chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder, Vaccination site pain
Clinical narrative: Did not Sleep; Headache; Pain Injection Site; COVID-19 Symptoms all over again; Bad Aches and Pain; Discomfort; Little Appetite; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19 Symptoms all over again), PAIN (Bad Aches and Pain), DISCOMFORT (Discomfort), APPETITE DISORDER (Little Appetite) and SLEEP DISORDER (Did not Sleep) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     medical history was not reported.     On 02-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-May-2021, the patient experienced COVID-19 (COVID-19 Symptoms all over again), PAIN (Bad Aches and Pain), DISCOMFORT (Discomfort), APPETITE DISORDER (Little Appetite), HEADACHE (Headache) and VACCINATION SITE PAIN (Pain Injection Site). On 03-May-2021, the patient experienced SLEEP DISORDER (Did not Sleep). The patient was treated with NAPROXEN SODIUM (ALEVE) for COVID-19, Ache, Headache, Injection site pain, Discomfort, Appetite decreased NOS and Sleep disturbance, at a dose of 1 dosage form. At the time of the report, COVID-19 (COVID-19 Symptoms all over again), PAIN (Bad Aches and Pain), DISCOMFORT (Discomfort), APPETITE DISORDER (Little Appetite), SLEEP DISORDER (Did not Sleep), HEADACHE (Headache) and VACCINATION SITE PAIN (Pain Injection Site) outcome was unknown. Aleve      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Patient received the first vaccine dose while being pregnant; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Patient received the first vaccine dose while being pregnant) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 039K20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 05-Jul-2020 and the estimated date of delivery was 12-Apr-2021. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Patient received the first vaccine dose while being pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-seventh week of the pregnancy. The vaginal delivery occurred on 15-Apr-2021, which was reported as Full-term. For neonate 1, The outcome was reported as Term Birth w/o Complications. Baby was female and baby details was reported as weight 3.8 kg, length 52.07 cm currently patient was breast feeding. At the time of the report, EXPOSURE DURING PREGNANCY (Patient received the first vaccine dose while being pregnant) had resolved.            On 20-Apr-20, the patient has a previous pregnancy that ended in miscarriage. The patient reports prior usage of marijuana once monthly from Mar-2002 to 2018 The patient reports current usage of alcohol 5 drinks per week. Ultrasound test was performed on 27-Aug-2020, 08-Sep-2020 and 19-Nov-2020 and showed the result as normal.   This case was linked to US-MODERNATX, INC.-MOD-2021-101819 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: patient demographics was updated , LMP was updated, fetus infant details were updated, concomitants were updated; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-101819:
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Pyrexia
Clinical narrative: some pain in the injection site arm; low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (some pain in the injection site arm) and PYREXIA (low grade fever) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced INJECTION SITE PAIN (some pain in the injection site arm) and PYREXIA (low grade fever). On 05-Apr-2021, INJECTION SITE PAIN (some pain in the injection site arm) and PYREXIA (low grade fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided. No treatment medication were provided.    This case was linked to MOD-2021-101818 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Follow up received on 28-Jul-2021 and contains no new information.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain on the R arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain on the R arm of injection) 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 VACCINATION SITE PAIN (Pain on the R arm of injection). At the time of the report, VACCINATION SITE PAIN (Pain on the R arm of injection) 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 information was not provided.   This case was linked to MOD-2021-100771, MOD21-084883 (E2B Linked Report).; Sender's Comments:  MOD-2021-100771:Second dose case MOD21-084883:Husband acse
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: patient did not receive a full dose, as most of it ran down the patient's arm; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (patient did not receive a full dose, as most of it ran down the patient's arm) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced UNDERDOSE (patient did not receive a full dose, as most of it ran down the patient's arm). At the time of the report, UNDERDOSE (patient did not receive a full dose, as most of it ran down the patient's arm) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication provided.  No treatment medication provided.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia, Pruritus, Swelling face
