chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Myalgia, Vaccination site pain
Clinical narrative: Tenderness at injection site; Body ache; Burning sensation on feet; A spontaneous report was received from a consumer concerning a 82-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events tenderness at injection site/ vaccination site tenderness, body ache/myalgia and burning sensation on feet/ burning sensation.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 16 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 023M20A) intramuscularly for prophylaxis of COVID-19 infection.On 16 Feb 2021, the patient experienced the event(s) tenderness at injection site for 2 days. On an unknown date, the patient experienced body ache and burning sensation on feet. Treatment details included paracetamol and ibuprofen.  Action taken with mRNA-1273 in response to the events was unknown.  On 18 Feb 2021, the outcome of event tenderness at injection site was resolved. The outcome of events  body ache and burning sensation on feet were unknown.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema of eyelid, Ocular hyperaemia, Pain, Vaccination site pain
Clinical narrative: Right eyebrow hurting; Right eyeball is blood shot; red under that eyelid; light soreness at the injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Feb-2021 and was forwarded to Moderna on 19-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Right eyebrow hurting), OCULAR HYPERAEMIA (Right eyeball is blood shot), ERYTHEMA OF EYELID (red under that eyelid) and VACCINATION SITE PAIN (light soreness at the injection site) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, the patient experienced VACCINATION SITE PAIN (light soreness at the injection site). On 17-Feb-2021, the patient experienced PAIN (Right eyebrow hurting), OCULAR HYPERAEMIA (Right eyeball is blood shot) and ERYTHEMA OF EYELID (red under that eyelid). At the time of the report, PAIN (Right eyebrow hurting), OCULAR HYPERAEMIA (Right eyeball is blood shot), ERYTHEMA OF EYELID (red under that eyelid) and VACCINATION SITE PAIN (light soreness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. Treatment details were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Email communication, no follow-up information
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling abnormal, Rash, Rash macular, Tenderness
Clinical narrative: Spotty; Redness; Like a patch; Rash; Tender; Didn't really feel too bad; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Tender), FEELING ABNORMAL (Didn't really feel too bad), RASH MACULAR (Spotty), ERYTHEMA (Redness) and RASH (Like a patch) in a 79-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 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced FEELING ABNORMAL (Didn't really feel too bad). On 16-Feb-2021, the patient experienced TENDERNESS (Tender), RASH MACULAR (Spotty), ERYTHEMA (Redness), RASH (Like a patch) and RASH (Rash). At the time of the report, TENDERNESS (Tender), FEELING ABNORMAL (Didn't really feel too bad), RASH MACULAR (Spotty), ERYTHEMA (Redness), RASH (Like a patch) and RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant was provided. Patient treatment information was not provided.; Reporter's Comments: Based on the current available information which includes a strong  temporal association between the use of the product and the start date of the reported events, a causal relationship with the event cannot be excluded.  Rash consistent with the known safety profile of mRNA-1273. Injection site rash is consistent with the known safety profile of mRNA-1273.
