chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling cold, Pyrexia
Clinical narrative: he's cold; he is running a fever; he is tired , he's sleeping; chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (he's cold), PYREXIA (he is running a fever), FATIGUE (he is tired , he's sleeping) and CHILLS (chills) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A2A) for COVID-19 vaccination.     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 10-Mar-2021, the patient experienced FEELING COLD (he's cold), PYREXIA (he is running a fever), FATIGUE (he is tired , he's sleeping) and CHILLS (chills). At the time of the report, FEELING COLD (he's cold), PYREXIA (he is running a fever), FATIGUE (he is tired , he's sleeping) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided. No concomitant product was reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Cold sweat, Confusional state, Fatigue, Headache
Clinical narrative: tightness in chest; confusion; cold sweats; raised pulse rate; tiredness; headache; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (tightness in chest), CONFUSIONAL STATE (confusion), COLD SWEAT (cold sweats), HEART RATE INCREASED (raised pulse rate) and FATIGUE (tiredness) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced CHEST DISCOMFORT (tightness in chest), CONFUSIONAL STATE (confusion), COLD SWEAT (cold sweats), HEART RATE INCREASED (raised pulse rate), FATIGUE (tiredness) and HEADACHE (headache). At the time of the report, CHEST DISCOMFORT (tightness in chest), CONFUSIONAL STATE (confusion), COLD SWEAT (cold sweats), HEART RATE INCREASED (raised pulse rate), FATIGUE (tiredness) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: tightness in chest; confusion; cold sweats; raised pulse rate; tiredness; headache; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (tightness in chest), CONFUSIONAL STATE (confusion), COLD SWEAT (cold sweats), HEART RATE INCREASED (raised pulse rate) and FATIGUE (tiredness) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced CHEST DISCOMFORT (tightness in chest), CONFUSIONAL STATE (confusion), COLD SWEAT (cold sweats), HEART RATE INCREASED (raised pulse rate), FATIGUE (tiredness) and HEADACHE (headache). At the time of the report, CHEST DISCOMFORT (tightness in chest), CONFUSIONAL STATE (confusion), COLD SWEAT (cold sweats), HEART RATE INCREASED (raised pulse rate), FATIGUE (tiredness) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Rash appears again and itches him.) and RASH (rash between her ankles and knees (on both legs)) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 022M20A) for COVID-19 vaccination. No Medical History information was reported. On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced PRURITUS (Rash appears again and itches him.). On 19-Mar-2021, the patient experienced RASH (rash between her ankles and knees (on both legs)). At the time of the report, PRURITUS (Rash appears again and itches him.) and RASH (rash between her ankles and knees (on both legs)) had not resolved.    Concomitant product use was unknown by the reporter. Treatment medication include Benadryl and alcohol.
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: muscle cramps in front of the chest; cant use his arm because of pain; muscle pain; fever; This spontaneous case was reported by a health care professional and describes the occurrence of PYREXIA (fever), MYALGIA (muscle pain), MUSCLE SPASMS (muscle cramps in front of the chest) and PAIN IN EXTREMITY (cant use his arm because of pain) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 08-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 PYREXIA (fever), MYALGIA (muscle pain), MUSCLE SPASMS (muscle cramps in front of the chest) and PAIN IN EXTREMITY (cant use his arm because of pain). At the time of the report, PYREXIA (fever), MYALGIA (muscle pain), MUSCLE SPASMS (muscle cramps in front of the chest) and PAIN IN EXTREMITY (cant use his arm because of pain) 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.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: migraine headache; pain at injection site (Left); This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (migraine headache) and VACCINATION SITE PAIN (pain at injection site (Left)) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 015Z20A) for COVID-19 vaccination.     The patient's past medical history included Migraine.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced HEADACHE (migraine headache) and VACCINATION SITE PAIN (pain at injection site (Left)). At the time of the report, HEADACHE (migraine headache) and VACCINATION SITE PAIN (pain at injection site (Left)) outcome was unknown. Not Provided          No concomitant medications was reported Treatment information was not provided
Age: 93.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Headache
