chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Headache, Nausea, SARS-CoV-2 test
Clinical narrative: COVID-19; coughing; Nausea; vomiting; headache; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), COUGH (coughing), NAUSEA (Nausea), VOMITING (vomiting) and HEADACHE (headache) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     The patient's past medical history included Asthma. Concurrent medical conditions included Fatigue (Prior to the vaccination due to working a lot).    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced COVID-19 (COVID-19), COUGH (coughing), NAUSEA (Nausea), VOMITING (vomiting) and HEADACHE (headache). At the time of the report, COVID-19 (COVID-19), COUGH (coughing) and HEADACHE (headache) had not resolved and NAUSEA (Nausea) and VOMITING (vomiting) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: COVID-19; coughing; Nausea; vomiting; headache; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), COUGH (coughing), NAUSEA (Nausea), VOMITING (vomiting) and HEADACHE (headache) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     The patient's past medical history included Asthma. Concurrent medical conditions included Fatigue (Prior to the vaccination due to working a lot).    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced COVID-19 (COVID-19), COUGH (coughing), NAUSEA (Nausea), VOMITING (vomiting) and HEADACHE (headache). At the time of the report, COVID-19 (COVID-19), COUGH (coughing) and HEADACHE (headache) had not resolved and NAUSEA (Nausea) and VOMITING (vomiting) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Hot at the site of injection; Swollen arm; Itchy at the site of injection; Red at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot at the site of injection), VACCINATION SITE SWELLING (Swollen arm), VACCINATION SITE PRURITUS (Itchy at the site of injection) and VACCINATION SITE ERYTHEMA (Red at the site of injection) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Hot at the site of injection), VACCINATION SITE SWELLING (Swollen arm), VACCINATION SITE PRURITUS (Itchy at the site of injection) and VACCINATION SITE ERYTHEMA (Red at the site of injection). The patient was treated with ASIMINA TRILOBA (LUCAS PAPAW) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Hot at the site of injection), VACCINATION SITE SWELLING (Swollen arm), VACCINATION SITE PRURITUS (Itchy at the site of injection) and VACCINATION SITE ERYTHEMA (Red at the site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Piloerection, Pruritus, Rash
Clinical narrative: ittle white bumps/goose bumps; legs red from scratching; rash on legs stomach, back and neck; itchy on my thigh and legs; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy on my thigh and legs), PILOERECTION (ittle white bumps/goose bumps), ERYTHEMA (legs red from scratching) and RASH (rash on legs stomach, back and neck) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A2JA or 011A21A) for COVID-19 immunisation.     Concurrent medical conditions included Hypertension. Concomitant products included METOPROLOL for Hypertension.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced PRURITUS (itchy on my thigh and legs). On 28-Feb-2021, the patient experienced PILOERECTION (ittle white bumps/goose bumps), ERYTHEMA (legs red from scratching) and RASH (rash on legs stomach, back and neck). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PRURITUS (itchy on my thigh and legs), PILOERECTION (ittle white bumps/goose bumps), ERYTHEMA (legs red from scratching) and RASH (rash on legs stomach, back and neck) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: fever 101; nausea; body aches and pain; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever 101), NAUSEA (nausea) and MYALGIA (body aches and pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced PYREXIA (fever 101), NAUSEA (nausea) and MYALGIA (body aches and pain). At the time of the report, PYREXIA (fever 101), NAUSEA (nausea) and MYALGIA (body aches and pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Oropharyngeal discomfort, Pain in extremity
Clinical narrative: had a nose bleed; Severe Arm Soreness; Scratchy throat; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (had a nose bleed), PAIN IN EXTREMITY (Severe Arm Soreness) and OROPHARYNGEAL DISCOMFORT (Scratchy throat) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 032M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VALACYCLOVIR [VALACICLOVIR] for an unknown indication.   On 02-Mar-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 08-Mar-2021, the patient experienced OROPHARYNGEAL DISCOMFORT (Scratchy throat). On an unknown date, the patient experienced EPISTAXIS (had a nose bleed) and PAIN IN EXTREMITY (Severe Arm Soreness). At the time of the report, EPISTAXIS (had a nose bleed), PAIN IN EXTREMITY (Severe Arm Soreness) and OROPHARYNGEAL DISCOMFORT (Scratchy throat) outcome was unknown.            Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Non significant follow up received on 07-MAY-2021, second dose details updated
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Headache, Vision blurred
