chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Hypersomnia, Pain in extremity
Clinical narrative: very tired; Slept a lot; arm hurt a little bit; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt a little bit), FATIGUE (very tired ) and HYPERSOMNIA (Slept a lot) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included TB. Concomitant products included VITAMIN B6 for an unknown indication.   On 30-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) (unknown route) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm hurt a little bit). On 28-Feb-2021, the patient experienced FATIGUE (very tired ) and HYPERSOMNIA (Slept a lot). At the time of the report, PAIN IN EXTREMITY (arm hurt a little bit), FATIGUE (very tired ) and HYPERSOMNIA (Slept a lot) outcome was unknown.            No treatment details were provided.    This case was linked.   See case for details regarding the child case.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Pain in extremity
Clinical narrative: chills; light headed; sore arm; This spontaneous case was reported by a patient and describes the occurrence of CHILLS (chills), DIZZINESS (light headed) and PAIN IN EXTREMITY (sore arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 001A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 01-Mar-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced CHILLS (chills), DIZZINESS (light headed) and PAIN IN EXTREMITY (sore arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and NAPROXEN at an unspecified dose and frequency. At the time of the report, CHILLS (chills), DIZZINESS (light headed) and PAIN IN EXTREMITY (sore arm) outcome was unknown.            No concomitant medications were provided.    This case was linked to MOD-2021-034965 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Pain, Pain in extremity, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (painful arm soreness), RASH (rash on the other arm), PYREXIA (fever), TASTE DISORDER (Weird Taste) and FATIGUE (Tired) in a 74-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.     Concurrent medical conditions included Penicillin allergy (result in hives) and Drug allergy (sulfur allergy which result in swelling). Concomitant products included LEVOTHYROXINE, EZETIMIBE, PANTOPRAZOLE and LORAZEPAM for an unknown indication.    On 01-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced PAIN IN EXTREMITY (painful arm soreness), PYREXIA (fever), TASTE DISORDER (Weird Taste), SWELLING (swelling blotchy rash near the site of injection) and URTICARIA (rash look like hives). On 02-Mar-2021, the patient experienced RASH (rash on the other arm). On an unknown date, the patient experienced FATIGUE (Tired), PAIN (Right upper arm where she got the shot is throbbing and very hard to move) and MALAISE (she felt like sheh as a GERD after the shot). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and NAPROXEN at an unspecified dose and frequency. On 02-Mar-2021, PYREXIA (fever) had resolved. At the time of the report, PAIN IN EXTREMITY (painful arm soreness), RASH (rash on the other arm), SWELLING (swelling blotchy rash near the site of injection) and URTICARIA (rash look like hives) had not resolved and TASTE DISORDER (Weird Taste), FATIGUE (Tired), PAIN (Right upper arm where she got the shot is throbbing and very hard to move) and MALAISE (she felt like sheh as a GERD after the shot) outcome was unknown.            Treatment: applied heat and icing
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Swelling, Taste disorder, Urticaria
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (painful arm soreness), RASH (rash on the other arm), PYREXIA (fever), TASTE DISORDER (Weird Taste) and FATIGUE (Tired) in a 74-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.     Concurrent medical conditions included Penicillin allergy (result in hives) and Drug allergy (sulfur allergy which result in swelling). Concomitant products included LEVOTHYROXINE, EZETIMIBE, PANTOPRAZOLE and LORAZEPAM for an unknown indication.    On 01-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced PAIN IN EXTREMITY (painful arm soreness), PYREXIA (fever), TASTE DISORDER (Weird Taste), SWELLING (swelling blotchy rash near the site of injection) and URTICARIA (rash look like hives). On 02-Mar-2021, the patient experienced RASH (rash on the other arm). On an unknown date, the patient experienced FATIGUE (Tired), PAIN (Right upper arm where she got the shot is throbbing and very hard to move) and MALAISE (she felt like sheh as a GERD after the shot). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and NAPROXEN at an unspecified dose and frequency. On 02-Mar-2021, PYREXIA (fever) had resolved. At the time of the report, PAIN IN EXTREMITY (painful arm soreness), RASH (rash on the other arm), SWELLING (swelling blotchy rash near the site of injection) and URTICARIA (rash look like hives) had not resolved and TASTE DISORDER (Weird Taste), FATIGUE (Tired), PAIN (Right upper arm where she got the shot is throbbing and very hard to move) and MALAISE (she felt like sheh as a GERD after the shot) outcome was unknown.            Treatment: applied heat and icing