Sex: M
Vaccine: COVID19
Symptoms: Chronic obstructive pulmonary disease
Clinical narrative: FLARE-UP COPD; A spontaneous report was received from a Consumer concerning a 61 year old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced flare-up COPD (chronic obstructive pulmonary disease).  The patient's medical history included COPD. No relevant concomitant medications were reported.     On 03 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly in the  for prophylaxis of COVID-19 infection.   On 03 Feb 2021, the patient's COPD flared up. The event was treated with levofloxacin 750 mg and prednisone.  Action taken with mRNA-1273 in response to the events was not reported.    The outcome of the event flare-up COPD is unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event of Flare-up COPD, a causal relationship cannot be excluded.  However, patient's underlying COPD is considered a confounder.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: Aches in all the body; Strong headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches in all the body) and HEADACHE (Strong headache) in a 70-year-old female 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 reported medical history).    On 15-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced PAIN (Aches in all the body) and HEADACHE (Strong headache). At the time of the report, PAIN (Aches in all the body) and HEADACHE (Strong headache) outcome was unknown.            No concomitant medications were provided.  No treatment information provided
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: Injection site swelling; Injection site redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Injection site swelling) and VACCINATION SITE ERYTHEMA (Injection site redness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 19-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 VACCINATION SITE SWELLING (Injection site swelling) and VACCINATION SITE ERYTHEMA (Injection site redness). At the time of the report, VACCINATION SITE SWELLING (Injection site swelling) and VACCINATION SITE ERYTHEMA (Injection site redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Bone pain, Pain, Pain in extremity
Clinical narrative: Arm start hurting; temp 103.8; stabbing to the bone pain; hurts all over body; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (stabbing to the bone pain), PAIN (hurts all over body), PAIN IN EXTREMITY (Arm start hurting) and BODY TEMPERATURE INCREASED (temp 103.8) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient was sick for 40 days.) in November 2020.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced BONE PAIN (stabbing to the bone pain) and PAIN (hurts all over body). On 18-Feb-2021, the patient experienced BODY TEMPERATURE INCREASED (temp 103.8). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm start hurting). At the time of the report, BONE PAIN (stabbing to the bone pain), PAIN (hurts all over body), PAIN IN EXTREMITY (Arm start hurting) and BODY TEMPERATURE INCREASED (temp 103.8) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  Treatment includes Ibuprofen.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Nausea
Clinical narrative: still not eating full meals; had nausea after receiving the first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of DECREASED APPETITE (still not eating full meals) and NAUSEA (had nausea after receiving the first dose) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    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 DECREASED APPETITE (still not eating full meals) and NAUSEA (had nausea after receiving the first dose). At the time of the report, DECREASED APPETITE (still not eating full meals) outcome was unknown and NAUSEA (had nausea after receiving the first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided No treatment information provided
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Inflammation, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), ERYTHEMA (arm red/redness size of a soccer), PERIPHERAL SWELLING (arm swollen), INFLAMMATION (arm inflamed) and SKIN WARM (arm hot to touch) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M2019) for COVID-19 vaccination. The patient's past medical history included No adverse event. Concomitant products included ADALIMUMAB, FOLIC ACID, CYANOCOBALAMIN (VITAMIN B 12), LEVOTHYROXINE, DULOXETINE, CITALOPRAM, POTASSIUM CHLORIDE, GLIMEPIRIDE, METFORMIN, METOPROLOL and CLONIDINE for an unknown indication. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm), ERYTHEMA (arm red/redness size of a soccer), PERIPHERAL SWELLING (arm swollen), INFLAMMATION (arm inflamed) and SKIN WARM (arm hot to touch). At the time of the report, PAIN IN EXTREMITY (sore arm), ERYTHEMA (arm red/redness size of a soccer), PERIPHERAL SWELLING (arm swollen), INFLAMMATION (arm inflamed) and SKIN WARM (arm hot to touch) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment details included Benadryl and ice.
