chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Mental disorder, Myalgia, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: administered the second dose earlier than 28 days; mental disorientation; dizziness; itching at injection site; headaches; muscle pain; fatigue; chills; swelling at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (administered the second dose earlier than 28 days), HEADACHE (headaches), MYALGIA (muscle pain), FATIGUE (fatigue) and CHILLS (chills) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma and Allergy.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2021, the patient experienced HEADACHE (headaches), MYALGIA (muscle pain), FATIGUE (fatigue), CHILLS (chills), VACCINATION SITE PRURITUS (itching at injection site), VACCINATION SITE SWELLING (swelling at injection site), DIZZINESS (dizziness) and MENTAL DISORDER (mental disorientation). On 27-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (administered the second dose earlier than 28 days). The patient was treated with PARACETAMOL (TYLENOL) in February 2021 for Adverse reaction, at a dose of 1 dosage form. On 27-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (administered the second dose earlier than 28 days) had resolved. At the time of the report, HEADACHE (headaches), MYALGIA (muscle pain), FATIGUE (fatigue), CHILLS (chills), VACCINATION SITE PRURITUS (itching at injection site), VACCINATION SITE SWELLING (swelling at injection site), DIZZINESS (dizziness) and MENTAL DISORDER (mental disorientation) had not resolved.            Patient's concomitant medications included unspecified medicines for asthma and allergies.  Patient experienced these symptoms following both the vaccination doses. Patient took Acetaminophen as treatment as reported that it had helped. Patient also reported that a lot the adverse events she experienced would come and go, and the patient was not fully recovered from it.   This case was linked to MOD-2021-037556 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Lip swelling, Malaise, Pain in extremity
Clinical narrative: Pain in her arm extending to the legs; felt so sick; chest pain; lips got swollen up; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in her arm extending to the legs), MALAISE (felt so sick), CHEST PAIN (chest pain) and LIP SWELLING (lips got swollen up) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in her arm extending to the legs), MALAISE (felt so sick), CHEST PAIN (chest pain) and LIP SWELLING (lips got swollen up). At the time of the report, PAIN IN EXTREMITY (Pain in her arm extending to the legs), MALAISE (felt so sick), CHEST PAIN (chest pain) and LIP SWELLING (lips got swollen up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.  Concomitant products included Thyroid medication. Treatment medication included Penedral.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Pruritus, Rash, Vulvovaginal burning sensation, Vulvovaginal pruritus
Clinical narrative: Rash on leg and groin; Burning on the inside of her left leg and top of vagina; Itch on the inside of her left leg and top of vagina; Burning on the inside of her left leg and top of vagina; Burning itch on the inside of her left leg and top of vagina; This spontaneous case was reported by a consumer and describes the occurrence of VULVOVAGINAL BURNING SENSATION (Burning on the inside of her left leg and top of vagina), VULVOVAGINAL PRURITUS (Itch on the inside of her left leg and top of vagina), BURNING SENSATION (Burning on the inside of her left leg and top of vagina), PRURITUS (Burning itch on the inside of her left leg and top of vagina) and RASH (Rash on leg and groin) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 306A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced VULVOVAGINAL BURNING SENSATION (Burning on the inside of her left leg and top of vagina), VULVOVAGINAL PRURITUS (Itch on the inside of her left leg and top of vagina), BURNING SENSATION (Burning on the inside of her left leg and top of vagina) and PRURITUS (Burning itch on the inside of her left leg and top of vagina). On 10-Mar-2021, the patient experienced RASH (Rash on leg and groin). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and FLUOCINONIDE (topical) at an unspecified dose and frequency. At the time of the report, VULVOVAGINAL BURNING SENSATION (Burning on the inside of her left leg and top of vagina), VULVOVAGINAL PRURITUS (Itch on the inside of her left leg and top of vagina), BURNING SENSATION (Burning on the inside of her left leg and top of vagina), PRURITUS (Burning itch on the inside of her left leg and top of vagina) and RASH (Rash on leg and groin) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 14 year old received the Moderna COVID19 Vaccine; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 year old received the Moderna COVID19 Vaccine) in a 14-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 year old received the Moderna COVID19 Vaccine). On 24-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 year old received the Moderna COVID19 Vaccine) had resolved. 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.   Concomitant product use was not provided by the reporter. No treatment information was provided.   This case was linked to MOD21-069865, MOD-2021-067272, US-MODERNATX, INC.-MOD-2021-067272 (E2B Linked Report).; Sender's Comments: This report refers to a case of Product administered to patient of inappropriate age for mRNA-1273, lot #016B21A with no associated AEs. MOD21-069865: MOD-2021-067272:Same reporter US-MODERNATX, INC.-MOD-2021-067272:Sister case
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Back pain, Groin pain, Musculoskeletal pain, Pain in extremity
Clinical narrative: Back pain; Pain in his groin area; Pain in stomach muscles area; Butt aches; Pain in his thighs; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BACK PAIN (Back pain), GROIN PAIN (Pain in his groin area), ABDOMINAL PAIN UPPER (Pain in stomach muscles area), MUSCULOSKELETAL PAIN (Butt aches) and PAIN IN EXTREMITY (Pain in his thighs) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced BACK PAIN (Back pain), GROIN PAIN (Pain in his groin area), ABDOMINAL PAIN UPPER (Pain in stomach muscles area), MUSCULOSKELETAL PAIN (Butt aches) and PAIN IN EXTREMITY (Pain in his thighs). At the time of the report, BACK PAIN (Back pain), GROIN PAIN (Pain in his groin area), ABDOMINAL PAIN UPPER (Pain in stomach muscles area), MUSCULOSKELETAL PAIN (Butt aches) and PAIN IN EXTREMITY (Pain in his thighs) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient stated that he visited a health care provider on 15-Mar-2021 and also on 5-Apr-2021 and has yet to receive any sort of treatment for events.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chest wall mass, Fatigue, Migraine, Nausea, Vaccination site pain
Clinical narrative: Soreness at the shot site; nauseated; Tired; Knot in her chest; Trigerred her migraine; This spontaneous case was reported by a consumer and describes the occurrence of CHEST WALL MASS (Knot in her chest), MIGRAINE (Trigerred her migraine), VACCINATION SITE PAIN (Soreness at the shot site), NAUSEA (nauseated) and FATIGUE (Tired) 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 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced MIGRAINE (Trigerred her migraine). On 19-Mar-2021, the patient experienced CHEST WALL MASS (Knot in her chest). On an unknown date, the patient experienced VACCINATION SITE PAIN (Soreness at the shot site), NAUSEA (nauseated) and FATIGUE (Tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 08-Mar-2021, MIGRAINE (Trigerred her migraine) had resolved. At the time of the report, CHEST WALL MASS (Knot in her chest), VACCINATION SITE PAIN (Soreness at the shot site), NAUSEA (nauseated) and FATIGUE (Tired) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications was not provided by the reporter.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Follow up received on 16-Jun-2021, patient reported feeling better, events outcome updated from unknown to recovering.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product administration duration
Clinical narrative: There was an email rescheduling glitch, & has not received the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT PRODUCT ADMINISTRATION DURATION (There was an email rescheduling glitch, & has not received the 2nd dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced INCORRECT PRODUCT ADMINISTRATION DURATION (There was an email rescheduling glitch, & has not received the 2nd dose). At the time of the report, INCORRECT PRODUCT ADMINISTRATION DURATION (There was an email rescheduling glitch, & has not received the 2nd dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue
Clinical narrative: Diarrhea; Tired; 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 DIARRHOEA (Diarrhea) and FATIGUE (Tired) 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 DIARRHOEA (Diarrhea) and FATIGUE (Tired). At the time of the report, DIARRHOEA (Diarrhea) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient knew of others who received Moderna and Pfizer vaccines and experienced diarrhea and tired. No concomitant medications were reported. No treatment information was provided.    This case was linked to MOD21-069669 (E2B Linked Report).; Sender's Comments:  MOD21-069669:patient's case
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Myalgia, Paraesthesia oral, Peripheral swelling
Clinical narrative: Tingling on tongue; swelling of lymph nodes on neck and arm of injection; swelling of lymph nodes on neck and arm of injection; Muscles and joint hurts; Muscles and joint hurts; Headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PARAESTHESIA ORAL (Tingling on tongue), SWELLING (swelling of lymph nodes on neck and arm of injection), PERIPHERAL SWELLING (swelling of lymph nodes on neck and arm of injection), MYALGIA (Muscles and joint hurts) and ARTHRALGIA (Muscles and joint hurts) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A42A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included COLECALCIFEROL, MENAQUINONE-7, PHYTOMENADIONE, RETINOL PALMITATE, TOCOPHEROL, TOCOTRIENOLS NOS (VITAMIN D COMPLEX) and ACETAMINOPHEN for an unknown indication.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced PARAESTHESIA ORAL (Tingling on tongue), SWELLING (swelling of lymph nodes on neck and arm of injection), PERIPHERAL SWELLING (swelling of lymph nodes on neck and arm of injection), MYALGIA (Muscles and joint hurts), ARTHRALGIA (Muscles and joint hurts) and HEADACHE (Headache). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 50 mg. At the time of the report, PARAESTHESIA ORAL (Tingling on tongue), SWELLING (swelling of lymph nodes on neck and arm of injection) and PERIPHERAL SWELLING (swelling of lymph nodes on neck and arm of injection) had resolved and MYALGIA (Muscles and joint hurts), ARTHRALGIA (Muscles and joint hurts) and HEADACHE (Headache) outcome was unknown.            Other relevant concomitant medications included berry tablets.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Tingling on tongue; swelling of lymph nodes on neck and arm of injection; swelling of lymph nodes on neck and arm of injection; Muscles and joint hurts; Muscles and joint hurts; Headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PARAESTHESIA ORAL (Tingling on tongue), SWELLING (swelling of lymph nodes on neck and arm of injection), PERIPHERAL SWELLING (swelling of lymph nodes on neck and arm of injection), MYALGIA (Muscles and joint hurts) and ARTHRALGIA (Muscles and joint hurts) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A42A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included COLECALCIFEROL, MENAQUINONE-7, PHYTOMENADIONE, RETINOL PALMITATE, TOCOPHEROL, TOCOTRIENOLS NOS (VITAMIN D COMPLEX) and ACETAMINOPHEN for an unknown indication.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced PARAESTHESIA ORAL (Tingling on tongue), SWELLING (swelling of lymph nodes on neck and arm of injection), PERIPHERAL SWELLING (swelling of lymph nodes on neck and arm of injection), MYALGIA (Muscles and joint hurts), ARTHRALGIA (Muscles and joint hurts) and HEADACHE (Headache). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 50 mg. At the time of the report, PARAESTHESIA ORAL (Tingling on tongue), SWELLING (swelling of lymph nodes on neck and arm of injection) and PERIPHERAL SWELLING (swelling of lymph nodes on neck and arm of injection) had resolved and MYALGIA (Muscles and joint hurts), ARTHRALGIA (Muscles and joint hurts) and HEADACHE (Headache) outcome was unknown.            Other relevant concomitant medications included berry tablets.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Redness; Itching; Rash; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness), PRURITUS (Itching) and RASH (Rash) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced ERYTHEMA (Redness), PRURITUS (Itching) and RASH (Rash). The patient was treated with GLYCYRRHIZA GLABRA, OLEA EUROPAEA OIL, PRUNUS DULCIS OIL (BABY LOTION) at an unspecified dose and frequency. At the time of the report, ERYTHEMA (Redness), PRURITUS (Itching) and RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17yr old received Moderna vaccine; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17yr old received Moderna vaccine) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17yr old received Moderna vaccine). On 09-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17yr old received Moderna vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  Treatment information was not provided..   