chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Malaise, Vomiting
Clinical narrative: hot sweats; not feeling well; threw up one episode; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (hot sweats), MALAISE (not feeling well), VOMITING (threw up one episode) and CHILLS (Chills) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 044A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced HYPERHIDROSIS (hot sweats), MALAISE (not feeling well), VOMITING (threw up one episode) and CHILLS (Chills). At the time of the report, HYPERHIDROSIS (hot sweats), MALAISE (not feeling well), VOMITING (threw up one episode) and CHILLS (Chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information as not reported. concomitants - Blood pressure Medication
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Dry throat, Maternal exposure during breast feeding, Odynophagia
Clinical narrative: dry throat; a swollen red hard patch in the arm; whole body itchiness (mostly back and arm) at night; lost strength on her body; Dizziness; throat pain; swallowing pain; Breastfeeding; This spontaneous case was reported by a consumer and describes the occurrence of DRY THROAT (dry throat), PERIPHERAL SWELLING (a swollen red hard patch in the arm), PRURITUS (whole body itchiness (mostly back and arm) at night), ASTHENIA (lost strength on her body) and DIZZINESS (Dizziness) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast feeding.    On 09-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 DRY THROAT (dry throat), PERIPHERAL SWELLING (a swollen red hard patch in the arm), PRURITUS (whole body itchiness (mostly back and arm) at night), ASTHENIA (lost strength on her body), DIZZINESS (Dizziness), OROPHARYNGEAL PAIN (throat pain), ODYNOPHAGIA (swallowing pain) and MATERNAL EXPOSURE DURING BREAST FEEDING (Breastfeeding). At the time of the report, DRY THROAT (dry throat), PERIPHERAL SWELLING (a swollen red hard patch in the arm), PRURITUS (whole body itchiness (mostly back and arm) at night), ASTHENIA (lost strength on her body), DIZZINESS (Dizziness), OROPHARYNGEAL PAIN (throat pain), ODYNOPHAGIA (swallowing pain) and MATERNAL EXPOSURE DURING BREAST FEEDING (Breastfeeding) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-078004, US-MODERNATX, INC.-MOD-2021-078363 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-078004:Husband Case US-MODERNATX, INC.-MOD-2021-078363:Baby Case
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Peripheral swelling, Pruritus
Clinical narrative: dry throat; a swollen red hard patch in the arm; whole body itchiness (mostly back and arm) at night; lost strength on her body; Dizziness; throat pain; swallowing pain; Breastfeeding; This spontaneous case was reported by a consumer and describes the occurrence of DRY THROAT (dry throat), PERIPHERAL SWELLING (a swollen red hard patch in the arm), PRURITUS (whole body itchiness (mostly back and arm) at night), ASTHENIA (lost strength on her body) and DIZZINESS (Dizziness) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast feeding.    On 09-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 DRY THROAT (dry throat), PERIPHERAL SWELLING (a swollen red hard patch in the arm), PRURITUS (whole body itchiness (mostly back and arm) at night), ASTHENIA (lost strength on her body), DIZZINESS (Dizziness), OROPHARYNGEAL PAIN (throat pain), ODYNOPHAGIA (swallowing pain) and MATERNAL EXPOSURE DURING BREAST FEEDING (Breastfeeding). At the time of the report, DRY THROAT (dry throat), PERIPHERAL SWELLING (a swollen red hard patch in the arm), PRURITUS (whole body itchiness (mostly back and arm) at night), ASTHENIA (lost strength on her body), DIZZINESS (Dizziness), OROPHARYNGEAL PAIN (throat pain), ODYNOPHAGIA (swallowing pain) and MATERNAL EXPOSURE DURING BREAST FEEDING (Breastfeeding) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-078004, US-MODERNATX, INC.-MOD-2021-078363 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-078004:Husband Case US-MODERNATX, INC.-MOD-2021-078363:Baby Case
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Myalgia
Clinical narrative: weakness; aches; generalized fatigue; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (weakness), MYALGIA (aches) and FATIGUE (generalized fatigue) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced ASTHENIA (weakness), MYALGIA (aches) and FATIGUE (generalized fatigue). At the time of the report, ASTHENIA (weakness), MYALGIA (aches) and FATIGUE (generalized fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication were reported. Treatment medication was not provided.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Swelling, Vaccination site reaction, Vaccination site warmth
