chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia, Tenderness
Clinical narrative: Hot-flashes; Difficulty breathing; Arm swollen like a baseball; Arm tender; Hear rate 194; Headache; Fatigue; Joint pain; Muscle pain; Fever of 101.9; Nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HOT FLUSH (Hot-flashes), DYSPNOEA (Difficulty breathing), PERIPHERAL SWELLING (Arm swollen like a baseball), TENDERNESS (Arm tender) and PALPITATIONS (Hear rate 194) in a 52-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 was provided by the reporter.  Concomitant products included CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), MAGNESIUM and CALCIUM for an unknown indication.   On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 17-Apr-2021, the patient experienced HOT FLUSH (Hot-flashes), DYSPNOEA (Difficulty breathing), PERIPHERAL SWELLING (Arm swollen like a baseball), TENDERNESS (Arm tender), PALPITATIONS (Hear rate 194), HEADACHE (Headache), FATIGUE (Fatigue), ARTHRALGIA (Joint pain), MYALGIA (Muscle pain), PYREXIA (Fever of 101.9) and NAUSEA (Nausea). On 19-Apr-2021, DYSPNOEA (Difficulty breathing) outcome was unknown. On 22-Apr-2021, HOT FLUSH (Hot-flashes), PERIPHERAL SWELLING (Arm swollen like a baseball), PALPITATIONS (Hear rate 194), HEADACHE (Headache), FATIGUE (Fatigue), ARTHRALGIA (Joint pain), PYREXIA (Fever of 101.9) and NAUSEA (Nausea) had resolved. At the time of the report, TENDERNESS (Arm tender) and MYALGIA (Muscle pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Apr-2021, Body temperature: 101.9 f (High) outcome was recovered/resolved. On 17-Apr-2021, Heart rate: 194 (High) outcome was recovered/resolved.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were reported
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: Slight fever; Headache; Fatigue; This spontaneous case was reported by a non-health professional and describes the occurrence of PYREXIA (Slight fever), HEADACHE (Headache) and FATIGUE (Fatigue) in a 57-year-old male 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) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced PYREXIA (Slight fever), HEADACHE (Headache) and FATIGUE (Fatigue). At the time of the report, PYREXIA (Slight fever), HEADACHE (Headache) and FATIGUE (Fatigue) outcome was unknown. Not Provided          No concomitant information and no treatment medication were reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: No additional information was provided.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose of Moderna COVID-19 vaccine on 24MAR2021 (Lot# 018B21A ) and the Second dose on 31MAR2021; This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose of Moderna COVID-19 vaccine on 24MAR2021 (Lot# 018B21A ) and the Second dose on 31MAR2021) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 018B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose of Moderna COVID-19 vaccine on 24MAR2021 (Lot# 018B21A ) and the Second dose on 31MAR2021). On 31-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose of Moderna COVID-19 vaccine on 24MAR2021 (Lot# 018B21A ) and the Second dose on 31MAR2021) 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 drugs and treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-090246 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-090246:
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Pain in arm; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Pain in arm) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder, Arthritis, GERD, Depression, Hyperglycemia, Drug allergy (Nexium), Drug allergy (Prilosec), Drug allergy (Zantac) and Drug allergy (PCN). Concomitant products included PAROXETINE HYDROCHLORIDE (PAXIL [PAROXETINE HYDROCHLORIDE]) for Depression, PIOGLITAZONE HYDROCHLORIDE (ACTOS) for Hyperglycemia, LEVOTHYROXINE SODIUM (LEVOTHYROXIN) for Thyroid disorder.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Pain in arm). On 18-Feb-2021, PAIN IN EXTREMITY (Pain in arm) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PAIN IN EXTREMITY (Pain in arm) to be probably related.    Treatment information was not provided by the reporter.   This case was linked to MOD-2021-009888, MOD-2021-009888 (Patient Link).