Clinical narrative: Blurry vision/sitting 7 feet from tv and couldn't read a word; head aches behind the eyes and pain; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MULTIPLE SCLEROSIS (Multiple Sclerosis) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. EN6290) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Multiple sclerosis since an unknown date.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VISION BLURRED (Blurry vision/sitting 7 feet from tv and couldn't read a word), EYE PAIN (head aches behind the eyes and pain), HEADACHE (Headache) and MULTIPLE SCLEROSIS (Multiple Sclerosis) (seriousness criterion medically significant). At the time of the report, VISION BLURRED (Blurry vision/sitting 7 feet from tv and couldn't read a word), EYE PAIN (head aches behind the eyes and pain), HEADACHE (Headache) and MULTIPLE SCLEROSIS (Multiple Sclerosis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included  Tylenol. Concomitant medications were not included.; Sender's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of INJECTION SITE PRURITUS (COVID arm Rash/Itching) and INJECTION SITE RASH (COVID arm Rash/Itching) 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) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PRURITUS (COVID arm Rash/Itching) and INJECTION SITE RASH (COVID arm Rash/Itching). At the time of the report, INJECTION SITE PRURITUS (COVID arm Rash/Itching) and INJECTION SITE RASH (COVID arm Rash/Itching) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product used was not provided by the reporter. Treatment information was not provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Headache, Injection site erythema, Lymphadenopathy
Clinical narrative: underneath her arm swollen "gland" big as a baseball; spread to chest; redness and swelling still spreading; injection site red down to elbow; injection site swollen down to elbow; body aches; chills; headaches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches), CHILLS (chills), HEADACHE (headaches), INJECTION SITE ERYTHEMA (injection site red down to elbow) and VACCINATION SITE SWELLING (injection site swollen down to elbow) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 04-Mar-2021, the patient experienced MYALGIA (body aches), CHILLS (chills) and HEADACHE (headaches). On 05-Mar-2021, the patient experienced INJECTION SITE ERYTHEMA (injection site red down to elbow) and VACCINATION SITE SWELLING (injection site swollen down to elbow). On an unknown date, the patient experienced LYMPHADENOPATHY (underneath her arm swollen "gland" big as a baseball), ERYTHEMA (spread to chest) and ERYTHEMA (redness and swelling still spreading). The patient was treated with LEVOTHYROXINE SODIUM (SYNTHYROID) ongoing since an unknown date at an unspecified dose and frequency; BUPROPION at an unspecified dose and frequency and ROSUVASTATIN CALCIUM (CRESTOR) at an unspecified dose and frequency. At the time of the report, MYALGIA (body aches), CHILLS (chills), HEADACHE (headaches), INJECTION SITE ERYTHEMA (injection site red down to elbow), VACCINATION SITE SWELLING (injection site swollen down to elbow), LYMPHADENOPATHY (underneath her arm swollen "gland" big as a baseball), ERYTHEMA (spread to chest) and ERYTHEMA (redness and swelling still spreading) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no concomitant medications reported.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site swelling
Clinical narrative: underneath her arm swollen "gland" big as a baseball; spread to chest; redness and swelling still spreading; injection site red down to elbow; injection site swollen down to elbow; body aches; chills; headaches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches), CHILLS (chills), HEADACHE (headaches), INJECTION SITE ERYTHEMA (injection site red down to elbow) and VACCINATION SITE SWELLING (injection site swollen down to elbow) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 04-Mar-2021, the patient experienced MYALGIA (body aches), CHILLS (chills) and HEADACHE (headaches). On 05-Mar-2021, the patient experienced INJECTION SITE ERYTHEMA (injection site red down to elbow) and VACCINATION SITE SWELLING (injection site swollen down to elbow). On an unknown date, the patient experienced LYMPHADENOPATHY (underneath her arm swollen "gland" big as a baseball), ERYTHEMA (spread to chest) and ERYTHEMA (redness and swelling still spreading). The patient was treated with LEVOTHYROXINE SODIUM (SYNTHYROID) ongoing since an unknown date at an unspecified dose and frequency; BUPROPION at an unspecified dose and frequency and ROSUVASTATIN CALCIUM (CRESTOR) at an unspecified dose and frequency. At the time of the report, MYALGIA (body aches), CHILLS (chills), HEADACHE (headaches), INJECTION SITE ERYTHEMA (injection site red down to elbow), VACCINATION SITE SWELLING (injection site swollen down to elbow), LYMPHADENOPATHY (underneath her arm swollen "gland" big as a baseball), ERYTHEMA (spread to chest) and ERYTHEMA (redness and swelling still spreading) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no concomitant medications reported.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Urticaria
