chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Pain
Clinical narrative: pains/ Aches; Loss of taste; Loss of smell; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pains/ Aches), AGEUSIA (Loss of taste) and ANOSMIA (Loss of smell) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 11-Mar-2021, the patient experienced AGEUSIA (Loss of taste) and ANOSMIA (Loss of smell). On an unknown date, the patient experienced PAIN (pains/ Aches). At the time of the report, PAIN (pains/ Aches), AGEUSIA (Loss of taste) and ANOSMIA (Loss of smell) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Vaccination site erythema, Vaccination site nodule, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Concomitant products included LEVOTHYROXINE SODIUM (L-THYROXIN 1A PHARMA) for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE NODULE (bumpy on left arm), DISCOMFORT (Discomfort of left arm like arthritis), VACCINATION SITE PRURITUS (itchy on left arm), VACCINATION SITE ERYTHEMA (Redness on left arm) and VACCINATION SITE SWELLING (Swollen on left arm). At the time of the report, VACCINATION SITE NODULE (bumpy on left arm), DISCOMFORT (Discomfort of left arm like arthritis), VACCINATION SITE PRURITUS (itchy on left arm), VACCINATION SITE ERYTHEMA (Redness on left arm) and VACCINATION SITE SWELLING (Swollen on left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Other relevant concomitant medications included an unspecified blood pressure medicine and statin.  The patient did not take any treatment medication.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Additional information was received on 10-May-2021 and contains no new information.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and CHILLS (Chills) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced HEADACHE (Headache) and CHILLS (Chills). At the time of the report, HEADACHE (Headache) and CHILLS (Chills) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Fatigue, Headache, Myalgia
Clinical narrative: Felt like someone hit them in the arm with a baseball bat; fatigue; muscle pain; joint pain; headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Felt like someone hit them in the arm with a baseball bat), FATIGUE (fatigue), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and HEADACHE (headache) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced FATIGUE (fatigue), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and HEADACHE (headache). On an unknown date, the patient experienced VACCINATION SITE PAIN (Felt like someone hit them in the arm with a baseball bat). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Felt like someone hit them in the arm with a baseball bat), FATIGUE (fatigue), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and HEADACHE (headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (Inconclusive) 101 F.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No relevant concomitant medications reported.  This case was linked to MOD-2021-104304 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Follow-up information received on 04-May-2021 contains updated information of second dose details
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Felt like someone hit them in the arm with a baseball bat; fatigue; muscle pain; joint pain; headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Felt like someone hit them in the arm with a baseball bat), FATIGUE (fatigue), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and HEADACHE (headache) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced FATIGUE (fatigue), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and HEADACHE (headache). On an unknown date, the patient experienced VACCINATION SITE PAIN (Felt like someone hit them in the arm with a baseball bat). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Felt like someone hit them in the arm with a baseball bat), FATIGUE (fatigue), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and HEADACHE (headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (Inconclusive) 101 F.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No relevant concomitant medications reported.  This case was linked to MOD-2021-104304 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Follow-up information received on 04-May-2021 contains updated information of second dose details
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Violet chills that lasted about 3 hrs; Injection site is sore; The injection site itches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (The injection site itches), CHILLS (Violet chills that lasted about 3 hrs) and VACCINATION SITE PAIN (Injection site is sore) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (The injection site itches) and VACCINATION SITE PAIN (Injection site is sore). On 11-Mar-2021 at 2:00 AM, the patient experienced CHILLS (Violet chills that lasted about 3 hrs). On 11-Mar-2021 at 5:00 AM, CHILLS (Violet chills that lasted about 3 hrs) had resolved. At the time of the report, VACCINATION SITE PRURITUS (The injection site itches) and VACCINATION SITE PAIN (Injection site is sore) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Periarthritis
