chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: patient developed shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (patient developed shingles) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced HERPES ZOSTER (patient developed shingles). At the time of the report, HERPES ZOSTER (patient developed shingles) outcome was unknown. Not Provided      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.   Concomitant product use was not provided. Patient is on medicine for shingles.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Feeling abnormal
Clinical narrative: her hips and back hurt a little bit; felt run down; her hips and back hurt a little bit; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (her hips and back hurt a little bit), FEELING ABNORMAL (felt run down) and ARTHRALGIA (her hips and back hurt a little bit) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038K20A and 038K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BACK PAIN (her hips and back hurt a little bit), FEELING ABNORMAL (felt run down) and ARTHRALGIA (her hips and back hurt a little bit). At the time of the report, BACK PAIN (her hips and back hurt a little bit), FEELING ABNORMAL (felt run down) and ARTHRALGIA (her hips and back hurt a little bit) outcome was unknown.            No Concomitant medications were provided No Treatment information provided     This case was linked to MOD21-065465, MOD-2021-065604 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  MOD21-065465:cross link MOD-2021-065604:Crosslinked
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Neck pain, Unevaluable event
Clinical narrative: neck pain; A mild reaction; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (neck pain) and UNEVALUABLE EVENT (A mild reaction) in a 91-year-old male 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NECK PAIN (neck pain) and UNEVALUABLE EVENT (A mild reaction). At the time of the report, NECK PAIN (neck pain) and UNEVALUABLE EVENT (A mild reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product was reported. Treatment information was not provided.    This case was linked to US-MODERNATX, INC.-MOD-2021-062327, US-MODERNATX, INC.-MOD-2021-062604.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow-up document was received. It contains an additional event mild reaction. It contains significant information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-062327: US-MODERNATX, INC.-MOD-2021-062604:
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site warmth
Clinical narrative: Redness in injection site; Heat in injection site; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness in injection site) and VACCINATION SITE WARMTH (Heat in injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness in injection site) and VACCINATION SITE WARMTH (Heat in injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Redness in injection site) and VACCINATION SITE WARMTH (Heat in injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was provided.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Joint stiffness, Myalgia, Nausea
Clinical narrative: joint stiffness; muscle pain; nausea; symptom of really bad headache.; This spontaneous case was reported by a consumer and describes the occurrence of JOINT STIFFNESS (joint stiffness), HEADACHE (symptom of really bad headache.), MYALGIA (muscle pain) and NAUSEA (nausea) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 HEADACHE (symptom of really bad headache.). On 30-Mar-2021, the patient experienced JOINT STIFFNESS (joint stiffness), MYALGIA (muscle pain) and NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, JOINT STIFFNESS (joint stiffness), HEADACHE (symptom of really bad headache.), MYALGIA (muscle pain) and NAUSEA (nausea) 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.   Treatment details: Tylenol and Heat pad
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Pain in extremity, Peripheral coldness, Pyrexia
Clinical narrative: cold feet; dizzy at times; sore arm; cold chills; fever of 103 for 3 days after the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL COLDNESS (cold feet), DIZZINESS (dizzy at times), PAIN IN EXTREMITY (sore arm), CHILLS (cold chills) and PYREXIA (fever of 103 for 3 days after the vaccine) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included HIV disease and Heart attack.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL COLDNESS (cold feet), DIZZINESS (dizzy at times), PAIN IN EXTREMITY (sore arm), CHILLS (cold chills) and PYREXIA (fever of 103 for 3 days after the vaccine). At the time of the report, PERIPHERAL COLDNESS (cold feet), DIZZINESS (dizzy at times), PAIN IN EXTREMITY (sore arm), CHILLS (cold chills) and PYREXIA (fever of 103 for 3 days after the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information was not reported. Treatment information as not reported.   Reporter did not allow further contact
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Neck pain
Clinical narrative: neck pain; shot up into neck; stomach ache; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (neck pain; shot up into neck) and ABDOMINAL PAIN UPPER (stomach ache) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (not reported).   On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NECK PAIN (neck pain; shot up into neck) and ABDOMINAL PAIN UPPER (stomach ache). At the time of the report, NECK PAIN (neck pain; shot up into neck) and ABDOMINAL PAIN UPPER (stomach ache) outcome was unknown.            This case was linked to MOD-2021-062322 (E2B Linked Report).; Sender's Comments:  MOD-2021-062322:1st dose