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Cold urticaria, Hypersensitivity, Pruritus
Clinical narrative: allergies have intensified; Urticaria with itching, on exposed parts and after exposure to cold; itching on exposed parts and after exposure to cold; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (allergies have intensified), COLD URTICARIA (Urticaria with itching, on exposed parts and after exposure to cold) and PRURITUS (itching on exposed parts and after exposure to cold) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (allergies have intensified), COLD URTICARIA (Urticaria with itching, on exposed parts and after exposure to cold) and PRURITUS (itching on exposed parts and after exposure to cold). At the time of the report, HYPERSENSITIVITY (allergies have intensified), COLD URTICARIA (Urticaria with itching, on exposed parts and after exposure to cold) and PRURITUS (itching on exposed parts and after exposure to cold) had not resolved.        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.  Company comment: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.; 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: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue
Clinical narrative: Little fatigued; Slight chills; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Little fatigued) and CHILLS (Slight chills) in a 73-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) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Little fatigued) and CHILLS (Slight chills). At the time of the report, FATIGUE (Little fatigued) and CHILLS (Slight chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication were reported.  No treatment medication were reported.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Migraine
Clinical narrative: Migraine aggravated; Sever Headache; Joint pains; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine aggravated), HEADACHE (Sever Headache) and ARTHRALGIA (Joint pains) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included Nerve block (On 5 April 2021,migraine came back.) on 01-Apr-2021. Concurrent medical conditions included Migraine. Concomitant products included DEXLANSOPRAZOLE (DEXILANT) and SUCRALFATE (CARAFATE) for Acid reflux (esophageal), BOTULINUM TOXIN TYPE A (BOTOX) and GALCANEZUMAB (EMGALITY [GALCANEZUMAB]) for Migraine.   On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Jan-2021, the patient experienced HEADACHE (Sever Headache) and ARTHRALGIA (Joint pains). On 05-Apr-2021, the patient experienced MIGRAINE (Migraine aggravated). The patient was treated with RIZATRIPTAN BENZOATE (MAXALT) at an unspecified dose and frequency. At the time of the report, MIGRAINE (Migraine aggravated), HEADACHE (Sever Headache) and ARTHRALGIA (Joint pains) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Nasopharyngitis, Pyrexia
Clinical narrative: Cold; Chills; Feeling tired; Fever; This spontaneous case was reported by a physician and describes the occurrence of NASOPHARYNGITIS (Cold), CHILLS (Chills), FATIGUE (Feeling tired) and PYREXIA (Fever) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 013L20A) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB RZAA (SKYRIZI [RISANKIZUMAB RZAA]) for Plaque psoriasis.    Concurrent medical conditions included Chronic obstructive pulmonary disease since 1998, Psoriatic arthritis since 2011, Rheumatoid arthritis since 2011, Drug allergy (Codeine allergy), Heart rate irregular, Osteoarthritis, Psoriasis, Arthritis and Pain in hand since 2020. Concomitant products included MELOXICAM for Arthritis, Osteoarthritis and Psoriatic arthritis, ACETYLSALICYLIC ACID (ASPIRIN 81) for Cardiovascular event prophylaxis, ALBUTEROL [SALBUTAMOL] and BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) for Chronic obstructive pulmonary disease, METOPROLOL for Heart rate irregular, DESONIDE for Psoriasis, VITAMIN D2 for Supplementation therapy, BETAMETHASONE DIPROPIONATE, CALCIPOTRIOL MONOHYDRATE (ENSTILAR) for an unknown indication.   In 2020, the patient started RISANKIZUMAB RZAA (SKYRIZI [RISANKIZUMAB RZAA]) (Subcutaneous) 150 milligram. On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced NASOPHARYNGITIS (Cold), CHILLS (Chills), FATIGUE (Feeling tired) and PYREXIA (Fever). On 10-Mar-2021, NASOPHARYNGITIS (Cold), CHILLS (Chills), FATIGUE (Feeling tired) and PYREXIA (Fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, Body temperature: 104 High.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NASOPHARYNGITIS (Cold), CHILLS (Chills), FATIGUE (Feeling tired) and PYREXIA (Fever) to be probably related.    Action taken with mRNA-1273 in response to the event was not applicable.  Treatment medication was not provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Malaise, Myalgia