Clinical narrative: It looks like COVID arm; warmer; It was bigger, warmer and itchy; It was bigger, warmer and itchy; Arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore), VACCINATION SITE REACTION (It looks like COVID arm), VACCINATION SITE WARMTH (warmer), SWELLING (It was bigger, warmer and itchy) and PRURITUS (It was bigger, warmer and itchy) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and unknown) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised and Psoriatic arthritis. Concomitant products included HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]) for Psoriatic arthritis.   On 12-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 12-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore). On 14-Apr-2021, the patient experienced VACCINATION SITE REACTION (It looks like COVID arm), VACCINATION SITE WARMTH (warmer), SWELLING (It was bigger, warmer and itchy) and PRURITUS (It was bigger, warmer and itchy). At the time of the report, PAIN IN EXTREMITY (Arm was sore), VACCINATION SITE REACTION (It looks like COVID arm), VACCINATION SITE WARMTH (warmer), SWELLING (It was bigger, warmer and itchy) and PRURITUS (It was bigger, warmer and itchy) outcome was unknown. Not Provided          On 13 Mar 2021,the patient received first of two planned doses of mRNA-1273  for prophylaxis of COVID-19 infection.  Action taken with mRNA-1273 in response to the events was not applicable.  Treatment information was not provided.  Concomitant medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 17-Apr-2021: conmed updated, medical history, event outcome of headache was updated recovered. On 20-Apr-2021: non new information
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Ear pruritus, Headache, Heart rate increased
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of headache, chills, arthralgia (joint pain), ear pruritus (itch at the back of the ear) and hypertension (hypertension 1 140/90) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine), batch# 038B21A) for COVID-19 immunization. The occurrence of additional events detailed below. Concurrent medical conditions included hypertension (hypertension I 140/90) on Apr 14, 2021. On Apr 13, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Apr 13, 2021, patient experienced headache, chills, arthralgia (joint pain), ear pruritus (itch at the back of the ear) and nausea. On Apr 14, 2021, patient experienced hypertension (hypertension 1 140/90) and increased heart rate (fast heart beat). The patient treated with Tylenol (paracetamol) for pain, 2 pills. At the time of the report, headache, chills, arthralgia (joint pain), ear pruritus (itch at the back of the ear), hypertension (hypertension 1 140/90), nausea and increased heart rate (fast heart beat) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication details reported. Reporter did not allow further contact.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Hypertension, Nausea
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of headache, chills, arthralgia (joint pain), ear pruritus (itch at the back of the ear) and hypertension (hypertension 1 140/90) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine), batch# 038B21A) for COVID-19 immunization. The occurrence of additional events detailed below. Concurrent medical conditions included hypertension (hypertension I 140/90) on Apr 14, 2021. On Apr 13, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Apr 13, 2021, patient experienced headache, chills, arthralgia (joint pain), ear pruritus (itch at the back of the ear) and nausea. On Apr 14, 2021, patient experienced hypertension (hypertension 1 140/90) and increased heart rate (fast heart beat). The patient treated with Tylenol (paracetamol) for pain, 2 pills. At the time of the report, headache, chills, arthralgia (joint pain), ear pruritus (itch at the back of the ear), hypertension (hypertension 1 140/90), nausea and increased heart rate (fast heart beat) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication details reported. Reporter did not allow further contact.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: soreness in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in arm) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (soreness in arm). On 12-Mar-2021, PAIN IN EXTREMITY (soreness in arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported No treatment medications were reported    This case was linked to MOD-2021-077936 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow-up information received on 18-May-2021 which contains batch number of first dose.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Vaccination site pruritus, Vaccination site rash
