chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: Patch at the injection site that looks like sunburn; Soreness in the arm; A spontaneous report was received from a (Consumer) concerning a  76 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events (PT term) list.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On  22/Jan/2021 date or an unknown date, The patient experienced the events list (verbatims) Per voicemail received: 76-year-old female Caller received the Moderna vaccine on 13Jan2021, all I had was a "little soreness in the arm. As of this morning, 22Jan2021, "I have a patch at the site of the injection." "About 2X4 inches," that "looks like a sunburn." Caller stated, It's not bothering me, I just wanted to report that "I'm having apparently a reaction to the vaccine." ****************************** Patient left another voicemail responding to the callback attempted. Upon callback, patient confirmed information provided in voicemail that was originally made. The reaction lasted about two days and it's back to looking normal. She took no medications in regards to her reaction and has no other questions at this time. Consent given to Safety for follow-up. 25JAN2021  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.
Sex: U
Vaccine: COVID19
Symptoms: Paranasal sinus discomfort, Vaccination site erythema
Clinical narrative: redness and swelling to the arm; redness and swelling to the arm; large sinus pressure; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of VACCINATION SITE ERYTHEMA (redness and swelling to the arm), the second episode of VACCINATION SITE ERYTHEMA (redness and swelling to the arm) and PARANASAL SINUS DISCOMFORT (large sinus pressure) 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 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 the first episode of VACCINATION SITE ERYTHEMA (redness and swelling to the arm), the second episode of VACCINATION SITE ERYTHEMA (redness and swelling to the arm) and PARANASAL SINUS DISCOMFORT (large sinus pressure). At the time of the report, last episode of VACCINATION SITE ERYTHEMA (redness and swelling to the arm) and PARANASAL SINUS DISCOMFORT (large sinus pressure) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) 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 the events, a causal relationship cannot be excluded.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure measurement, Dizziness, Hyperhidrosis, Hypoaesthesia
Clinical narrative: tachycardia; severe weakness; numbness; lightheadedness; sweaty; itchy around her neck; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of TACHYCARDIA (tachycardia), ASTHENIA (severe weakness), HYPOAESTHESIA (numbness), DIZZINESS (lightheadedness) and HYPERHIDROSIS (sweaty) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced TACHYCARDIA (tachycardia), ASTHENIA (severe weakness), HYPOAESTHESIA (numbness), DIZZINESS (lightheadedness), HYPERHIDROSIS (sweaty) and PRURITUS (itchy around her neck). On 14-Jan-2021, TACHYCARDIA (tachycardia), ASTHENIA (severe weakness) and DIZZINESS (lightheadedness) had resolved. At the time of the report, HYPOAESTHESIA (numbness), HYPERHIDROSIS (sweaty) and PRURITUS (itchy around her neck) 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 treatment information was provided.  No concomitant medication was provided.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Tachycardia
Clinical narrative: tachycardia; severe weakness; numbness; lightheadedness; sweaty; itchy around her neck; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of TACHYCARDIA (tachycardia), ASTHENIA (severe weakness), HYPOAESTHESIA (numbness), DIZZINESS (lightheadedness) and HYPERHIDROSIS (sweaty) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced TACHYCARDIA (tachycardia), ASTHENIA (severe weakness), HYPOAESTHESIA (numbness), DIZZINESS (lightheadedness), HYPERHIDROSIS (sweaty) and PRURITUS (itchy around her neck). On 14-Jan-2021, TACHYCARDIA (tachycardia), ASTHENIA (severe weakness) and DIZZINESS (lightheadedness) had resolved. At the time of the report, HYPOAESTHESIA (numbness), HYPERHIDROSIS (sweaty) and PRURITUS (itchy around her neck) 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 treatment information was provided.  No concomitant medication was provided.
