chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vulvovaginal pruritus
Clinical narrative: Itchiness in the injection arm; Had itchy in her vaginal area; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (Itchiness in the injection arm) and VULVOVAGINAL PRURITUS (Had itchy in her vaginal area) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 006M20A) for COVID-19 vaccination.     Concurrent medical conditions included Lymphoma.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-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 PRURITUS (Itchiness in the injection arm) and VULVOVAGINAL PRURITUS (Had itchy in her vaginal area). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) for Itching, at an unspecified dose and frequency and ALCOHOL for Itching, at an unspecified dose and frequency. At the time of the report, PRURITUS (Itchiness in the injection arm) and VULVOVAGINAL PRURITUS (Had itchy in her vaginal area) outcome was unknown. Not Provided          HCP recommended that she need a surgery because its look like a cancer and surgery was scheduled on 29 April 2021.  No concomitant medication was reported.  Action taken with mRNA-1273 in response to the event was not applicable.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Oral mucosal blistering, Vaccination site pain
Clinical narrative: Blister in mouth; Very light headache; Pain in injection arm; This spontaneous case was reported by a consumer and describes the occurrence of ORAL MUCOSAL BLISTERING (Blister in mouth), HEADACHE (Very light headache) and VACCINATION SITE PAIN (Pain in injection arm) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030821A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced HEADACHE (Very light headache) and VACCINATION SITE PAIN (Pain in injection arm). On 30-Mar-2021, the patient experienced ORAL MUCOSAL BLISTERING (Blister in mouth). On 27-Mar-2021, HEADACHE (Very light headache) and VACCINATION SITE PAIN (Pain in injection arm) had resolved. At the time of the report, ORAL MUCOSAL BLISTERING (Blister in mouth) 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.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Influenza like illness, Myalgia
Clinical narrative: flu-like symptoms; injection site soreness/sore left arm; fatigue; headache; muscle ache; fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), VACCINATION SITE PAIN (injection site soreness/sore left arm), FATIGUE (fatigue), HEADACHE (headache) and MYALGIA (muscle ache) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 648A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), VACCINATION SITE PAIN (injection site soreness/sore left arm), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle ache) and PYREXIA (fever). At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms), VACCINATION SITE PAIN (injection site soreness/sore left arm), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle ache) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2021, Body temperature: 101 (High) 101 F.         No relevant concomitant medications were reported. No treatment information was provided. The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: flu-like symptoms; injection site soreness/sore left arm; fatigue; headache; muscle ache; fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), VACCINATION SITE PAIN (injection site soreness/sore left arm), FATIGUE (fatigue), HEADACHE (headache) and MYALGIA (muscle ache) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 648A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), VACCINATION SITE PAIN (injection site soreness/sore left arm), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle ache) and PYREXIA (fever). At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms), VACCINATION SITE PAIN (injection site soreness/sore left arm), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle ache) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2021, Body temperature: 101 (High) 101 F.         No relevant concomitant medications were reported. No treatment information was provided. The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore Throat) 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 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (Sore Throat). At the time of the report, OROPHARYNGEAL PAIN (Sore Throat) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication was reported. Treatment medication was not provided by the reporter. The patient reported that she developed sore throat the day before the scheduled second dose on 2nd Apr 2021 and she wants to know if the appointment should be rescheduled. No fever reported. She mentioned that sore throat might be due to allergies.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm was sore for 2 days after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore for 2 days after the first dose) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore for 2 days after the first dose). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 24-Feb-2021, PAIN IN EXTREMITY (Arm was sore for 2 days after the first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       concomitant medications includes heart medications and diabetic medications   This case was linked to US-MODERNATX, INC.-MOD-2021-065257 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-065257:Cross-linked with second dose
