chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Exposure during pregnancy, Headache, Hyperhidrosis, Vaccination site pain
Clinical narrative: sweat; Pregnancy; Chills; Soreness at injection site; little bit of a headache; This spontaneous prospective pregnancy case was reported by a pharmacist and describes the occurrence of HYPERHIDROSIS (sweat), EXPOSURE DURING PREGNANCY (Pregnancy), CHILLS (Chills), VACCINATION SITE PAIN (Soreness at injection site) and HEADACHE (little bit of a headache) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concomitant products included BECLOMETASONE DIPROPIONATE (QNASL) for Nasal allergy, LEVOTHYROXINE SODIUM (SYNTHROID), ACETYLSALICYLIC ACID (ASPIRIN 81), COLECALCIFEROL (VITAMINS D3), SELENIUM, ZINC, LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL), MONTELUKAST, OLOPATADINE HYDROCHLORIDE (PATADAY) and MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 04-Jan-2021, the patient experienced HYPERHIDROSIS (sweat), EXPOSURE DURING PREGNANCY (Pregnancy), CHILLS (Chills), VACCINATION SITE PAIN (Soreness at injection site) and HEADACHE (little bit of a headache). On 04-Jan-2021, EXPOSURE DURING PREGNANCY (Pregnancy) had resolved. On 07-Jan-2021, HEADACHE (little bit of a headache) had resolved. At the time of the report, HYPERHIDROSIS (sweat), CHILLS (Chills) and VACCINATION SITE PAIN (Soreness at injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The pharmacist believed that the headache was in correlation with the soreness in the arm for which the patient  just iced her arm . The patient never had fever. The patient received 2nd dose of vaccine on 01-FEB-2021.   No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: Delayed due to systems/technical; Sender's Comments: This is a case of product exposure during pregnancy with associated AEs for this 39-year-old female. Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Pruritus, Rash, Swelling
Clinical narrative: pain; swelling; chills; rash; itchy; This spontaneous case was reported by a consumer and describes the occurrence of   in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant and treatment information not provided; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and got vaccinated) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.  No Medical History information was reported.   On 15-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 15-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and got vaccinated). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 15-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and got vaccinated) had resolved.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient stated that she did not want to register for the pregnancy form and that she didn't experience any side effects and was feeling fine.  No concomitant medication was provided by the reporter.  No treatment information was provided by the reporter.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 35-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in attention, Dizziness, Nausea
Clinical narrative: very dizzy; Nausea off and on; off balance focusing; This spontaneous case was reported by a nurse and describes the occurrence of DIZZINESS (very dizzy), NAUSEA (Nausea off and on) and DISTURBANCE IN ATTENTION (off balance focusing) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided).    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced DIZZINESS (very dizzy), NAUSEA (Nausea off and on) and DISTURBANCE IN ATTENTION (off balance focusing). On 30-Dec-2020, DIZZINESS (very dizzy) had resolved. At the time of the report, NAUSEA (Nausea off and on) and DISTURBANCE IN ATTENTION (off balance focusing) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no concomitant medication and treatment provided; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K2DA) for COVID-19 vaccination.     Concomitant products included LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) and MOMETASONE FUROATE (FLONASE [MOMETASONE FUROATE]) for Allergy, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 10-Jun-2021. On 06-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy). On 06-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment related information has been reported.; Sender's Comments: This is a case of vaccine exposure during pregnancy with no associated AEs for this 35 year old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Sciatica
Clinical narrative: Sciatica; This spontaneous case was reported by a consumer and describes the occurrence of SCIATICA (Sciatica) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced SCIATICA (Sciatica). At the time of the report, SCIATICA (Sciatica) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment medications included Prednisone.; 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: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Maternal exposure during pregnancy
