chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Vaccination site erythema, Vaccination site warmth
Clinical narrative: arm hot to the touch; arm started to swell; arm became red; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm started to swell), VACCINATION SITE ERYTHEMA (arm became red) and VACCINATION SITE WARMTH (arm hot to the touch) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025320A) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy. Concomitant products included BECLOMETASONE DIPROPIONATE (QVAR), FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), RANITIDINE HYDROCHLORIDE (ZANTAC), MULTIVITAMINS [VITAMINS NOS], OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]), VITAMIN K NOS and CALCIUM, COLECALCIFEROL (CALCIUM WITH D3) for an unknown indication.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced PERIPHERAL SWELLING (arm started to swell), VACCINATION SITE ERYTHEMA (arm became red) and VACCINATION SITE WARMTH (arm hot to the touch). On 06-Jan-2021, PERIPHERAL SWELLING (arm started to swell), VACCINATION SITE ERYTHEMA (arm became red) and VACCINATION SITE WARMTH (arm hot to the touch) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medications included ibuprofen and ice therapy.; Reporter's Comments: Based on the information provided which includes temporal association between the reported events and administration of mRNA-1273 vaccine, an excluding any other etiology, a causal association cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Fever 100; Chills; A spontaneous report was received from a Non-Health Professional concerning a male patient, of unknown age, who was administered Moderna's COVID-19 vaccine on 22-DEC-2020 and experienced fever 100 and chills.  The patient's medical history was not reported. No relevant concomitant medications were reported.  The patient received his first of two planned doses of mRNA-1273 (Batch number: unknown) for prophylaxis of COVID-19 infection on 22-DEC-2020.   The patient experienced fever 100 and chills on 08-JAN-2021. The treatment history was not reported.  The action taken for Moderna COVID-19 vaccine was unknown. The outcome of the events, which were fever 100 and chills was unknown.  The Non-Health Professional did not declared any relatedness between the events, fever 100 and chills and  the Moderna COVID-19 vaccine.; 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. Further information has been requested
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Post-acute COVID-19 syndrome, Vaccination site erythema, Vaccination site pain
Clinical narrative: I was still feeling the long haulers symptoms when I received the 1st shot; Itchy arm; Red arm; Arm being sore; Feeling Queezy; Feeling tired; This spontaneous case was reported by a consumer and describes the occurrence of POST-ACUTE COVID-19 SYNDROME (I was still feeling the long haulers symptoms when I received the 1st shot), NAUSEA (Feeling Queezy), FATIGUE (Feeling tired), VACCINATION SITE PRURITUS (Itchy arm) and VACCINATION SITE ERYTHEMA (Red arm) in a 63-year-old female 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 COVID-19 (Long hauler with additional side effects.) in July 2020. Concomitant products included PROGESTERONE (PROMETRIUM [PROGESTERONE]) and TESTOSTERONE for Hormone level abnormal, VITAMINS NOS, ESTRADIOL and PARACETAMOL (TYLENOL) for an unknown indication.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced NAUSEA (Feeling Queezy), FATIGUE (Feeling tired) and VACCINATION SITE PAIN (Arm being sore). On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POST-ACUTE COVID-19 SYNDROME (I was still feeling the long haulers symptoms when I received the 1st shot), VACCINATION SITE PRURITUS (Itchy arm) and VACCINATION SITE ERYTHEMA (Red arm). At the time of the report, POST-ACUTE COVID-19 SYNDROME (I was still feeling the long haulers symptoms when I received the 1st shot) had not resolved and NAUSEA (Feeling Queezy), FATIGUE (Feeling tired), VACCINATION SITE PRURITUS (Itchy arm), VACCINATION SITE ERYTHEMA (Red arm) and VACCINATION SITE PAIN (Arm being sore) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient's concomitant medications included antianxiety drugs.  Unspecified medical tests were done which came back as normal without damage to lungs or heart.  No treatment information was 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. Further information has been requested   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Added event Covid long haulers; 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. Further information has been requested
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: I was still feeling the long haulers symptoms when I received the 1st shot; Itchy arm; Red arm; Arm being sore; Feeling Queezy; Feeling tired; This spontaneous case was reported by a consumer and describes the occurrence of POST-ACUTE COVID-19 SYNDROME (I was still feeling the long haulers symptoms when I received the 1st shot), NAUSEA (Feeling Queezy), FATIGUE (Feeling tired), VACCINATION SITE PRURITUS (Itchy arm) and VACCINATION SITE ERYTHEMA (Red arm) in a 63-year-old female 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 COVID-19 (Long hauler with additional side effects.) in July 2020. Concomitant products included PROGESTERONE (PROMETRIUM [PROGESTERONE]) and TESTOSTERONE for Hormone level abnormal, VITAMINS NOS, ESTRADIOL and PARACETAMOL (TYLENOL) for an unknown indication.