chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: soreness on her arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness on her arm) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045a21a and 030b21a) for COVID-19 vaccination.     Concomitant products included AMOXICILLIN TRIHYDRATE, CLARITHROMYCIN, ESOMEPRAZOLE MAGNESIUM (NEXIUM 1-2-3) and VITAMINS NOS for an unknown indication.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced VACCINATION SITE PAIN (soreness on her arm). The patient was treated with PARACETAMOL (TYLENOL) for Symptomatic treatment, at an unspecified dose and frequency and SUMATRIPTAN for Symptomatic treatment, at an unspecified dose and frequency. On 18-Mar-2021, VACCINATION SITE PAIN (soreness on her arm) had resolved. Not Provided          This case was linked to US-MODERNATX, INC.-MOD-2021-076198 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-076198:For Second dose
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: both arms got numb; tingly; This spontaneous case was reported by a pharmacist and describes the occurrence of HYPOAESTHESIA (both arms got numb) and PARAESTHESIA (tingly) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021 at 11:37 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced HYPOAESTHESIA (both arms got numb) and PARAESTHESIA (tingly). On 14-Apr-2021, HYPOAESTHESIA (both arms got numb) and PARAESTHESIA (tingly) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.   No treatment information was provided.     Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Outcome updated.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pyrexia, Vaccination site swelling
Clinical narrative: today I have low grade fever; injection site slightly swollen; minimal headache; it is achy undearneath my left armpit; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (today I have low grade fever), VACCINATION SITE SWELLING (injection site slightly swollen), HEADACHE (minimal headache) and MYALGIA (it is achy undearneath my left armpit) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced PYREXIA (today I have low grade fever), VACCINATION SITE SWELLING (injection site slightly swollen), HEADACHE (minimal headache) and MYALGIA (it is achy undearneath my left armpit). At the time of the report, PYREXIA (today I have low grade fever), VACCINATION SITE SWELLING (injection site slightly swollen), HEADACHE (minimal headache) and MYALGIA (it is achy undearneath my left armpit) outcome was unknown. Not Provided          No concomitant medications were provided. No treatment drugs were reported. Consent for follow-up by Safety - Declined   Reporter did not allow further contact
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Vaccination site erythema, Vaccination site pain
Clinical narrative: Injection site was red; injection site was painful; hand fingers were swollen on left hand for 3 to 4 hours; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (hand fingers were swollen on left hand for 3 to 4 hours), VACCINATION SITE ERYTHEMA (Injection site was red) and VACCINATION SITE PAIN (injection site was painful) in a 61-year-old female patient 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 PERIPHERAL SWELLING (hand fingers were swollen on left hand for 3 to 4 hours), VACCINATION SITE ERYTHEMA (Injection site was red) and VACCINATION SITE PAIN (injection site was painful). At the time of the report, PERIPHERAL SWELLING (hand fingers were swollen on left hand for 3 to 4 hours) had resolved and VACCINATION SITE ERYTHEMA (Injection site was red) and VACCINATION SITE PAIN (injection site was painful) outcome was unknown.            Concomitant medications were not provided by the reporter.   Treatment information not provided.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Recurrent diarrhea; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea) and DIARRHOEA (Recurrent diarrhea) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 031M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Mar-2021, the patient experienced DIARRHOEA (diarrhea). On 14-Apr-2021, the patient experienced DIARRHOEA (Recurrent diarrhea). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) for Diarrhea, at an unspecified dose and frequency. On 21-Mar-2021, DIARRHOEA (diarrhea) had resolved. At the time of the report, DIARRHOEA (Recurrent diarrhea) had not resolved.            No concomitant medications were reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea, Peripheral swelling, Pyrexia
Clinical narrative: Swollen arm; Nausea; achiness all over her body; fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen arm), NAUSEA (Nausea), MYALGIA (achiness all over her body), PYREXIA (fever) and HEADACHE (headache) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm), NAUSEA (Nausea), MYALGIA (achiness all over her body), PYREXIA (fever) and HEADACHE (headache). At the time of the report, PERIPHERAL SWELLING (Swollen arm), NAUSEA (Nausea), MYALGIA (achiness all over her body), PYREXIA (fever) and HEADACHE (headache) outcome was unknown.        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.; 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: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Influenza like illness, Myalgia, Pain
Clinical narrative: Flu like symptoms; Pain; Chills; Muscle pain/muscle ache; Fever; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (Pain), HEADACHE (Headaches), CHILLS (Chills) and MYALGIA (Muscle pain/muscle ache) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.  Concomitant products included ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) and VITAMINS NOS for an unknown indication.    On 13-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced HEADACHE (Headaches). On 14-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (Pain), CHILLS (Chills), MYALGIA (Muscle pain/muscle ache) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and SUMATRIPTAN for Adverse event, at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (Pain), HEADACHE (Headaches), CHILLS (Chills), MYALGIA (Muscle pain/muscle ache) and PYREXIA (Fever) had not resolved.            Treatment information included paracetamol and sumatriptan. Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-076192 (Patient Link).