Clinical narrative: Pregnant; Headache; Pain at the injectiion site; This spontaneous prospective pregnancy case was reported by a pharmacist and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant), HEADACHE (Headache) and INJECTION SITE PAIN (Pain at the injectiion site) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Pregnant. Concomitant products included LEVOTHYROXINE SODIUM (THYROXINE) for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 22-Jun-2021. On 13-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant), HEADACHE (Headache) and INJECTION SITE PAIN (Pain at the injectiion site). On 13-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved. At the time of the report, HEADACHE (Headache) and INJECTION SITE PAIN (Pain at the injectiion site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.; Sender's Comments: This case of a 28-year-old female who experienced Vaccine exposure during pregnancy.  Obstetric history, last menstrual period and estimated date of conception were unknown. Estimated due date was 22 JUN 2021. The patient experienced headache and injection site pain.  The events are temporarily associated with mRNA-1273 use, consistent with product profile and causal relationship cannot be excluded. Vaccine exposure during pregnancy is assessed as not applicable.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and CHILLS (Chills) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced PYREXIA (Fever) and CHILLS (Chills). At the time of the report, PYREXIA (Fever) and CHILLS (Chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported.  Treatment medication was not reported.    This case was linked to MOD-2021-004189 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Paraesthesia, Pharyngeal hypoaesthesia
Clinical narrative: tingling sensation; numbness in her tongue, mouth, and throat; numbness in her tongue, mouth, and throat; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling sensation), PHARYNGEAL HYPOAESTHESIA (numbness in her tongue, mouth, and throat) and HYPOAESTHESIA ORAL (numbness in her tongue, mouth, and 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 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 PARAESTHESIA (tingling sensation), PHARYNGEAL HYPOAESTHESIA (numbness in her tongue, mouth, and throat) and HYPOAESTHESIA ORAL (numbness in her tongue, mouth, and throat). At the time of the report, PARAESTHESIA (tingling sensation), PHARYNGEAL HYPOAESTHESIA (numbness in her tongue, mouth, and throat) and HYPOAESTHESIA ORAL (numbness in her tongue, mouth, and throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Influenza like illness, Malaise
Clinical narrative: Don't feel like myself; Dizziness; flu-like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), DIZZINESS (Dizziness) and MALAISE (Don't feel like myself) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L(Q/Z)0A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.). Concomitant products included VITAMINS NOS and OMEPRAZOLE for an unknown indication, CETIRIZINE HYDROCHLORIDE (ZYRTEC D).    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms). On 03-Jan-2021, the patient experienced DIZZINESS (Dizziness). On 11-Jan-2021, the patient experienced MALAISE (Don't feel like myself). On 31-Dec-2020, INFLUENZA LIKE ILLNESS (flu-like symptoms) had resolved. At the time of the report, DIZZINESS (Dizziness) and MALAISE (Don't feel like myself) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant and treatment information not provided; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness; Swollen injection site; Tenderness; A spontaneous report was received from a consumer who was a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed redness, swollen injection site and tenderness.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On 07 Jan 2021, approximately eight days prior to the onset of the events the patient received her first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.  On 15 Jan 2021, the patient experienced side effects which included redness, swollen injection site and tenderness. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, redness, swollen injection site and tenderness was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of   in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case concerns a female of unknown age with a nonserious expected event of lymphadenopathy.  Treatment not reported.  Event outcome unknown. Based on the current available information and temporal association between the use of the product and the start date of the lymphadenopathy, a causal relationship cannot be excluded.; Reporter's Comments: This case concerns a female of unknown age with a nonserious expected event of lymphadenopathy.  Treatment not reported.  Event outcome unknown. Based on the current available information and temporal association between the use of the product and the start date of the lymphadenopathy, a causal relationship cannot be excluded.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Glucose tolerance test, Maternal exposure during pregnancy, Ultrasound foetal