Sex: F
Vaccine: COVID19
Symptoms: Accident, Fatigue, Vaccination complication
Clinical narrative: Accident that required an admission to ER; Felt ill; Extremely unusually tired; A spontaneous report was received on 18 Feb 2021 from a consumer concerning a 54-year-old, female patient who received Moderna's COVID-19 vaccine and felt ill, felt unusually tired and had an accident.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 12 Jan, 2021, patient received her first of two planned doses of mRNA-1273(BATCH/LOT # 011L20A) injection in the left arm  for the prophylaxis of COVID-19 infection.  On 12 Jan 2021, After receiving the vaccine, the patient felt ill and unusually tired. Treatment for the events were not provided.  On 05 Feb 2021, the patient had an accident and  was admitted to ER (emergency room) and required an intervention on her arm and leg. The patient  received pain shots for the intervention he underwent.  The patient had an appointment for the second dose of the Moderna's COVID-19 vaccine on 14 Feb 2021, but  the vaccine facility,  sent back the patient due to the pain shots she received for the intervention on arm and leg.  Action taken with the second dose of mRNA-1273 in response to the events unknown.  The outcome of the events, are patient felt ill and unusually tired.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site rash
Clinical narrative: Arm has a red mark; Arm has like a rash, about 3x2 inches in size, spreading, turning further to the left; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Arm has a red mark) and VACCINATION SITE RASH (Arm has like a rash, about 3x2 inches in size, spreading, turning further to the left) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 032NM20A) for COVID-19 vaccination.     The patient's past medical history included Fungal infection (Medical history reported as fungal infection.). Concurrent medical conditions included Thyroid activity decreased (Thyroid over 25 year), Milk allergy, Acid reflux (oesophageal) and Fungal infection (on toe). Concomitant products included LEVOTHYROXINE for Thyroid activity decreased.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Arm has a red mark). 18-Feb-2021, the patient experienced VACCINATION SITE RASH (Arm has like a rash, about 3x2 inches in size, spreading, turning further to the left). On 20-Feb-2021, VACCINATION SITE ERYTHEMA (Arm has a red mark) and VACCINATION SITE RASH (Arm has like a rash, about 3x2 inches in size, spreading, turning further to the left) had resolved. 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 considered VACCINATION SITE RASH (Arm has like a rash, about 3x2 inches in size, spreading, turning further to the left) to be not related. No further causality assessment was provided for VACCINATION SITE ERYTHEMA (Arm has a red mark).    Patient reported that some rubbing alcohol may have come into contact with the rash, while attending to an insect bite above it.  Concomitant drugs included acid reflux medication and topical medication for a fungi infection on their toe.  Treatment information were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Follow up was received on 28-APR-2021 in which, past medical history of patient ,concomitant medication, Second dose details of vaccine, causality of Vaccination site rash  were updated .
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Erythema, Fatigue, Hypersensitivity, Insomnia
Clinical narrative: allergic reaction; Diarrhea; vomiting; Fever; Fatigue; Pain at the injection site; Sore arm; Difficulty sleeping; arm was swollen; arm was swollen and was red; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Sore arm), INSOMNIA (Difficulty sleeping), DIARRHOEA (Diarrhea), HYPERSENSITIVITY (allergic reaction) and PERIPHERAL SWELLING (arm was swollen) in an 84-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.     Concurrent medical conditions included Allergy to vaccine (Allergic to pneumonia shots).    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced INSOMNIA (Difficulty sleeping). On 01-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), VACCINATION SITE PAIN (Pain at the injection site), PYREXIA (Fever) and FATIGUE (Fatigue). On 02-Feb-2021, the patient experienced DIARRHOEA (Diarrhea) and VOMITING (vomiting). On an unknown date, the patient experienced HYPERSENSITIVITY (allergic reaction), PERIPHERAL SWELLING (arm was swollen) and ERYTHEMA (arm was swollen and was red). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at an unspecified dose and frequency and BISMUTH SUBSALICYLATE (PEPTO-BISMOL) at a dose of UNK dosage form. At the time of the report, PAIN IN EXTREMITY (Sore arm), INSOMNIA (Difficulty sleeping), DIARRHOEA (Diarrhea), HYPERSENSITIVITY (allergic reaction), VACCINATION SITE PAIN (Pain at the injection site), VOMITING (vomiting), PYREXIA (Fever) and FATIGUE (Fatigue) outcome was unknown and PERIPHERAL SWELLING (arm was swollen) and ERYTHEMA (arm was swollen and was red) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       No concomitant medications were reported.  The patient reported that her physician told her she had an allergic reaction and recommended not to take the second planned dose.   Most recent FOLLOW-UP information incorporated above includes: On 10-Jul-2021: Added events ( allergic reaction, swollen arm, erythema) was added  and medical history was added  action taken updated to withdrawn
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia, Vaccination site pain, Vomiting
Clinical narrative: allergic reaction; Diarrhea; vomiting; Fever; Fatigue; Pain at the injection site; Sore arm; Difficulty sleeping; arm was swollen; arm was swollen and was red; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Sore arm), INSOMNIA (Difficulty sleeping), DIARRHOEA (Diarrhea), HYPERSENSITIVITY (allergic reaction) and PERIPHERAL SWELLING (arm was swollen) in an 84-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.     Concurrent medical conditions included Allergy to vaccine (Allergic to pneumonia shots).    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced INSOMNIA (Difficulty sleeping). On 01-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), VACCINATION SITE PAIN (Pain at the injection site), PYREXIA (Fever) and FATIGUE (Fatigue). On 02-Feb-2021, the patient experienced DIARRHOEA (Diarrhea) and VOMITING (vomiting). On an unknown date, the patient experienced HYPERSENSITIVITY (allergic reaction), PERIPHERAL SWELLING (arm was swollen) and ERYTHEMA (arm was swollen and was red). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at an unspecified dose and frequency and BISMUTH SUBSALICYLATE (PEPTO-BISMOL) at a dose of UNK dosage form. At the time of the report, PAIN IN EXTREMITY (Sore arm), INSOMNIA (Difficulty sleeping), DIARRHOEA (Diarrhea), HYPERSENSITIVITY (allergic reaction), VACCINATION SITE PAIN (Pain at the injection site), VOMITING (vomiting), PYREXIA (Fever) and FATIGUE (Fatigue) outcome was unknown and PERIPHERAL SWELLING (arm was swollen) and ERYTHEMA (arm was swollen and was red) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       No concomitant medications were reported.  The patient reported that her physician told her she had an allergic reaction and recommended not to take the second planned dose.   Most recent FOLLOW-UP information incorporated above includes: On 10-Jul-2021: Added events ( allergic reaction, swollen arm, erythema) was added  and medical history was added  action taken updated to withdrawn
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Tremor
Clinical narrative: Chills; shaking really bad due to chills; Low grade 100.5F fever; A spontaneous report was received from a Healthcare Professional concerning a 82 Years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events, chills, shaking really bad due to chills, and low grade 100.5f fever.  The patient's medical history was included bypass surgery. Concomitant medications reported were not provided for drug use for unknown indication.  On unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot batch: Not provided) intramuscularly for prophylaxis of COVID-19 infection.  On 18 Feb 2021, the patient experienced the events, chills. shaking really bad due to chills, low grade 100.5f fever,  term.  Treatment details included ibuprofen.  Action taken with mRNA-1273 in response to the events, chills, shaking really bad due to chills, and low grade 100.5f fever,  was not reported.   On an unknown date the outcome of events include, chills, shaking really bad due to chills, and low grade 100.5 f fever was not reported.; Reporter's Comments: This case concerns an 82 year old male patient, with history of bypass surgery, who experienced a non-serious unexpected event of tremor, and expected events of chills and pyrexia, 3 days after receiving second dose of mRNA- 1273 (Lot# Unknown). Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue
Clinical narrative: Really bad chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Really bad chills) and FATIGUE (Fatigue) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-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 CHILLS (Really bad chills) and FATIGUE (Fatigue). At the time of the report, CHILLS (Really bad chills) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow up received on 14-JUL-2021 contains TCR document and No New information.