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Flu like symptoms; Pain; Chills; Muscle pain/muscle ache; Fever; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (Pain), HEADACHE (Headaches), CHILLS (Chills) and MYALGIA (Muscle pain/muscle ache) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.  Concomitant products included ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) and VITAMINS NOS for an unknown indication.    On 13-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced HEADACHE (Headaches). On 14-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (Pain), CHILLS (Chills), MYALGIA (Muscle pain/muscle ache) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and SUMATRIPTAN for Adverse event, at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (Pain), HEADACHE (Headaches), CHILLS (Chills), MYALGIA (Muscle pain/muscle ache) and PYREXIA (Fever) had not resolved.            Treatment information included paracetamol and sumatriptan. Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-076192 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Dyspnoea, Fatigue
Clinical narrative: Diarrhea; Worsening of Shortness of Breath; Fatigue; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), DYSPNOEA (Worsening of Shortness of Breath), FATIGUE (Fatigue) and CHILLS (Chills) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031821A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (She said she had Covid at the end of December and was very sick and this feels a little like it but not as bad.). Concurrent medical conditions included Heart disorder (she has a heart condition and does suffer from shortness of breath).    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced DIARRHOEA (Diarrhea), DYSPNOEA (Worsening of Shortness of Breath), FATIGUE (Fatigue) and CHILLS (Chills). At the time of the report, DIARRHOEA (Diarrhea), DYSPNOEA (Worsening of Shortness of Breath), FATIGUE (Fatigue) and CHILLS (Chills) outcome was unknown.        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.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: typical immune response; injection site was itchy; injection site was more redder; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (typical immune response), VACCINATION SITE PRURITUS (injection site was itchy) and VACCINATION SITE ERYTHEMA (injection site was more redder) in a 61-year-old female patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (typical immune response), VACCINATION SITE PRURITUS (injection site was itchy) and VACCINATION SITE ERYTHEMA (injection site was more redder). At the time of the report, VACCINATION COMPLICATION (typical immune response), VACCINATION SITE PRURITUS (injection site was itchy) and VACCINATION SITE ERYTHEMA (injection site was more redder) outcome was unknown.            Concomitant medications were not provided by the reporter.  The reporter denied treatment of the events.    This case was linked to US-MODERNATX, INC.-MOD-2021-076195 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-076195:1st dose case
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Feeling hot, Pyrexia
Clinical narrative: warm sensation; chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (warm sensation), PYREXIA (Fever) and CHILLS (chills) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 046A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021 at 3:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (Fever). On 14-Apr-2021 at 12:00 PM, the patient experienced FEELING HOT (warm sensation) and CHILLS (chills). At the time of the report, FEELING HOT (warm sensation), PYREXIA (Fever) and CHILLS (chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Apr-2021, Body temperature: 99.2 (High) 99.2 at the time of report and 100.6 (High) 100.6, at 5 pm.         No concomitant medications reported by investigator  No treatment medications provided by the reporter.     This case was linked to MOD-2021-076215 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow up information received and updated Event outcome for all the events  Feeling hot, Pyrexia and Chills from Unknown to Recovered
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Vaccination site swelling
Clinical narrative: Swollen arm at injection site came back; Chills; Normal dizziness; Swollen at injection site; Tired; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Normal dizziness), VACCINATION SITE SWELLING (Swollen arm at injection site came back), VACCINATION SITE SWELLING (Swollen at injection site), FATIGUE (Tired) and CHILLS (Chills) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety. Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) and BUSPIRONE for Anxiety.    On 26-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 DIZZINESS (Normal dizziness), VACCINATION SITE SWELLING (Swollen at injection site) and FATIGUE (Tired). On 12-Apr-2021, the patient experienced VACCINATION SITE SWELLING (Swollen arm at injection site came back) and CHILLS (Chills). At the time of the report, DIZZINESS (Normal dizziness), VACCINATION SITE SWELLING (Swollen arm at injection site came back), VACCINATION SITE SWELLING (Swollen at injection site), FATIGUE (Tired) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Vaccination site pain, Vaccination site swelling