Age: 84.0
Sex: M
Vaccine: UNK
Symptoms: Abdominal distension, Abdominal pain, Atrial fibrillation, Blood creatinine, Blood electrolytes
Clinical narrative: Astra Zenica second shot given. Sore arm  48 hrs only reaction to first shot. This time no sore arm, but severe muscular pain lower limbs, abdominal distension and pain, atrial fibrillation, severe SOBOE. Note. I am an Infectious Diseases Physician (retired). All the investigations were ordered by my GP.  We do not appear to have an adequate reporting system for adverse events.
Age: 84.0
Sex: M
Vaccine: UNK
Symptoms: Blood urea, Chest X-ray normal, Dyspnoea exertional, Electrocardiogram normal, Liver function test normal
Clinical narrative: Astra Zenica second shot given. Sore arm  48 hrs only reaction to first shot. This time no sore arm, but severe muscular pain lower limbs, abdominal distension and pain, atrial fibrillation, severe SOBOE. Note. I am an Infectious Diseases Physician (retired). All the investigations were ordered by my GP.  We do not appear to have an adequate reporting system for adverse events.
Age: 84.0
Sex: M
Vaccine: UNK
Symptoms: Myalgia
Clinical narrative: Astra Zenica second shot given. Sore arm  48 hrs only reaction to first shot. This time no sore arm, but severe muscular pain lower limbs, abdominal distension and pain, atrial fibrillation, severe SOBOE. Note. I am an Infectious Diseases Physician (retired). All the investigations were ordered by my GP.  We do not appear to have an adequate reporting system for adverse events.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Fatigue, Mobility decreased, Pain
Clinical narrative: Fatigue and arm pain the day of, tapering off in the days following (arm pain was bad enough that arm could barely be lifted without pain). Shortness of breath and chest tightness after about three days following vaccine.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Fatigue and arm pain the day of, tapering off in the days following (arm pain was bad enough that arm could barely be lifted without pain). Shortness of breath and chest tightness after about three days following vaccine.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site erythema, Vaccination site induration, Vaccination site pain
Clinical narrative: injection site hard; injection site a little red; injection site sore; headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (injection site hard), VACCINATION SITE ERYTHEMA (injection site a little red), VACCINATION SITE PAIN (injection site sore) and HEADACHE (headache) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol and Blood pressure (High blood pressure patient. On meds but unspecified.). Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) for an unknown indication.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced VACCINATION SITE INDURATION (injection site hard), VACCINATION SITE ERYTHEMA (injection site a little red), VACCINATION SITE PAIN (injection site sore) and HEADACHE (headache). At the time of the report, VACCINATION SITE INDURATION (injection site hard), VACCINATION SITE ERYTHEMA (injection site a little red), VACCINATION SITE PAIN (injection site sore) and HEADACHE (headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medicines also include water pill and medicines for cholesterol and high blood pressure.   No treatment medication information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: NNI
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Eye pain, Headache, Neck pain
Clinical narrative: pain went from her neck to eye; dizziness, needs to use the wall to walk down the hall; severe headaches; pain went from her neck to eye; A spontaneous report was received from a consumer concerning a 69 years old female  patient who received Moderna's Covid 19 vaccine and experienced severe headaches, pain from her neck to eye and dizziness.   The patient's medical history was not provided.No relevant concomitant medications were provided.   The patient received their first of two planned doses of mRNA-1273 (Batch number: 037K20A), intramuscularly,in her left arm on 9-Jan-2021. On 12-Jan-2021, the patient experienced severe headache. The patient also stated that pain went from her neck to eye.She also experienced dizziness and she needs to use the wall for aid as she walks down the hall.( Dizziness ensued once she lays down)  Lab data was not provided.   Treatment information included Ibuprofen.    Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the event was unknown.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Illness, Vaccination site pain