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced DIARRHOEA (Diarrhea). On 04-Mar-2021, DIARRHOEA (Diarrhea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment details were provided.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: Slight sore felt achy; headache the next morning; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Slight sore felt achy) and HEADACHE (headache the next morning) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (Slight sore felt achy) and HEADACHE (headache the next morning). At the time of the report, PAIN (Slight sore felt achy) and HEADACHE (headache the next morning) had resolved.            No concomitant medications were reported.  No treatment information was reported.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Extreme pain in her arm from shoulder to elbow; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Extreme pain in her arm from shoulder to elbow) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002Az1A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced PAIN IN EXTREMITY (Extreme pain in her arm from shoulder to elbow). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and IBUPROFEN (ADVIL 12 HOUR) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Extreme pain in her arm from shoulder to elbow) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site pruritus
Clinical narrative: Red at injection site; Knot at injection site; Itches at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Red at injection site), VACCINATION SITE MASS (Knot at injection site) and VACCINATION SITE PRURITUS (Itches at injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03l20a) for COVID-19 vaccination.     Concomitant products included RANITIDINE HYDROCHLORIDE (ZANTAC) for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red at injection site), VACCINATION SITE MASS (Knot at injection site) and VACCINATION SITE PRURITUS (Itches at injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Red at injection site), VACCINATION SITE MASS (Knot at injection site) and VACCINATION SITE PRURITUS (Itches at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications also included Cholesterol medicines.  No treatment information was reported.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site mass, Injection site warmth
Clinical narrative: lump size of duck egg at injection site; hot to the touch; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE MASS (lump size of duck egg at injection site) and INJECTION SITE WARMTH (hot to the touch) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 93M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-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 MASS (lump size of duck egg at injection site) and INJECTION SITE WARMTH (hot to the touch). At the time of the report, INJECTION SITE MASS (lump size of duck egg at injection site) and INJECTION SITE WARMTH (hot to the touch) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included unknown medicine for blood pressure  No treatment information was reported.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced HEADACHE (Headache). The patient was treated with ACETYLSALICYLIC ACID, DIPHENHYDRAMINE CITRATE, PARACETAMOL (EXCEDRIN PM HEADACHE) for Headache, at an unspecified dose and frequency. On 04-Feb-2021, HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided.   This case was linked to MOD-2021-034974 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Slight headache) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced HEADACHE (Slight headache). The patient was treated with ACETYLSALICYLIC ACID, DIPHENHYDRAMINE CITRATE, PARACETAMOL (EXCEDRIN PM HEADACHE) for Headache, at an unspecified dose and frequency. At the time of the report, HEADACHE (Slight headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   This case was linked to MOD-2021-034973 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Musculoskeletal discomfort, Pain, Skin irritation
Clinical narrative: Pain in lower back; Pain in waist; Pain in shoulder blade to neck jaw and right shoulder; Can not turn neck; Scalp above your right ear is sensitive; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Pain in lower back), PAIN (Pain in waist), ARTHRALGIA (Pain in shoulder blade to neck jaw and right shoulder), MUSCULOSKELETAL DISCOMFORT (Can not turn neck) and SKIN IRRITATION (Scalp above your right ear is sensitive) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BACK PAIN (Pain in lower back), PAIN (Pain in waist), ARTHRALGIA (Pain in shoulder blade to neck jaw and right shoulder), MUSCULOSKELETAL DISCOMFORT (Can not turn neck) and SKIN IRRITATION (Scalp above your right ear is sensitive). At the time of the report, BACK PAIN (Pain in lower back), PAIN (Pain in waist), ARTHRALGIA (Pain in shoulder blade to neck jaw and right shoulder), MUSCULOSKELETAL DISCOMFORT (Can not turn neck) and SKIN IRRITATION (Scalp above your right ear is sensitive) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was reported.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Pyrexia
