chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Said she had every side effect listed; Sickness; Fatigue; Muscle pain; Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Said she had every side effect listed), ILLNESS (Sickness), FATIGUE (Fatigue), MYALGIA (Muscle pain) and HEADACHE (Headache) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B218) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included APIXABAN (ELIQUIS) for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Apr-2021, the patient experienced ADVERSE EVENT (Said she had every side effect listed), ILLNESS (Sickness), FATIGUE (Fatigue), MYALGIA (Muscle pain), HEADACHE (Headache) and PYREXIA (Fever). At the time of the report, ADVERSE EVENT (Said she had every side effect listed), ILLNESS (Sickness), FATIGUE (Fatigue), MYALGIA (Muscle pain), HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication included High blood pressure pill , medicine for cholesterol and pill for irregular heart beat, all to be taken every day respectively. Treatment medication included Tylenol 1000 mg 3 times a day, as advised by doctor.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Migraine
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of back pain (low-back pain), migraine headache and chills in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 040B21A and 032B21A) for COVID-19 immunization. Concurrent medical conditions included migraine. On Apr 6, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19  vaccine), intramuscular; 1 dosage form. On May 4, 2021, received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On May 5, 2021, patient experienced back pain (low-back pain), migraine headache and chills. At the time of the report, back pain (low-back pain), migraine headache and chills outcome: unknown. Action taken with mRNA-1273 in response to the events: not applicable. Concomitant medication not provided. Treatment: ice applied to back. Most recent follow-up information incorporated: On May 6, 2021: Follow-up received on May 6, 2021 contained no new information. On Jun 9, 2021: Follow-up information received contained non-significant information.
Sex: F
Vaccine: COVID19
Symptoms: Allergy test, Biopsy, Folliculitis, Localised oedema, Skin swelling
Clinical narrative: Today, she noticed that lumps and bumps are spreading to the left side of neck and going down; A month after receiving 2nd dose, she started with lumps and bumps on her head (scalp); Dermatologist said her scalp is infected; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SKIN SWELLING (A month after receiving 2nd dose, she started with lumps and bumps on her head (scalp)), FOLLICULITIS (Dermatologist said her scalp is infected) and LOCALISED OEDEMA (Today, she noticed that lumps and bumps are spreading to the left side of neck and going down) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (chloroxylenol ingredient) since April 2021.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Apr-2021, the patient experienced SKIN SWELLING (A month after receiving 2nd dose, she started with lumps and bumps on her head (scalp)) and FOLLICULITIS (Dermatologist said her scalp is infected). On 06-May-2021, the patient experienced LOCALISED OEDEMA (Today, she noticed that lumps and bumps are spreading to the left side of neck and going down). The patient was treated with GABAPENTIN ongoing since an unknown date at an unspecified dose and frequency; RIFAMPIN ongoing since an unknown date at an unspecified dose and frequency and DEXAMETHASONE ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, SKIN SWELLING (A month after receiving 2nd dose, she started with lumps and bumps on her head (scalp)), FOLLICULITIS (Dermatologist said her scalp is infected) and LOCALISED OEDEMA (Today, she noticed that lumps and bumps are spreading to the left side of neck and going down) outcome was unknown. Unknown    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Allergy test: abnormal (abnormal) Found out that she is allergic to chloroxylenol ingredient.. In April 2021, Biopsy: abnormal (abnormal) Her scalp is infected.         Concomitant medication list was not provided. Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Follow-up information received on 06-May-2021 contains non-significant information.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Biopsy, Chills, Nausea, Vaccination site erythema