Clinical narrative: it is itchy; Big rash about 3 inch by 2 inches size around injection site; Soreness of left arm; headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Soreness of left arm), VACCINATION SITE PRURITUS (it is itchy), HEADACHE (headache) and VACCINATION SITE RASH (Big rash about 3 inch by 2 inches size around injection site) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     Concurrent medical conditions included Osteoporosis, Anxiety and Blood pressure abnormal. Concomitant products included LISINOPRIL, RALOXIFENE, PAROXETINE and VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced PAIN IN EXTREMITY (Soreness of left arm) and HEADACHE (headache). On 14-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (it is itchy) and VACCINATION SITE RASH (Big rash about 3 inch by 2 inches size around injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Soreness of left arm), VACCINATION SITE PRURITUS (it is itchy), HEADACHE (headache) and VACCINATION SITE RASH (Big rash about 3 inch by 2 inches size around injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included medications for Blood pressure, osteoporosis, anxiety.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Product administration error
Clinical narrative: Felt sick after one day; Vaccine given after 48 hours of a punctured vial; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Vaccine given after 48 hours of a punctured vial) and MALAISE (Felt sick after one day) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006821A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Vaccine given after 48 hours of a punctured vial). On an unknown date, the patient experienced MALAISE (Felt sick after one day). At the time of the report, PRODUCT ADMINISTRATION ERROR (Vaccine given after 48 hours of a punctured vial) and MALAISE (Felt sick after one day) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant Medications were not provided by the reporter. Treatment Information was not provided by the reporter.   This case was linked to MOD-2021-077668, US-MODERNATX, INC.-MOD-2021-078047, US-MODERNATX, INC.-MOD-2021-078057 (E2B Linked Report).; Sender's Comments:  MOD-2021-077668: US-MODERNATX, INC.-MOD-2021-078057: US-MODERNATX, INC.-MOD-2021-078047:
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Cold sweat, Insomnia
Clinical narrative: Thought he had covid-19; Sleeping on and off; Cold sweats in night; Feel terribly weak; Chills, Teeth chattering; sore arm, bodyache; Fever with 101 degree celsius; This spontaneous case was reported by a consumer and describes the occurrence of THINKING ABNORMAL (Thought he had covid-19), INSOMNIA (Sleeping on and off), COLD SWEAT (Cold sweats in night), ASTHENIA (Feel terribly weak) and CHILLS (Chills, Teeth chattering) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Radical nephrectomy in February 2020 and Colonoscopy (02Apr the patient underwent colonoscopy). Concurrent medical conditions included Kidney cancer since February 2020.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced THINKING ABNORMAL (Thought he had covid-19), INSOMNIA (Sleeping on and off), COLD SWEAT (Cold sweats in night), ASTHENIA (Feel terribly weak), CHILLS (Chills, Teeth chattering), MYALGIA (sore arm, bodyache) and PYREXIA (Fever with 101 degree celsius). At the time of the report, THINKING ABNORMAL (Thought he had covid-19), INSOMNIA (Sleeping on and off), COLD SWEAT (Cold sweats in night), ASTHENIA (Feel terribly weak), CHILLS (Chills, Teeth chattering), MYALGIA (sore arm, bodyache) and PYREXIA (Fever with 101 degree celsius) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, SARS-CoV-2 test: negative (Negative) covid-19 test and tested negative.. On 13-Apr-2021, Body temperature: 101 (Inconclusive) Fever with 101 degree celsius.         Concomitant product use was not provided by the reporter.  Action taken with mRNA-1273 in response to the events was not applicable.  Treatment information was not provided.   On Feb 2020 patient took nine treatments of BCG , stent put in the heart. On 13-Apr-2021 patient took the tenth BCG maintenance treatment and the patient was taking BCG treatment for past one year.     This case was linked to US-MODERNATX, INC.-MOD-2021-077899 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-077899:First dose case
