chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Covid positive after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Covid positive after 1st dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Covid positive after 1st dose). At the time of the report, SARS-COV-2 TEST POSITIVE (Covid positive after 1st dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       the patient got 1st shot on 1Mar2021 and is Scheduled to get the 2nd shot on 29Mar2021 but on 17Mar2021 he tested positive for Covid 19. Consent for safety follow up denied.   Reporter did not allow further contact
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Some of the vaccine spilled on patient's arm; A spontaneous report was received from a pharmaist concerning a 63-years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced some of the vaccine spilled on arm/ accidental underdose.  The patient's medical history included blood pressure, thyroid and acid reflux. Concomitant product use was not provided by the reporter.   On 23 Feb 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 030M20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 23 Mar 2021, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 030M20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 23 Mar 2021, the patient experienced some of the vaccine spilled on arm.  Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.   The event, some of the vaccine spilled on arm was considered resolved on 23 Mar 2021.; Reporter's Comments: This report refers to a case of accidental under dose for mRNA-1273, lot # 030M20A with no associated AEs.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: red, hot , swollen mark at the injection site , in the right arm.; red, hot , swollen mark at the injection site , in the right arm.; red, hot , swollen mark at the injection site , in the right arm.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (red, hot , swollen mark at the injection site , in the right arm.), VACCINATION SITE SWELLING (red, hot , swollen mark at the injection site , in the right arm.) and VACCINATION SITE ERYTHEMA (red, hot , swollen mark at the injection site , in the right arm.) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced VACCINATION SITE WARMTH (red, hot , swollen mark at the injection site , in the right arm.), VACCINATION SITE SWELLING (red, hot , swollen mark at the injection site , in the right arm.) and VACCINATION SITE ERYTHEMA (red, hot , swollen mark at the injection site , in the right arm.). At the time of the report, VACCINATION SITE WARMTH (red, hot , swollen mark at the injection site , in the right arm.), VACCINATION SITE SWELLING (red, hot , swollen mark at the injection site , in the right arm.) and VACCINATION SITE ERYTHEMA (red, hot , swollen mark at the injection site , in the right arm.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Nausea, Vaccination site pain
Clinical narrative: Soreness at the injection site which worsened between day 1 and 2; Headache; Exhausted/ some tiredness; Nauseated for 3 days; Diarrhea for 3 days; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHEA (Diarrhea for 3 days), VACCINATION SITE PAIN (Soreness at the injection site which worsened between day 1 and 2), NAUSEA (Nauseated for 3 days), HEADACHE (Headache) and FATIGUE (Exhausted/ some tiredness) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 044A21A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis. Concomitant products included IBUPROFEN for Arthritis.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIARRHEA (Diarrhea for 3 days), VACCINATION SITE PAIN (Soreness at the injection site which worsened between day 1 and 2), NAUSEA (Nauseated for 3 days), HEADACHE (Headache) and FATIGUE (Exhausted/ some tiredness). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE]) at an unspecified dose and frequency. At the time of the report, DIARRHEA (Diarrhea for 3 days) and NAUSEA (Nauseated for 3 days) had resolved and VACCINATION SITE PAIN (Soreness at the injection site which worsened between day 1 and 2), HEADACHE (Headache) and FATIGUE (Exhausted/ some tiredness) outcome was unknown.            The events occurred after the first dose of the vaccination. Treatment included ibuprofen for the soreness arm.  Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-056391 (Patient Link).
