chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chills, Dysstasia, Pyrexia
Clinical narrative: Trouble getting off of the couch; Back ache in the small of his back; Chills; Slight fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (Slight fever), DYSSTASIA (Trouble getting off of the couch) and BACK PAIN (Back ache in the small of his back) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026b21a) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LOSARTAN for an unknown indication.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced CHILLS (Chills), PYREXIA (Slight fever), DYSSTASIA (Trouble getting off of the couch) and BACK PAIN (Back ache in the small of his back). On 09-Apr-2021, CHILLS (Chills), PYREXIA (Slight fever) and DYSSTASIA (Trouble getting off of the couch) had resolved. At the time of the report, BACK PAIN (Back ache in the small of his back) had resolved. Not Provided          Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was  not applicable.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to US-MODERNATX, INC.-MOD-2021-080004 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-080004:1 st dose case
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: Red circular shaped rash 2-3 inches wide; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red circular shaped rash 2-3 inches wide) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included AMLODIPINE, CALCIUM CARBONATE, COLECALCIFEROL (CALCIUM WITH VITAMIN D [CALCIUM CARBONATE;COLECALCIFEROL]), VITAMIN B NOS and ANASTROZOLE (ANASTRAZOLE DENK) for an unknown indication.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced RASH ERYTHEMATOUS (Red circular shaped rash 2-3 inches wide). At the time of the report, RASH ERYTHEMATOUS (Red circular shaped rash 2-3 inches wide) had resolved. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medications included allergy injections.  No treatment medications were provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-080025 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Follow-up received contains no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-080025:crosslink - Second dose
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea, Fatigue, Heart rate increased
Clinical narrative: Difficulty breathing; Accelerated heartbeat; General weakness; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficulty breathing), HEART RATE INCREASED (Accelerated heartbeat), ASTHENIA (General weakness) and FATIGUE (Fatigue) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     Concomitant products included GLATIRAMER ACETATE, ATORVASTATIN, ACETYLSALICYLIC ACID (BABY ASPIRIN), TOLTERODINE, ZOLPIDEM and SERTRALINE for an unknown indication.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced DYSPNOEA (Difficulty breathing), HEART RATE INCREASED (Accelerated heartbeat), ASTHENIA (General weakness) and FATIGUE (Fatigue). At the time of the report, DYSPNOEA (Difficulty breathing), HEART RATE INCREASED (Accelerated heartbeat), ASTHENIA (General weakness) and FATIGUE (Fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: he is not sleeping well since he received the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (he is not sleeping well since he received the vaccine) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     Concomitant products included OMEPRAZOLE and SERTRALINE for an unknown indication.    On 12-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 INSOMNIA (he is not sleeping well since he received the vaccine). At the time of the report, INSOMNIA (he is not sleeping well since he received the vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient believes that the event experienced is due to the interaction of a medication he takes-omeprazole
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Illness, Injection site mass, Injection site pruritus, Injection site reaction
Clinical narrative: Stuffy nose; Throat hurts; Headache; broke out around injection site; little bumps; itching; a bump around injection site and it was itchy; little sick; bump around injection site; Sore arm; Fever; hurting when touch; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (Stuffy nose), OROPHARYNGEAL PAIN (Throat hurts), ILLNESS (little sick), INJECTION SITE MASS (bump around injection site) and INJECTION SITE REACTION (broke out around injection site) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LOSARTAN for Blood pressure management.    