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Arm  is sore at the site of injection; Fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm  is sore at the site of injection) and PYREXIA (Fever) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 02-Mar-2021, the patient experienced VACCINATION SITE PAIN (Arm  is sore at the site of injection) and PYREXIA (Fever). At the time of the report, VACCINATION SITE PAIN (Arm  is sore at the site of injection) and PYREXIA (Fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant details was provided.  No treatment details was provided.   This case was linked to MOD-2021-067172 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Cough, Hyperhidrosis, Influenza
Clinical narrative: Feels week all over; Coughing; Sweating at night; Though it was a flu bug; Trouble all night sleeping; Blotches in both arms; Joint pain; Feeling achy/Muscle aches; Nausea; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Feels week all over), COUGH (Coughing), HYPERHIDROSIS (Sweating at night), INFLUENZA (Though it was a flu bug) and INSOMNIA (Trouble all night sleeping) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced ASTHENIA (Feels week all over), COUGH (Coughing), HYPERHIDROSIS (Sweating at night), INFLUENZA (Though it was a flu bug), INSOMNIA (Trouble all night sleeping), PAPULE (Blotches in both arms), ARTHRALGIA (Joint pain), MYALGIA (Feeling achy/Muscle aches), NAUSEA (Nausea) and PYREXIA (Fever). At the time of the report, ASTHENIA (Feels week all over), COUGH (Coughing), HYPERHIDROSIS (Sweating at night), INFLUENZA (Though it was a flu bug), INSOMNIA (Trouble all night sleeping), PAPULE (Blotches in both arms), ARTHRALGIA (Joint pain), MYALGIA (Feeling achy/Muscle aches), NAUSEA (Nausea) and PYREXIA (Fever) outcome was unknown.            No concomitant medication was reported.  Treatment medication was not provided by the reporter.  Action taken with mRNA-1273 in response to the event was not applicable.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Myalgia, Nausea, Papule, Pyrexia
Clinical narrative: Feels week all over; Coughing; Sweating at night; Though it was a flu bug; Trouble all night sleeping; Blotches in both arms; Joint pain; Feeling achy/Muscle aches; Nausea; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Feels week all over), COUGH (Coughing), HYPERHIDROSIS (Sweating at night), INFLUENZA (Though it was a flu bug) and INSOMNIA (Trouble all night sleeping) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced ASTHENIA (Feels week all over), COUGH (Coughing), HYPERHIDROSIS (Sweating at night), INFLUENZA (Though it was a flu bug), INSOMNIA (Trouble all night sleeping), PAPULE (Blotches in both arms), ARTHRALGIA (Joint pain), MYALGIA (Feeling achy/Muscle aches), NAUSEA (Nausea) and PYREXIA (Fever). At the time of the report, ASTHENIA (Feels week all over), COUGH (Coughing), HYPERHIDROSIS (Sweating at night), INFLUENZA (Though it was a flu bug), INSOMNIA (Trouble all night sleeping), PAPULE (Blotches in both arms), ARTHRALGIA (Joint pain), MYALGIA (Feeling achy/Muscle aches), NAUSEA (Nausea) and PYREXIA (Fever) outcome was unknown.            No concomitant medication was reported.  Treatment medication was not provided by the reporter.  Action taken with mRNA-1273 in response to the event was not applicable.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Pain in extremity
Clinical narrative: sore arm; minimal discomfort; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and DISCOMFORT (minimal discomfort) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21A and 011A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and DISCOMFORT (minimal discomfort). At the time of the report, PAIN IN EXTREMITY (sore arm) and DISCOMFORT (minimal discomfort) outcome was unknown.            No relevant concomitant medications were reported. The patient did not take any treatment medication. Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-065300, MOD-2021-130965, MOD-2021-131034, MOD-2021-130965 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Follow up received on 14-May-2021 and contains no new information about this case. All information related to other linked cases.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pain in extremity, Pyrexia
Clinical narrative: Pain; Fever; Chills; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), PAIN IN EXTREMITY (sore arm), PYREXIA (Fever) and CHILLS (Chills) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    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 PAIN IN EXTREMITY (sore arm). On 24-Mar-2021, the patient experienced PAIN (Pain), PYREXIA (Fever) and CHILLS (Chills). On 26-Mar-2021, PAIN (Pain), PYREXIA (Fever) and CHILLS (Chills) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  Treatment medication was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Follow up received on 14-MAY-2021: contain no new information On 28-Jun-2021: Follow up received on 28-JUN-2021: contain no new information
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pruritus, Milia, Pruritus, Rash, Swelling