Clinical narrative: Loss of appetite; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Loss of appetite) and HEADACHE (Headache) in a 93-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 011L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism since December 2020.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced DECREASED APPETITE (Loss of appetite) and HEADACHE (Headache). On 10-Feb-2021, HEADACHE (Headache) had resolved. On 17-Feb-2021, DECREASED APPETITE (Loss of appetite) had resolved.            Concomitant product used was not provided by the reporter. Treatment information was not reported.    Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Follow-up information received on 05-May-2021 will be submitted at the same time as the initial report. Follow-up information included patient's demographics and medical history updated. Events updated to headache and loss of appetite.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Pain in extremity
Clinical narrative: Sore arm; Allergies have been out of control, (very very bad, much much mcuh worse); This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and HYPERSENSITIVITY (Allergies have been out of control, (very very bad, much much mcuh worse)) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and HYPERSENSITIVITY (Allergies have been out of control, (very very bad, much much mcuh worse)). On 28-Feb-2021, PAIN IN EXTREMITY (Sore arm) had resolved. At the time of the report, HYPERSENSITIVITY (Allergies have been out of control, (very very bad, much much mcuh worse)) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter.  Treatment information was not reported.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Swelling face
Clinical narrative: Swelling on his face; Rash on his face; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Swelling on his face) and RASH (Rash on his face) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001a21a) 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 09-Mar-2021, the patient experienced SWELLING FACE (Swelling on his face) and RASH (Rash on his face). At the time of the report, SWELLING FACE (Swelling on his face) and RASH (Rash on his face) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter.  Treatment information was not provided.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: Itching at the area of the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching at the area of the injection) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-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 VACCINATION SITE PRURITUS (Itching at the area of the injection). The patient was treated with CORTISONE at an unspecified dose and frequency. On 03-Mar-2021, VACCINATION SITE PRURITUS (Itching at the area of the injection) had resolved.            Concomitant product used was not provided by the reporter.  Treatment included cortisone cream on the injection site.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: A spontaneous report was received from a consumer concerning a female patient of unspecified age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore in the arm/Pain in extremity. The patient's medical history was not provided. No relevant concomitant medications were reported. On 02 Jan 2021 , prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: Unknown) for prophylaxis of COVID-19 infection. On an unknown date, the patient experienced the event sore in the arm. No treatment information was provided. Action taken with mRNA-1273 in response to the events was unknown. The outcome of event, sore in the arm was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site warmth
Clinical narrative: warm to touch at injection site; 3-4 inches diameter at the injection site which is red; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (warm to touch at injection site) and VACCINATION SITE ERYTHEMA (3-4 inches diameter at the injection site which is red) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     Concomitant products included APIXABAN (ELIQUIS), SEMAGLUTIDE (OZEMPIC), GLIPIZIDE, CALCIUM CITRATE, VITAMIN D3 and VITAMIN B12 NOS (VITAMIN B 12 [VITAMIN B12 NOS]) for an unknown indication.    On 03-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 VACCINATION SITE WARMTH (warm to touch at injection site) and VACCINATION SITE ERYTHEMA (3-4 inches diameter at the injection site which is red). At the time of the report, VACCINATION SITE WARMTH (warm to touch at injection site) and VACCINATION SITE ERYTHEMA (3-4 inches diameter at the injection site which is red) 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.   Treatment Medication included Steroidal cream.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure via breast milk
Clinical narrative: breastfeeding patient received first dose; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (breastfeeding patient received first dose) in a 29-year-old female adult exposed to mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M2DA) , while the mother received the product for COVID-19 vaccination.    MEDICAL HISTORY (Parent): The mother's past medical history included Maternal exposure during breast feeding.    MEDICAL HISTORY (Patient): Concomitant product exposures included LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder NOS.    On 10-Mar-2021, the mother received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 10-Mar-2021, the adult was diagnosed with EXPOSURE VIA BREAST MILK (breastfeeding patient received first dose). At the time of the report, EXPOSURE VIA BREAST MILK (breastfeeding patient received first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided. Upon internal review on 19-May-21, the age was corrected 29 years.