On 31-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 (hurting when touch), MYALGIA (Sore arm) and PYREXIA (Fever). On 01-Apr-2021, the patient experienced ILLNESS (little sick), INJECTION SITE MASS (bump around injection site) and INJECTION SITE PRURITUS (a bump around injection site and it was itchy). On 16-Apr-2021, the patient experienced INJECTION SITE REACTION (broke out around injection site), MASS (little bumps) and PRURITUS (itching). On 17-Apr-2021, the patient experienced NASAL CONGESTION (Stuffy nose), OROPHARYNGEAL PAIN (Throat hurts) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at a dose of 1 dosage form. On 01-Apr-2021, PAIN IN EXTREMITY (hurting when touch), MYALGIA (Sore arm) and PYREXIA (Fever) had resolved. At the time of the report, NASAL CONGESTION (Stuffy nose), OROPHARYNGEAL PAIN (Throat hurts), ILLNESS (little sick), INJECTION SITE MASS (bump around injection site), INJECTION SITE REACTION (broke out around injection site), MASS (little bumps), PRURITUS (itching), HEADACHE (Headache) and INJECTION SITE PRURITUS (a bump around injection site and it was itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment drugs were not provided.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Mass, Myalgia, Nasal congestion, Oropharyngeal pain, Pain in extremity
Clinical narrative: Stuffy nose; Throat hurts; Headache; broke out around injection site; little bumps; itching; a bump around injection site and it was itchy; little sick; bump around injection site; Sore arm; Fever; hurting when touch; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (Stuffy nose), OROPHARYNGEAL PAIN (Throat hurts), ILLNESS (little sick), INJECTION SITE MASS (bump around injection site) and INJECTION SITE REACTION (broke out around injection site) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LOSARTAN for Blood pressure management.    On 31-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 (hurting when touch), MYALGIA (Sore arm) and PYREXIA (Fever). On 01-Apr-2021, the patient experienced ILLNESS (little sick), INJECTION SITE MASS (bump around injection site) and INJECTION SITE PRURITUS (a bump around injection site and it was itchy). On 16-Apr-2021, the patient experienced INJECTION SITE REACTION (broke out around injection site), MASS (little bumps) and PRURITUS (itching). On 17-Apr-2021, the patient experienced NASAL CONGESTION (Stuffy nose), OROPHARYNGEAL PAIN (Throat hurts) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at a dose of 1 dosage form. On 01-Apr-2021, PAIN IN EXTREMITY (hurting when touch), MYALGIA (Sore arm) and PYREXIA (Fever) had resolved. At the time of the report, NASAL CONGESTION (Stuffy nose), OROPHARYNGEAL PAIN (Throat hurts), ILLNESS (little sick), INJECTION SITE MASS (bump around injection site), INJECTION SITE REACTION (broke out around injection site), MASS (little bumps), PRURITUS (itching), HEADACHE (Headache) and INJECTION SITE PRURITUS (a bump around injection site and it was itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment drugs were not provided.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia
Clinical narrative: Stuffy nose; Throat hurts; Headache; broke out around injection site; little bumps; itching; a bump around injection site and it was itchy; little sick; bump around injection site; Sore arm; Fever; hurting when touch; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (Stuffy nose), OROPHARYNGEAL PAIN (Throat hurts), ILLNESS (little sick), INJECTION SITE MASS (bump around injection site) and INJECTION SITE REACTION (broke out around injection site) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LOSARTAN for Blood pressure management.    On 31-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 (hurting when touch), MYALGIA (Sore arm) and PYREXIA (Fever). On 01-Apr-2021, the patient experienced ILLNESS (little sick), INJECTION SITE MASS (bump around injection site) and INJECTION SITE PRURITUS (a bump around injection site and it was itchy). On 16-Apr-2021, the patient experienced INJECTION SITE REACTION (broke out around injection site), MASS (little bumps) and PRURITUS (itching). On 17-Apr-2021, the patient experienced NASAL CONGESTION (Stuffy nose), OROPHARYNGEAL PAIN (Throat hurts) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at a dose of 1 dosage form. On 01-Apr-2021, PAIN IN EXTREMITY (hurting when touch), MYALGIA (Sore arm) and PYREXIA (Fever) had resolved. At the time of the report, NASAL CONGESTION (Stuffy nose), OROPHARYNGEAL PAIN (Throat hurts), ILLNESS (little sick), INJECTION SITE MASS (bump around injection site), INJECTION SITE REACTION (broke out around injection site), MASS (little bumps), PRURITUS (itching), HEADACHE (Headache) and INJECTION SITE PRURITUS (a bump around injection site and it was itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment drugs were not provided.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain, Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in the arm that was vaccinated, in the "upper muscle area"), PAIN (has severe pain if she is touched/really hurts to raise her arm), ARTHRALGIA (pain radiates to shoulder) and ARTHRALGIA (pain radiates to elbow) 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 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On 16-Apr-2021, the patient experienced PAIN IN EXTREMITY (pain in the arm that was vaccinated, in the "upper muscle area"), PAIN (has severe pain if she is touched/really hurts to raise her arm), ARTHRALGIA (pain radiates to shoulder) and ARTHRALGIA (pain radiates to elbow). At the time of the report, PAIN IN EXTREMITY (pain in the arm that was vaccinated, in the "upper muscle area"), PAIN (has severe pain if she is touched/really hurts to raise her arm), ARTHRALGIA (pain radiates to shoulder) and ARTHRALGIA (pain radiates to elbow) outcome was unknown. Not Provided          Treatment was unknown.  Upon in internal review on 21 May 2021, the age was corrected to an unknown age.   Reporter did not allow further contact