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Nausea
Clinical narrative: Dizziness; Diarrhea; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), DIARRHOEA (Diarrhea) and NAUSEA (Nausea) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced DIZZINESS (Dizziness), DIARRHOEA (Diarrhea) and NAUSEA (Nausea). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIZZINESS (Dizziness), DIARRHOEA (Diarrhea) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Used partially and kept in the refrigerator) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M21A) for COVID-19 vaccination. No Medical History information was reported. On 22-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Used partially and kept in the refrigerator). On 22-Mar-2021, EXPIRED PRODUCT ADMINISTERED (Used partially and kept in the refrigerator) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Treatment information was not provided. This case was linked to MOD-2021-056309, MOD-2021-056442, MOD-2021-056507, MOD-2021-056393.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnant patient received the vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant patient received the vaccine) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003b21a) for COVID-19 vaccination.     Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 22-Mar-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 01-May-2021. On 22-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant patient received the vaccine). On 22-Mar-2021, EXPOSURE DURING PREGNANCY (Pregnant patient received the vaccine) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: chills; This spontaneous case was reported by a patient and describes the occurrence of CHILLS (chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 24-Mar-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 24-Feb-2021, the patient experienced CHILLS (chills). At the time of the report, CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication were reported. Treatment medication was not provided.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of headache, myalgia (body ache), nausea, extreme fatigue and COVID-19 (COVID-19 positive) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 006M20A) for an unknown indication. The patient's past medical history included no adverse event since an unknown date. On Feb 17, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Feb 18, 2021, patient experienced headache, myalgia (body ache), nausea and extreme fatigue. On Feb 19, 2021, patient experienced COVID-19 (COVID-19 positive). At the time of the report, headache, myalgia (body ache), nausea and extreme fatigue outcome: unknown. Diagnostic results: On Mar 19, 2021, SARS-CoV-2 test: positive.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of headache, myalgia (body ache), nausea, extreme fatigue and COVID-19 (COVID-19 positive) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 006M20A) for an unknown indication. The patient's past medical history included no adverse event since an unknown date. On Feb 17, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Feb 18, 2021, patient experienced headache, myalgia (body ache), nausea and extreme fatigue. On Feb 19, 2021, patient experienced COVID-19 (COVID-19 positive). At the time of the report, headache, myalgia (body ache), nausea and extreme fatigue outcome: unknown. Diagnostic results: On Mar 19, 2021, SARS-CoV-2 test: positive.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash
Clinical narrative: rash at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (rash at injection site) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041620A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced INJECTION SITE RASH (rash at injection site). At the time of the report, INJECTION SITE RASH (rash at injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Pruritus, Rhinorrhoea
Clinical narrative: Running itching nose; Itching nose; Sick; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Running itching nose), PRURITUS (Itching nose) and ILLNESS (Sick) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RHINORRHOEA (Running itching nose), PRURITUS (Itching nose) and ILLNESS (Sick). At the time of the report, RHINORRHOEA (Running itching nose), PRURITUS (Itching nose) and ILLNESS (Sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter  Treatment information was not provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: 2 Moderna doses that were given 50 days apart; Slightly sorer left arm; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2 Moderna doses that were given 50 days apart) and PAIN IN EXTREMITY (Slightly sorer left arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 025J20-2A) for COVID-19 vaccination.     The patient's past medical history included Gastroesophageal reflux disease from 1995 to 1996, Asthma and Acid reflux (esophageal). Concurrent medical conditions included Iodine contrast media allergy (allergy reported: iodine contrast dye (anaphylactic reaction).) and Blood pressure high. Concomitant products included OMEPRAZOLE, HCTZ, MONTELUKAST SODIUM (SINGULAIR), FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (WIXELA INHUB) and AMLODIPINE BESILATE, OLMESARTAN MEDOXOMIL (AMLODIPINE AND OLMESARTAN MEDOXOMIL) for an unknown indication.