Clinical narrative: left arm feels like it is going to fall/left shoulder feels frozen; pain in left arm resolved and then recurred and the pain has traveled to hand; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in left arm resolved and then recurred and the pain has traveled to hand) and PERIARTHRITIS (left arm feels like it is going to fall/left shoulder feels frozen) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced PAIN IN EXTREMITY (pain in left arm resolved and then recurred and the pain has traveled to hand). On 05-Mar-2021, the patient experienced PERIARTHRITIS (left arm feels like it is going to fall/left shoulder feels frozen). At the time of the report, PAIN IN EXTREMITY (pain in left arm resolved and then recurred and the pain has traveled to hand) and PERIARTHRITIS (left arm feels like it is going to fall/left shoulder feels frozen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment information was provided.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pain in extremity, Pregnancy test
Clinical narrative: Pregnancy; Left arm soreness; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) and PAIN IN EXTREMITY (Left arm soreness) in a 35-year-old female patient (gravida 3, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     The patient's past medical history included Abortion (The patient had a spontaneous abortion.) on 01-Aug-2017 and Pregnancy (The patient had a live full term birth.) on 23-Jun-2018. Previously administered products included for an unreported indication: ALCOHOL until 01-Nov-2020. Concurrent medical conditions included No adverse event and No adverse event. 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 04-Mar-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 04-Aug-2020 and the estimated date of delivery was 11-May-2021. On 04-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) and PAIN IN EXTREMITY (Left arm soreness). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirtieth 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. The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 04-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) had resolved. On 07-Mar-2021, PAIN IN EXTREMITY (Left arm soreness) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Sep-2020, Pregnancy test: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Live, Full term birth was reported on 23-Jun-2018.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Is itchy; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Is itchy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PRURITUS (Is itchy). At the time of the report, PRURITUS (Is itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment medications were not reported.   Reporter did not allow further contact
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain, Pruritus, Swelling
Clinical narrative: Redness; Swelling; Soreness; itchy; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness), SWELLING (Swelling), PRURITUS (itchy) and PAIN (Soreness) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), ATORVASTATIN CALCIUM (STATIN [ATORVASTATIN CALCIUM]) and SERTRALINE HYDROCHLORIDE (ZOLOFT) for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced ERYTHEMA (Redness), SWELLING (Swelling), PRURITUS (itchy) and PAIN (Soreness). At the time of the report, ERYTHEMA (Redness), SWELLING (Swelling), PRURITUS (itchy) and PAIN (Soreness) outcome was unknown.            Treatment information was not reported.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for Covid virus; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (tested positive for Covid virus) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced COVID-19 (tested positive for Covid virus). At the time of the report, COVID-19 (tested positive for Covid virus) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Feb-2021, SARS-CoV-2 test: unknown (Positive) Positive.     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 concomitant information was reported. Treatment information included antiviral infusion.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Maternal exposure during breast feeding
Clinical narrative: numbness in her right arm; exposure during breastfeeding; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness in her right arm) and MATERNAL EXPOSURE DURING BREAST FEEDING (exposure during breastfeeding) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (numbness in her right arm) and MATERNAL EXPOSURE DURING BREAST FEEDING (exposure during breastfeeding). At the time of the report, HYPOAESTHESIA (numbness in her right arm) and MATERNAL EXPOSURE DURING BREAST FEEDING (exposure during breastfeeding) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information was reported. No treatment information was reported.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Vaccination site felt hot; Vaccination site was hard; vaccination site Swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Vaccination site felt hot), VACCINATION SITE INDURATION (Vaccination site was hard) and VACCINATION SITE SWELLING (vaccination site Swollen) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Vaccination site felt hot), VACCINATION SITE INDURATION (Vaccination site was hard) and VACCINATION SITE SWELLING (vaccination site Swollen). At the time of the report, VACCINATION SITE WARMTH (Vaccination site felt hot), VACCINATION SITE INDURATION (Vaccination site was hard) and VACCINATION SITE SWELLING (vaccination site Swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. Treatment information was not provided.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Cough, Dizziness, Fatigue
