chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: backache; feeling terrible; pain in left knee, excruciating and cannot bend the knee; Red hot lump at injection site; hard, red hot lump at injection site; Itching at injection site; Red hot lump at injection site; Swelling at injection site 2.5 inches; Throwing up; Feeling weak and tired; Low grade fever; head was hurting; Felt weak; Dizziness; Sleepy; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Felt weak), DIZZINESS (Dizziness), SOMNOLENCE (Sleepy), BACK PAIN (backache) and MALAISE (feeling terrible) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma and Allergy. Concomitant products included METOPROLOL SUCCINATE, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), PREGABALIN, BIOTIN and VITAMINS NOS for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced ASTHENIA (Felt weak), DIZZINESS (Dizziness), SOMNOLENCE (Sleepy), VOMITING (Throwing up), FATIGUE (Feeling weak and tired), PYREXIA (Low grade fever) and HEADACHE (head was hurting). On 11-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Red hot lump at injection site), VACCINATION SITE MASS (hard, red hot lump at injection site), VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE ERYTHEMA (Red hot lump at injection site) and VACCINATION SITE SWELLING (Swelling at injection site 2.5 inches). On 12-Mar-2021, the patient experienced BACK PAIN (backache), MALAISE (feeling terrible) and ARTHRALGIA (pain in left knee, excruciating and cannot bend the knee). On 10-Mar-2021, PYREXIA (Low grade fever) had resolved. At the time of the report, ASTHENIA (Felt weak), SOMNOLENCE (Sleepy), BACK PAIN (backache), MALAISE (feeling terrible), VACCINATION SITE WARMTH (Red hot lump at injection site), VACCINATION SITE MASS (hard, red hot lump at injection site), VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE ERYTHEMA (Red hot lump at injection site), VACCINATION SITE SWELLING (Swelling at injection site 2.5 inches), VOMITING (Throwing up), FATIGUE (Feeling weak and tired) and ARTHRALGIA (pain in left knee, excruciating and cannot bend the knee) outcome was unknown and DIZZINESS (Dizziness) and HEADACHE (head was hurting) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Mar-2021, Ultrasound Doppler: normal (normal) To rule out blood clot.   Action taken with mRNA-1273 in response to the events was not applicable     no treatment medications provided   This case was linked to MOD-2021-044459 (Patient Link).
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash macular
Clinical narrative: Itching by her wrist; Red bumps on legs, torso and up to hip; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (Itching by her wrist) and RASH MACULAR (Red bumps on legs, torso and up to hip) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 042120A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (Temperature extremes makes her react with bumps on back.). Concomitant products included VITAMINS NOS for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced PRURITUS (Itching by her wrist) and RASH MACULAR (Red bumps on legs, torso and up to hip). At the time of the report, PRURITUS (Itching by her wrist) and RASH MACULAR (Red bumps on legs, torso and up to hip) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   concomitants - bariatric medicine, osteoporosis medicine, for bladder sensitivity. Treatment information as not reported. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) is considered as not applicable.   This case was linked to MOD-2021-021562 (Patient Link).; 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: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Insomnia, Pain, Restlessness
Clinical narrative: burning pain down left leg to calf which still hurts when he lays down; Cannot sleep; Tossing turning to get comfortable; hip pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (burning pain down left leg to calf which still hurts when he lays down), INSOMNIA (Cannot sleep), RESTLESSNESS (Tossing turning to get comfortable) and ARTHRALGIA (hip pain) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012AZ1A) for COVID-19 vaccination.     Concurrent medical conditions included Spinal stenosis, Hypertension, Diabetes mellitus and Arthritis. Concomitant products included BISACODYL (DULCOLAX [BISACODYL]), HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (HYDROCHLOROTHIAZIDE + LOSARTAN), MELOXICAM, ACETAMINOPHEN, DULOXETINE, METFORMIN, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), MAGNESIUM, GABAPENTIN and ATORVASTATIN for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PAIN (burning pain down left leg to calf which still hurts when he lays down), INSOMNIA (Cannot sleep), RESTLESSNESS (Tossing turning to get comfortable) and ARTHRALGIA (hip pain). At the time of the report, PAIN (burning pain down left leg to calf which still hurts when he lays down), INSOMNIA (Cannot sleep), RESTLESSNESS (Tossing turning to get comfortable) and ARTHRALGIA (hip pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Pain
