chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia, Rash, Vaccination site pain, Vertigo
Clinical narrative: arm was swollen and red, like an allergic reaction; vertigo/the room was spinning; big red square 3x3; big red square 3x3; freezing with chills and fever; fever of 101.2; burning at the injection site; nauseated; Headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PERIPHERAL SWELLING (arm was swollen and red, like an allergic reaction), ERYTHEMA (big red square 3x3), VERTIGO (vertigo/the room was spinning), RASH (big red square 3x3) and VACCINATION SITE PAIN (burning at the injection site) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002121A and 022B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (LEVOTHYROXINE [LEVOTHYROXINE SODIUM]) and ESTRADIOL for an unknown indication.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced VACCINATION SITE PAIN (burning at the injection site), NAUSEA (nauseated) and HEADACHE (Headache). On 22-Apr-2021, the patient experienced CHILLS (freezing with chills and fever) and PYREXIA (fever of 101.2). On 26-Apr-2021, the patient experienced ERYTHEMA (big red square 3x3) and RASH (big red square 3x3). On 05-May-2021, the patient experienced VERTIGO (vertigo/the room was spinning). On an unknown date, the patient experienced PERIPHERAL SWELLING (arm was swollen and red, like an allergic reaction). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Redness, at a dose of UNK dosage form. On 22-Apr-2021, CHILLS (freezing with chills and fever) and PYREXIA (fever of 101.2) had resolved. At the time of the report, PERIPHERAL SWELLING (arm was swollen and red, like an allergic reaction), ERYTHEMA (big red square 3x3), RASH (big red square 3x3), VACCINATION SITE PAIN (burning at the injection site), NAUSEA (nauseated) and HEADACHE (Headache) outcome was unknown and VERTIGO (vertigo/the room was spinning) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Apr-2021, Body temperature: 101.2 (High) 101.2.         The reporter has stated that the patient was taking an unknown medication for vertigo and that it was reported that the medication was not helpful. The patient was still experiencing vertigo from the vaccine. After getting first shot on 21 Apr 2021, exactly 14 days later, the patient had major vertigo.   Most recent FOLLOW-UP information incorporated above includes: On 13-Aug-2021: Follow up information received on 13-AUG-2021- Non significant follow up received
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 15 patients vaccinated after day 30 in the refrigerator; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (15 patients vaccinated after day 30 in the refrigerator) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) 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 EXPIRED PRODUCT ADMINISTERED (15 patients vaccinated after day 30 in the refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (15 patients vaccinated after day 30 in the refrigerator) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: sinus infection after first dose; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (sinus infection after first dose) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-May-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 SINUSITIS (sinus infection after first dose). At the time of the report, SINUSITIS (sinus infection after first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not reported. Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Fells fabulous after getting the vaccine/has more energy/has less brain fog; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Fells fabulous after getting the vaccine/has more energy/has less brain fog) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054C21A and 026B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included GABAPENTIN for an unknown indication.   On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-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 THERAPEUTIC RESPONSE UNEXPECTED (Fells fabulous after getting the vaccine/has more energy/has less brain fog). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Fells fabulous after getting the vaccine/has more energy/has less brain fog) outcome was unknown.            Treatment medication was not provided.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal distension
Clinical narrative: her stomach was very full and cannot eat much before full.; stomach larger than normal; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISTENSION (her stomach was very full and cannot eat much before full.) and ABDOMINAL DISCOMFORT (stomach larger than normal) in a 54-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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISTENSION (her stomach was very full and cannot eat much before full.) and ABDOMINAL DISCOMFORT (stomach larger than normal). At the time of the report, ABDOMINAL DISTENSION (her stomach was very full and cannot eat much before full.) and ABDOMINAL DISCOMFORT (stomach larger than normal) outcome was unknown.            No concomitant medications were reported.   Treatment medications were unknown.   The action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-231216 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: heart issues; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (heart issues) 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 CARDIAC DISORDER (heart issues). At the time of the report, CARDIAC DISORDER (heart issues) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided. No Treatment medications were not provided.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, Gastrointestinal pain, Hyperhidrosis, Mobility decreased, Therapeutic response unexpected