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: sore shoulder; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (sore shoulder) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced ARTHRALGIA (sore shoulder). At the time of the report, ARTHRALGIA (sore shoulder) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient is mother in law of the reporter. Concomitant drug information not provided. Treatment was unknown.   This case was linked to MOD-2021-062307, MOD-2021-062340 (E2B Linked Report).; Sender's Comments:  MOD-2021-062307: MOD-2021-062340:
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Vomiting
Clinical narrative: Severe Hives; Vomiting; This spontaneous case was reported by a pharmacist and describes the occurrence of URTICARIA (Severe Hives) and VOMITING (Vomiting) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 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 URTICARIA (Severe Hives) and VOMITING (Vomiting). At the time of the report, URTICARIA (Severe Hives) and VOMITING (Vomiting) outcome was unknown. Not Provided      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.   Concomitant product use was not provided by the reporter. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Acne, Vaccination site rash
Clinical narrative: little pimples all over her body; rash at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash at the site of injection) and ACNE (little pimples all over her body) 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 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced VACCINATION SITE RASH (rash at the site of injection). On an unknown date, the patient experienced ACNE (little pimples all over her body). At the time of the report, VACCINATION SITE RASH (rash at the site of injection) had not resolved and ACNE (little pimples all over her body) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication was available. No Treatment Medication was available.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: large red area; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (large red area) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    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 VACCINATION SITE ERYTHEMA (large red area). At the time of the report, VACCINATION SITE ERYTHEMA (large red area) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Treatment details were not provided.   Reporter did not allow further contact
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Swelling face
Clinical narrative: Severe swelling on upper cheeks, under eyes; not feeling to good; fatigue; This spontaneous case was reported by an other health care professional and describes the occurrence of SWELLING FACE (Severe swelling on upper cheeks, under eyes), MALAISE (not feeling to good) and FATIGUE (fatigue) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in September 2020 and Dermal filler injection (dermatological fillers in her) since an unknown date. Concomitant products included ESTRADIOL (ESTROGEN) and IBUPROFEN (ADVIL [IBUPROFEN]) for an unknown indication.    On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced SWELLING FACE (Severe swelling on upper cheeks, under eyes), MALAISE (not feeling to good) and FATIGUE (fatigue). The patient was treated with PREDNISONE (oral) for Swelling, at an unspecified dose and frequency; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) (oral) for Swelling, at an unspecified dose and frequency and FAMOTIDINE (PEPCID [FAMOTIDINE]) (oral) for Swelling, at an unspecified dose and frequency. On 05-Jan-2021, MALAISE (not feeling to good) and FATIGUE (fatigue) had resolved. On 28-Jan-2021, SWELLING FACE (Severe swelling on upper cheeks, under eyes) 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.   Swelling returned after tapering off steroid, and as a result patient resumed treatment with Zyrtec and pepsid. Symptoms resolved days later and have remained suppressed.
Age: 30.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Exposure via breast milk
Clinical narrative: Breastfeeding after receiving the vaccine; This spontaneous case was reported by a patient and describes the occurrence of EXPOSURE VIA BREAST MILK (Breastfeeding after receiving the vaccine) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047a21a) for an unknown indication.    Co-suspect product included non-company product 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.    The patient's past medical history included No adverse event (No reported medical history).   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, the patient started 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] (unknown route) at an unspecified dose. On an unknown date, the patient experienced EXPOSURE VIA BREAST MILK (Breastfeeding after receiving the vaccine). At the time of the report, EXPOSURE VIA BREAST MILK (Breastfeeding after receiving the vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: Nausea; Headache; Dizziness; Severe pain all over the body; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), HEADACHE (Headache), DIZZINESS (Dizziness), MYALGIA (Severe pain all over the body) and FATIGUE (Tiredness) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 025J20ZA) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included OMEPRAZOLE, HYDROCHLOROTHIAZIDE, SULFAMETHOXAZOLE;TRIMETHOPRIM and CITALOPRAM HYDROBROMIDE for an unknown indication.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-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 (Nausea), HEADACHE (Headache), DIZZINESS (Dizziness), MYALGIA (Severe pain all over the body) and FATIGUE (Tiredness). On 09-Feb-2021, NAUSEA (Nausea) and DIZZINESS (Dizziness) had resolved. On 11-Feb-2021, MYALGIA (Severe pain all over the body) and FATIGUE (Tiredness) had resolved. At the time of the report, HEADACHE (Headache) outcome was unknown. Not Provided          No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.  Patient explained that the pain was similar to the pain after surgery.   This case was linked to US-MODERNATX, INC.-MOD-2021-062314.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-062314:First dose case
