chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Eye allergy, Lip swelling, Pruritus, Swelling face
Clinical narrative: Face swelling; Lips swelling; Eyes itchy and red like allergies; Neck itchy and red; Neck itchy and red; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Face swelling), LIP SWELLING (Lips swelling), EYE ALLERGY (Eyes itchy and red like allergies), ERYTHEMA (Neck itchy and red) and PRURITUS (Neck itchy and red) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced SWELLING FACE (Face swelling), LIP SWELLING (Lips swelling), EYE ALLERGY (Eyes itchy and red like allergies), ERYTHEMA (Neck itchy and red) and PRURITUS (Neck itchy and red). At the time of the report, SWELLING FACE (Face swelling), LIP SWELLING (Lips swelling), EYE ALLERGY (Eyes itchy and red like allergies), ERYTHEMA (Neck itchy and red) and PRURITUS (Neck itchy and red) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, General physical health deterioration
Clinical narrative: Dizzy; weak; body not responding correctly; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), ASTHENIA (weak) and GENERAL PHYSICAL HEALTH DETERIORATION (body not responding correctly) 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 09-Apr-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 DIZZINESS (Dizzy), ASTHENIA (weak) and GENERAL PHYSICAL HEALTH DETERIORATION (body not responding correctly). At the time of the report, DIZZINESS (Dizzy), ASTHENIA (weak) and GENERAL PHYSICAL HEALTH DETERIORATION (body not responding correctly) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided. No treatment information provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-077920 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-077920:Case for wife
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: redness; itchy; little bit of swelling; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness), PRURITUS (itchy) and SWELLING (little bit of swelling) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced ERYTHEMA (redness), PRURITUS (itchy) and SWELLING (little bit of swelling). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, ERYTHEMA (redness), PRURITUS (itchy) and SWELLING (little bit of swelling) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medications were provided
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Received Moderna vaccine under 18 yrs of age; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received Moderna vaccine under 18 yrs of age) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received Moderna vaccine under 18 yrs of age). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received Moderna vaccine under 18 yrs of age) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication were reported.  No treatment medication were reported.   This case was linked to MOD-2021-207585 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Significant Follow up appended
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling hot, Rash, Skin warm
Clinical narrative: patch is hot to touch; knees are feeling hot in waves; left arm red swollen patch on the arm; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of SKIN WARM (patch is hot to touch), FEELING HOT (knees are feeling hot in waves), RASH (left arm red swollen patch on the arm) and FATIGUE (fatigue) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SKIN WARM (patch is hot to touch), FEELING HOT (knees are feeling hot in waves), RASH (left arm red swollen patch on the arm) and FATIGUE (fatigue). At the time of the report, SKIN WARM (patch is hot to touch), FEELING HOT (knees are feeling hot in waves), RASH (left arm red swollen patch on the arm) and FATIGUE (fatigue) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications provided. No treatment information provided.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in jaw
Clinical narrative: Pain in jaw after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN JAW (Pain in jaw after 2nd dose) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016b21a and 001b21a) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-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 PAIN IN JAW (Pain in jaw after 2nd dose). At the time of the report, PAIN IN JAW (Pain in jaw after 2nd dose) outcome was unknown. Not Provided
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 10-Mar-2021, PAIN IN EXTREMITY (sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Within a few hours, entire arm, including hand, had swelling, arm was hurting a lot that day and; Within a few hours, entire arm, including hand, had swelling, arm was hurting a lot that day and; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Within a few hours, entire arm, including hand, had swelling, arm was hurting a lot that day and) and PERIPHERAL SWELLING (Within a few hours, entire arm, including hand, had swelling, arm was hurting a lot that day and) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 (Within a few hours, entire arm, including hand, had swelling, arm was hurting a lot that day and) and PERIPHERAL SWELLING (Within a few hours, entire arm, including hand, had swelling, arm was hurting a lot that day and). The patient was treated with PARACETAMOL (TYLENOL) for Pain in arm and Swelling of hands, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Within a few hours, entire arm, including hand, had swelling, arm was hurting a lot that day and) and PERIPHERAL SWELLING (Within a few hours, entire arm, including hand, had swelling, arm was hurting a lot that day and) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.    This case was linked to MOD-2021-078024, MOD-2021-078032 (Patient Link).
