chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Furuncle, Swelling
Clinical narrative: Couple boils on his back/ neck; Old incision site puffed up; Needle marks flared up (turned red) from 2 years ago; This spontaneous case was reported by a consumer and describes the occurrence of FURUNCLE (Couple boils on his back/ neck), SWELLING (Old incision site puffed up) and ERYTHEMA (Needle marks flared up (turned red) from 2 years ago) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced SWELLING (Old incision site puffed up) and ERYTHEMA (Needle marks flared up (turned red) from 2 years ago). On 23-Apr-2021, the patient experienced FURUNCLE (Couple boils on his back/ neck). At the time of the report, FURUNCLE (Couple boils on his back/ neck) was resolving and SWELLING (Old incision site puffed up) and ERYTHEMA (Needle marks flared up (turned red) from 2 years ago) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported. No treatment medication was provided   Reporter did not allow further contact
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Itchy Injection Site; Red Injection Site Size of a Quarter; Pain Injection Site; Burning Injection Site; Swollen Injection Site; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy Injection Site), VACCINATION SITE ERYTHEMA (Red Injection Site Size of a Quarter), VACCINATION SITE PAIN (Pain Injection Site), VACCINATION SITE PAIN (Burning Injection Site) and VACCINATION SITE SWELLING (Swollen Injection Site) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no medical history reported).    On 25-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy Injection Site), VACCINATION SITE ERYTHEMA (Red Injection Site Size of a Quarter), VACCINATION SITE PAIN (Pain Injection Site), VACCINATION SITE PAIN (Burning Injection Site), VACCINATION SITE SWELLING (Swollen Injection Site), HEADACHE (Headache) and CHILLS (Chills). On 27-Apr-2021, HEADACHE (Headache) and CHILLS (Chills) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Itchy Injection Site), VACCINATION SITE ERYTHEMA (Red Injection Site Size of a Quarter), VACCINATION SITE PAIN (Pain Injection Site), VACCINATION SITE PAIN (Burning Injection Site) and VACCINATION SITE SWELLING (Swollen Injection Site) outcome was unknown.            No concomitant medications were provided. No treatment drugs were reported. She also updated that on 06April2021 she delivered a healthy Boy (8 Lbs. & 4 Oz) and is Breastfeeding.   This case was linked to MOD-2021-095716 (Parent-Child Link). This case was linked to MOD-2021-060886 (Patient Link).   See case MOD-2021-095716 for details regarding the child case.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Itchy Injection Site; Red Injection Site Size of a Quarter; Pain Injection Site; Burning Injection Site; Swollen Injection Site; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy Injection Site), VACCINATION SITE ERYTHEMA (Red Injection Site Size of a Quarter), VACCINATION SITE PAIN (Pain Injection Site), VACCINATION SITE PAIN (Burning Injection Site) and VACCINATION SITE SWELLING (Swollen Injection Site) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no medical history reported).    On 25-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy Injection Site), VACCINATION SITE ERYTHEMA (Red Injection Site Size of a Quarter), VACCINATION SITE PAIN (Pain Injection Site), VACCINATION SITE PAIN (Burning Injection Site), VACCINATION SITE SWELLING (Swollen Injection Site), HEADACHE (Headache) and CHILLS (Chills). On 27-Apr-2021, HEADACHE (Headache) and CHILLS (Chills) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Itchy Injection Site), VACCINATION SITE ERYTHEMA (Red Injection Site Size of a Quarter), VACCINATION SITE PAIN (Pain Injection Site), VACCINATION SITE PAIN (Burning Injection Site) and VACCINATION SITE SWELLING (Swollen Injection Site) outcome was unknown.            No concomitant medications were provided. No treatment drugs were reported. She also updated that on 06April2021 she delivered a healthy Boy (8 Lbs. & 4 Oz) and is Breastfeeding.   This case was linked to MOD-2021-095716 (Parent-Child Link). This case was linked to MOD-2021-060886 (Patient Link).   See case MOD-2021-095716 for details regarding the child case.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Bone pain, Chills, Headache, Night sweats, Pain in extremity