Clinical narrative: left side of face is numb; left side of face is now tingling; itching; swelling of the left side of her face; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (left side of face is numb), PRURITUS (itching), SWELLING FACE (swelling of the left side of her face) and PARAESTHESIA (left side of face is now tingling) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (steroids), Caffeine allergy, Drug allergy (amoxicillin) and Anemia.    On 25-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced PRURITUS (itching) and SWELLING FACE (swelling of the left side of her face). On an unknown date, the patient experienced HYPOAESTHESIA (left side of face is numb) and PARAESTHESIA (left side of face is now tingling). At the time of the report, HYPOAESTHESIA (left side of face is numb) and PARAESTHESIA (left side of face is now tingling) had not resolved and PRURITUS (itching) and SWELLING FACE (swelling of the left side of her face) 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.   No treatment medications were reported. No Concomitant medications were reported.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: soreness; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (soreness) and FATIGUE (fatigue) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     Concomitant products included DIAZEPAM (VALIUM) and SERTRALINE HYDROCHLORIDE (ZOLOFT) for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced PAIN (soreness) and FATIGUE (fatigue). At the time of the report, PAIN (soreness) and FATIGUE (fatigue) outcome was unknown.            Patient (pastor) states that he lost both parents, brother and nephew 13 days apart.Patient states that he's calling the FDA and CDC and going to the supreme court with congressman. Patient wants to know how many in the country have been vaccinated? Will there be any booster shots? How many vaccines were given out.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 43 days out from 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (43 days out from 1st dose) 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (43 days out from 1st dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (43 days out from 1st dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications reported.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (low grade fever) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and 016B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced PYREXIA (low grade fever). On 02-May-2021, PYREXIA (low grade fever) had resolved. Not Provided          No concomitant medications reported. No treatment information was provided.  Action taken with the mRNA-1273 in response to the event is not applicable.   This case was linked to MOD-2021-101812 (Patient Link).
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Patient received the second vaccine dose while being pregnant; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Patient received the second vaccine dose while being pregnant) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-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 in July 2020 and the estimated date of delivery was 12-Apr-2021. On 11-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (Patient received the second vaccine dose while being pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy. The delivery occurred  on 15-Apr-2021, which was reported as Normal Pregnancy Outcome. For neonate 1, The outcome was reported as Term Birth w/o Complications. On 11-Feb-2021, EXPOSURE DURING PREGNANCY (Patient received the second vaccine dose while being pregnant) had resolved. Not Provided          No concomitant medications were reported.  Treatment information was not provided.   This case was linked to MOD-2021-101811 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Patient tested positive for Covid-19 around 11 days after receiving 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Patient tested positive for Covid-19 around 11 days after receiving 1st dose) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 19-Apr-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Patient tested positive for Covid-19 around 11 days after receiving 1st dose). At the time of the report, SARS-COV-2 TEST POSITIVE (Patient tested positive for Covid-19 around 11 days after receiving 1st dose) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Apr-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. Treatment information was not provided by the reporter.    Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Pruritus, Rash erythematous, Skin burning sensation, Urticaria
Clinical narrative: Itchy and burning; Hives; big blotchy and red raised welts; Itchy and burning; 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 SKIN BURNING SENSATION (Itchy and burning), URTICARIA (Hives), RASH ERYTHEMATOUS (big blotchy and red raised welts) and PRURITUS (Itchy and burning) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SKIN BURNING SENSATION (Itchy and burning), URTICARIA (Hives), RASH ERYTHEMATOUS (big blotchy and red raised welts) and PRURITUS (Itchy and burning). At the time of the report, SKIN BURNING SENSATION (Itchy and burning), URTICARIA (Hives), RASH ERYTHEMATOUS (big blotchy and red raised welts) and PRURITUS (Itchy and burning) 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.   This case was linked to MOD21-085375 (E2B Linked Report).; Sender's Comments:  MOD21-085375:
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure decreased, Dizziness, Eye pruritus, Fatigue, Headache
Clinical narrative: low blood pressure; right part of her face swollen; like itches around her right eye(like cramps and stitches); dizziness; headache; She feels stitches in her right arm; swelling; nausea; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE DECREASED (low blood pressure), SWELLING FACE (right part of her face swollen), EYE PRURITUS (like itches around her right eye(like cramps and stitches)), DIZZINESS (dizziness) and HEADACHE (headache) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced BLOOD PRESSURE DECREASED (low blood pressure), SWELLING FACE (right part of her face swollen), EYE PRURITUS (like itches around her right eye(like cramps and stitches)), DIZZINESS (dizziness), HEADACHE (headache), LIMB DISCOMFORT (She feels stitches in her right arm), SWELLING (swelling), NAUSEA (nausea) and FATIGUE (fatigue). The patient was treated with CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) at an unspecified dose and frequency and DICLOFENAC at an unspecified dose and frequency. At the time of the report, BLOOD PRESSURE DECREASED (low blood pressure), SWELLING FACE (right part of her face swollen), EYE PRURITUS (like itches around her right eye(like cramps and stitches)), DIZZINESS (dizziness), HEADACHE (headache), LIMB DISCOMFORT (She feels stitches in her right arm), SWELLING (swelling), NAUSEA (nausea) and FATIGUE (fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant product usage were not reported by the reporter
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Nausea, Swelling, Swelling face
Clinical narrative: low blood pressure; right part of her face swollen; like itches around her right eye(like cramps and stitches); dizziness; headache; She feels stitches in her right arm; swelling; nausea; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE DECREASED (low blood pressure), SWELLING FACE (right part of her face swollen), EYE PRURITUS (like itches around her right eye(like cramps and stitches)), DIZZINESS (dizziness) and HEADACHE (headache) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced BLOOD PRESSURE DECREASED (low blood pressure), SWELLING FACE (right part of her face swollen), EYE PRURITUS (like itches around her right eye(like cramps and stitches)), DIZZINESS (dizziness), HEADACHE (headache), LIMB DISCOMFORT (She feels stitches in her right arm), SWELLING (swelling), NAUSEA (nausea) and FATIGUE (fatigue). The patient was treated with CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) at an unspecified dose and frequency and DICLOFENAC at an unspecified dose and frequency. At the time of the report, BLOOD PRESSURE DECREASED (low blood pressure), SWELLING FACE (right part of her face swollen), EYE PRURITUS (like itches around her right eye(like cramps and stitches)), DIZZINESS (dizziness), HEADACHE (headache), LIMB DISCOMFORT (She feels stitches in her right arm), SWELLING (swelling), NAUSEA (nausea) and FATIGUE (fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant product usage were not reported by the reporter
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Acne, Eye swelling, Headache, Lymphadenopathy, Myalgia
Clinical narrative: upper respiratory tract infection; Swelling eye; strep throat; acne on chin; jaw locking; gland swelling; muscle pain; headache; This spontaneous case was reported by a consumer and describes the occurrence of UPPER RESPIRATORY TRACT INFECTION (upper respiratory tract infection), EYE SWELLING (Swelling eye), PHARYNGITIS STREPTOCOCCAL (strep throat), ACNE (acne on chin) and TRISMUS (jaw locking) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Chronic migraine. Concomitant products included FREMANEZUMAB VFRM (AJOVY [FREMANEZUMAB VFRM]) for an unknown indication.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced UPPER RESPIRATORY TRACT INFECTION (upper respiratory tract infection), EYE SWELLING (Swelling eye), PHARYNGITIS STREPTOCOCCAL (strep throat), ACNE (acne on chin), TRISMUS (jaw locking), LYMPHADENOPATHY (gland swelling), MYALGIA (muscle pain) and HEADACHE (headache). The patient was treated with DOXYCYCLINE for Upper respiratory infection, at an unspecified dose and frequency. At the time of the report, UPPER RESPIRATORY TRACT INFECTION (upper respiratory tract infection), EYE SWELLING (Swelling eye), PHARYNGITIS STREPTOCOCCAL (strep throat), ACNE (acne on chin), TRISMUS (jaw locking), LYMPHADENOPATHY (gland swelling), MYALGIA (muscle pain) and HEADACHE (headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngitis streptococcal, Trismus, Upper respiratory tract infection