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: Prickly feeling on elbow to hand; arm was red with hives; warmness on the site of injection; Itchy on site of injection; feverish; headache; difficult breathing; numbness in the fingers; felt needles going down her legs and arms; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Prickly feeling on elbow to hand), URTICARIA (arm was red with hives), DYSPNOEA (difficult breathing), HYPOAESTHESIA (numbness in the fingers) and PAIN IN EXTREMITY (felt needles going down her legs and arms) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN MIGRAINE) for Migraine.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced DYSPNOEA (difficult breathing), HYPOAESTHESIA (numbness in the fingers), PAIN IN EXTREMITY (felt needles going down her legs and arms) and HEADACHE (headache). On 26-Feb-2021, the patient experienced PARAESTHESIA (Prickly feeling on elbow to hand), URTICARIA (arm was red with hives), VACCINATION SITE WARMTH (warmness on the site of injection), VACCINATION SITE PRURITUS (Itchy on site of injection) and PYREXIA (feverish). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PARAESTHESIA (Prickly feeling on elbow to hand), URTICARIA (arm was red with hives), DYSPNOEA (difficult breathing), HYPOAESTHESIA (numbness in the fingers), PAIN IN EXTREMITY (felt needles going down her legs and arms), VACCINATION SITE WARMTH (warmness on the site of injection), VACCINATION SITE PRURITUS (Itchy on site of injection), HEADACHE (headache) and PYREXIA (feverish) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication reported was Excedrin for Migraine and sinus pills for her sinus.   Most recent FOLLOW-UP information incorporated above includes: On 22-Mar-2021: New events added
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Urticaria, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Prickly feeling on elbow to hand; arm was red with hives; warmness on the site of injection; Itchy on site of injection; feverish; headache; difficult breathing; numbness in the fingers; felt needles going down her legs and arms; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Prickly feeling on elbow to hand), URTICARIA (arm was red with hives), DYSPNOEA (difficult breathing), HYPOAESTHESIA (numbness in the fingers) and PAIN IN EXTREMITY (felt needles going down her legs and arms) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN MIGRAINE) for Migraine.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced DYSPNOEA (difficult breathing), HYPOAESTHESIA (numbness in the fingers), PAIN IN EXTREMITY (felt needles going down her legs and arms) and HEADACHE (headache). On 26-Feb-2021, the patient experienced PARAESTHESIA (Prickly feeling on elbow to hand), URTICARIA (arm was red with hives), VACCINATION SITE WARMTH (warmness on the site of injection), VACCINATION SITE PRURITUS (Itchy on site of injection) and PYREXIA (feverish). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PARAESTHESIA (Prickly feeling on elbow to hand), URTICARIA (arm was red with hives), DYSPNOEA (difficult breathing), HYPOAESTHESIA (numbness in the fingers), PAIN IN EXTREMITY (felt needles going down her legs and arms), VACCINATION SITE WARMTH (warmness on the site of injection), VACCINATION SITE PRURITUS (Itchy on site of injection), HEADACHE (headache) and PYREXIA (feverish) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication reported was Excedrin for Migraine and sinus pills for her sinus.   Most recent FOLLOW-UP information incorporated above includes: On 22-Mar-2021: New events added
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Pharyngeal hypoaesthesia
Clinical narrative: numbing on lips; numbing on throat; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (numbing on lips) and PHARYNGEAL HYPOAESTHESIA (numbing on throat) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced HYPOAESTHESIA ORAL (numbing on lips) and PHARYNGEAL HYPOAESTHESIA (numbing on throat). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, HYPOAESTHESIA ORAL (numbing on lips) and PHARYNGEAL HYPOAESTHESIA (numbing on throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: mentioned several other cases of adverse reactions; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (mentioned several other cases of adverse reactions) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (mentioned several other cases of adverse reactions). At the time of the report, VACCINATION COMPLICATION (mentioned several other cases of adverse reactions) outcome was unknown.            Concomitant medications were not provided.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not applicable.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Pain in extremity, Peripheral swelling, Rash