Clinical narrative: Bumps are itchy; Rash she had bumps came; Itchiness; Bumps are going around her eyes; Itchiness is affecting her left eye; Bumps on the skin primarily on her arms and back; Swelling and tenderness around injection site; Swelling and tenderness around injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchiness), PRURITUS (Bumps are itchy), MILIA (Bumps are going around her eyes), EYE PRURITUS (Itchiness is affecting her left eye) and SWELLING (Bumps on the skin primarily on her arms and back) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced PRURITUS (Itchiness), MILIA (Bumps are going around her eyes), EYE PRURITUS (Itchiness is affecting her left eye), SWELLING (Bumps on the skin primarily on her arms and back), VACCINATION SITE SWELLING (Swelling and tenderness around injection site) and VACCINATION SITE PAIN (Swelling and tenderness around injection site). On an unknown date, the patient experienced PRURITUS (Bumps are itchy) and RASH (Rash she had bumps came). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PRURITUS (Itchiness), PRURITUS (Bumps are itchy), MILIA (Bumps are going around her eyes), EYE PRURITUS (Itchiness is affecting her left eye), SWELLING (Bumps on the skin primarily on her arms and back), VACCINATION SITE SWELLING (Swelling and tenderness around injection site), VACCINATION SITE PAIN (Swelling and tenderness around injection site) and RASH (Rash she had bumps came) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment medication also included Eucerin Cream.   This case was linked to US-MODERNATX, INC.-MOD-2021-034286 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 01-May-2021: new AE added; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-034286:Dose 1
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Bumps are itchy; Rash she had bumps came; Itchiness; Bumps are going around her eyes; Itchiness is affecting her left eye; Bumps on the skin primarily on her arms and back; Swelling and tenderness around injection site; Swelling and tenderness around injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchiness), PRURITUS (Bumps are itchy), MILIA (Bumps are going around her eyes), EYE PRURITUS (Itchiness is affecting her left eye) and SWELLING (Bumps on the skin primarily on her arms and back) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced PRURITUS (Itchiness), MILIA (Bumps are going around her eyes), EYE PRURITUS (Itchiness is affecting her left eye), SWELLING (Bumps on the skin primarily on her arms and back), VACCINATION SITE SWELLING (Swelling and tenderness around injection site) and VACCINATION SITE PAIN (Swelling and tenderness around injection site). On an unknown date, the patient experienced PRURITUS (Bumps are itchy) and RASH (Rash she had bumps came). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PRURITUS (Itchiness), PRURITUS (Bumps are itchy), MILIA (Bumps are going around her eyes), EYE PRURITUS (Itchiness is affecting her left eye), SWELLING (Bumps on the skin primarily on her arms and back), VACCINATION SITE SWELLING (Swelling and tenderness around injection site), VACCINATION SITE PAIN (Swelling and tenderness around injection site) and RASH (Rash she had bumps came) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment medication also included Eucerin Cream.   This case was linked to US-MODERNATX, INC.-MOD-2021-034286 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 01-May-2021: new AE added; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-034286:Dose 1
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: Major migraine; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Major migraine) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-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 MIGRAINE (Major migraine). At the time of the report, MIGRAINE (Major migraine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The lot number was either 046A21A or 046A21D, the numbers was illegible.  Patient was taking other medication.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Malaise, Pyrexia
Clinical narrative: Bad reaction; Not feeling well; Got a fever that is consistently around 102; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Bad reaction), MALAISE (Not feeling well) and PYREXIA (Got a fever that is consistently around 102) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Bad reaction), MALAISE (Not feeling well) and PYREXIA (Got a fever that is consistently around 102). At the time of the report, FEELING ABNORMAL (Bad reaction), MALAISE (Not feeling well) and PYREXIA (Got a fever that is consistently around 102) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Treatment medication was not provided by the reporter.  Action taken with mRNA-1273 in response to the event was not applicable.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Maternal exposure during pregnancy, Pregnancy test, Ultrasound scan
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 33-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 040A21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Amoxicillin).   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 01-Jul-2020 and the estimated date of delivery was 17-Apr-2021. On 06-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-first week of the pregnancy.  On 06-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, Blood glucose: normal (normal) Normal. In March 2021, Ultrasound scan: normal (normal) normal. On 08-Oct-2021, Pregnancy test: positive (Positive) Positive.         Lab test : Ultrasound on 03/03/2021 was normal                 Glucose test was normal. Estimated date of conception was 25 Jul 2020. No relevant concomitant medications were reported. No treatment information was provided.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea
Clinical narrative: She had headache; chills; nausea; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (She had headache), CHILLS (chills) and NAUSEA (nausea) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced HEADACHE (She had headache), CHILLS (chills) and NAUSEA (nausea). On 24-Feb-2021, HEADACHE (She had headache), CHILLS (chills) and NAUSEA (nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment information included meclizine ( The patient did not specify for which dose event the patient had taken the drug).   This case was linked to MOD-2021-065280 (Patient Link).
