chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Headache, Multiple allergies
Clinical narrative: sore arm; Allergies; Headache; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY PAIN (sore arm), MULTIPLE ALLERGIES (Allergies) and HEADACHE (Headache) 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 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 02-Mar-2021, the patient experienced AXILLARY PAIN (sore arm), MULTIPLE ALLERGIES (Allergies) and HEADACHE (Headache).   On 03-Mar-2021, AXILLARY PAIN (sore arm) and HEADACHE (Headache) had resolved. At the time of the report, MULTIPLE ALLERGIES (Allergies) had not resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No concomitant medications reported. No treatment information provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Axillary pain, Body temperature, Fatigue, Nausea
Clinical narrative: had nightmares; very weak; nauseated; fever; tired; left arm was sore; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of AXILLARY PAIN (left arm was sore), NIGHTMARE (had nightmares), ASTHENIA (very weak), NAUSEA (nauseated) and PYREXIA (fever) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 25-Feb-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) (Intramuscular) 1 dosage form.   On 25-Feb-2021, the patient experienced AXILLARY PAIN (left arm was sore). On 26-Feb-2021, the patient experienced NIGHTMARE (had nightmares), ASTHENIA (very weak), NAUSEA (nauseated), PYREXIA (fever) and FATIGUE (tired). The patient was treated with ONDANSETRON 26-Feb-2021 for Nauseated, at a dose of 1 dosage form.   On 26-Feb-2021, AXILLARY PAIN (left arm was sore), NIGHTMARE (had nightmares), ASTHENIA (very weak), NAUSEA (nauseated) and PYREXIA (fever) had resolved. On 27-Feb-2021, FATIGUE (tired) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Body temperature: 101.5 (High) 101.5 F. On 26-Feb-2021, Oxygen saturation: 98% (normal) 98%. On 26-Feb-2021, Respiratory rate: 16 (normal) 16.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Nightmare, Oxygen saturation, Pyrexia, Respiratory rate
Clinical narrative: had nightmares; very weak; nauseated; fever; tired; left arm was sore; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of AXILLARY PAIN (left arm was sore), NIGHTMARE (had nightmares), ASTHENIA (very weak), NAUSEA (nauseated) and PYREXIA (fever) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 25-Feb-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) (Intramuscular) 1 dosage form.   On 25-Feb-2021, the patient experienced AXILLARY PAIN (left arm was sore). On 26-Feb-2021, the patient experienced NIGHTMARE (had nightmares), ASTHENIA (very weak), NAUSEA (nauseated), PYREXIA (fever) and FATIGUE (tired). The patient was treated with ONDANSETRON 26-Feb-2021 for Nauseated, at a dose of 1 dosage form.   On 26-Feb-2021, AXILLARY PAIN (left arm was sore), NIGHTMARE (had nightmares), ASTHENIA (very weak), NAUSEA (nauseated) and PYREXIA (fever) had resolved. On 27-Feb-2021, FATIGUE (tired) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Body temperature: 101.5 (High) 101.5 F. On 26-Feb-2021, Oxygen saturation: 98% (normal) 98%. On 26-Feb-2021, Respiratory rate: 16 (normal) 16.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Red big spot at site of injection, kind of hard in the center; no pain but Itches at the red spot at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Red big spot at site of injection, kind of hard in the center) and INJECTION SITE PRURITUS (no pain but Itches at the red spot at the injection site) in a 74-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 19-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 INJECTION SITE ERYTHEMA (Red big spot at site of injection, kind of hard in the center) and INJECTION SITE PRURITUS (no pain but Itches at the red spot at the injection site). At the time of the report, INJECTION SITE ERYTHEMA (Red big spot at site of injection, kind of hard in the center) and INJECTION SITE PRURITUS (no pain but Itches at the red spot at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  Patient did not use any treatment medications for the symptoms.