Clinical narrative: Injection site itching; Chills; Pain in knee; Nausea; Injection site redness; Vaccination site pain; Injection site swelling; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PRURITUS (Injection site itching), CHILLS (Chills), ARTHRALGIA (Pain in knee), NAUSEA (Nausea) and VACCINATION SITE ERYTHEMA (Injection site redness) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pulmonary oedema, Lymphadenopathy, Squamous cell carcinoma of skin, Pruritus, Photodermatosis, Weight increased, Skin irritation, Skin texture abnormal, Contusion, Epistaxis, Diarrhea and Onychoclasis. Family history included Osteoporosis (Family history of osteoporosis) since an unknown date. Concurrent medical conditions included Chronic lymphocytic leukemia and Diverticulitis. Concomitant products included IBRUTINIB (IMBRUVICA) for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Injection site itching), CHILLS (Chills), ARTHRALGIA (Pain in knee), NAUSEA (Nausea), VACCINATION SITE ERYTHEMA (Injection site redness), VACCINATION SITE PAIN (Vaccination site pain) and VACCINATION SITE SWELLING (Injection site swelling). At the time of the report, VACCINATION SITE PRURITUS (Injection site itching) and VACCINATION SITE ERYTHEMA (Injection site redness) was resolving and CHILLS (Chills), ARTHRALGIA (Pain in knee), NAUSEA (Nausea), VACCINATION SITE PAIN (Vaccination site pain) and VACCINATION SITE SWELLING (Injection site swelling) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy: squamous cell carcinoma (Inconclusive) Squamous cell carcinoma.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.  Company Comment - Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Injection site itching; Chills; Pain in knee; Nausea; Injection site redness; Vaccination site pain; Injection site swelling; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PRURITUS (Injection site itching), CHILLS (Chills), ARTHRALGIA (Pain in knee), NAUSEA (Nausea) and VACCINATION SITE ERYTHEMA (Injection site redness) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pulmonary oedema, Lymphadenopathy, Squamous cell carcinoma of skin, Pruritus, Photodermatosis, Weight increased, Skin irritation, Skin texture abnormal, Contusion, Epistaxis, Diarrhea and Onychoclasis. Family history included Osteoporosis (Family history of osteoporosis) since an unknown date. Concurrent medical conditions included Chronic lymphocytic leukemia and Diverticulitis. Concomitant products included IBRUTINIB (IMBRUVICA) for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Injection site itching), CHILLS (Chills), ARTHRALGIA (Pain in knee), NAUSEA (Nausea), VACCINATION SITE ERYTHEMA (Injection site redness), VACCINATION SITE PAIN (Vaccination site pain) and VACCINATION SITE SWELLING (Injection site swelling). At the time of the report, VACCINATION SITE PRURITUS (Injection site itching) and VACCINATION SITE ERYTHEMA (Injection site redness) was resolving and CHILLS (Chills), ARTHRALGIA (Pain in knee), NAUSEA (Nausea), VACCINATION SITE PAIN (Vaccination site pain) and VACCINATION SITE SWELLING (Injection site swelling) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy: squamous cell carcinoma (Inconclusive) Squamous cell carcinoma.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.  Company Comment - Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Peripheral swelling, Swelling, Urticaria
Clinical narrative: hives; swollen lips and arm; swelling in whole body; swollen lips and arm; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives), LIP SWELLING (swollen lips and arm), SWELLING (swelling in whole body) and VACCINATION SITE SWELLING (swollen lips and arm) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included INSULIN and blood pressure medication for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2021, the patient experienced URTICARIA (hives), LIP SWELLING (swollen lips and arm), SWELLING (swelling in whole body) and VACCINATION SITE SWELLING (swollen lips and arm). At the time of the report, URTICARIA (hives), LIP SWELLING (swollen lips and arm), SWELLING (swelling in whole body) and VACCINATION SITE SWELLING (swollen lips and arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Age: 36.0
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 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BIOTIN;MINERALS NOS;NICOTINIC ACID;RETINOL;TOCOPHEROL;VITAMIN B NOS;VITAMIN D NOS] for an unknown indication.    On 30-Apr-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-Sep-2020 and the estimated date of delivery was 06-Jul-2021. On 30-Apr-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirtieth week of the pregnancy.  On 30-Apr-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       treatment to the events not provided.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Somnolence, Urine analysis