Clinical narrative: hives; difficulty breathing; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives) and DYSPNOEA (difficulty breathing) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 06-Mar-2021, the patient experienced URTICARIA (hives) and DYSPNOEA (difficulty breathing). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and PREDNISONE at an unspecified dose and frequency. At the time of the report, URTICARIA (hives) and DYSPNOEA (difficulty breathing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication includes Nebulizer.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Injection site mass, Pain
Clinical narrative: red itchy lump; dizzy; pain; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE MASS (red itchy lump), DIZZINESS (dizzy) and PAIN (pain) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced INJECTION SITE MASS (red itchy lump), DIZZINESS (dizzy) and PAIN (pain). At the time of the report, INJECTION SITE MASS (red itchy lump), DIZZINESS (dizzy) and PAIN (pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness in arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Soreness in arm) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0MM20A) for COVID-19 vaccination.     Concomitant products included CLOZAPINE (CLOZARIL), LANSOPRAZOLE (PREVACID) and LISINOPRIL for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced VACCINATION SITE PAIN (Soreness in arm). The patient was treated with PREDNISONE ongoing since an unknown date at an unspecified dose and frequency. On 03-Mar-2021, VACCINATION SITE PAIN (Soreness in arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache of shooting pain in her head; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache of shooting pain in her head) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-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 03-Mar-2021, the patient experienced HEADACHE (Headache of shooting pain in her head). The patient was treated with PARACETAMOL (TYLENOL) for Headache aggravated, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Headache aggravated, at an unspecified dose and frequency. At the time of the report, HEADACHE (Headache of shooting pain in her head) had not resolved.            Concomitant medications were not reported.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Pain, Pain in extremity
Clinical narrative: Pain in arm; body aches; felt crummy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm), PAIN (body aches) and FEELING ABNORMAL (felt crummy) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 012M20A) for COVID-19 vaccination.     Concomitant products included HYDROCODONE BITARTRATE, PARACETAMOL (VICODIN) for Arthritis.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm), PAIN (body aches) and FEELING ABNORMAL (felt crummy). At the time of the report, PAIN IN EXTREMITY (Pain in arm), PAIN (body aches) and FEELING ABNORMAL (felt crummy) outcome was unknown.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030AZIA) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 06-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced RASH (Rash). At the time of the report, RASH (Rash) outcome was unknown. Not Provided          Concomitant product use was not provided  by the reporter.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Product temperature excursion issue, Wrong technique in product usage process
Clinical narrative: Lowest freezer temperature was 50 Fahrenheit and Highest was 86 Fahrenheit; Vaccination site used some vaccine this morning 09MAR2021, to vaccinate people; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Lowest freezer temperature was 50 Fahrenheit and Highest was 86 Fahrenheit) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Vaccination site used some vaccine this morning 09MAR2021, to vaccinate people) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 001B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Lowest freezer temperature was 50 Fahrenheit and Highest was 86 Fahrenheit) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Vaccination site used some vaccine this morning 09MAR2021, to vaccinate people). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Lowest freezer temperature was 50 Fahrenheit and Highest was 86 Fahrenheit) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Vaccination site used some vaccine this morning 09MAR2021, to vaccinate people) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: New event added vaccination site used some vaccine this morning 09-MAR-2021, to vaccinate people
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Back pain, Chest pain, Chills, Headache
Clinical narrative: Stomach pretty painfull; Chest and back pain; Chest and back pain; Nausea hiccups; Nausea hiccups; Headache; Chills; Body aches; Pain in the arm; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest and back pain), ABDOMINAL PAIN UPPER (Stomach pretty painfull), PAIN IN EXTREMITY (Pain in the arm), BACK PAIN (Chest and back pain) and HICCUPS (Nausea hiccups) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE, OLMESARTAN, PROPRANOLOL and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced PAIN IN EXTREMITY (Pain in the arm), HICCUPS (Nausea hiccups), NAUSEA (Nausea hiccups), HEADACHE (Headache), CHILLS (Chills) and MYALGIA (Body aches). On 01-Mar-2021, the patient experienced CHEST PAIN (Chest and back pain) and BACK PAIN (Chest and back pain). On 07-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach pretty painfull). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 1 dosage form. At the time of the report, CHEST PAIN (Chest and back pain), ABDOMINAL PAIN UPPER (Stomach pretty painfull), PAIN IN EXTREMITY (Pain in the arm), BACK PAIN (Chest and back pain), HICCUPS (Nausea hiccups), NAUSEA (Nausea hiccups), HEADACHE (Headache), CHILLS (Chills) and MYALGIA (Body aches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment included Tea with star anise was reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-037875 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Follow-up was received on 23-Jun-2021. Event outcomes were updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-037875:Crosslinked case