Sex: M
Vaccine: COVID19
Symptoms: Eye swelling, Hypersensitivity
Clinical narrative: Allergy issues; Eyes are swollen; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Allergy issues) and EYE SWELLING (Eyes are swollen) 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 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (Allergy issues) and EYE SWELLING (Eyes are swollen). At the time of the report, HYPERSENSITIVITY (Allergy issues) and EYE SWELLING (Eyes are swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, Chills, Fatigue
Clinical narrative: FATIGUE; Chills; felt something running down her arm and it was the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of UNDERDOSE (felt something running down her arm and it was the vaccine), FATIGUE (FATIGUE) and CHILLS (Chills) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was reported.).    On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced UNDERDOSE (felt something running down her arm and it was the vaccine). On 03-Mar-2021, the patient experienced FATIGUE (FATIGUE) and CHILLS (Chills). On 02-Mar-2021, UNDERDOSE (felt something running down her arm and it was the vaccine) had resolved. At the time of the report, FATIGUE (FATIGUE) and CHILLS (Chills) outcome was unknown.        There was no concomitant medication provided   Reporter did not allow further contact; Sender's Comments: This report refers to a case of accidental underdose for mRNA-1273, lot # 013A21A with associated AEs fatigue and chills.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Ear pain, Ear pruritus, Erythema
Clinical narrative: Pain in ears; Headache; Both ears itching; Lightheaded; Both ears red; Crawling skin and scalp; Constricted throat; No energy; Tender arm; This spontaneous case was reported by a consumer and describes the occurrence of EAR PRURITUS (Both ears itching), EAR PAIN (Pain in ears), FORMICATION (Crawling skin and scalp), THROAT TIGHTNESS (Constricted throat) and ASTHENIA (No energy) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Shellfish allergy.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced TENDERNESS (Tender arm). On 10-Feb-2021, the patient experienced EAR PRURITUS (Both ears itching), FORMICATION (Crawling skin and scalp), THROAT TIGHTNESS (Constricted throat), ASTHENIA (No energy), DIZZINESS (Lightheaded) and ERYTHEMA (Both ears red). On 11-Feb-2021, the patient experienced EAR PAIN (Pain in ears) and HEADACHE (Headache). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of UNK UNK, bid and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 10-Feb-2021, DIZZINESS (Lightheaded) had resolved. On 12-Feb-2021, EAR PRURITUS (Both ears itching), EAR PAIN (Pain in ears) and HEADACHE (Headache) had resolved. At the time of the report, FORMICATION (Crawling skin and scalp), THROAT TIGHTNESS (Constricted throat) and ASTHENIA (No energy) had resolved and TENDERNESS (Tender arm) and ERYTHEMA (Both ears red) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient symptoms happened a while ago. They lasted 2 days and went away. She was okay now   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Patient gender and events outcome was updated.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Formication, Headache, Tenderness, Throat tightness
Clinical narrative: Pain in ears; Headache; Both ears itching; Lightheaded; Both ears red; Crawling skin and scalp; Constricted throat; No energy; Tender arm; This spontaneous case was reported by a consumer and describes the occurrence of EAR PRURITUS (Both ears itching), EAR PAIN (Pain in ears), FORMICATION (Crawling skin and scalp), THROAT TIGHTNESS (Constricted throat) and ASTHENIA (No energy) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Shellfish allergy.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced TENDERNESS (Tender arm). On 10-Feb-2021, the patient experienced EAR PRURITUS (Both ears itching), FORMICATION (Crawling skin and scalp), THROAT TIGHTNESS (Constricted throat), ASTHENIA (No energy), DIZZINESS (Lightheaded) and ERYTHEMA (Both ears red). On 11-Feb-2021, the patient experienced EAR PAIN (Pain in ears) and HEADACHE (Headache). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of UNK UNK, bid and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 10-Feb-2021, DIZZINESS (Lightheaded) had resolved. On 12-Feb-2021, EAR PRURITUS (Both ears itching), EAR PAIN (Pain in ears) and HEADACHE (Headache) had resolved. At the time of the report, FORMICATION (Crawling skin and scalp), THROAT TIGHTNESS (Constricted throat) and ASTHENIA (No energy) had resolved and TENDERNESS (Tender arm) and ERYTHEMA (Both ears red) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient symptoms happened a while ago. They lasted 2 days and went away. She was okay now   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Patient gender and events outcome was updated.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Facial pain, Limb discomfort, Migraine, Vision blurred
