chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pallor, Palpitations, Tachycardia, Vaccination site pain
Clinical narrative: sore arm; heat feeling "warm throughout her body"; tachycardia shot up to 130 BPs for 20 mins; alter sensation in her tongue; her voice had mild hoarseness; period palpitations over the next 12 hours or so; looked pale; not feeling well; headache; This spontaneous case was reported by a physician and describes the occurrence of   in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concomitant products included PREDNISONE.    On 08-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jan-2021, Heart rate: 130 bps 130 bps.     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.   On 08-Jan-2021, the patient experienced heat feeling "warm feeling through out her body" similar to IV contrast for an MRI. Tachycardia shot up to 130BPS for 20 minutes at the same time alter sensation in her tongue and her voice had "mild hoarseness" then the tachycardia came back to normal over the next hour. She had period palpitations over the next 12 hours or so. Headache started that evening on 08-Jan-2021 and she looked "pale". The patient was just not feeling well. On 09-Jan-2021, morning just had sore arm but overall the patient felt great. The patient was on tapering course of prednisone for IBU. Concomitant medications were not provided. Treatment information was not reported.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Pain in extremity, Pruritus, Vaccination site induration, Vaccination site lymphadenopathy
Clinical narrative: Sore arm; quarter size hard red reaction; lymph nodes on the same arm got swollen; two quarter size hard red reaction; itching; A spontaneous case report was received from a other healthcare facility staff member concerning a 57 years old female patient was participating in the mRNA-1273 Emergency Use Program and experienced sore arm and a quarter size hard red reaction, then, the lymph nodes on the same arm got swollen and then it got to a two-quarter size. It's red, hot and started itching.   The patient received their first of two planned doses of mRNA-1273 on 08-01=2021 intramuscularly for prophylaxis of COVID-19 infection.  The Lot/Batch no was 026L20A  In a chronological sequence, it started with a sore arm and a quarter size hard red reaction then the lymph nodes on the same arm got swollen on 08-01-2021. Yesterday , it got to a two  quarter size. Its red, hot and started itching.     Treatment for the event was unknown  however Patient is immunocompromised and takes medication for her rheumatoid arthritis and Naproxen daily    Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events were considered to be unknown  Based on agency comment, determined causality missing, please add possible for (Pain in extremity, vaccination site lymphadenopathy and vaccination site induration)
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain
Clinical narrative: having headaches; I am nauseous; body aches; chills; A spontaneous report was received from a Consumer concerning 27-year-old, Female patient, participating Moderna's COVID-19 vaccine (mRNA-1273) Emergency Use Program headaches, nausea, body aches and chills.   The patient's medical history, is not provided by the reporter.  Concomitant medications were not reported.   The patient received their first of two planned dose of mRNA-1273 on 18JAN2021. The patient received their first of two planned doses of mRNA-1273 in(Lot number: 025J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.    Experienced headaches, nausea, body aches and chills.   No lab data is reported by the reporter.   Action taken with mRNA-1273 in response to the events was not reported.     The outcome of events headaches, nausea, body aches and chills were unknown.   The reporter did not provide an assessment headaches, nausea, body aches and chills.  Since no Seriousness criteria is reported , hence the case is considered to be Non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: we both don't feel well; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (we both don't feel well) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event).    On 18-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 MALAISE (we both don't feel well).        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-009867, MOD-2021-009867 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Swelling face, Urticaria
Clinical narrative: hives noted developing on anterior chest wall, extending down chest and to bilateral arms; Moderate facial edema extending into ears, moderate edema to oropharynx; tachycardic; This spontaneous case was reported by an other health care professional and describes the occurrence of URTICARIA (hives noted developing on anterior chest wall, extending down chest and to bilateral arms), SWELLING FACE (Moderate facial edema extending into ears, moderate edema to oropharynx) and HEART RATE INCREASED (tachycardic) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical condition was reported).    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced URTICARIA (hives noted developing on anterior chest wall, extending down chest and to bilateral arms), SWELLING FACE (Moderate facial edema extending into ears, moderate edema to oropharynx) and HEART RATE INCREASED (tachycardic). At the time of the report, URTICARIA (hives noted developing on anterior chest wall, extending down chest and to bilateral arms), SWELLING FACE (Moderate facial edema extending into ears, moderate edema to oropharynx) and HEART RATE INCREASED (tachycardic) 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.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discolouration