Clinical narrative: 41 Days post first dose and has not received the second dose; Swollen injection site left arm; Injection site left arm hurt; This spontaneous case was reported by a patient family member or friend and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (41 Days post first dose and has not received the second dose), VACCINATION SITE SWELLING (Swollen injection site left arm) and VACCINATION SITE PAIN (Injection site left arm hurt) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced VACCINATION SITE SWELLING (Swollen injection site left arm) and VACCINATION SITE PAIN (Injection site left arm hurt). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (41 Days post first dose and has not received the second dose). On 12-Mar-2021, VACCINATION SITE SWELLING (Swollen injection site left arm) and VACCINATION SITE PAIN (Injection site left arm hurt) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (41 Days post first dose and has not received the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment information was provided.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Lymphadenopathy, Pyrexia, Vomiting
Clinical narrative: her lymph nodes are swollen on the right side of her neck; Fever; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), VOMITING (vomiting) and LYMPHADENOPATHY (her lymph nodes are swollen on the right side of her neck) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (blood clots, stents, and COVID toes) in December 2020. Concomitant products included METOPROLOL, NIFEDIPINE and LOSARTAN for an unknown indication.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced PYREXIA (Fever). On 13-Apr-2021, the patient experienced LYMPHADENOPATHY (her lymph nodes are swollen on the right side of her neck). In April 2021, the patient experienced VOMITING (vomiting). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. On 04-Apr-2021, PYREXIA (Fever) had resolved. In April 2021, VOMITING (vomiting) had resolved. At the time of the report, LYMPHADENOPATHY (her lymph nodes are swollen on the right side of her neck) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2021, Body temperature: 102 (High) Temperature ranged from 101 to 102.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient is also taking fluid pill and blood thinners concomitantly.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Tinnitus
Clinical narrative: mild headache towards back of head on the right side; ringing in both ears; mild body ache; fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TINNITUS (ringing in both ears), PAIN (mild body ache), FATIGUE (fatigue) and HEADACHE (mild headache towards back of head on the right side) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 027L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (Allergic to Ampicillin) and Allergy to chemicals (Allergic to sulphur). Concomitant products included VITAMIN B COMPLEX (VIT B COMPLEX), COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), MAGNESIUM CITRATE, COQ10 [ASCORBIC ACID;BETACAROTENE;CUPRIC OXIDE;MANGANESE SULFATE;SELENIUM;TOCOPHERYL ACETATE;UBIDECARENONE;ZINC OXIDE] and DOCOSAHEXAENOIC ACID, EICOSAPENTAENOIC ACID, TOCOPHEROL (OMEGA 3 [DOCOSAHEXAENOIC ACID;EICOSAPENTAENOIC ACID;TOCOPHEROL]) for Routine health maintenance.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced PAIN (mild body ache) and FATIGUE (fatigue). On 03-Mar-2021, the patient experienced HEADACHE (mild headache towards back of head on the right side). In March 2021, the patient experienced TINNITUS (ringing in both ears). The patient was treated with IBUPROFEN for Headache, at a dose of 2 tablets once a day, 2 times a week. On 16-Feb-2021, PAIN (mild body ache) and FATIGUE (fatigue) had resolved. At the time of the report, TINNITUS (ringing in both ears) had not resolved and HEADACHE (mild headache towards back of head on the right side) had resolved.            Physician recommend patient to take breaks from computer screen, doing shoulder exercises and getting nightguard for headaches.  As per audiologist and ENT specialist, patient's ears are fine.   Most recent FOLLOW-UP information incorporated above includes: On 09-May-2021: Updated medical history, concomitant medications, ethnicity, reporter causality and event outcome.