Clinical narrative: She got migraine 3 days after receiving 1st dose and continued on next day; Patient got blurred vision 2 days after receiving 1st dose and it got worst on day 5; Patient's right side of face (jaw, cheek and right ear)started hurting immediately after receiving 1st; Couldn't move right arm; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PAIN (Patient's right side of face (jaw, cheek and right ear)started hurting immediately after receiving 1st), VISION BLURRED (Patient got blurred vision 2 days after receiving 1st dose and it got worst on day 5), MIGRAINE (She got migraine 3 days after receiving 1st dose and continued on next day) and LIMB DISCOMFORT (Couldn't move right arm) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M204) for COVID-19 vaccination.     The patient's past medical history included Migraine. Concomitant products included BOTULINUM TOXIN TYPE A (BOTOX) for Migraine, CYPROHEPTADINE, METFORMIN, MOMETASONE FUROATE (NASONEX), NARATRIPTAN HYDROCHLORIDE (AMERGE) and METOCLOPRAMIDE HYDROCHLORIDE (REGLAN [METOCLOPRAMIDE HYDROCHLORIDE]) for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 25-Feb-2021, the patient experienced FACIAL PAIN (Patient's right side of face (jaw, cheek and right ear)started hurting immediately after receiving 1st) and LIMB DISCOMFORT (Couldn't move right arm). On 27-Feb-2021, the patient experienced VISION BLURRED (Patient got blurred vision 2 days after receiving 1st dose and it got worst on day 5). On 28-Feb-2021, the patient experienced MIGRAINE (She got migraine 3 days after receiving 1st dose and continued on next day). The patient was treated with PARACETAMOL (TYLENOL) for Symptomatic treatment, at an unspecified dose and frequency. On 25-Feb-2021, FACIAL PAIN (Patient's right side of face (jaw, cheek and right ear)started hurting immediately after receiving 1st) had resolved. At the time of the report, VISION BLURRED (Patient got blurred vision 2 days after receiving 1st dose and it got worst on day 5), MIGRAINE (She got migraine 3 days after receiving 1st dose and continued on next day) and LIMB DISCOMFORT (Couldn't move right arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The right side of face of the patient started hurting immediately after the vaccine. It went away within few hours but couldn't move her right arm. By Saturday, the arm was much better. Patient got blurred vision on 27-Feb-2021 and on 28-Feb-2021, she got migraine. On Monday(1-Mar-2021) she got 2nd migraine and her vision was worst. She goes for Botox treatment every 12 weeks. She received 31 shots of Botox the day before vaccine. Her Cataracts were done in October (both). She also mentioned that she is going for 2nd shot on 22March2021 and she is legally blind.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Still not received the second dose and missed 42 day window; A spontaneous report was received on 02 MAR 2021 from a consumer, who was a 82-year old,  female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and did not receive the second dose and missed the 42-days  window (inappropriate schedule of vaccine administration ).   The patient's medical history was not provided. No concomitant product use was reported.   On 16 Jan 2021, the patient received the first of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly for prophylaxis of COVID-19 infection and did not receive the second dose and missed the 42-day window. No adverse events were reported, and no treatment medications were reported.   Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the event, not receive the second dose and missed the 42-days window, was considered recovered.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administration for mRNA-1273, no vaccine administered, with no associated AEs.
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pyrexia
Clinical narrative: having a ruff time with sore throat; fever of 101.9 deg F; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (having a ruff time with sore throat) and PYREXIA (fever of 101.9 deg F) 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 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (having a ruff time with sore throat) and PYREXIA (fever of 101.9 deg F). At the time of the report, OROPHARYNGEAL PAIN (having a ruff time with sore throat) and PYREXIA (fever of 101.9 deg F) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  Treatment medications was not provided by the reporter
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Dizziness, Headache, Rhinorrhoea
Clinical narrative: chills; dizziness; runny stuffed nose; upper abdominal pain, right under the breast; very bad sleep problem; massive headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), RHINORRHOEA (runny stuffed nose), ABDOMINAL PAIN UPPER (upper abdominal pain, right under the breast), SLEEP DISORDER (very bad sleep problem) and HEADACHE (massive headache) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Neuropathy, Shingles and Epstein Barr virus positive mucocutaneous ulcer.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced DIZZINESS (dizziness), RHINORRHOEA (runny stuffed nose), ABDOMINAL PAIN UPPER (upper abdominal pain, right under the breast), SLEEP DISORDER (very bad sleep problem) and HEADACHE (massive headache). On an unknown date, the patient experienced CHILLS (chills). At the time of the report, DIZZINESS (dizziness), RHINORRHOEA (runny stuffed nose), ABDOMINAL PAIN UPPER (upper abdominal pain, right under the breast), SLEEP DISORDER (very bad sleep problem), HEADACHE (massive headache) and CHILLS (chills) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was reported    This case was linked to US-MODERNATX, INC.-MOD-2021-100878 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Follow up received on 20-JUL-2021.Updated events outcome .Added  reporter causality.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-100878:
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: chills; dizziness; runny stuffed nose; upper abdominal pain, right under the breast; very bad sleep problem; massive headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), RHINORRHOEA (runny stuffed nose), ABDOMINAL PAIN UPPER (upper abdominal pain, right under the breast), SLEEP DISORDER (very bad sleep problem) and HEADACHE (massive headache) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Neuropathy, Shingles and Epstein Barr virus positive mucocutaneous ulcer.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced DIZZINESS (dizziness), RHINORRHOEA (runny stuffed nose), ABDOMINAL PAIN UPPER (upper abdominal pain, right under the breast), SLEEP DISORDER (very bad sleep problem) and HEADACHE (massive headache). On an unknown date, the patient experienced CHILLS (chills). At the time of the report, DIZZINESS (dizziness), RHINORRHOEA (runny stuffed nose), ABDOMINAL PAIN UPPER (upper abdominal pain, right under the breast), SLEEP DISORDER (very bad sleep problem), HEADACHE (massive headache) and CHILLS (chills) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was reported    This case was linked to US-MODERNATX, INC.-MOD-2021-100878 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Follow up received on 20-JUL-2021.Updated events outcome .Added  reporter causality.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-100878:
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Continous headaches that come and go; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEADACHE (Continous headaches that come and go) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 31M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high, High cholesterol and Weight above normal. Concomitant products included APIXABAN (ELIQUIS) and VITAMIN D3 for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 17-Feb-2021, the patient experienced HEADACHE (Continous headaches that come and go). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Headache, at an unspecified dose and frequency. At the time of the report, HEADACHE (Continous headaches that come and go) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient's concomitant medications also included unspecified medicines for high blood pressure and high cholesterol.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Extremely minor or little pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Extremely minor or little pain at injection site) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, 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 PAIN (Extremely minor or little pain at injection site). At the time of the report, INJECTION SITE PAIN (Extremely minor or little pain at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Eye irritation, Throat irritation, Vaccination complication
Clinical narrative: symptoms began within 30 minutes; eye burning; itchy throat; chest tightness; dizziness; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of VACCINATION COMPLICATION (symptoms began within 30 minutes), EYE IRRITATION (eye burning), THROAT IRRITATION (itchy throat), CHEST DISCOMFORT (chest tightness) and DIZZINESS (dizziness) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     The patient's past medical history included Hypertension, Hashimoto's disease and Hyperlipidemia.  On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On an unknown date, the patient experienced VACCINATION COMPLICATION (symptoms began within 30 minutes), EYE IRRITATION (eye burning), THROAT IRRITATION (itchy throat), CHEST DISCOMFORT (chest tightness) and DIZZINESS (dizziness). The patient was treated with EPINEPHRINE (intravenous) at a dose of 0.03 milligram; FEXOFENADINE HYDROCHLORIDE (ALLEGRA) at an unspecified dose and frequency and FAMOTIDINE at an unspecified dose and frequency.    At the time of the report, VACCINATION COMPLICATION (symptoms began within 30 minutes), EYE IRRITATION (eye burning), THROAT IRRITATION (itchy throat), CHEST DISCOMFORT (chest tightness) and DIZZINESS (dizziness) 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.   Concomitant product use was not provided by the reporter.   This case was linked to MOD21-026901, MOD21-026902, MOD21-026903 (E2B Linked Report). This case was linked to MOD-2021-029012, MOD-2021-028961, MOD-2021-055838, MOD-2021-055838 (Patient Link).; Sender's Comments:  MOD21-026901: MOD21-026902: MOD21-026903:
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Irritability, Pyrexia