Clinical narrative: Green circles that appeared on my arm; A spontaneous report was received from a female patient concerning herself who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events Green circles that appeared on her arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 01-Jan-2021, on Friday prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: unknown) via unknown route at unknown anatomical location  the left arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the events green circles that appeared on arm. (skin discoloration).  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of events was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of   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.    On 18-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No relevant concomitant medications was reported.  Treatment for the event was not provided.  Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded.     Reporter did not allow further contact; Sender's Comments: Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Maternal exposure during pregnancy, Prenatal screening test
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 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L204 and 014M20A) for COVID-19 vaccination.     The patient's past medical history included Pre-eclampsia (patient had high blood pressure during delivery and there was a live full-time birth) on 07-Jan-2019 and Hypertension in January 2019. Concurrent medical conditions included Postpartum thyroiditis since January 2019. Concomitant products included LEVOTHYROXINE for Thyroid disorder, ACETYLSALICYLIC ACID (BABY ASPIRIN) and MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 30-Jan-2021 at 10:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021 at 8:00 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 13-Nov-2020 and the estimated date of delivery was 20-Aug-2021. On 30-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  eleventh week of the pregnancy.  On 28-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Dec-2020, Pregnancy test: positive (Positive) Positive. In 2021, Blood glucose: no glucose intolerance (normal) No glucose intolerance. In 2021, Prenatal screening test: normal (normal) normal. In 2021, Ultrasound foetal: normal (normal) normal.         No treatment were provided.  It was reported that, the patient's estimated date of conception was 28-Nov-2020. Her previous pregnancy included live full term birth on 07-Jan-2019.   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Added lab data, medical history, concomitant medications and second dosage regimen.; Sender's Comments: This is a case of product exposure during pregnancy with no associated adverse events for this 35-year-old female patient. Patient will continue to be contacted for further monitoring of adverse events during the pregnancy.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test, Ultrasound scan
Clinical narrative: Pregnant and received the vaccine; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and received the vaccine) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included Induced abortion on 17-Aug-2003, Miscarriage in November 2019, Pregnancy (Live, full-term birth) on 06-Oct-2014 and Pregnancy (Live, full-term birth) on 30-Oct-2017. Concurrent medical conditions included Hypothyroidism since 2018. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) and LEVOTHYROXINE for an unknown indication.    On 16-Jan-2021 at 8:45 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 25-Jun-2020 and the estimated date of delivery was 25-Mar-2021. On 16-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and received the vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-ninth week of the pregnancy.  On 16-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and received the vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Jul-2020, Pregnancy test: positive (Positive) Positive. On an unknown date, Ultrasound scan: normal (normal) ultrasound on 12 week and 20 week: report was 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.   The patient had no maternal history of subfertility and had established prenatal care. There was no complications or acute illness reported during tis pregnancy. Conception date of patient was as 2020. On an unspecified date lab tests included NIPT testing on 12, 20 weeks, however the result was normal.  The female patient had four prior pregnancies. Second pregnancy, the delivery occurred on 06-Oct-2014, which was reported as full-term baby. Third pregnancy, the delivery occurred on 30-Oct-2017, which was reported as full-term baby.   Treatment information was not provided.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test, Ultrasound antenatal screen normal