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching
Clinical narrative: Muscle twitching in entire body but mostly in legs; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TWITCHING (Muscle twitching in entire body but mostly in legs) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history provided).    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCLE TWITCHING (Muscle twitching in entire body but mostly in legs). At the time of the report, MUSCLE TWITCHING (Muscle twitching in entire body but mostly in legs) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided Treatment include magnesium.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm when extending; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm when extending) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concomitant products included CALCIUM for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm when extending). At the time of the report, PAIN IN EXTREMITY (Sore arm when extending) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea) and VOMITING (Vomiting) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NAUSEA (Nausea) and VOMITING (Vomiting). At the time of the report, NAUSEA (Nausea) and VOMITING (Vomiting) 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   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: TCR
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Mastication disorder, Odynophagia
Clinical narrative: She can't chew on the left side of the face near her chin; it hurts when she swallows near the neck area; This spontaneous case was reported by a consumer and describes the occurrence of MASTICATION DISORDER (She can't chew on the left side of the face near her chin) and ODYNOPHAGIA (it hurts when she swallows near the neck area) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), METOPROLOL, nortriptyline (Pamelor                                                        ), AMLODIPINE, HYDROCODONE and ACETAMINOPHEN for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced MASTICATION DISORDER (She can't chew on the left side of the face near her chin) and ODYNOPHAGIA (it hurts when she swallows near the neck area). At the time of the report, MASTICATION DISORDER (She can't chew on the left side of the face near her chin) and ODYNOPHAGIA (it hurts when she swallows near the neck area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included None.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nasal dryness, Pain in extremity
Clinical narrative: sore arm; dry nose; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), NASAL DRYNESS (dry nose), CHILLS (chills) and HEADACHE (headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm), NASAL DRYNESS (dry nose), CHILLS (chills) and HEADACHE (headache). At the time of the report, PAIN IN EXTREMITY (sore arm), NASAL DRYNESS (dry nose), CHILLS (chills) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        concomitant medications for high blood pressure medication, vitamins and something for her eyes. Treatment details included Tylenol. Cetirizine.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Periarthritis, Rotator cuff syndrome
Clinical narrative: Damage to rotor cuff; Frozen shoulder; arm she felt soreness which; This spontaneous case was reported by a physician and describes the occurrence of periarthritis, pain in extremity and rotator cuff syndrome in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.  The patient's past medical history included No adverse event.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm she felt soreness which). On 30-Jan-2021, the patient experienced PERIARTHRITIS (Frozen shoulder). On 05-Feb-2021, the patient experienced ROTATOR CUFF SYNDROME (Damage to rotor cuff). On 30-Jan-2021, PAIN IN EXTREMITY (arm she felt soreness which) outcome was unknown. On 02-Feb-2021, PERIARTHRITIS (Frozen shoulder) had resolved. At the time of the report, ROTATOR CUFF SYNDROME (Damage to rotor cuff) 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 concomitant medications were provided No treatment information provided
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Pain in extremity, Peripheral swelling
Clinical narrative: swollen arm; bruised arm; hurting arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen arm), CONTUSION (bruised arm) and PAIN IN EXTREMITY (hurting arm) in a female patient of an unknown age 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (swollen arm), CONTUSION (bruised arm) and PAIN IN EXTREMITY (hurting arm). At the time of the report, PERIPHERAL SWELLING (swollen arm), CONTUSION (bruised arm) and PAIN IN EXTREMITY (hurting arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information provided.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Vaccination site swelling
Clinical narrative: injection site started swelling; sweating; headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (injection site started swelling), HYPERHIDROSIS (sweating) and HEADACHE (headache) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced VACCINATION SITE SWELLING (injection site started swelling), HYPERHIDROSIS (sweating) and HEADACHE (headache). At the time of the report, VACCINATION SITE SWELLING (injection site started swelling), HYPERHIDROSIS (sweating) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment information provided.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Face injury, Hypoaesthesia, Pharyngeal swelling
Clinical narrative: tightness in the face; numbness in the face; throat was swollen; This spontaneous case was reported by a consumer and describes the occurrence of FACE INJURY (tightness in the face), HYPOAESTHESIA (numbness in the face) and PHARYNGEAL SWELLING (throat was swollen) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2021, the patient experienced FACE INJURY (tightness in the face), HYPOAESTHESIA (numbness in the face) and PHARYNGEAL SWELLING (throat was swollen). On 31-Jan-2021, FACE INJURY (tightness in the face), HYPOAESTHESIA (numbness in the face) and PHARYNGEAL SWELLING (throat was swollen) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash macular, Vaccination site erythema