Clinical narrative: 35 weeks pregnant received vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (35 weeks pregnant received vaccine) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     The patient's past medical history included Fibromyalgia (stable.) on 01-Jan-2021. Concurrent medical conditions included Drug allergy (Allergies to Percodan,Percocet.), Morning sickness, Gestational diabetes, Hyperthyroidism and Shaking. Concomitant products included METFORMIN for Gestational diabetes, LEVOTHYROXINE for Hyperthyroidism, AMITRIPTYLINE HYDROCHLORIDE (AMITRIP) for Shaking.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 01-May-2020 and the estimated date of delivery was 18-Feb-2021. On 15-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (35 weeks pregnant received vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-seventh week of the pregnancy.  On 15-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (35 weeks pregnant received vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2020, Glucose tolerance test: abnormal gestational diabetes. In 2020, Ultrasound foetal: pregnant pregnancy confirmation.     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.   There was no treatment medication reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jan-2021: Upon internal review on 21-Jul-2021, patient, events, analysis and regulatory reports tabs were updated.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 42-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Pruritus, Vaccination site mass, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: developed itchiness and a big welp around the injection site; a "big knot" and it is hot and itchy; big welp around the injection site, describes it as "big knot"; Itching in different places of her body; a little bruise on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching in different places of her body), CONTUSION (a little bruise on the injection site), VACCINATION SITE PRURITUS (developed itchiness and a big welp around the injection site), VACCINATION SITE WARMTH (a "big knot" and it is hot and itchy) and VACCINATION SITE MASS (big welp around the injection site, describes it as "big knot") in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced PRURITUS (Itching in different places of her body) and CONTUSION (a little bruise on the injection site). On 14-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (developed itchiness and a big welp around the injection site), VACCINATION SITE WARMTH (a "big knot" and it is hot and itchy) and VACCINATION SITE MASS (big welp around the injection site, describes it as "big knot"). At the time of the report, PRURITUS (Itching in different places of her body) and CONTUSION (a little bruise on the injection site) had resolved and VACCINATION SITE PRURITUS (developed itchiness and a big welp around the injection site), VACCINATION SITE WARMTH (a "big knot" and it is hot and itchy) and VACCINATION SITE MASS (big welp around the injection site, describes it as "big knot") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 02-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). On 02-Jan-2021, EXPOSURE DURING PREGNANCY (Pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 34ear-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site lymphadenopathy
Clinical narrative: on the left side swollen supraclavicular lymph nodes; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE LYMPHADENOPATHY (on the left side swollen supraclavicular lymph nodes) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2020 at 6:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION SITE LYMPHADENOPATHY (on the left side swollen supraclavicular lymph nodes). At the time of the report, VACCINATION SITE LYMPHADENOPATHY (on the left side swollen supraclavicular lymph nodes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. Patient has not taken any treatment.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Glucose tolerance test normal, Maternal exposure during pregnancy, Pregnancy test, Prenatal screening test, Ultrasound abdomen
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 41-year-old female patient (gravida 5, para 3) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included High cholesterol since 2000, Infertility and Allergy (allergy to poultry). Concomitant products included PROGESTERONE for Infertility, METFORMIN for Polycystic ovarian syndrome, 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] and FAMOTIDINE (PEPCID AC) for Pregnancy, CALCIUM LEVOMEFOLATE (METHYL FOLATE) for Prenatal care, MARIJUANA for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 16-Jul-2020 and the estimated date of delivery was 18-Apr-2021. On 14-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-sixth week of the pregnancy.  On 14-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Aug-2020, Pregnancy test: (Positive) Positive. On an unknown date, Glucose tolerance test normal: normal (normal) normal. On an unknown date, Prenatal screening test: normal (normal) normal. On an unknown date, Ultrasound abdomen: (Inconclusive) no result.     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 treatment medication details was reported.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 41-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy. Patient was contacted for AE follow-up, which is still pending.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure via breast milk, Urticaria, Vaccination site rash