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Lacrimation increased
Clinical narrative: Tear in the eye; This spontaneous case was reported by a consumer and describes the occurrence of LACRIMATION INCREASED (Tear in the eye) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced LACRIMATION INCREASED (Tear in the eye). At the time of the report, LACRIMATION INCREASED (Tear in the eye) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: TCR report where the patient denied further calling.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Dysgeusia
Clinical narrative: bitter taste; dry mouth; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (bitter taste) and DRY MOUTH (dry mouth) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced DYSGEUSIA (bitter taste) and DRY MOUTH (dry mouth). At the time of the report, DYSGEUSIA (bitter taste) and DRY MOUTH (dry mouth) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       There were no concomitant medications provided.   Patient has been using mouthwash to treat her symptoms, but it doesn't do anything.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash macular, Rash morbilliform
Clinical narrative: Rash that looks like measles all over his body but face; Red spots; Some places itchy; This spontaneous case was reported by a consumer and describes the occurrence of RASH MORBILLIFORM (Rash that looks like measles all over his body but face), RASH MACULAR (Red spots) and PRURITUS (Some places itchy) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Bladder cancer and Hypertension. Concomitant products included MITOMYCIN for Bladder cancer, ATENOLOL for an unknown indication.   On 07-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH MORBILLIFORM (Rash that looks like measles all over his body but face), RASH MACULAR (Red spots) and PRURITUS (Some places itchy). At the time of the report, RASH MORBILLIFORM (Rash that looks like measles all over his body but face), RASH MACULAR (Red spots) and PRURITUS (Some places itchy) outcome was unknown. Not Provided          Treatment information was not provided.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Tongue discolouration
Clinical narrative: This spontaneous case reported by a nurse, describes the occurrence of tongue discoloration in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 026L20A) for COVID-19 immunization. No medical history reported. On Jan 13, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Feb 10, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 28, 2021, after the mRNA-1273 (Moderna COVID-19 vaccine), patient experienced tongue discoloration. At the time of the report, tongue discoloration: not resolved. The action taken with mRNA-1273 (COVID-19 Moderna vaccine): not applicable. The reporter did not provide any causality assessments, concomitant medications or treatment information.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Fatigue, Feeling hot
Clinical narrative: Chills; Hot; Cold; sweats-very wet arms/chest; Terrible headache; joint and muscle aches; Fatigue; Feels weak; extreme nausea; sick-rally bad-had all the symptoms for 3 days; dose really high up on the shoulder and it hurt; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick-rally bad-had all the symptoms for 3 days), PAIN IN EXTREMITY (dose really high up on the shoulder and it hurt), CHILLS (Chills), FEELING HOT (Hot) and NASOPHARYNGITIS (Cold) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 06-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) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced PAIN IN EXTREMITY (dose really high up on the shoulder and it hurt). On 03-Apr-2021, the patient experienced ILLNESS (sick-rally bad-had all the symptoms for 3 days), CHILLS (Chills), FEELING HOT (Hot), NASOPHARYNGITIS (Cold), HYPERHIDROSIS (sweats-very wet arms/chest), HEADACHE (Terrible headache), ARTHRALGIA (joint and muscle aches), FATIGUE (Fatigue), ASTHENIA (Feels weak) and NAUSEA (extreme nausea). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, ILLNESS (sick-rally bad-had all the symptoms for 3 days), PAIN IN EXTREMITY (dose really high up on the shoulder and it hurt), CHILLS (Chills), FEELING HOT (Hot), NASOPHARYNGITIS (Cold), HYPERHIDROSIS (sweats-very wet arms/chest), HEADACHE (Terrible headache), ARTHRALGIA (joint and muscle aches), FATIGUE (Fatigue), ASTHENIA (Feels weak) and NAUSEA (extreme nausea) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Illness, Nasopharyngitis, Nausea