Clinical narrative: upper respiratory tract infection; Swelling eye; strep throat; acne on chin; jaw locking; gland swelling; muscle pain; headache; This spontaneous case was reported by a consumer and describes the occurrence of UPPER RESPIRATORY TRACT INFECTION (upper respiratory tract infection), EYE SWELLING (Swelling eye), PHARYNGITIS STREPTOCOCCAL (strep throat), ACNE (acne on chin) and TRISMUS (jaw locking) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Chronic migraine. Concomitant products included FREMANEZUMAB VFRM (AJOVY [FREMANEZUMAB VFRM]) for an unknown indication.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced UPPER RESPIRATORY TRACT INFECTION (upper respiratory tract infection), EYE SWELLING (Swelling eye), PHARYNGITIS STREPTOCOCCAL (strep throat), ACNE (acne on chin), TRISMUS (jaw locking), LYMPHADENOPATHY (gland swelling), MYALGIA (muscle pain) and HEADACHE (headache). The patient was treated with DOXYCYCLINE for Upper respiratory infection, at an unspecified dose and frequency. At the time of the report, UPPER RESPIRATORY TRACT INFECTION (upper respiratory tract infection), EYE SWELLING (Swelling eye), PHARYNGITIS STREPTOCOCCAL (strep throat), ACNE (acne on chin), TRISMUS (jaw locking), LYMPHADENOPATHY (gland swelling), MYALGIA (muscle pain) and HEADACHE (headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: lot of kids are getting vaccine as off-label use; 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 OFF LABEL USE (lot of kids are getting vaccine as off-label use) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced OFF LABEL USE (lot of kids are getting vaccine as off-label use). At the time of the report, OFF LABEL USE (lot of kids are getting vaccine as off-label use) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications were provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-101698 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-101698:
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Peripheral swelling, Pyrexia, Vaccination site erythema
Clinical narrative: Swelled Up Left Arm; Red spots on the injection site; Fever (does not remember how high); Headache; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelled Up Left Arm), VACCINATION SITE ERYTHEMA (Red spots on the injection site), PYREXIA (Fever (does not remember how high)) and HEADACHE (Headache) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced PERIPHERAL SWELLING (Swelled Up Left Arm), VACCINATION SITE ERYTHEMA (Red spots on the injection site), PYREXIA (Fever (does not remember how high)) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 31-Mar-2021, PERIPHERAL SWELLING (Swelled Up Left Arm), VACCINATION SITE ERYTHEMA (Red spots on the injection site), PYREXIA (Fever (does not remember how high)) and HEADACHE (Headache) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medication was reported. Treatment information was not provided.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dizziness, Nausea, Peripheral swelling
Clinical narrative: Stomach pain; Lightheadedness; Back of calf swollen; Nausea; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach pain), DIZZINESS (Lightheadedness), PERIPHERAL SWELLING (Back of calf swollen) and NAUSEA (Nausea) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Apr-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 an unknown date, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain), DIZZINESS (Lightheadedness), PERIPHERAL SWELLING (Back of calf swollen) and NAUSEA (Nausea). At the time of the report, ABDOMINAL PAIN UPPER (Stomach pain), DIZZINESS (Lightheadedness) and NAUSEA (Nausea) outcome was unknown and PERIPHERAL SWELLING (Back of calf swollen) had not resolved. Not Provided          No concomitant medications were reported. The patient's daughter reported that three days after administration of the vaccine her father started to experience stomach pain, lightheadedness, and the back of his calf got swollen. Her dad went to the emergency room on 02-May-2021. He was given medications for nausea.   This case was linked to US-MODERNATX, INC.-MOD-2021-101833 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-101833:Case for daughter
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: experiencing difficulty with the vaccine; 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 VACCINATION COMPLICATION (experiencing difficulty with the vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (experiencing difficulty with the vaccine). At the time of the report, VACCINATION COMPLICATION (experiencing difficulty with the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported  No treatment drugs were reported   This case was linked to MODERNATX, INC.-MOD-2021-101616 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: FU attached is for the patient, therefore no information has been taken as the case is of patient's neighbor. On 21-Jul-2021: Follow up received contains no new information (NNI); Sender's Comments:  MODERNATX, INC.-MOD-2021-101616:Patient's case
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Headache, Hypoaesthesia, Limb discomfort, Lymphadenopathy
