chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test
Clinical narrative: Got vaccine during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Got vaccine during pregnancy) in a 34-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (Accessory Tragus Live, full-term birth) on 18-Jun-2019 and Alcohol use (1-2 drinks per week) on 01-Nov-2020. Concomitant products included VITAMIN D NOS from 2019 to an unknown date and MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 2018 to an unknown date for an unknown indication.    On 09-Jan-2021 at 2:30 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 05-Nov-2020 and the estimated date of delivery was 12-Aug-2021. On 09-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Got vaccine during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  ninth week of the pregnancy.  On 09-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Got vaccine during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-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.   Estimated date of conception was on 18-Nov-2020. Number of fetus was found to be one. On ??-???-2012, lab test included genetic predisposition test, however the result included heterozygous for factor 5 Lieden.  Concomitant product Vitamin D was used for the indication to help breast milk.  Treatment information was not provided.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Pyrexia, SARS-CoV-2 test
Clinical narrative: Mild fever 99-100 F; Coughing; Tested positive for covid; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Mild fever 99-100 F) and COUGH (Coughing) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 613L20A) for COVID-19 vaccination.     No medical history reported.  Concomitant products included ATORVASTATIN for Cholesterol.    On 15-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 PYREXIA (Mild fever 99-100 F) and COUGH (Coughing). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency and OMEPRAZOLE for Reflexes abnormal, at an unspecified dose and frequency. At the time of the report, PYREXIA (Mild fever 99-100 F) and COUGH (Coughing) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Jan-2021, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: NNI
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash, Vaccination site warmth
Clinical narrative: Hot at the site; Itchy at the site; Rash at the site; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE WARMTH (Hot at the site), VACCINATION SITE PRURITUS (Itchy at the site) and VACCINATION SITE RASH (Rash at the site) 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 08-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 WARMTH (Hot at the site), VACCINATION SITE PRURITUS (Itchy at the site) and VACCINATION SITE RASH (Rash at the site). At the time of the report, VACCINATION SITE WARMTH (Hot at the site), VACCINATION SITE PRURITUS (Itchy at the site) and VACCINATION SITE RASH (Rash at the site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Glucose tolerance test, Maternal exposure during pregnancy, Ultrasound antenatal screen normal
Clinical narrative: MEDICAL HISTORY (Patient): The patient's past medical history included Alcoholic (1 drink/ week ,patient stop drinking on 01-Jul-2020) in 2011, Pregnancy (live full term birth) on 08-May-2016, Pregnancy (live full term birth) on 27-Feb-2018 and Miscarriage on 18-Jun-2020. Concomitant products included Colace for Constipation, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy, VITAMIN D NOS for Prevention, FAMOTIDINE (PEPCID AC) for Reflux esophagitis.   On 05-Jan-2021 at 12:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021 at 10:15 PM, 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 18-Jun-2020 and the estimated date of delivery was 31-Mar-2021. On 05-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Got vaccine during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-eighth week of the pregnancy.  On 05-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Got vaccine during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Nov-2020, Ultrasound antenatal screen normal: normal (normal) normal. On 16-Dec-2020, Glucose tolerance test: normal (normal) normal. On 03-Feb-2021, Ultrasound antenatal screen normal: normal (normal) normal.         Treatment information not provided.   Most recent FOLLOW-UP information incorporated above includes: On 04-Feb-2021: internal review on 21-JUL-2021 to update analysis and patient pregnancy details. On 25-Jun-2021: follow-up received on 25-Jun-2021 contains no new information
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: pregnant; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (pregnant) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnant). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (pregnant) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment information was provided.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Malaise, Myalgia, Sinus disorder