Clinical narrative: Tested COVID19 positive; Lack of efficacy; Fatigue; Fever; Chills; Cough; Runny nose; Dizziness; A spontaneous report was received from a consumer concerning a 70-year-old,female patient, who received the first dose of the Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever/ pyrexia, chills, cough, runny nose/ rhinorrhoea, dizziness, fatigue, Covid positive/ SARS-CoV-2 test positive, and lack of efficacy/therapeutic product ineffective.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 05 Mar 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Batch Number: 027A21A) intramuscularly for prophylaxis of COVID-19 infection.   On 05 Mar 2021, the same day as receiving the vaccine, the patient experienced fever, chills, cough, runny nose, dizziness, fatigue and lack of efficacy.    On 11 Mar 2021, the patient tested positive for COVID-19.  Treatment information included corsin(?), acetaminophen, Vitamin C and zinc.  Action taken with mRNA-1273 in response to the events was unknown; however, the patient was advised to not take the second dose.  The event, lack of efficacy, was considered resolved on 11-Mar-2021. The outcome of the events, fever, chills, cough, runny nose, dizziness, fatigue, and Covid positive, was 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 event, a causal relationship cannot be excluded.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rhinorrhoea, SARS-CoV-2 test positive, Therapeutic product ineffective
Clinical narrative: Tested COVID19 positive; Lack of efficacy; Fatigue; Fever; Chills; Cough; Runny nose; Dizziness; A spontaneous report was received from a consumer concerning a 70-year-old,female patient, who received the first dose of the Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever/ pyrexia, chills, cough, runny nose/ rhinorrhoea, dizziness, fatigue, Covid positive/ SARS-CoV-2 test positive, and lack of efficacy/therapeutic product ineffective.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 05 Mar 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Batch Number: 027A21A) intramuscularly for prophylaxis of COVID-19 infection.   On 05 Mar 2021, the same day as receiving the vaccine, the patient experienced fever, chills, cough, runny nose, dizziness, fatigue and lack of efficacy.    On 11 Mar 2021, the patient tested positive for COVID-19.  Treatment information included corsin(?), acetaminophen, Vitamin C and zinc.  Action taken with mRNA-1273 in response to the events was unknown; however, the patient was advised to not take the second dose.  The event, lack of efficacy, was considered resolved on 11-Mar-2021. The outcome of the events, fever, chills, cough, runny nose, dizziness, fatigue, and Covid positive, was 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 event, a causal relationship cannot be excluded.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Head discomfort, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: left arm in pain,; heavy head; felling like when he had Covid but less strong; body aches like when you have a virus; fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), PAIN IN EXTREMITY (left arm in pain,), HEAD DISCOMFORT (heavy head), MYALGIA (body aches like when you have a virus) and COVID-19 (felling like when he had Covid but less strong) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     The patient's past medical history included Blood pressure since an unknown date and COVID-19 in 2020. Concomitant products included LISINOPRIL.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced PYREXIA (fever), PAIN IN EXTREMITY (left arm in pain,), HEAD DISCOMFORT (heavy head), MYALGIA (body aches like when you have a virus) and COVID-19 (felling like when he had Covid but less strong). At the time of the report, PYREXIA (fever), PAIN IN EXTREMITY (left arm in pain,), HEAD DISCOMFORT (heavy head), MYALGIA (body aches like when you have a virus) and COVID-19 (felling like when he had Covid but less strong) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-041539 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-041539:husband crosslinked case
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: fever of 101.5 degrees; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever of 101.5 degrees) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 PYREXIA (fever of 101.5 degrees). At the time of the report, PYREXIA (fever of 101.5 degrees) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.5 (High) increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment medications were not provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular, Vaccination site swelling