Clinical narrative: sleepy; headache; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (sleepy) and HEADACHE (headache) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included OXYCODONE HYDROCHLORIDE, PARACETAMOL (ACETAMINOPHEN W/OXYCODONE), VENLAFAXINE, LAMOTRIGINE, LEVOTHYROXINE and FERROUS SULFATE for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (sleepy) and HEADACHE (headache). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, SOMNOLENCE (sleepy) and HEADACHE (headache) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Apr-2021, Urine analysis: positive large traces of Tramadol.     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.    Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Non significant follow up received on 07-JUN-2021, no new information
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Sneezing
Clinical narrative: Runny nose; sneezing; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny nose) and SNEEZING (sneezing) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included Thyroid pill for Product used for unknown indication, LOVASTATIN, OMEPRAZOLE and MELOXICAM for an unknown indication.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, the patient experienced RHINORRHOEA (Runny nose) and SNEEZING (sneezing). The patient was treated with CHLORPHENAMINE MALEATE, PARACETAMOL (CORICIDIN HBP COLD AND FLU) ongoing since an unknown date at an unspecified dose and frequency. On 06-May-2021, RHINORRHOEA (Runny nose) had resolved. At the time of the report, SNEEZING (sneezing) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment drug include Coricidin  Action taken with mRNA-1273 in response to the event was unknown
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Urine abnormality, Urine analysis
Clinical narrative: fever; large traces of Tramadol present in urine; This spontaneous case was reported by a consumer and describes the occurrence of URINE ABNORMALITY (large traces of Tramadol present in urine) and PYREXIA (fever) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 003B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included OXYCODONE HYDROCHLORIDE, PARACETAMOL (OXYCODONE AND ACETAMINOPHEN), VENLAFAXINE, LAMOTRIGINE, LEVOTHYROXINE and FERROUS SULFATE for an unknown indication.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced URINE ABNORMALITY (large traces of Tramadol present in urine). On an unknown date, the patient experienced PYREXIA (fever). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, URINE ABNORMALITY (large traces of Tramadol present in urine) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Mar-2021, Urine analysis: normal (normal) urine test on 24Mar2021 was clear.. On 15-Apr-2021, Urine analysis: positive (Positive) tested positive for large traces of Tramadol.         This case was linked to MOD-2021-109389 (Patient Link).
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: L arm is swollen; L arm hot; L arm still sore.; covid symptoms from the vaccine; horrible headache; extreme fatigue; lower fever; chills; joint pain; nausea; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (L arm is swollen), SKIN WARM (L arm hot), PAIN IN EXTREMITY (L arm still sore.), VACCINATION COMPLICATION (covid symptoms from the vaccine) and HEADACHE (horrible headache) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, the patient experienced PERIPHERAL SWELLING (L arm is swollen), SKIN WARM (L arm hot), PAIN IN EXTREMITY (L arm still sore.), VACCINATION COMPLICATION (covid symptoms from the vaccine), HEADACHE (horrible headache), FATIGUE (extreme fatigue), PYREXIA (lower fever), CHILLS (chills), ARTHRALGIA (joint pain), NAUSEA (nausea) and MYALGIA (muscle pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (L arm is swollen), SKIN WARM (L arm hot), PAIN IN EXTREMITY (L arm still sore.), VACCINATION COMPLICATION (covid symptoms from the vaccine), HEADACHE (horrible headache), FATIGUE (extreme fatigue), PYREXIA (lower fever), CHILLS (chills), ARTHRALGIA (joint pain), NAUSEA (nausea) and MYALGIA (muscle pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test: positive (Positive) had COVID-19 on JAN2021..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Peripheral swelling, Pyrexia, SARS-CoV-2 test