Clinical narrative: Breastfeeding; Big welt, rash; Big welt, rash; This spontaneous case was reported by a patient and describes the occurrence of EXPOSURE VIA BREAST MILK (Breastfeeding), URTICARIA (Big welt, rash) and VACCINATION SITE RASH (Big welt, rash) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J02A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy.    On 28-Dec-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced EXPOSURE VIA BREAST MILK (Breastfeeding), URTICARIA (Big welt, rash) and VACCINATION SITE RASH (Big welt, rash). At the time of the report, EXPOSURE VIA BREAST MILK (Breastfeeding), URTICARIA (Big welt, rash) and VACCINATION SITE RASH (Big welt, rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-043890 (Parent-Child Link).   See case MOD-2021-043890 for details regarding the child case.; Sender's Comments: This is a case of product exposure during breastfeeding with associated AEs of urticaria and rash. Patient will continue to be contacted for further monitoring of AEs.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    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 RASH (Rash). At the time of the report, RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Malaise, Nausea, Pruritus, Vertigo
Clinical narrative: Dizzy; Vertigo; Feeling sick; Nausea; her arms were super itchy; A spontaneous report was received from a 46-year-old female consumer who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced feeling sick, nausea, vertigo, itchy arms, and dizziness.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On 31-Dec-2020, approximately 8 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot 026L20A) intramuscularly in the arm for prophylaxis of COVID-19 infection.   The patient took the first dose of Moderna COVID-19 vaccine on 31-Dec -020 and on 8-Jan-2021 she started feeling sick. She became nauseous and had vertigo. She reported that her arms were super itchy, and she felt dizzy. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, experienced feeling sick, nausea, vertigo, itchy arms, and dizziness were considered unknown.; Sender's Comments: This case concerns a 46-year-old female who experienced non-serious events of unexpected malaise, dizziness, vertigo and expected nausea, pruritus.  Event onset occurred 8 days after the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on 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: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Seasonal allergy, Skin warm, Swelling
Clinical narrative: Shoulder suddenly swollen, hot and red; Shoulder suddenly swollen, hot and red; Shoulder suddenly swollen, hot and red; Increasingly worse seasonal allergies; This spontaneous case was reported by a consumer and describes the occurrence of SEASONAL ALLERGY (Increasingly worse seasonal allergies), SWELLING (Shoulder suddenly swollen, hot and red), ERYTHEMA (Shoulder suddenly swollen, hot and red) and SKIN WARM (Shoulder suddenly swollen, hot and red) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2021, the patient experienced SEASONAL ALLERGY (Increasingly worse seasonal allergies). On 10-Jan-2021, the patient experienced SWELLING (Shoulder suddenly swollen, hot and red), ERYTHEMA (Shoulder suddenly swollen, hot and red) and SKIN WARM (Shoulder suddenly swollen, hot and red). At the time of the report, SEASONAL ALLERGY (Increasingly worse seasonal allergies), SWELLING (Shoulder suddenly swollen, hot and red), ERYTHEMA (Shoulder suddenly swollen, hot and red) and SKIN WARM (Shoulder suddenly swollen, hot and red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and treatment information not provided; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Warmth at injection site; Swelling at injection site; Pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warmth at injection site), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE PAIN (Pain at injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse effect (No Medical History Provided).    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Warmth at injection site), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE PAIN (Pain at injection site). At the time of the report, VACCINATION SITE WARMTH (Warmth at injection site), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE PAIN (Pain at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.  Concomitant medication was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pain in extremity, Pregnancy
Clinical narrative: Pregnant; Pain in the injection site; sore arm; This spontaneous pregnancy case was reported by an other health care professional and describes the occurrence of PREGNANCY (Pregnant), INJECTION SITE PAIN (Pain in the injection site) and PAIN IN EXTREMITY (sore arm) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 01-Jul-2021. On 14-Jan-2021, the patient experienced INJECTION SITE PAIN (Pain in the injection site) and PAIN IN EXTREMITY (sore arm). On an unknown date, the patient experienced PREGNANCY (Pregnant). At the time of the report, PREGNANCY (Pregnant) had resolved and INJECTION SITE PAIN (Pain in the injection site) and PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment details were not provided; Sender's Comments: This is a case of product exposure during pregnancy in this 34-year-old female patient who also experienced Injection site pain and Pain in extremity. Based on the current available information and temporal association between the use of the product and the start date of the other events, a causal relationship cannot be excluded. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Rash