Clinical narrative: Light headedness and dizziness; Achy; Tired; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light headedness and dizziness), PAIN (Achy) and FATIGUE (Tired) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 015M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced PAIN (Achy) and FATIGUE (Tired). On 15-Mar-2021, the patient experienced DIZZINESS (Light headedness and dizziness). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, DIZZINESS (Light headedness and dizziness), PAIN (Achy) and FATIGUE (Tired) outcome was unknown.            No relevant concomitant medications were reported.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: Sore arm; Only sore if she touched it and it only was at the injection site; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and VACCINATION SITE PAIN (Only sore if she touched it and it only was at the injection site) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and VACCINATION SITE PAIN (Only sore if she touched it and it only was at the injection site). On 14-Mar-2021, PAIN IN EXTREMITY (Sore arm) had resolved. At the time of the report, VACCINATION SITE PAIN (Only sore if she touched it and it only was at the injection site) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was provided.  No treatment information was provided.   This case was linked to MOD-2021-214539 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Email added on 14-may-2021.. outcome updated.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Neck pain
Clinical narrative: sharp pain in his neck; pain in his armpit; sore; pain in both hips; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (sharp pain in his neck), MYALGIA (sore), ARTHRALGIA (pain in both hips) and MYALGIA (pain in his armpit) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced MYALGIA (sore) and ARTHRALGIA (pain in both hips). On 12-Mar-2021, the patient experienced MYALGIA (pain in his armpit). On 15-Mar-2021, the patient experienced NECK PAIN (sharp pain in his neck). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 13-Mar-2021, MYALGIA (pain in his armpit) had resolved. At the time of the report, NECK PAIN (sharp pain in his neck), MYALGIA (sore) and ARTHRALGIA (pain in both hips) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported No treatment drugs were reported
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Arm started to swell, get red, throb and ache; Arm started to swell, get red, throb and ache; Arm started to swell, get red, throb and ache; Arm started to swell, get red, throb and ache; Patient's arm itches and is spreading down the upper arm; Temperature is 99.2 F at the part on patient's arm that is swollen; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm started to swell, get red, throb and ache), PAIN IN EXTREMITY (Arm started to swell, get red, throb and ache), ERYTHEMA (Arm started to swell, get red, throb and ache), PAIN (Arm started to swell, get red, throb and ache) and PRURITUS (Patient's arm itches and is spreading down the upper arm) in a 78-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 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PERIPHERAL SWELLING (Arm started to swell, get red, throb and ache), PAIN IN EXTREMITY (Arm started to swell, get red, throb and ache), ERYTHEMA (Arm started to swell, get red, throb and ache), PAIN (Arm started to swell, get red, throb and ache) and PRURITUS (Patient's arm itches and is spreading down the upper arm). In March 2021, the patient experienced FEELING HOT (Temperature is 99.2 F at the part on patient's arm that is swollen). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and HYDROCORTISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (Arm started to swell, get red, throb and ache) outcome was unknown and PAIN IN EXTREMITY (Arm started to swell, get red, throb and ache), ERYTHEMA (Arm started to swell, get red, throb and ache), PAIN (Arm started to swell, get red, throb and ache), PRURITUS (Patient's arm itches and is spreading down the upper arm) and FEELING HOT (Temperature is 99.2 F at the part on patient's arm that is swollen) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient tried cold packs as corrective for events. No concomitants were reported.   Most recent FOLLOW-UP information incorporated above includes: On 24-Mar-2021: Events added, outcome and corrective updated.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Arm started to swell, get red, throb and ache; Arm started to swell, get red, throb and ache; Arm started to swell, get red, throb and ache; Arm started to swell, get red, throb and ache; Patient's arm itches and is spreading down the upper arm; Temperature is 99.2 F at the part on patient's arm that is swollen; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm started to swell, get red, throb and ache), PAIN IN EXTREMITY (Arm started to swell, get red, throb and ache), ERYTHEMA (Arm started to swell, get red, throb and ache), PAIN (Arm started to swell, get red, throb and ache) and PRURITUS (Patient's arm itches and is spreading down the upper arm) in a 78-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 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PERIPHERAL SWELLING (Arm started to swell, get red, throb and ache), PAIN IN EXTREMITY (Arm started to swell, get red, throb and ache), ERYTHEMA (Arm started to swell, get red, throb and ache), PAIN (Arm started to swell, get red, throb and ache) and PRURITUS (Patient's arm itches and is spreading down the upper arm). In March 2021, the patient experienced FEELING HOT (Temperature is 99.2 F at the part on patient's arm that is swollen). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and HYDROCORTISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (Arm started to swell, get red, throb and ache) outcome was unknown and PAIN IN EXTREMITY (Arm started to swell, get red, throb and ache), ERYTHEMA (Arm started to swell, get red, throb and ache), PAIN (Arm started to swell, get red, throb and ache), PRURITUS (Patient's arm itches and is spreading down the upper arm) and FEELING HOT (Temperature is 99.2 F at the part on patient's arm that is swollen) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient tried cold packs as corrective for events. No concomitants were reported.   Most recent FOLLOW-UP information incorporated above includes: On 24-Mar-2021: Events added, outcome and corrective updated.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Felt crappy; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Felt crappy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (Felt crappy). At the time of the report, ILLNESS (Felt crappy) outcome was unknown.            Concomitant product use was not provided by the reporter.   ? No treatment information was provided. ? The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events was not applicable. ? Action taken with mRNA-1273 in response to the event was not applicable.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Daughter given moderna vaccine but she is only 16; A spontaneous report was received from a consumer concerning her daughter, a 16-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history was not provided. No relevant concomitant medications were reported.    On an unspecified date, prior to the onset of event, the patient received their first of two planned doses of mRNA-1273 (Batch Number: Unknown) via unknown route for prophylaxis of COVID-19 infection.  On an unspecified date, the patient was given moderna vaccine, but she was only 16.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event, patient was given moderna vaccine, but she was only 16 was considered resolved.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (16 year old female) for mRNA-1273 (lot number unknown) with no associated AEs reported.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chest pain, Lymphadenopathy
Clinical narrative: Pain in chest; Pain in back; Lymph nodes discomfort in same arm of injection; Pain in shoulder; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHEST PAIN (Pain in chest), BACK PAIN (Pain in back), LYMPHADENOPATHY (Lymph nodes discomfort in same arm of injection) and ARTHRALGIA (Pain in shoulder) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 012L20A) for COVID-19 vaccination.     The patient's past medical history included Ovarian cancer. Concurrent medical conditions included Blood pressure high, Anxiety and Cholesterol. Concomitant products included VITAMIN D NOS for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced CHEST PAIN (Pain in chest), BACK PAIN (Pain in back), LYMPHADENOPATHY (Lymph nodes discomfort in same arm of injection) and ARTHRALGIA (Pain in shoulder). The patient was treated with PARACETAMOL (TYLENOL) for Lymph node disorder, Pain chest, Pain back and Shoulder pain, at a dose of 1 dosage form. At the time of the report, CHEST PAIN (Pain in chest), BACK PAIN (Pain in back), LYMPHADENOPATHY (Lymph nodes discomfort in same arm of injection) and ARTHRALGIA (Pain in shoulder) outcome was unknown.            Diagnostic tests included X-ray and blood tests on 01Mar2021 and it was confirmed that patient's heart was fine. No specific findings were provided.   Patient did not experience any adverse event after the first dose.  concomitant product included pills for blood pressure, cholesterol and anxiety  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Younger than 18 years of age received Moderna Covid-19 vaccine; A spontaneous report 7was received from a consumer concerning his son who was 17 years of age (Product administered to patient of inappropriate age) at the time of administration of Moderna's COVID-19 vaccine (mRNA-1273).   There was no medical history. Concomitant medications included vitamins.   On 10 Mar 2021, the patient received their first dose mRNA-1273 ((Lot number : 014M20A) intramuscularly in left arm for prophylaxis of COVID-19 infection.  It was reported that patient who was younger than 18 years of age received Moderna's COVID-19 vaccine.  Action taken with m-RNA 1273 in response to the event was not applicable.; Reporter's Comments: This report refers to a case of Product administered to patient of inappropriate age for mRNA-1273, lot# 014M20A, with no associated adverse events.