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Hiccups, Myalgia, Nausea, Vaccination site pain
Clinical narrative: Stomach pretty painfull; Chest and back pain; Chest and back pain; Nausea hiccups; Nausea hiccups; Headache; Chills; Body aches; Pain in the arm; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest and back pain), ABDOMINAL PAIN UPPER (Stomach pretty painfull), PAIN IN EXTREMITY (Pain in the arm), BACK PAIN (Chest and back pain) and HICCUPS (Nausea hiccups) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE, OLMESARTAN, PROPRANOLOL and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced PAIN IN EXTREMITY (Pain in the arm), HICCUPS (Nausea hiccups), NAUSEA (Nausea hiccups), HEADACHE (Headache), CHILLS (Chills) and MYALGIA (Body aches). On 01-Mar-2021, the patient experienced CHEST PAIN (Chest and back pain) and BACK PAIN (Chest and back pain). On 07-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach pretty painfull). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 1 dosage form. At the time of the report, CHEST PAIN (Chest and back pain), ABDOMINAL PAIN UPPER (Stomach pretty painfull), PAIN IN EXTREMITY (Pain in the arm), BACK PAIN (Chest and back pain), HICCUPS (Nausea hiccups), NAUSEA (Nausea hiccups), HEADACHE (Headache), CHILLS (Chills) and MYALGIA (Body aches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment included Tea with star anise was reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-037875 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Follow-up was received on 23-Jun-2021. Event outcomes were updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-037875:Crosslinked case
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain, Pyrexia
Clinical narrative: nausea; vomiting; headaches; chills; fever; Pain; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea), VOMITING (vomiting), HEADACHE (headaches), CHILLS (chills) and PYREXIA (fever) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LOSARTAN POTASSIUM (LOSATAN), AMLODIPINE and ATORVASTATIN CALCIUM (LIPITOR) 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 NAUSEA (nausea), VOMITING (vomiting), HEADACHE (headaches), CHILLS (chills), PYREXIA (fever) and PAIN (Pain). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, NAUSEA (nausea), VOMITING (vomiting), HEADACHE (headaches), CHILLS (chills), PYREXIA (fever) and PAIN (Pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Follow up was received on 21 may 2021  non significant case included no new information
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: nausea; vomiting; headaches; chills; fever; Pain; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea), VOMITING (vomiting), HEADACHE (headaches), CHILLS (chills) and PYREXIA (fever) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LOSARTAN POTASSIUM (LOSATAN), AMLODIPINE and ATORVASTATIN CALCIUM (LIPITOR) 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 NAUSEA (nausea), VOMITING (vomiting), HEADACHE (headaches), CHILLS (chills), PYREXIA (fever) and PAIN (Pain). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, NAUSEA (nausea), VOMITING (vomiting), HEADACHE (headaches), CHILLS (chills), PYREXIA (fever) and PAIN (Pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Follow up was received on 21 may 2021  non significant case included no new information
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Hypoaesthesia
Clinical narrative: numbness in her arms and legs; blood pressure is spiking; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness in her arms and legs) and HYPERTENSION (blood pressure is spiking) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20a) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (numbness in her arms and legs) and HYPERTENSION (blood pressure is spiking). At the time of the report, HYPOAESTHESIA (numbness in her arms and legs) and HYPERTENSION (blood pressure is spiking) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication use was not provided by the reporter.  Treatment information was not provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Limb discomfort