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Back pain, Diarrhoea, Dizziness, Nausea
Clinical narrative: Diarrhea; Stomach pain; Back pain; Dizziness; Vertigo; Desquamation in the hands; Whole body itchiness; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomach pain), BACK PAIN (Back pain), DIZZINESS (Dizziness) and VERTIGO (Vertigo) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included METFORMIN for an unknown indication, HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN/HYDROCHLOORTHIAZIDE).    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomach pain), BACK PAIN (Back pain), DIZZINESS (Dizziness), VERTIGO (Vertigo), SKIN EXFOLIATION (Desquamation in the hands), PRURITUS (Whole body itchiness) and NAUSEA (Nausea). The patient was treated with NAPROXEN at an unspecified dose and frequency and LOPERAMIDE HYDROCHLORIDE (IMODIUM) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomach pain), BACK PAIN (Back pain), DIZZINESS (Dizziness), VERTIGO (Vertigo), SKIN EXFOLIATION (Desquamation in the hands), PRURITUS (Whole body itchiness) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Skin exfoliation, Vertigo
Clinical narrative: Diarrhea; Stomach pain; Back pain; Dizziness; Vertigo; Desquamation in the hands; Whole body itchiness; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomach pain), BACK PAIN (Back pain), DIZZINESS (Dizziness) and VERTIGO (Vertigo) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included METFORMIN for an unknown indication, HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN/HYDROCHLOORTHIAZIDE).    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomach pain), BACK PAIN (Back pain), DIZZINESS (Dizziness), VERTIGO (Vertigo), SKIN EXFOLIATION (Desquamation in the hands), PRURITUS (Whole body itchiness) and NAUSEA (Nausea). The patient was treated with NAPROXEN at an unspecified dose and frequency and LOPERAMIDE HYDROCHLORIDE (IMODIUM) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomach pain), BACK PAIN (Back pain), DIZZINESS (Dizziness), VERTIGO (Vertigo), SKIN EXFOLIATION (Desquamation in the hands), PRURITUS (Whole body itchiness) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Vomiting
Clinical narrative: Loss of balance; Vomiting; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), BALANCE DISORDER (Loss of balance) and VOMITING (Vomiting) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 010M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIZZINESS (Dizziness). On 31-Mar-2021, the patient experienced BALANCE DISORDER (Loss of balance) and VOMITING (Vomiting). The patient was treated with MECLOZINE HYDROCHLORIDE (BONINE) at an unspecified dose and frequency. On 29-Mar-2021, DIZZINESS (Dizziness) had resolved. At the time of the report, BALANCE DISORDER (Loss of balance) and VOMITING (Vomiting) outcome was unknown.            No relevant concomitant medications were reported.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore, the action taken with the drug in response to the events was not applicable.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Itchy; Rash; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy) and RASH (Rash) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Denosuaub v (got flu). Concurrent medical conditions included Seizure (under control for 30 years), Mitral valve disease, Osteoporosis and Raynaud's syndrome. Concomitant products included CARBAMAZEPINE (TEGRETOL), PHENOBARBITAL, CALCIUM, CENTRUM SILVER WOMEN 50+, VITAMIN D [VITAMIN D NOS] and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 30-Mar-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced RASH (Rash). On an unknown date, the patient experienced PRURITUS (Itchy). At the time of the report, PRURITUS (Itchy) and RASH (Rash) outcome was unknown.            The patient reported that she had the first vaccine and there was no adverse event, she was fine.  The patient reported that She is going to get tested for autoimmune disease, not sure if she has.  She got tested for Sjogren's syndrome, but she does not have it.  Treatment details was not reported.  Consent for safety follow up given
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Asthenia, Depression, Headache
Clinical narrative: Anxiety levels high; A little depression; Weakness; Headache; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (Anxiety levels high), DEPRESSION (A little depression), ASTHENIA (Weakness) and HEADACHE (Headache) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included CARBAMAZEPINE (TEGRETOL), RISPERIDONE and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.   On 28-Mar-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, the patient experienced ASTHENIA (Weakness) and HEADACHE (Headache). On 30-Mar-2021, the patient experienced ANXIETY (Anxiety levels high) and DEPRESSION (A little depression). At the time of the report, ANXIETY (Anxiety levels high), DEPRESSION (A little depression), ASTHENIA (Weakness) and HEADACHE (Headache) outcome was unknown.            Treatment medication was not provided by the reporter.  Action taken with mRNA-1273 in response to the event was not applicable.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Body temperature, Decreased appetite, Iron deficiency