Clinical narrative: Body pain; Knee Soreness; Joint soreness; Did not feel good; Headache; Chills; Fever; This spontaneous case was reported by a physician and describes the occurrence of MALAISE (Did not feel good), ARTHRALGIA (Knee Soreness), ARTHRALGIA (Joint soreness), MYALGIA (Body pain) and HEADACHE (Headache) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    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. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced MALAISE (Did not feel good), ARTHRALGIA (Knee Soreness), ARTHRALGIA (Joint soreness), MYALGIA (Body pain), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Fever). At the time of the report, MALAISE (Did not feel good), ARTHRALGIA (Knee Soreness), ARTHRALGIA (Joint soreness), MYALGIA (Body pain), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Fever) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MALAISE (Did not feel good), ARTHRALGIA (Knee Soreness), ARTHRALGIA (Joint soreness), MYALGIA (Body pain), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Fever) to be probably related.    Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medication was reported.  The patient was treated with TYLENOL.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The patient received 1st dose COVID-19 Vaccine manufactured by Manderna.  The patient received 2nd dose COVID-19 Vaccine manufactured by Manderna.    The reporter's causality for the event(s) of CHILLS, DID NOT FEEL GOOD, JOINT SORENESS, BODY SORENES, FEVER and KNEE SORENESS with HUMIRA (ADALIMUMAB) was no reasonable possibility.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Body pain; Knee Soreness; Joint soreness; Did not feel good; Headache; Chills; Fever; This spontaneous case was reported by a physician and describes the occurrence of MALAISE (Did not feel good), ARTHRALGIA (Knee Soreness), ARTHRALGIA (Joint soreness), MYALGIA (Body pain) and HEADACHE (Headache) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    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. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced MALAISE (Did not feel good), ARTHRALGIA (Knee Soreness), ARTHRALGIA (Joint soreness), MYALGIA (Body pain), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Fever). At the time of the report, MALAISE (Did not feel good), ARTHRALGIA (Knee Soreness), ARTHRALGIA (Joint soreness), MYALGIA (Body pain), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Fever) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MALAISE (Did not feel good), ARTHRALGIA (Knee Soreness), ARTHRALGIA (Joint soreness), MYALGIA (Body pain), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Fever) to be probably related.    Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medication was reported.  The patient was treated with TYLENOL.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The patient received 1st dose COVID-19 Vaccine manufactured by Manderna.  The patient received 2nd dose COVID-19 Vaccine manufactured by Manderna.    The reporter's causality for the event(s) of CHILLS, DID NOT FEEL GOOD, JOINT SORENESS, BODY SORENES, FEVER and KNEE SORENESS with HUMIRA (ADALIMUMAB) was no reasonable possibility.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal dreams, Dysgeusia, Fatigue, Feeling abnormal, Flushing
Clinical narrative: Metallic taste in her mouth; FELT LIKE HIT BY A TRUCK; SPLITTING HEADACHE; TOUNGE STARTED TO ITCH; Fatigue; PAINS; CRAZY DREAMS; Sore arm; Face little flush; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore arm), FLUSHING (Face little flush), ORAL PRURITUS (TOUNGE STARTED TO ITCH), FATIGUE (Fatigue) and PAIN (PAINS) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     NO MEDICAL HISTORY WAS PROVIDED.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81) and LOSARTAN for Product used for unknown indication.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 ml. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 ml. On 25-Mar-2021, the patient experienced MYALGIA (Sore arm) and FLUSHING (Face little flush). On 21-Apr-2021, the patient experienced ORAL PRURITUS (TOUNGE STARTED TO ITCH), FATIGUE (Fatigue), PAIN (PAINS) and ABNORMAL DREAMS (CRAZY DREAMS). On 22-Apr-2021, the patient experienced FEELING ABNORMAL (FELT LIKE HIT BY A TRUCK) and HEADACHE (SPLITTING HEADACHE). On 23-Apr-2021, the patient experienced DYSGEUSIA (Metallic taste in her mouth). On 25-Apr-2021, ORAL PRURITUS (TOUNGE STARTED TO ITCH), FATIGUE (Fatigue), PAIN (PAINS), ABNORMAL DREAMS (CRAZY DREAMS), DYSGEUSIA (Metallic taste in her mouth), FEELING ABNORMAL (FELT LIKE HIT BY A TRUCK) and HEADACHE (SPLITTING HEADACHE) had resolved. At the time of the report, MYALGIA (Sore arm) and FLUSHING (Face little flush) outcome was unknown. Not Provided          CONCOMINANT MEDICATIONS LOSARTAN AND ASPIRIN WERE USED.  GATORADE ,WATER AND TYLENOL WERE USED   This case was linked to MOD-2021-090828, MOD-2021-090828 (Patient Link).