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced NAUSEA (Feeling Queezy), FATIGUE (Feeling tired) and VACCINATION SITE PAIN (Arm being sore). On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POST-ACUTE COVID-19 SYNDROME (I was still feeling the long haulers symptoms when I received the 1st shot), VACCINATION SITE PRURITUS (Itchy arm) and VACCINATION SITE ERYTHEMA (Red arm). At the time of the report, POST-ACUTE COVID-19 SYNDROME (I was still feeling the long haulers symptoms when I received the 1st shot) had not resolved and NAUSEA (Feeling Queezy), FATIGUE (Feeling tired), VACCINATION SITE PRURITUS (Itchy arm), VACCINATION SITE ERYTHEMA (Red arm) and VACCINATION SITE PAIN (Arm being sore) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient's concomitant medications included antianxiety drugs.  Unspecified medical tests were done which came back as normal without damage to lungs or heart.  No treatment information was 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. Further information has been requested   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Added event Covid long haulers; 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. Further information has been requested
Sex: M
Vaccine: COVID19
Symptoms: Coronavirus test, SARS-CoV-2 test positive
Clinical narrative: Tested positive with covid-19; A spontaneous report was received from a pharmacist concerning an unspecified age male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and tested positive with covid-19(covid-19).  The patient's medical history was not provided. No relevant concomitant medications were reported.    On an unknown date, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (lot unknown) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient tested positive with covid-19.   No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.  The seriousness criteria of event was non serious.  The outcome of the event tested positive with covid-19 was unknown.; Reporter's Comments: Based on reporter's causality ,the event SARS-CoV-2 test positive is assessed as unlikely related to mRNA-1273.
Sex: F
Vaccine: COVID19
Symptoms: Blood phosphorus, Maternal exposure during pregnancy, Pregnancy test
Clinical narrative: Exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Exposure during pregnancy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-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 29-Oct-2020 and the estimated date of delivery was 05-Aug-2021. On 06-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  tenth week of the pregnancy.  On 06-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Nov-2020, Blood phosphorus: positive (Positive) Positive. On 23-Nov-2020, Pregnancy test: positive (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.   No relevant concomitant medications were reported.   Treatment information was not reported. Estimated due date Aug 2021.  This is a case of product exposure during pregnancy with no associated AEs for this female patient of an unknown age. 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 of an unknown age. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: received my Moderna vaccine and I am pregnant; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (received my Moderna vaccine and I am pregnant) in a 38-year-old female patient (gravida 4, para 3) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Pregnant and Thyroid disorder NOS.    On 10-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 25-Feb-2021. On 10-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (received my Moderna vaccine and I am pregnant). On 10-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (received my Moderna vaccine and I am pregnant) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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; 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
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test, Prenatal screening test, Ultrasound abdomen
Clinical narrative: Pregnant and just got the Moderna vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and just got the Moderna vaccine) in a 33-year-old female patient (gravida 2, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. D27L20A and O24M20A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (Delivered  live full term baby) on Aug-2018. Concurrent medical conditions included Chemical sensitivity (paraben) and Alcohol use (2-3 glasses of wine per week through pregnancy and now in post-partum).   On 11-Jan-2021 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-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 02-May-2020 and the estimated date of delivery was 06-Feb-2021. On 11-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and just got the Moderna vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-sixth week of the pregnancy. The delivery occurred  on 15-Feb-2021, which was reported as Full-term. For neonate 1, The outcome was reported as Term Birth w/o Complications. Estimated date of conception was 16 May 2020. On 11-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and just got the Moderna vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-May-2020, Pregnancy test: positive (Positive) Positive. On an unknown date, Prenatal screening test: 12 week genetic test for fetus normal (normal) 12 week genetic test for fetus normal. On an unknown date, Ultrasound abdomen: 8 weeks, 20 weeks, and 41 weeks (normal) 8 weeks, 20 weeks, and 41 weeks.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided.  No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Apr-2021: initial pregnancy report form: Reporter address, doctor information, Second dose vaccine information, patient initials changed, Allergy to paraben, LMP date, date positive pregnancy test, estimated date of conception provided. Number of fetuses ,investigations during pregnancy, number of previous pregnancies with end date and outcome. in medical history current condition: Alcohol use.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 33-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea, Vaccination site erythema