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, Vaccination site pain
Clinical narrative: Exposed to COVID 19; Soreness in her left arm; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE TO SARS-COV-2 (Exposed to COVID 19) and VACCINATION SITE PAIN (Soreness in her left arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced EXPOSURE TO SARS-COV-2 (Exposed to COVID 19) and VACCINATION SITE PAIN (Soreness in her left arm). On 08-Apr-2021, EXPOSURE TO SARS-COV-2 (Exposed to COVID 19) had resolved. At the time of the report, VACCINATION SITE PAIN (Soreness in her left arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported Treatment information was not provided   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: TCR attached contains no new information.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site swelling
Clinical narrative: Swelling on the arm; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swelling on the arm) and HEADACHE (Headache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-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 04-Mar-2021, the patient experienced VACCINATION SITE SWELLING (Swelling on the arm) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and NAPROXEN at an unspecified dose and frequency. On 07-Mar-2021, VACCINATION SITE SWELLING (Swelling on the arm) and HEADACHE (Headache) had resolved.            Treatment information included generic for tylenol and naproxen.   This case was linked to MOD21-042548 (Patient Link).
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Peripheral swelling
Clinical narrative: both knees swollen to the size of a big softball; legs started to swell; within a couple days their ankles swollen; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (both knees swollen to the size of a big softball), PERIPHERAL SWELLING (legs started to swell) and JOINT SWELLING (within a couple days their ankles swollen) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     Concurrent medical conditions included Walker user. Concomitant products included SERTRALINE for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced JOINT SWELLING (both knees swollen to the size of a big softball), PERIPHERAL SWELLING (legs started to swell) and JOINT SWELLING (within a couple days their ankles swollen). The patient was treated with PARACETAMOL (TYLENOL ARTHRITIS) for Adverse event, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, JOINT SWELLING (both knees swollen to the size of a big softball), PERIPHERAL SWELLING (legs started to swell) and JOINT SWELLING (within a couple days their ankles swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  Corrective treatment included over the counter pain medication and extra strength tylenol.