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, SARS-CoV-2 test, Thinking abnormal
Clinical narrative: Thought he had covid-19; Sleeping on and off; Cold sweats in night; Feel terribly weak; Chills, Teeth chattering; sore arm, bodyache; Fever with 101 degree celsius; This spontaneous case was reported by a consumer and describes the occurrence of THINKING ABNORMAL (Thought he had covid-19), INSOMNIA (Sleeping on and off), COLD SWEAT (Cold sweats in night), ASTHENIA (Feel terribly weak) and CHILLS (Chills, Teeth chattering) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Radical nephrectomy in February 2020 and Colonoscopy (02Apr the patient underwent colonoscopy). Concurrent medical conditions included Kidney cancer since February 2020.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced THINKING ABNORMAL (Thought he had covid-19), INSOMNIA (Sleeping on and off), COLD SWEAT (Cold sweats in night), ASTHENIA (Feel terribly weak), CHILLS (Chills, Teeth chattering), MYALGIA (sore arm, bodyache) and PYREXIA (Fever with 101 degree celsius). At the time of the report, THINKING ABNORMAL (Thought he had covid-19), INSOMNIA (Sleeping on and off), COLD SWEAT (Cold sweats in night), ASTHENIA (Feel terribly weak), CHILLS (Chills, Teeth chattering), MYALGIA (sore arm, bodyache) and PYREXIA (Fever with 101 degree celsius) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, SARS-CoV-2 test: negative (Negative) covid-19 test and tested negative.. On 13-Apr-2021, Body temperature: 101 (Inconclusive) Fever with 101 degree celsius.         Concomitant product use was not provided by the reporter.  Action taken with mRNA-1273 in response to the events was not applicable.  Treatment information was not provided.   On Feb 2020 patient took nine treatments of BCG , stent put in the heart. On 13-Apr-2021 patient took the tenth BCG maintenance treatment and the patient was taking BCG treatment for past one year.     This case was linked to US-MODERNATX, INC.-MOD-2021-077899 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-077899:First dose case
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: Later noticed a cough that has not gone away; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Later noticed a cough that has not gone away) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy NOS.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced COUGH (Later noticed a cough that has not gone away). At the time of the report, COUGH (Later noticed a cough that has not gone away) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Breast mass, Breast pain, Breast tenderness, Cyst
Clinical narrative: decided not to go ahead with 2nd Vaccine; hives over entire body; 1 was a cyst; a lump on left breast; lump on left breast, was tender; lump on left breast, was sore and had pain; This spontaneous case was reported by a consumer and describes the occurrence of BREAST MASS (a lump on left breast), BREAST TENDERNESS (lump on left breast, was tender), BREAST PAIN (lump on left breast, was sore and had pain), CYST (1 was a cyst) and URTICARIA (hives over entire body) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma since 03-Mar-1996, Allergy to animals (Cats) and Allergy to animals (Horses). Concomitant products included FLUTICASONE FUROATE (ARNUITY ELLIPTA) from 05-Jan-2018 to an unknown date and MONTELUKAST from 05-Jan-2018 to an unknown date for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced BREAST MASS (a lump on left breast), BREAST TENDERNESS (lump on left breast, was tender) and BREAST PAIN (lump on left breast, was sore and had pain). On 30-Mar-2021, the patient experienced CYST (1 was a cyst). On 12-Apr-2021, the patient experienced URTICARIA (hives over entire body). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (decided not to go ahead with 2nd Vaccine). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Hives, at an unspecified dose and frequency. On 15-Apr-2021, URTICARIA (hives over entire body) had resolved. At the time of the report, BREAST MASS (a lump on left breast), BREAST TENDERNESS (lump on left breast, was tender), BREAST PAIN (lump on left breast, was sore and had pain) and CYST (1 was a cyst) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (decided not to go ahead with 2nd Vaccine) had resolved.    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Mar-2021, Mammogram: inconclusive (Inconclusive) Found 2 lumps and 1 was a cyst. On 30-Mar-2021, Ultrasound breast: inconclusive (Inconclusive) Found 2 lumps and 1 was a cyst. On 06-Apr-2021, Biopsy: inconclusive (Inconclusive) The doctor could not identify one of the lumps and felt the other was a cyst, that was aspirated.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Updated allergies. Updated diagnostic data - biopsy. Updated Event onset date of Lump on breast, Tenderness Breast, Pain Breast. Updated event outcome of Hives to recovered. Updated concomitant medications.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Mammogram, Product dose omission issue, Ultrasound breast, Urticaria
Clinical narrative: decided not to go ahead with 2nd Vaccine; hives over entire body; 1 was a cyst; a lump on left breast; lump on left breast, was tender; lump on left breast, was sore and had pain; This spontaneous case was reported by a consumer and describes the occurrence of BREAST MASS (a lump on left breast), BREAST TENDERNESS (lump on left breast, was tender), BREAST PAIN (lump on left breast, was sore and had pain), CYST (1 was a cyst) and URTICARIA (hives over entire body) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma since 03-Mar-1996, Allergy to animals (Cats) and Allergy to animals (Horses). Concomitant products included FLUTICASONE FUROATE (ARNUITY ELLIPTA) from 05-Jan-2018 to an unknown date and MONTELUKAST from 05-Jan-2018 to an unknown date for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced BREAST MASS (a lump on left breast), BREAST TENDERNESS (lump on left breast, was tender) and BREAST PAIN (lump on left breast, was sore and had pain). On 30-Mar-2021, the patient experienced CYST (1 was a cyst). On 12-Apr-2021, the patient experienced URTICARIA (hives over entire body). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (decided not to go ahead with 2nd Vaccine). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Hives, at an unspecified dose and frequency. On 15-Apr-2021, URTICARIA (hives over entire body) had resolved. At the time of the report, BREAST MASS (a lump on left breast), BREAST TENDERNESS (lump on left breast, was tender), BREAST PAIN (lump on left breast, was sore and had pain) and CYST (1 was a cyst) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (decided not to go ahead with 2nd Vaccine) had resolved.    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Mar-2021, Mammogram: inconclusive (Inconclusive) Found 2 lumps and 1 was a cyst. On 30-Mar-2021, Ultrasound breast: inconclusive (Inconclusive) Found 2 lumps and 1 was a cyst. On 06-Apr-2021, Biopsy: inconclusive (Inconclusive) The doctor could not identify one of the lumps and felt the other was a cyst, that was aspirated.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Updated allergies. Updated diagnostic data - biopsy. Updated Event onset date of Lump on breast, Tenderness Breast, Pain Breast. Updated event outcome of Hives to recovered. Updated concomitant medications.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, SARS-CoV-2 test positive
Clinical narrative: covid-19 positive; little bit cough; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid-19 positive) and COUGH (little bit cough) 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 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced COVID-19 (covid-19 positive) and COUGH (little bit cough). At the time of the report, COVID-19 (covid-19 positive) and COUGH (little bit cough) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Apr-2021, SARS-CoV-2 test positive: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication was reported.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-077959 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-077959:case for husband
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Feeling abnormal, Pyrexia
