chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of peripheral swelling (little swelling in left arm), paresthesia (tingling/feet tingling), pain in extremity (pain in left arm), dizziness and asthenia (weak) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 017B21A) for COVID-19 vaccination. The occurrence of additional events detailed below. Concurrent medical conditions included anxiety and depression. Concomitant products included (Prozac) fluoxetine hydrochloride for anxiety and depression. On Mar 31, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 31, 2021, patient experienced peripheral swelling (little swelling in left arm), paresthesia (tingling/feet tingling), pain in extremity (pain in left arm), dizziness, asthenia (weak) and fatigue (tired). On Mar 31, 2021, peripheral swelling (little swelling in left arm), paresthesia (tingling/feet tingling), pain in extremity (pain in left arm), dizziness, asthenia (weak) and fatigue (tired) resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. The reporter did not provide any causality assessments or treatment medication.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: slightly loose stools; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (slightly loose stools) 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 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced DIARRHOEA (slightly loose stools). At the time of the report, DIARRHOEA (slightly loose stools) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Treatment details were not provided.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure.    On 27-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient is on concomitant medications of blood pressure medication on regular basis. No treatment medications were mentioned.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, SARS-CoV-2 test
Clinical narrative: Didnt get the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Didnt get the 2nd dose) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     Concomitant products included LOSARTAN, LEVOTHYROXINE, CHLORTALIDONE, OMEPRAZOLE and FAMOTIDINE for an unknown indication.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Didnt get the 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Didnt get the 2nd dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     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 history was not reported.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate schedule of vaccine administered; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 044B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 28-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Received the second dose of Moderna covid-19 vaccine on 28Apr2021.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow-up information received on 29-JUN-2021 contains no new information. On 29-Jun-2021: Follow up received on 29-Jun-2021, no new information was recorded
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received the second dose of Moderna covid-19 vaccine on 28Apr2021; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the second dose of Moderna covid-19 vaccine on 28Apr2021) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the second dose of Moderna covid-19 vaccine on 28Apr2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the second dose of Moderna covid-19 vaccine on 28Apr2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported   No treatment medications provided by the reporter.  Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: follow up information received on 3-jun-2021 , it does not contain any new information.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: She mentions that it feels like she crushed bottle of Motrin/cannot taste anything except medicinal taste; She noticed that her mouth tasted metallic 2 hours after receiving vaccine.; her mouth tastes bitter; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (She mentions that it feels like she crushed bottle of Motrin/cannot taste anything except medicinal taste), DYSGEUSIA (She noticed that her mouth tasted metallic 2 hours after receiving vaccine.) and DYSGEUSIA (her mouth tastes bitter) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 24-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, the patient experienced DYSGEUSIA (She mentions that it feels like she crushed bottle of Motrin/cannot taste anything except medicinal taste), DYSGEUSIA (She noticed that her mouth tasted metallic 2 hours after receiving vaccine.) and DYSGEUSIA (her mouth tastes bitter). At the time of the report, DYSGEUSIA (She mentions that it feels like she crushed bottle of Motrin/cannot taste anything except medicinal taste), DYSGEUSIA (She noticed that her mouth tasted metallic 2 hours after receiving vaccine.) and DYSGEUSIA (her mouth tastes bitter) outcome was unknown. Not Provided          Concomitant medication included birth control pill. Treatment included eating candy and chewing gum.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Chromaturia, Presyncope, Product administered at inappropriate site
Clinical narrative: Almost blacking out twice; Pinkish coloring in urine, darker and darker until red tint; vaccine administered Midway in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (Almost blacking out twice), CHROMATURIA (Pinkish coloring in urine, darker and darker until red tint) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (vaccine administered Midway in the arm) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No relevant medical history provided.  Concomitant products included ALBUTEROL SULFATE for an unknown indication.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (vaccine administered Midway in the arm). On 21-Apr-2021, the patient experienced CHROMATURIA (Pinkish coloring in urine, darker and darker until red tint). On 22-Apr-2021, the patient experienced PRESYNCOPE (Almost blacking out twice). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. On 14-Apr-2021, PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (vaccine administered Midway in the arm) had resolved. On 22-Apr-2021, CHROMATURIA (Pinkish coloring in urine, darker and darker until red tint) had resolved. On 24-Apr-2021, PRESYNCOPE (Almost blacking out twice) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient taking oral aspirin 81mg daily "to prevent blood clot." No treatment information reported for dizzy spells.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Product administered to patient of inappropriate age