Clinical narrative: Weakness; Headache; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (Fever), ASTHENIA (Weakness) and HEADACHE (Headache) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) 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 03-Mar-2021, the patient experienced CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache). On 04-Mar-2021, the patient experienced ASTHENIA (Weakness). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 04-Mar-2021, CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache) had resolved. At the time of the report, ASTHENIA (Weakness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Headache, Myalgia
Clinical narrative: Dizziness; Chest pain; headache; Muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), CHEST PAIN (Chest pain), HEADACHE (headache) and MYALGIA (Muscle aches) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced DIZZINESS (Dizziness), CHEST PAIN (Chest pain), HEADACHE (headache) and MYALGIA (Muscle aches). At the time of the report, DIZZINESS (Dizziness), CHEST PAIN (Chest pain), HEADACHE (headache) and MYALGIA (Muscle aches) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported that she has not been taking any medications. She has not received any treatment for her symptoms.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Ring like rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Ring like rash) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (Ring like rash). At the time of the report, RASH (Ring like rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported. No concomitant medications were reported.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: itching; redness reemerged; pain at injection site; warm to touch; A spontaneous report (United States) was received from a consumer concerning a 74-year-old female patient who received Moderna (mRNA-1273) vaccine and experienced Redness re-emerged/ vaccination site erythema, warm/ vaccination site warmth, pain/ vaccination site pain and itching/ vaccination site pruritus at injection site.  The patient's medical history was not provided. No Relevant concomitant medications were reported.  On 30 Jan 2021, prior to the onset of symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number: 041L20A) intramuscularly for prophylaxis of COVID-19 infection.    On 30 Jan 2021, the patient developed Redness re-emerged, warm and pain at injection site.  On 6 Feb 2021, the patient experienced itching at the injection site.  No Treatment information was provided.  Action taken with mRNA-1273 in response to the event(s) was unknown.  On an unknown date, the outcome of the event redness re-emerged, warm, pain and itching at injection site were unknown.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Injection site pain, Nausea
Clinical narrative: diarrhea; nausea; soreness at the injected arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (soreness at the injected arm), DIARRHOEA (diarrhea) and NAUSEA (nausea) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (ANORO) for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced INJECTION SITE PAIN (soreness at the injected arm) and NAUSEA (nausea). On an unknown date, the patient experienced DIARRHOEA (diarrhea). The patient was treated with CANNABIS SATIVA (CBD COMPLEX) for Adverse event, at an unspecified dose and frequency. At the time of the report, INJECTION SITE PAIN (soreness at the injected arm), DIARRHOEA (diarrhea) and NAUSEA (nausea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Tenderness, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Swollen around the injection site; redness around the injection site; Tender arm; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Tender arm), VACCINATION SITE SWELLING (Swollen around the injection site) and VACCINATION SITE ERYTHEMA (redness around the injection site) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) 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) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced TENDERNESS (Tender arm). On 25-Feb-2021, the patient experienced VACCINATION SITE SWELLING (Swollen around the injection site) and VACCINATION SITE ERYTHEMA (redness around the injection site). On 19-Feb-2021, TENDERNESS (Tender arm) had resolved. At the time of the report, VACCINATION SITE SWELLING (Swollen around the injection site) and VACCINATION SITE ERYTHEMA (redness around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was reported.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dyskinesia, Fatigue, Vertigo
Clinical narrative: Vertigo; I feel like I'm going to lose my balance; don't dare to bend over from the waist; feeling fatigue; This spontaneous case was reported by a physician and describes the occurrence of VERTIGO (Vertigo), BALANCE DISORDER (I feel like I'm going to lose my balance), DYSKINESIA (don't dare to bend over from the waist) and FATIGUE (feeling fatigue) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Lot# 031L20A) for COVID-19 vaccination.     Concomitant products included ROSUVASTATIN and ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VERTIGO (Vertigo), BALANCE DISORDER (I feel like I'm going to lose my balance), DYSKINESIA (don't dare to bend over from the waist) and FATIGUE (feeling fatigue). At the time of the report, VERTIGO (Vertigo), BALANCE DISORDER (I feel like I'm going to lose my balance), DYSKINESIA (don't dare to bend over from the waist) and FATIGUE (feeling fatigue) outcome was unknown.        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 treatment medication was provided.