Clinical narrative: Pain in the arm; Rash in the arm; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Pain in the arm) and RASH (Rash in the arm) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    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 IN EXTREMITY (Pain in the arm) and RASH (Rash in the arm). At the time of the report, PAIN IN EXTREMITY (Pain in the arm) and RASH (Rash in the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant and treatment information not provided; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cough, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Body aches; Cough; Fever; Sore throat; Weakness; This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (Fever), OROPHARYNGEAL PAIN (Sore throat), COUGH (Cough), PAIN (Body aches) and ASTHENIA (Weakness) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  The patient's past medical history included No adverse event (No medical history reported). Concomitant products included MORPHINE for an unknown indication.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced PYREXIA (Fever), OROPHARYNGEAL PAIN (Sore throat), COUGH (Cough), PAIN (Body aches) and ASTHENIA (Weakness). At the time of the report, PYREXIA (Fever), OROPHARYNGEAL PAIN (Sore throat), COUGH (Cough), PAIN (Body aches) and ASTHENIA (Weakness) 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 medications were reported.  No treatment information was provided.  Company Comment: This case concerns a 74-year-old female who had NS events of unexpected oropharyngeal pain, cough, pain, asthenia and expected pyrexia. Event onset Day 10 after first dose mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.  Reporter's Comments: .  Sender's Comments: This case concerns a 74-year-old female who had NS events of unexpected oropharyngeal pain, cough, pain, asthenia and expected pyrexia. Event onset Day 10 after first dose mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: 101 fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (101 fever) 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 12-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced PYREXIA (101 fever). At the time of the report, PYREXIA (101 fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jan-2021, Body temperature: 101 (High) fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pain
Clinical narrative: Vaccine exposure during pregnancy; Soreness; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) and PAIN (Soreness) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20a) for COVID-19 vaccination.     No Medical History was provided by the reporter.     On 11-Jan-2021 at 2:50 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 17-Mar-2021. On 11-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) and PAIN (Soreness). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 11-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. At the time of the report, PAIN (Soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were  reported. No treatment information was provided.  Company comment:This is a case of product exposure during pregnancy with the associated event of Pain for this female patient. Based on the current available information and temporal association between the use of the product and the start date of the event (Pain), a causal relationship cannot be excluded. The patient will continue to be contacted for further monitoring of AEs during the pregnancy.; Sender's Comments: This is a case of product exposure during pregnancy with the associated event of Pain for this female patient. Based on the current available information and temporal association between the use of the product and the start date of the event (Pain), a causal relationship cannot be excluded. The patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site rash, Peripheral swelling
Clinical narrative: arm is red around vaccine area; hard and tight around vaccine area; blotch around vaccine area; swelling goes up to bra strap and down to wrist; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling goes up to bra strap and down to wrist), INJECTION SITE INDURATION (hard and tight around vaccine area), INJECTION SITE ERYTHEMA (arm is red around vaccine area) and INJECTION SITE RASH (blotch around vaccine area) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025-J20A) for COVID-19 vaccination.  The patient's past medical history included No adverse event (No reported medical history).    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (swelling goes up to bra strap and down to wrist), INJECTION SITE INDURATION (hard and tight around vaccine area), INJECTION SITE ERYTHEMA (arm is red around vaccine area) and INJECTION SITE RASH (blotch around vaccine area). At the time of the report, PERIPHERAL SWELLING (swelling goes up to bra strap and down to wrist), INJECTION SITE INDURATION (hard and tight around vaccine area), INJECTION SITE ERYTHEMA (arm is red around vaccine area) and INJECTION SITE RASH (blotch around vaccine area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the established safety profile of mRNA-1273 vaccine, a causal association between the reported events and the product use cannot be excluded.  Injection site erythema, Injection site rash, and injection site induration are consistent with the known safety profile of the vaccine; Reporter's Comments: Based on the established safety profile of mRNA-1273 vaccine, a causal association between the reported events and the product use cannot be excluded.  Injection site erythema, Injection site rash, and injection site induration are consistent with the known safety profile of the vaccine