Clinical narrative: Her back felt like it was about to break; Sinus was messed up; Feeling really bad; Her muscle still feels kinda sore; A spontaneous report was received from a consumer concerning a 73-year-old, female patient who experienced her muscle feeling sore (myalgia), sinus was messed up (sinus disorder), feeling really bad (malaise)  and her back felt like it was about to break (back pain).  The patient's medical history included shingles. Concomitant products known to have been used by the patient, within two weeks prior to the event, included iron, vitamin B12, spironolactone, vitamin C, zinc, vitamin D, and rosuvastatin.  The patient received their first dose of mRNA-1273  on 11 Jan 2021 for prophylaxis of COVID-19 infection.  On 11 Jan 2021, after the patient received her vaccine, her back felt like it was about to break, her muscle still felt like it was sore. The patient's sinus was messed up and she felt really bad.    Treatments of these events included paracetamol, acetylsalicylic acid and pseudoephedrine.    Action taken with mRNA-1273 in response to the event was unknown.  The outcomes of the events, muscle feeling sore, feeling really bad, sinus messed up and back felt like it was about to break were unknown.; 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: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pain in extremity
Clinical narrative: arm soreness; pregnancy; This spontaneous prospective pregnancy case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (arm soreness) and MATERNAL EXPOSURE DURING PREGNANCY (pregnancy) in a 32-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No medical history information provided.  Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Prenatal care, ALUMINIUM HYDROXIDE GEL, DRIED, MAGNESIUM CARBONATE (PEPCID [ALUMINIUM HYDROXIDE GEL, DRIED;MAGNESIUM CARBONATE]) for an unknown indication.    On 03-Feb-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 25-Aug-2020 and the estimated date of delivery was 25-May-2021. On 03-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm soreness) and MATERNAL EXPOSURE DURING PREGNANCY (pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-third week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 03-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (pregnancy) had resolved. At the time of the report, PAIN IN EXTREMITY (arm soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided.
Age: 35.0
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 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-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 08-Nov-2020 and the estimated date of delivery was 08-Aug-2021. On 03-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twelfth week of the pregnancy.  On 03-Feb-2021, EXPOSURE DURING PREGNANCY (Pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided .
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (pregnant) 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 01-Feb-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 01-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnant). On 01-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (pregnant) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant meds were provided. No treatment information provided.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Palpitations
Clinical narrative: Heart was racing really fast; Shortness of Breath; Tightness on the chest; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart was racing really fast), DYSPNOEA (Shortness of Breath) and CHEST DISCOMFORT (Tightness on the chest) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-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 PALPITATIONS (Heart was racing really fast), DYSPNOEA (Shortness of Breath) and CHEST DISCOMFORT (Tightness on the chest). The patient was treated with METOPROLOL (oral) for Hypertension, at a dose of 1 dosage form and LORAZEPAM (oral) for Anxiety, at a dose of 1 dosage form. At the time of the report, PALPITATIONS (Heart was racing really fast), DYSPNOEA (Shortness of Breath) and CHEST DISCOMFORT (Tightness on the chest) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications details were not reported by the reporter.; 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: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Glucose tolerance test, Pregnancy test, Ultrasound abdomen
Clinical narrative: vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use. Concurrent medical conditions included Pregnancy since August 2020. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 04-Feb-2021 at 1:45 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was in July 2020 and the estimated date of delivery was on an unknown date. On 04-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  On 04-Feb-2021, EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2020, Pregnancy test: positive (Positive) positive. On 03-Dec-2020, Ultrasound abdomen: normal (normal) normal. In January 2021, Glucose tolerance test: normal (normal) Normal.     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.   Patient estimated due date is on an unknown date in APR 2021.  No information was provided on concomitant medication.  No treatment information was provided.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site urticaria