Clinical narrative: bones aching; woke up at 2:00AM completely soaked runing a sweat; chills; fever/temperature of 103.7; headache; pain in arm but manageable; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in arm but manageable), BONE PAIN (bones aching), NIGHT SWEATS (woke up at 2:00AM completely soaked runing a sweat), HEADACHE (headache) and CHILLS (chills) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced PAIN IN EXTREMITY (pain in arm but manageable) and HEADACHE (headache). On 23-Apr-2021, the patient experienced BONE PAIN (bones aching), NIGHT SWEATS (woke up at 2:00AM completely soaked runing a sweat), CHILLS (chills) and PYREXIA (fever/temperature of 103.7). On 24-Apr-2021, NIGHT SWEATS (woke up at 2:00AM completely soaked runing a sweat) and CHILLS (chills) had resolved. On 25-Apr-2021, HEADACHE (headache) and PYREXIA (fever/temperature of 103.7) had resolved. At the time of the report, PAIN IN EXTREMITY (pain in arm but manageable) had resolved and BONE PAIN (bones aching) outcome was unknown.            No concomitant and treatment medication were provided  Action taken with mRNA-1273 Moderna vaccine was Not applicable    This case was linked to MOD-2021-095535 (Patient Link).
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: bones aching; woke up at 2:00AM completely soaked runing a sweat; chills; fever/temperature of 103.7; headache; pain in arm but manageable; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in arm but manageable), BONE PAIN (bones aching), NIGHT SWEATS (woke up at 2:00AM completely soaked runing a sweat), HEADACHE (headache) and CHILLS (chills) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced PAIN IN EXTREMITY (pain in arm but manageable) and HEADACHE (headache). On 23-Apr-2021, the patient experienced BONE PAIN (bones aching), NIGHT SWEATS (woke up at 2:00AM completely soaked runing a sweat), CHILLS (chills) and PYREXIA (fever/temperature of 103.7). On 24-Apr-2021, NIGHT SWEATS (woke up at 2:00AM completely soaked runing a sweat) and CHILLS (chills) had resolved. On 25-Apr-2021, HEADACHE (headache) and PYREXIA (fever/temperature of 103.7) had resolved. At the time of the report, PAIN IN EXTREMITY (pain in arm but manageable) had resolved and BONE PAIN (bones aching) outcome was unknown.            No concomitant and treatment medication were provided  Action taken with mRNA-1273 Moderna vaccine was Not applicable    This case was linked to MOD-2021-095535 (Patient Link).
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong technique in device usage process
Clinical narrative: dose administered after vial appeared to have frost-like ring at the bottom after drawing up 5 doses; This spontaneous case was reported by a physician and describes the occurrence of WRONG TECHNIQUE IN DEVICE USAGE PROCESS (dose administered after vial appeared to have frost-like ring at the bottom after drawing up 5 doses) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced WRONG TECHNIQUE IN DEVICE USAGE PROCESS (dose administered after vial appeared to have frost-like ring at the bottom after drawing up 5 doses). On 28-Apr-2021, WRONG TECHNIQUE IN DEVICE USAGE PROCESS (dose administered after vial appeared to have frost-like ring at the bottom after drawing up 5 doses) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-095200, US-MODERNATX, INC.-MOD-2021-095384, US-MODERNATX, INC.-MOD-2021-095302, US-MODERNATX, INC.-MOD-2021-095367 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-095200: US-MODERNATX, INC.-MOD-2021-095384: US-MODERNATX, INC.-MOD-2021-095302: US-MODERNATX, INC.-MOD-2021-095367:
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of chills and pyrexia (fever) in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. The patient's past medical history included no adverse reaction. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 10, 2021, patient experienced chills and pyrexia (fever). At the time of the report, chills and pyrexia (fever) outcome: unknown/not provided. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. This case  linked to MOD-2021-023166 (patient link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: achey all over; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (achey all over) and HEADACHE (headache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ENALAPRIL and TOLTERODINE L-TARTRATE (DETROL) for an unknown indication.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, the patient experienced PAIN (achey all over) and HEADACHE (headache). On 22-Mar-2021, PAIN (achey all over) and HEADACHE (headache) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swelling in lymph nodes under arms, knees, neck; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swelling in lymph nodes under arms, knees, neck) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (Swelling in lymph nodes under arms, knees, neck). At the time of the report, LYMPHADENOPATHY (Swelling in lymph nodes under arms, knees, neck) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications details were provided No treatment details were provided