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Nervous system disorder
Clinical narrative: Aggravation of neurological issues; Aggravation of neurological issues; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NERVOUS SYSTEM DISORDER (Aggravation of neurological issues) and CONDITION AGGRAVATED (Aggravation of neurological issues) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Neurological symptom.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Mar-2021, the patient experienced NERVOUS SYSTEM DISORDER (Aggravation of neurological issues) and CONDITION AGGRAVATED (Aggravation of neurological issues). At the time of the report, NERVOUS SYSTEM DISORDER (Aggravation of neurological issues) and CONDITION AGGRAVATED (Aggravation of neurological issues) outcome was unknown. Not Provided          Concomitant product use was not provided.   The patient was advised by the physician to wait until 2 weeks in order to start the medication post second dose.  Treatment information included anti-epilepsy medication and carbamazepine.  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.  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. However, Very limited information regarding this event has  been provided at this time.  Further information has been requested; 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. However, Very limited information regarding this event has  been provided at this time.  Further information has been requested
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia
Clinical narrative: achiness; minor chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (minor chills) and MYALGIA (achiness) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     The patient's past medical history included Arthritis. Concomitant products included IBUPROFEN for Arthritis, SALBUTAMOL (ALBUTEROL HFA), FORMOTEROL FUMARATE, MOMETASONE FUROATE (DULERA), FOLIC ACID, TIOTROPIUM BROMIDE (SPIRIVA RESPIMAT), HYDROCHLOROTHIAZIDE, AMLODIPINE, VITAMIN D3, CALCIUM, MAGNESIUM OXIDE, ATORVASTATIN, ASCORBIC ACID (VITAMIN C ACID), ZINC and MULTIVITAMIN FOR WOMEN for an unknown indication.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced CHILLS (minor chills). On an unknown date, the patient experienced MYALGIA (achiness). At the time of the report, CHILLS (minor chills) and MYALGIA (achiness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       the Treatment information was not provided.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Nasal discharge discolouration
Clinical narrative: joint pain; runny nose with greenish thing coming out; This spontaneous case was reported by a consumer and describes the occurrence of NASAL DISCHARGE DISCOLOURATION (runny nose with greenish thing coming out) and ARTHRALGIA (joint pain) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006m20A and 031K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced NASAL DISCHARGE DISCOLOURATION (runny nose with greenish thing coming out). On 21-Mar-2021, the patient experienced ARTHRALGIA (joint pain). On 21-Mar-2021, NASAL DISCHARGE DISCOLOURATION (runny nose with greenish thing coming out) had resolved. On 22-Mar-2021, ARTHRALGIA (joint pain) had resolved.            No concomitant medications provided. No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Non significant follow up appended
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Headache, Oropharyngeal pain, Pyrexia, Rhinorrhoea
Clinical narrative: sore throat; runny nose; fever; slight headache; tested positive for Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), RHINORRHOEA (runny nose), SARS-COV-2 TEST POSITIVE (tested positive for Covid-19), PYREXIA (fever) and HEADACHE (slight headache) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for Covid-19). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (sore throat), RHINORRHOEA (runny nose), PYREXIA (fever) and HEADACHE (slight headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL PAIN (sore throat), RHINORRHOEA (runny nose), SARS-COV-2 TEST POSITIVE (tested positive for Covid-19), PYREXIA (fever) and HEADACHE (slight headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Apr-2021, COVID-19: positive (Positive) The patient tested covid-19 positive..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication include, Descovy for PrEP.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: sore throat; runny nose; fever; slight headache; tested positive for Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), RHINORRHOEA (runny nose), SARS-COV-2 TEST POSITIVE (tested positive for Covid-19), PYREXIA (fever) and HEADACHE (slight headache) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for Covid-19). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (sore throat), RHINORRHOEA (runny nose), PYREXIA (fever) and HEADACHE (slight headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL PAIN (sore throat), RHINORRHOEA (runny nose), SARS-COV-2 TEST POSITIVE (tested positive for Covid-19), PYREXIA (fever) and HEADACHE (slight headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Apr-2021, COVID-19: positive (Positive) The patient tested covid-19 positive..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication include, Descovy for PrEP.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain in extremity, Vomiting