Clinical narrative: welts; injection site redness; injection site pain; headache; A spontaneous report was received from a consumer concerning a 57- year old-female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced injection site urticaria,injection site erythema,injection site pain and headache.  The patient's medical history was not provided.No relevant concomitant medications were reported.   On 11-Jan-2021,prior to the onset of the events, the patient received their planned dose of mRNA-1273 (lot/batch 026L20A) intramuscularly on right arm for prophylaxis of COVID-19 infection.  On 11-jan-2021,the patient experienced injection site was red and was very sore and had a welt. she did get a headache then everything went away and she felt great. Then on the 20Jan2021 the site became red again but was not sore but the size became the half dollar. No laboratory data was provided.Treatment information was not provided.  Action taken with mRNA-1273 in response to the events  was unknown. The outcome of the events injection site urticaria,injection site pain and headache was considered as resolved at the time of the report.The outcome of the event injection site erythema was considered as not resolved at the time of the report
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Vaccination site reaction
Clinical narrative: Face was swollen; Bad result from the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Bad result from the injection) and SWELLING FACE (Face was swollen) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (Bad result from the injection) and SWELLING FACE (Face was swollen). At the time of the report, VACCINATION SITE REACTION (Bad result from the injection) and SWELLING FACE (Face was swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Facial pain, Vaccination site pain
Clinical narrative: cheek bones hurt underneath her eyes.; Experienced chest pain; Experienced arm soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PAIN (cheek bones hurt underneath her eyes.), CHEST PAIN (Experienced chest pain) and VACCINATION SITE PAIN (Experienced arm soreness at the injection site) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Knee replacement, Stent placement (Kidney stent.), Hysterectomy and Diverticulitis (Diverticulitis surgery(bagged then reversal).). Concurrent medical conditions included Aching in knees, Bladder discomfort, Migraine, Back pain, Sciatic nerve injury (Sciatic nerve pain.), Blood pressure inadequately controlled (High Blood pressure), Acid reflux (esophageal), Penicillin allergy, Allergy (Sulfa allergy.), Allergy (Codeine allergy.), Iodine allergy, Allergy (Morphine allergy.), Allergy (Patient reported: NSAID's (can't take due to bad kidneys).), Allergy (Ultram allergy.), Allergy (Cymbalta allergy.) and Allergy (Requip allergy. Reporter mentioned:Requip (hallucinated).). Concomitant products included ZOLMITRIPTAN (ZOMIG) for Migraine, HYDROCODONE BITARTRATE, PARACETAMOL (VICODIN) for Pain, CLOPIDOGREL BISULFATE (PLAVIX), MIRABEGRON (MYRBETRIQ), FESOTERODINE FUMARATE (TOVIAZ), FAMOTIDINE, CALCIUM CITRATE, COLECALCIFEROL (CITRACAL + D3), DOCUSATE (Col-rite), GABAPENTIN (NEURONTIN), LUTEIN [XANTOFYL], ROSUVASTATIN CALCIUM (CRESTOR) and OLMESARTAN MEDOXOMIL (BENICAR) for an unknown indication.    On 19-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 FACIAL PAIN (cheek bones hurt underneath her eyes.), CHEST PAIN (Experienced chest pain) and VACCINATION SITE PAIN (Experienced arm soreness at the injection site). On 20-Jan-2021, FACIAL PAIN (cheek bones hurt underneath her eyes.) and CHEST PAIN (Experienced chest pain) had resolved. At the time of the report, VACCINATION SITE PAIN (Experienced arm soreness at the injection site) had not resolved. The consumer reported that on 20JAN2021, her cheek bones hurt underneath her eyes, and she experienced chest pain. Both events lasted 20 minutes and resolved. She reported that she pushed on her face to help with the pain and held her chest. No treatment medication reported. That same night, she again experienced and reported that her cheek bones hurt underneath her eyes and she experienced chest pain. This time, these same events lasted 30 minutes and resolved.      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 the events, a causal relationship cannot be excluded.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Maternal exposure during pregnancy, Pregnancy test, Ultrasound antenatal screen
Clinical narrative: exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (exposure during pregnancy) in a 37-year-old female patient (gravida 4, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included Stillbirth (16 weeks 2 days due to infection) on 11-Jul-2019 and Induced abortion (Induced Abortion at 6 weeks and 6 days trisomy 17 triploid. At 10 weeks had DNC.) on 11-Feb-2020. Concurrent medical conditions included Difficulty with anesthesia (Anesthesia sensitivity) and Ex-alcohol user (2-4 drinks a month (prior use)). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) and FISH OIL (OMEGA 3 [FISH OIL]) for an unknown indication.    On 03-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 09-Jul-2020 and the estimated date of delivery was 15-Apr-2021. On 03-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirtieth week of the pregnancy.  On 03-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (exposure during pregnancy) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Aug-2020, Pregnancy test: positive (Positive) positive. On an unknown date, Blood glucose: normal (normal) normal. On an unknown date, Ultrasound antenatal screen: normal (normal) At 19 weeks and normal (normal) At 28 weeks.     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.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Vaccination site mass