Clinical narrative: Chills; Hot; Cold; sweats-very wet arms/chest; Terrible headache; joint and muscle aches; Fatigue; Feels weak; extreme nausea; sick-rally bad-had all the symptoms for 3 days; dose really high up on the shoulder and it hurt; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick-rally bad-had all the symptoms for 3 days), PAIN IN EXTREMITY (dose really high up on the shoulder and it hurt), CHILLS (Chills), FEELING HOT (Hot) and NASOPHARYNGITIS (Cold) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 06-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) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced PAIN IN EXTREMITY (dose really high up on the shoulder and it hurt). On 03-Apr-2021, the patient experienced ILLNESS (sick-rally bad-had all the symptoms for 3 days), CHILLS (Chills), FEELING HOT (Hot), NASOPHARYNGITIS (Cold), HYPERHIDROSIS (sweats-very wet arms/chest), HEADACHE (Terrible headache), ARTHRALGIA (joint and muscle aches), FATIGUE (Fatigue), ASTHENIA (Feels weak) and NAUSEA (extreme nausea). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, ILLNESS (sick-rally bad-had all the symptoms for 3 days), PAIN IN EXTREMITY (dose really high up on the shoulder and it hurt), CHILLS (Chills), FEELING HOT (Hot), NASOPHARYNGITIS (Cold), HYPERHIDROSIS (sweats-very wet arms/chest), HEADACHE (Terrible headache), ARTHRALGIA (joint and muscle aches), FATIGUE (Fatigue), ASTHENIA (Feels weak) and NAUSEA (extreme nausea) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Chills; Hot; Cold; sweats-very wet arms/chest; Terrible headache; joint and muscle aches; Fatigue; Feels weak; extreme nausea; sick-rally bad-had all the symptoms for 3 days; dose really high up on the shoulder and it hurt; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick-rally bad-had all the symptoms for 3 days), PAIN IN EXTREMITY (dose really high up on the shoulder and it hurt), CHILLS (Chills), FEELING HOT (Hot) and NASOPHARYNGITIS (Cold) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 06-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) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced PAIN IN EXTREMITY (dose really high up on the shoulder and it hurt). On 03-Apr-2021, the patient experienced ILLNESS (sick-rally bad-had all the symptoms for 3 days), CHILLS (Chills), FEELING HOT (Hot), NASOPHARYNGITIS (Cold), HYPERHIDROSIS (sweats-very wet arms/chest), HEADACHE (Terrible headache), ARTHRALGIA (joint and muscle aches), FATIGUE (Fatigue), ASTHENIA (Feels weak) and NAUSEA (extreme nausea). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, ILLNESS (sick-rally bad-had all the symptoms for 3 days), PAIN IN EXTREMITY (dose really high up on the shoulder and it hurt), CHILLS (Chills), FEELING HOT (Hot), NASOPHARYNGITIS (Cold), HYPERHIDROSIS (sweats-very wet arms/chest), HEADACHE (Terrible headache), ARTHRALGIA (joint and muscle aches), FATIGUE (Fatigue), ASTHENIA (Feels weak) and NAUSEA (extreme nausea) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Miliaria, Rash, Rash pruritic
Clinical narrative: Hot rash; Itchy rah; Oblong shaped rash 6 inches in length; Red circular shaped rash 2-3 inches wide; This spontaneous case was reported by a consumer and describes the occurrence of MILIARIA (Hot rash), RASH PRURITIC (Itchy rah), RASH (Oblong shaped rash 6 inches in length) and RASH (Red circular shaped rash 2-3 inches wide) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 001A21A) for COVID-19 vaccination.     Concomitant products included AMLODIPINE, CALCIUM CARBONATE, COLECALCIFEROL (CALCIUM WITH VITAMIN D [CALCIUM CARBONATE;COLECALCIFEROL]), VITAMIN B NOS and ANASTROZOLE for an unknown indication.   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced RASH (Red circular shaped rash 2-3 inches wide). On 28-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MILIARIA (Hot rash), RASH PRURITIC (Itchy rah) and RASH (Oblong shaped rash 6 inches in length). At the time of the report, MILIARIA (Hot rash), RASH PRURITIC (Itchy rah), RASH (Oblong shaped rash 6 inches in length) and RASH (Red circular shaped rash 2-3 inches wide) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Other Concomitant product included Allergy Injections. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-080014 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Follow up information was received which contains no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-080014:first dose
Sex: F
Vaccine: COVID19
Symptoms: Depressed mood