Clinical narrative: Weakness; Legs gave out; Joint pain, all her joints, Joints started to hurt, all her joints; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), LIMB DISCOMFORT (Legs gave out) and ARTHRALGIA (Joint pain, all her joints, Joints started to hurt, all her joints) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. Concurrent medical conditions included Hypertension, Diabetes and Lupus syndrome. Concomitant products included METOPROLOL, METFORMIN, PREDNISONE, HYDROXYCHLOROQUINE, PREGABALIN (LIRICA), ROSUVASTATIN and CICLOSPORIN (RESTASIS) for an unknown indication. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced ASTHENIA (Weakness), LIMB DISCOMFORT (Legs gave out) and ARTHRALGIA (Joint pain, all her joints, Joints started to hurt, all her joints). At the time of the report, ASTHENIA (Weakness), LIMB DISCOMFORT (Legs gave out) and ARTHRALGIA (Joint pain, all her joints, Joints started to hurt, all her joints) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. It was reported that the patient used to take Furosemide (Lasix) but got off the medicine recently. She also took an unspecified blood thinner. Treatment taken for joint pain was over the counter medication.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Gait inability, Hyperhidrosis, Pyrexia, Vaccination complication
Clinical narrative: Sweats; Unable to walk; Felt sick; Fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERHIDROSIS (Sweats), GAIT INABILITY (Unable to walk), VACCINATION COMPLICATION (Felt sick) and PYREXIA (Fever) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007MZ0A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (Sweats), GAIT INABILITY (Unable to walk), VACCINATION COMPLICATION (Felt sick) and PYREXIA (Fever). At the time of the report, HYPERHIDROSIS (Sweats), GAIT INABILITY (Unable to walk), VACCINATION COMPLICATION (Felt sick) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.    This case was linked to MOD-2021-045138 (Patient Link).; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Follow-up: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 58.0
Sex: U
Vaccine: COVID19
Symptoms: Dental caries, Injection site pain
Clinical narrative: cavity; pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of DENTAL CARIES (cavity) and INJECTION SITE PAIN (pain at injection site) in a 58-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced INJECTION SITE PAIN (pain at injection site). On 09-Mar-2021, the patient experienced DENTAL CARIES (cavity). On 06-Mar-2021, INJECTION SITE PAIN (pain at injection site) outcome was unknown. At the time of the report, DENTAL CARIES (cavity) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs were reported. No treatment medications were reported. However, the patient was scheduling appointment to see dentist.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Vaccination site movement impairment, Vaccination site pain
Clinical narrative: Vaccination site movement impairment; Vaccination site pain; Expired vaccine used; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Vaccination site movement impairment), VACCINATION SITE PAIN (Vaccination site pain) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Vaccination site movement impairment), VACCINATION SITE PAIN (Vaccination site pain) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at a dose of 1 dosage form. On 05-Mar-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Vaccination site movement impairment) outcome was unknown and VACCINATION SITE PAIN (Vaccination site pain) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient was taking Cholesterol Medications , Blood Pressure medication as concomitant medication. Patient stated that vaccine was drawn on 3 March 2021 and she received that same vaccine on 5 March 2021.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 22-Sep-2020 and the estimated date of delivery was 29-Jun-2021. On 08-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-fourth week of the pregnancy.  On 08-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product use was reported No treatment information was provided
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Lip blister
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of LIP BLISTER (Fever blisters,they are inside and outside the bottom lip) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A.) for COVID-19 vaccination. Concurrent medical conditions included Asthma. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced LIP BLISTER (Fever blisters,they are inside and outside the bottom lip). At the time of the report, LIP BLISTER (Fever blisters,they are inside and outside the bottom lip) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant Medications were not provided by the reporter. For the treatment of lip blisters lip gel abreva, mouth wash peroxyl were given.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Vaccination site erythema, Vaccination site pain, Vaccination site rash
Clinical narrative: Pin Pricking sensation; Redness; Rash; Soreness; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Pin Pricking sensation), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE RASH (Rash) and VACCINATION SITE PAIN (Soreness) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A71A and 032L20A) for COVID-19 vaccination.     Concomitant products included APIXABAN (ELIQUIS), METOPROLOL SUCCINATE (TOPROL) and PROTON PUMP INHIBITORS for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced PARAESTHESIA (Pin Pricking sensation), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE RASH (Rash) and VACCINATION SITE PAIN (Soreness). At the time of the report, PARAESTHESIA (Pin Pricking sensation), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE RASH (Rash) and VACCINATION SITE PAIN (Soreness) outcome was unknown.            Treatment information included, cortisone cream was provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Bite, Limb discomfort, Peripheral swelling, Vaccination site joint erythema, Vaccination site pain