Clinical narrative: nausea; vomiting; headache; sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore left arm), NAUSEA (nausea), VOMITING (vomiting) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore left arm). On 16-Apr-2021, the patient experienced NAUSEA (nausea), VOMITING (vomiting) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) (oral) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore left arm), NAUSEA (nausea), VOMITING (vomiting) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test
Clinical narrative: Vaccinated while pregnant; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccinated while pregnant) in a 38-year-old female patient (gravida 2, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 047A21A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (alcohol consumption reported to be 2-3 times per week) from 08-Jan-2000 to 30-Aug-2020 and Delivery (Patient had to undergo Intrauterine insemination (IUI) for first pregnancy.Pregnancy outcome: Live, full-term birth) on 06-May-2018. Concurrent medical conditions included Allergy to antibiotic (Allergic to levaquin), Fruit allergy (mango), Fruit allergy (papaya), Fruit allergy (guava) and Fruit allergy (passion fruit). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from an unknown date to 02-May-2021 for Pregnancy.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 09-Aug-2020 and the estimated date of delivery was 03-May-2021. On 16-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccinated while pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-first week of the pregnancy. The vaginal delivery occurred on 01-May-2021, which was reported as Full-term. For neonate 1, the birth weight was 2721 grams (6lbs). The outcome was reported as Delivered NOS. Pregnancy outcome: Live, full-term birth. Patient delivered a baby boy at 40 weeks gestation period weighing 6 lbs and 19.5 inches in length. It was reported that no perinatal complications were observed for the infant, and that no fetal/infant abnormalities were identified on delivery and at 1-month post partum. On 16-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccinated while pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Aug-2020, Pregnancy test: positive Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On 15-APR-2021, the patient reported that she did not experience any side effects following both the vaccine doses while being pregnant, and that no treatment was required. On 21-JUN-2021, upon post-partum follow-up, it was reported that the patient did start to consume alcohol once a week as of 01-JUN-2021, and was reported to be breastfeeding.       Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Significant follow-up received :- updated pregnancy outcome details
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Oral pain, Scalloped tongue, Swollen tongue
Clinical narrative: Tongue has been swollen; Scalloped in appearance; No taste; Mouth sores; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SWOLLEN TONGUE (Tongue has been swollen), SCALLOPED TONGUE (Scalloped in appearance), AGEUSIA (No taste) and ORAL PAIN (Mouth sores) 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 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced SWOLLEN TONGUE (Tongue has been swollen), SCALLOPED TONGUE (Scalloped in appearance), AGEUSIA (No taste) and ORAL PAIN (Mouth sores). The patient was treated with GABAPENTIN at an unspecified dose and frequency; NYSTATIN at an unspecified dose and frequency; PREDNISONE at an unspecified dose and frequency and LIDOCAINE at an unspecified dose and frequency. At the time of the report, SWOLLEN TONGUE (Tongue has been swollen), SCALLOPED TONGUE (Scalloped in appearance), AGEUSIA (No taste) and ORAL PAIN (Mouth sores) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Treatment medications included magic mouth wash, yogurt.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial flutter, Injection site erythema, Injection site rash, Injection site swelling, Rash
Clinical narrative: a-flutter; Itchy rash on the injection site; Rash on the lower part of upper body; rash under left nipple area; rash around shoulders; Rash around the neck; injection site swelling; redness; Itchy rash on the injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ATRIAL FLUTTER (a-flutter), RASH PRURITIC (Itchy rash on the injection site), RASH (Rash on the lower part of upper body), RASH (rash under left nipple area) and RASH (rash around shoulders) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A214) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included HYDROCHLOROTHIAZIDE, POTASSIUM CHLORIDE, LISINOPRIL, OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC), UBIDECARENONE (COQ), Stool softner, GUAIFENESIN and RIVAROXABAN (XARELTO) for an unknown indication.    