Clinical narrative: Golf-sized lump in my arm; Body aches real bad; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Golf-sized lump in my arm), MYALGIA (Body aches real bad) and NAUSEA (Nausea) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) 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) (unknown route) 1 dosage form. On 12-Jan-2021, the patient experienced VACCINATION SITE MASS (Golf-sized lump in my arm), MYALGIA (Body aches real bad) and NAUSEA (Nausea). On 12-Jan-2021, MYALGIA (Body aches real bad) had resolved. On 13-Jan-2021, NAUSEA (Nausea) had resolved. At the time of the report, VACCINATION SITE MASS (Golf-sized lump in my arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details were not reported by the reporter.; 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: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Itches; Rash on right shoulder; A spontaneous report was received from a (Consumer) concerning a  89Years-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.   On17JAN2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 028LZON ) intramuscularly in the Anatomical location for prophylaxis of COVID-19 infection.  On17JAN2021, The patient experienced the events list (verbatims) with seriousness criteria. Moderna Customer Care. Case Number Patient reaceived the first dose of the Moderna Covid-19 vaccine on the 17JAN2021 on her left and yesterday, she noticed rash on right shoulder and it itches.On the first day after receiving the vaccine, she took ibuprofen and 4 hours later she took it again. Patient is an 89 year old female. She takes vitamins, Prevagen, Losartan, Amlodipine. She received the vaccine at a Pharmacy. Lot number 028LZON Consent was received for safety to follow-up and for this call to be documented. She wants to know when she will receive her second dose and How will she find out about it. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  unknown outcomes: At the time of this report, the outcome of the event(s) (when there are multiple events, list out which events are being referenced here) was unknown>.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product administration duration
Clinical narrative: This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Feb-2021 and was forwarded to Moderna on 04-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT PRODUCT ADMINISTRATION DURATION (scheduled to receive 2nd dose of the moderna vaccine 50 days instead of 21-42 day after 1st dose) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032120A) 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) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced INCORRECT PRODUCT ADMINISTRATION DURATION (scheduled to receive 2nd dose of the moderna vaccine 50 days instead of 21-42 day after 1st dose). At the time of the report, INCORRECT PRODUCT ADMINISTRATION DURATION (scheduled to receive 2nd dose of the moderna vaccine 50 days instead of 21-42 day after 1st dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient received the first dose of Moderna covid-19 vaccine on 20-Jan-2021 and reported that she is scheduled on 11-Mar-2021 to receive the second dose which is a 50 days instead of 21-42 days. Patient stated that she hadn't scheduled yet.  No concomitant medications were reported.  No treatment information was reported
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site haemorrhage
Clinical narrative: few dots of blood on the Band Aid; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMORRHAGE (few dots of blood on the Band Aid.) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE HAEMORRHAGE (few dots of blood on the Band Aid.).        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.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: 8 weeks pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (8 weeks pregnant) in a 27-year-old female patient (gravida 3, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-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 16-Sep-2021. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (8 weeks pregnant). At the time of the report, EXPOSURE DURING PREGNANCY (8 weeks pregnant) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (8 weeks pregnant) in a 27-year-old female patient (gravida 4) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Pregnancy.    On 05-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 16-Sep-2021. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (8 weeks pregnant). The delivery occurred  on 15-Sep-2021. For neonate 1, The outcome was reported as Unknown. At the time of the report, EXPOSURE DURING PREGNANCY (8 weeks pregnant) had 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 29-Jan-2021: No specific follow-up information recorded.  No significant information on follow-up.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jan-2021: No specific follow-up information recorded.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 27-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 28-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021 at 11:00 AM, 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-Oct-2020 and the estimated date of delivery was 21-Jul-2021. On 29-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). 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 DURING PREGNANCY (Pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not reported . Treatment history was not reported . Previous pregnancy end date was 2018 outcome was live birth.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Pain in extremity