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Hypoaesthesia
Clinical narrative: left leg went completely went numb and disappeared and felt as if it was not there; sank down to the ground and was on floor; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (left leg went completely went numb and disappeared and felt as if it was not there) and FALL (sank down to the ground and was on floor) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE, LEVOTHYROXINE SODIUM (SYNTHROID), TOPIRAMATE and AMLODIPINE for an unknown indication.    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 HYPOAESTHESIA (left leg went completely went numb and disappeared and felt as if it was not there) and FALL (sank down to the ground and was on floor). At the time of the report, HYPOAESTHESIA (left leg went completely went numb and disappeared and felt as if it was not there) and FALL (sank down to the ground and was on floor) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment was received for events.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: More achiness; Ridiculously tired ever since the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (More achiness) and FATIGUE (Ridiculously tired ever since the second dose) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 030L20A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included VALACYCLOVIR [VALACICLOVIR] for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced PAIN (More achiness) and FATIGUE (Ridiculously tired ever since the second dose). The patient was treated with PARACETAMOL (TYLENOL) for Fatigue and Pain, at a dose of 1 dosage form and NAPROXEN SODIUM (ALEVE) for Fatigue and Pain, at a dose of 1 dosage form. At the time of the report, PAIN (More achiness) and FATIGUE (Ridiculously tired ever since the second dose) outcome was unknown.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Fatigue, Nausea, Pain in extremity
Clinical narrative: Diarrhea; Had queasiness and nausea; Throwing up; Really bad nausea; Stomach was bothering him; Loose stool several hours later; Felt super tired, on and off sleeping all day; Felt super tired, on and off sleeping all day; Sore arm; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Sore arm), SOMNOLENCE (Felt super tired, on and off sleeping all day), ABDOMINAL DISCOMFORT (Stomach was bothering him), DIARRHOEA (Loose stool several hours later) and DIARRHOEA (Diarrhea) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 1012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 21-Jan-2021 and Colonoscopy on 24-Jan-2021.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 28-Feb-2021, the patient experienced SOMNOLENCE (Felt super tired, on and off sleeping all day) and FATIGUE (Felt super tired, on and off sleeping all day). On 01-Mar-2021, the patient experienced ABDOMINAL DISCOMFORT (Stomach was bothering him), DIARRHOEA (Loose stool several hours later), NAUSEA (Really bad nausea) and VOMITING (Throwing up). On 10-Mar-2021, the patient experienced DIARRHOEA (Diarrhea) and NAUSEA (Had queasiness and nausea). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) for Nausea, at an unspecified dose and frequency. On 02-Mar-2021, DIARRHOEA (Loose stool several hours later), NAUSEA (Really bad nausea) and VOMITING (Throwing up) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm), DIARRHOEA (Diarrhea) and FATIGUE (Felt super tired, on and off sleeping all day) outcome was unknown and SOMNOLENCE (Felt super tired, on and off sleeping all day), ABDOMINAL DISCOMFORT (Stomach was bothering him) and NAUSEA (Had queasiness and nausea) 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.   No concomitant medications were reported.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence, Vomiting
Clinical narrative: Diarrhea; Had queasiness and nausea; Throwing up; Really bad nausea; Stomach was bothering him; Loose stool several hours later; Felt super tired, on and off sleeping all day; Felt super tired, on and off sleeping all day; Sore arm; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Sore arm), SOMNOLENCE (Felt super tired, on and off sleeping all day), ABDOMINAL DISCOMFORT (Stomach was bothering him), DIARRHOEA (Loose stool several hours later) and DIARRHOEA (Diarrhea) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 1012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 21-Jan-2021 and Colonoscopy on 24-Jan-2021.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 28-Feb-2021, the patient experienced SOMNOLENCE (Felt super tired, on and off sleeping all day) and FATIGUE (Felt super tired, on and off sleeping all day). On 01-Mar-2021, the patient experienced ABDOMINAL DISCOMFORT (Stomach was bothering him), DIARRHOEA (Loose stool several hours later), NAUSEA (Really bad nausea) and VOMITING (Throwing up). On 10-Mar-2021, the patient experienced DIARRHOEA (Diarrhea) and NAUSEA (Had queasiness and nausea). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) for Nausea, at an unspecified dose and frequency. On 02-Mar-2021, DIARRHOEA (Loose stool several hours later), NAUSEA (Really bad nausea) and VOMITING (Throwing up) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm), DIARRHOEA (Diarrhea) and FATIGUE (Felt super tired, on and off sleeping all day) outcome was unknown and SOMNOLENCE (Felt super tired, on and off sleeping all day), ABDOMINAL DISCOMFORT (Stomach was bothering him) and NAUSEA (Had queasiness and nausea) 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.   No concomitant medications were reported.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia
Clinical narrative: Body aches; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches), CHILLS (Chills) and HEADACHE (Headache) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced MYALGIA (Body aches), CHILLS (Chills) and HEADACHE (Headache). At the time of the report, MYALGIA (Body aches), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.            The action taken with mRNA-1273(Moderna COVID-19 Vaccine) was not applicable  No concomitant medications were reported  No treatment drugs were reported
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Eating disorder, Feeling of body temperature change, Headache, Malaise
Clinical narrative: Sore throat; Headache; Fever, temperature of 100-101; Didn't feel well enough to eat; Being cold and then hot; Having chills, being cold then hot, but reports no elevated temperature; Feeling pretty rough; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling pretty rough), EATING DISORDER (Didn't feel well enough to eat), OROPHARYNGEAL PAIN (Sore throat), FEELING OF BODY TEMPERATURE CHANGE (Being cold and then hot) and CHILLS (Having chills, being cold then hot, but reports no elevated temperature) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sinus infection, Bladder infection and Overactive bladder. Concomitant products included SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM) from 11-Mar-2021 to an unknown date for Sinus infection and Bladder infection, DICLOFENAC and TRAMADOL for an unknown indication.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced MALAISE (Feeling pretty rough). On 12-Mar-2021, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (Being cold and then hot). 12-Mar-2021, the patient experienced CHILLS (Having chills, being cold then hot, but reports no elevated temperature). On 14-Mar-2021, the patient experienced EATING DISORDER (Didn't feel well enough to eat) and PYREXIA (Fever, temperature of 100-101). On 15-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat) and HEADACHE (Headache). The patient was treated with PSEUDOEPHEDRINE HYDROCHLORIDE (SUDAFED [PSEUDOEPHEDRINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency and DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, MALAISE (Feeling pretty rough), EATING DISORDER (Didn't feel well enough to eat), OROPHARYNGEAL PAIN (Sore throat), FEELING OF BODY TEMPERATURE CHANGE (Being cold and then hot), CHILLS (Having chills, being cold then hot, but reports no elevated temperature), PYREXIA (Fever, temperature of 100-101) and HEADACHE (Headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient is concomitantly taking Overactive bladder medication (unspecified).   Patient is taking Alka Seltzer Cold and Flu as a corrective for events.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pyrexia
Clinical narrative: Sore throat; Headache; Fever, temperature of 100-101; Didn't feel well enough to eat; Being cold and then hot; Having chills, being cold then hot, but reports no elevated temperature; Feeling pretty rough; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling pretty rough), EATING DISORDER (Didn't feel well enough to eat), OROPHARYNGEAL PAIN (Sore throat), FEELING OF BODY TEMPERATURE CHANGE (Being cold and then hot) and CHILLS (Having chills, being cold then hot, but reports no elevated temperature) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sinus infection, Bladder infection and Overactive bladder. Concomitant products included SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM) from 11-Mar-2021 to an unknown date for Sinus infection and Bladder infection, DICLOFENAC and TRAMADOL for an unknown indication.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced MALAISE (Feeling pretty rough). On 12-Mar-2021, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (Being cold and then hot). 12-Mar-2021, the patient experienced CHILLS (Having chills, being cold then hot, but reports no elevated temperature). On 14-Mar-2021, the patient experienced EATING DISORDER (Didn't feel well enough to eat) and PYREXIA (Fever, temperature of 100-101). On 15-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat) and HEADACHE (Headache). The patient was treated with PSEUDOEPHEDRINE HYDROCHLORIDE (SUDAFED [PSEUDOEPHEDRINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency and DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, MALAISE (Feeling pretty rough), EATING DISORDER (Didn't feel well enough to eat), OROPHARYNGEAL PAIN (Sore throat), FEELING OF BODY TEMPERATURE CHANGE (Being cold and then hot), CHILLS (Having chills, being cold then hot, but reports no elevated temperature), PYREXIA (Fever, temperature of 100-101) and HEADACHE (Headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient is concomitantly taking Overactive bladder medication (unspecified).   