On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ATRIAL FLUTTER (a-flutter), RASH PRURITIC (Itchy rash on the injection site), RASH (Rash on the lower part of upper body), RASH (rash under left nipple area), RASH (rash around shoulders), RASH (Rash around the neck), INJECTION SITE SWELLING (injection site swelling), INJECTION SITE ERYTHEMA (redness) and INJECTION SITE RASH (Itchy rash on the injection site). At the time of the report, ATRIAL FLUTTER (a-flutter), RASH PRURITIC (Itchy rash on the injection site), RASH (Rash on the lower part of upper body), RASH (rash under left nipple area), RASH (rash around shoulders), RASH (Rash around the neck), INJECTION SITE SWELLING (injection site swelling), INJECTION SITE ERYTHEMA (redness) and INJECTION SITE RASH (Itchy rash on the injection site) outcome was unknown.            The patient applied topical medication, Betamethasone to relive the symptoms. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: ADR-events updated
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: a-flutter; Itchy rash on the injection site; Rash on the lower part of upper body; rash under left nipple area; rash around shoulders; Rash around the neck; injection site swelling; redness; Itchy rash on the injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ATRIAL FLUTTER (a-flutter), RASH PRURITIC (Itchy rash on the injection site), RASH (Rash on the lower part of upper body), RASH (rash under left nipple area) and RASH (rash around shoulders) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A214) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included HYDROCHLOROTHIAZIDE, POTASSIUM CHLORIDE, LISINOPRIL, OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC), UBIDECARENONE (COQ), Stool softner, GUAIFENESIN and RIVAROXABAN (XARELTO) for an unknown indication.    On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ATRIAL FLUTTER (a-flutter), RASH PRURITIC (Itchy rash on the injection site), RASH (Rash on the lower part of upper body), RASH (rash under left nipple area), RASH (rash around shoulders), RASH (Rash around the neck), INJECTION SITE SWELLING (injection site swelling), INJECTION SITE ERYTHEMA (redness) and INJECTION SITE RASH (Itchy rash on the injection site). At the time of the report, ATRIAL FLUTTER (a-flutter), RASH PRURITIC (Itchy rash on the injection site), RASH (Rash on the lower part of upper body), RASH (rash under left nipple area), RASH (rash around shoulders), RASH (Rash around the neck), INJECTION SITE SWELLING (injection site swelling), INJECTION SITE ERYTHEMA (redness) and INJECTION SITE RASH (Itchy rash on the injection site) outcome was unknown.            The patient applied topical medication, Betamethasone to relive the symptoms. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: ADR-events updated
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: took the two doses of the Moderna vaccine 9 days apart; This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (took the two doses of the Moderna vaccine 9 days apart) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (took the two doses of the Moderna vaccine 9 days apart). On 10-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (took the two doses of the Moderna vaccine 9 days apart) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable. Concomitant medications was not provided by the reporter. Treatment information was not provided.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0011321A) for COVID-19 vaccination.     Concurrent medical conditions included Lung cancer. Concomitant products included LOSARTAN and ATORVASTATIN for an unknown indication.   On 15-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. On 29-Mar-2021, the patient experienced HEADACHE (headache). The patient was treated with NAPROXEN for Headache, at an unspecified dose and frequency. At the time of the report, HEADACHE (headache) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the events was not applicable.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Hypertension, Illness, Paraesthesia, Tremor
Clinical narrative: very ill; tingles; very high blood pressure; Shaking; shivering; chills; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (very ill), PARAESTHESIA (tingles), HYPERTENSION (very high blood pressure), TREMOR (Shaking) and CHILLS (shivering) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Mar-2021, the patient experienced ILLNESS (very ill), PARAESTHESIA (tingles), HYPERTENSION (very high blood pressure), TREMOR (Shaking), CHILLS (shivering) and CHILLS (chills). At the time of the report, ILLNESS (very ill), PARAESTHESIA (tingles), HYPERTENSION (very high blood pressure), TREMOR (Shaking), CHILLS (shivering) and CHILLS (chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications. Treatment information includes Metoprolol 50mg. Patient did not remember all the medications  given to him.   This case was linked to MOD21-076620 (E2B Linked Report).; Sender's Comments:  MOD21-076620:MOD-2021-078045 -2nd dose of vaccine
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong technique in device usage process