Clinical narrative: vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) in a 31-year-old female patient (gravida 6, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included Miscarriage, Abortion (2 Terminated), Pregnancy (2 Full term pregnancies.) and Nicotine addiction (pack/day) in March 2019. Concomitant products included ventyl for gall bladder attacks, PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE].    On 21-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 17-Sep-2020 and the estimated date of delivery was 01-Jul-2021. On 21-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  eighteenth week of the pregnancy.  At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Oct-2020, Pregnancy test: positive (Positive) Positive. On an unknown date, Ultrasound antenatal screen normal: (normal) 2* ultrasound.     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.   Additional laboratory data include genetic testing and results were normal. Patient had 1 miscarriage, 2 terminated and 2 full term pregnancies.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Pregnant and got the vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and got the vaccine) in a 26-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for an unknown indication.    On 21-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 in October 2020 and the estimated date of delivery was 01-Aug-2021. On 21-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and got the vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and got the vaccine) 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.   Treatment information not provided. The patient's estimated date of conception was 01-Aug-2021.  The patient had one previous full term birth on 06-Apr-2019.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: positive for covid; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (positive for covid) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (positive for covid). At the time of the report, COVID-19 (positive for covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: positive (Positive) Individuals tested positive for COVID-19 after receiving their first vaccine..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Oropharyngeal discomfort, Pyrexia
Clinical narrative: Low Grade Fever; Soreness at Injection site; Scratchy Throat; A spontaneous report was received from customer concerning a 58-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pyrexia, injection site pain and oropharyngeal discomfort.  The patient's medical history is not provided . Concomitant medications reported included High Blood Pressure Medication, Anti-Anxiety medication and Aspirin.   On 17 JAN 2020 , the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. Patient experienced low grade fever, Soreness at injection site and Scratchy throat. Expiry date of vaccine is 07/08/2021  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event is Unknown.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
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 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-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 05-Jun-2020 and the estimated date of delivery was 12-Mar-2021. On 07-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-fifth week of the pregnancy.  On 07-Feb-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient reported that there is no Complications or acute illness during the pregnancy to date . No concomitant medications were provided.  No treatment information provided.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test, Ultrasound scan
Clinical narrative: Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 31-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (Moxociene), Cholesterol (Low Cholesterol) and Graves' disease (Treated with medication and normal) since 02-Jan-2015. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder NOS.    On 05-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 14-Jul-2020 and the estimated date of delivery was 03-May-2021. On 05-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-ninth week of the pregnancy.  On 05-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Aug-2020, Pregnancy test: positive (Positive) positive. In August 2021, Ultrasound scan: 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.   No concomitant medications were provided.  No treatment information provided. Estimated date of conception was 03 Aug 2021.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: redness below injection site; itching below injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itching below injection site) and VACCINATION SITE ERYTHEMA (redness below injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (itching below injection site). On 13-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness below injection site). At the time of the report, VACCINATION SITE PRURITUS (itching below injection site) and VACCINATION SITE ERYTHEMA (redness below injection site) 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   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: Patient declined follow up.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain in extremity, Pyrexia