Clinical narrative: down for a day or two; This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSED MOOD (down for a day or two) 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) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced DEPRESSED MOOD (down for a day or two). At the time of the report, DEPRESSED MOOD (down for a day or two) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD21-077966, US-MODERNATX, INC.-MOD-2021-080428, US-MODERNATX, INC.-MOD-2021-080393 (E2B Linked Report).; Sender's Comments:  MOD21-077966:Crossed linked as per source doc US-MODERNATX, INC.-MOD-2021-080393:case for wife US-MODERNATX, INC.-MOD-2021-080428:wife case
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Illness, SARS-CoV-2 antibody test
Clinical narrative: got sick; tested positive for COVID19; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got sick) and COVID-19 (tested positive for COVID19) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced ILLNESS (got sick) and COVID-19 (tested positive for COVID19). At the time of the report, ILLNESS (got sick) and COVID-19 (tested positive for COVID19) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Apr-2021, SARS-CoV-2 antibody test: unknown (Positive) COVID positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Asthenia, Chills, Headache, Hypokinesia
Clinical narrative: Severe Hair Loss (May be due to COVID Positive); Difficulty getting up and going to the bathroom; Low stamina, her Body was weak; Headache; Severe chills; Fever 100F to 101F; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Severe Hair Loss (May be due to COVID Positive)), HYPOKINESIA (Difficulty getting up and going to the bathroom), ASTHENIA (Low stamina, her Body was weak), HEADACHE (Headache) and CHILLS (Severe chills) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 pneumonia.    On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced HYPOKINESIA (Difficulty getting up and going to the bathroom), ASTHENIA (Low stamina, her Body was weak), HEADACHE (Headache), CHILLS (Severe chills) and PYREXIA (Fever 100F to 101F). On 04-Apr-2021, the patient experienced ALOPECIA (Severe Hair Loss (May be due to COVID Positive)). On 28-Mar-2021, HYPOKINESIA (Difficulty getting up and going to the bathroom), ASTHENIA (Low stamina, her Body was weak), HEADACHE (Headache), CHILLS (Severe chills) and PYREXIA (Fever 100F to 101F) outcome was unknown. At the time of the report, ALOPECIA (Severe Hair Loss (May be due to COVID Positive)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test: positve (Positive) she had Patient had COVID Pneumonia towards end of JAN2021, a positive PCR test, and  was Hospitalized.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported that she had COVID Pneumonia towards end of JAN2021, a positive PCR test, and was Hospitalized.   No relevant concomitant medication information was provided by the reporter.  No relevant treatment medication information was provided by the reporter.  Patient wanted to know whether the second dose will have more side effects.   Reporter did not allow further contact
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: Severe Hair Loss (May be due to COVID Positive); Difficulty getting up and going to the bathroom; Low stamina, her Body was weak; Headache; Severe chills; Fever 100F to 101F; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Severe Hair Loss (May be due to COVID Positive)), HYPOKINESIA (Difficulty getting up and going to the bathroom), ASTHENIA (Low stamina, her Body was weak), HEADACHE (Headache) and CHILLS (Severe chills) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 pneumonia.    On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced HYPOKINESIA (Difficulty getting up and going to the bathroom), ASTHENIA (Low stamina, her Body was weak), HEADACHE (Headache), CHILLS (Severe chills) and PYREXIA (Fever 100F to 101F). On 04-Apr-2021, the patient experienced ALOPECIA (Severe Hair Loss (May be due to COVID Positive)). On 28-Mar-2021, HYPOKINESIA (Difficulty getting up and going to the bathroom), ASTHENIA (Low stamina, her Body was weak), HEADACHE (Headache), CHILLS (Severe chills) and PYREXIA (Fever 100F to 101F) outcome was unknown. At the time of the report, ALOPECIA (Severe Hair Loss (May be due to COVID Positive)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test: positve (Positive) she had Patient had COVID Pneumonia towards end of JAN2021, a positive PCR test, and  was Hospitalized.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported that she had COVID Pneumonia towards end of JAN2021, a positive PCR test, and was Hospitalized.   No relevant concomitant medication information was provided by the reporter.  No relevant treatment medication information was provided by the reporter.  Patient wanted to know whether the second dose will have more side effects.   Reporter did not allow further contact
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Pain