Clinical narrative: taste was off. Lemonade smelled like gas, and tasted like it sat for a month. Blueberries tasted like mold; Feet and toes turned black and blue; Lemonade smelled like gas; Didn't feel like eating; Didn't feel well; Tingling from left knee down leg; Acute iron deficiency; fever of 104 F but then temperature back down to 99 F; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (taste was off. Lemonade smelled like gas, and tasted like it sat for a month. Blueberries tasted like mold), SKIN DISCOLOURATION (Feet and toes turned black and blue), ANOSMIA (Lemonade smelled like gas), DECREASED APPETITE (Didn't feel like eating) and MALAISE (Didn't feel well) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 16B21A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart valve replacement NOS (mechanical heart valve).   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-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 AGEUSIA (taste was off. Lemonade smelled like gas, and tasted like it sat for a month. Blueberries tasted like mold), SKIN DISCOLOURATION (Feet and toes turned black and blue), ANOSMIA (Lemonade smelled like gas), DECREASED APPETITE (Didn't feel like eating), MALAISE (Didn't feel well), PARAESTHESIA (Tingling from left knee down leg), IRON DEFICIENCY (Acute iron deficiency) and PYREXIA (fever of 104 F but then temperature back down to 99 F). At the time of the report, AGEUSIA (taste was off. Lemonade smelled like gas, and tasted like it sat for a month. Blueberries tasted like mold), SKIN DISCOLOURATION (Feet and toes turned black and blue), ANOSMIA (Lemonade smelled like gas), DECREASED APPETITE (Didn't feel like eating), MALAISE (Didn't feel well), PARAESTHESIA (Tingling from left knee down leg) and IRON DEFICIENCY (Acute iron deficiency) outcome was unknown and PYREXIA (fever of 104 F but then temperature back down to 99 F) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 104 (High) 104 degree Fahrenheit and 99 (normal) 99 degree Fahrenheit.         The action taken for mRNA-1273  Moderna COVID -19 vaccine was not applicable. Patient stated that  concomitant medication  are taken( didn't not specify which).  No Treatment medication was provided.  Patient had gone to ER 30MAR2021.   This case was linked to US-MODERNATX, INC.-MOD-2021-065322 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: New event added acute iron deficiency having out come unknown.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-065322:1st dose case
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Paraesthesia, Pyrexia, Skin discolouration
Clinical narrative: taste was off. Lemonade smelled like gas, and tasted like it sat for a month. Blueberries tasted like mold; Feet and toes turned black and blue; Lemonade smelled like gas; Didn't feel like eating; Didn't feel well; Tingling from left knee down leg; Acute iron deficiency; fever of 104 F but then temperature back down to 99 F; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (taste was off. Lemonade smelled like gas, and tasted like it sat for a month. Blueberries tasted like mold), SKIN DISCOLOURATION (Feet and toes turned black and blue), ANOSMIA (Lemonade smelled like gas), DECREASED APPETITE (Didn't feel like eating) and MALAISE (Didn't feel well) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 16B21A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart valve replacement NOS (mechanical heart valve).   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-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 AGEUSIA (taste was off. Lemonade smelled like gas, and tasted like it sat for a month. Blueberries tasted like mold), SKIN DISCOLOURATION (Feet and toes turned black and blue), ANOSMIA (Lemonade smelled like gas), DECREASED APPETITE (Didn't feel like eating), MALAISE (Didn't feel well), PARAESTHESIA (Tingling from left knee down leg), IRON DEFICIENCY (Acute iron deficiency) and PYREXIA (fever of 104 F but then temperature back down to 99 F). At the time of the report, AGEUSIA (taste was off. Lemonade smelled like gas, and tasted like it sat for a month. Blueberries tasted like mold), SKIN DISCOLOURATION (Feet and toes turned black and blue), ANOSMIA (Lemonade smelled like gas), DECREASED APPETITE (Didn't feel like eating), MALAISE (Didn't feel well), PARAESTHESIA (Tingling from left knee down leg) and IRON DEFICIENCY (Acute iron deficiency) outcome was unknown and PYREXIA (fever of 104 F but then temperature back down to 99 F) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 104 (High) 104 degree Fahrenheit and 99 (normal) 99 degree Fahrenheit.         