Clinical narrative: COVID-19 Diagnoses; Sickness; Soreness and pain in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness and pain in the injection site), ILLNESS (Sickness) and COVID-19 (COVID-19 Diagnoses) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L2OA) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE PAIN (Soreness and pain in the injection site). On 21-Jan-2021, the patient experienced ILLNESS (Sickness). On 22-Jan-2021, the patient experienced COVID-19 (COVID-19 Diagnoses). At the time of the report, VACCINATION SITE PAIN (Soreness and pain in the injection site), ILLNESS (Sickness) and COVID-19 (COVID-19 Diagnoses) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
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 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 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: On my right ankle about a 4" batch of red rash. Rash is smooth and not itching.; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (On my right ankle about a 4" batch of red rash. Rash is smooth and not itching.) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     Concomitant products included HYDROCODONE, FUROSEMIDE, ESCITALOPRAM, AMLODIPINE, LISINOPRIL, MIRABEGRON, OMEPRAZOLE, ERGOCALCIFEROL, EZETIMIBE and RIVAROXABAN for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced RASH ERYTHEMATOUS (On my right ankle about a 4" batch of red rash. Rash is smooth and not itching.). At the time of the report, RASH ERYTHEMATOUS (On my right ankle about a 4" batch of red rash. Rash is smooth and not itching.) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.    Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Event outcome updated as recovered.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event following immunisation
Clinical narrative: Something that could be considered a side effect; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of ADVERSE EVENT FOLLOWING IMMUNISATION (Something that could be considered a side effect) 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 ADVERSE EVENT FOLLOWING IMMUNISATION (Something that could be considered a side effect). At the time of the report, ADVERSE EVENT FOLLOWING IMMUNISATION (Something that could be considered a side effect) 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 treatment information was provided.  No concomitant medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Peripheral swelling
Clinical narrative: arm became swollen to the elbow; Hurts at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm became swollen to the elbow) and INJECTION SITE PAIN (Hurts at injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012620A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced PERIPHERAL SWELLING (arm became swollen to the elbow) and INJECTION SITE PAIN (Hurts at injection site). At the time of the report, PERIPHERAL SWELLING (arm became swollen to the elbow) and INJECTION SITE PAIN (Hurts at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: they can only feel where the injection was by slightly pressing on it; redness and itching at the site of the injection; redness and itching at the site of the injection; hat localize area is warm to the touch; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE INDURATION (they can only feel where the injection was by slightly pressing on it), VACCINATION SITE ERYTHEMA (redness and itching at the site of the injection), VACCINATION SITE PRURITUS (redness and itching at the site of the injection) and VACCINATION SITE WARMTH (hat localize area is warm to the touch) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness and itching at the site of the injection), VACCINATION SITE PRURITUS (redness and itching at the site of the injection) and VACCINATION SITE WARMTH (hat localize area is warm to the touch). On an unknown date, the patient experienced VACCINATION SITE INDURATION (they can only feel where the injection was by slightly pressing on it). At the time of the report, VACCINATION SITE INDURATION (they can only feel where the injection was by slightly pressing on it), VACCINATION SITE ERYTHEMA (redness and itching at the site of the injection), VACCINATION SITE PRURITUS (redness and itching at the site of the injection) and VACCINATION SITE WARMTH (hat localize area is warm to the touch) 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 treatment information was provided.  No concomitant medication was provided.