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Translated document received on 14-JUN-2021 . No new information reported.; Sender's Comments: This report refers to a case of Product administered to patient of inappropriate age, for mRNA-1273, lot # 030A21A,  with no associated AEs.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: didnt feel well; feeling nauseous; having a headache; Chills; body aches; felt tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (didnt feel well), NAUSEA (feeling nauseous), HEADACHE (having a headache), CHILLS (Chills) and MYALGIA (body aches) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 024N20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced VACCINATION COMPLICATION (didnt feel well), NAUSEA (feeling nauseous), HEADACHE (having a headache), CHILLS (Chills), MYALGIA (body aches) and FATIGUE (felt tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 04-Apr-2021, VACCINATION COMPLICATION (didnt feel well), NAUSEA (feeling nauseous), HEADACHE (having a headache), CHILLS (Chills), MYALGIA (body aches) and FATIGUE (felt tired) had resolved.            No relevant concomitant medications reported. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: didnt feel well; feeling nauseous; having a headache; Chills; body aches; felt tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (didnt feel well), NAUSEA (feeling nauseous), HEADACHE (having a headache), CHILLS (Chills) and MYALGIA (body aches) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 024N20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced VACCINATION COMPLICATION (didnt feel well), NAUSEA (feeling nauseous), HEADACHE (having a headache), CHILLS (Chills), MYALGIA (body aches) and FATIGUE (felt tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 04-Apr-2021, VACCINATION COMPLICATION (didnt feel well), NAUSEA (feeling nauseous), HEADACHE (having a headache), CHILLS (Chills), MYALGIA (body aches) and FATIGUE (felt tired) had resolved.            No relevant concomitant medications reported. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Dyspnoea
Clinical narrative: some breathing problems; Dizzy; weak; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (some breathing problems), DIZZINESS (Dizzy) and ASTHENIA (weak) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in January 2021.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced DYSPNOEA (some breathing problems), DIZZINESS (Dizzy) and ASTHENIA (weak). At the time of the report, DYSPNOEA (some breathing problems), DIZZINESS (Dizzy) and ASTHENIA (weak) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. The patient stated that the events might be due to her previous positive for COVID-19 in JAN-2021. No treatment information was provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest discomfort, Disorientation, Eye disorder, Nausea
Clinical narrative: she felt tingling down her arm into her fingertips like going numb; tightening of her chest, head and sinus cavity; tightening of her chest, head and sinus cavity; stabbing pain in her right eye; felt very very weak; disoriented; tightening of her chest, head and sinus cavity; a little nausea; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (she felt tingling down her arm into her fingertips like going numb), TENSION HEADACHE (tightening of her chest, head and sinus cavity), SINUS HEADACHE (tightening of her chest, head and sinus cavity), EYE DISORDER (stabbing pain in her right eye) and ASTHENIA (felt very very weak) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 075A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced PARAESTHESIA (she felt tingling down her arm into her fingertips like going numb), TENSION HEADACHE (tightening of her chest, head and sinus cavity), SINUS HEADACHE (tightening of her chest, head and sinus cavity), EYE DISORDER (stabbing pain in her right eye), ASTHENIA (felt very very weak), DISORIENTATION (disoriented), CHEST DISCOMFORT (tightening of her chest, head and sinus cavity) and NAUSEA (a little nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 17-Mar-2021, PARAESTHESIA (she felt tingling down her arm into her fingertips like going numb), EYE DISORDER (stabbing pain in her right eye), ASTHENIA (felt very very weak), DISORIENTATION (disoriented), CHEST DISCOMFORT (tightening of her chest, head and sinus cavity) and NAUSEA (a little nausea) had resolved. On 18-Mar-2021, TENSION HEADACHE (tightening of her chest, head and sinus cavity) and SINUS HEADACHE (tightening of her chest, head and sinus cavity) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Sinus headache, Tension headache