Sex: M
Vaccine: COVID19
Symptoms: Rash macular, Urticaria
Clinical narrative: hives; itchy blotches; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of URTICARIA (hives) and RASH MACULAR (itchy blotches) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), ASPIRIN [ACETYLSALICYLIC ACID], METOPROLOL SUCCINATE (TOPROL) and CLONAZEPAM for an unknown indication.    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 URTICARIA (hives) and RASH MACULAR (itchy blotches). At the time of the report, URTICARIA (hives) and RASH MACULAR (itchy blotches) outcome was unknown.        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 medications were reported.  No treatment information was reported.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Eyelid ptosis, Pain in extremity, Somnolence
Clinical narrative: droopy; Sleepy; doesn't have an appetite; knot on arm and it sore; This spontaneous case was reported by a consumer and describes the occurrence of EYELID PTOSIS (droopy), SOMNOLENCE (Sleepy), DECREASED APPETITE (doesn't have an appetite) and PAIN IN EXTREMITY (knot on arm and it sore) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concomitant products included BENAZEPRIL, HCTZ, PRAVASTATIN, MEMANTINE and METFORMIN for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced EYELID PTOSIS (droopy), SOMNOLENCE (Sleepy), DECREASED APPETITE (doesn't have an appetite) and PAIN IN EXTREMITY (knot on arm and it sore). At the time of the report, EYELID PTOSIS (droopy), SOMNOLENCE (Sleepy), DECREASED APPETITE (doesn't have an appetite) and PAIN IN EXTREMITY (knot on arm and it sore) 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.   No treatment medications provided
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Pain in extremity, Pyrexia, Rhinitis, SARS-CoV-2 test
Clinical narrative: sensitive nose; sore arm; tested positive for COVID; fever; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for COVID), RHINITIS (sensitive nose), PAIN IN EXTREMITY (sore arm) and PYREXIA (fever) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L204) for COVID-19 vaccination.     No medical history was reported.     On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced PYREXIA (fever). On 10-Feb-2021, the patient experienced COVID-19 (tested positive for COVID). On an unknown date, the patient experienced RHINITIS (sensitive nose) and PAIN IN EXTREMITY (sore arm). At the time of the report, COVID-19 (tested positive for COVID), RHINITIS (sensitive nose), PAIN IN EXTREMITY (sore arm) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Jan-2021, SARS-CoV-2 test: (Negative) On 26Jan2021, he tested negative for COVID.. On 31-Jan-2021, SARS-CoV-2 test: (Negative) On 31Jan2021, he tested negative again for COVID. On 10-Feb-2021, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant  information was  provided. No Treatment information was  provided.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Fatigue, Headache, Injection site erythema
Clinical narrative: muscle aches; joint pain; headache; big red spot that was sore; Big red spot that was sore; diarrhea; fatigue; This spontaneous case was reported by an other health care professional and describes the occurrence of HEADACHE (headache), INJECTION SITE PAIN (big red spot that was sore), INJECTION SITE ERYTHEMA (Big red spot that was sore), DIARRHOEA (diarrhea) and FATIGUE (fatigue) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 030L20A) 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 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 02-Feb-2021, the patient experienced HEADACHE (headache), INJECTION SITE PAIN (big red spot that was sore), INJECTION SITE ERYTHEMA (Big red spot that was sore), DIARRHOEA (diarrhea) and FATIGUE (fatigue). On 04-Feb-2021, the patient experienced MYALGIA (muscle aches) and ARTHRALGIA (joint pain). At the time of the report, HEADACHE (headache), INJECTION SITE PAIN (big red spot that was sore), INJECTION SITE ERYTHEMA (Big red spot that was sore), DIARRHOEA (diarrhea) and FATIGUE (fatigue) outcome was unknown and MYALGIA (muscle aches) and ARTHRALGIA (joint pain) had not resolved.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Myalgia