Sex: M
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: right face was swelling up; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (right face was swelling up) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     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 SWELLING FACE (right face was swelling up). At the time of the report, SWELLING FACE (right face was swelling up) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment information provided.   Reporter did not allow further contact
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Vaccination site pain
Clinical narrative: sore arm; pregnancy; This spontaneous prospective pregnancy case was reported by a physician and describes the occurrence of VACCINATION SITE PAIN (sore arm) and EXPOSURE DURING PREGNANCY (pregnancy) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 08-Feb-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 31-Mar-2021. On 08-Feb-2021, the patient experienced VACCINATION SITE PAIN (sore arm) and EXPOSURE DURING PREGNANCY (pregnancy). On 08-Feb-2021, EXPOSURE DURING PREGNANCY (pregnancy) had resolved. At the time of the report, VACCINATION SITE PAIN (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.   No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 10-Feb-2021: Internal review on 21-JUL-2021resulted in update of birth type and fetal outcome was updated.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Rash around the injection site and slightly above it; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash around the injection site and slightly above it) in a 73-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.  Concomitant products included ACICLOVIR SODIUM (ACYCLOVIR ABBOTT VIAL) and HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN HCTZ) for an unknown indication.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced VACCINATION SITE RASH (Rash around the injection site and slightly above it). At the time of the report, VACCINATION SITE RASH (Rash around the injection site and slightly above it) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Additional concomitant medication included supplements (unspecified).   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Reporter did not follow up with HCP- she received second dose in other arm and did not have any event.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site swelling
Clinical narrative: Hardness at injection site, 8 days post injection; Redness at injection site, 8 days post injection; Swelling at injection site, 8 days post injection; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE INDURATION (Hardness at injection site, 8 days post injection), VACCINATION SITE ERYTHEMA (Redness at injection site, 8 days post injection) and VACCINATION SITE SWELLING (Swelling at injection site, 8 days post injection) 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 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 VACCINATION SITE INDURATION (Hardness at injection site, 8 days post injection), VACCINATION SITE ERYTHEMA (Redness at injection site, 8 days post injection) and VACCINATION SITE SWELLING (Swelling at injection site, 8 days post injection). At the time of the report, VACCINATION SITE INDURATION (Hardness at injection site, 8 days post injection), VACCINATION SITE ERYTHEMA (Redness at injection site, 8 days post injection) and VACCINATION SITE SWELLING (Swelling at injection site, 8 days post injection) 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.   The patient's concomitant medication was not reported.  The patient's treatment medication was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 18-Mar-2021: TCR added- No answer On 07-Apr-2021: TCR added- Spoke with HCP and she refused follow-up.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Pregnancy test
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a 38-year-old female patient (gravida 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 011L20A) for COVID-19 vaccination.     Concurrent medical conditions included Ehlers-Danlos syndrome, Anxiety since 2003, Depression since 2003 and Herpes NOS. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]), VALACYCLOVIR [VALACICLOVIR] and ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-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 05-Jan-2021 and the estimated date of delivery was 12-Oct-2021. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fourth week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Feb-2021, Pregnancy test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site swelling, Vaccination site warmth