Clinical narrative: circle around the vaccine site size of a tennis ball, swollen,; sleeve she noticed a red bump; swelling, feeling feverish just on the arm,; hot; circle around the injection site is size of tennis ball; patches of little bump; Sore arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VACCINATION SITE WARMTH (circle around the vaccine site size of a tennis ball, swollen,), ERYTHEMA (sleeve she noticed a red bump), PERIPHERAL SWELLING (swelling, feeling feverish just on the arm,) and FEELING HOT (hot) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included SERTRALINE, LOVASTATIN, METOPROLOL and OMEPRAZOLE for an unknown indication.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On an unknown date, the patient experienced VACCINATION SITE WARMTH (circle around the vaccine site size of a tennis ball, swollen,), ERYTHEMA (sleeve she noticed a red bump), PERIPHERAL SWELLING (swelling, feeling feverish just on the arm,), FEELING HOT (hot), VACCINATION SITE RASH (circle around the injection site is size of tennis ball) and RASH (patches of little bump). At the time of the report, PAIN IN EXTREMITY (Sore arm), VACCINATION SITE WARMTH (circle around the vaccine site size of a tennis ball, swollen,), ERYTHEMA (sleeve she noticed a red bump), PERIPHERAL SWELLING (swelling, feeling feverish just on the arm,), FEELING HOT (hot), VACCINATION SITE RASH (circle around the injection site is size of tennis ball) and RASH (patches of little bump) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash, Vaccination site warmth
Clinical narrative: circle around the vaccine site size of a tennis ball, swollen,; sleeve she noticed a red bump; swelling, feeling feverish just on the arm,; hot; circle around the injection site is size of tennis ball; patches of little bump; Sore arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VACCINATION SITE WARMTH (circle around the vaccine site size of a tennis ball, swollen,), ERYTHEMA (sleeve she noticed a red bump), PERIPHERAL SWELLING (swelling, feeling feverish just on the arm,) and FEELING HOT (hot) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included SERTRALINE, LOVASTATIN, METOPROLOL and OMEPRAZOLE for an unknown indication.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On an unknown date, the patient experienced VACCINATION SITE WARMTH (circle around the vaccine site size of a tennis ball, swollen,), ERYTHEMA (sleeve she noticed a red bump), PERIPHERAL SWELLING (swelling, feeling feverish just on the arm,), FEELING HOT (hot), VACCINATION SITE RASH (circle around the injection site is size of tennis ball) and RASH (patches of little bump). At the time of the report, PAIN IN EXTREMITY (Sore arm), VACCINATION SITE WARMTH (circle around the vaccine site size of a tennis ball, swollen,), ERYTHEMA (sleeve she noticed a red bump), PERIPHERAL SWELLING (swelling, feeling feverish just on the arm,), FEELING HOT (hot), VACCINATION SITE RASH (circle around the injection site is size of tennis ball) and RASH (patches of little bump) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Patient had a sore right arm at the end of the day after receiving 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Patient had a sore right arm at the end of the day after receiving 1st dose) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concomitant products included HYDROXYCHLOROQUINE, ENALAPRIL and HYDROCHLOROTHIAZIDE for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 04-Feb-2021, the patient experienced VACCINATION SITE PAIN (Patient had a sore right arm at the end of the day after receiving 1st dose). At the time of the report, VACCINATION SITE PAIN (Patient had a sore right arm at the end of the day after receiving 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information as not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Paraesthesia oral, Upper-airway cough syndrome
Clinical narrative: Tired; headache; lip tingling with second vaccine; lip tingling with first vaccine; left sided postnasal drip; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (lip tingling with first vaccine), UPPER-AIRWAY COUGH SYNDROME (left sided postnasal drip), PARAESTHESIA ORAL (lip tingling with second vaccine), FATIGUE (Tired) and HEADACHE (headache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 015M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE and ROSUVASTATIN for an unknown indication.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced PARAESTHESIA ORAL (lip tingling with first vaccine) and UPPER-AIRWAY COUGH SYNDROME (left sided postnasal drip). On 09-Mar-2021, the patient experienced PARAESTHESIA ORAL (lip tingling with second vaccine). On an unknown date, the patient experienced FATIGUE (Tired) and HEADACHE (headache). On 06-Feb-2021, PARAESTHESIA ORAL (lip tingling with first vaccine) and UPPER-AIRWAY COUGH SYNDROME (left sided postnasal drip) had resolved. On 09-Mar-2021, PARAESTHESIA ORAL (lip tingling with second vaccine) had resolved. At the time of the report, FATIGUE (Tired) and HEADACHE (headache) had resolved.            Events include term tingling in the left arm and hand,itching in the face and neck had resolved    Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Consumer reported additional events
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 09-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 an unknown date, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Patient should not take anything with aspirin in it.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: Redness around the injection site; Tender to the touch injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Tender to the touch injection site) and VACCINATION SITE ERYTHEMA (Redness around the injection site) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) 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) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced VACCINATION SITE PAIN (Tender to the touch injection site). On 04-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness around the injection site). At the time of the report, VACCINATION SITE PAIN (Tender to the touch injection site) and VACCINATION SITE ERYTHEMA (Redness around the injection site) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: TCR: Outcome of events updated