Clinical narrative: red blotch; vaccination site swelling; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Mar-2021 and was forwarded to Moderna on 11-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (red blotch) and RASH PAPULAR (raised red bump) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021 at 2:20 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced RASH MACULAR (red blotch). 11-Mar-2021, the patient experienced RASH PAPULAR (raised red bump). At the time of the report, RASH MACULAR (red blotch) and RASH PAPULAR (raised red bump) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient developed two bumps on the inner area of left arm (not at the injection site). She described one was red blotch and the other one was raised red bump. These spots were not present until after she got the shot.  No relevant concomitant medications were reported.   Treatment information included, calamine lotion was provided.   Reporter did not allow further contact
Age: 15.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: By accident they gave a vaccine to a 16 year old; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (By accident they gave a vaccine to a 16 year old) in a 16-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 immunisation.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (By accident they gave a vaccine to a 16 year old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (By accident they gave a vaccine to a 16 year old) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications provided.   No treatment information provided.; Sender's Comments: This report refers to a case of product administered to patient of inappropriate age (16 year old) for mRNA-1273 (lot number 001B21A) with no associated AEs reported.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Gait disturbance, Speech disorder
Clinical narrative: problems walking; problems talking; balance off; dizzy; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (problems walking), SPEECH DISORDER (problems talking), BALANCE DISORDER (balance off) and DIZZINESS (dizzy) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced GAIT DISTURBANCE (problems walking), SPEECH DISORDER (problems talking), BALANCE DISORDER (balance off) and DIZZINESS (dizzy). At the time of the report, GAIT DISTURBANCE (problems walking), SPEECH DISORDER (problems talking), BALANCE DISORDER (balance off) and DIZZINESS (dizzy) outcome was unknown. Not Provided          Patient said She didn't work, went to the ER , but they said couldn't help her. She had a call into her doctor.   No concomitant information was reported.  No treatment information was reported.
Sex: M
Vaccine: COVID19
Symptoms: Syringe issue, Underdose
Clinical narrative: Injection leaked out of the syringe over his arm and on to the floor; Injection leaked out of the syringe over his arm and on to the floor; A spontaneous report was received from a consumer concerning a male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and reports an injection leaked out of the syringe over his arm and on to the floor/ Syringe leak, Underdose.  The patient's medical history was not provided by reporter. Concomitant medications were not provided by reporter.  On unknown date, prior to the onset of the events, the patient received the first of the two of their planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.  On 11 Mar 2021, prior to the onset of the events, the patient received the second of the two of their planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.   On 11 Mar 2021, the injection leaked out of the syringe over arm and on to the floor/underdoes, Syringe leak.  Treatment information was not provided by reporter.  Action taken with mRNA-1273 in response to the events was not applicable as patient has taken both doses of the vaccine.  The outcome of the events, under dose and syringe leakage due to error, was considered recovered/resolved.; Reporter's Comments: This report refers to a case of Underdose and Syringe issue for mRNA-1273, lot # unknown with no associated AEs.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Headache
Clinical narrative: Headache; Upset stomach; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (Headache) and ABDOMINAL DISCOMFORT (Upset stomach) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030m20A) for COVID-19 vaccination.     Concomitant products included MORPHINE, DULOXETINE, CYCLOBENZAPRINE and OMEPRAZOLE for an unknown indication.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced HEADACHE (Headache) and ABDOMINAL DISCOMFORT (Upset stomach). On 11-Mar-2021, HEADACHE (Headache) and ABDOMINAL DISCOMFORT (Upset stomach) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reports that he had a headache and upset stomach in the morning. He thought it was related to taking his pills before he ate. Patient reported he felt better after he ate breakfast.   No treatment information was reported.