Clinical narrative: pregnant; Experienced sore arm both times; This spontaneous prospective pregnancy case was reported by a physician and describes the occurrence of EXPOSURE DURING PREGNANCY (pregnant) and PAIN IN EXTREMITY (Experienced sore arm both times) in a 32-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20A and 028L20A) 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 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-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 an unknown date and the estimated date of delivery was 25-Sep-2021. On 30-Dec-2020, the patient experienced EXPOSURE DURING PREGNANCY (pregnant) and PAIN IN EXTREMITY (Experienced sore arm both times). On 30-Dec-2020, EXPOSURE DURING PREGNANCY (pregnant) had resolved. At the time of the report, PAIN IN EXTREMITY (Experienced sore arm both times) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Hyperhidrosis, Nausea
Clinical narrative: Sweats; Injection site hot to touch; Redness on the injeciton site; Fatigue; Headache; Fever; Nausea; Chills; This spontaneous case was reported by an other health care professional and describes the occurrence of HYPERHIDROSIS (Sweats), VACCINATION SITE WARMTH (Injection site hot to touch), VACCINATION SITE ERYTHEMA (Redness on the injeciton site), FATIGUE (Fatigue) and HEADACHE (Headache) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Polycystic ovarian syndrome. Concurrent medical conditions included Drug allergy (Allergic to Codeine).   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Jan-2021, the patient experienced HYPERHIDROSIS (Sweats), VACCINATION SITE WARMTH (Injection site hot to touch), VACCINATION SITE ERYTHEMA (Redness on the injeciton site), FATIGUE (Fatigue), HEADACHE (Headache), PYREXIA (Fever), NAUSEA (Nausea) and CHILLS (Chills). On 17-Jan-2021, HEADACHE (Headache), PYREXIA (Fever), NAUSEA (Nausea) and CHILLS (Chills) had resolved. On 21-Jan-2021, FATIGUE (Fatigue) had resolved. At the time of the report, HYPERHIDROSIS (Sweats) had resolved and VACCINATION SITE WARMTH (Injection site hot to touch) and VACCINATION SITE ERYTHEMA (Redness on the injeciton site) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter. Treatment medication not reported. Action taken with mRNA-1273 was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Follow-up received on 22-Apr-2021: Added patient medical history, allergic conditions and update in events outcome.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site warmth
Clinical narrative: Sweats; Injection site hot to touch; Redness on the injeciton site; Fatigue; Headache; Fever; Nausea; Chills; This spontaneous case was reported by an other health care professional and describes the occurrence of HYPERHIDROSIS (Sweats), VACCINATION SITE WARMTH (Injection site hot to touch), VACCINATION SITE ERYTHEMA (Redness on the injeciton site), FATIGUE (Fatigue) and HEADACHE (Headache) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Polycystic ovarian syndrome. Concurrent medical conditions included Drug allergy (Allergic to Codeine).   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Jan-2021, the patient experienced HYPERHIDROSIS (Sweats), VACCINATION SITE WARMTH (Injection site hot to touch), VACCINATION SITE ERYTHEMA (Redness on the injeciton site), FATIGUE (Fatigue), HEADACHE (Headache), PYREXIA (Fever), NAUSEA (Nausea) and CHILLS (Chills). On 17-Jan-2021, HEADACHE (Headache), PYREXIA (Fever), NAUSEA (Nausea) and CHILLS (Chills) had resolved. On 21-Jan-2021, FATIGUE (Fatigue) had resolved. At the time of the report, HYPERHIDROSIS (Sweats) had resolved and VACCINATION SITE WARMTH (Injection site hot to touch) and VACCINATION SITE ERYTHEMA (Redness on the injeciton site) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter. Treatment medication not reported. Action taken with mRNA-1273 was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Follow-up received on 22-Apr-2021: Added patient medical history, allergic conditions and update in events outcome.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Nausea, Presyncope, Pyrexia
Clinical narrative: almost blacked out; Sweating; Vomiting (24 hours); Nausea; Fever (101); severe headache; A spontaneous report was received from a consumer concerning a female patient of unknown age who experienced fever (101), severe headache, nausea, sweating, vomiting (24 hours), and almost "blacked out"..   The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.     On 06JAN2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 039k20a) intramuscularly for prophylaxis of COVID-19 infection.    Patient called on 04Feb2021 to inquire about getting second dose of Moderna COVID-19 vaccine. She was concerned about the side effects she experienced after getting the first dose on 06Jan2021 (expiration date unknown). She is due for her second dose on 06Feb2021. The side effects she experienced were fever (101), severe headache, nausea, sweating, vomiting (24hours), and almost "blacked out". Patient was advised by HCP to contact Moderna before getting second dose. Treatment information included Tylenol and Zofran.     