Clinical narrative: she felt tingling down her arm into her fingertips like going numb; tightening of her chest, head and sinus cavity; tightening of her chest, head and sinus cavity; stabbing pain in her right eye; felt very very weak; disoriented; tightening of her chest, head and sinus cavity; a little nausea; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (she felt tingling down her arm into her fingertips like going numb), TENSION HEADACHE (tightening of her chest, head and sinus cavity), SINUS HEADACHE (tightening of her chest, head and sinus cavity), EYE DISORDER (stabbing pain in her right eye) and ASTHENIA (felt very very weak) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 075A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced PARAESTHESIA (she felt tingling down her arm into her fingertips like going numb), TENSION HEADACHE (tightening of her chest, head and sinus cavity), SINUS HEADACHE (tightening of her chest, head and sinus cavity), EYE DISORDER (stabbing pain in her right eye), ASTHENIA (felt very very weak), DISORIENTATION (disoriented), CHEST DISCOMFORT (tightening of her chest, head and sinus cavity) and NAUSEA (a little nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 17-Mar-2021, PARAESTHESIA (she felt tingling down her arm into her fingertips like going numb), EYE DISORDER (stabbing pain in her right eye), ASTHENIA (felt very very weak), DISORIENTATION (disoriented), CHEST DISCOMFORT (tightening of her chest, head and sinus cavity) and NAUSEA (a little nausea) had resolved. On 18-Mar-2021, TENSION HEADACHE (tightening of her chest, head and sinus cavity) and SINUS HEADACHE (tightening of her chest, head and sinus cavity) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication provided.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Muscle spasms, Vaccination site pain
Clinical narrative: Minimum bone pain; Had cramps on that same arm( right one); Felt the pain of the needle on her arm; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Minimum bone pain), MUSCLE SPASMS (Had cramps on that same arm( right one)) and VACCINATION SITE PAIN (Felt the pain of the needle on her arm) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. Concurrent medical conditions included Blood pressure high. Concomitant products included VITAMINS NOS for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE PAIN (Felt the pain of the needle on her arm). On 06-Feb-2021, the patient experienced BONE PAIN (Minimum bone pain) and MUSCLE SPASMS (Had cramps on that same arm( right one)). On 05-Feb-2021, VACCINATION SITE PAIN (Felt the pain of the needle on her arm) had resolved. On 06-Feb-2021, BONE PAIN (Minimum bone pain) and MUSCLE SPASMS (Had cramps on that same arm( right one)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Other relevant concomitant medication included blood pressure medications.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-067366 (E2B Linked Report). This case was linked to MOD-2021-067366 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-067366:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pain, Vaccination site discolouration
Clinical narrative: injection site was pink; Soreness; nausea; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (injection site was pink), PAIN (Soreness), NAUSEA (nausea) and FATIGUE (tiredness) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in October 2020. Concurrent medical conditions included Diabetes.    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 DISCOLOURATION (injection site was pink), PAIN (Soreness), NAUSEA (nausea) and FATIGUE (tiredness). At the time of the report, VACCINATION SITE DISCOLOURATION (injection site was pink), PAIN (Soreness), NAUSEA (nausea) and FATIGUE (tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided. No treatments medications were reported.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Hypersensitivity, Pyrexia