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milligram. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milligram. On 26-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2 Moderna doses that were given 50 days apart) and PAIN IN EXTREMITY (Slightly sorer left arm). On 26-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2 Moderna doses that were given 50 days apart) had resolved. At the time of the report, PAIN IN EXTREMITY (Slightly sorer left arm) had resolved.            Treatment information was not provided.   This case was linked to MOD-2021-030063 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Follow up on 21 Apr 2021 11:13 AM : added event 2 Moderna doses that were given 50 days apart. On 21-Apr-2021: same source document On 21-Apr-2021: same source document
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Peripheral coldness
Clinical narrative: both legs are cold; right leg cannot be lifted; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL COLDNESS (both legs are cold) and MOBILITY DECREASED (right leg cannot be lifted) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reported.  Concomitant products included INSULIN HUMAN, INSULIN HUMAN INJECTION, ISOPHANE (HUMULINE) for Diabetes mellitus, CLONAZEPAM and SERTRALINE for Schizophrenia.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL COLDNESS (both legs are cold) and MOBILITY DECREASED (right leg cannot be lifted). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, PERIPHERAL COLDNESS (both legs are cold) and MOBILITY DECREASED (right leg cannot be lifted) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Musculoskeletal stiffness, Pruritus, Skin burning sensation, Urticaria
Clinical narrative: Itching all over the body; Hives all over the body (Looked Like Shingles); Skin Burning (Hives Area); Warm to the touch injection site; Stiff Neck; Difficult to keep head up; This spontaneous case was reported by a nurse and describes the occurrence of PRURITUS (Itching all over the body), URTICARIA (Hives all over the body (Looked Like Shingles)), SKIN BURNING SENSATION (Skin Burning (Hives Area)), VACCINATION SITE WARMTH (Warm to the touch injection site) and MUSCULOSKELETAL STIFFNESS (Stiff Neck) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Arthrodesis.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced PRURITUS (Itching all over the body), URTICARIA (Hives all over the body (Looked Like Shingles)), SKIN BURNING SENSATION (Skin Burning (Hives Area)), VACCINATION SITE WARMTH (Warm to the touch injection site), MUSCULOSKELETAL STIFFNESS (Stiff Neck) and HEAD DISCOMFORT (Difficult to keep head up). At the time of the report, PRURITUS (Itching all over the body), URTICARIA (Hives all over the body (Looked Like Shingles)), SKIN BURNING SENSATION (Skin Burning (Hives Area)), VACCINATION SITE WARMTH (Warm to the touch injection site), MUSCULOSKELETAL STIFFNESS (Stiff Neck) and HEAD DISCOMFORT (Difficult to keep head up) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Treatment medication was not reported. The patient had itching 1 hour after vaccination. The hives were mostly in the lower back and shoulders. It was painful and itchy on her back while taking hot shower. After shower, the patient was relieved for a couple of hours and had less itching.   This case was linked to MOD-2021-034571 (E2B Linked Report).
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Itching all over the body; Hives all over the body (Looked Like Shingles); Skin Burning (Hives Area); Warm to the touch injection site; Stiff Neck; Difficult to keep head up; This spontaneous case was reported by a nurse and describes the occurrence of PRURITUS (Itching all over the body), URTICARIA (Hives all over the body (Looked Like Shingles)), SKIN BURNING SENSATION (Skin Burning (Hives Area)), VACCINATION SITE WARMTH (Warm to the touch injection site) and MUSCULOSKELETAL STIFFNESS (Stiff Neck) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Arthrodesis.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced PRURITUS (Itching all over the body), URTICARIA (Hives all over the body (Looked Like Shingles)), SKIN BURNING SENSATION (Skin Burning (Hives Area)), VACCINATION SITE WARMTH (Warm to the touch injection site), MUSCULOSKELETAL STIFFNESS (Stiff Neck) and HEAD DISCOMFORT (Difficult to keep head up). At the time of the report, PRURITUS (Itching all over the body), URTICARIA (Hives all over the body (Looked Like Shingles)), SKIN BURNING SENSATION (Skin Burning (Hives Area)), VACCINATION SITE WARMTH (Warm to the touch injection site), MUSCULOSKELETAL STIFFNESS (Stiff Neck) and HEAD DISCOMFORT (Difficult to keep head up) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Treatment medication was not reported. The patient had itching 1 hour after vaccination. The hives were mostly in the lower back and shoulders. It was painful and itchy on her back while taking hot shower. After shower, the patient was relieved for a couple of hours and had less itching.   This case was linked to MOD-2021-034571 (E2B Linked Report).