Clinical narrative: red line in her arm; raised; hot; scattered bumps; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (red line in her arm), VACCINATION SITE SWELLING (raised), VACCINATION SITE WARMTH (hot) and VACCINATION SITE MASS (scattered bumps) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Osteoarthritis and Fibromyalgia. Concomitant products included ATORVASTATIN for Cholesterol, DULOXETINE for Fibromyalgia, LEVOTHYROXINE for Hypothyroidism, ETODOLAC for Osteoarthritis, CALCIUM CARBONATE (OSCAL [CALCIUM CARBONATE]) for Supplementation therapy, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (red line in her arm), VACCINATION SITE SWELLING (raised), VACCINATION SITE WARMTH (hot) and VACCINATION SITE MASS (scattered bumps). At the time of the report, VACCINATION SITE ERYTHEMA (red line in her arm), VACCINATION SITE SWELLING (raised), VACCINATION SITE WARMTH (hot) and VACCINATION SITE MASS (scattered bumps) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 32.0
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 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 06-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 14-Dec-2020 and the estimated date of delivery was 20-Sep-2021. On 06-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  third week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (pregnant) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications were provided. No treatment information provided.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea, Pyrexia
Clinical narrative: Nausea; Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), HEADACHE (Headache) and PYREXIA (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 20-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced NAUSEA (Nausea), HEADACHE (Headache) and PYREXIA (Fever). At the time of the report, NAUSEA (Nausea), HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment information provided.   Reporter did not allow further contact
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising, Vaccination site haemorrhage, Vaccination site mass
Clinical narrative: instantly started bleeding after getting the shot; bump on the arm; Bruise; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMORRHAGE (instantly started bleeding after getting the shot), VACCINATION SITE MASS (bump on the arm) and VACCINATION SITE BRUISING (Bruise) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (instantly started bleeding after getting the shot), VACCINATION SITE MASS (bump on the arm) and VACCINATION SITE BRUISING (Bruise). At the time of the report, VACCINATION SITE HAEMORRHAGE (instantly started bleeding after getting the shot), VACCINATION SITE MASS (bump on the arm) and VACCINATION SITE BRUISING (Bruise) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Follow up document is received on 08-JUN-2021 and it doesn't have any new information
Sex: U
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: Visual disturbance; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of VISUAL IMPAIRMENT (Visual disturbance) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced VISUAL IMPAIRMENT (Visual disturbance). At the time of the report, VISUAL IMPAIRMENT (Visual disturbance) 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 relevant concomitant medications were reported. No treatment information was provided.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Pregnant and received Moderna COVID vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and received Moderna COVID vaccine) in a 32-year-old female patient (gravida 3, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hay fever. Concomitant products included PRENATAL + DHA for an unknown indication.    On 09-Feb-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 28-Nov-2020 and the estimated date of delivery was 04-Sep-2021. On 09-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and received Moderna COVID vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  tenth week of the pregnancy.  On 09-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and received Moderna COVID vaccine) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       There was no treatment medication reported. No maternal history of subfertility was reported. No family history of congenital anomalies/genetic disease was reported. No complications or acute illnesses during this pregnancy to date were reported.  On an unknown date in Nov-2016, it was reported that 1st pregnancy ended with live, full-term birth. On an unknown date in Nov-2019,  it was reported that 2st pregnancy ended with live, full-term birth.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Oropharyngeal pain, Pyrexia, Rhinorrhoea