Clinical narrative: He had some cramps in his lower intestine; Couldn't go to the bathroom; He has some vertigo when he wakes up; sweaty; feels recovered and was able to exercise,feeling better; first 2 vaccines of Pfizer and again third one of moderna on 16 Jun 2021; This spontaneous case was reported by a consumer and describes the occurrence of GASTROINTESTINAL PAIN (He had some cramps in his lower intestine), MOBILITY DECREASED (Couldn't go to the bathroom), VERTIGO (He has some vertigo when he wakes up), HYPERHIDROSIS (sweaty) and THERAPEUTIC RESPONSE UNEXPECTED (feels recovered and was able to exercise,feeling better) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No medical history was provided by the reporter.  Concurrent medical conditions included Bladder cancer and Heart attack. Concomitant products included LISINOPRIL, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), CARVEDILOL, SPIRONOLACTONE and ATORVASTATIN for an unknown indication.   On 26-Feb-2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On 16-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced GASTROINTESTINAL PAIN (He had some cramps in his lower intestine), MOBILITY DECREASED (Couldn't go to the bathroom), VERTIGO (He has some vertigo when he wakes up), HYPERHIDROSIS (sweaty), THERAPEUTIC RESPONSE UNEXPECTED (feels recovered and was able to exercise,feeling better) and WRONG PRODUCT ADMINISTERED (first 2 vaccines of Pfizer and again third one of moderna on 16 Jun 2021). At the time of the report, GASTROINTESTINAL PAIN (He had some cramps in his lower intestine), MOBILITY DECREASED (Couldn't go to the bathroom), VERTIGO (He has some vertigo when he wakes up), HYPERHIDROSIS (sweaty), THERAPEUTIC RESPONSE UNEXPECTED (feels recovered and was able to exercise,feeling better) and WRONG PRODUCT ADMINISTERED (first 2 vaccines of Pfizer and again third one of moderna on 16 Jun 2021) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: high (High) Blood pressure is 150/125.     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 medication has been reported.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vertigo, Wrong product administered
Clinical narrative: He had some cramps in his lower intestine; Couldn't go to the bathroom; He has some vertigo when he wakes up; sweaty; feels recovered and was able to exercise,feeling better; first 2 vaccines of Pfizer and again third one of moderna on 16 Jun 2021; This spontaneous case was reported by a consumer and describes the occurrence of GASTROINTESTINAL PAIN (He had some cramps in his lower intestine), MOBILITY DECREASED (Couldn't go to the bathroom), VERTIGO (He has some vertigo when he wakes up), HYPERHIDROSIS (sweaty) and THERAPEUTIC RESPONSE UNEXPECTED (feels recovered and was able to exercise,feeling better) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No medical history was provided by the reporter.  Concurrent medical conditions included Bladder cancer and Heart attack. Concomitant products included LISINOPRIL, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), CARVEDILOL, SPIRONOLACTONE and ATORVASTATIN for an unknown indication.   On 26-Feb-2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On 16-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced GASTROINTESTINAL PAIN (He had some cramps in his lower intestine), MOBILITY DECREASED (Couldn't go to the bathroom), VERTIGO (He has some vertigo when he wakes up), HYPERHIDROSIS (sweaty), THERAPEUTIC RESPONSE UNEXPECTED (feels recovered and was able to exercise,feeling better) and WRONG PRODUCT ADMINISTERED (first 2 vaccines of Pfizer and again third one of moderna on 16 Jun 2021). At the time of the report, GASTROINTESTINAL PAIN (He had some cramps in his lower intestine), MOBILITY DECREASED (Couldn't go to the bathroom), VERTIGO (He has some vertigo when he wakes up), HYPERHIDROSIS (sweaty), THERAPEUTIC RESPONSE UNEXPECTED (feels recovered and was able to exercise,feeling better) and WRONG PRODUCT ADMINISTERED (first 2 vaccines of Pfizer and again third one of moderna on 16 Jun 2021) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: high (High) Blood pressure is 150/125.     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 medication has been reported.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Rash erythematous, Urticaria