Clinical narrative: Vaccination site scar; Arm discomfort; Vaccination site rash; Vaccination site pain; Swollen arm; Vaccination site joint redness; Bite; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PERIPHERAL SWELLING (Swollen arm), VACCINATION SITE JOINT ERYTHEMA (Vaccination site joint redness), BITE (Bite), VACCINATION SITE SCAR (Vaccination site scar ) and LIMB DISCOMFORT (Arm discomfort) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 04-Apr-2020. Concomitant products included VITAMIN D NOS for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm), VACCINATION SITE JOINT ERYTHEMA (Vaccination site joint redness), BITE (Bite), LIMB DISCOMFORT (Arm discomfort), VACCINATION SITE RASH (Vaccination site rash ) and VACCINATION SITE PAIN (Vaccination site pain ). On 14-Feb-2021, the patient experienced VACCINATION SITE SCAR (Vaccination site scar ). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 14-Feb-2021, PERIPHERAL SWELLING (Swollen arm), VACCINATION SITE JOINT ERYTHEMA (Vaccination site joint redness), BITE (Bite), VACCINATION SITE SCAR (Vaccination site scar ), LIMB DISCOMFORT (Arm discomfort), VACCINATION SITE RASH (Vaccination site rash ) and VACCINATION SITE PAIN (Vaccination site pain ) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was scheduled to receive her second dose of the vaccine on 11Mar2021, but she was told by her doctor that she may not need the second dose, as she may have acquired the antibodies. He also suggested if she does had  the second dose, that she take Tylenol and Benadryl the day of the second dose to avoid swelling. The patient wished to know if she could avoid the second dose and if she did have the second dose, could she take Benadryl and Tylenol. The patient provided no further information but provided consent to be contacted by Safety.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash, Vaccination site scar
Clinical narrative: Vaccination site scar; Arm discomfort; Vaccination site rash; Vaccination site pain; Swollen arm; Vaccination site joint redness; Bite; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PERIPHERAL SWELLING (Swollen arm), VACCINATION SITE JOINT ERYTHEMA (Vaccination site joint redness), BITE (Bite), VACCINATION SITE SCAR (Vaccination site scar ) and LIMB DISCOMFORT (Arm discomfort) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 04-Apr-2020. Concomitant products included VITAMIN D NOS for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm), VACCINATION SITE JOINT ERYTHEMA (Vaccination site joint redness), BITE (Bite), LIMB DISCOMFORT (Arm discomfort), VACCINATION SITE RASH (Vaccination site rash ) and VACCINATION SITE PAIN (Vaccination site pain ). On 14-Feb-2021, the patient experienced VACCINATION SITE SCAR (Vaccination site scar ). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 14-Feb-2021, PERIPHERAL SWELLING (Swollen arm), VACCINATION SITE JOINT ERYTHEMA (Vaccination site joint redness), BITE (Bite), VACCINATION SITE SCAR (Vaccination site scar ), LIMB DISCOMFORT (Arm discomfort), VACCINATION SITE RASH (Vaccination site rash ) and VACCINATION SITE PAIN (Vaccination site pain ) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was scheduled to receive her second dose of the vaccine on 11Mar2021, but she was told by her doctor that she may not need the second dose, as she may have acquired the antibodies. He also suggested if she does had  the second dose, that she take Tylenol and Benadryl the day of the second dose to avoid swelling. The patient wished to know if she could avoid the second dose and if she did have the second dose, could she take Benadryl and Tylenol. The patient provided no further information but provided consent to be contacted by Safety.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Taste disorder, Tongue disorder
Clinical narrative: Area of her tongue taste weird; Food taste weird; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Mar-2021. The most recent information was received on 03-May-2021 and was forwarded to Moderna on 03-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of TONGUE DISORDER (Area of her tongue taste weird) and TASTE DISORDER (Food taste weird) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010m20a) for COVID-19 immunisation.     The patient's medical history was not provided.  Concomitant products included LISINOPRIL, VENLAFAXINE HYDROCHLORIDE (VENLAFAXINE XR), ATORVASTATIN CALCIUM (LIPITOR) and CELECOXIB.    On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced TONGUE DISORDER (Area of her tongue taste weird) and TASTE DISORDER (Food taste weird). At the time of the report, TONGUE DISORDER (Area of her tongue taste weird) and TASTE DISORDER (Food taste weird) was resolving.            Treatment information was not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: AE outcome