Clinical narrative: Sore throat; Runny nose; Sore Arm; A little rash around the shot; Shoulders ached; Fever; Cold Chills; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (Runny nose), VACCINATION SITE PAIN (Sore Arm), VACCINATION SITE RASH (A little rash around the shot) and ARTHRALGIA (Shoulders ached) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (Runny nose), VACCINATION SITE PAIN (Sore Arm), VACCINATION SITE RASH (A little rash around the shot), ARTHRALGIA (Shoulders ached), PYREXIA (Fever) and CHILLS (Cold Chills). At the time of the report, OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (Runny nose), ARTHRALGIA (Shoulders ached), PYREXIA (Fever) and CHILLS (Cold Chills) outcome was unknown and VACCINATION SITE PAIN (Sore Arm) and VACCINATION SITE RASH (A little rash around the shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment information provided.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site rash
Clinical narrative: Sore throat; Runny nose; Sore Arm; A little rash around the shot; Shoulders ached; Fever; Cold Chills; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (Runny nose), VACCINATION SITE PAIN (Sore Arm), VACCINATION SITE RASH (A little rash around the shot) and ARTHRALGIA (Shoulders ached) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (Runny nose), VACCINATION SITE PAIN (Sore Arm), VACCINATION SITE RASH (A little rash around the shot), ARTHRALGIA (Shoulders ached), PYREXIA (Fever) and CHILLS (Cold Chills). At the time of the report, OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (Runny nose), ARTHRALGIA (Shoulders ached), PYREXIA (Fever) and CHILLS (Cold Chills) outcome was unknown and VACCINATION SITE PAIN (Sore Arm) and VACCINATION SITE RASH (A little rash around the shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment information provided.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Headache, Hypersensitivity, Lip swelling
Clinical narrative: Elevated WBC; Body was red; Lips swelling; Itching; Allergic reaction; Migraine; Tachycardia; Hives/Red spots on skin; Myalgia; Chills; Vomits; Headache; Vaccination site pain; This spontaneous case was reported by a physician assistant and describes the occurrence of MIGRAINE (Migraine), TACHYCARDIA (Tachycardia), URTICARIA (Hives/Red spots on skin), LIP SWELLING (Lips swelling) and WHITE BLOOD CELL COUNT INCREASED (Elevated WBC) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: GARDASIL 9 (Dose 3/3 and Route i.m) on 03-Dec-2020. Concurrent medical conditions included Drug allergy (methimazole), Hives (Skin Allergy) since 22-Jan-2021 and Hypothyroidism (Recent changes: High levels, Medication increased) since 2016. Concomitant products included LEVOTHYROXINE for Hypothyroidism, CONTRACEPTIVES and NORETHINDRONE ACETATE for an unknown indication.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Dec-2020, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). On 20-Jan-2021, the patient experienced MIGRAINE (Migraine), TACHYCARDIA (Tachycardia), URTICARIA (Hives/Red spots on skin), MYALGIA (Myalgia), CHILLS (Chills), VOMITING (Vomits) and HEADACHE (Headache). On 22-Jan-2021 at 1:00 AM, the patient experienced HYPERSENSITIVITY (Allergic reaction). On 01-Feb-2021, the patient experienced LIP SWELLING (Lips swelling) and PRURITUS (Itching). On an unknown date, the patient experienced WHITE BLOOD CELL COUNT INCREASED (Elevated WBC) and ERYTHEMA (Body was red). The patient was treated with METHYLPREDNISOLONE (MEDROL DOSEPAK) (oral) for Symptomatic treatment, at a dose of 4 mg. On 23-Dec-2020, VACCINATION SITE PAIN (Vaccination site pain) had resolved. On 31-Jan-2021, MIGRAINE (Migraine), TACHYCARDIA (Tachycardia), MYALGIA (Myalgia), VOMITING (Vomits) and HEADACHE (Headache) had resolved, CHILLS (Chills) had resolved with sequelae. On 10-Feb-2021, PRURITUS (Itching) had resolved. At the time of the report, URTICARIA (Hives/Red spots on skin), LIP SWELLING (Lips swelling), WHITE BLOOD CELL COUNT INCREASED (Elevated WBC) and ERYTHEMA (Body was red) outcome was unknown and HYPERSENSITIVITY (Allergic reaction) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Follow-up received on 17-JUN-2021: updated reporter details, added patient details, medical history, Concomitant medications, treatment medication and event
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Myalgia, Pruritus, Tachycardia, Urticaria
Clinical narrative: Elevated WBC; Body was red; Lips swelling; Itching; Allergic reaction; Migraine; Tachycardia; Hives/Red spots on skin; Myalgia; Chills; Vomits; Headache; Vaccination site pain; This spontaneous case was reported by a physician assistant and describes the occurrence of MIGRAINE (Migraine), TACHYCARDIA (Tachycardia), URTICARIA (Hives/Red spots on skin), LIP SWELLING (Lips swelling) and WHITE BLOOD CELL COUNT INCREASED (Elevated WBC) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: GARDASIL 9 (Dose 3/3 and Route i.m) on 03-Dec-2020. Concurrent medical conditions included Drug allergy (methimazole), Hives (Skin Allergy) since 22-Jan-2021 and Hypothyroidism (Recent changes: High levels, Medication increased) since 2016. Concomitant products included LEVOTHYROXINE for Hypothyroidism, CONTRACEPTIVES and NORETHINDRONE ACETATE for an unknown indication.