Clinical narrative: Larger red spot in the IS; Very Itchy; red spot in the IS; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Larger red spot in the IS), PRURITUS (Very Itchy) and VACCINATION SITE ERYTHEMA (red spot in the IS) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (red spot in the IS). On 21-Feb-2021, the patient experienced RASH MACULAR (Larger red spot in the IS) and PRURITUS (Very Itchy). On 20-Feb-2021, VACCINATION SITE ERYTHEMA (red spot in the IS) had resolved. At the time of the report, RASH MACULAR (Larger red spot in the IS) and PRURITUS (Very Itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information provided.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site mass, Pruritus, Rash
Clinical narrative: Lumps; Itchiness; Redness; Rash; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE MASS (Lumps), PRURITUS (Itchiness), ERYTHEMA (Redness) and RASH (Rash) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to animal (Allergy to cats. sneezing, coughing, itching, short of breath if scratched) since 1966, Allergy to antibiotic (Allergy to erythromycin. Drug induced Urticaria, 2 inch by 2 inch circular hives lower legs lasting) since 1996 and Drug allergy (Allergy to Rocuronium. causes long skips of heart beats, then pounds, dizziness.) since 1990. Concomitant products included LOSARTAN from 20-Dec-2000 to an unknown date, CALCIUM, VITAMINS NOS, SIMVASTATIN from 20-Dec-2000 to an unknown date, ZOLPIDEM from 20-Dec-2000 to an unknown date and CALCIUM CARBONATE from 18-Oct-1955 to an unknown date 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 10-Feb-2021, the patient experienced INJECTION SITE MASS (Lumps), PRURITUS (Itchiness), ERYTHEMA (Redness) and RASH (Rash). On 18-Feb-2021, RASH (Rash) outcome was unknown. At the time of the report, INJECTION SITE MASS (Lumps), PRURITUS (Itchiness) and ERYTHEMA (Redness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment details were provided. Patient reported that she took her second dose on 05-MAR-2021 in her left arm with unknown route of administration and batch number was 041L20A.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Follow up received, patient demographics, concomitant medications, event and second dose information was added.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Herpes zoster, Rash
Clinical narrative: rash around his waist; may be shingles; back pain; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back pain), RASH (rash around his waist) and HERPES ZOSTER (may be shingles) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20a) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced BACK PAIN (back pain). On 17-Feb-2021, the patient experienced RASH (rash around his waist) and HERPES ZOSTER (may be shingles). At the time of the report, BACK PAIN (back pain), RASH (rash around his waist) and HERPES ZOSTER (may be shingles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. Treatment included Heating Pad.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Have a rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Have a rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No prior medical history 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, the patient experienced RASH (Have a rash). At the time of the report, RASH (Have a rash) outcome was unknown.            No concomitant medications reported. No treatment information provided.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Upon in internal review on 28 May 2021, the age was corrected to unknown age.   Most recent FOLLOW-UP information incorporated above includes: On 18-Feb-2021: Upon internal review on 28 May 2021, it was discovered that the patient age was incorrectly captured as 121 years and DOB mentioned in source document was date, which was a error. The patient age and narrative has been updated to unknown age with reports re-submission and significant amendment is performed for the correction.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of SWOLLEN TONGUE (Swelling under her tongue) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced SWOLLEN TONGUE (Swelling under her tongue). At the time of the report, SWOLLEN TONGUE (Swelling under her tongue) outcome was unknown. No concomitant medications reported. No treatment information provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Chills, Cough
Clinical narrative: slight dry cough; tested positive for COVID-19; loss of some taste and smell; loss of smell; arm was a little bit sore; chills; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (loss of some taste and smell), ANOSMIA (loss of smell), COUGH (slight dry cough), COVID-19 (tested positive for COVID-19) and PAIN IN EXTREMITY (arm was a little bit sore) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 047A21A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ROSUVASTATIN, HYDROCHLOROTHIAZIDE and METOPROLOL for an unknown indication.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm was a little bit sore) and CHILLS (chills). On 18-Feb-2021, the patient experienced AGEUSIA (loss of some taste and smell) and ANOSMIA (loss of smell). On 19-Feb-2021, the patient experienced COUGH (slight dry cough) and COVID-19 (tested positive for COVID-19). The patient was treated with PARACETAMOL (TYLENOL) for Prevention, at an unspecified dose and frequency. On 27-Apr-2021, AGEUSIA (loss of some taste and smell), ANOSMIA (loss of smell) and COUGH (slight dry cough) had resolved. At the time of the report, COVID-19 (tested positive for COVID-19) had resolved and PAIN IN EXTREMITY (arm was a little bit sore) and CHILLS (chills) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Feb-2021, SARS-CoV-2 test: positive (Positive) Tested positive for Covid-19.         The patient stated that she quarantined from 19Feb2021 to 06Mar2021 which was 15 days. Reportedly, the patient was asymptomatic after her second dose.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Initial additional included- route of administration of vaccine, 2nd dose details, concomitant medications, new event and updated stop date of event .