Clinical narrative: Leg hurt; Numbness and tingling down left arm; Pain in chest on my left side all the way down to my arm/ Chest pains; Lymph nodes were swollen/ Swollen lymph nodes armpit; Muscle ache/ Whole body aches; Nausea/ Feeling nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Leg hurt), HYPOAESTHESIA (Numbness and tingling down left arm), CHEST PAIN (Pain in chest on my left side all the way down to my arm/ Chest pains), LYMPHADENOPATHY (Lymph nodes were swollen/ Swollen lymph nodes armpit) and MYALGIA (Muscle ache/ Whole body aches) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy, Allergy to antibiotic (Erythromycin) and Allergy to antibiotic (Amoxicillin).    On 10-Apr-2021 at 12:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021 at 7:30 AM, the patient experienced LIMB DISCOMFORT (Leg hurt), HYPOAESTHESIA (Numbness and tingling down left arm), CHEST PAIN (Pain in chest on my left side all the way down to my arm/ Chest pains), LYMPHADENOPATHY (Lymph nodes were swollen/ Swollen lymph nodes armpit), MYALGIA (Muscle ache/ Whole body aches), NAUSEA (Nausea/ Feeling nausea) and HEADACHE (Headache). The patient was treated with IBUPROFEN on 15-Apr-2021 for Symptomatic treatment, at an unspecified dose and frequency. On 26-Apr-2021, HYPOAESTHESIA (Numbness and tingling down left arm), CHEST PAIN (Pain in chest on my left side all the way down to my arm/ Chest pains), LYMPHADENOPATHY (Lymph nodes were swollen/ Swollen lymph nodes armpit), MYALGIA (Muscle ache/ Whole body aches), NAUSEA (Nausea/ Feeling nausea) and HEADACHE (Headache) had resolved. At the time of the report, LIMB DISCOMFORT (Leg hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Other treatment information includes Nausea medicine.  Patient stated that she experienced Low heart rate on an unspecified date.   This case was linked to US-MODERNATX, INC.-MOD-2021-101829 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Follow up received on 24-JUN-2021.  Patient's demographics, medical history and causality assessment was updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-101829:Case for daughter
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea
Clinical narrative: Leg hurt; Numbness and tingling down left arm; Pain in chest on my left side all the way down to my arm/ Chest pains; Lymph nodes were swollen/ Swollen lymph nodes armpit; Muscle ache/ Whole body aches; Nausea/ Feeling nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Leg hurt), HYPOAESTHESIA (Numbness and tingling down left arm), CHEST PAIN (Pain in chest on my left side all the way down to my arm/ Chest pains), LYMPHADENOPATHY (Lymph nodes were swollen/ Swollen lymph nodes armpit) and MYALGIA (Muscle ache/ Whole body aches) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy, Allergy to antibiotic (Erythromycin) and Allergy to antibiotic (Amoxicillin).    On 10-Apr-2021 at 12:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021 at 7:30 AM, the patient experienced LIMB DISCOMFORT (Leg hurt), HYPOAESTHESIA (Numbness and tingling down left arm), CHEST PAIN (Pain in chest on my left side all the way down to my arm/ Chest pains), LYMPHADENOPATHY (Lymph nodes were swollen/ Swollen lymph nodes armpit), MYALGIA (Muscle ache/ Whole body aches), NAUSEA (Nausea/ Feeling nausea) and HEADACHE (Headache). The patient was treated with IBUPROFEN on 15-Apr-2021 for Symptomatic treatment, at an unspecified dose and frequency. On 26-Apr-2021, HYPOAESTHESIA (Numbness and tingling down left arm), CHEST PAIN (Pain in chest on my left side all the way down to my arm/ Chest pains), LYMPHADENOPATHY (Lymph nodes were swollen/ Swollen lymph nodes armpit), MYALGIA (Muscle ache/ Whole body aches), NAUSEA (Nausea/ Feeling nausea) and HEADACHE (Headache) had resolved. At the time of the report, LIMB DISCOMFORT (Leg hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Other treatment information includes Nausea medicine.  Patient stated that she experienced Low heart rate on an unspecified date.   This case was linked to US-MODERNATX, INC.-MOD-2021-101829 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Follow up received on 24-JUN-2021.  Patient's demographics, medical history and causality assessment was updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-101829:Case for daughter
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Fatigue, Feeling abnormal, Headache