Clinical narrative: Icky; Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of IRRITABILITY (Icky), PYREXIA (Fever) and HEADACHE (Headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 01-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) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced IRRITABILITY (Icky), PYREXIA (Fever) and HEADACHE (Headache). At the time of the report, IRRITABILITY (Icky), PYREXIA (Fever) and HEADACHE (Headache) outcome was unknown.            No concomitant or treatment medications were reported.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: Cold sore in mouth, bottom lip; A spontaneous report was received from a 79-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced cold sore in mouth and cold sore on bottom of her lip/oral herpes.  The patient's medical history was not provided. No concomitant product use was reported.  On 25-Jan-2021, the patient received their first of two planned vaccine doses of mRNA-1273 (Lot number: 027L20A) intramuscularly on left upper arm for prophylaxis of COVID-19 infection.   On 26JAN2021, the patient started experiencing cold sore in mouth and cold sore on bottom of her lip that lasted about a week. The patient reported gargling with salt water and used Abreva (docosanol) for her sore on the lip.  Action taken with mRNA-1273 was not applicable.  The outcome of the event oral herpes was unknown.; 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.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Diarrhoea, Disorientation, Fatigue, Insomnia
Clinical narrative: Concurrent medical conditions included Fibromyalgia and Thyroid disorder. Concomitant products included GABAPENTIN for Fibromyalgia.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced DISORIENTATION ("out of it"), DECREASED APPETITE (loss of appetite), INSOMNIA (difficulty sleeping), FATIGUE (extremely tired), NAUSEA (nauseous) and MYALGIA (body aches). On 02-Mar-2021, the patient experienced DIARRHOEA (diarrhea). At the time of the report, DISORIENTATION ("out of it"), DECREASED APPETITE (loss of appetite), INSOMNIA (difficulty sleeping), DIARRHOEA (diarrhea), FATIGUE (extremely tired), NAUSEA (nauseous) and MYALGIA (body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was provided as thyroid medication and gabapentin.  Treatment information was provided as paracetamol.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea
Clinical narrative: Concurrent medical conditions included Fibromyalgia and Thyroid disorder. Concomitant products included GABAPENTIN for Fibromyalgia.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced DISORIENTATION ("out of it"), DECREASED APPETITE (loss of appetite), INSOMNIA (difficulty sleeping), FATIGUE (extremely tired), NAUSEA (nauseous) and MYALGIA (body aches). On 02-Mar-2021, the patient experienced DIARRHOEA (diarrhea). At the time of the report, DISORIENTATION ("out of it"), DECREASED APPETITE (loss of appetite), INSOMNIA (difficulty sleeping), DIARRHOEA (diarrhea), FATIGUE (extremely tired), NAUSEA (nauseous) and MYALGIA (body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was provided as thyroid medication and gabapentin.  Treatment information was provided as paracetamol.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injection site swelling, Injection site warmth, Tendon pain
Clinical narrative: Hot, itchy sore red rash over injection site; Raised hot spot over injection site: 4"X4'; Mild tendon pain; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of TENDON PAIN (Mild tendon pain), INJECTION SITE WARMTH (Hot, itchy sore red rash over injection site), ARTHRALGIA (Joint pain) and INJECTION SITE SWELLING (Raised hot spot over injection site: 4"X4') in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Tendonitis and Arthritis. Concomitant products included APIXABAN (ELIQUIS), CARVEDILOL and HYDROCODONE;PARACETAMOL for an unknown indication.    On 25-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 TENDON PAIN (Mild tendon pain) and ARTHRALGIA (Joint pain). On 05-Mar-2021, the patient experienced INJECTION SITE WARMTH (Hot, itchy sore red rash over injection site) and INJECTION SITE SWELLING (Raised hot spot over injection site: 4"X4'). The patient was treated with HYDROCODONE BITARTRATE, PARACETAMOL (VICODIN) for Adverse event NOS, at a dose of 500 mg and TRIAMCINOLONE (topical) for Itch and Ache, at a dose of UNK, tid. On 04-Mar-2021, TENDON PAIN (Mild tendon pain) and ARTHRALGIA (Joint pain) had resolved. At the time of the report, INJECTION SITE WARMTH (Hot, itchy sore red rash over injection site) and INJECTION SITE SWELLING (Raised hot spot over injection site: 4"X4') outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 08-Mar-2021: Additional information received on 08-Mar-2021 added new event and outcome On 07-Jul-2021: Follow up contains information about second dose events, new case created and action taken for dose 1 updated to no change
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling hot, Hyperhidrosis, Malaise, Pain in extremity