Clinical narrative: no energy; reaction to second covid shot; extremely fatigued; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (no energy), HYPERSENSITIVITY (reaction to second covid shot), FATIGUE (extremely fatigued), CHILLS (chills) and PYREXIA (fever) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A/80777-0273-99 and 025A21A/80777-0273-99) for COVID-19 vaccination.     Concurrent medical conditions included Type 1 diabetes mellitus since 30-Mar-2019 and Hypercholesterolaemia (much lower LDL and higher HDL) since 11-Jan-2018. Concomitant products included METFORMIN from 30-Mar-2019 to an unknown date and INSULIN from 16-May-2021 to an unknown date for Diabetes, ATORVASTATIN from 11-Jan-2018 to an unknown date for High cholesterol, CALCIUM for an unknown indication.   On 05-Mar-2021 at 3:05 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021 at 3:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced ASTHENIA (no energy), HYPERSENSITIVITY (reaction to second covid shot), FATIGUE (extremely fatigued), CHILLS (chills) and PYREXIA (fever). The patient was treated with ACETYLSALICYLIC ACID (ALKA-SELTZER) at an unspecified dose and frequency. On 04-Apr-2021, HYPERSENSITIVITY (reaction to second covid shot), CHILLS (chills) and PYREXIA (fever) had resolved. At the time of the report, ASTHENIA (no energy) and FATIGUE (extremely fatigued) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Added the reporter address, patient demographics (Concurrent medical conditions), concomitant medication (Insulin). Added the start date and stop date of the events and updated the outcome of the events (Fatigue, Asthenia) from unknown to recovering and (Pyrexia, Chills) from unknown to recovered. Added one more event  Hypersensitivity (Reaction to second covid shot).
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Increased Hand Shaking; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Increased Hand Shaking) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL, AMLODIPINE, ALPRAZOLAM and FINASTERIDE for an unknown indication.    On 23-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 TREMOR (Increased Hand Shaking). At the time of the report, TREMOR (Increased Hand Shaking) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Cough
Clinical narrative: loss of smell; loss of taste; cough; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (loss of smell), AGEUSIA (loss of taste) and COUGH (cough) 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 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, the patient experienced ANOSMIA (loss of smell), AGEUSIA (loss of taste) and COUGH (cough). At the time of the report, ANOSMIA (loss of smell), AGEUSIA (loss of taste) and COUGH (cough) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nasopharyngitis, Rhinorrhoea
Clinical narrative: cold symptoms such as runny nose; cold symptoms such as runny nose; some tiredness; This spontaneous case was reported by an other health care professional and describes the occurrence of NASOPHARYNGITIS (cold symptoms such as runny nose), RHINORRHOEA (cold symptoms such as runny nose) and FATIGUE (some tiredness) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (NSAIDs allergy) and Sulfonamide allergy.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced NASOPHARYNGITIS (cold symptoms such as runny nose), RHINORRHOEA (cold symptoms such as runny nose) and FATIGUE (some tiredness). At the time of the report, NASOPHARYNGITIS (cold symptoms such as runny nose), RHINORRHOEA (cold symptoms such as runny nose) and FATIGUE (some tiredness) 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.   No relevant concomitant medications reported.  No treatment information was provided.  On 28-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine).
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: did not receive second dose of Moderna Covid-19 vaccine within 35 days of first dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (did not receive second dose of Moderna Covid-19 vaccine within 35 days of first dose) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular)  (lot no unknown) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (did not receive second dose of Moderna Covid-19 vaccine within 35 days of first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (did not receive second dose of Moderna Covid-19 vaccine within 35 days of first dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.; Sender's Comments: .