Clinical narrative: Stomach issues; Progressive physical fatigue/long term side effects of chronic fatigue; Muscle Pain; Minor Headache; Diarrhea; Not feeling with self; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), FEELING ABNORMAL (Not feeling with self), FATIGUE (Progressive physical fatigue/long term side effects of chronic fatigue), MYALGIA (Muscle Pain) and HEADACHE (Minor Headache) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension and Diabetes mellitus. Concomitant products included METFORMIN for Diabetes mellitus, CARVEDILOL, LOSARTAN and AMLODIPINE for Hypertension.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced DIARRHOEA (Diarrhea), FEELING ABNORMAL (Not feeling with self), FATIGUE (Progressive physical fatigue/long term side effects of chronic fatigue), MYALGIA (Muscle Pain) and HEADACHE (Minor Headache). On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (Stomach issues). The patient was treated with ACETAMINOPHEN ongoing since an unknown date at an unspecified dose and frequency. In April 2021, FEELING ABNORMAL (Not feeling with self) had resolved. At the time of the report, DIARRHOEA (Diarrhea), MYALGIA (Muscle Pain), HEADACHE (Minor Headache) and ABDOMINAL DISCOMFORT (Stomach issues) outcome was unknown and FATIGUE (Progressive physical fatigue/long term side effects of chronic fatigue) had not resolved. Not Provided          Action taken: Not  applicable Treatment medication included: Acetaminophen.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jun-2021: No specific follow-up information recorded.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Stomach issues; Progressive physical fatigue/long term side effects of chronic fatigue; Muscle Pain; Minor Headache; Diarrhea; Not feeling with self; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), FEELING ABNORMAL (Not feeling with self), FATIGUE (Progressive physical fatigue/long term side effects of chronic fatigue), MYALGIA (Muscle Pain) and HEADACHE (Minor Headache) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension and Diabetes mellitus. Concomitant products included METFORMIN for Diabetes mellitus, CARVEDILOL, LOSARTAN and AMLODIPINE for Hypertension.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced DIARRHOEA (Diarrhea), FEELING ABNORMAL (Not feeling with self), FATIGUE (Progressive physical fatigue/long term side effects of chronic fatigue), MYALGIA (Muscle Pain) and HEADACHE (Minor Headache). On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (Stomach issues). The patient was treated with ACETAMINOPHEN ongoing since an unknown date at an unspecified dose and frequency. In April 2021, FEELING ABNORMAL (Not feeling with self) had resolved. At the time of the report, DIARRHOEA (Diarrhea), MYALGIA (Muscle Pain), HEADACHE (Minor Headache) and ABDOMINAL DISCOMFORT (Stomach issues) outcome was unknown and FATIGUE (Progressive physical fatigue/long term side effects of chronic fatigue) had not resolved. Not Provided          Action taken: Not  applicable Treatment medication included: Acetaminophen.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jun-2021: No specific follow-up information recorded.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus
Clinical narrative: Itchiness on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (Itchiness on the injection site) in a 57-year-old female patient 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 INJECTION SITE PRURITUS (Itchiness on the injection site). At the time of the report, INJECTION SITE PRURITUS (Itchiness on the injection site) 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. No treatment information was provided.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash, Urticaria
Clinical narrative: Itchy skin all over body/Itching/pruritus (Generalized); hives and bumps on my body/ red bumps like the measles on my skin all over at first/ Hives/urticaria (Generalized); Redness/erythema (Generalized); Rash on body/Rash (Generalized); This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy skin all over body/Itching/pruritus (Generalized)), URTICARIA (hives and bumps on my body/ red bumps like the measles on my skin all over at first/ Hives/urticaria (Generalized)), ERYTHEMA (Redness/erythema (Generalized)) and RASH (Rash on body/Rash (Generalized)) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 046A21A) 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) (unknown route) 1 dosage form. On 04-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced PRURITUS (Itchy skin all over body/Itching/pruritus (Generalized)), URTICARIA (hives and bumps on my body/ red bumps like the measles on my skin all over at first/ Hives/urticaria (Generalized)), ERYTHEMA (Redness/erythema (Generalized)) and RASH (Rash on body/Rash (Generalized)). The patient was treated with PREDNISONE at an unspecified dose and frequency; FEXOFENADINE HYDROCHLORIDE (ALLEGRA) ongoing from 22-Mar-2021 at a dose of 1 Daily and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) ongoing from 22-Mar-2021 at a dose of 1 Daily. At the time of the report, PRURITUS (Itchy skin all over body/Itching/pruritus (Generalized)), URTICARIA (hives and bumps on my body/ red bumps like the measles on my skin all over at first/ Hives/urticaria (Generalized)), ERYTHEMA (Redness/erythema (Generalized)) and RASH (Rash on body/Rash (Generalized)) had not resolved.            Concomitant medication of the patient was not reported.  Treatment also include steroid cream.     Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Follow-up received on 08-Jun-2021 added event, containing the 2 nd dose information On 24-Jul-2021: Patient demographics (height and weight) and additional corrective treatments were added.