Clinical narrative: Didnt feel so good; Arm was hot; Swollen; Itchy; Arm was black and blue; Rash; Fatigue; Sweatiness; Pain in the arm; Fever 99.5-101.2; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweatiness), PAIN IN EXTREMITY (Pain in the arm), MALAISE (Didnt feel so good), FEELING HOT (Arm was hot) and SWELLING (Swollen) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 19-Feb-2021, the patient experienced HYPERHIDROSIS (Sweatiness), PAIN IN EXTREMITY (Pain in the arm) and PYREXIA (Fever 99.5-101.2). On an unknown date, the patient experienced MALAISE (Didnt feel so good), FEELING HOT (Arm was hot), SWELLING (Swollen), PRURITUS (Itchy), SKIN DISCOLOURATION (Arm was black and blue), RASH (Rash) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, HYPERHIDROSIS (Sweatiness), PAIN IN EXTREMITY (Pain in the arm), MALAISE (Didnt feel so good), FEELING HOT (Arm was hot), SWELLING (Swollen), PRURITUS (Itchy), SKIN DISCOLOURATION (Arm was black and blue), RASH (Rash), PYREXIA (Fever 99.5-101.2) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia, Rash, Skin discolouration, Swelling
Clinical narrative: Didnt feel so good; Arm was hot; Swollen; Itchy; Arm was black and blue; Rash; Fatigue; Sweatiness; Pain in the arm; Fever 99.5-101.2; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweatiness), PAIN IN EXTREMITY (Pain in the arm), MALAISE (Didnt feel so good), FEELING HOT (Arm was hot) and SWELLING (Swollen) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 19-Feb-2021, the patient experienced HYPERHIDROSIS (Sweatiness), PAIN IN EXTREMITY (Pain in the arm) and PYREXIA (Fever 99.5-101.2). On an unknown date, the patient experienced MALAISE (Didnt feel so good), FEELING HOT (Arm was hot), SWELLING (Swollen), PRURITUS (Itchy), SKIN DISCOLOURATION (Arm was black and blue), RASH (Rash) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, HYPERHIDROSIS (Sweatiness), PAIN IN EXTREMITY (Pain in the arm), MALAISE (Didnt feel so good), FEELING HOT (Arm was hot), SWELLING (Swollen), PRURITUS (Itchy), SKIN DISCOLOURATION (Arm was black and blue), RASH (Rash), PYREXIA (Fever 99.5-101.2) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia, Vaccination site discolouration, Vaccination site rash
Clinical narrative: 1.5-2 inch wide circle around injection site; Warm if you touch it; Like a rash; Has a bump; Body aches; Chills; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (1.5-2 inch wide circle around injection site), VACCINATION SITE WARMTH (Warm if you touch it), VACCINATION SITE RASH (Like a rash), VACCINATION SITE SWELLING (Has a bump) and MYALGIA (Body aches) in a 38-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.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Feb-2021, the patient experienced MYALGIA (Body aches), CHILLS (Chills) and PYREXIA (Low grade fever). On 01-Mar-2021, the patient experienced VACCINATION SITE DISCOLOURATION (1.5-2 inch wide circle around injection site), VACCINATION SITE WARMTH (Warm if you touch it), VACCINATION SITE RASH (Like a rash) and VACCINATION SITE SWELLING (Has a bump). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event NOS, at an unspecified dose and frequency. On 28-Feb-2021, MYALGIA (Body aches), CHILLS (Chills) and PYREXIA (Low grade fever) had resolved. At the time of the report, VACCINATION SITE DISCOLOURATION (1.5-2 inch wide circle around injection site), VACCINATION SITE WARMTH (Warm if you touch it), VACCINATION SITE RASH (Like a rash) and VACCINATION SITE SWELLING (Has a bump) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: 1.5-2 inch wide circle around injection site; Warm if you touch it; Like a rash; Has a bump; Body aches; Chills; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (1.5-2 inch wide circle around injection site), VACCINATION SITE WARMTH (Warm if you touch it), VACCINATION SITE RASH (Like a rash), VACCINATION SITE SWELLING (Has a bump) and MYALGIA (Body aches) in a 38-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.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Feb-2021, the patient experienced MYALGIA (Body aches), CHILLS (Chills) and PYREXIA (Low grade fever). On 01-Mar-2021, the patient experienced VACCINATION SITE DISCOLOURATION (1.5-2 inch wide circle around injection site), VACCINATION SITE WARMTH (Warm if you touch it), VACCINATION SITE RASH (Like a rash) and VACCINATION SITE SWELLING (Has a bump). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event NOS, at an unspecified dose and frequency. On 28-Feb-2021, MYALGIA (Body aches), CHILLS (Chills) and PYREXIA (Low grade fever) had resolved. At the time of the report, VACCINATION SITE DISCOLOURATION (1.5-2 inch wide circle around injection site), VACCINATION SITE WARMTH (Warm if you touch it), VACCINATION SITE RASH (Like a rash) and VACCINATION SITE SWELLING (Has a bump) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Pain, Pain in extremity