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Feeling abnormal, Lacrimation increased
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of LACRIMATION INCREASED (watery eyes), FEELING ABNORMAL (did not feel too good) and CONDITION AGGRAVATED (flare up of his allergies) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 002A21A) for COVID-19 vaccination. No Medical History information was reported. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 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 29-Mar-2021, the patient experienced LACRIMATION INCREASED (watery eyes), FEELING ABNORMAL (did not feel too good) and CONDITION AGGRAVATED (flare up of his allergies). At the time of the report, LACRIMATION INCREASED (watery eyes), FEELING ABNORMAL (did not feel too good) and CONDITION AGGRAVATED (flare up of his allergies) had resolved. Not provided for mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. It was reported that the patient scheduled for a cortisone shot on 01Apr2021. Med Agent received call from Moderna case number 00166416 crosslinked with MOD21-065494. Patient states that he got a call from Moderna and is returning the call. Patient states that he has never called Moderna to report anything because he is feeling fine and doing well. He received full cycle of vaccine few months ago. He is not sure what the voicemail stated and provided no case number. Agent checked the case query and no results found with name and phone number. Concomitant medication information was not reported. Treatment information as not reported. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) is considered as not applicable. Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: No new information.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Lymphadenopathy, Tenderness, Vaccination site induration, Vaccination site swelling
Clinical narrative: injection site swollen; injection site hard; swelling in lymph nodes in armpit; tenderness in armpit; feels bruised in armpit; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (swelling in lymph nodes in armpit), TENDERNESS (tenderness in armpit), CONTUSION (feels bruised in armpit), VACCINATION SITE SWELLING (injection site swollen) and VACCINATION SITE INDURATION (injection site hard) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, the patient experienced LYMPHADENOPATHY (swelling in lymph nodes in armpit), TENDERNESS (tenderness in armpit) and CONTUSION (feels bruised in armpit). On an unknown date, the patient experienced VACCINATION SITE SWELLING (injection site swollen) and VACCINATION SITE INDURATION (injection site hard). At the time of the report, LYMPHADENOPATHY (swelling in lymph nodes in armpit), TENDERNESS (tenderness in armpit), CONTUSION (feels bruised in armpit), VACCINATION SITE SWELLING (injection site swollen) and VACCINATION SITE INDURATION (injection site hard) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. Treatment details were not reported.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood test, Echocardiogram, Maternal exposure during pregnancy, Pregnancy test
Clinical narrative: Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 34-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 001C21A) for COVID-19 vaccination.     The patient's past medical history included Prolactinoma (Managed with Cabergoline.no changes recently reduced visits to monitor. Prolactin levels were maintain normal range pre-pregnancy) on 07-Jan-2004 and Alcohol use (2 drinks per month.) from 08-Mar-2005 to 22-Feb-2020. Concurrent medical conditions included Drug allergy (Hydrocodone) and Drug allergy (Bactrim). Concomitant products included ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN MIGRAINE) from 01-Jan-2015 to 22-Dec-2020 for Migraine, CABERGOLINE from 01-Jul-2020 to 22-Dec-2020 for Prolactinoma, VITAMIN D [VITAMIN D NOS] from 01-Jan-2018 to an unknown date, VITAMINS NOS (DAILY VITAMINS) from 01-Jan-2016 to 22-Dec-2020 and PRENATAL + DHA from 23-Dec-2020 to an unknown date for Vitamin supplementation.   On 30-Mar-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021 at 4:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 15-Aug-2020 and the estimated date of delivery was 18-Jul-2021. On 30-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-second week of the pregnancy.  On 30-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Dec-2020, Pregnancy test: positive (Positive) Positive. On 05-Jan-2021, Ultrasound antenatal screen: abnormal (abnormal) Slightly abnormal nuchal spacing. On 14-Jan-2021, Blood test: normal (normal) No genetic abnormalities found. On 29-Mar-2021, Echocardiogram: normal (normal) no heart concerns or abnormalities.. On 22-Apr-2021, Blood glucose: normal (normal) normal test results or gestational diabetes and normal (normal) no gestational diabetes..         Lab test also include : Anatomy Scan:25-02-2021-No abnormalities. Estimated date of conception-25 Aug 2020  No Treatment medications were reported.  Action taken with mRNA-1273 in response to the event was Not Applicable   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Initial pregnancy report form was received: Patient demography, Allergies, Medical history, Concomitant medications and Lab tests were added.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound antenatal screen