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045AZ1A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced URTICARIA (Hives). On 24-Mar-2021, URTICARIA (Hives) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medication information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Updated medical history.
Age: 97.0
Sex: F
Vaccine: COVID19
Symptoms: Dyskinesia
Clinical narrative: Involuntary jerk movement; This spontaneous case was reported by an other caregiver and describes the occurrence of DYSKINESIA (Involuntary jerk movement) in a 97-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006m2ca) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced DYSKINESIA (Involuntary jerk movement). At the time of the report, DYSKINESIA (Involuntary jerk movement) outcome was unknown.            No concomitant medications were reported. No treatment was reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Follow Up received on 15-APR-2021 Contains Non-significant information - Added daughter's email address On 20-Apr-2021: Follow Up received on 20-APR-2021 Contains Non-Significant Information On 17-May-2021: Follow Up received on 17-MAY-2021 Contains Non-Significant information; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy, Nausea, Pain in extremity
Clinical narrative: Sore Arm; Fatigue; Swollen lymph nodes; Nausea; This spontaneous case was reported by a  and describes the occurrence of FATIGUE (Fatigue), PAIN IN EXTREMITY (Sore Arm), LYMPHADENOPATHY (Swollen lymph nodes) and NAUSEA (Nausea) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced FATIGUE (Fatigue), PAIN IN EXTREMITY (Sore Arm), LYMPHADENOPATHY (Swollen lymph nodes) and NAUSEA (Nausea).            Reporter did not allow further contact
Age: 92.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Patient is almost 60 days out and still has not received the second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient is almost 60 days out and still has not received the second dose) in a 92-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 26-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 PRODUCT DOSE OMISSION ISSUE (Patient is almost 60 days out and still has not received the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient is almost 60 days out and still has not received the second dose) 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 report refers to a case of Product dose omission issue, for mRNA-1273, lot #: 004M20A, with no associated AEs.; Sender's Comments: This report refers to a case of Product dose omission issue, for mRNA-1273, lot #: 004M20A, with no associated AEs.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Feeling hot, Headache, Myalgia, Nasopharyngitis
Clinical narrative: having a cold; covid symptoms; Warm; headache; body ache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), MYALGIA (body ache), NASOPHARYNGITIS (having a cold), COVID-19 (covid symptoms) and FEELING HOT (Warm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     The patient's past medical history included Herniated disc. Concurrent medical conditions included Blood pressure and Acid dyspepsia.   On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 23-Mar-2021, the patient experienced HEADACHE (headache) and MYALGIA (body ache). On 24-Mar-2021, the patient experienced NASOPHARYNGITIS (having a cold) and COVID-19 (covid symptoms). On an unknown date, the patient experienced FEELING HOT (Warm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HEADACHE (headache), MYALGIA (body ache), NASOPHARYNGITIS (having a cold), COVID-19 (covid symptoms) and FEELING HOT (Warm) outcome was unknown. Not Provided          No concomitant details were provided. The action taken with the drug was Not applicable.   Reporter did not allow further contact
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Pain
Clinical narrative: gas like cramps; aches; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (gas like cramps) and PAIN (aches) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No medical history was provided by the reported.  Concomitant products included AMLODIPINE for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCLE SPASMS (gas like cramps) and PAIN (aches). At the time of the report, MUSCLE SPASMS (gas like cramps) and PAIN (aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information were reported.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Injection site swelling, Injection site warmth, Vaccination site erythema, Vaccination site induration