Clinical narrative: Patient has a reaction; a little pain and soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (a little pain and soreness) and ADVERSE REACTION (Patient has a reaction) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) 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(s). On 18-Mar-2021, the patient experienced PAIN (a little pain and soreness). On an unknown date, the patient experienced ADVERSE REACTION (Patient has a reaction). At the time of the report, PAIN (a little pain and soreness) and ADVERSE REACTION (Patient has a reaction) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided  Treatment medication was not provided   This case was linked to MOD-2021-080058 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Follow up information received on 21-APR-2021  :  Event updated
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort, Myalgia, Pain, Pyrexia, Swelling
Clinical narrative: carpel tunnel in her shoulders; the "normal" aches; swelling on her shoulders; muscles are still very sore; Fever; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (carpel tunnel in her shoulders), PAIN (the "normal" aches), SWELLING (swelling on her shoulders), MYALGIA (muscles are still very sore) and PYREXIA (Fever) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (carpel tunnel in her shoulders), PAIN (the "normal" aches), SWELLING (swelling on her shoulders), MYALGIA (muscles are still very sore) and PYREXIA (Fever). On 12-Feb-2021, PAIN (the "normal" aches) outcome was unknown, PYREXIA (Fever) had resolved. At the time of the report, MUSCULOSKELETAL DISCOMFORT (carpel tunnel in her shoulders), SWELLING (swelling on her shoulders) and MYALGIA (muscles are still very sore) outcome was unknown.            No concomitant medication were not provided Patient underwent treatment medication of Steroid shot   This case was linked to MOD21-14950, MOD21-15037 (E2B Linked Report).; Sender's Comments:  MOD21-14950:1st dose of vaccine MOD21-15037:1st dose of vaccine
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Headache, Illness, Malaise, Nasopharyngitis
Clinical narrative: general malaise; major tinnitus; burning brain with burning ears and burning tongue; crushing headache; Ringing ear; Tongue tingly; Brain tingly; Cold; Shaking; Fever; Headache; very ill; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (very ill), TINNITUS (Ringing ear), PARAESTHESIA ORAL (Tongue tingly), PARAESTHESIA (Brain tingly) and NASOPHARYNGITIS (Cold) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-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,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ILLNESS (very ill). On 17-Apr-2021, the patient experienced PYREXIA (Fever) and HEADACHE (Headache). On 19-Apr-2021, the patient experienced TINNITUS (Ringing ear), PARAESTHESIA ORAL (Tongue tingly), PARAESTHESIA (Brain tingly), NASOPHARYNGITIS (Cold) and TREMOR (Shaking). On an unknown date, the patient experienced MALAISE (general malaise), TINNITUS (major tinnitus), BURNING SENSATION (burning brain with burning ears and burning tongue) and HEADACHE (crushing headache). On 18-Apr-2021, PYREXIA (Fever) and HEADACHE (Headache) had resolved. At the time of the report, ILLNESS (very ill), TINNITUS (Ringing ear), PARAESTHESIA ORAL (Tongue tingly), PARAESTHESIA (Brain tingly), NASOPHARYNGITIS (Cold), TREMOR (Shaking), MALAISE (general malaise), TINNITUS (major tinnitus), BURNING SENSATION (burning brain with burning ears and burning tongue) and HEADACHE (crushing headache) outcome was unknown.            Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Follow up information received on 28-APR-2021 Updated AE information
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Paraesthesia oral, Pyrexia, Tinnitus, Tremor
Clinical narrative: general malaise; major tinnitus; burning brain with burning ears and burning tongue; crushing headache; Ringing ear; Tongue tingly; Brain tingly; Cold; Shaking; Fever; Headache; very ill; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (very ill), TINNITUS (Ringing ear), PARAESTHESIA ORAL (Tongue tingly), PARAESTHESIA (Brain tingly) and NASOPHARYNGITIS (Cold) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-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,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ILLNESS (very ill). On 17-Apr-2021, the patient experienced PYREXIA (Fever) and HEADACHE (Headache). On 19-Apr-2021, the patient experienced TINNITUS (Ringing ear), PARAESTHESIA ORAL (Tongue tingly), PARAESTHESIA (Brain tingly), NASOPHARYNGITIS (Cold) and TREMOR (Shaking). On an unknown date, the patient experienced MALAISE (general malaise), TINNITUS (major tinnitus), BURNING SENSATION (burning brain with burning ears and burning tongue) and HEADACHE (crushing headache). On 18-Apr-2021, PYREXIA (Fever) and HEADACHE (Headache) had resolved. At the time of the report, ILLNESS (very ill), TINNITUS (Ringing ear), PARAESTHESIA ORAL (Tongue tingly), PARAESTHESIA (Brain tingly), NASOPHARYNGITIS (Cold), TREMOR (Shaking), MALAISE (general malaise), TINNITUS (major tinnitus), BURNING SENSATION (burning brain with burning ears and burning tongue) and HEADACHE (crushing headache) outcome was unknown.            Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Follow up information received on 28-APR-2021 Updated AE information