Sex: M
Vaccine: COVID19
Symptoms: Muscle strain
Clinical narrative: Pulled muscle; This spontaneous case was reported by a patient and describes the occurrence of MUSCLE STRAIN (Pulled muscle) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 MUSCLE STRAIN (Pulled muscle). At the time of the report, MUSCLE STRAIN (Pulled muscle) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment medication use was not provided by the reporter.  In the follow up patient was reported feeling fine   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Follow-up information received  contains non-significant information
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Myalgia, Pain in extremity, Pregnancy test
Clinical narrative: Extreme arm soreness; Pregnancy; Extreme muscle soreness; This spontaneous retrospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Extreme arm soreness), EXPOSURE DURING PREGNANCY (Pregnancy) and MYALGIA (Extreme muscle soreness) in a 36-year-old female patient (gravida 1, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20-2A and 029L20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (occasional use). Concurrent medical conditions included Allergy to antibiotic (Allergic to amoxicillin) and Penicillin allergy. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 01-May-2020 to an unknown date for an unknown indication.   On 13-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. Last menstrual period and estimated date of delivery were not provided. On 13-Jan-2021, the patient experienced PAIN IN EXTREMITY (Extreme arm soreness), EXPOSURE DURING PREGNANCY (Pregnancy) and MYALGIA (Extreme muscle soreness). The delivery occurred  on 29-Jan-2021, which was reported as Full-term. For neonate 1, the birth weight was 3231 grams (7lbs 2oz). The outcome was reported as Term Birth w/o Complications. Born at 37 weeks and 5 days not pre-term. On 13-Jan-2021, EXPOSURE DURING PREGNANCY (Pregnancy) had resolved. On 15-Jan-2021, PAIN IN EXTREMITY (Extreme arm soreness) and MYALGIA (Extreme muscle soreness) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2020, Pregnancy test: positive (Positive) positive.         Patient had ultrasound and Glucose Tolerance Test on unknown date and reported no findings.    No treatment details was provided.   This case was linked to MOD-2021-162876 (Parent-Child Link).   See case MOD-2021-162876 for details regarding the child case.  Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: This follow-up was received on 19-MAY-2021 which updated re-challenge date and events.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia, Tenderness
Clinical narrative: Tender arm; Metallic taste in his mouth within an hour. He tried to eat something, but he couldn't taste it; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Tender arm) and DYSGEUSIA (Metallic taste in his mouth within an hour. He tried to eat something, but he couldn't taste it) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 003A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced TENDERNESS (Tender arm) and DYSGEUSIA (Metallic taste in his mouth within an hour. He tried to eat something, but he couldn't taste it). At the time of the report, TENDERNESS (Tender arm) outcome was unknown and DYSGEUSIA (Metallic taste in his mouth within an hour. He tried to eat something, but he couldn't taste it) was resolving. Unknown          No concomitant information was reported.  No treatment information was reported.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Glycosylated haemoglobin, Glycosylated haemoglobin increased
Clinical narrative: A1C went from 6.7 to 7.9 within 6 months; A spontaneous report was received from a consumer (patient) concerning a 62-years -old female patient was who received Moderna's COVID-19 Vaccine (mRNA-1273) and A1C went from 6.7 to 7.9 within 6 months.  No medical history was reported. The concomitant medications included metformin, hydrochlorothiazide, lisinopril, levothyroxine, vitamin d [vitamin d nos], acetylsalicylic acid, calcium, alendronate, fluticasone, simvastatin, and fluticasone furoate.  On 06 Jan 2021, the patient received their first of the two planned doses of mRNA-1273 (Batch NUMBER: 025L20A) intramuscularly in left arm, and on 03 Feb 2021, the patient received their second of the two planned doses of mRNA-1273 (Batch NUMBER: 013M20A) intramuscularly in left arm for the prophylaxis of COVID-19 infection.  On 08 Mar 2021, the patient had a blood work done and her glycosylated haemoglobin (A1C) came high. Within six months, it went from 6.7 to 7.9 which she thought was really high. No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in response to the event is not applicable.   The outcome of the event of A1C went from 6.7 to 7.9 within 6 months was unknown.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizzy spell; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy spell) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced DIZZINESS (Dizzy spell). On 02-Mar-2021, DIZZINESS (Dizzy spell) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  The patient had a dizzy spell that lasted for a few minutes.  No treatment information was provided.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Itching, turning red and feverish on the site of the injection; Itching, turning red and feverish on the site of the injection; Feverish; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching, turning red and feverish on the site of the injection), VACCINATION SITE ERYTHEMA (Itching, turning red and feverish on the site of the injection) and PYREXIA (Feverish) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included FOLIC ACID for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itching, turning red and feverish on the site of the injection), VACCINATION SITE ERYTHEMA (Itching, turning red and feverish on the site of the injection) and PYREXIA (Feverish). The patient was treated with CALAMINE, GLYCEROL, ZINC OXIDE (CALAMINE LOTION) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (Itching, turning red and feverish on the site of the injection), VACCINATION SITE ERYTHEMA (Itching, turning red and feverish on the site of the injection) and PYREXIA (Feverish) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication included  Centroid.  The patient was holding a cold pack on her arm.