Sex: F
Vaccine: COVID19
Symptoms: Induration, Pruritus
Clinical narrative: Itchy bumps on her ear/ itchy bumps on her back/ itchy bumps on her extremities multiplying; Itchy bumps on her ear/ itchy bumps on her back/ itchy bumps on her extremities multiplying; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (Itchy bumps on her ear/ itchy bumps on her back/ itchy bumps on her extremities multiplying) and INDURATION (Itchy bumps on her ear/ itchy bumps on her back/ itchy bumps on her extremities multiplying) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-May-2012, the patient experienced INDURATION (Itchy bumps on her ear/ itchy bumps on her back/ itchy bumps on her extremities multiplying). On 02-May-2021, the patient experienced PRURITUS (Itchy bumps on her ear/ itchy bumps on her back/ itchy bumps on her extremities multiplying). At the time of the report, PRURITUS (Itchy bumps on her ear/ itchy bumps on her back/ itchy bumps on her extremities multiplying) and INDURATION (Itchy bumps on her ear/ itchy bumps on her back/ itchy bumps on her extremities multiplying) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   The patient plans to take allergy medications as treatment for the events.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Breast pain, Gynaecomastia, Induration, Nipple pain, Sensory disturbance
Clinical narrative: right breast has gotten enlarged; right nipple hurts; right nipple hard as a rock; pain in the right breast; sensitive and tender; sensation was located on the nipple and felt sensitive and tender; This spontaneous case was reported by a consumer and describes the occurrence of BREAST PAIN (pain in the right breast), TENDERNESS (sensitive and tender), SENSORY DISTURBANCE (sensation was located on the nipple and felt sensitive and tender), GYNAECOMASTIA (right breast has gotten enlarged) and NIPPLE PAIN (right nipple hurts) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast cancer in 1982 and Mastectomy bilateral (Tests results showed benign condition and no breast cancer.) in 1982. Concomitant products included SPIRONOLACTONE for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Mar-2021, the patient experienced BREAST PAIN (pain in the right breast), TENDERNESS (sensitive and tender) and SENSORY DISTURBANCE (sensation was located on the nipple and felt sensitive and tender). On an unknown date, the patient experienced GYNAECOMASTIA (right breast has gotten enlarged), NIPPLE PAIN (right nipple hurts) and INDURATION (right nipple hard as a rock). At the time of the report, BREAST PAIN (pain in the right breast), TENDERNESS (sensitive and tender), SENSORY DISTURBANCE (sensation was located on the nipple and felt sensitive and tender), GYNAECOMASTIA (right breast has gotten enlarged), NIPPLE PAIN (right nipple hurts) and INDURATION (right nipple hard as a rock) outcome was unknown. Not Provided          The patient reported that he was on several maintenance medications.  On an unspecified date, the heart doctor told the patient that the he had other patients who used spironolactone and experienced the same symptoms as him and that the suspect drug could be spironolactone.  The patient reported that he did not take any medications for treatment of the symptoms and that the tests came back negative. concomitants were provided. no treatment medication were provided.   This case was linked to MODERNATX, INC.-MOD-2021-101868 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: New events right nipple hurts, right nipple hard as rock and right breast has gotten enlarged.; Sender's Comments:  MODERNATX, INC.-MOD-2021-101868:cross linked case