Clinical narrative: Big red rash and she still has in her face, neck collar bone; breaking out in big welts, started out in the right side of her face and went up the neck, back of neck, hairline, back, mouth and now breaking out in arm, hand, and wrist; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (breaking out in big welts, started out in the right side of her face and went up the neck, back of neck, hairline, back, mouth and now breaking out in arm, hand, and wrist), RASH ERYTHEMATOUS (Big red rash and she still has in her face, neck collar bone), CHILLS (chills) and PYREXIA (fever) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 013A21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to plants (Allergy to Poison Ivy.), Allergy (Allergy to Oak.) and Blood pressure high. Concomitant products included HYDROCHLOROTHIAZIDE, TELMISARTAN (TELMISARTAN/HYDROCHLOROTHIAZIDE) for Hypertension.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced CHILLS (chills) and PYREXIA (fever). On 13-Jun-2021, the patient experienced URTICARIA (breaking out in big welts, started out in the right side of her face and went up the neck, back of neck, hairline, back, mouth and now breaking out in arm, hand, and wrist). On an unknown date, the patient experienced RASH ERYTHEMATOUS (Big red rash and she still has in her face, neck collar bone). At the time of the report, URTICARIA (breaking out in big welts, started out in the right side of her face and went up the neck, back of neck, hairline, back, mouth and now breaking out in arm, hand, and wrist) and RASH ERYTHEMATOUS (Big red rash and she still has in her face, neck collar bone) had not resolved and CHILLS (chills) and PYREXIA (fever) had resolved.            No treatments were provided.   This case was linked to MOD-2021-231517 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: She is past the 42 day window between first and second shot / Has not received her second dose; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She is past the 42 day window between first and second shot / Has not received her second dose) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She is past the 42 day window between first and second shot / Has not received her second dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She is past the 42 day window between first and second shot / Has not received her second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication provided. No treatment information mentioned. No patient history provided.    Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Second dose after day 42; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Second dose after day 42   ) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Second dose after day 42   ). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Second dose after day 42   ) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: isn't going to get the second dose in the series from Moderna's vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (isn't going to get the second dose in the series from Moderna's vaccine) 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 PRODUCT DOSE OMISSION ISSUE (isn't going to get the second dose in the series from Moderna's vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (isn't going to get the second dose in the series from Moderna's vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were provided
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discolouration
Clinical narrative: pink spot below the injection site after second dose; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE DISCOLOURATION (pink spot below the injection site after second dose) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jun-2021, the patient experienced VACCINATION SITE DISCOLOURATION (pink spot below the injection site after second dose). At the time of the report, VACCINATION SITE DISCOLOURATION (pink spot below the injection site after second dose) outcome was unknown. Not Provided          No concomitant medications were reported. No treatment information was provided by the reporter.    This case was linked to MOD-2021-230043 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: had the same rash that he got; 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 RASH (had the same rash that he got) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (had the same rash that he got). At the time of the report, RASH (had the same rash that he got) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided  Treatment medication was not provided by the reporter    Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Non Significant follow-up received on 16-JUN-2021. Mailing address was updated
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: I got sick on first injection; 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 ILLNESS (I got sick on first injection) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (I got sick on first injection). At the time of the report, ILLNESS (I got sick on first injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment medication was reported.   This case was linked to MOD-2021-231578 (Patient Link).