The events, fever (101), severe headache, nausea, sweating, vomiting (24hours), and almost "blacked out". were considered recovered/resolved.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: almost blacked out; Sweating; Vomiting (24 hours); Nausea; Fever (101); severe headache; A spontaneous report was received from a consumer concerning a female patient of unknown age who experienced fever (101), severe headache, nausea, sweating, vomiting (24 hours), and almost "blacked out"..   The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.     On 06JAN2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 039k20a) intramuscularly for prophylaxis of COVID-19 infection.    Patient called on 04Feb2021 to inquire about getting second dose of Moderna COVID-19 vaccine. She was concerned about the side effects she experienced after getting the first dose on 06Jan2021 (expiration date unknown). She is due for her second dose on 06Feb2021. The side effects she experienced were fever (101), severe headache, nausea, sweating, vomiting (24hours), and almost "blacked out". Patient was advised by HCP to contact Moderna before getting second dose. Treatment information included Tylenol and Zofran.     The events, fever (101), severe headache, nausea, sweating, vomiting (24hours), and almost "blacked out". were considered recovered/resolved.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash, Vaccination site warmth
Clinical narrative: arm was "hot"; very itchy; rash at the injection site; red sport at site of injection; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (arm was "hot"), VACCINATION SITE PRURITUS (very itchy), VACCINATION SITE RASH (rash at the injection site) and VACCINATION SITE ERYTHEMA (red sport at site of injection) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Breast cancer (Status is controlled.) since 1985, Breast cancer (Status is controlled.) since 2015, Breast cancer (Status is controlled.) in 2017 and Bypass surgery (Status is controlled.) in 2017. Concurrent medical conditions included Diabetes (Status is controlled.) since 2002, Penicillin allergy, Drug allergy (Codeine allergy), Food allergy (Citrus allergy) and Drug allergy (Sulfa allergy). Concomitant products included CLOPIDOGREL for Anticoagulant therapy, EXEMESTANE for Cancer, DULAGLUTIDE (TRULICITY) for Diabetes, LOSARTAN, CLONIDINE and METOPROLOL for Heart disease, unspecified, DEXLANSOPRAZOLE (DEXILANT) for Reflux gastritis, LEVOTHYROXINE for Thyroid disorder, METHENAMINE for UTI.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (arm was "hot"), VACCINATION SITE PRURITUS (very itchy), VACCINATION SITE RASH (rash at the injection site) and VACCINATION SITE ERYTHEMA (red sport at site of injection). At the time of the report, VACCINATION SITE WARMTH (arm was "hot"), VACCINATION SITE PRURITUS (very itchy), VACCINATION SITE RASH (rash at the injection site) and VACCINATION SITE ERYTHEMA (red sport at site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient started to get a rash at the injection site. The rash was larger and very itchy. Cannot reach any of the doctors. Otherwise patient feels ok. Patient does not feel sick or have a fever. Due for second injection 02 Feb 2021 and does not know what to do. Treatment included antihistamine and cortisone cream.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: New events added, Patient demographics added, Concomitant medications added
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Arm Soreness; Shoulder Soreness; A spontaneous report was received from a consumer concerning a male  patient who received Moderna's Covid 19 vaccine  and developed arm soreness and shoulder soreness. The patient's medical history and lab datas were not provided.  Concomitant product used was not provided .     The patient received his first dose of mRNA-1273 (Batch number:  013L20A), intramuscularly on 13-JAN-2021. On 15-JAN-2021, the patient developed arm soreness and shoulder soreness.The patient told that he is hypochondriac and didn't want to disclose his details.  He also stated that two of his co-workers were also experiencing exactly the same AEs but didn't want to share/disclose their names.  Treatment information was unknown.    Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events were unknown.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Vaccination site swelling
Clinical narrative: Arm swelling with a size of 8x 9 cm; arm itching; A spontaneous report  was received from a Physician concerning a 84-year-old, female patient who experienced arm swelling with a size of 8x 9 cm and Itching.   The patient's medical history was not provided by the reporter. Concomitant medications reported included lisinopril and primidone.   On 11-01-2021, time not specified, eight days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 013L20A) intramuscularly in the left deltoid .arm for prophylaxis of COVID-19 infection.     On 19-01-2021, the patient experienced Arm swelling with a size of 8x 9 cm and Itching. The patient is still experiencing these symptoms. Treatment for the events was not provided.    Action taken with mRNA-1273 in response to the events was not reported.     The events, Arm swelling with a size of 8x 9 cm and Itching were considered not resolved.