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Nasal congestion, Nasopharyngitis, Sinusitis
Clinical narrative: Cold; Congestion; Sinus infection; Vaccine exposure during pregnancy; This spontaneous pregnancy case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold), NASAL CONGESTION (Congestion), SINUSITIS (Sinus infection) and EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003a21a) for COVID-19 vaccination.     Concurrent medical conditions included Migraine.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 09-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). On 05-Apr-2021, the patient experienced NASOPHARYNGITIS (Cold), NASAL CONGESTION (Congestion) and SINUSITIS (Sinus infection). On 09-Mar-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. At the time of the report, NASOPHARYNGITIS (Cold), NASAL CONGESTION (Congestion) and SINUSITIS (Sinus infection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included Migraine medicine and Mental health medicine. Patient had scheduled for second Moderna vaccine on 4-6-2021.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Gait inability, Joint lock
Clinical narrative: knee has given out completely; haven't been able to walk; sharp pain in  left knee; fatigue; This spontaneous case was reported by a nurse and describes the occurrence of JOINT LOCK (knee has given out completely), GAIT INABILITY (haven't been able to walk), ARTHRALGIA (sharp pain in  left knee) and FATIGUE (fatigue) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 022M20A) for COVID-19 vaccination.     The patient's past medical history included Rheumatoid arthritis. Concurrent medical conditions included Hypertension in 2000 and Drug allergy (Codeine). Concomitant products included AMLODIPINE BESILATE (NORVASC) for Hypertension.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-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 JOINT LOCK (knee has given out completely), GAIT INABILITY (haven't been able to walk), ARTHRALGIA (sharp pain in  left knee) and FATIGUE (fatigue). At the time of the report, JOINT LOCK (knee has given out completely), GAIT INABILITY (haven't been able to walk), ARTHRALGIA (sharp pain in  left knee) and FATIGUE (fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-May-2021: Follow up was received on 16 may 2021 included patient details,height,weight,race and historical condition, and event are added. On 22-Jul-2021: NNI Followup received
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea, Vomiting
Clinical narrative: dizziness; headache; nausea; vomited; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (dizziness), HEADACHE (headache), NAUSEA (nausea) and VOMITING (vomited) 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 30-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 DIZZINESS (dizziness), HEADACHE (headache), NAUSEA (nausea) and VOMITING (vomited). At the time of the report, DIZZINESS (dizziness), HEADACHE (headache), NAUSEA (nausea) and VOMITING (vomited) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. no treatment drug was reported
Sex: M
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Vaccination site haemorrhage
Clinical narrative: hit a blood vessel when administering the vaccine; lot more blood came out than expected; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (hit a blood vessel when administering the vaccine) and VACCINATION SITE HAEMORRHAGE (lot more blood came out than expected) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was reported.).    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (hit a blood vessel when administering the vaccine) and VACCINATION SITE HAEMORRHAGE (lot more blood came out than expected). On 03-Apr-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (hit a blood vessel when administering the vaccine) had resolved. At the time of the report, VACCINATION SITE HAEMORRHAGE (lot more blood came out than expected) 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.  Treatment information was not provided.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Pharyngitis, Urticaria
Clinical narrative: Hives are itchy and migrate from the neck, under breast, groin area, back of legs; Throat feels a little weird (comes and goes), voice is hoarse, feels like one side of throat has something there.; After first dose she had an allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives are itchy and migrate from the neck, under breast, groin area, back of legs), PHARYNGITIS (Throat feels a little weird (comes and goes), voice is hoarse, feels like one side of throat has something there.) and HYPERSENSITIVITY (After first dose she had an allergic reaction) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Hives in August 2019 and Hives in January 2017.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced HYPERSENSITIVITY (After first dose she had an allergic reaction). On an unknown date, the patient experienced URTICARIA (Hives are itchy and migrate from the neck, under breast, groin area, back of legs). an unknown date, the patient experienced PHARYNGITIS (Throat feels a little weird (comes and goes), voice is hoarse, feels like one side of throat has something there.). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) on 22-Apr-2021 for Swelling, at a dose of 1 UNK and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL DYE FREE ALLERGY) at a dose of 10 mg. At the time of the report, URTICARIA (Hives are itchy and migrate from the neck, under breast, groin area, back of legs), PHARYNGITIS (Throat feels a little weird (comes and goes), voice is hoarse, feels like one side of throat has something there.) and HYPERSENSITIVITY (After first dose she had an allergic reaction) 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.   The concomitant medications were not reported.   This case was linked to MOD-2021-239952 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Follow-up document was received and had significant information. Added patient demographic and event(Allergic reaction).  Updated reporter's contact address.; 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.