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Fatigue, Hypoaesthesia, Musculoskeletal discomfort
Clinical narrative: felt numbness going down his arm immediately after the injection; whole left arm fell asleep and numb; unable to sleep on his left side/shoulder for 3 nights; energy was gone; fatigued after getting the vaccine and so had to go for nap; pain in his left shoulder, and still feels that sometimes the sensation is still there; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (felt numbness going down his arm immediately after the injection), HYPOAESTHESIA (whole left arm fell asleep and numb), MUSCULOSKELETAL DISCOMFORT (unable to sleep on his left side/shoulder for 3 nights), ASTHENIA (energy was gone) and FATIGUE (fatigued after getting the vaccine and so had to go for nap) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jun-2021, the patient experienced HYPOAESTHESIA (felt numbness going down his arm immediately after the injection), HYPOAESTHESIA (whole left arm fell asleep and numb), MUSCULOSKELETAL DISCOMFORT (unable to sleep on his left side/shoulder for 3 nights), ASTHENIA (energy was gone), FATIGUE (fatigued after getting the vaccine and so had to go for nap) and ARTHRALGIA (pain in his left shoulder, and still feels that sometimes the sensation is still there). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. At the time of the report, HYPOAESTHESIA (felt numbness going down his arm immediately after the injection), HYPOAESTHESIA (whole left arm fell asleep and numb), MUSCULOSKELETAL DISCOMFORT (unable to sleep on his left side/shoulder for 3 nights), ASTHENIA (energy was gone), FATIGUE (fatigued after getting the vaccine and so had to go for nap) and ARTHRALGIA (pain in his left shoulder, and still feels that sometimes the sensation is still there) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information, if any, was not provided by the reporter.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Bone pain, Dizziness, Dyspnoea, Eye swelling
Clinical narrative: Now has bone pain; Hard to eat; Joint pain in jaw and teeth; Joint pain in jaw and teeth; Fever; Allergic reaction; Hives all over the body; Difficulty breathing; Swollen lips; Swollen eyes; Numbness in hands and feet; Numbness in hands and feet; Felt very dizzy; Was out of it; Massive stomach pain; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Allergic reaction), URTICARIA (Hives all over the body), DYSPNOEA (Difficulty breathing), LIP SWELLING (Swollen lips) and EYE SWELLING (Swollen eyes) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Nickel sensitivity and Allergy to metals (Lithium). Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for an unknown indication.    On 18-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jun-2021, the patient experienced HYPERSENSITIVITY (Allergic reaction), URTICARIA (Hives all over the body), DYSPNOEA (Difficulty breathing), LIP SWELLING (Swollen lips), EYE SWELLING (Swollen eyes), the first episode of HYPOAESTHESIA (Numbness in hands and feet), the second episode of HYPOAESTHESIA (Numbness in hands and feet), DIZZINESS (Felt very dizzy), FEELING ABNORMAL (Was out of it) and ABDOMINAL PAIN UPPER (Massive stomach pain). On an unknown date, the patient experienced BONE PAIN (Now has bone pain), PYREXIA (Fever), MASTICATION DISORDER (Hard to eat), PAIN IN JAW (Joint pain in jaw and teeth) and TOOTHACHE (Joint pain in jaw and teeth). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, DIPHENHYDRAMINE HYDROCHLORIDE, PSEUDOEPHEDRINE (BENADRYL CHILDREN [DEXTROMETHORPHAN HYDROBROMIDE;DIPHENHYDRAMINE HYDROCHLORIDE;PSEUDOEPHEDRINE]) at an unspecified dose and frequency; PREDNISONE for Stomach pain, at an unspecified dose and frequency and HYDROCODONE for Stomach pain, at an unspecified dose and frequency. At the time of the report, HYPERSENSITIVITY (Allergic reaction), URTICARIA (Hives all over the body), DYSPNOEA (Difficulty breathing), LIP SWELLING (Swollen lips), EYE SWELLING (Swollen eyes) and the last episode of HYPOAESTHESIA (Numbness in hands and feet) had not resolved and DIZZINESS (Felt very dizzy), FEELING ABNORMAL (Was out of it), ABDOMINAL PAIN UPPER (Massive stomach pain), BONE PAIN (Now has bone pain), PYREXIA (Fever), MASTICATION DISORDER (Hard to eat), PAIN IN JAW (Joint pain in jaw and teeth) and TOOTHACHE (Joint pain in jaw and teeth) 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.   Patient stated that she could not afford to go to the ER.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypersensitivity, Hypoaesthesia, Lip swelling, Mastication disorder