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: nausea; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea) 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 NAUSEA (nausea). At the time of the report, NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment information was provided.   This case was linked to MOD21-075634 (E2B Linked Report).; Sender's Comments:  MOD21-075634:
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal sleep-related event, Chills, Cough, Pain in extremity, Rhinorrhoea
Clinical narrative: wheezing in her chest; cough waking her up; coughing her head off; runny nose; Chills; coughing cold that went on for a few days; arm hurting a little bit; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (coughing cold that went on for a few days), PAIN IN EXTREMITY (arm hurting a little bit), WHEEZING (wheezing in her chest), ABNORMAL SLEEP-RELATED EVENT (cough waking her up) and COUGH (coughing her head off) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 040A12A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history were reported.  Concomitant products included AMLODIPINE, METOPROLOL, METFORMIN, LEVOTHYROXINE, GLIMEPIRIDE and ATORVASTATIN for an unknown indication.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (arm hurting a little bit). On 12-Apr-2021, the patient experienced COUGH (coughing cold that went on for a few days), WHEEZING (wheezing in her chest), ABNORMAL SLEEP-RELATED EVENT (cough waking her up), COUGH (coughing her head off), RHINORRHOEA (runny nose) and CHILLS (Chills). On 12-Apr-2021, PAIN IN EXTREMITY (arm hurting a little bit) had resolved. At the time of the report, COUGH (coughing cold that went on for a few days), WHEEZING (wheezing in her chest), ABNORMAL SLEEP-RELATED EVENT (cough waking her up), COUGH (coughing her head off), RHINORRHOEA (runny nose) and CHILLS (Chills) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable.  Treatment medication included honey halls cough drops.   This case was linked to MOD21-075530 (E2B Linked Report).; Sender's Comments:  MOD21-075530:
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Wheezing
Clinical narrative: wheezing in her chest; cough waking her up; coughing her head off; runny nose; Chills; coughing cold that went on for a few days; arm hurting a little bit; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (coughing cold that went on for a few days), PAIN IN EXTREMITY (arm hurting a little bit), WHEEZING (wheezing in her chest), ABNORMAL SLEEP-RELATED EVENT (cough waking her up) and COUGH (coughing her head off) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 040A12A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history were reported.  Concomitant products included AMLODIPINE, METOPROLOL, METFORMIN, LEVOTHYROXINE, GLIMEPIRIDE and ATORVASTATIN for an unknown indication.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (arm hurting a little bit). On 12-Apr-2021, the patient experienced COUGH (coughing cold that went on for a few days), WHEEZING (wheezing in her chest), ABNORMAL SLEEP-RELATED EVENT (cough waking her up), COUGH (coughing her head off), RHINORRHOEA (runny nose) and CHILLS (Chills). On 12-Apr-2021, PAIN IN EXTREMITY (arm hurting a little bit) had resolved. At the time of the report, COUGH (coughing cold that went on for a few days), WHEEZING (wheezing in her chest), ABNORMAL SLEEP-RELATED EVENT (cough waking her up), COUGH (coughing her head off), RHINORRHOEA (runny nose) and CHILLS (Chills) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable.  Treatment medication included honey halls cough drops.   This case was linked to MOD21-075530 (E2B Linked Report).; Sender's Comments:  MOD21-075530:
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Cough, Headache
Clinical narrative: COVID positive after first dose; Congestion; Cough; Loss of taste and smell; Loss of taste and smell; Headache recurrent; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (COVID positive after first dose), AGEUSIA (Loss of taste and smell), ANOSMIA (Loss of taste and smell), NASAL CONGESTION (Congestion) and COUGH (Cough) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-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 HEADACHE (Headache recurrent). On 30-Mar-2021, the patient experienced AGEUSIA (Loss of taste and smell) and ANOSMIA (Loss of taste and smell). On 31-Mar-2021, the patient experienced COVID-19 (COVID positive after first dose), NASAL CONGESTION (Congestion) and COUGH (Cough). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID positive after first dose), AGEUSIA (Loss of taste and smell), ANOSMIA (Loss of taste and smell), NASAL CONGESTION (Congestion), COUGH (Cough) and HEADACHE (Headache recurrent) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  COVID-19 test was positive on 31-Mar-2021 and 07-Apr-2021.