Clinical narrative: pharmacist used a smaller needle for the second; This spontaneous case was reported by a consumer and describes the occurrence of WRONG TECHNIQUE IN DEVICE USAGE PROCESS (pharmacist used a smaller needle for the second) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0381C20A and 015N20A) 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) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG TECHNIQUE IN DEVICE USAGE PROCESS (pharmacist used a smaller needle for the second). On 29-Mar-2021, WRONG TECHNIQUE IN DEVICE USAGE PROCESS (pharmacist used a smaller needle for the second) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications provided. Treatment information was not provided.  The action taken with mRNA-1273 in response to the event was not applicable.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Hyperhidrosis, Illness, Myalgia
Clinical narrative: hard time breathing; sick; dizzy; sweating profusely; sore all over; throwing up for a week,; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (hard time breathing), ILLNESS (sick), DIZZINESS (dizzy), HYPERHIDROSIS (sweating profusely) and MYALGIA (sore all over) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0281921A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD and Fibromyalgia.    On 25-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 DYSPNOEA (hard time breathing), ILLNESS (sick), DIZZINESS (dizzy), HYPERHIDROSIS (sweating profusely), MYALGIA (sore all over) and VOMITING (throwing up for a week,). At the time of the report, DYSPNOEA (hard time breathing), ILLNESS (sick), DIZZINESS (dizzy), HYPERHIDROSIS (sweating profusely), MYALGIA (sore all over) and VOMITING (throwing up for a week,) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Follow up received contains no new information.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: hard time breathing; sick; dizzy; sweating profusely; sore all over; throwing up for a week,; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (hard time breathing), ILLNESS (sick), DIZZINESS (dizzy), HYPERHIDROSIS (sweating profusely) and MYALGIA (sore all over) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0281921A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD and Fibromyalgia.    On 25-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 DYSPNOEA (hard time breathing), ILLNESS (sick), DIZZINESS (dizzy), HYPERHIDROSIS (sweating profusely), MYALGIA (sore all over) and VOMITING (throwing up for a week,). At the time of the report, DYSPNOEA (hard time breathing), ILLNESS (sick), DIZZINESS (dizzy), HYPERHIDROSIS (sweating profusely), MYALGIA (sore all over) and VOMITING (throwing up for a week,) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Follow up received contains no new information.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Pyrexia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of diarrhea, pyrexia (high temp) and fatigue in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Apr 13, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced diarrhea, pyrexia (high temp) and fatigue. At the time of the report, diarrhea, pyrexia (high temp) and fatigue outcome: unknown. No concomitant medication or treatment information reported.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Shoulder pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Shoulder pain) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced ARTHRALGIA (Shoulder pain). The patient was treated with PARACETAMOL (TYLENOL) for Shoulder pain, at a dose of 1 dosage form. At the time of the report, ARTHRALGIA (Shoulder pain) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided.   This case was linked to INC.-MOD-2021-081263, INC.-MOD-2021-082203 (E2B Linked Report).
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Myalgia, Pain in extremity
Clinical narrative: Sore arm; Patient received his first shot on 2Jan2021 and he received another shot on 13Apr2021; Aching body; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received his first shot on 2Jan2021 and he received another shot on 13Apr2021) and MYALGIA (Aching body) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 048A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-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 PAIN IN EXTREMITY (Sore arm), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received his first shot on 2Jan2021 and he received another shot on 13Apr2021) and MYALGIA (Aching body). At the time of the report, PAIN IN EXTREMITY (Sore arm) and MYALGIA (Aching body) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received his first shot on 2Jan2021 and he received another shot on 13Apr2021) had resolved. Not Provided          No relevant concomitant product use was reported.  No treatment details were provided.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: pain on her left ankle; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (pain on her left ankle) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     Concomitant products included AMLODIPINE, CHLORTHALIDONE and SIMVASTATINE for an unknown indication.    On 15-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 ARTHRALGIA (pain on her left ankle). At the time of the report, ARTHRALGIA (pain on her left ankle) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       treatment to the events not provided   This case was linked to MOD-2021-078049 (Patient Link).