Clinical narrative: Now has bone pain; Hard to eat; Joint pain in jaw and teeth; Joint pain in jaw and teeth; Fever; Allergic reaction; Hives all over the body; Difficulty breathing; Swollen lips; Swollen eyes; Numbness in hands and feet; Numbness in hands and feet; Felt very dizzy; Was out of it; Massive stomach pain; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Allergic reaction), URTICARIA (Hives all over the body), DYSPNOEA (Difficulty breathing), LIP SWELLING (Swollen lips) and EYE SWELLING (Swollen eyes) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Nickel sensitivity and Allergy to metals (Lithium). Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for an unknown indication.    On 18-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jun-2021, the patient experienced HYPERSENSITIVITY (Allergic reaction), URTICARIA (Hives all over the body), DYSPNOEA (Difficulty breathing), LIP SWELLING (Swollen lips), EYE SWELLING (Swollen eyes), the first episode of HYPOAESTHESIA (Numbness in hands and feet), the second episode of HYPOAESTHESIA (Numbness in hands and feet), DIZZINESS (Felt very dizzy), FEELING ABNORMAL (Was out of it) and ABDOMINAL PAIN UPPER (Massive stomach pain). On an unknown date, the patient experienced BONE PAIN (Now has bone pain), PYREXIA (Fever), MASTICATION DISORDER (Hard to eat), PAIN IN JAW (Joint pain in jaw and teeth) and TOOTHACHE (Joint pain in jaw and teeth). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, DIPHENHYDRAMINE HYDROCHLORIDE, PSEUDOEPHEDRINE (BENADRYL CHILDREN [DEXTROMETHORPHAN HYDROBROMIDE;DIPHENHYDRAMINE HYDROCHLORIDE;PSEUDOEPHEDRINE]) at an unspecified dose and frequency; PREDNISONE for Stomach pain, at an unspecified dose and frequency and HYDROCODONE for Stomach pain, at an unspecified dose and frequency. At the time of the report, HYPERSENSITIVITY (Allergic reaction), URTICARIA (Hives all over the body), DYSPNOEA (Difficulty breathing), LIP SWELLING (Swollen lips), EYE SWELLING (Swollen eyes) and the last episode of HYPOAESTHESIA (Numbness in hands and feet) had not resolved and DIZZINESS (Felt very dizzy), FEELING ABNORMAL (Was out of it), ABDOMINAL PAIN UPPER (Massive stomach pain), BONE PAIN (Now has bone pain), PYREXIA (Fever), MASTICATION DISORDER (Hard to eat), PAIN IN JAW (Joint pain in jaw and teeth) and TOOTHACHE (Joint pain in jaw and teeth) 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.   Patient stated that she could not afford to go to the ER.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in jaw, Pyrexia, Toothache, Urticaria
Clinical narrative: Now has bone pain; Hard to eat; Joint pain in jaw and teeth; Joint pain in jaw and teeth; Fever; Allergic reaction; Hives all over the body; Difficulty breathing; Swollen lips; Swollen eyes; Numbness in hands and feet; Numbness in hands and feet; Felt very dizzy; Was out of it; Massive stomach pain; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Allergic reaction), URTICARIA (Hives all over the body), DYSPNOEA (Difficulty breathing), LIP SWELLING (Swollen lips) and EYE SWELLING (Swollen eyes) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Nickel sensitivity and Allergy to metals (Lithium). Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for an unknown indication.    On 18-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jun-2021, the patient experienced HYPERSENSITIVITY (Allergic reaction), URTICARIA (Hives all over the body), DYSPNOEA (Difficulty breathing), LIP SWELLING (Swollen lips), EYE SWELLING (Swollen eyes), the first episode of HYPOAESTHESIA (Numbness in hands and feet), the second episode of HYPOAESTHESIA (Numbness in hands and feet), DIZZINESS (Felt very dizzy), FEELING ABNORMAL (Was out of it) and ABDOMINAL PAIN UPPER (Massive stomach pain). On an unknown date, the patient experienced BONE PAIN (Now has bone pain), PYREXIA (Fever), MASTICATION DISORDER (Hard to eat), PAIN IN JAW (Joint pain in jaw and teeth) and TOOTHACHE (Joint pain in jaw and teeth). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, DIPHENHYDRAMINE HYDROCHLORIDE, PSEUDOEPHEDRINE (BENADRYL CHILDREN [DEXTROMETHORPHAN HYDROBROMIDE;DIPHENHYDRAMINE HYDROCHLORIDE;PSEUDOEPHEDRINE]) at an unspecified dose and frequency; PREDNISONE for Stomach pain, at an unspecified dose and frequency and HYDROCODONE for Stomach pain, at an unspecified dose and frequency. At the time of the report, HYPERSENSITIVITY (Allergic reaction), URTICARIA (Hives all over the body), DYSPNOEA (Difficulty breathing), LIP SWELLING (Swollen lips), EYE SWELLING (Swollen eyes) and the last episode of HYPOAESTHESIA (Numbness in hands and feet) had not resolved and DIZZINESS (Felt very dizzy), FEELING ABNORMAL (Was out of it), ABDOMINAL PAIN UPPER (Massive stomach pain), BONE PAIN (Now has bone pain), PYREXIA (Fever), MASTICATION DISORDER (Hard to eat), PAIN IN JAW (Joint pain in jaw and teeth) and TOOTHACHE (Joint pain in jaw and teeth) 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.   Patient stated that she could not afford to go to the ER.