Clinical narrative: feeling miserable; now 101.2 degrees Fahrenheit; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feeling miserable) and PYREXIA (now 101.2 degrees Fahrenheit) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 044A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 15-Apr-2021, the patient experienced FEELING ABNORMAL (feeling miserable) and PYREXIA (now 101.2 degrees Fahrenheit). At the time of the report, FEELING ABNORMAL (feeling miserable) and PYREXIA (now 101.2 degrees Fahrenheit) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Apr-2021, Body temperature: 102 (High) fever of 102 degrees Fahrenheit.         Concomitant medications are not provided by the reporter. No treatment drugs are not provided by reporter.    Reporter did not allow further contact
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Eating disorder, Fatigue, Headache
Clinical narrative: Torso is still Itchy; Tired and slept part of day; Diarrhea; Could not move; Could not eat; Did not feel good for 3 days; Head ache she said was indescribable; Chills; Stayed in bed all day Friday; Red; Kicked my ass; Itchy around injection site; Moderna arm; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (Kicked my ass), DIARRHOEA (Diarrhea), MOVEMENT DISORDER (Could not move), EATING DISORDER (Could not eat) and SOMNOLENCE (Tired and slept part of day) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (Kicked my ass), TYPE IV HYPERSENSITIVITY REACTION (Moderna arm), VACCINATION SITE PRURITUS (Itchy around injection site) and VACCINATION SITE ERYTHEMA (Red). On 09-Apr-2021, the patient experienced DIARRHOEA (Diarrhea), MOVEMENT DISORDER (Could not move), EATING DISORDER (Could not eat), MALAISE (Did not feel good for 3 days), HEADACHE (Head ache she said was indescribable), CHILLS (Chills) and FATIGUE (Stayed in bed all day Friday). On 10-Apr-2021, the patient experienced SOMNOLENCE (Tired and slept part of day). On an unknown date, the patient experienced PRURITUS (Torso is still Itchy). On 10-Apr-2021, HEADACHE (Head ache she said was indescribable) and FATIGUE (Stayed in bed all day Friday) had resolved. On 11-Apr-2021, MUSCULOSKELETAL DISCOMFORT (Kicked my ass), DIARRHOEA (Diarrhea), MOVEMENT DISORDER (Could not move), EATING DISORDER (Could not eat), SOMNOLENCE (Tired and slept part of day) and CHILLS (Chills) had resolved. On 12-Apr-2021, MALAISE (Did not feel good for 3 days) had resolved. At the time of the report, TYPE IV HYPERSENSITIVITY REACTION (Moderna arm), VACCINATION SITE PRURITUS (Itchy around injection site) and VACCINATION SITE ERYTHEMA (Red) outcome was unknown and PRURITUS (Torso is still Itchy) had not resolved.            No concomitant medications were provided.  Treatment medications were unknown.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events was not applicable.   This case was linked to MOD-2021-077925 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Updated Contact details. Added patient demographics, Lot number (1st dose and 2nd dose). Added New event (Torso is still Itchy)
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Movement disorder, Musculoskeletal discomfort, Pruritus, Somnolence
Clinical narrative: Torso is still Itchy; Tired and slept part of day; Diarrhea; Could not move; Could not eat; Did not feel good for 3 days; Head ache she said was indescribable; Chills; Stayed in bed all day Friday; Red; Kicked my ass; Itchy around injection site; Moderna arm; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (Kicked my ass), DIARRHOEA (Diarrhea), MOVEMENT DISORDER (Could not move), EATING DISORDER (Could not eat) and SOMNOLENCE (Tired and slept part of day) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (Kicked my ass), TYPE IV HYPERSENSITIVITY REACTION (Moderna arm), VACCINATION SITE PRURITUS (Itchy around injection site) and VACCINATION SITE ERYTHEMA (Red). On 09-Apr-2021, the patient experienced DIARRHOEA (Diarrhea), MOVEMENT DISORDER (Could not move), EATING DISORDER (Could not eat), MALAISE (Did not feel good for 3 days), HEADACHE (Head ache she said was indescribable), CHILLS (Chills) and FATIGUE (Stayed in bed all day Friday). On 10-Apr-2021, the patient experienced SOMNOLENCE (Tired and slept part of day). On an unknown date, the patient experienced PRURITUS (Torso is still Itchy). On 10-Apr-2021, HEADACHE (Head ache she said was indescribable) and FATIGUE (Stayed in bed all day Friday) had resolved. On 11-Apr-2021, MUSCULOSKELETAL DISCOMFORT (Kicked my ass), DIARRHOEA (Diarrhea), MOVEMENT DISORDER (Could not move), EATING DISORDER (Could not eat), SOMNOLENCE (Tired and slept part of day) and CHILLS (Chills) had resolved. On 12-Apr-2021, MALAISE (Did not feel good for 3 days) had resolved. At the time of the report, TYPE IV HYPERSENSITIVITY REACTION (Moderna arm), VACCINATION SITE PRURITUS (Itchy around injection site) and VACCINATION SITE ERYTHEMA (Red) outcome was unknown and PRURITUS (Torso is still Itchy) had not resolved.            