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Oral pruritus, Pain
Clinical narrative: Metallic taste in her mouth; FELT LIKE HIT BY A TRUCK; SPLITTING HEADACHE; TOUNGE STARTED TO ITCH; Fatigue; PAINS; CRAZY DREAMS; Sore arm; Face little flush; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore arm), FLUSHING (Face little flush), ORAL PRURITUS (TOUNGE STARTED TO ITCH), FATIGUE (Fatigue) and PAIN (PAINS) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     NO MEDICAL HISTORY WAS PROVIDED.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81) and LOSARTAN for Product used for unknown indication.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 ml. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 ml. On 25-Mar-2021, the patient experienced MYALGIA (Sore arm) and FLUSHING (Face little flush). On 21-Apr-2021, the patient experienced ORAL PRURITUS (TOUNGE STARTED TO ITCH), FATIGUE (Fatigue), PAIN (PAINS) and ABNORMAL DREAMS (CRAZY DREAMS). On 22-Apr-2021, the patient experienced FEELING ABNORMAL (FELT LIKE HIT BY A TRUCK) and HEADACHE (SPLITTING HEADACHE). On 23-Apr-2021, the patient experienced DYSGEUSIA (Metallic taste in her mouth). On 25-Apr-2021, ORAL PRURITUS (TOUNGE STARTED TO ITCH), FATIGUE (Fatigue), PAIN (PAINS), ABNORMAL DREAMS (CRAZY DREAMS), DYSGEUSIA (Metallic taste in her mouth), FEELING ABNORMAL (FELT LIKE HIT BY A TRUCK) and HEADACHE (SPLITTING HEADACHE) had resolved. At the time of the report, MYALGIA (Sore arm) and FLUSHING (Face little flush) outcome was unknown. Not Provided          CONCOMINANT MEDICATIONS LOSARTAN AND ASPIRIN WERE USED.  GATORADE ,WATER AND TYLENOL WERE USED   This case was linked to MOD-2021-090828, MOD-2021-090828 (Patient Link).