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Dec-2020, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). On 20-Jan-2021, the patient experienced MIGRAINE (Migraine), TACHYCARDIA (Tachycardia), URTICARIA (Hives/Red spots on skin), MYALGIA (Myalgia), CHILLS (Chills), VOMITING (Vomits) and HEADACHE (Headache). On 22-Jan-2021 at 1:00 AM, the patient experienced HYPERSENSITIVITY (Allergic reaction). On 01-Feb-2021, the patient experienced LIP SWELLING (Lips swelling) and PRURITUS (Itching). On an unknown date, the patient experienced WHITE BLOOD CELL COUNT INCREASED (Elevated WBC) and ERYTHEMA (Body was red). The patient was treated with METHYLPREDNISOLONE (MEDROL DOSEPAK) (oral) for Symptomatic treatment, at a dose of 4 mg. On 23-Dec-2020, VACCINATION SITE PAIN (Vaccination site pain) had resolved. On 31-Jan-2021, MIGRAINE (Migraine), TACHYCARDIA (Tachycardia), MYALGIA (Myalgia), VOMITING (Vomits) and HEADACHE (Headache) had resolved, CHILLS (Chills) had resolved with sequelae. On 10-Feb-2021, PRURITUS (Itching) had resolved. At the time of the report, URTICARIA (Hives/Red spots on skin), LIP SWELLING (Lips swelling), WHITE BLOOD CELL COUNT INCREASED (Elevated WBC) and ERYTHEMA (Body was red) outcome was unknown and HYPERSENSITIVITY (Allergic reaction) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Follow-up received on 17-JUN-2021: updated reporter details, added patient details, medical history, Concomitant medications, treatment medication and event
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vomiting, White blood cell count increased
Clinical narrative: Elevated WBC; Body was red; Lips swelling; Itching; Allergic reaction; Migraine; Tachycardia; Hives/Red spots on skin; Myalgia; Chills; Vomits; Headache; Vaccination site pain; This spontaneous case was reported by a physician assistant and describes the occurrence of MIGRAINE (Migraine), TACHYCARDIA (Tachycardia), URTICARIA (Hives/Red spots on skin), LIP SWELLING (Lips swelling) and WHITE BLOOD CELL COUNT INCREASED (Elevated WBC) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: GARDASIL 9 (Dose 3/3 and Route i.m) on 03-Dec-2020. Concurrent medical conditions included Drug allergy (methimazole), Hives (Skin Allergy) since 22-Jan-2021 and Hypothyroidism (Recent changes: High levels, Medication increased) since 2016. Concomitant products included LEVOTHYROXINE for Hypothyroidism, CONTRACEPTIVES and NORETHINDRONE ACETATE for an unknown indication.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Dec-2020, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). On 20-Jan-2021, the patient experienced MIGRAINE (Migraine), TACHYCARDIA (Tachycardia), URTICARIA (Hives/Red spots on skin), MYALGIA (Myalgia), CHILLS (Chills), VOMITING (Vomits) and HEADACHE (Headache). On 22-Jan-2021 at 1:00 AM, the patient experienced HYPERSENSITIVITY (Allergic reaction). On 01-Feb-2021, the patient experienced LIP SWELLING (Lips swelling) and PRURITUS (Itching). On an unknown date, the patient experienced WHITE BLOOD CELL COUNT INCREASED (Elevated WBC) and ERYTHEMA (Body was red). The patient was treated with METHYLPREDNISOLONE (MEDROL DOSEPAK) (oral) for Symptomatic treatment, at a dose of 4 mg. On 23-Dec-2020, VACCINATION SITE PAIN (Vaccination site pain) had resolved. On 31-Jan-2021, MIGRAINE (Migraine), TACHYCARDIA (Tachycardia), MYALGIA (Myalgia), VOMITING (Vomits) and HEADACHE (Headache) had resolved, CHILLS (Chills) had resolved with sequelae. On 10-Feb-2021, PRURITUS (Itching) had resolved. At the time of the report, URTICARIA (Hives/Red spots on skin), LIP SWELLING (Lips swelling), WHITE BLOOD CELL COUNT INCREASED (Elevated WBC) and ERYTHEMA (Body was red) outcome was unknown and HYPERSENSITIVITY (Allergic reaction) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Follow-up received on 17-JUN-2021: updated reporter details, added patient details, medical history, Concomitant medications, treatment medication and event
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure timing unspecified, Pregnancy test
Clinical narrative: Pregnant at the time of vaccination; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE TIMING UNSPECIFIED (Pregnant at the time of vaccination) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 01-Oct-2020 to an unknown date for an unknown indication.    On 10-Feb-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 25-Oct-2020 and the estimated date of delivery was 02-Aug-2021. On 10-Feb-2021, the patient experienced MATERNAL EXPOSURE TIMING UNSPECIFIED (Pregnant at the time of vaccination). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fifteenth week of the pregnancy.  At the time of the report, MATERNAL EXPOSURE TIMING UNSPECIFIED (Pregnant at the time of vaccination) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Nov-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.