Patient is taking Alka Seltzer Cold and Flu as a corrective for events.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: On and off joint pains on the knees and elbows; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (On and off joint pains on the knees and elbows) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced ARTHRALGIA (On and off joint pains on the knees and elbows). At the time of the report, ARTHRALGIA (On and off joint pains on the knees and elbows) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Bradyphrenia, Breast swelling, Breast tenderness
Clinical narrative: breast swelling; Tenderness in Breast; Slow Brain; This spontaneous case was reported by a consumer and describes the occurrence of BREAST SWELLING (breast swelling), BREAST TENDERNESS (Tenderness in Breast) and BRADYPHRENIA (Slow Brain) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002M20A) for COVID-19 vaccination.     No medical history was reported.     On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced BRADYPHRENIA (Slow Brain). On 08-Mar-2021, the patient experienced BREAST SWELLING (breast swelling) and BREAST TENDERNESS (Tenderness in Breast). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, BREAST SWELLING (breast swelling), BREAST TENDERNESS (Tenderness in Breast) and BRADYPHRENIA (Slow Brain) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant information was reported. Patient reported that she was still not feeling well.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Contact details updated (Mail id)
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Musculoskeletal stiffness, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Arms numb; Pain travelling; Swollen; Stiff; Sore/pain in his arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen), MUSCULOSKELETAL STIFFNESS (Stiff), PAIN IN EXTREMITY (Sore/pain in his arm), HYPOAESTHESIA (Arms numb) and PAIN (Pain travelling) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and LOSARTAN for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced PERIPHERAL SWELLING (Swollen), MUSCULOSKELETAL STIFFNESS (Stiff) and PAIN IN EXTREMITY (Sore/pain in his arm). On 09-Mar-2021, the patient experienced HYPOAESTHESIA (Arms numb) and PAIN (Pain travelling). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (Swollen), MUSCULOSKELETAL STIFFNESS (Stiff), PAIN IN EXTREMITY (Sore/pain in his arm), HYPOAESTHESIA (Arms numb) and PAIN (Pain travelling) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included eyedrops.   This case was linked to MOD-2021-109546 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Follow up document is received and contain no new information regarding dose 1. On 07-Jun-2021: Follow up document is received and contain no new information regarding 1st dose. Second dose details are added. On 26-Jul-2021: No new information reported.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Chills, Cough, Diarrhoea
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Dry cough), OROPHARYNGEAL PAIN (Sore throat), AGEUSIA (Loss of taste), ANOSMIA (Loss of smell) and INFLUENZA LIKE ILLNESS (flu like symptoms) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes mellitus. Concomitant products included HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN/HCTZ) and INSULIN GLARGINE (LANTUS) 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 20-Feb-2021, the patient experienced COUGH (Dry cough), OROPHARYNGEAL PAIN (Sore throat), AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), INFLUENZA LIKE ILLNESS (flu like symptoms), DIARRHEA (Diarrhea), PAIN (Body aches), CHILLS (Chills), PYREXIA (Fever) and VOMITING (Vomiting). The patient was treated with CEFDINIR for Dry cough and Sore throat, at a dose of 300 mg twice a day and BENZONATATE for Dry cough and Sore throat, at a dose of 200 mg three times a day. At the time of the report, COUGH (Dry cough), OROPHARYNGEAL PAIN (Sore throat), AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), INFLUENZA LIKE ILLNESS (flu like symptoms), DIARRHEA (Diarrhea), PAIN (Body aches), CHILLS (Chills), PYREXIA (Fever) and VOMITING (Vomiting) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient stated that she was doing better
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Oropharyngeal pain, Pain, Pyrexia, Vomiting