Clinical narrative: muscle aches; joint pain; headache; big red spot that was sore; Big red spot that was sore; diarrhea; fatigue; This spontaneous case was reported by an other health care professional and describes the occurrence of HEADACHE (headache), INJECTION SITE PAIN (big red spot that was sore), INJECTION SITE ERYTHEMA (Big red spot that was sore), DIARRHOEA (diarrhea) and FATIGUE (fatigue) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 030L20A) 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 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 02-Feb-2021, the patient experienced HEADACHE (headache), INJECTION SITE PAIN (big red spot that was sore), INJECTION SITE ERYTHEMA (Big red spot that was sore), DIARRHOEA (diarrhea) and FATIGUE (fatigue). On 04-Feb-2021, the patient experienced MYALGIA (muscle aches) and ARTHRALGIA (joint pain). At the time of the report, HEADACHE (headache), INJECTION SITE PAIN (big red spot that was sore), INJECTION SITE ERYTHEMA (Big red spot that was sore), DIARRHOEA (diarrhea) and FATIGUE (fatigue) outcome was unknown and MYALGIA (muscle aches) and ARTHRALGIA (joint pain) had not resolved.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Decreased appetite, Dizziness, Fatigue
Clinical narrative: Weak; Dizzy; Doesn't have an appetite; Head is hurting bad; Chills; Fever; Slept the whole day; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weak), DIZZINESS (Dizzy), DECREASED APPETITE (Doesn't have an appetite), HEADACHE (Head is hurting bad) and CHILLS (Chills) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) 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 BENAZEPRIL and HCTZ for an unknown indication.    On 11-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced ASTHENIA (Weak), DIZZINESS (Dizzy), DECREASED APPETITE (Doesn't have an appetite), HEADACHE (Head is hurting bad), CHILLS (Chills), PYREXIA (Fever) and FATIGUE (Slept the whole day). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, ASTHENIA (Weak), DIZZINESS (Dizzy), DECREASED APPETITE (Doesn't have an appetite), HEADACHE (Head is hurting bad), CHILLS (Chills), PYREXIA (Fever) and FATIGUE (Slept the whole day) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 11-Feb-2021, the patient received their second dose of vaccine and slept for the whole day. The patient was very weak and experienced fever, chills and felt dizzy. The patient also reported that they don't had an appetite and their head was hurting bad.  Treatment medication included Tylenol which helped.   This case was linked to MOD-2021-035003 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: Weak; Dizzy; Doesn't have an appetite; Head is hurting bad; Chills; Fever; Slept the whole day; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weak), DIZZINESS (Dizzy), DECREASED APPETITE (Doesn't have an appetite), HEADACHE (Head is hurting bad) and CHILLS (Chills) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) 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 BENAZEPRIL and HCTZ for an unknown indication.    On 11-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced ASTHENIA (Weak), DIZZINESS (Dizzy), DECREASED APPETITE (Doesn't have an appetite), HEADACHE (Head is hurting bad), CHILLS (Chills), PYREXIA (Fever) and FATIGUE (Slept the whole day). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, ASTHENIA (Weak), DIZZINESS (Dizzy), DECREASED APPETITE (Doesn't have an appetite), HEADACHE (Head is hurting bad), CHILLS (Chills), PYREXIA (Fever) and FATIGUE (Slept the whole day) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 11-Feb-2021, the patient received their second dose of vaccine and slept for the whole day. The patient was very weak and experienced fever, chills and felt dizzy. The patient also reported that they don't had an appetite and their head was hurting bad.  Treatment medication included Tylenol which helped.   This case was linked to MOD-2021-035003 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Ear swelling, Pruritus, Urticaria
Clinical narrative: Swollen right earlobe; Itching; Hives on right arm, neck chest and waist; This spontaneous case was reported by a consumer and describes the occurrence of EAR SWELLING (Swollen right earlobe), PRURITUS (Itching) and URTICARIA (Hives on right arm, neck chest and waist) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.  On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 29-Jan-2021, the patient experienced URTICARIA (Hives on right arm, neck chest and waist).   On an unknown date, the patient experienced EAR SWELLING (Swollen right earlobe) and PRURITUS (Itching). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency.   At the time of the report, EAR SWELLING (Swollen right earlobe), PRURITUS (Itching) and URTICARIA (Hives on right arm, neck chest and waist) outcome was unknown.       The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Blister
Clinical narrative: Blisters; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (Blisters) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. EL8982 and EL1284) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Jan-2021, the patient experienced BLISTER (Blisters). At the time of the report, BLISTER (Blisters) was resolving.            Concomitant medication use was not provided Treatment information included Benadryl.