No concomitant medications were provided.  Treatment medications were unknown.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events was not applicable.   This case was linked to MOD-2021-077925 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Updated Contact details. Added patient demographics, Lot number (1st dose and 2nd dose). Added New event (Torso is still Itchy)
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Type IV hypersensitivity reaction, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Torso is still Itchy; Tired and slept part of day; Diarrhea; Could not move; Could not eat; Did not feel good for 3 days; Head ache she said was indescribable; Chills; Stayed in bed all day Friday; Red; Kicked my ass; Itchy around injection site; Moderna arm; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (Kicked my ass), DIARRHOEA (Diarrhea), MOVEMENT DISORDER (Could not move), EATING DISORDER (Could not eat) and SOMNOLENCE (Tired and slept part of day) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (Kicked my ass), TYPE IV HYPERSENSITIVITY REACTION (Moderna arm), VACCINATION SITE PRURITUS (Itchy around injection site) and VACCINATION SITE ERYTHEMA (Red). On 09-Apr-2021, the patient experienced DIARRHOEA (Diarrhea), MOVEMENT DISORDER (Could not move), EATING DISORDER (Could not eat), MALAISE (Did not feel good for 3 days), HEADACHE (Head ache she said was indescribable), CHILLS (Chills) and FATIGUE (Stayed in bed all day Friday). On 10-Apr-2021, the patient experienced SOMNOLENCE (Tired and slept part of day). On an unknown date, the patient experienced PRURITUS (Torso is still Itchy). On 10-Apr-2021, HEADACHE (Head ache she said was indescribable) and FATIGUE (Stayed in bed all day Friday) had resolved. On 11-Apr-2021, MUSCULOSKELETAL DISCOMFORT (Kicked my ass), DIARRHOEA (Diarrhea), MOVEMENT DISORDER (Could not move), EATING DISORDER (Could not eat), SOMNOLENCE (Tired and slept part of day) and CHILLS (Chills) had resolved. On 12-Apr-2021, MALAISE (Did not feel good for 3 days) had resolved. At the time of the report, TYPE IV HYPERSENSITIVITY REACTION (Moderna arm), VACCINATION SITE PRURITUS (Itchy around injection site) and VACCINATION SITE ERYTHEMA (Red) outcome was unknown and PRURITUS (Torso is still Itchy) had not resolved.            No concomitant medications were provided.  Treatment medications were unknown.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events was not applicable.   This case was linked to MOD-2021-077925 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Updated Contact details. Added patient demographics, Lot number (1st dose and 2nd dose). Added New event (Torso is still Itchy)
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Nausea
Clinical narrative: Migraine-like headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine-like headache) and NAUSEA (Nausea) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure. Concomitant products included OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]) for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced MIGRAINE (Migraine-like headache) and NAUSEA (Nausea). On 09-Mar-2021, MIGRAINE (Migraine-like headache) and NAUSEA (Nausea) had resolved. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       patient uses concomitant medications that includes High Blood Pressure Medication. Treatment includes Pain Reliever.   This case was linked to US-MODERNATX, INC.-MOD-2021-077943 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-077943:CROSS LINKED WITH DOSE 2
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: Nose Bleeding 4 times a week lasting between 6 minutes to 10 minutes each time; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (Nose Bleeding 4 times a week lasting between 6 minutes to 10 minutes each time) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX) for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced EPISTAXIS (Nose Bleeding 4 times a week lasting between 6 minutes to 10 minutes each time). At the time of the report, EPISTAXIS (Nose Bleeding 4 times a week lasting between 6 minutes to 10 minutes each time) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications not reported.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Nasopharyngitis, SARS-CoV-2 test positive, Sneezing