The action taken for mRNA-1273  Moderna COVID -19 vaccine was not applicable. Patient stated that  concomitant medication  are taken( didn't not specify which).  No Treatment medication was provided.  Patient had gone to ER 30MAR2021.   This case was linked to US-MODERNATX, INC.-MOD-2021-065322 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: New event added acute iron deficiency having out come unknown.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-065322:1st dose case
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Soreness) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 01021A 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) (unknown route) 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 an unknown date, the patient experienced PAIN (Soreness). At the time of the report, PAIN (Soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications include thyroid medication. Treatment information not provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Chills with severe shaking; Fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills with severe shaking) and PYREXIA (Fever) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ATORVASTATIN, CLOPIDOGREL, HYDROCHLOROTHIAZIDE, LISINOPRIL, Metoprolol Succinate ER and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 30-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced CHILLS (Chills with severe shaking) and PYREXIA (Fever). At the time of the report, CHILLS (Chills with severe shaking) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Mar-2021, Pyrexia: 100.1 fever of 100.1F.         The patient's medical history was not provided.  The patient did not receive any treatment. The patient received both scheduled doses of mRNA-1273 prior to the events, therefore, the action taken with the drug in response to the events was not applicable.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash pruritic
Clinical narrative: arm hurt; latex reaction: bloody itchy rash; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt) and RASH PRURITIC (latex reaction: bloody itchy rash) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     Concurrent medical conditions included Latex allergy.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm hurt) and RASH PRURITIC (latex reaction: bloody itchy rash). At the time of the report, PAIN IN EXTREMITY (arm hurt) and RASH PRURITIC (latex reaction: bloody itchy rash) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medications provided
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Red spot about 1 inch around injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination. No Medical History information was reported. On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red spot about 1 inch around injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Red spot about 1 inch around injection site) 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. No treatment information was provided. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Follow up received on 10-Jun-2021 and updated contact information like city, add phone number, email ID.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Pregnancy test
Clinical narrative: Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical conditions reported.). Concomitant products included Pre-natal vits for an unknown indication.    On 01-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 15-Nov-2020 and the estimated date of delivery was 15-Aug-2021. On 01-Apr-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  nineteenth week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Pregnancy test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were provided.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Pain
Clinical narrative: Pain moved from different locations sometimes on and off; Couldn't stand up or move; Back pain; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain), PAIN (Pain moved from different locations sometimes on and off) and FATIGUE (Couldn't stand up or move) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced BACK PAIN (Back pain) and FATIGUE (Couldn't stand up or move). On an unknown date, the patient experienced PAIN (Pain moved from different locations sometimes on and off). The patient was treated with NAPROXEN at an unspecified dose and frequency. At the time of the report, BACK PAIN (Back pain), PAIN (Pain moved from different locations sometimes on and off) and FATIGUE (Couldn't stand up or move) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.