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Hypoaesthesia, Myalgia
Clinical narrative: Sweat after second dose; Numb finger tips after second dose; Chills after second dose; Fever after second dose; Headache after second dose; Nausea after second dose; Body aches after second dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERHIDROSIS (Sweat after second dose), HYPOAESTHESIA (Numb finger tips after second dose), CHILLS (Chills after second dose), PYREXIA (Fever after second dose) and HEADACHE (Headache after second dose) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced HYPERHIDROSIS (Sweat after second dose), HYPOAESTHESIA (Numb finger tips after second dose), CHILLS (Chills after second dose), PYREXIA (Fever after second dose), HEADACHE (Headache after second dose), NAUSEA (Nausea after second dose) and MYALGIA (Body aches after second dose). The patient was treated with PREGNAZON at a dose of 20 mg once a day. At the time of the report, HYPERHIDROSIS (Sweat after second dose), HYPOAESTHESIA (Numb finger tips after second dose), CHILLS (Chills after second dose), PYREXIA (Fever after second dose), NAUSEA (Nausea after second dose) and MYALGIA (Body aches after second dose) outcome was unknown and HEADACHE (Headache after second dose) had not resolved.            Action taken with mRNA-1273 in response to the events was not applicable. No concomitant medications information was reported. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Sweat after second dose; Numb finger tips after second dose; Chills after second dose; Fever after second dose; Headache after second dose; Nausea after second dose; Body aches after second dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERHIDROSIS (Sweat after second dose), HYPOAESTHESIA (Numb finger tips after second dose), CHILLS (Chills after second dose), PYREXIA (Fever after second dose) and HEADACHE (Headache after second dose) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced HYPERHIDROSIS (Sweat after second dose), HYPOAESTHESIA (Numb finger tips after second dose), CHILLS (Chills after second dose), PYREXIA (Fever after second dose), HEADACHE (Headache after second dose), NAUSEA (Nausea after second dose) and MYALGIA (Body aches after second dose). The patient was treated with PREGNAZON at a dose of 20 mg once a day. At the time of the report, HYPERHIDROSIS (Sweat after second dose), HYPOAESTHESIA (Numb finger tips after second dose), CHILLS (Chills after second dose), PYREXIA (Fever after second dose), NAUSEA (Nausea after second dose) and MYALGIA (Body aches after second dose) outcome was unknown and HEADACHE (Headache after second dose) had not resolved.            Action taken with mRNA-1273 in response to the events was not applicable. No concomitant medications information was reported. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments
Sex: U
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: arm hurts; 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 LIMB DISCOMFORT (arm hurts) 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 28-Apr-2021, the patient experienced LIMB DISCOMFORT (arm hurts). At the time of the report, LIMB DISCOMFORT (arm hurts) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Relevant concomitant medications was reported.  Treatment information was not provided
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Nasopharyngitis, Pyrexia
Clinical narrative: had a cold for a couple of days; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (had a cold for a couple of days), CHILLS (chills) and PYREXIA (fever) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.    Co-suspect product included non-company product ESCITALOPRAM for an unknown indication.    No medical history was provided by the reporter.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On an unknown date, the patient started ESCITALOPRAM (unknown route) at an unspecified dose. On 27-Mar-2021, the patient experienced NASOPHARYNGITIS (had a cold for a couple of days), CHILLS (chills) and PYREXIA (fever). In April 2021, NASOPHARYNGITIS (had a cold for a couple of days), CHILLS (chills) and PYREXIA (fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2021, Body temperature: 101 (High) temperature above 101 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included ibuprofen or paracetamol (didn't remember). The patient was recovered on either 05-Apr-2021 or 06-Apr-2021.   This case was linked to MOD-2021-095786, MOD-2021-095578, MOD-2021-095613, MOD-2021-095705 (Patient Link).