Clinical narrative: dizziness; nausea; headache; red 3 inch by 3 inch oval shaped circle at injection site; This spontaneous case was reported by a health care professional and describes the occurrence of DIZZINESS (dizziness), VACCINATION SITE ERYTHEMA (red 3 inch by 3 inch oval shaped circle at injection site), NAUSEA (nausea) and HEADACHE (headache) in a 44-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 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 ERYTHEMA (red 3 inch by 3 inch oval shaped circle at injection site). On 08-Jan-2021, the patient experienced DIZZINESS (dizziness), NAUSEA (nausea) and HEADACHE (headache). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEK) for Adverse event, at an unspecified dose and frequency. At the time of the report, DIZZINESS (dizziness), VACCINATION SITE ERYTHEMA (red 3 inch by 3 inch oval shaped circle at injection site), NAUSEA (nausea) and HEADACHE (headache) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were 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: U
Vaccine: COVID19
Symptoms: Skin warm, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: arm became very itchy; arm became very itchy, swollen (size of a baseball)/is still swollen; Hot to touch; arm became very itchy, swollen (size of a baseball), red; Pain; Redness; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PRURITUS (arm became very itchy), VACCINATION SITE SWELLING (arm became very itchy, swollen (size of a baseball)/is still swollen), SKIN WARM (Hot to touch), VACCINATION SITE ERYTHEMA (arm became very itchy, swollen (size of a baseball), red) and VACCINATION SITE PAIN (Pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced VACCINATION SITE PAIN (Pain) and VACCINATION SITE ERYTHEMA (Redness). On 15-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (arm became very itchy), VACCINATION SITE SWELLING (arm became very itchy, swollen (size of a baseball)/is still swollen), SKIN WARM (Hot to touch) and VACCINATION SITE ERYTHEMA (arm became very itchy, swollen (size of a baseball), red). At the time of the report, VACCINATION SITE PRURITUS (arm became very itchy) and VACCINATION SITE SWELLING (arm became very itchy, swollen (size of a baseball)/is still swollen) had not resolved, SKIN WARM (Hot to touch) and VACCINATION SITE ERYTHEMA (arm became very itchy, swollen (size of a baseball), red) was resolving and VACCINATION SITE PAIN (Pain) and VACCINATION SITE ERYTHEMA (Redness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment and concomitant medications were not provided by reporter.; 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: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Myalgia
Clinical narrative: Body ache; Headache; Joint pain; Fatigue; This spontaneous case was reported by an other health care professional and describes the occurrence of MYALGIA (Body ache), HEADACHE (Headache), ARTHRALGIA (Joint pain) and FATIGUE (Fatigue) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 11j20A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included LEVOTHYROXINE and ESTROGENS CONJUGATED (PREMARIN) for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced MYALGIA (Body ache), HEADACHE (Headache), ARTHRALGIA (Joint pain) and FATIGUE (Fatigue). At the time of the report, MYALGIA (Body ache), HEADACHE (Headache), ARTHRALGIA (Joint pain) and FATIGUE (Fatigue) 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.   Treatment information not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jan-2021: Follow-up received on 14-JAN-2021, included no new information.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Pain in extremity, Pyrexia, SARS-CoV-2 antibody test
Clinical narrative: Felt so cold; Teeth chattering; Fever ranging from 101-103.6F for a couple of days; Has been sick all weekend; Arm started to hurt; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Has been sick all weekend), PAIN IN EXTREMITY (Arm started to hurt), FEELING COLD (Felt so cold), PYREXIA (Fever ranging from 101-103.6F for a couple of days) and CHILLS (Teeth chattering) in a 69-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 reaction (No reported medical history.).   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jan-2021, the patient experienced VACCINATION COMPLICATION (Has been sick all weekend), PAIN IN EXTREMITY (Arm started to hurt) and PYREXIA (Fever ranging from 101-103.6F for a couple of days). On 09-Jan-2021, the patient experienced FEELING COLD (Felt so cold) and CHILLS (Teeth chattering). At the time of the report, VACCINATION COMPLICATION (Has been sick all weekend), PAIN IN EXTREMITY (Arm started to hurt), FEELING COLD (Felt so cold), PYREXIA (Fever ranging from 101-103.6F for a couple of days) and CHILLS (Teeth chattering) was resolving.   DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, SARS-CoV-2 antibody test: Negative.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.  Company Comment  Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.   Reporter did not allow further contact