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Dry cough), OROPHARYNGEAL PAIN (Sore throat), AGEUSIA (Loss of taste), ANOSMIA (Loss of smell) and INFLUENZA LIKE ILLNESS (flu like symptoms) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes mellitus. Concomitant products included HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN/HCTZ) and INSULIN GLARGINE (LANTUS) 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 20-Feb-2021, the patient experienced COUGH (Dry cough), OROPHARYNGEAL PAIN (Sore throat), AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), INFLUENZA LIKE ILLNESS (flu like symptoms), DIARRHEA (Diarrhea), PAIN (Body aches), CHILLS (Chills), PYREXIA (Fever) and VOMITING (Vomiting). The patient was treated with CEFDINIR for Dry cough and Sore throat, at a dose of 300 mg twice a day and BENZONATATE for Dry cough and Sore throat, at a dose of 200 mg three times a day. At the time of the report, COUGH (Dry cough), OROPHARYNGEAL PAIN (Sore throat), AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), INFLUENZA LIKE ILLNESS (flu like symptoms), DIARRHEA (Diarrhea), PAIN (Body aches), CHILLS (Chills), PYREXIA (Fever) and VOMITING (Vomiting) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient stated that she was doing better
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Warm to the touch; Felt her arm that was swollen, knot; Red mark the size of a baseball; It is painful; This spontaneous case was reported by a consumer and describes the occurrence of SKIN WARM (Warm to the touch), PERIPHERAL SWELLING (Felt her arm that was swollen, knot), ERYTHEMA (Red mark the size of a baseball) and PAIN IN EXTREMITY (It is painful) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced SKIN WARM (Warm to the touch), PERIPHERAL SWELLING (Felt her arm that was swollen, knot), ERYTHEMA (Red mark the size of a baseball) and PAIN IN EXTREMITY (It is painful). At the time of the report, SKIN WARM (Warm to the touch), PERIPHERAL SWELLING (Felt her arm that was swollen, knot), ERYTHEMA (Red mark the size of a baseball) and PAIN IN EXTREMITY (It is painful) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Cough, Hyperhidrosis, Hyperventilation
Clinical narrative: Chest pain; Her chest hurts when she runs her fingers through her chest; Tightness in her chest; Slight coughing; Heavy breathing; Sweating; Body ache; Her arm pain is twice as bad; Fever only at night; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain), CHEST DISCOMFORT (Her chest hurts when she runs her fingers through her chest), CHEST DISCOMFORT (Tightness in her chest), COUGH (Slight coughing) and HYPERVENTILATION (Heavy breathing) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Joint pain. Concurrent medical conditions included Asthma and Depression.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced CHEST PAIN (Chest pain), CHEST DISCOMFORT (Her chest hurts when she runs her fingers through her chest), CHEST DISCOMFORT (Tightness in her chest), COUGH (Slight coughing), HYPERVENTILATION (Heavy breathing), HYPERHIDROSIS (Sweating), PAIN (Body ache), PAIN IN EXTREMITY (Her arm pain is twice as bad) and PYREXIA (Fever only at night). At the time of the report, CHEST PAIN (Chest pain), CHEST DISCOMFORT (Her chest hurts when she runs her fingers through her chest), CHEST DISCOMFORT (Tightness in her chest), COUGH (Slight coughing), HYPERVENTILATION (Heavy breathing), HYPERHIDROSIS (Sweating), PAIN (Body ache), PAIN IN EXTREMITY (Her arm pain is twice as bad) and PYREXIA (Fever only at night) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  Concomitant medication included Antidepressant medication. No treatment medications were provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: Chest pain; Her chest hurts when she runs her fingers through her chest; Tightness in her chest; Slight coughing; Heavy breathing; Sweating; Body ache; Her arm pain is twice as bad; Fever only at night; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain), CHEST DISCOMFORT (Her chest hurts when she runs her fingers through her chest), CHEST DISCOMFORT (Tightness in her chest), COUGH (Slight coughing) and HYPERVENTILATION (Heavy breathing) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Joint pain. Concurrent medical conditions included Asthma and Depression.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced CHEST PAIN (Chest pain), CHEST DISCOMFORT (Her chest hurts when she runs her fingers through her chest), CHEST DISCOMFORT (Tightness in her chest), COUGH (Slight coughing), HYPERVENTILATION (Heavy breathing), HYPERHIDROSIS (Sweating), PAIN (Body ache), PAIN IN EXTREMITY (Her arm pain is twice as bad) and PYREXIA (Fever only at night). At the time of the report, CHEST PAIN (Chest pain), CHEST DISCOMFORT (Her chest hurts when she runs her fingers through her chest), CHEST DISCOMFORT (Tightness in her chest), COUGH (Slight coughing), HYPERVENTILATION (Heavy breathing), HYPERHIDROSIS (Sweating), PAIN (Body ache), PAIN IN EXTREMITY (Her arm pain is twice as bad) and PYREXIA (Fever only at night) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  Concomitant medication included Antidepressant medication. No treatment medications were provided.