN EXTREMITY (Arm is sore), HEADACHE (Headache), NAUSEA (Sick to stomach) and the second episode of FATIGUE (Feeling tired). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. At the time of the report, INFLUENZA LIKE ILLNESS (Feels like when she had Covid 19), SOMNOLENCE (Feels like sleeping or resting all the time), COUGH (Dry cough), PAIN IN EXTREMITY (Arm is sore), HEADACHE (Headache), NAUSEA (Sick to stomach) and the last episode of FATIGUE (Feeling tired) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Tylenol was used as treatment medication.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Non-Significant Follow-Up; Sender's Comments: This case concerns a 68-year-old female with a nonserious unexpected event of influenza like illness, somnolence, illness, cough, pain in extremity, and expected headache, nausea, fatigue. Event onset the same day as first dose mRNA-1273. Events ongoing. Based on 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: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Somnolence
Clinical narrative: Feels like when she had Covid 19; Feeling tired; Feels like sleeping or resting all the time; Dry cough; Arm is sore; Headache; Sick to stomach; Feeling tired; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Feels like when she had Covid 19), the first episode of FATIGUE (Feeling tired), SOMNOLENCE (Feels like sleeping or resting all the time), COUGH (Dry cough) and PAIN IN EXTREMITY (Arm is sore) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01ZLZA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Recovery date not provided) from March 2020 to 2020. Concomitant products included SIMVASTATIN, PANTOPRAZOLE and TRIAMTERENE for an unknown indication.    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (Feels like when she had Covid 19), the first episode of FATIGUE (Feeling tired), SOMNOLENCE (Feels like sleeping or resting all the time), COUGH (Dry cough), PAIN IN EXTREMITY (Arm is sore), HEADACHE (Headache), NAUSEA (Sick to stomach) and the second episode of FATIGUE (Feeling tired). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. At the time of the report, INFLUENZA LIKE ILLNESS (Feels like when she had Covid 19), SOMNOLENCE (Feels like sleeping or resting all the time), COUGH (Dry cough), PAIN IN EXTREMITY (Arm is sore), HEADACHE (Headache), NAUSEA (Sick to stomach) and the last episode of FATIGUE (Feeling tired) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Tylenol was used as treatment medication.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Non-Significant Follow-Up; Sender's Comments: This case concerns a 68-year-old female with a nonserious unexpected event of influenza like illness, somnolence, illness, cough, pain in extremity, and expected headache, nausea, fatigue. Event onset the same day as first dose mRNA-1273. Events ongoing. Based on 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: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Tested positive after vaccination; This spontaneous case was reported by a health care professional and describes the occurrence of COVID-19 (Tested positive after vaccination) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2021, the patient experienced COVID-19 (Tested positive after vaccination). At the time of the report, COVID-19 (Tested positive after vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.  Company comment:The event of COVID-19 is unlikely related to mRNA-1273 since the vaccine does not contain virus capable of causing infection resulting in producing a positive test.; Sender's Comments: The event of COVID-19 is unlikely related to mRNA-1273 since the vaccine does not contain virus capable of causing infection resulting in producing a positive test.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Vaccination during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccination during pregnancy) in a 38-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) 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. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 27-Jun-2021. On 16-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccination during pregnancy). On 16-Jan-2021, EXPOSURE DURING PREGNANCY (Vaccination during pregnancy) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported by the reporter. Treatment details was not reported by the reporter.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 38-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.