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Painful Injection Site), VACCINATION SITE ERYTHEMA, VACCINATION SITE INDURATION, VACCINATION SITE PRURITUS, and VACCINATION SITE SWELLING in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included FLONASE ALLERGY for Allergy, BYSTOLIC for an unknown indication.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced VACCINATION SITE PAIN. On 23-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA, VACCINATION SITE INDURATION, and VACCINATION SITE SWELLING. On 31-Mar-2021, the patient experienced FEELING HOT, INJECTION SITE WARMTH, and INJECTION SITE SWELLING. On an unknown date, the patient experienced VACCINATION SITE PRURITUS, and VACCINATION SITE RASH. The patient was treated with CEPHALEXIN (oral) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN, VACCINATION SITE ERYTHEMA, VACCINATION SITE INDURATION, VACCINATION SITE PRURITUS, VACCINATION SITE SWELLING, VACCINATION SITE RASH, FEELING HOT, INJECTION SITE WARMTH, and INJECTION SITE SWELLING outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 24-Mar-2021: No specific follow-up information recorded.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Painful Injection Site), VACCINATION SITE ERYTHEMA, VACCINATION SITE INDURATION, VACCINATION SITE PRURITUS, and VACCINATION SITE SWELLING in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included FLONASE ALLERGY for Allergy, BYSTOLIC for an unknown indication.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced VACCINATION SITE PAIN. On 23-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA, VACCINATION SITE INDURATION, and VACCINATION SITE SWELLING. On 31-Mar-2021, the patient experienced FEELING HOT, INJECTION SITE WARMTH, and INJECTION SITE SWELLING. On an unknown date, the patient experienced VACCINATION SITE PRURITUS, and VACCINATION SITE RASH. The patient was treated with CEPHALEXIN (oral) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN, VACCINATION SITE ERYTHEMA, VACCINATION SITE INDURATION, VACCINATION SITE PRURITUS, VACCINATION SITE SWELLING, VACCINATION SITE RASH, FEELING HOT, INJECTION SITE WARMTH, and INJECTION SITE SWELLING outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 24-Mar-2021: No specific follow-up information recorded.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling abnormal, Pain, Pruritus, Vaccination site reaction
Clinical narrative: Felt bad for 6 days; Soreness; L arm egg raised ball; Itchy; Redness; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy), ERYTHEMA (Redness), VACCINATION SITE REACTION (L arm egg raised ball), FEELING ABNORMAL (Felt bad for 6 days) and PAIN (Soreness) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 007M00A) for COVID-19 vaccination.     Concurrent medical conditions included Depression, Blood pressure abnormal and Hypercholesterolaemia. Concomitant products included PROPRANOLOL from 26-Mar-2021 to an unknown date for Blood pressure management, AMITRIPTYLINE HYDROCHLORIDE (AMITRIPTYLINE [AMITRIPTYLINE HYDROCHLORIDE]) from 08-Mar-2020 to an unknown date for Depression, ATORVASTATIN from 04-Apr-2020 to an unknown date for Hyperlipidemia, ATENOLOL, CALCIUM, VITAMIN E NOS, VITAMIN D3, ASCORBIC ACID (VITAMIN C ASC ACID), CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]), ACETYLSALICYLIC ACID (ASPIRIN ANALGESIC), UBIDECARENONE (COQ10 [UBIDECARENONE]), VITAMIN B NOS (B-COMPLEX [VITAMIN B NOS]), GARLIC [ALLIUM SATIVUM] and AIRBORNE for an unknown indication.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Mar-2021, the patient experienced PRURITUS (Itchy) and ERYTHEMA (Redness). On 22-Mar-2021, the patient experienced VACCINATION SITE REACTION (L arm egg raised ball). On an unknown date, the patient experienced FEELING ABNORMAL (Felt bad for 6 days) and PAIN (Soreness). On 29-Mar-2021, VACCINATION SITE REACTION (L arm egg raised ball) had resolved. At the time of the report, PRURITUS (Itchy), ERYTHEMA (Redness) and PAIN (Soreness) had resolved and FEELING ABNORMAL (Felt bad for 6 days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Other Concomitant medication include Airborne. Treatment information included Ice packs.  Patient had big red itchy lump on left arm went to physician they said to keep an eye on it was about the size of 3 inches in diameter.   Upon internal review on 06 Jul 2021, medical history was updated.  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.  ?   This case was linked to MOD-2021-135872 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-May-2021: Additional information received and Patient demographics were updated and medical history includes Depression Blood Pressure, Cholesterol were added.Dose 2 details were added.Concomitant product information was updated.Event Left arm egg raised ball,felt bad for 6 days were added On 20-Jul-2021: Event Soreness was added