Clinical narrative: L arm is swollen; L arm hot; L arm still sore.; covid symptoms from the vaccine; horrible headache; extreme fatigue; lower fever; chills; joint pain; nausea; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (L arm is swollen), SKIN WARM (L arm hot), PAIN IN EXTREMITY (L arm still sore.), VACCINATION COMPLICATION (covid symptoms from the vaccine) and HEADACHE (horrible headache) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, the patient experienced PERIPHERAL SWELLING (L arm is swollen), SKIN WARM (L arm hot), PAIN IN EXTREMITY (L arm still sore.), VACCINATION COMPLICATION (covid symptoms from the vaccine), HEADACHE (horrible headache), FATIGUE (extreme fatigue), PYREXIA (lower fever), CHILLS (chills), ARTHRALGIA (joint pain), NAUSEA (nausea) and MYALGIA (muscle pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (L arm is swollen), SKIN WARM (L arm hot), PAIN IN EXTREMITY (L arm still sore.), VACCINATION COMPLICATION (covid symptoms from the vaccine), HEADACHE (horrible headache), FATIGUE (extreme fatigue), PYREXIA (lower fever), CHILLS (chills), ARTHRALGIA (joint pain), NAUSEA (nausea) and MYALGIA (muscle pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test: positive (Positive) had COVID-19 on JAN2021..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Skin warm, Vaccination complication
Clinical narrative: L arm is swollen; L arm hot; L arm still sore.; covid symptoms from the vaccine; horrible headache; extreme fatigue; lower fever; chills; joint pain; nausea; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (L arm is swollen), SKIN WARM (L arm hot), PAIN IN EXTREMITY (L arm still sore.), VACCINATION COMPLICATION (covid symptoms from the vaccine) and HEADACHE (horrible headache) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, the patient experienced PERIPHERAL SWELLING (L arm is swollen), SKIN WARM (L arm hot), PAIN IN EXTREMITY (L arm still sore.), VACCINATION COMPLICATION (covid symptoms from the vaccine), HEADACHE (horrible headache), FATIGUE (extreme fatigue), PYREXIA (lower fever), CHILLS (chills), ARTHRALGIA (joint pain), NAUSEA (nausea) and MYALGIA (muscle pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (L arm is swollen), SKIN WARM (L arm hot), PAIN IN EXTREMITY (L arm still sore.), VACCINATION COMPLICATION (covid symptoms from the vaccine), HEADACHE (horrible headache), FATIGUE (extreme fatigue), PYREXIA (lower fever), CHILLS (chills), ARTHRALGIA (joint pain), NAUSEA (nausea) and MYALGIA (muscle pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test: positive (Positive) had COVID-19 on JAN2021..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: nagging headache for a day; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (nagging headache for a day) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     Concurrent medical conditions included Migraine. Concomitant products included SUMATRIPTAN for Migraine headache.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced HEADACHE (nagging headache for a day). At the time of the report, HEADACHE (nagging headache for a day) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling hot, Headache, Hyperhidrosis, Influenza like illness
Clinical narrative: really bad flu symptoms; waking up sweaty on wet sheets; feeling hot; feeling nauseous; body aches; headache; feeling really tired; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (really bad flu symptoms), HYPERHIDROSIS (waking up sweaty on wet sheets), FEELING HOT (feeling hot), NAUSEA (feeling nauseous) and MYALGIA (body aches) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-May-2021, the patient experienced INFLUENZA LIKE ILLNESS (really bad flu symptoms), HYPERHIDROSIS (waking up sweaty on wet sheets), FEELING HOT (feeling hot), NAUSEA (feeling nauseous), MYALGIA (body aches), HEADACHE (headache) and FATIGUE (feeling really tired). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (really bad flu symptoms), HYPERHIDROSIS (waking up sweaty on wet sheets), FEELING HOT (feeling hot), NAUSEA (feeling nauseous), MYALGIA (body aches) and FATIGUE (feeling really tired) had not resolved and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea
Clinical narrative: really bad flu symptoms; waking up sweaty on wet sheets; feeling hot; feeling nauseous; body aches; headache; feeling really tired; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (really bad flu symptoms), HYPERHIDROSIS (waking up sweaty on wet sheets), FEELING HOT (feeling hot), NAUSEA (feeling nauseous) and MYALGIA (body aches) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-May-2021, the patient experienced INFLUENZA LIKE ILLNESS (really bad flu symptoms), HYPERHIDROSIS (waking up sweaty on wet sheets), FEELING HOT (feeling hot), NAUSEA (feeling nauseous), MYALGIA (body aches), HEADACHE (headache) and FATIGUE (feeling really tired). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (really bad flu symptoms), HYPERHIDROSIS (waking up sweaty on wet sheets), FEELING HOT (feeling hot), NAUSEA (feeling nauseous), MYALGIA (body aches) and FATIGUE (feeling really tired) had not resolved and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Musculoskeletal stiffness, Pain in extremity, Pyrexia