Sex: F
Vaccine: COVID19
Symptoms: Muscle tightness, Vaccination site pain
Clinical narrative: site injection soreness; tightness extended into her neck on the same side as the injection; This spontaneous case was reported by an other and describes the occurrence of VACCINATION SITE PAIN (site injection soreness) and MUSCLE TIGHTNESS (tightness extended into her neck on the same side as the injection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE PAIN (site injection soreness) and MUSCLE TIGHTNESS (tightness extended into her neck on the same side as the injection). At the time of the report, VACCINATION SITE PAIN (site injection soreness) and MUSCLE TIGHTNESS (tightness extended into her neck on the same side as the injection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment and concomitant information was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: Followup received on 12-APR-2021 and contains NNI.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Pain in extremity, Peripheral swelling, Rash, Rash pruritic
Clinical narrative: Vaccination site reaction; Swollen arm; Itchy rash; blister; Rash; Pain in arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE REACTION (Vaccination site reaction), PERIPHERAL SWELLING (Swollen arm), PAIN IN EXTREMITY (Pain in arm), RASH PRURITIC (Itchy rash ) and BLISTER (blister) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm). On 08-Feb-2021, the patient experienced VACCINATION SITE REACTION (Vaccination site reaction), PERIPHERAL SWELLING (Swollen arm), RASH PRURITIC (Itchy rash ), BLISTER (blister) and RASH (Rash). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, VACCINATION SITE REACTION (Vaccination site reaction), PERIPHERAL SWELLING (Swollen arm), PAIN IN EXTREMITY (Pain in arm), RASH PRURITIC (Itchy rash ), BLISTER (blister) and RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided. Patient received (Something like zerotax) prescribed by her HCP as treatment medication.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: Vaccination site reaction; Swollen arm; Itchy rash; blister; Rash; Pain in arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE REACTION (Vaccination site reaction), PERIPHERAL SWELLING (Swollen arm), PAIN IN EXTREMITY (Pain in arm), RASH PRURITIC (Itchy rash ) and BLISTER (blister) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm). On 08-Feb-2021, the patient experienced VACCINATION SITE REACTION (Vaccination site reaction), PERIPHERAL SWELLING (Swollen arm), RASH PRURITIC (Itchy rash ), BLISTER (blister) and RASH (Rash). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, VACCINATION SITE REACTION (Vaccination site reaction), PERIPHERAL SWELLING (Swollen arm), PAIN IN EXTREMITY (Pain in arm), RASH PRURITIC (Itchy rash ), BLISTER (blister) and RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided. Patient received (Something like zerotax) prescribed by her HCP as treatment medication.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Vaccination site erythema, Vaccination site mass, Vaccination site pain
Clinical narrative: tenderness, redness, and the arm was swollen/3 cm wide 5 cm long; tenderness, redness, and the arm was swollen; it's a little bit firmer than the rest of the arm; tenderness but past away; A spontaneous report was received from a healthcare professional concerning a 70 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events left arm on the deltoid muscle, did not noticed absolutely nothing, tenderness but past away, tenderness, redness, and the arm was swollen, 3 cm wide 5 cm long and it's a little bit firmer than the rest of the arm.  The patient's medical history was not provided. Concomitant medications reported were Supplements, Vitamins, Clariton for drug use for unknown indication.  On 02 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 041L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 2 Feb 2021, the patient experienced the event(s) left arm on the deltoid muscle, did not noticed absolutely nothing. On 3 Feb 2021, the patient experienced the event(s) tenderness but past away, tenderness. On an unknown date, the patient experienced the event(s) redness, and the arm was swollen, 3 cm wide 5 cm long, it's a little bit firmer than the rest of the arm  Treatment details included None.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), left arm on the deltoid muscle, did not noticed absolutely nothing, tenderness but past away, tenderness, redness, and the arm was swollen, 3 cm wide 5 cm long and it's a little bit firmer than the rest of the arm 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 events, a causal relationship cannot be excluded.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Feeling abnormal, Headache, Pain in extremity, Pyrexia
Clinical narrative: felt worse; itchy at the injection site; red arm, has extended down and to the bicep area, inside of his right arm; fever; headache; arm hurt; felt terrify; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt worse), PAIN IN EXTREMITY (arm hurt), FEELING ABNORMAL (felt terrify), VACCINATION SITE PRURITUS (itchy at the injection site) and VACCINATION SITE ERYTHEMA (red arm, has extended down and to the bicep area, inside of his right arm) in an 89-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.     The patient's past medical history included COVID-19 in March 2020. Concurrent medical conditions included UTI, High cholesterol and Blood pressure. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm hurt), FEELING ABNORMAL (felt terrify) and HEADACHE (headache). On 07-Feb-2021, the patient experienced PYREXIA (fever). On 11-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (itchy at the injection site) and VACCINATION SITE ERYTHEMA (red arm, has extended down and to the bicep area, inside of his right arm). On an unknown date, the patient experienced FEELING ABNORMAL (felt worse). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and CORTISONE for Itchy, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (felt worse), PAIN IN EXTREMITY (arm hurt), FEELING ABNORMAL (felt terrify), VACCINATION SITE PRURITUS (itchy at the injection site), VACCINATION SITE ERYTHEMA (red arm, has extended down and to the bicep area, inside of his right arm), PYREXIA (fever) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.3 (High) 101.3 degree F usual temperature is 98 F.     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 medication include urinary tract pills, blood pressure pills and one more medication.