Clinical narrative: Diarrhea; Mild headache; Mild aches and pain; Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Mild aches and pain), PAIN IN EXTREMITY (Arm soreness), DIARRHOEA (Diarrhea) and HEADACHE (Mild headache) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced PAIN (Mild aches and pain), PAIN IN EXTREMITY (Arm soreness) and HEADACHE (Mild headache). On 02-Mar-2021, the patient experienced DIARRHOEA (Diarrhea). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event NOS, at an unspecified dose and frequency. At the time of the report, PAIN (Mild aches and pain), PAIN IN EXTREMITY (Arm soreness), DIARRHOEA (Diarrhea) and HEADACHE (Mild headache) outcome was unknown.            No relevant concomitant medications were reported.   This case was linked to MOD-2021-064039 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm at injection site) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included Surgery (spinal). Concurrent medical conditions included Anxiety, Obsessive-compulsive disorder and Wheelchair user (semi-disabled). Concomitant products included PARACETAMOL (TYLENOL) for Pain.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced VACCINATION SITE PAIN (Sore arm at injection site). At the time of the report, VACCINATION SITE PAIN (Sore arm at injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications was not provided by the reporter
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: Warm; Itchy; Rash around the injection site; It was a little swollen; Painful; The edges are red still but the center is more of a skin like tone; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE WARMTH (Warm), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE RASH (Rash around the injection site), VACCINATION SITE SWELLING (It was a little swollen) and VACCINATION SITE PAIN (Painful) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No treatment information was provided.  Concomitant products included BISOPROLOL FUMARATE (PROBIS) for Blood pressure abnormal, ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    On 13-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 VACCINATION SITE WARMTH (Warm), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE RASH (Rash around the injection site), VACCINATION SITE SWELLING (It was a little swollen), VACCINATION SITE PAIN (Painful) and VACCINATION SITE ERYTHEMA (The edges are red still but the center is more of a skin like tone). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency and IBUPROFEN for Itching, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Warm), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE RASH (Rash around the injection site), VACCINATION SITE SWELLING (It was a little swollen), VACCINATION SITE PAIN (Painful) and VACCINATION SITE ERYTHEMA (The edges are red still but the center is more of a skin like tone) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Other treatment information included: cold wash cloth.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Warm; Itchy; Rash around the injection site; It was a little swollen; Painful; The edges are red still but the center is more of a skin like tone; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE WARMTH (Warm), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE RASH (Rash around the injection site), VACCINATION SITE SWELLING (It was a little swollen) and VACCINATION SITE PAIN (Painful) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No treatment information was provided.  Concomitant products included BISOPROLOL FUMARATE (PROBIS) for Blood pressure abnormal, ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    On 13-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 VACCINATION SITE WARMTH (Warm), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE RASH (Rash around the injection site), VACCINATION SITE SWELLING (It was a little swollen), VACCINATION SITE PAIN (Painful) and VACCINATION SITE ERYTHEMA (The edges are red still but the center is more of a skin like tone). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency and IBUPROFEN for Itching, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Warm), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE RASH (Rash around the injection site), VACCINATION SITE SWELLING (It was a little swollen), VACCINATION SITE PAIN (Painful) and VACCINATION SITE ERYTHEMA (The edges are red still but the center is more of a skin like tone) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Other treatment information included: cold wash cloth.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Hypersomnia, Nausea
Clinical narrative: Little bit of dizziness; Sleeping during the day; Extreme Fatigue / really tired; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Little bit of dizziness), HYPERSOMNIA (Sleeping during the day), FATIGUE (Extreme Fatigue / really tired) and NAUSEA (Nausea) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced DIZZINESS (Little bit of dizziness), HYPERSOMNIA (Sleeping during the day), FATIGUE (Extreme Fatigue / really tired) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event NOS, at an unspecified dose and frequency. At the time of the report, DIZZINESS (Little bit of dizziness), HYPERSOMNIA (Sleeping during the day), FATIGUE (Extreme Fatigue / really tired) and NAUSEA (Nausea) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No relevant concomitant medications were reported.   This case was linked to MOD-2021-032452 (Patient Link).