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion
Clinical narrative: COVID positive after first dose; Congestion; Cough; Loss of taste and smell; Loss of taste and smell; Headache recurrent; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (COVID positive after first dose), AGEUSIA (Loss of taste and smell), ANOSMIA (Loss of taste and smell), NASAL CONGESTION (Congestion) and COUGH (Cough) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-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 HEADACHE (Headache recurrent). On 30-Mar-2021, the patient experienced AGEUSIA (Loss of taste and smell) and ANOSMIA (Loss of taste and smell). On 31-Mar-2021, the patient experienced COVID-19 (COVID positive after first dose), NASAL CONGESTION (Congestion) and COUGH (Cough). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID positive after first dose), AGEUSIA (Loss of taste and smell), ANOSMIA (Loss of taste and smell), NASAL CONGESTION (Congestion), COUGH (Cough) and HEADACHE (Headache recurrent) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  COVID-19 test was positive on 31-Mar-2021 and 07-Apr-2021.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity, Pain in jaw, Rash
Clinical narrative: joint pain on the right side; full breakout of body rash; really bad left jaw pain - excruciation pain; soreness on left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN JAW (really bad left jaw pain - excruciation pain), RASH (full breakout of body rash), PAIN IN EXTREMITY (soreness on left arm) and ARTHRALGIA (joint pain on the right side) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028H21A or 028H21H) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced PAIN IN EXTREMITY (soreness on left arm). On 05-Apr-2021, the patient experienced PAIN IN JAW (really bad left jaw pain - excruciation pain). On 09-Apr-2021, the patient experienced RASH (full breakout of body rash). On an unknown date, the patient experienced ARTHRALGIA (joint pain on the right side). On 02-Apr-2021, PAIN IN EXTREMITY (soreness on left arm) had resolved. On 09-Apr-2021, PAIN IN JAW (really bad left jaw pain - excruciation pain) outcome was unknown, ARTHRALGIA (joint pain on the right side) had resolved. At the time of the report, RASH (full breakout of body rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information included clindamycin.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection site tender to touch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection site tender to touch) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced VACCINATION SITE PAIN (Injection site tender to touch). At the time of the report, VACCINATION SITE PAIN (Injection site tender to touch) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported.   No treatment information was provided.   This case was linked to MOD-2021-076201 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow up received - Event Outcome updated.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: pain in his arm and hands; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (pain in his arm and hands) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (pain in his arm and hands). At the time of the report, MYALGIA (pain in his arm and hands) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment medication were reported.  Didn't clarify if the vaccine was from Moderna.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Gait disturbance, Lymph node pain, Myalgia, Rash erythematous
Clinical narrative: Lymph nodes in groin (both sides) hurt; Could hardly walk; Terrible back ache; Moon shaped red rash on arm; Didn't feel well; Aches; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Moon shaped red rash on arm), VACCINATION COMPLICATION (Didn't feel well), LYMPH NODE PAIN (Lymph nodes in groin (both sides) hurt), GAIT DISTURBANCE (Could hardly walk) and BACK PAIN (Terrible back ache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 01-Apr-2021 at 12:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced VACCINATION COMPLICATION (Didn't feel well) and MYALGIA (Aches). On 03-Apr-2021, the patient experienced RASH ERYTHEMATOUS (Moon shaped red rash on arm). On 04-Apr-2021, the patient experienced LYMPH NODE PAIN (Lymph nodes in groin (both sides) hurt), GAIT DISTURBANCE (Could hardly walk) and BACK PAIN (Terrible back ache). On 02-Apr-2021, VACCINATION COMPLICATION (Didn't feel well) and MYALGIA (Aches) had resolved. On 08-Apr-2021, LYMPH NODE PAIN (Lymph nodes in groin (both sides) hurt), GAIT DISTURBANCE (Could hardly walk) and BACK PAIN (Terrible back ache) had resolved. At the time of the report, RASH ERYTHEMATOUS (Moon shaped red rash on arm) outcome was unknown.            