Clinical narrative: Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 34-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 001C21A) for COVID-19 vaccination.     The patient's past medical history included Prolactinoma (Managed with Cabergoline.no changes recently reduced visits to monitor. Prolactin levels were maintain normal range pre-pregnancy) on 07-Jan-2004 and Alcohol use (2 drinks per month.) from 08-Mar-2005 to 22-Feb-2020. Concurrent medical conditions included Drug allergy (Hydrocodone) and Drug allergy (Bactrim). Concomitant products included ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN MIGRAINE) from 01-Jan-2015 to 22-Dec-2020 for Migraine, CABERGOLINE from 01-Jul-2020 to 22-Dec-2020 for Prolactinoma, VITAMIN D [VITAMIN D NOS] from 01-Jan-2018 to an unknown date, VITAMINS NOS (DAILY VITAMINS) from 01-Jan-2016 to 22-Dec-2020 and PRENATAL + DHA from 23-Dec-2020 to an unknown date for Vitamin supplementation.   On 30-Mar-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021 at 4:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 15-Aug-2020 and the estimated date of delivery was 18-Jul-2021. On 30-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-second week of the pregnancy.  On 30-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Dec-2020, Pregnancy test: positive (Positive) Positive. On 05-Jan-2021, Ultrasound antenatal screen: abnormal (abnormal) Slightly abnormal nuchal spacing. On 14-Jan-2021, Blood test: normal (normal) No genetic abnormalities found. On 29-Mar-2021, Echocardiogram: normal (normal) no heart concerns or abnormalities.. On 22-Apr-2021, Blood glucose: normal (normal) normal test results or gestational diabetes and normal (normal) no gestational diabetes..         Lab test also include : Anatomy Scan:25-02-2021-No abnormalities. Estimated date of conception-25 Aug 2020  No Treatment medications were reported.  Action taken with mRNA-1273 in response to the event was Not Applicable   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Initial pregnancy report form was received: Patient demography, Allergies, Medical history, Concomitant medications and Lab tests were added.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient probably will be receiving 2nd dose on 48 days interval; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient probably will be receiving 2nd dose on 48 days interval) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient probably will be receiving 2nd dose on 48 days interval). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient probably will be receiving 2nd dose on 48 days interval) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: very sick for two days; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (very sick for two days) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) 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 03-Mar-2021, the patient experienced ILLNESS (very sick for two days). On 05-Mar-2021, ILLNESS (very sick for two days) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant details were provided No treatment details were provided   This case was linked to MOD-2021-062329, MOD-2021-062307 (E2B Linked Report).; Sender's Comments:  MOD-2021-062329: MOD-2021-062307:
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Anosmia, Decreased appetite, Eye irritation, Fatigue, Headache
Clinical narrative: Loss sense of smell; Changed his apatite for meat (he cant eat meat or even look at it); Very thirsty; Terrible headache; Fatigue; Low grade fever 100.4 was highest with burning in the eyes; Low grade fever 100.4 was highest with burning in the eyes; This spontaneous case was reported by a consumer and describes the occurrence of EYE IRRITATION (Low grade fever 100.4 was highest with burning in the eyes), ANOSMIA (Loss sense of smell), DECREASED APPETITE (Changed his apatite for meat (he cant eat meat or even look at it)), THIRST (Very thirsty) and HEADACHE (Terrible headache) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced EYE IRRITATION (Low grade fever 100.4 was highest with burning in the eyes), DECREASED APPETITE (Changed his apatite for meat (he cant eat meat or even look at it)), THIRST (Very thirsty), HEADACHE (Terrible headache), FATIGUE (Fatigue) and PYREXIA (Low grade fever 100.4 was highest with burning in the eyes). On 26-Mar-2021, the patient experienced ANOSMIA (Loss sense of smell). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 30-Mar-2021, HEADACHE (Terrible headache) and FATIGUE (Fatigue) had resolved. On 15-May-2021, EYE IRRITATION (Low grade fever 100.4 was highest with burning in the eyes), ANOSMIA (Loss sense of smell), DECREASED APPETITE (Changed his apatite for meat (he cant eat meat or even look at it)), THIRST (Very thirsty) and PYREXIA (Low grade fever 100.4 was highest with burning in the eyes) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-May-2021: Follow up information received on 15-May-2021 contained updated event outcomes.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Thirst