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Vaccination site discolouration
Clinical narrative: slight itching on trunk(abdomen, back, below breast); black and blue mark at the injection site; rash on trunk(abdomen, back, below breast); This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (slight itching on trunk(abdomen, back, below breast)), VACCINATION SITE DISCOLOURATION (black and blue mark at the injection site) and RASH (rash on trunk(abdomen, back, below breast)) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included METOPROLOL, ASPIRIN [ACETYLSALICYLIC ACID], ATORVASTATIN, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and ALPHA LIPOIC ACID for an unknown indication.    On 08-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 PRURITUS (slight itching on trunk(abdomen, back, below breast)), VACCINATION SITE DISCOLOURATION (black and blue mark at the injection site) and RASH (rash on trunk(abdomen, back, below breast)). At the time of the report, PRURITUS (slight itching on trunk(abdomen, back, below breast)), VACCINATION SITE DISCOLOURATION (black and blue mark at the injection site) and RASH (rash on trunk(abdomen, back, below breast)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       treatment was unknown.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Disorientation, Feeling abnormal, Headache
Clinical narrative: A spontaneous report was received from a consumer conerning a 78-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who developed a lot more difficult to think and plan things that were easy to do before/mental impairment, intense nightmare/nightmare, I was very confused; woke up not knowing where I was/confusional state, brain fog/mental fatigue, headache like an ice cream headache/headache, disorientation, loss of taste/ageusia and loss of smell/anosmia. The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included atorvastatin daily, vortioxetine daily, calcitonin nasal spray daily not specified. The patient received the first of two planned doses of mRNA-1273 (Batch number: 037K20A) on 04 Jan 2021. On 01 Feb 2021, approximately 15 days prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 032L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 04 Jan 2021, on first dose, the Patient developed symptom of pain at the site of injection in patient's left (nondominant) arm patient was not able to lift objects weighing more than a few pounds. This symptom resolved spontaneously approximately 2 days later. On 15 Feb 2021, the patient had brain fog, including confusion, nightmares, disorientation, slowed thought and reasoning processes, and difficulty planning. Caller also reported slight loss of taste and smell as well as intermittent headaches. Treatment information was not provided. 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. The outcome of the events was considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Nightmare
Clinical narrative: A spontaneous report was received from a consumer conerning a 78-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who developed a lot more difficult to think and plan things that were easy to do before/mental impairment, intense nightmare/nightmare, I was very confused; woke up not knowing where I was/confusional state, brain fog/mental fatigue, headache like an ice cream headache/headache, disorientation, loss of taste/ageusia and loss of smell/anosmia. The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included atorvastatin daily, vortioxetine daily, calcitonin nasal spray daily not specified. The patient received the first of two planned doses of mRNA-1273 (Batch number: 037K20A) on 04 Jan 2021. On 01 Feb 2021, approximately 15 days prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 032L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 04 Jan 2021, on first dose, the Patient developed symptom of pain at the site of injection in patient's left (nondominant) arm patient was not able to lift objects weighing more than a few pounds. This symptom resolved spontaneously approximately 2 days later. On 15 Feb 2021, the patient had brain fog, including confusion, nightmares, disorientation, slowed thought and reasoning processes, and difficulty planning. Caller also reported slight loss of taste and smell as well as intermittent headaches. Treatment information was not provided. 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. The outcome of the events was considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Headache, Heart rate, Heart rate increased