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Circumoral swelling, Hypoaesthesia, Lymphadenopathy, Paraesthesia
Clinical narrative: numbness, tingling and falling asleep sensation in her hand, feet, legs, and arms; numbness, tingling and falling asleep sensation in her hand, feet, legs, and arms; numbness in face; swollen glands in neck; prickly sensation like someone sticking her with "a plastic fork all over my body"; swell around mouth; This spontaneous case was reported by an other and describes the occurrence of HYPOAESTHESIA (numbness, tingling and falling asleep sensation in her hand, feet, legs, and arms), PARAESTHESIA (numbness, tingling and falling asleep sensation in her hand, feet, legs, and arms), HYPOAESTHESIA (numbness in face), LYMPHADENOPATHY (swollen glands in neck) and PARAESTHESIA (prickly sensation like someone sticking her with "a plastic fork all over my body") in a 56-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 22-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 HYPOAESTHESIA (numbness, tingling and falling asleep sensation in her hand, feet, legs, and arms), PARAESTHESIA (numbness, tingling and falling asleep sensation in her hand, feet, legs, and arms), HYPOAESTHESIA (numbness in face), LYMPHADENOPATHY (swollen glands in neck), PARAESTHESIA (prickly sensation like someone sticking her with "a plastic fork all over my body") and CIRCUMORAL SWELLING (swell around mouth). At the time of the report, HYPOAESTHESIA (numbness, tingling and falling asleep sensation in her hand, feet, legs, and arms), PARAESTHESIA (numbness, tingling and falling asleep sensation in her hand, feet, legs, and arms), HYPOAESTHESIA (numbness in face), LYMPHADENOPATHY (swollen glands in neck) and CIRCUMORAL SWELLING (swell around mouth) had resolved and PARAESTHESIA (prickly sensation like someone sticking her with "a plastic fork all over my body") had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient reported to a pharmaceutical company that she had received the first dose of the Moderna vaccine on 22-Feb-2021. She didn't have immediate usual side effects but began having the following symptoms a week later that lasted up to 5 weeks: numbness, tingling, and falling asleep sensation in her hand, feet, legs and arms; numbness in her face; swollen glands in her neck; and up to the day she reported to Pfizer, a prickly sensation like someone sticking her with a "plastic fork all over my body." At night time, she had some tingling in her face and swelling around the mouth. Concomitant medications and treatment information was not reported.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Cough, Dyspnoea, Rash, Vaccination site mass
Clinical narrative: This spontaneous case reported by a consumer (subsequently medically confirmed), describes the occurrence of dyspnea (could not breath), cough, vaccination site mass (lump at injection site), burning sensation (arm was burning) and rash (like shingles) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 038B21A) for COVID-19 immunization. No medical history reported. On Apr 9, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Apr 9, 2021, patient had dyspnea (could not breath), cough, vaccination site mass (lump at injection site), burning sensation (arm was burning) and rash (like shingles). On Apr 23, 2021, dyspnea (could not breath), cough, vaccination site mass (lump at injection site), burning sensation (arm was burning) and rash (like shingles) resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. The reporter did not provide any causality assessments or concomitant medications. Treatment medication included steroids.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthropathy, Bone disorder, Exostosis, Osteoarthritis, X-ray limb abnormal
Clinical narrative: Worsened wrist osteoarthritis; Wrist bone spurs; No space in between wrist bones; Two wrist bones growing together; This spontaneous case was reported by an other health care professional and describes the occurrence of OSTEOARTHRITIS (Worsened wrist osteoarthritis), EXOSTOSIS (Wrist bone spurs), ARTHROPATHY (No space in between wrist bones) and BONE DISORDER (Two wrist bones growing together) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) for Psoriatic arthritis and Ankylosing spondylitis and MELOXICAM for an unknown indication.    The patient's past medical history included Wrist osteoarthritis, Wrist pain, Spinal fusion surgery (In the neck) on 28-Feb-2019 and Joint replacement. Concurrent medical conditions included Seasonal allergy.   In December 2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 mg. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to dosage form. On an unknown date, the patient started MELOXICAM (unknown route) at an unspecified dose. In February 2021, the patient experienced OSTEOARTHRITIS (Worsened wrist osteoarthritis), EXOSTOSIS (Wrist bone spurs), ARTHROPATHY (No space in between wrist bones) and BONE DISORDER (Two wrist bones growing together). In March 2021, EXOSTOSIS (Wrist bone spurs) had resolved. At the time of the report, OSTEOARTHRITIS (Worsened wrist osteoarthritis), ARTHROPATHY (No space in between wrist bones) and BONE DISORDER (Two wrist bones growing together) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, X-ray limb abnormal: significantly worse osteoarthritis (Inconclusive) significantly worse osteoarthritis, two bones in wrist growing together, no space in between bones. Bone spurs in wrist.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Initial Additional-2 : VAERS (incomplete) On 24-May-2021: Email received, NNI. On 25-May-2021: Email
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal dreams, Dysgeusia, Fatigue, Feeling abnormal, Headache
Clinical narrative: Now tastes like metallic; Felt like hit by a truck; Splitting headache; Tongue started to itch; Crazy dreams; Pains; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of TONGUE PRURITUS (Tongue started to itch), ABNORMAL DREAMS (Crazy dreams), DYSGEUSIA (Now tastes like metallic), FEELING ABNORMAL (Felt like hit by a truck) and PAIN (Pains) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LOSARTAN for Hypertension, GLUCOSAMINE HCL for Joint pain, LORATADINE for Seasonal allergy, ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced TONGUE PRURITUS (Tongue started to itch), ABNORMAL DREAMS (Crazy dreams), PAIN (Pains) and FATIGUE (Fatigue). On 22-Apr-2021, the patient experienced FEELING ABNORMAL (Felt like hit by a truck) and HEADACHE (Splitting headache). On 23-Apr-2021, the patient experienced DYSGEUSIA (Now tastes like metallic). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 24-Apr-2021, TONGUE PRURITUS (Tongue started to itch) had resolved. On 25-Apr-2021, ABNORMAL DREAMS (Crazy dreams), DYSGEUSIA (Now tastes like metallic), FEELING ABNORMAL (Felt like hit by a truck), PAIN (Pains), FATIGUE (Fatigue) and HEADACHE (Splitting headache) had resolved.            The patient drank Gatorade and water more than normal.   This case was linked to MOD-2021-090755 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Updated concomitant product use.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Tongue pruritus
Clinical narrative: Now tastes like metallic; Felt like hit by a truck; Splitting headache; Tongue started to itch; Crazy dreams; Pains; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of TONGUE PRURITUS (Tongue started to itch), ABNORMAL DREAMS (Crazy dreams), DYSGEUSIA (Now tastes like metallic), FEELING ABNORMAL (Felt like hit by a truck) and PAIN (Pains) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LOSARTAN for Hypertension, GLUCOSAMINE HCL for Joint pain, LORATADINE for Seasonal allergy, ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced TONGUE PRURITUS (Tongue started to itch), ABNORMAL DREAMS (Crazy dreams), PAIN (Pains) and FATIGUE (Fatigue). On 22-Apr-2021, the patient experienced FEELING ABNORMAL (Felt like hit by a truck) and HEADACHE (Splitting headache). On 23-Apr-2021, the patient experienced DYSGEUSIA (Now tastes like metallic). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 24-Apr-2021, TONGUE PRURITUS (Tongue started to itch) had resolved. On 25-Apr-2021, ABNORMAL DREAMS (Crazy dreams), DYSGEUSIA (Now tastes like metallic), FEELING ABNORMAL (Felt like hit by a truck), PAIN (Pains), FATIGUE (Fatigue) and HEADACHE (Splitting headache) had resolved.            The patient drank Gatorade and water more than normal.   This case was linked to MOD-2021-090755 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Updated concomitant product use.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Headache, Myalgia, Pyrexia
Clinical narrative: headaches; fever; muscle pain; pressure on her chest; chills; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (pressure on her chest), CHILLS (chills), HEADACHE (headaches), PYREXIA (fever) and MYALGIA (muscle pain) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001b21a) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, the patient experienced CHEST DISCOMFORT (pressure on her chest) and CHILLS (chills). On an unknown date, the patient experienced HEADACHE (headaches), PYREXIA (fever) and MYALGIA (muscle pain). The patient was treated with IBUPROFEN at a dose of 2 dosage form. At the time of the report, CHEST DISCOMFORT (pressure on her chest), CHILLS (chills), HEADACHE (headaches), PYREXIA (fever) and MYALGIA (muscle pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  Concomitant medication not provided.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Feeding disorder, Flushing, Gait disturbance, Memory impairment