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Felt so cold; Teeth chattering; Fever ranging from 101-103.6F for a couple of days; Has been sick all weekend; Arm started to hurt; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Has been sick all weekend), PAIN IN EXTREMITY (Arm started to hurt), FEELING COLD (Felt so cold), PYREXIA (Fever ranging from 101-103.6F for a couple of days) and CHILLS (Teeth chattering) in a 69-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 reaction (No reported medical history.).   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jan-2021, the patient experienced VACCINATION COMPLICATION (Has been sick all weekend), PAIN IN EXTREMITY (Arm started to hurt) and PYREXIA (Fever ranging from 101-103.6F for a couple of days). On 09-Jan-2021, the patient experienced FEELING COLD (Felt so cold) and CHILLS (Teeth chattering). At the time of the report, VACCINATION COMPLICATION (Has been sick all weekend), PAIN IN EXTREMITY (Arm started to hurt), FEELING COLD (Felt so cold), PYREXIA (Fever ranging from 101-103.6F for a couple of days) and CHILLS (Teeth chattering) was resolving.   DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, SARS-CoV-2 antibody test: Negative.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.  Company Comment  Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling, Vaccination site urticaria
Clinical narrative: Swelling slightly larger than a 50 cent piece; Big welt at the injection site; Arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE URTICARIA (Big welt at the injection site), VACCINATION SITE PAIN (Arm was sore) and VACCINATION SITE SWELLING (Swelling slightly larger than a 50 cent piece) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No prior medical history were reported.).    On 31-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 VACCINATION SITE PAIN (Arm was sore). On 08-Jan-2021, the patient experienced VACCINATION SITE URTICARIA (Big welt at the injection site). On 11-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Swelling slightly larger than a 50 cent piece). At the time of the report, VACCINATION SITE URTICARIA (Big welt at the injection site), VACCINATION SITE PAIN (Arm was sore) and VACCINATION SITE SWELLING (Swelling slightly larger than a 50 cent piece) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) 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 dates 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 dates of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event following immunisation, Ageusia, Anosmia
Clinical narrative: Loss of Taste; Loss of Smell; Lot of symptoms; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Jan-2021 and was forwarded to Moderna on 12-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Loss of Taste), ANOSMIA (Loss of Smell) and UNEVALUABLE EVENT (Lot of symptoms) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse effect (No medical history provided).    In January 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. In January 2021, the patient experienced AGEUSIA (Loss of Taste), ANOSMIA (Loss of Smell) and UNEVALUABLE EVENT (Lot of symptoms). At the time of the report, AGEUSIA (Loss of Taste), ANOSMIA (Loss of Smell) and UNEVALUABLE EVENT (Lot of symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant product use was not provided by the reporter. No treatment information 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.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Cyst, Head discomfort, Joint stiffness
Clinical narrative: Whole left side swollen; A lump above the clavicle, really painful; Pain in left shoulder; Pain at the injection site/Soreness at the injection site; Pressure in head like headache; Pain in upper chest; Pain in neck; Tightness in the jaw; This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (Pressure in head like headache), CHEST PAIN (Pain in upper chest), NECK PAIN (Pain in neck), JOINT STIFFNESS (Tightness in the jaw) and PERIPHERAL SWELLING (Whole left side swollen) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L2QA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.     On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jan-2021, the patient experienced HEAD DISCOMFORT (Pressure in head like headache), CHEST PAIN (Pain in upper chest), NECK PAIN (Pain in neck), JOINT STIFFNESS (Tightness in the jaw), ARTHRALGIA (Pain in left shoulder) and VACCINATION SITE PAIN (Pain at the injection site/Soreness at the injection site). On 11-Jan-2021, the patient experienced PERIPHERAL SWELLING (Whole left side swollen) and CYST (A lump above the clavicle, really painful). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 05-Jan-2021, HEAD DISCOMFORT (Pressure in head like headache), CHEST PAIN (Pain in upper chest), NECK PAIN (Pain in neck), JOINT STIFFNESS (Tightness in the jaw) and ARTHRALGIA (Pain in left shoulder) had resolved. On 06-Jan-2021, VACCINATION SITE PAIN (Pain at the injection site/Soreness at the injection site) had resolved. At the time of the report, PERIPHERAL SWELLING (Whole left side swollen) and CYST (A lump above the clavicle, really painful) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication include hormones.; 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: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Peripheral swelling, Vaccination site pain