Clinical narrative: dizziness; body aches; weakness; fast heart rate; headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), PAIN (body aches), ASTHENIA (weakness), HEART RATE INCREASED (fast heart rate) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     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 DIZZINESS (dizziness), PAIN (body aches), ASTHENIA (weakness), HEART RATE INCREASED (fast heart rate) and HEADACHE (headache). At the time of the report, DIZZINESS (dizziness), PAIN (body aches), ASTHENIA (weakness), HEART RATE INCREASED (fast heart rate) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Mar-2021, Heart rate: 55. On 09-Mar-2021, Heart rate: 82 and 103.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was reported Treatment medication included Tylenol
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: dizziness; body aches; weakness; fast heart rate; headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), PAIN (body aches), ASTHENIA (weakness), HEART RATE INCREASED (fast heart rate) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     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 DIZZINESS (dizziness), PAIN (body aches), ASTHENIA (weakness), HEART RATE INCREASED (fast heart rate) and HEADACHE (headache). At the time of the report, DIZZINESS (dizziness), PAIN (body aches), ASTHENIA (weakness), HEART RATE INCREASED (fast heart rate) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Mar-2021, Heart rate: 55. On 09-Mar-2021, Heart rate: 82 and 103.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was reported Treatment medication included Tylenol
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA 1273 in response to event was not applicable.  No concomitant medications reported.  No treatment medications were provided
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling hot, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Injection site was swollen, itchy and had a red spot; Injection site was swollen, itchy and had a red spot; Injection site was swollen, itchy and had a red spot/now little red dots; Felt tired; Forehead was a little warm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Forehead was a little warm), INJECTION SITE PRURITUS (Injection site was swollen, itchy and had a red spot), INJECTION SITE SWELLING (Injection site was swollen, itchy and had a red spot), INJECTION SITE ERYTHEMA (Injection site was swollen, itchy and had a red spot/now little red dots) and FATIGUE (Felt tired) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 012M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CITALOPRAM, TAMOXIFEN, VITAMINS NOS and CALCIUM 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 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Mar-2021, the patient experienced FEELING HOT (Forehead was a little warm) and FATIGUE (Felt tired). On 08-Mar-2021, the patient experienced INJECTION SITE PRURITUS (Injection site was swollen, itchy and had a red spot), INJECTION SITE SWELLING (Injection site was swollen, itchy and had a red spot) and INJECTION SITE ERYTHEMA (Injection site was swollen, itchy and had a red spot/now little red dots). On 07-Mar-2021, FEELING HOT (Forehead was a little warm) and FATIGUE (Felt tired) had resolved. At the time of the report, INJECTION SITE PRURITUS (Injection site was swollen, itchy and had a red spot), INJECTION SITE SWELLING (Injection site was swollen, itchy and had a red spot) and INJECTION SITE ERYTHEMA (Injection site was swollen, itchy and had a red spot/now little red dots) outcome was unknown.            Treatment information was not provided.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) in response to the events was not applicable.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Injection site pain, Pregnancy test
Clinical narrative: Pregnancy; Left arm pain at the site of injection; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnancy) and INJECTION SITE PAIN (Left arm pain at the site of injection) in a 36-year-old female patient (gravida 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 043L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 02-Feb-2021 and the estimated date of delivery was 09-Nov-2021. On 03-Mar-2021, the patient experienced INJECTION SITE PAIN (Left arm pain at the site of injection). On 05-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fourth week of the pregnancy.  On 05-Mar-2021, EXPOSURE DURING PREGNANCY (Pregnancy) had resolved. At the time of the report, INJECTION SITE PAIN (Left arm pain at the site of injection) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, Pregnancy test: positive (Positive) Positive.         Concomitant product used was not provided by the reporter. This patient went to a nearby clinic and was told to follow-up with the hospital. Treatment information was not provided. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) in response to the events was not applicable.
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: little soreness at injection site; This spontaneous case was reported by a patient and describes the occurrence of INJECTION SITE PAIN (little soreness at injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy. Concomitant products included LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) for Allergy.    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 INJECTION SITE PAIN (little soreness at injection site). At the time of the report, INJECTION SITE PAIN (little soreness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product included unspecified blood pressure and gout medication.  Treatment information was not provided.