Clinical narrative: Stiff Neck; Fever 102.8F; Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm), MUSCULOSKELETAL STIFFNESS (Stiff Neck) and PYREXIA (Fever 102.8F) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     Concurrent medical conditions included Rectal cancer (Atypical Rectal Cancer for 5 years now.). Concomitant products included INFLIXIMAB (REMICADE) for Rectal cancer.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm). On 16-Apr-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiff Neck) and PYREXIA (Fever 102.8F). On 16-Apr-2021, PAIN IN EXTREMITY (Sore Arm) had resolved. On 17-Apr-2021, MUSCULOSKELETAL STIFFNESS (Stiff Neck) and PYREXIA (Fever 102.8F) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Apr-2021, Body temperature: 102.8 f (High) Fever 102.8F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Colonoscopy, Condition aggravated, Gastrointestinal disorder
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (worse lower back pain), GASTROINTESTINAL DISORDER (Worse abdominal issues) and CONDITION AGGRAVATED (Condition aggravated) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Chronic back pain (chronic left lower back pain) in 2012, Bowel movement irregularity in 2012 and Fatty liver. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced BACK PAIN (worse lower back pain), GASTROINTESTINAL DISORDER (Worse abdominal issues) and CONDITION AGGRAVATED (Condition aggravated). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Pain, at an unspecified dose and frequency and ACETAMINOPHEN for Pain, at an unspecified dose and frequency. At the time of the report, BACK PAIN (worse lower back pain), GASTROINTESTINAL DISORDER (Worse abdominal issues) and CONDITION AGGRAVATED (Condition aggravated) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Colonoscopy: negative (Negative) Negative.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Rash pruritic, Vaccination site erythema, Vaccination site rash
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Rashes are itchy), FEELING HOT (rashes are hot to touch), VACCINATION SITE RASH (red rashes around the injection site of right arm) and VACCINATION SITE ERYTHEMA (red rashes around the injection site of right arm) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 025A21A) for COVID-19 vaccination. No medical history reported. Concomitant products included GABAPENTIN, FUROSEMIDE, Cyclobenzamine, POTASSIUM, ATORVASTATIN CALCIUM (CRYSTORVAS), ZOLPIDEM TARTRATE (AMBIEN), DULOXETINE, HCTZ, METFORMIN and CARVEDILOL for an unknown indication. On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-May-2021, the patient experienced RASH PRURITIC (Rashes are itchy), FEELING HOT (rashes are hot to touch), VACCINATION SITE RASH (red rashes around the injection site of right arm) and VACCINATION SITE ERYTHEMA (red rashes around the injection site of right arm). At the time of the report, RASH PRURITIC (Rashes are itchy), FEELING HOT (rashes are hot to touch), VACCINATION SITE RASH (red rashes around the injection site of right arm) and VACCINATION SITE ERYTHEMA (red rashes around the injection site of right arm) outcome was unknown.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pruritus, Eye swelling, Pruritus, Swelling, Swelling face
Clinical narrative: itchy face; swollen eyes; swollen face; itchy face around eyes; swollen neck; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy face), EYE SWELLING (swollen eyes), SWELLING FACE (swollen face), EYE PRURITUS (itchy face around eyes) and SWELLING (swollen neck) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A31A and 023M207A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, the patient experienced PRURITUS (itchy face), EYE SWELLING (swollen eyes), SWELLING FACE (swollen face), EYE PRURITUS (itchy face around eyes) and SWELLING (swollen neck). At the time of the report, PRURITUS (itchy face), EYE SWELLING (swollen eyes), SWELLING FACE (swollen face), EYE PRURITUS (itchy face around eyes) and SWELLING (swollen neck) outcome was unknown.            No Relevant concomitant medications was reported. Treatment information included anti itch cream hydrocortisone over the counter.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable. .