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Heart rate, Nervousness
Clinical narrative: Chest pain; Nervousness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NERVOUSNESS (Nervousness) and CHEST PAIN (Chest pain) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.  No Medical History information was reported.  On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced NERVOUSNESS (Nervousness) and CHEST PAIN (Chest pain). The patient was treated with CEFALEXIN MONOHYDRATE (KEFLEX [CEFALEXIN MONOHYDRATE]) at an unspecified dose and frequency. On 01-Mar-2021, NERVOUSNESS (Nervousness) and CHEST PAIN (Chest pain) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Feb-2021, Heart rate: increased (High) Heart Racing. On an unknown date, Heart rate: normal (normal) She saw the cardiologist and was told her heart is functioning normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Hyperhidrosis, Lethargy, Pain
Clinical narrative: Severe pain; Uncontrolled sweating; Lethargic; Joint pain; Injection site pain; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Severe pain), HYPERHIDROSIS (Uncontrolled sweating), LETHARGY (Lethargic), ARTHRALGIA (Joint pain) and VACCINATION SITE PAIN (Injection site pain) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced PAIN (Severe pain), HYPERHIDROSIS (Uncontrolled sweating), LETHARGY (Lethargic), ARTHRALGIA (Joint pain), VACCINATION SITE PAIN (Injection site pain), CHILLS (Chills) and PYREXIA (Fever). At the time of the report, PAIN (Severe pain), HYPERHIDROSIS (Uncontrolled sweating), LETHARGY (Lethargic), ARTHRALGIA (Joint pain), VACCINATION SITE PAIN (Injection site pain), CHILLS (Chills) and PYREXIA (Fever) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   Treatment information included paracetamol.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Severe pain; Uncontrolled sweating; Lethargic; Joint pain; Injection site pain; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Severe pain), HYPERHIDROSIS (Uncontrolled sweating), LETHARGY (Lethargic), ARTHRALGIA (Joint pain) and VACCINATION SITE PAIN (Injection site pain) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced PAIN (Severe pain), HYPERHIDROSIS (Uncontrolled sweating), LETHARGY (Lethargic), ARTHRALGIA (Joint pain), VACCINATION SITE PAIN (Injection site pain), CHILLS (Chills) and PYREXIA (Fever). At the time of the report, PAIN (Severe pain), HYPERHIDROSIS (Uncontrolled sweating), LETHARGY (Lethargic), ARTHRALGIA (Joint pain), VACCINATION SITE PAIN (Injection site pain), CHILLS (Chills) and PYREXIA (Fever) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   Treatment information included paracetamol.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Reddish Wheal at injection site; Itching at injection site; Tender at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Tender at injection site), VACCINATION SITE ERYTHEMA (Reddish Wheal at injection site) and VACCINATION SITE PRURITUS (Itching at injection site) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     Concomitant products included METFORMIN, LOSARTAN, HYDROCHLOROTHIAZIDE and ALLERGY MEDICATION for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 16-Mar-2021, the patient experienced VACCINATION SITE PAIN (Tender at injection site). On 18-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Reddish Wheal at injection site) and VACCINATION SITE PRURITUS (Itching at injection site). At the time of the report, VACCINATION SITE PAIN (Tender at injection site), VACCINATION SITE ERYTHEMA (Reddish Wheal at injection site) and VACCINATION SITE PRURITUS (Itching at injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Product dispensing error, Vaccination site discharge