Clinical narrative: Whole left side swollen; A lump above the clavicle, really painful; Pain in left shoulder; Pain at the injection site/Soreness at the injection site; Pressure in head like headache; Pain in upper chest; Pain in neck; Tightness in the jaw; This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (Pressure in head like headache), CHEST PAIN (Pain in upper chest), NECK PAIN (Pain in neck), JOINT STIFFNESS (Tightness in the jaw) and PERIPHERAL SWELLING (Whole left side swollen) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L2QA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.     On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jan-2021, the patient experienced HEAD DISCOMFORT (Pressure in head like headache), CHEST PAIN (Pain in upper chest), NECK PAIN (Pain in neck), JOINT STIFFNESS (Tightness in the jaw), ARTHRALGIA (Pain in left shoulder) and VACCINATION SITE PAIN (Pain at the injection site/Soreness at the injection site). On 11-Jan-2021, the patient experienced PERIPHERAL SWELLING (Whole left side swollen) and CYST (A lump above the clavicle, really painful). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 05-Jan-2021, HEAD DISCOMFORT (Pressure in head like headache), CHEST PAIN (Pain in upper chest), NECK PAIN (Pain in neck), JOINT STIFFNESS (Tightness in the jaw) and ARTHRALGIA (Pain in left shoulder) had resolved. On 06-Jan-2021, VACCINATION SITE PAIN (Pain at the injection site/Soreness at the injection site) had resolved. At the time of the report, PERIPHERAL SWELLING (Whole left side swollen) and CYST (A lump above the clavicle, really painful) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication include hormones.; 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: Swelling face, Urticaria
Clinical narrative: Covered in Hives; Significant swelling in face; A spontaneous report (United States) was received from a Consumer concerning a  24Years-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events like Significant Swelling in Face, Covered in Hives.  The patient's medical history was not reported.  Products known to have been used by the patient, within two weeks prior to the event, included lisdexamfetamine and bupropion.  On 02 Jan 2021 2:00 pm, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch:026-L20A  Exp : 28th May 2021) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On date 02 Jan 2021, the patient experienced the event significant swelling in face.  On date 8th Jan 2021, the patient experienced the event like covered in hives.  The events were treated with diphenhydramine.   Action taken with mRNA-1273 in response to the events was not reported.    The outcome of the events were 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 event, a causal relationship cannot be excluded.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Vaccination site induration, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Shoulder that she got the vaccine in is a little hot; Shoulder that she got the vaccine in is hard; Shoulder that she got the vaccine in is swollen a little bit; Shoulder started to hurt; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Shoulder that she got the vaccine in is a little hot), VACCINATION SITE INDURATION (Shoulder that she got the vaccine in is hard), VACCINATION SITE SWELLING (Shoulder that she got the vaccine in is swollen a little bit) and ARTHRALGIA (Shoulder started to hurt) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-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 VACCINATION SITE WARMTH (Shoulder that she got the vaccine in is a little hot), VACCINATION SITE INDURATION (Shoulder that she got the vaccine in is hard), VACCINATION SITE SWELLING (Shoulder that she got the vaccine in is swollen a little bit) and ARTHRALGIA (Shoulder started to hurt). At the time of the report, VACCINATION SITE WARMTH (Shoulder that she got the vaccine in is a little hot), VACCINATION SITE INDURATION (Shoulder that she got the vaccine in is hard), VACCINATION SITE SWELLING (Shoulder that she got the vaccine in is swollen a little bit) and ARTHRALGIA (Shoulder started to hurt) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication were provided. No concomitant medication information was provided.    Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Follow-up information received on 22-06-2021 contains no new information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (COVID-19) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    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 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) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Company comment: Very limited information regarding this event has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Urticaria, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Injection site and itching; Injection site started swelling; injection site red; hives around injection site; Sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (Injection site and itching), VACCINATION SITE PAIN (Sore left arm), VACCINATION SITE SWELLING (Injection site started swelling), VACCINATION SITE ERYTHEMA (injection site red) and URTICARIA (hives around injection site) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included HYDROCHLOROTHIAZIDE (HCT) for an unknown indication.    