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain in the arm of the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain in the arm of the injection) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0ZSB21A) for COVID-19 vaccination.     Concurrent medical conditions included Pollen allergy. Concomitant products included ATORVASTATIN, LISINOPRIL and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain in the arm of the injection). The patient was treated with MONTELUKAST ongoing since an unknown date for Pollen allergy, at a dose of 1 dosage form. At the time of the report, VACCINATION SITE PAIN (Pain in the arm of the injection) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD21-083785 (E2B Linked Report). This case was linked to MOD-2021-095693 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Updated the outcome of the event vaccination site pain from unknown to recovered/resolved.; Sender's Comments:  MOD21-083785:
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Dental implantation (Dental implant). Concurrent medical conditions included Migraine. Concomitant products included GALCANEZUMAB GNLM (EMGALITY [GALCANEZUMAB GNLM]) for Migraine, DEXAMETHASONE (DECADRON [DEXAMETHASONE]) for an unknown indication.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced MYALGIA (sore arm). At the time of the report, MYALGIA (sore arm) outcome was unknown. Not Provided          Treatment information not provided. Action taken with mRNA-1273 in response to the events was not applicable.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hangover, Headache, Nausea, Vision blurred
Clinical narrative: he felt dizzy; he focused his sight incorrectly with his glasses on and off, close and far away/Can't focus eyes correctly; he gets dizzy even with his eyes closed; he has nauseas; headache; felt like hungover; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HANGOVER (felt like hungover), DIZZINESS (he felt dizzy), VISION BLURRED (he focused his sight incorrectly with his glasses on and off, close and far away/Can't focus eyes correctly), DIZZINESS (he gets dizzy even with his eyes closed) and NAUSEA (he has nauseas) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes. Concomitant products included INSULIN, ACETYLSALICYLIC ACID (BABY ASPIRIN), ATORVASTATIN, METOPROLOL, EZETIMIBE, ENALAPRIL, SITAGLIPTIN, DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE (FARXIGA), GLIMEPIRIDE, OMEPRAZOLE (OMPRAZOLE), REPAGLINIDE (PAGE) and PARACETAMOL (TYLENOL INFANT) from 24-Apr-2021 to an unknown date 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 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Apr-2021, the patient experienced HANGOVER (felt like hungover) and HEADACHE (headache). On 26-Apr-2021, the patient experienced DIZZINESS (he felt dizzy), VISION BLURRED (he focused his sight incorrectly with his glasses on and off, close and far away/Can't focus eyes correctly), DIZZINESS (he gets dizzy even with his eyes closed) and NAUSEA (he has nauseas). At the time of the report, HANGOVER (felt like hungover), DIZZINESS (he felt dizzy), VISION BLURRED (he focused his sight incorrectly with his glasses on and off, close and far away/Can't focus eyes correctly), DIZZINESS (he gets dizzy even with his eyes closed), NAUSEA (he has nauseas) and HEADACHE (headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Follow up received on 30APR2021, added information on patient's medical history
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site reaction
Clinical narrative: A little "COVID arm" after vaccine; Arm itchy after vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (A little "COVID arm" after vaccine) and VACCINATION SITE PRURITUS (Arm itchy after 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 VACCINATION SITE REACTION (A little "COVID arm" after vaccine) and VACCINATION SITE PRURITUS (Arm itchy after vaccine). At the time of the report, VACCINATION SITE REACTION (A little "COVID arm" after vaccine) and VACCINATION SITE PRURITUS (Arm itchy after vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route), the reporter did not provide any causality assessments. Treatment includes Benadryl. no concomitant information was reported   This case was linked to US-MODERNATX, INC.-MOD-2021-026604 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-026604:Husband Case
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain, Pregnancy test