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Outside dosing Interval (>42 days); A spontaneous report was received from a Consumer concerning a male patient of unknown age, who experienced outside dosing Interval (>42 days)/product dose omission issue.   The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.   The patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) on 21 Jan 2021 intramuscularly  for prophylaxis of COVID-19 infection.    The patient is having difficulty getting the 2nd dose as the earliest appointment he can get is in April which put him beyond the recommended 28 days of getting the second dose and even beyond the 42 days after getting the 1st dose.   Treatment information was not provided.    Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the event was unknown.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administration, no vaccine administered, for mRNA-1273,  with no associated AEs
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness at injection site) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE PAIN (Soreness at injection site). At the time of the report, VACCINATION SITE PAIN (Soreness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise
Clinical narrative: Malaise; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Malaise) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Malaise) and HEADACHE (Headache). At the time of the report, MALAISE (Malaise) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were provided. No concomitant medications were reported. .   This case was linked to MOD-2021-020456 (Patient Link).
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity
Clinical narrative: Quizzes; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Quizzes) and PAIN IN EXTREMITY (Sore arm) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 023M20A) for COVID-19 vaccination.     Concurrent medical conditions included COPD, Penicillin allergy and Seasonal allergy (Summertime allergy). Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) for COPD, METOPROLOL, IPRATROPIUM BROMIDE and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced NAUSEA (Quizzes) and PAIN IN EXTREMITY (Sore arm). At the time of the report, NAUSEA (Quizzes) and PAIN IN EXTREMITY (Sore arm) outcome was unknown. Not Provided          No treatment information was provided.   This case was linked to MOD-2021-060126 (Patient Link).
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: legs achy; headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and PAIN IN EXTREMITY (legs achy) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0258218) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 09-Mar-2021, the patient experienced HEADACHE (headache). On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (legs achy). At the time of the report, HEADACHE (headache) and PAIN IN EXTREMITY (legs achy) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not provided. Concomitant medications were not provided.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Pain, Vaccination site erythema
Clinical narrative: Headache; Red all the way around; Arm was sore and hot; Arm was sore and hot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Arm was sore and hot), FEELING HOT (Arm was sore and hot), VACCINATION SITE ERYTHEMA (Red all the way around) and HEADACHE (Headache) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 09-Mar-2021, the patient experienced PAIN (Arm was sore and hot) and FEELING HOT (Arm was sore and hot). On 10-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red all the way around). On 11-Mar-2021, the patient experienced HEADACHE (Headache). The patient was treated with IBUPROFEN for Headache, at an unspecified dose and frequency. At the time of the report, PAIN (Arm was sore and hot), FEELING HOT (Arm was sore and hot), VACCINATION SITE ERYTHEMA (Red all the way around) and HEADACHE (Headache) outcome was unknown. Related      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was taking other medication. No concomitant medication details were provided.