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Fever; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and MYALGIA (Body ache) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 047A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Apr-2021, the patient experienced PYREXIA (Fever) and MYALGIA (Body ache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1000 milligram. At the time of the report, PYREXIA (Fever) and MYALGIA (Body ache) outcome was unknown. Not Provided
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypoaesthesia, Myalgia, Paraesthesia
Clinical narrative: Tingling on her Left face; numbness on her left face; feels a little weird; few muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling on her Left face), HYPOAESTHESIA (numbness on her left face), FEELING ABNORMAL (feels a little weird) and MYALGIA (few muscle pain) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 038B21A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy.   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 15-Apr-2021, the patient experienced PARAESTHESIA (Tingling on her Left face), HYPOAESTHESIA (numbness on her left face), FEELING ABNORMAL (feels a little weird) and MYALGIA (few muscle pain). At the time of the report, PARAESTHESIA (Tingling on her Left face), HYPOAESTHESIA (numbness on her left face), FEELING ABNORMAL (feels a little weird) and MYALGIA (few muscle pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient took Tylenol 1 tablet only for the symptoms she was experiencing.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Pain in shoulder; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Pain in shoulder) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Pain in shoulder). At the time of the report, ARTHRALGIA (Pain in shoulder) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided. No treatment medication information was provided.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Dyspnoea, Myalgia, Pyrexia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of dyspnea (difficulty breathing), myalgia (soreness in his chest muscles) and pyrexia (fever) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 048A21A) for COVID-19 immunization. Concurrent medical conditions included atrial fibrillation. Concomitant products included Eliquis (apixaban) for an unknown indication. On Mar 23, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Mar 24, 2021, patient experienced  dyspnea (difficulty breathing) and myalgia (soreness in his chest muscles). On Mar 25, 2021, patient experienced pyrexia (fever). On Mar 24, 2021, dyspnea (difficulty breathing) and myalgia (soreness in his chest muscles) resolved. On Mar 25, 2021, pyrexia (fever) resolved. Diagnostic results: On Mar 25, 2021, body temperature: (high) 100ºF. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Illness
Clinical narrative: got sick; tested positive for COVID19; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got sick) and COVID-19 (tested positive for COVID19) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced ILLNESS (got sick) and COVID-19 (tested positive for COVID19). At the time of the report, ILLNESS (got sick) and COVID-19 (tested positive for COVID19) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were reported. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to US-MODERNATX, INC.-MOD-2021-080039, US-MODERNATX, INC.-MOD-2021-080039 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-080039:case of mother US-MODERNATX, INC.-MOD-2021-080039:case of mother
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site pain
Clinical narrative: rash all over her body/ rash on face; soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash all over her body/ rash on face) and VACCINATION SITE PAIN (soreness at the injection site) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety. Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) for Antidepressant therapy, BUSPIRONE for Anxiety, BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE (SUBOXONE) for an unknown indication.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, the patient experienced RASH (rash all over her body/ rash on face) and VACCINATION SITE PAIN (soreness at the injection site). The patient was treated with IBUPROFEN (oral) at an unspecified dose and frequency. At the time of the report, RASH (rash all over her body/ rash on face) and VACCINATION SITE PAIN (soreness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other relevant concomitant medications included Birth control implant was reported.