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dehydration, Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Dehydration; Vomiting; Fever; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), DEHYDRATION (Dehydration), VOMITING (Vomiting) and PYREXIA (Fever) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination.     Concurrent medical conditions included Type 1 diabetes mellitus. Concomitant products included INSULIN DETEMIR (LEVEMIR) and INSULIN ASPART (NOVOLOG) for Type 1 diabetes mellitus.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, the patient experienced DIARRHOEA (Diarrhea), VOMITING (Vomiting) and PYREXIA (Fever). On 02-May-2021, the patient experienced DEHYDRATION (Dehydration). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 01-May-2021, DIARRHOEA (Diarrhea) and VOMITING (Vomiting) had resolved. On 02-May-2021, DEHYDRATION (Dehydration) and PYREXIA (Fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-May-2021, Body temperature: 102 (High) fever, 102..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac murmur, Dyspnoea, Echocardiogram, Physical examination, Product administered to patient of inappropriate age
Clinical narrative: shortness of breath which is on and off/shortness of breath can be from anxiety from schooling; heart murmur; 16 year old patient received 1st dose of Moderna COVID-19 vaccine; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old patient received 1st dose of Moderna COVID-19 vaccine), DYSPNOEA (shortness of breath which is on and off/shortness of breath can be from anxiety from schooling) and CARDIAC MURMUR (heart murmur) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     The patient's past medical history included Anxiety (anxiety from schooling). Concomitant products included DESOGESTREL, ETHINYLESTRADIOL (APRI) for Birth control pill, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for Supplementation therapy.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old patient received 1st dose of Moderna COVID-19 vaccine). On 17-Apr-2021, the patient experienced CARDIAC MURMUR (heart murmur). On an unknown date, the patient experienced DYSPNOEA (shortness of breath which is on and off/shortness of breath can be from anxiety from schooling). On 07-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old patient received 1st dose of Moderna COVID-19 vaccine) had resolved. At the time of the report, DYSPNOEA (shortness of breath which is on and off/shortness of breath can be from anxiety from schooling) and CARDIAC MURMUR (heart murmur) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Apr-2021, Echocardiogram: abnormal (abnormal) 2 different readings for patient's echocardiogram. On 17-Apr-2021, Physical examination: abnormal (abnormal) heart murmur at physical checkup.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Did not receive 2nd Moderna Vaccination within 42 days from 1st Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not receive 2nd Moderna Vaccination within 42 days from 1st Vaccine) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not receive 2nd Moderna Vaccination within 42 days from 1st Vaccine). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not receive 2nd Moderna Vaccination within 42 days from 1st Vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Body temperature, Chills, Malaise, Maternal exposure during pregnancy
Clinical narrative: Felt off Throughout day; Chills; Fever 102; Muscle aches; Pregnancy; Nausea; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of MALAISE (Felt off Throughout day), NAUSEA (Nausea), CHILLS (Chills), PYREXIA (Fever 102) and MYALGIA (Muscle aches) in a 34-year-old female patient (gravida 4, para 3) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20 and 025I20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Spontaneous abortion in 2017, Full term baby on 12-May-2018, Spontaneous abortion in 2020, Alcohol use (Occasional,Before Pregnancy) and Smoker (1 pack/day). Concurrent medical conditions included Drug allergy (Migraine), Peanut allergy (Migraine) and Asthma.   On 26-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 29-Dec-2020 and the estimated date of delivery was 12-Oct-2021. On 20-Jan-2021, the patient experienced NAUSEA (Nausea) and MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy). On 21-Jan-2021, the patient experienced CHILLS (Chills), PYREXIA (Fever 102) and MYALGIA (Muscle aches). On an unknown date, the patient experienced MALAISE (Felt off Throughout day). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  third week of the pregnancy.  On 20-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) had resolved. On 24-Jan-2021, NAUSEA (Nausea) had resolved. On 25-Jan-2021, CHILLS (Chills), PYREXIA (Fever 102) and MYALGIA (Muscle aches) had resolved. At the time of the report, MALAISE (Felt off Throughout day) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jan-2021, Body temperature: 102 (High) 102. On an unknown date, Blood test: normal (normal) WNL. On an unknown date, Scan: normal (normal) WNL. On an unknown date, Ultrasound scan: normal (normal) WNL.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient's day of conception was 20-Jan-2021. Patient's Positive Pregnancy is 23 Mar 2021 Concomitant products includes Rainbow light prenatal(Oral),ongoing Treatment information was not provided.   This case was linked to MOD-2021-109802 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Additional information received contains non significant information On 28-Jul-2021: Medical History includes 3 previous pregnancies, Alcohol use, Allergies includes Imitrex,peanuts, Nicotine use. Lab data includes Ultrasound, Blood Work, Anatomy Scan. Concomitant products were added. Felt throughout the day was added.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia, Scan, Ultrasound scan