On 28-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 VACCINATION SITE PAIN (Sore left arm). On 09-Jan-2021, the patient experienced INJECTION SITE PRURITUS (Injection site and itching), VACCINATION SITE SWELLING (Injection site started swelling), VACCINATION SITE ERYTHEMA (injection site red) and URTICARIA (hives around injection site). On 30-Dec-2020, VACCINATION SITE PAIN (Sore left arm) had resolved. At the time of the report, INJECTION SITE PRURITUS (Injection site and itching), VACCINATION SITE SWELLING (Injection site started swelling), VACCINATION SITE ERYTHEMA (injection site red) and URTICARIA (hives around injection site) had resolved.            No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: NNI On 08-Jun-2021: Follow-up information received on 8 JUN 2021 contains information related to Event Tab, event outcome updated and product tab updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
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 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 21-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 21-Jan-2021, 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.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided.; 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.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Migraine, Myalgia
Clinical narrative: itchy hives at the injection site; severe pain at the injection site; episodes of chills; felt feverish; her highest measured; nausea; muscle and joint pain; muscle and joint pain; fatigue; injection site swelling; limits the mobility of that [right] arm; migraine headache; 3" x 3" patch of itchy, painful hives on her right thigh; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (limits the mobility of that [right] arm), MIGRAINE (migraine headache), URTICARIA (3" x 3" patch of itchy, painful hives on her right thigh), VACCINATION SITE URTICARIA (itchy hives at the injection site) and VACCINATION SITE PAIN (severe pain at the injection site) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2019, the patient experienced MIGRAINE (migraine headache) and URTICARIA (3" x 3" patch of itchy, painful hives on her right thigh). On 14-Jan-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (limits the mobility of that [right] arm), VACCINATION SITE URTICARIA (itchy hives at the injection site), VACCINATION SITE PAIN (severe pain at the injection site), CHILLS (episodes of chills), PYREXIA (felt feverish; her highest measured), NAUSEA (nausea), MYALGIA (muscle and joint pain), ARTHRALGIA (muscle and joint pain), FATIGUE (fatigue) and VACCINATION SITE SWELLING (injection site swelling). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (limits the mobility of that [right] arm), MIGRAINE (migraine headache), URTICARIA (3" x 3" patch of itchy, painful hives on her right thigh), VACCINATION SITE URTICARIA (itchy hives at the injection site), VACCINATION SITE PAIN (severe pain at the injection site), CHILLS (episodes of chills), PYREXIA (felt feverish; her highest measured), NAUSEA (nausea), MYALGIA (muscle and joint pain), ARTHRALGIA (muscle and joint pain), FATIGUE (fatigue) and VACCINATION SITE SWELLING (injection site swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment related information has been reported.; 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: Nausea, Pyrexia, Urticaria, Vaccination site movement impairment, Vaccination site pain
Clinical narrative: itchy hives at the injection site; severe pain at the injection site; episodes of chills; felt feverish; her highest measured; nausea; muscle and joint pain; muscle and joint pain; fatigue; injection site swelling; limits the mobility of that [right] arm; migraine headache; 3" x 3" patch of itchy, painful hives on her right thigh; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (limits the mobility of that [right] arm), MIGRAINE (migraine headache), URTICARIA (3" x 3" patch of itchy, painful hives on her right thigh), VACCINATION SITE URTICARIA (itchy hives at the injection site) and VACCINATION SITE PAIN (severe pain at the injection site) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2019, the patient experienced MIGRAINE (migraine headache) and URTICARIA (3" x 3" patch of itchy, painful hives on her right thigh). On 14-Jan-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (limits the mobility of that [right] arm), VACCINATION SITE URTICARIA (itchy hives at the injection site), VACCINATION SITE PAIN (severe pain at the injection site), CHILLS (episodes of chills), PYREXIA (felt feverish; her highest measured), NAUSEA (nausea), MYALGIA (muscle and joint pain), ARTHRALGIA (muscle and joint pain), FATIGUE (fatigue) and VACCINATION SITE SWELLING (injection site swelling). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (limits the mobility of that [right] arm), MIGRAINE (migraine headache), URTICARIA (3" x 3" patch of itchy, painful hives on her right thigh), VACCINATION SITE URTICARIA (itchy hives at the injection site), VACCINATION SITE PAIN (severe pain at the injection site), CHILLS (episodes of chills), PYREXIA (felt feverish; her highest measured), NAUSEA (nausea), MYALGIA (muscle and joint pain), ARTHRALGIA (muscle and joint pain), FATIGUE (fatigue) and VACCINATION SITE SWELLING (injection site swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment related information has been reported.; 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.