Clinical narrative: Fever; Chills; pain in arm; Headache; Fatigue; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PYREXIA (Fever), CHILLS (Chills), PAIN IN EXTREMITY (pain in arm), HEADACHE (Headache) and FATIGUE (Fatigue) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    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 PYREXIA (Fever), CHILLS (Chills), PAIN IN EXTREMITY (pain in arm), HEADACHE (Headache) and FATIGUE (Fatigue). At the time of the report, PYREXIA (Fever), CHILLS (Chills), PAIN IN EXTREMITY (pain in arm), HEADACHE (Headache) and FATIGUE (Fatigue) 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 considered CHILLS (Chills) to be possibly related. No further causality assessments were provided for PYREXIA (Fever), PAIN IN EXTREMITY (pain in arm), HEADACHE (Headache) and FATIGUE (Fatigue).    Treatment medication included Tylenol. Concomitant medications were not provided by reporter.   Reporter did not allow further contact
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site rash, Vaccination site warmth
Clinical narrative: Felt warm near injection site; Rash near the injection site; Red rash near the injection site; Itchy sensation near vaccination site; Mild Arm Pain near the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Mild Arm Pain - Near Injection Site), VACCINATION SITE RASH (Rash - Near Injection site), VACCINATION SITE ERYTHEMA (Redness - Near Injection Site), VACCINATION SITE PRURITUS (Itchy Sensation - Near Injection site) and VACCINATION SITE WARMTH (Warmth - Near Injection Site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    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 (Mild Arm Pain - Near Injection Site). On 21-Jan-2021, the patient experienced VACCINATION SITE RASH (Rash - Near Injection site), VACCINATION SITE ERYTHEMA (Redness - Near Injection Site), VACCINATION SITE PRURITUS (Itchy Sensation - Near Injection site) and VACCINATION SITE WARMTH (Warmth - Near Injection Site). At the time of the report, VACCINATION SITE PAIN (Mild Arm Pain - Near Injection Site), VACCINATION SITE RASH (Rash - Near Injection site), VACCINATION SITE ERYTHEMA (Redness - Near Injection Site), VACCINATION SITE PRURITUS (Itchy Sensation - Near Injection site) and VACCINATION SITE WARMTH (Warmth - Near Injection Site) 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.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: NNI
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Vaccination site rash
Clinical narrative: itching of the site; rash; redness; swelling; A spontaneous report was received from a Reporter  concerning about a female patient who received Moderna's COVID-19 vaccine (mRNA-1273)  The patient's medical history was not provided. No relevant concomitant medications were reported.  On Calling regarding a rash develop from the Moderna injection for Covid-19 vaccine. It is spreading from the site and is having itching of the site, is redness and swelling. No further details within this voicemail  No treatment details were provided  Action taken with mRNA-1273 in response to the events was not reported.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: rash came out with sort of a bump and that hurt; redness at injection site; injection site swollen; injection site hurt a little; A spontaneous report was received from a consumer concerning a female patient of unknown age who received Modern's COVID-19 vaccine (mRNA-1273) and experienced redness at injection site, injection site swollen and hurt a little and later on developed rash came out with sort of a bump and that hurt.  The patient's medical history included Parkinson's disease. Concomitant medications reported included Sinemet, Carbidopa-Levodopa, Levothyroxine, Antidepressants and Midodrine.   On 21-JAN-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 029L20A) for prophylaxis of COVID-19 infection.    On 21-Jan-2021 the patient developed redness at injection site, injection site swollen and hurt a little. Then it went away and a week later her left arm developed another rash came out with sort of a bump and that hurt, this was 8 days after the vaccine. Now it is not hurting and dissipating.   No laboratory details provided.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the redness and swelling of the injection site was resolved while the rash developed after 8 days is unknown.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test, Ultrasound scan
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 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 011J20A) for COVID-19 vaccination.    MEDICAL HISTORY (Parent): unknown.     MEDICAL HISTORY (Patient): Concomitant products included LORATADINE (CLARITIN [LORATADINE]) for an unknown indication.   On 27-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-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 29-Nov-2020 and the estimated date of delivery was 05-Sep-2021. On 27-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  eighth week of the pregnancy.  On 24-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Jan-2021, Pregnancy test: positive Positive. On an unknown date, Ultrasound scan: normal (normal) normal.         The patient denied consent to contact her doctor because she wants to get contacted first.  Action taken with mRNA-19 in response to the event was not applicable.  No treatment information was provided by the reporter.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test