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test
Clinical narrative: slight dry cough; tested positive for COVID-19; loss of some taste and smell; loss of smell; arm was a little bit sore; chills; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (loss of some taste and smell), ANOSMIA (loss of smell), COUGH (slight dry cough), COVID-19 (tested positive for COVID-19) and PAIN IN EXTREMITY (arm was a little bit sore) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 047A21A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ROSUVASTATIN, HYDROCHLOROTHIAZIDE and METOPROLOL for an unknown indication.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm was a little bit sore) and CHILLS (chills). On 18-Feb-2021, the patient experienced AGEUSIA (loss of some taste and smell) and ANOSMIA (loss of smell). On 19-Feb-2021, the patient experienced COUGH (slight dry cough) and COVID-19 (tested positive for COVID-19). The patient was treated with PARACETAMOL (TYLENOL) for Prevention, at an unspecified dose and frequency. On 27-Apr-2021, AGEUSIA (loss of some taste and smell), ANOSMIA (loss of smell) and COUGH (slight dry cough) had resolved. At the time of the report, COVID-19 (tested positive for COVID-19) had resolved and PAIN IN EXTREMITY (arm was a little bit sore) and CHILLS (chills) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Feb-2021, SARS-CoV-2 test: positive (Positive) Tested positive for Covid-19.         The patient stated that she quarantined from 19Feb2021 to 06Mar2021 which was 15 days. Reportedly, the patient was asymptomatic after her second dose.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Initial additional included- route of administration of vaccine, 2nd dose details, concomitant medications, new event and updated stop date of event .
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Hyperhidrosis, Lymphoedema
Clinical narrative: had lymphedema in her left arm; sweats; headache; Chills; extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHOEDEMA (had lymphedema in her left arm), HYPERHIDROSIS (sweats), HEADACHE (headache), CHILLS (Chills) and FATIGUE (extreme fatigue) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Cancer in 2008. Concurrent medical conditions included Emphysema (Upper left quadrant emphysema). Concomitant products included LISINOPRIL, METOPROLOL, ATORVASTATIN, BRIMONIDINE TARTRATE (ALPHAGAN), TIOTROPIUM BROMIDE (SPIRIVA) and LORAZEPAM for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced HEADACHE (headache), CHILLS (Chills) and FATIGUE (extreme fatigue). On 06-Feb-2021, the patient experienced HYPERHIDROSIS (sweats). On 07-Feb-2021, the patient experienced LYMPHOEDEMA (had lymphedema in her left arm). On 14-Feb-2021, HEADACHE (headache), CHILLS (Chills) and FATIGUE (extreme fatigue) had resolved. At the time of the report, LYMPHOEDEMA (had lymphedema in her left arm) and HYPERHIDROSIS (sweats) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information not provided.   Most recent FOLLOW-UP information incorporated above includes: On 19-Feb-2021: Follow up document was received on 19th Feb with following information updated: weight, concomitant drugs, medical histories and new event was added. On 26-Apr-2021: The follow up was received on 26th Apr- only reporter's address was updated.