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Lacrimation increased, Pruritus, Rhinorrhoea, Urinary incontinence
Clinical narrative: I having Hives and a lot of itching all over my body. I checked my blood pressure during the event and it was elevated to 190/100. I have never had Hives or this intense itching (which last for several hours).  I'm losing my ability to hold my urine - I never had this issue before July 3, 2021). My eyes are watery and my nose always seem wet. -  I never had this issue before July 3, 2021).
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: I having Hives and a lot of itching all over my body. I checked my blood pressure during the event and it was elevated to 190/100. I have never had Hives or this intense itching (which last for several hours).  I'm losing my ability to hold my urine - I never had this issue before July 3, 2021). My eyes are watery and my nose always seem wet. -  I never had this issue before July 3, 2021).
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Malaise, Myalgia, Nausea, Pyrexia
Clinical narrative: headache, nausea/vomiting, low grade fevers, malaise, myalgias
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: headache, nausea/vomiting, low grade fevers, malaise, myalgias
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Feeling abnormal, Illness
Clinical narrative: In bed all day the day; "thought she was gonna die"; Felt so sick; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (In bed all day the day), FEELING ABNORMAL ("thought she was gonna die") and ILLNESS (Felt so sick) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced BEDRIDDEN (In bed all day the day), FEELING ABNORMAL ("thought she was gonna die") and ILLNESS (Felt so sick). At the time of the report, BEDRIDDEN (In bed all day the day), FEELING ABNORMAL ("thought she was gonna die") and ILLNESS (Felt so sick) outcome was unknown. Not Provided          No concomitant medications were reported.  No treatment information was provided.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: tiredness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tiredness) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 026A21A) for COVID-19 vaccination.     Concomitant products included VALSARTAN, SIMVASTATIN and VENLAFAXINE for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 02-Feb-2021, the patient experienced FATIGUE (tiredness). The patient was treated with NAPROXEN SODIUM (ALEVE) at a dose of UNK dosage form and IBUPROFEN at a dose of UNK dosage form. At the time of the report, FATIGUE (tiredness) had not resolved. Not Provided          This case was linked to US-MODERNATX, INC.-MOD-2021-078051 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-078051:
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Vaccination complication
Clinical narrative: Dizzy; Weak; body not responding correctly; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), ASTHENIA (Weak) and VACCINATION COMPLICATION (body not responding correctly) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizzy), ASTHENIA (Weak) and VACCINATION COMPLICATION (body not responding correctly). At the time of the report, DIZZINESS (Dizzy), ASTHENIA (Weak) and VACCINATION COMPLICATION (body not responding correctly) outcome was unknown. Not Provided      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 reported.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: Headache; Body aches; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), MYALGIA (Body aches) and PYREXIA (Fever) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced HEADACHE (Headache), MYALGIA (Body aches) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown and MYALGIA (Body aches) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  The patient's mother reported that he was told not to take Ibuprofen at the time of vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Maternal exposure during pregnancy, Pregnancy test, Vaccination site pain
Clinical narrative: mild diarrhoea; sore under injection site; pregnant during first dose; This spontaneous prospective pregnancy case was reported by a patient and describes the occurrence of DIARRHOEA (mild diarrhoea), VACCINATION SITE PAIN (sore under injection site) and MATERNAL EXPOSURE DURING PREGNANCY (pregnant during first dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B2A) for COVID-19 vaccination.     Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for Pregnancy, ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. The patient's last menstrual period was on 19-Aug-2020 and the estimated date of delivery was 26-May-2021. On 13-Apr-2021, the patient experienced DIARRHOEA (mild diarrhoea) and MATERNAL EXPOSURE DURING PREGNANCY (pregnant during first dose). 13-Apr-2021, the patient experienced VACCINATION SITE PAIN (sore under injection site). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fourth week of the pregnancy.  On 13-Apr-2021, MATERNAL EXPOSURE DURING PREGNANCY (pregnant during first dose) had resolved. At the time of the report, DIARRHOEA (mild diarrhoea) and VACCINATION SITE PAIN (sore under injection site) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Sep-2020, Pregnancy test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication not reported.  Estimated conception date was 02 Sep 2020.