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 33-year-old female patient (gravida 3, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038K20A and 036A21A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (C- section, Live, full-term birth) on 14-Mar-2019, Pregnancy (C- section, Live, full-term birth) on 27-Jul-2020 and Asthma.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 28-Dec-2020 and the estimated date of delivery was 04-Oct-2021. On 06-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fifth week of the pregnancy.  On 06-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Jan-2021, Pregnancy test: positive (Positive) Pregnancy test - positive.         Estimated date of conception was on 07-Jan-2021. Number of fetuses was one. Patient had missed miscarriage and fetus stopped growing at eight weeks.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: Second dose details, pregnancy details were updated
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test, Ultrasound antenatal screen
Clinical narrative: maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) in a 32-year-old female patient (gravida 3, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 012M20A) for COVID-19 vaccination.     The patient's past medical history included Abortion spontaneous (Miscarriage (9 weeks)was reported.) on 02-Oct-2018. Family history included Turner's syndrome (Sister with turner's syndrome - still born). Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Allergy, FAMOTIDINE (PEPCID [FAMOTIDINE]) for Heartburn, PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for Pregnancy.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-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 14-Nov-2020 and the estimated date of delivery was 21-Aug-2021. On 28-Nov-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  eighth week of the pregnancy.  At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Dec-2020, Pregnancy test: positive (Positive) Positive. On 24-Mar-2021, Ultrasound antenatal screen: normal (normal) Normal except mild placenta previa. On 24-Apr-2021, Ultrasound antenatal screen: normal (normal) Placenta previa resolved.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient's estimated date of conception 28-Nov-2020 was reported. The complications that were occurred during this pregnancy were Gastrointestinal virus and upper respiratory infection besides placenta previa which was resolved. Prior use of alcohol before 28-Nov-2020 was reported Treatment medication was not reported. .   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow up received as pregnancy report form with pregnancy details, dose 1 and dose 2 details, concomitant medications. This case was received for pregnancy data clean up, but at QC level it was observed that FU 1 was not processed . hence FU 1 information is added now into this case as well as changes were made in pregnancy data field.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Tested COVID-19 positive; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested COVID-19 positive) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided).    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced COVID-19 (Tested COVID-19 positive). At the time of the report, COVID-19 (Tested COVID-19 positive) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication and treatment information were not reported.  It was reported that the patient never experienced any symptoms (Still feeling good).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Diarrhoea, Headache, Pyrexia, Vomiting
Clinical narrative: Diarrhea; vomiting; High temperature; Head aches; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), VOMITING (vomiting), PYREXIA (High temperature) and HEADACHE (Head aches) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hepatitis B. Concomitant products included ENTECAVIR (BARACLUDE) for Hepatitis B, LOVASTATIN and ENTECAVIR for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced HEADACHE (Head aches). On 29-Jan-2021, the patient experienced DIARRHOEA (Diarrhea), VOMITING (vomiting) and PYREXIA (High temperature). At the time of the report, DIARRHOEA (Diarrhea), VOMITING (vomiting), PYREXIA (High temperature) and HEADACHE (Head aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) °F.   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 25-Jun-2021: Follow-up information received on 25 Jun 2021 contains no new information.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Red blotchy spot on her injection site; Itchy at injection site/rash on her arms; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Red blotchy spot on her injection site) and VACCINATION SITE PRURITUS (Itchy at injection site/rash on her arms) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) 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. On 10-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red blotchy spot on her injection site) and VACCINATION SITE PRURITUS (Itchy at injection site/rash on her arms). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE ERYTHEMA (Red blotchy spot on her injection site) and VACCINATION SITE PRURITUS (Itchy at injection site/rash on her arms) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were provided.  The patient had received second dose of Moderna vaccine on 26-Feb-2021 and the batch number was reported as 010A21A.   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Follow-up information received on 27-MAY-2021 contains information regarding reporter contact details. On 02-Jun-2021: Follow-up information received on 02-Jun-2021 contains information regarding second dose of Moderna vaccine.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Blood immunoglobulin M, Body temperature, Bronchitis, Cough, Dysphonia
Clinical narrative: Voice lowered; bronchioles are pretty swollen; Cough; horrible headache; Queasy; fire red at inner and upper thigh; Rash peripheral; red rash at injection site; Rash on leg; Rash trunk; fever 101.2; Pain; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHONIA (Voice lowered), PAIN (Pain), ERYTHEMA (fire red at inner and upper thigh), RASH (Rash on leg) and COUGH (Cough) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy.   On 05-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced PAIN (Pain). On 06-Feb-2021, the patient experienced RASH (Rash trunk) and PYREXIA (fever 101.2). On 07-Feb-2021, the patient experienced ERYTHEMA (fire red at inner and upper thigh), RASH (Rash on leg), RASH (Rash peripheral) and INJECTION SITE RASH (red rash at injection site). On 08-Feb-2021, the patient experienced DYSPHONIA (Voice lowered), COUGH (Cough), BRONCHITIS (bronchioles are pretty swollen), HEADACHE (horrible headache) and NAUSEA (Queasy). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at a dose of 10 mg once daily; FAMOTIDINE at a dose of twice daily; LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL) at a dose of 50 mg every 4 hours and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 06-Feb-2021, PAIN (Pain) had resolved. On 08-Feb-2021, NAUSEA (Queasy) had resolved. At the time of the report, DYSPHONIA (Voice lowered), ERYTHEMA (fire red at inner and upper thigh), RASH (Rash on leg), COUGH (Cough), RASH (Rash trunk), RASH (Rash peripheral), BRONCHITIS (bronchioles are pretty swollen), INJECTION SITE RASH (red rash at injection site), HEADACHE (horrible headache) and PYREXIA (fever 101.2) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood immunoglobulin M: Low. On an unknown date, Body temperature: 101.2 (Inconclusive) 101.2.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was taking antihistamines. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 08-Feb-2021: Follow up received on 08/02/2021. included patient demographic information. Second dose information, concomitant medication, Additional events are included On 07-May-2021: Patient given permission to contact the mentioned healthcare professional
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Headache, Injection site rash, Nausea, Pain
Clinical narrative: Voice lowered; bronchioles are pretty swollen; Cough; horrible headache; Queasy; fire red at inner and upper thigh; Rash peripheral; red rash at injection site; Rash on leg; Rash trunk; fever 101.2; Pain; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHONIA (Voice lowered), PAIN (Pain), ERYTHEMA (fire red at inner and upper thigh), RASH (Rash on leg) and COUGH (Cough) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy.   On 05-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced PAIN (Pain). On 06-Feb-2021, the patient experienced RASH (Rash trunk) and PYREXIA (fever 101.2). On 07-Feb-2021, the patient experienced ERYTHEMA (fire red at inner and upper thigh), RASH (Rash on leg), RASH (Rash peripheral) and INJECTION SITE RASH (red rash at injection site). On 08-Feb-2021, the patient experienced DYSPHONIA (Voice lowered), COUGH (Cough), BRONCHITIS (bronchioles are pretty swollen), HEADACHE (horrible headache) and NAUSEA (Queasy). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at a dose of 10 mg once daily; FAMOTIDINE at a dose of twice daily; LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL) at a dose of 50 mg every 4 hours and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 06-Feb-2021, PAIN (Pain) had resolved. On 08-Feb-2021, NAUSEA (Queasy) had resolved. At the time of the report, DYSPHONIA (Voice lowered), ERYTHEMA (fire red at inner and upper thigh), RASH (Rash on leg), COUGH (Cough), RASH (Rash trunk), RASH (Rash peripheral), BRONCHITIS (bronchioles are pretty swollen), INJECTION SITE RASH (red rash at injection site), HEADACHE (horrible headache) and PYREXIA (fever 101.2) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood immunoglobulin M: Low. On an unknown date, Body temperature: 101.2 (Inconclusive) 101.2.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was taking antihistamines. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 08-Feb-2021: Follow up received on 08/02/2021. included patient demographic information. Second dose information, concomitant medication, Additional events are included On 07-May-2021: Patient given permission to contact the mentioned healthcare professional