Clinical narrative: The vaccination was was dripping down her arm; lure lock system wasn't completely closed; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE DISCHARGE (The vaccination was was dripping down her arm) and PRODUCT DISPENSING ERROR (lure lock system wasn't completely closed) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 040A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 24-Mar-2021, the patient experienced VACCINATION SITE DISCHARGE (The vaccination was was dripping down her arm) and PRODUCT DISPENSING ERROR (lure lock system wasn't completely closed). At the time of the report, VACCINATION SITE DISCHARGE (The vaccination was was dripping down her arm) and PRODUCT DISPENSING ERROR (lure lock system wasn't completely closed) outcome 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 medications were reported
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: Patient started feeling vertigo 5 days after receiving 2nd dose; Started feeling dizzy; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Patient started feeling vertigo 5 days after receiving 2nd dose) and DIZZINESS (Started feeling dizzy) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 16-Mar-2021, the patient experienced VERTIGO (Patient started feeling vertigo 5 days after receiving 2nd dose) and DIZZINESS (Started feeling dizzy). At the time of the report, VERTIGO (Patient started feeling vertigo 5 days after receiving 2nd dose) and DIZZINESS (Started feeling dizzy) had not resolved.            Reporter did not allow further contact.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Pregnancy test, Ultrasound foetal
Clinical narrative: Received vaccine while pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Received vaccine while pregnant) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21a) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (Not used during pregnancy or while breastfeeding  when not pregnant 4 drinks a week) from 01-Jan-2006 to 19-Aug-2020. Concurrent medical conditions included Anxiety since 06-Jul-2017, Asthma (Improved during pregnancy) and Penicillin allergy. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Allergy, BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) and SALBUTAMOL (VENTOLIN [SALBUTAMOL]) for Asthma, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy, ZINC for an unknown indication.    On 24-Mar-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 19-Aug-2020 and the estimated date of delivery was 26-May-2021. On 24-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Received vaccine while pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-first week of the pregnancy. The cesarean delivery occurred on 04-Jun-2021, which was reported as Full-term. For neonate 1, the birth weight was 4000 grams (8lbs 13oz) with an APGAR score of 9 and 9 at (1, 5 minutes). The outcome was reported as Term Birth NOS. Delivered in June 2021 but the due date was meant to be 26th of May 2021. It was a long labor (30 hours) that resulted in an emergency Caesarean due to babies position, size and stress to baby causing issues with his heart rate during the labor. Apgar score at 1 minute was 9 Apgar score at 5 minute was 9 Baby just hitting 3 weeks. At the time of the report, EXPOSURE DURING PREGNANCY (Received vaccine while pregnant) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Sep-2020, Pregnancy test: positive (Positive) Positive. On 04-Nov-2020, Ultrasound foetal: abnormal (abnormal) border line irregular. On 11-Nov-2020, Ultrasound foetal: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 08-Jan-2021 the patient had Ultrasound scan which was inconclusive (Inconclusive) Inconclusive. On 01-Apr-2021 the patient had Ultrasound scan which was  inconclusive (Inconclusive) Inconclusive. In April 2021 the patient had Blood glucose test which was inconclusive (Inconclusive) inconclusive.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: pregnancy outcome, weight of the newborn, lab data, concomitant medications were updated.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Influenza like illness, Nausea, Vomiting
Clinical narrative: felt like I had the flu; nauseous; threw up; chilled; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (felt like I had the flu), NAUSEA (nauseous), VOMITING (threw up) and CHILLS (chilled) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     Concurrent medical conditions included Breast cancer (Breast cancer 12 years ago.).    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (felt like I had the flu), NAUSEA (nauseous), VOMITING (threw up) and CHILLS (chilled). The patient was treated with PARACETAMOL (TYLENOL) on 06-Mar-2021 at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (felt like I had the flu), NAUSEA (nauseous), VOMITING (threw up) and CHILLS (chilled) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.