Clinical narrative: Loss sense of smell; Changed his apatite for meat (he cant eat meat or even look at it); Very thirsty; Terrible headache; Fatigue; Low grade fever 100.4 was highest with burning in the eyes; Low grade fever 100.4 was highest with burning in the eyes; This spontaneous case was reported by a consumer and describes the occurrence of EYE IRRITATION (Low grade fever 100.4 was highest with burning in the eyes), ANOSMIA (Loss sense of smell), DECREASED APPETITE (Changed his apatite for meat (he cant eat meat or even look at it)), THIRST (Very thirsty) and HEADACHE (Terrible headache) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced EYE IRRITATION (Low grade fever 100.4 was highest with burning in the eyes), DECREASED APPETITE (Changed his apatite for meat (he cant eat meat or even look at it)), THIRST (Very thirsty), HEADACHE (Terrible headache), FATIGUE (Fatigue) and PYREXIA (Low grade fever 100.4 was highest with burning in the eyes). On 26-Mar-2021, the patient experienced ANOSMIA (Loss sense of smell). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 30-Mar-2021, HEADACHE (Terrible headache) and FATIGUE (Fatigue) had resolved. On 15-May-2021, EYE IRRITATION (Low grade fever 100.4 was highest with burning in the eyes), ANOSMIA (Loss sense of smell), DECREASED APPETITE (Changed his apatite for meat (he cant eat meat or even look at it)), THIRST (Very thirsty) and PYREXIA (Low grade fever 100.4 was highest with burning in the eyes) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-May-2021: Follow up information received on 15-May-2021 contained updated event outcomes.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Headache, Nausea, Pain in extremity
Clinical narrative: Being sick to her stomach; Arm pain; Chills; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Being sick to her stomach), PAIN IN EXTREMITY (Arm pain), CHILLS (Chills), HEADACHE (Headache) and NAUSEA (Nausea) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Mar-2021, the patient experienced ABDOMINAL DISCOMFORT (Being sick to her stomach), PAIN IN EXTREMITY (Arm pain), CHILLS (Chills), HEADACHE (Headache) and NAUSEA (Nausea). The patient was treated with ACETYLSALICYLIC ACID, BUTALBITAL, CAFFEINE, CODEINE PHOSPHATE, PHENACETIN (FIORINAL WITH CODEINE) at an unspecified dose and frequency. At the time of the report, ABDOMINAL DISCOMFORT (Being sick to her stomach), PAIN IN EXTREMITY (Arm pain), CHILLS (Chills), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown.            No concomitant medications were provided. Action taken with mRNA-1273 in response to the events was not applicable.    Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Follow-up information received on 23-JUN-2021 contains non-significant information On 23-Jun-2021: Follow-up information received on 23-JUN-2021 contains significant information: Added date of 1st dose of vaccine. Patient declined further follow-up.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass
Clinical narrative: Knot; red bump; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Knot) and VACCINATION SITE ERYTHEMA (red bump) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for an unknown indication.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 25-Mar-2021, the patient experienced VACCINATION SITE MASS (Knot) and VACCINATION SITE ERYTHEMA (red bump). At the time of the report, VACCINATION SITE MASS (Knot) and VACCINATION SITE ERYTHEMA (red bump) outcome was unknown.            No treatment information was provided.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Influenza like illness, Pain in extremity, Paraesthesia oral
Clinical narrative: tongue tingled; half her mouth had a tingling feeling; half her mouth had numbness; flu-like symptoms; arm ached; This spontaneous case was reported by a nurse and describes the occurrence of PARAESTHESIA ORAL (tongue tingled), PARAESTHESIA ORAL (half her mouth had a tingling feeling), HYPOAESTHESIA ORAL (half her mouth had numbness), INFLUENZA LIKE ILLNESS (flu-like symptoms) and PAIN IN EXTREMITY (arm ached) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012a21a) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history.).    On 02-Mar-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 PARAESTHESIA ORAL (tongue tingled), PARAESTHESIA ORAL (half her mouth had a tingling feeling), HYPOAESTHESIA ORAL (half her mouth had numbness), INFLUENZA LIKE ILLNESS (flu-like symptoms) and PAIN IN EXTREMITY (arm ached). On 02-Mar-2021, PARAESTHESIA ORAL (tongue tingled) and PARAESTHESIA ORAL (half her mouth had a tingling feeling) had resolved, HYPOAESTHESIA ORAL (half her mouth had numbness) outcome was unknown. On 03-Mar-2021, INFLUENZA LIKE ILLNESS (flu-like symptoms) had resolved. In March 2021, PAIN IN EXTREMITY (arm ached) had resolved. Not Provided      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 medications were given Treatment information provided as Benadryl, rest and sleep
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Rash erythematous