Clinical narrative: Colicky pain, in lower abdomen, that comes and goes; I felt very swollen in my lower belly; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ABDOMINAL PAIN (Colicky pain, in lower abdomen, that comes and goes) and ABDOMINAL DISTENSION (I felt very swollen in my lower belly) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     Concomitant products included ORAL CONTRACEPTIVE NOS, MONTELUKAST and LORATADINA for an unknown indication.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2021, the patient experienced ABDOMINAL PAIN (Colicky pain, in lower abdomen, that comes and goes) and ABDOMINAL DISTENSION (I felt very swollen in my lower belly). The patient was treated with PARACETAMOL (TYLENOL) (oral) at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN (Colicky pain, in lower abdomen, that comes and goes) and ABDOMINAL DISTENSION (I felt very swollen in my lower belly) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Apr-2021, Pregnancy test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Vaccination site pain
Clinical narrative: ¨stings¨, in his neck arteries; Pain in the arm of the injection; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (¨stings¨, in his neck arteries) and VACCINATION SITE PAIN (Pain in the arm of the injection) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     No medical history provided by the reporter.  Concomitant products included ATORVASTATIN, LISINOPRIL and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2021, the patient experienced PAIN (¨stings¨, in his neck arteries) and VACCINATION SITE PAIN (Pain in the arm of the injection). The patient was treated with MONTELUKAST ongoing since an unknown date for Pollen allergy, at an unspecified dose and frequency. At the time of the report, PAIN (¨stings¨, in his neck arteries) and VACCINATION SITE PAIN (Pain in the arm of the injection) had resolved.            This case was linked to MOD21-083785 (E2B Linked Report). This case was linked to MOD-2021-095666 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: TCR: Pt AE improved, everything is fine, declined HCP consent.; Sender's Comments:  MOD21-083785:
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms) outcome was unknown.            concomitant medications were not  provided.  No treatment information provided.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Exposure via breast milk
Clinical narrative: Breastfeeding; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (Breastfeeding) in a 19-day-old male neonate exposed to mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017C21A and 028A21A) , while the mother received the product for COVID-19 vaccination.     No Medical History information was reported.   On 28-Mar-2021, the mother received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 25-Apr-2021, the neonate was diagnosed with EXPOSURE VIA BREAST MILK (Breastfeeding). The Neonate was exposed to mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy. The delivery occurred  on 06-Apr-2021. For neonate 1, the birth weight was 3741 grams (8lbs 4oz). At the time of the report, EXPOSURE VIA BREAST MILK (Breastfeeding) outcome was unknown. Not Provided          Concomitant medication was not provided. Treatment information was not provided.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.    This case was linked to MOD-2021-095626 (Parent-Child Link).   See case MOD-2021-095626 for details regarding the Parent case.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Syringe issue
Clinical narrative: Syringe leaked a quarter of the liquid during patient's vaccine administration; needle was tight enough separated from the syringe; This spontaneous case was reported by a health care professional and describes the occurrence of SYRINGE ISSUE (Syringe leaked a quarter of the liquid during patient's vaccine administration) and DEVICE CONNECTION ISSUE (needle was tight enough separated from the syringe) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced SYRINGE ISSUE (Syringe leaked a quarter of the liquid during patient's vaccine administration) and DEVICE CONNECTION ISSUE (needle was tight enough separated from the syringe). At the time of the report, SYRINGE ISSUE (Syringe leaked a quarter of the liquid during patient's vaccine administration) and DEVICE CONNECTION ISSUE (needle was tight enough separated from the syringe) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The concomitant medication was not provided.  The treatment information was not provided.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue
Clinical narrative: Laying down and get up, I'll be dizzy for 6 or 7 seconds; 10 seconds in the morning; Really tired; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Laying down and get up, I'll be dizzy for 6 or 7 seconds; 10 seconds in the morning) and FATIGUE (Really tired) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced DIZZINESS (Laying down and get up, I'll be dizzy for 6 or 7 seconds; 10 seconds in the morning) and FATIGUE (Really tired). At the time of the report, DIZZINESS (Laying down and get up, I'll be dizzy for 6 or 7 seconds; 10 seconds in the morning) and FATIGUE (Really tired) outcome was unknown.            No relevant concomitant medications reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Additional information include no new information. On 02-Aug-2021: Additional information contains no new information - consent for further follow-up declined. Added second dose details from the initial source document as it was missed in the initial version and action taken was updated.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Lethargy, Pyrexia
Clinical narrative: Felt a cloud smashed on me; Lethargic; Slept for two days; Bright red rash 2-3 inches below the injection site; Felt tired; Headache; Fever; injection site was tender,No grip; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt a cloud smashed on me), LETHARGY (Lethargic), SOMNOLENCE (Slept for two days), RASH ERYTHEMATOUS (Bright red rash 2-3 inches below the injection site) and FATIGUE (Felt tired) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) 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 MONTELUKAST for Allergy, METFORMIN for Diabetes mellitus, LOSARTAN, HYDROCHLOROTHIAZIDE and AMLODIPINE for Hypertension, LEVOTHYROXINE for Hypothyroidism, GABAPENTIN for Pain.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced FEELING ABNORMAL (Felt a cloud smashed on me), LETHARGY (Lethargic), SOMNOLENCE (Slept for two days), RASH ERYTHEMATOUS (Bright red rash 2-3 inches below the injection site), FATIGUE (Felt tired), HEADACHE (Headache), PYREXIA (Fever) and VACCINATION SITE PAIN (injection site was tender,No grip). On 27-Apr-2021, FEELING ABNORMAL (Felt a cloud smashed on me), RASH ERYTHEMATOUS (Bright red rash 2-3 inches below the injection site), HEADACHE (Headache) and VACCINATION SITE PAIN (injection site was tender,No grip) had resolved and LETHARGY (Lethargic), SOMNOLENCE (Slept for two days), FATIGUE (Felt tired) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment details were provided.   This case was linked to MOD-2021-094926 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Somnolence, Vaccination site pain
Clinical narrative: Felt a cloud smashed on me; Lethargic; Slept for two days; Bright red rash 2-3 inches below the injection site; Felt tired; Headache; Fever; injection site was tender,No grip; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt a cloud smashed on me), LETHARGY (Lethargic), SOMNOLENCE (Slept for two days), RASH ERYTHEMATOUS (Bright red rash 2-3 inches below the injection site) and FATIGUE (Felt tired) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) 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 MONTELUKAST for Allergy, METFORMIN for Diabetes mellitus, LOSARTAN, HYDROCHLOROTHIAZIDE and AMLODIPINE for Hypertension, LEVOTHYROXINE for Hypothyroidism, GABAPENTIN for Pain.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced FEELING ABNORMAL (Felt a cloud smashed on me), LETHARGY (Lethargic), SOMNOLENCE (Slept for two days), RASH ERYTHEMATOUS (Bright red rash 2-3 inches below the injection site), FATIGUE (Felt tired), HEADACHE (Headache), PYREXIA (Fever) and VACCINATION SITE PAIN (injection site was tender,No grip). On 27-Apr-2021, FEELING ABNORMAL (Felt a cloud smashed on me), RASH ERYTHEMATOUS (Bright red rash 2-3 inches below the injection site), HEADACHE (Headache) and VACCINATION SITE PAIN (injection site was tender,No grip) had resolved and LETHARGY (Lethargic), SOMNOLENCE (Slept for two days), FATIGUE (Felt tired) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment details were provided.   This case was linked to MOD-2021-094926 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Retching
Clinical narrative: daughter got the dry heaves after her 2nd dose of the Moderna Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of RETCHING (daughter got the dry heaves after her 2nd dose of the Moderna 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 RETCHING (daughter got the dry heaves after her 2nd dose of the Moderna Vaccine). At the time of the report, RETCHING (daughter got the dry heaves after her 2nd dose of the Moderna Vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No lab data has been provided by the reporter. No Treatment medication has been provided by the reporter. No concomitant medicines.   This case was linked to US-MODERNATX, INC.-MOD-2021-095547, US-MODERNATX, INC.-MOD-2021-094798 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-095547: US-MODERNATX, INC.-MOD-2021-094798:
Age: 75.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Crohn's disease, Influenza like illness
Clinical narrative: crohns disease aggravated; flu-like illness; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of CROHN'S DISEASE (crohns disease aggravated) and INFLUENZA LIKE ILLNESS (flu-like illness) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) citrate free. On an unknown date, the patient experienced CROHN'S DISEASE (crohns disease aggravated) and INFLUENZA LIKE ILLNESS (flu-like illness). At the time of the report, CROHN'S DISEASE (crohns disease aggravated) had resolved and INFLUENZA LIKE ILLNESS (flu-like illness) outcome was unknown.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications and treatment details were provided.  Company comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Gastrooesophageal reflux disease, Pain in extremity, Photophobia, Throat irritation
Clinical narrative: Light sensitivity; Arm pain; Throat itching; Acid reflux like sensation in his throat; This spontaneous case was reported by a consumer and describes the occurrence of PHOTOPHOBIA (Light sensitivity), PAIN IN EXTREMITY (Arm pain), THROAT IRRITATION (Throat itching) and GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux like sensation in his throat) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 027B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced PHOTOPHOBIA (Light sensitivity), PAIN IN EXTREMITY (Arm pain), THROAT IRRITATION (Throat itching) and GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux like sensation in his throat). On 28-Apr-2021, PHOTOPHOBIA (Light sensitivity), THROAT IRRITATION (Throat itching) and GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux like sensation in his throat) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm pain) had not resolved.            No concomitant medications were reported.   No treatment information was provided.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: a little diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL, Isosorbide Monohydrate, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), PAROXETINE and PRAVASTATIN for an unknown indication.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (diarrhea). Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD21-083701 (E2B Linked Report).; Sender's Comments:  MOD21-083701:cross linked id
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Swollen tongue
Clinical narrative: Lump under her tongue; Left heel foot pain; This spontaneous case was reported by a consumer and describes the occurrence of SWOLLEN TONGUE (Lump under her tongue) and PAIN IN EXTREMITY (Left heel foot pain) 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 31-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 SWOLLEN TONGUE (Lump under her tongue) and PAIN IN EXTREMITY (Left heel foot pain). At the time of the report, SWOLLEN TONGUE (Lump under her tongue) and PAIN IN EXTREMITY (Left heel foot pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. No treatment information was provided.   Reporter did not allow further contact
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Upper respiratory tract infection
Clinical narrative: presumed upper respiratory infection; chest pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHEST PAIN (chest pain) and UPPER RESPIRATORY TRACT INFECTION (presumed upper respiratory infection) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 043L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Mar-2021, the patient experienced CHEST PAIN (chest pain). On an unknown date, the patient experienced UPPER RESPIRATORY TRACT INFECTION (presumed upper respiratory infection). At the time of the report, CHEST PAIN (chest pain) and UPPER RESPIRATORY TRACT INFECTION (presumed upper respiratory infection) had not resolved. Not Provided          Treatment medications were not provided by reporter. No concomitant medications were reported by reporter.  Action taken with mRNA-1273 in response to the event was not applicable.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Panic attack
Clinical narrative: Panic attack; Anxiety attack; This spontaneous case was reported by a consumer and describes the occurrence of PANIC ATTACK (Panic attack) and ANXIETY (Anxiety attack) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced PANIC ATTACK (Panic attack) and ANXIETY (Anxiety attack). At the time of the report, PANIC ATTACK (Panic attack) and ANXIETY (Anxiety attack) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitants and treatments were not reported.