Sex: F
Vaccine: COVID19
Symptoms: Diverticulitis, Product dose omission issue
Clinical narrative: Did not get 2nd dose due to "problems with diverticulitis" and missed appointment; was supposed to receive 2nd dose on 2Jun2021 but had "problems with diverticulitis" and never ended up making it to 2nd dose appointment.; This spontaneous case was reported by a consumer and describes the occurrence of DIVERTICULITIS (Did not get 2nd dose due to "problems with diverticulitis" and missed appointment) and PRODUCT DOSE OMISSION ISSUE (was supposed to receive 2nd dose on 2Jun2021 but had "problems with diverticulitis" and never ended up making it to 2nd dose appointment.) 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 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (was supposed to receive 2nd dose on 2Jun2021 but had "problems with diverticulitis" and never ended up making it to 2nd dose appointment.). On 02-Jun-2021, the patient experienced DIVERTICULITIS (Did not get 2nd dose due to "problems with diverticulitis" and missed appointment). At the time of the report, DIVERTICULITIS (Did not get 2nd dose due to "problems with diverticulitis" and missed appointment) and PRODUCT DOSE OMISSION ISSUE (was supposed to receive 2nd dose on 2Jun2021 but had "problems with diverticulitis" and never ended up making it to 2nd dose appointment.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided by the reporter. Consumer was called 22 JUN 2021 with medical information questions. Follow up consent was declined.  Company Comment: Very limited information regarding this event of diverticulitis has been provided at this time.  Further information has been requested  For product dose omission issue, causality is assessed as not applicable; Sender's Comments: Very limited information regarding this event of diverticulitis has been provided at this time.  Further information has been requested  For product dose omission issue, causality is assessed as not applicable
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Product dose omission issue
Clinical narrative: missed second dose; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed second dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 PRODUCT DOSE OMISSION ISSUE (missed second dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed second dose) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved.            Concomitant medication was not provided.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow-up received on 27 Jul 2021, contains updated information on second dose and added new event inappropriate schedule of vaccine administration.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Nausea, Vaccination site pain
Clinical narrative: Pain in the arm; Nausea; Headache; 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 SITE PAIN (Pain in the arm), NAUSEA (Nausea) and HEADACHE (Headache) 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 SITE PAIN (Pain in the arm), NAUSEA (Nausea) and HEADACHE (Headache). At the time of the report, VACCINATION SITE PAIN (Pain in the arm), NAUSEA (Nausea) and HEADACHE (Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication was reported.  No Treatment medication was reported.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Had the same rash that he got; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Had the same rash that he got) 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 RASH (Had the same rash that he got). At the time of the report, RASH (Had the same rash that he got) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: TCR  document received on 16-JUL-2021 Contain AE outcome.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Consumer reported she had symptoms after receiving the 1st vaccine; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION COMPLICATION (Consumer reported she had symptoms after receiving the 1st vaccine) 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 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Consumer reported she had symptoms after receiving the 1st vaccine). At the time of the report, VACCINATION COMPLICATION (Consumer reported she had symptoms after receiving the 1st vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Dermatitis atopic, Dyspnoea, Intentional dose omission, Limb injury, Musculoskeletal disorder