Clinical narrative: red rash; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (red rash), HEADACHE (Headache) and FATIGUE (Fatigue) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced RASH ERYTHEMATOUS (red rash), HEADACHE (Headache) and FATIGUE (Fatigue). On 11-Mar-2021, HEADACHE (Headache) and FATIGUE (Fatigue) had resolved. At the time of the report, RASH ERYTHEMATOUS (red rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: hives on her left arm from the top of her shoulder to the crease of her elbow; itching; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives on her left arm from the top of her shoulder to the crease of her elbow) and PRURITUS (itching) 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 25-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced URTICARIA (hives on her left arm from the top of her shoulder to the crease of her elbow) and PRURITUS (itching). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itch, at a dose of 1 dosage form. On 30-Mar-2021, URTICARIA (hives on her left arm from the top of her shoulder to the crease of her elbow) and PRURITUS (itching) had resolved.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (unknown) was not applicable. No concomitant treatment was provided. She is scheduled for a Humira injection on 31Mar2021.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Followup received;
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain in extremity, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Itching really bad Injection Site; Rash on Injection Site; Pain in the left leg (All the way to her calf); Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in the left leg (All the way to her calf)), VACCINATION SITE PRURITUS (Itching really bad Injection Site), HEADACHE (Headache), CHILLS (Chills) and VACCINATION SITE RASH (Rash on Injection Site) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in the left leg (All the way to her calf)), HEADACHE (Headache) and CHILLS (Chills). On 30-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itching really bad Injection Site) and VACCINATION SITE RASH (Rash on Injection Site). On 29-Mar-2021, PAIN IN EXTREMITY (Pain in the left leg (All the way to her calf)), HEADACHE (Headache) and CHILLS (Chills) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Itching really bad Injection Site) and VACCINATION SITE RASH (Rash on Injection Site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medicines were not included  Treatment drugs were  not provided,  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-126068, MOD-2021-126068 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: NNI. Email.  2nd dose case created.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Red bump on injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. No Medical History information was reported. On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced VACCINATION SITE SWELLING (Red bump on injection site). On 30-Mar-2021, VACCINATION SITE SWELLING (Red bump on injection site) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. Treatment details was not provided. Reporter did not allow further contact.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypoaesthesia
Clinical narrative: numbness in arm; felt like someone hit arm with a bat; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt like someone hit arm with a bat) and HYPOAESTHESIA (numbness in arm) in a 30-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 03-Mar-2021, the patient experienced FEELING ABNORMAL (felt like someone hit arm with a bat). On 30-Mar-2021, the patient experienced HYPOAESTHESIA (numbness in arm). On 06-Mar-2021, FEELING ABNORMAL (felt like someone hit arm with a bat) had resolved. At the time of the report, HYPOAESTHESIA (numbness in arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment details were not provided.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site oedema
Clinical narrative: Fluid buildup under arm after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE OEDEMA (Fluid buildup under arm after 1st dose) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010a21a) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, 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 OEDEMA (Fluid buildup under arm after 1st dose). At the time of the report, VACCINATION SITE OEDEMA (Fluid buildup under arm after 1st dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided No treatment information provided
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: FEVER; HEADACHE; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (FEVER) and HEADACHE (HEADACHE) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included CLONAZEPAM, LOSARTAN, HCTZ, BUPROPION, METOPROLOL and PANTOPRAZOLE for an unknown indication.    On 25-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 PYREXIA (FEVER) and HEADACHE (HEADACHE). At the time of the report, PYREXIA (FEVER) and HEADACHE (HEADACHE) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details not provided. Concomitant product includes Centrum Multivitamins for men.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Product availability issue
Clinical narrative: Second dose scheduled more than 36 days after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT AVAILABILITY ISSUE (Second dose scheduled more than 36 days after the first dose) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     Concomitant products included MULTIVITAMIN & MINERAL 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 an unknown date, the patient experienced PRODUCT AVAILABILITY ISSUE (Second dose scheduled more than 36 days after the first dose). At the time of the report, PRODUCT AVAILABILITY ISSUE (Second dose scheduled more than 36 days after the first dose) outcome was unknown.            Treatment information as not reported. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) is considered as not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021.