Clinical narrative: Felt off Throughout day; Chills; Fever 102; Muscle aches; Pregnancy; Nausea; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of MALAISE (Felt off Throughout day), NAUSEA (Nausea), CHILLS (Chills), PYREXIA (Fever 102) and MYALGIA (Muscle aches) in a 34-year-old female patient (gravida 4, para 3) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20 and 025I20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Spontaneous abortion in 2017, Full term baby on 12-May-2018, Spontaneous abortion in 2020, Alcohol use (Occasional,Before Pregnancy) and Smoker (1 pack/day). Concurrent medical conditions included Drug allergy (Migraine), Peanut allergy (Migraine) and Asthma.   On 26-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 29-Dec-2020 and the estimated date of delivery was 12-Oct-2021. On 20-Jan-2021, the patient experienced NAUSEA (Nausea) and MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy). On 21-Jan-2021, the patient experienced CHILLS (Chills), PYREXIA (Fever 102) and MYALGIA (Muscle aches). On an unknown date, the patient experienced MALAISE (Felt off Throughout day). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  third week of the pregnancy.  On 20-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) had resolved. On 24-Jan-2021, NAUSEA (Nausea) had resolved. On 25-Jan-2021, CHILLS (Chills), PYREXIA (Fever 102) and MYALGIA (Muscle aches) had resolved. At the time of the report, MALAISE (Felt off Throughout day) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jan-2021, Body temperature: 102 (High) 102. On an unknown date, Blood test: normal (normal) WNL. On an unknown date, Scan: normal (normal) WNL. On an unknown date, Ultrasound scan: normal (normal) WNL.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient's day of conception was 20-Jan-2021. Patient's Positive Pregnancy is 23 Mar 2021 Concomitant products includes Rainbow light prenatal(Oral),ongoing Treatment information was not provided.   This case was linked to MOD-2021-109802 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Additional information received contains non significant information On 28-Jul-2021: Medical History includes 3 previous pregnancies, Alcohol use, Allergies includes Imitrex,peanuts, Nicotine use. Lab data includes Ultrasound, Blood Work, Anatomy Scan. Concomitant products were added. Felt throughout the day was added.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Maternal exposure during pregnancy, Myalgia
Clinical narrative: Moderna vaccine administered to pregnant patient; Achy; Tired; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Moderna vaccine administered to pregnant patient), MYALGIA (Achy) and FATIGUE (Tired) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 005C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-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 10-Aug-2020 and the estimated date of delivery was 21-May-2021. On 07-Apr-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Moderna vaccine administered to pregnant patient), MYALGIA (Achy) and FATIGUE (Tired). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-fourth week of the pregnancy.  On 07-Apr-2021, MATERNAL EXPOSURE DURING PREGNANCY (Moderna vaccine administered to pregnant patient) had resolved. At the time of the report, MYALGIA (Achy) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concurrent medications usage has been not provided by the reporter  No treatment were medicines were reported.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jun-2021: Updated Patient's Age from 37 Years to 27 Years
Sex: U
Vaccine: COVID19
Symptoms: Wrong technique in product usage process
Clinical narrative: 2 patients received vaccine from vial that was not swirled before administering; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (2 patients received vaccine from vial that was not swirled before administering) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (2 patients received vaccine from vial that was not swirled before administering). On 30-Apr-2021, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (2 patients received vaccine from vial that was not swirled before administering) 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.   This case was linked to US-MODERNATX, INC.-MOD-2021-109462 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-109462:Patient 2