No concomitant information was reported. Treatment for lymph node pain in the groin and terrible backache included heat and rest. Action taken with mRNA-1273 in response to the events was not applicable.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Lymph nodes in groin (both sides) hurt; Could hardly walk; Terrible back ache; Moon shaped red rash on arm; Didn't feel well; Aches; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Moon shaped red rash on arm), VACCINATION COMPLICATION (Didn't feel well), LYMPH NODE PAIN (Lymph nodes in groin (both sides) hurt), GAIT DISTURBANCE (Could hardly walk) and BACK PAIN (Terrible back ache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 01-Apr-2021 at 12:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced VACCINATION COMPLICATION (Didn't feel well) and MYALGIA (Aches). On 03-Apr-2021, the patient experienced RASH ERYTHEMATOUS (Moon shaped red rash on arm). On 04-Apr-2021, the patient experienced LYMPH NODE PAIN (Lymph nodes in groin (both sides) hurt), GAIT DISTURBANCE (Could hardly walk) and BACK PAIN (Terrible back ache). On 02-Apr-2021, VACCINATION COMPLICATION (Didn't feel well) and MYALGIA (Aches) had resolved. On 08-Apr-2021, LYMPH NODE PAIN (Lymph nodes in groin (both sides) hurt), GAIT DISTURBANCE (Could hardly walk) and BACK PAIN (Terrible back ache) had resolved. At the time of the report, RASH ERYTHEMATOUS (Moon shaped red rash on arm) outcome was unknown.            No concomitant information was reported. Treatment for lymph node pain in the groin and terrible backache included heat and rest. Action taken with mRNA-1273 in response to the events was not applicable.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Nausea, Rash macular, Vaccination site rash
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Blotchy area around injection site on her left shoulder and arm), MYALGIA (body aches), NAUSEA (nausea), VOMITING (vomiting) and CHILLS (chills) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VITAMIN C [ASCORBIC ACID], VITAMIN D NOS and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Mar-2021, the patient experienced VACCINATION SITE RASH (Blotchy area around injection site on her left shoulder and arm). On 13-Apr-2021, the patient experienced MYALGIA (body aches), NAUSEA (nausea), VOMITING (vomiting) and CHILLS (chills). On 14-Apr-2021, the patient experienced RASH MACULAR (Blotchy area around injection site on her left shoulder and arm). The patient was treated with PARACETAMOL (TYLENOL) for Vaccination site rash, at an unspecified dose and frequency. At the time of the report, RASH MACULAR (Blotchy area around injection site on her left shoulder and arm), MYALGIA (body aches), NAUSEA (nausea), VOMITING (vomiting), CHILLS (chills) and VACCINATION SITE RASH (Blotchy area around injection site on her left shoulder and arm) outcome was unknown.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Blotchy area around injection site on her left shoulder and arm), MYALGIA (body aches), NAUSEA (nausea), VOMITING (vomiting) and CHILLS (chills) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VITAMIN C [ASCORBIC ACID], VITAMIN D NOS and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Mar-2021, the patient experienced VACCINATION SITE RASH (Blotchy area around injection site on her left shoulder and arm). On 13-Apr-2021, the patient experienced MYALGIA (body aches), NAUSEA (nausea), VOMITING (vomiting) and CHILLS (chills). On 14-Apr-2021, the patient experienced RASH MACULAR (Blotchy area around injection site on her left shoulder and arm). The patient was treated with PARACETAMOL (TYLENOL) for Vaccination site rash, at an unspecified dose and frequency. At the time of the report, RASH MACULAR (Blotchy area around injection site on her left shoulder and arm), MYALGIA (body aches), NAUSEA (nausea), VOMITING (vomiting), CHILLS (chills) and VACCINATION SITE RASH (Blotchy area around injection site on her left shoulder and arm) outcome was unknown.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Swelling
Clinical narrative: Swelling; redness; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling) and ERYTHEMA (redness) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 036B21A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroiditis, Hypertension and Cholesterol. Concomitant products included ATORVASTATIN for Cholesterol, LISINOPRIL for Hypertension, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder NOS, MELOXICAM and ACYCLOVIR [ACICLOVIR] for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced SWELLING (Swelling) and ERYTHEMA (redness). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, SWELLING (Swelling) and ERYTHEMA (redness) had resolved.            This case was linked to US-MODERNATX, INC.-MOD-2021-076225 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-076225:Dose 2