Clinical narrative: unable to feed himself; confused; unsteady gate; urinary incontinence; could not remember wife's phone number; flush; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (confused), FLUSHING (flush), GAIT DISTURBANCE (unsteady gate), URINARY INCONTINENCE (urinary incontinence) and MEMORY IMPAIRMENT (could not remember wife's phone number) in a 61-year-old male 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 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced FLUSHING (flush). On 23-Apr-2021, the patient experienced CONFUSIONAL STATE (confused), GAIT DISTURBANCE (unsteady gate), URINARY INCONTINENCE (urinary incontinence) and MEMORY IMPAIRMENT (could not remember wife's phone number). On 25-Apr-2021, the patient experienced FEEDING DISORDER (unable to feed himself). At the time of the report, CONFUSIONAL STATE (confused), FLUSHING (flush), GAIT DISTURBANCE (unsteady gate), URINARY INCONTINENCE (urinary incontinence), MEMORY IMPAIRMENT (could not remember wife's phone number) and FEEDING DISORDER (unable to feed himself) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details were provided. No treatment medication details were provided.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Urinary incontinence
Clinical narrative: unable to feed himself; confused; unsteady gate; urinary incontinence; could not remember wife's phone number; flush; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (confused), FLUSHING (flush), GAIT DISTURBANCE (unsteady gate), URINARY INCONTINENCE (urinary incontinence) and MEMORY IMPAIRMENT (could not remember wife's phone number) in a 61-year-old male 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 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced FLUSHING (flush). On 23-Apr-2021, the patient experienced CONFUSIONAL STATE (confused), GAIT DISTURBANCE (unsteady gate), URINARY INCONTINENCE (urinary incontinence) and MEMORY IMPAIRMENT (could not remember wife's phone number). On 25-Apr-2021, the patient experienced FEEDING DISORDER (unable to feed himself). At the time of the report, CONFUSIONAL STATE (confused), FLUSHING (flush), GAIT DISTURBANCE (unsteady gate), URINARY INCONTINENCE (urinary incontinence), MEMORY IMPAIRMENT (could not remember wife's phone number) and FEEDING DISORDER (unable to feed himself) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details were provided. No treatment medication details were provided.
Age: 71.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Chills, Malaise, Pain, Tongue disorder
Clinical narrative: Chills; Body aches; Malaise; Spots on Tongue; This spontaneous case was reported by a physician and describes the occurrence of CHILLS (Chills), PAIN (Body aches), MALAISE (Malaise) and TONGUE DISORDER (Spots on Tongue) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 13-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and ADALIMUMAB (HUMIRA) (unknown route) at an unspecified dose. In March 2021, the patient experienced CHILLS (Chills), PAIN (Body aches), MALAISE (Malaise) and TONGUE DISORDER (Spots on Tongue). In March 2021, CHILLS (Chills), PAIN (Body aches), MALAISE (Malaise) and TONGUE DISORDER (Spots on Tongue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and 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 treatment information was reported.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue; This spontaneous case was reported by a physician and describes the occurrence of FATIGUE (Fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    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 and ADALIMUMAB (HUMIRA) (Subcutaneous) dosage form. On an unknown date, the patient experienced FATIGUE (Fatigue). At the time of the report, FATIGUE (Fatigue) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was reported.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Device connection issue, Discomfort, Underdose
Clinical narrative: Dose Leaked from the arm to the elbow; Dose Leaked from the arm to the elbow; Slight Discomfort; This spontaneous case was reported by a consumer and describes the occurrence of UNDERDOSE (Dose Leaked from the arm to the elbow), DEVICE CONNECTION ISSUE (Dose Leaked from the arm to the elbow) and DISCOMFORT (Slight Discomfort) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, the patient experienced UNDERDOSE (Dose Leaked from the arm to the elbow), DEVICE CONNECTION ISSUE (Dose Leaked from the arm to the elbow) and DISCOMFORT (Slight Discomfort). At the time of the report, UNDERDOSE (Dose Leaked from the arm to the elbow), DEVICE CONNECTION ISSUE (Dose Leaked from the arm to the elbow) and DISCOMFORT (Slight Discomfort) outcome was unknown.            No concomitant medications reported by investigator  No treatment medications provided by the reporter.    Reporter did not allow further contact