Clinical narrative: Hand injury; Musculoskeletal disorder; Edema legs; Shortness of breath; Atopic dermatitis; Unevaluable event; Intentional dose omission; Skin breakout; This spontaneous case was reported by a consumer and describes the occurrence of LIMB INJURY (Hand injury), MUSCULOSKELETAL DISORDER (Musculoskeletal disorder), OEDEMA PERIPHERAL (Edema legs), DYSPNOEA (Shortness of breath) and DERMATITIS ATOPIC (Atopic dermatitis) in an 88-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.    Co-suspect product included non-company product DUPILUMAB injection for Atopic dermatitis and Nasal polyps.    No Medical History information was reported.   On 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Jun-2021, the patient started DUPILUMAB (Subcutaneous) 600 milligram. 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 LIMB INJURY (Hand injury), MUSCULOSKELETAL DISORDER (Musculoskeletal disorder), OEDEMA PERIPHERAL (Edema legs), DYSPNOEA (Shortness of breath), DERMATITIS ATOPIC (Atopic dermatitis), UNEVALUABLE EVENT (Unevaluable event), INTENTIONAL DOSE OMISSION (Intentional dose omission) and RASH (Skin breakout). The patient was treated with PREDNISONE for Limb injury and Musculoskeletal disorder, at a dose of 1 dosage form. At the time of the report, LIMB INJURY (Hand injury) and MUSCULOSKELETAL DISORDER (Musculoskeletal disorder) was resolving, OEDEMA PERIPHERAL (Edema legs), DYSPNOEA (Shortness of breath), DERMATITIS ATOPIC (Atopic dermatitis) and UNEVALUABLE EVENT (Unevaluable event) had not resolved and INTENTIONAL DOSE OMISSION (Intentional dose omission) and RASH (Skin breakout) had resolved.            Concomitant medication was not provided.  Action taken with respect to mRNA-1273 was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: TCR received on 16-07-2021 contain no new information
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Oedema peripheral, Rash, Unevaluable event
Clinical narrative: Hand injury; Musculoskeletal disorder; Edema legs; Shortness of breath; Atopic dermatitis; Unevaluable event; Intentional dose omission; Skin breakout; This spontaneous case was reported by a consumer and describes the occurrence of LIMB INJURY (Hand injury), MUSCULOSKELETAL DISORDER (Musculoskeletal disorder), OEDEMA PERIPHERAL (Edema legs), DYSPNOEA (Shortness of breath) and DERMATITIS ATOPIC (Atopic dermatitis) in an 88-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.    Co-suspect product included non-company product DUPILUMAB injection for Atopic dermatitis and Nasal polyps.    No Medical History information was reported.   On 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Jun-2021, the patient started DUPILUMAB (Subcutaneous) 600 milligram. 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 LIMB INJURY (Hand injury), MUSCULOSKELETAL DISORDER (Musculoskeletal disorder), OEDEMA PERIPHERAL (Edema legs), DYSPNOEA (Shortness of breath), DERMATITIS ATOPIC (Atopic dermatitis), UNEVALUABLE EVENT (Unevaluable event), INTENTIONAL DOSE OMISSION (Intentional dose omission) and RASH (Skin breakout). The patient was treated with PREDNISONE for Limb injury and Musculoskeletal disorder, at a dose of 1 dosage form. At the time of the report, LIMB INJURY (Hand injury) and MUSCULOSKELETAL DISORDER (Musculoskeletal disorder) was resolving, OEDEMA PERIPHERAL (Edema legs), DYSPNOEA (Shortness of breath), DERMATITIS ATOPIC (Atopic dermatitis) and UNEVALUABLE EVENT (Unevaluable event) had not resolved and INTENTIONAL DOSE OMISSION (Intentional dose omission) and RASH (Skin breakout) had resolved.            Concomitant medication was not provided.  Action taken with respect to mRNA-1273 was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: TCR received on 16-07-2021 contain no new information
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: Adverse reaction until 40hrs after the second shot; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Adverse reaction until 40hrs after the second shot) 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 ADVERSE REACTION (Adverse reaction until 40hrs after the second shot). At the time of the report, ADVERSE REACTION (Adverse reaction until 40hrs after the second shot) had resolved.            The action taken for mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) was NOT APPLICABLE.   No concomitant medication was reported.  No treatment medication was reported.   This case was linked to MOD-2021-054243 (Patient Link).