Clinical narrative: cold; Sneezing; weakness; Felt tired; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold), SNEEZING (Sneezing), ASTHENIA (weakness) and FATIGUE (Felt tired) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced NASOPHARYNGITIS (cold), SNEEZING (Sneezing), ASTHENIA (weakness) and FATIGUE (Felt tired). At the time of the report, NASOPHARYNGITIS (cold), SNEEZING (Sneezing), ASTHENIA (weakness) and FATIGUE (Felt tired) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Apr-2021, SARS-CoV-2 test positive: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication was provided.  No treatment medication were provided.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Event associated with Dose-1 is recovered.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site lymphadenopathy, Vaccination site pain
Clinical narrative: "swollen lymph node under arm pit." (injection site arm); Pain in arm.( injection site arm); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE LYMPHADENOPATHY ("swollen lymph node under arm pit." (injection site arm)) and VACCINATION SITE PAIN (Pain in arm.( injection site arm)) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE LYMPHADENOPATHY ("swollen lymph node under arm pit." (injection site arm)) and VACCINATION SITE PAIN (Pain in arm.( injection site arm)). At the time of the report, VACCINATION SITE LYMPHADENOPATHY ("swollen lymph node under arm pit." (injection site arm)) and VACCINATION SITE PAIN (Pain in arm.( injection site arm)) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.    This case was linked to MOD21-076254, US-MODERNATX, INC.-MOD-2021-077735, US-MODERNATX, INC.-MOD-2021-077745, US-MODERNATX, INC.-MOD-2021-077965 (E2B Linked Report).; Sender's Comments:  MOD21-076254: US-MODERNATX, INC.-MOD-2021-077735: US-MODERNATX, INC.-MOD-2021-077745: US-MODERNATX, INC.-MOD-2021-077965:
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Alcoholic hangover
Clinical narrative: Still feeling the effects of the alcohol today; This spontaneous case was reported by a consumer and describes the occurrence of ALCOHOLIC HANGOVER (Still feeling the effects of the alcohol today) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     The patient's past medical history included Alcoholic hangover (The patient consumed alcohol 14-APR-2021 night and was still feeling the effects of the alcohol.) on 14-Apr-2021.    On 14-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced ALCOHOLIC HANGOVER (Still feeling the effects of the alcohol today). At the time of the report, ALCOHOLIC HANGOVER (Still feeling the effects of the alcohol today) outcome was unknown. Not Provided          No concomitant medications reported. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable. No treatment medication details were provided.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: pain in left arm; pain in left shoulder; pain in thigh muscle; pain in left hip; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in left arm), ARTHRALGIA (pain in left shoulder), PAIN IN EXTREMITY (pain in thigh muscle) and ARTHRALGIA (pain in left hip) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 011A21A;) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included LISINOPRIL, GABAPENTIN, ALPRAZOLAM, ASPIRIN [ACETYLSALICYLIC ACID], COLECALCIFEROL (VITAMIN D 3), glucosamine chondroitin + vitD and DICLOFENAC for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced PAIN IN EXTREMITY (pain in left arm), ARTHRALGIA (pain in left shoulder), PAIN IN EXTREMITY (pain in thigh muscle) and ARTHRALGIA (pain in left hip). The patient was treated with IBUPROFEN on 14-Apr-2021 for Pain, at a dose of 200 milligram twice a day. At the time of the report, PAIN IN EXTREMITY (pain in left arm), ARTHRALGIA (pain in left shoulder), PAIN IN EXTREMITY (pain in thigh muscle) and ARTHRALGIA (pain in left hip) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   treatment to the events given as Ice pack on back and leg is making it go away.   This case was linked to US-MODERNATX, INC.-MOD-2021-077967 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-077967:1 st dose