Sex: M
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Fatigue, Headache
Clinical narrative: Fatigue; Headache; Aching joints; This spontaneous case was reported by a physician and describes the occurrence of FATIGUE (Fatigue), HEADACHE (Headache) and ARTHRALGIA (Aching joints) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriasis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced FATIGUE (Fatigue), HEADACHE (Headache) and ARTHRALGIA (Aching joints). At the time of the report, FATIGUE (Fatigue), HEADACHE (Headache) and ARTHRALGIA (Aching joints) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment and concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: flu-like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications provided by the reporter.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Influenza like illness, Oropharyngeal pain, Pain, Rhinorrhoea
Clinical narrative: Slight sore throat; Running nose; Sweating; Body aches; Viral flu-like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Slight sore throat), RHINORRHOEA (Running nose), HYPERHIDROSIS (Sweating), PAIN (Body aches) and INFLUENZA LIKE ILLNESS (Viral flu-like symptoms) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     Concurrent medical conditions included Tonsillitis, Infection, Flu-like symptoms, Allergy and Diabetes. Concomitant products included PAROXETINE HCL for Anxiety, GLIPIZIDE, METFORMIN HCL and BENAZEPRIL HCL for Diabetes, PRAVASTATIN, METOPROLOL SUCCINATE, LORATADINE, PSEUDOEPHEDRINE SULFATE (CLARITIN D 12 HOUR) and MULTIVITAMIN FOR WOMEN for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (Slight sore throat), RHINORRHOEA (Running nose), HYPERHIDROSIS (Sweating), PAIN (Body aches) and INFLUENZA LIKE ILLNESS (Viral flu-like symptoms). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (DAYQUIL) for Symptomatic treatment, at an unspecified dose and frequency and IBUPROFEN for Symptomatic treatment, at an unspecified dose and frequency. On 26-Apr-2021, HYPERHIDROSIS (Sweating), PAIN (Body aches) and INFLUENZA LIKE ILLNESS (Viral flu-like symptoms) had resolved. At the time of the report, OROPHARYNGEAL PAIN (Slight sore throat) and RHINORRHOEA (Running nose) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medications also included Claritin D.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Neck pain, Pain in extremity
Clinical narrative: Sore arm; Progressive and gradual pain at the neck; Bad headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), NECK PAIN (Progressive and gradual pain at the neck) and HEADACHE (Bad headache) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032120A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, 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 experienced PAIN IN EXTREMITY (Sore arm), NECK PAIN (Progressive and gradual pain at the neck) and HEADACHE (Bad headache). At the time of the report, PAIN IN EXTREMITY (Sore arm), NECK PAIN (Progressive and gradual pain at the neck) and HEADACHE (Bad headache) had resolved.            No concomitant medications and treatment information was provided. Patient reported that "progressive and gradual pain at the neck, sore arm and bad headache that lasted for about 48 hours and it subsided the next day."   This case was linked to MOD-2021-018463 (Patient Link).
Age: 81.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pain in extremity
Clinical narrative: Painful R arm; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (Painful R arm) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No medical history was reported by the reporter.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Painful R arm). At the time of the report, PAIN IN EXTREMITY (Painful R arm) 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 treatment and concomitant medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Nightmare, Thinking abnormal
Clinical narrative: Nightmare; Crazy thoughts; This spontaneous case was reported by a consumer and describes the occurrence of NIGHTMARE (Nightmare) and THINKING ABNORMAL (Crazy thoughts) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NIGHTMARE (Nightmare) and THINKING ABNORMAL (Crazy thoughts). At the time of the report, NIGHTMARE (Nightmare) and THINKING ABNORMAL (Crazy thoughts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.