Clinical narrative: Vaccine administered to a 16 years old patient; Felt little crappy; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to a 16 years old patient) and FEELING ABNORMAL (Felt little crappy) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (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 26-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to a 16 years old patient) and FEELING ABNORMAL (Felt little crappy). On 26-Apr-2021, FEELING ABNORMAL (Felt little crappy) had resolved. At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to a 16 years old patient) outcome was unknown.            No concomitant medications were provided.  No treatment drugs were reported.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia, Rash
Clinical narrative: Rash on her arm and stomach; Fever; Chills; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on her arm and stomach), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Sore arm) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     Concomitant products included DROSPIRENONE, ETHINYLESTRADIOL (GIANVI) for Birth control, ESCITALOPRAM OXALATE (LEXAPRO), METFORMIN and BUSPIRONE for an unknown indication.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced RASH (Rash on her arm and stomach), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Sore arm). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK, in the middle of the night. At the time of the report, RASH (Rash on her arm and stomach), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Email address was updated.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Burning sensation, Decreased appetite, Dyspepsia, Erythema
Clinical narrative: indigestion; Can't eat; lost her appetite; Lower legs felt like burning,burning feels like fire; Stomach feels swollen like its already full; Nauseous; low grade fever; Injection site swollen; Injection site warm to the touch; Pink and kinda red; This spontaneous case was reported by a consumer and describes the occurrence of DYSPEPSIA (indigestion), FEEDING DISORDER (Can't eat), DECREASED APPETITE (lost her appetite), BURNING SENSATION (Lower legs felt like burning,burning feels like fire) and ABDOMINAL DISTENSION (Stomach feels swollen like its already full) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included WARFARIN, ROSUVASTATIN and AMLODIPINE for an unknown indication.    On 23-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, the patient experienced ERYTHEMA (Pink and kinda red), VACCINATION SITE SWELLING (Injection site swollen) and VACCINATION SITE WARMTH (Injection site warm to the touch). On 25-Apr-2021, the patient experienced DYSPEPSIA (indigestion), FEEDING DISORDER (Can't eat), DECREASED APPETITE (lost her appetite), BURNING SENSATION (Lower legs felt like burning,burning feels like fire), ABDOMINAL DISTENSION (Stomach feels swollen like its already full), NAUSEA (Nauseous) and PYREXIA (low grade fever). The patient was treated with PREGABALIN (LYRICA) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DYSPEPSIA (indigestion), FEEDING DISORDER (Can't eat), DECREASED APPETITE (lost her appetite), BURNING SENSATION (Lower legs felt like burning,burning feels like fire), ABDOMINAL DISTENSION (Stomach feels swollen like its already full), ERYTHEMA (Pink and kinda red), NAUSEA (Nauseous), VACCINATION SITE SWELLING (Injection site swollen), VACCINATION SITE WARMTH (Injection site warm to the touch) and PYREXIA (low grade fever) outcome was unknown.            No concomitant medications were provided. No treatment information was provided.  Action taken with mRNA-1273 was not applicable
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Feeding disorder, Nausea, Pyrexia, Vaccination site swelling, Vaccination site warmth
Clinical narrative: indigestion; Can't eat; lost her appetite; Lower legs felt like burning,burning feels like fire; Stomach feels swollen like its already full; Nauseous; low grade fever; Injection site swollen; Injection site warm to the touch; Pink and kinda red; This spontaneous case was reported by a consumer and describes the occurrence of DYSPEPSIA (indigestion), FEEDING DISORDER (Can't eat), DECREASED APPETITE (lost her appetite), BURNING SENSATION (Lower legs felt like burning,burning feels like fire) and ABDOMINAL DISTENSION (Stomach feels swollen like its already full) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included WARFARIN, ROSUVASTATIN and AMLODIPINE for an unknown indication.    On 23-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, the patient experienced ERYTHEMA (Pink and kinda red), VACCINATION SITE SWELLING (Injection site swollen) and VACCINATION SITE WARMTH (Injection site warm to the touch). On 25-Apr-2021, the patient experienced DYSPEPSIA (indigestion), FEEDING DISORDER (Can't eat), DECREASED APPETITE (lost her appetite), BURNING SENSATION (Lower legs felt like burning,burning feels like fire), ABDOMINAL DISTENSION (Stomach feels swollen like its already full), NAUSEA (Nauseous) and PYREXIA (low grade fever). The patient was treated with PREGABALIN (LYRICA) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DYSPEPSIA (indigestion), FEEDING DISORDER (Can't eat), DECREASED APPETITE (lost her appetite), BURNING SENSATION (Lower legs felt like burning,burning feels like fire), ABDOMINAL DISTENSION (Stomach feels swollen like its already full), ERYTHEMA (Pink and kinda red), NAUSEA (Nauseous), VACCINATION SITE SWELLING (Injection site swollen), VACCINATION SITE WARMTH (Injection site warm to the touch) and PYREXIA (low grade fever) outcome was unknown.            No concomitant medications were provided. No treatment information was provided.  Action taken with mRNA-1273 was not applicable
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Hyperhidrosis
Clinical narrative: Shortly after receiving 2nd dose, he started sweating; He started with stomach cramps within 2 hours; diarrhea within 2 hours; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-Apr-2021 and was forwarded to Moderna on 28-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Shortly after receiving 2nd dose, he started sweating), ABDOMINAL PAIN UPPER (He started with stomach cramps within 2 hours) and DIARRHOEA (diarrhea within 2 hours) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included Sleep medicine for an unknown indication.   On 27-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, the patient experienced HYPERHIDROSIS (Shortly after receiving 2nd dose, he started sweating), ABDOMINAL PAIN UPPER (He started with stomach cramps within 2 hours) and DIARRHOEA (diarrhea within 2 hours). At the time of the report, HYPERHIDROSIS (Shortly after receiving 2nd dose, he started sweating), ABDOMINAL PAIN UPPER (He started with stomach cramps within 2 hours) and DIARRHOEA (diarrhea within 2 hours) outcome was unknown. Not Provided          No laboratory was not given.   Patient was still experienced stomach cramps, diarrhea,sweating  No treatment information was not given.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Sore arm; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and PYREXIA (fever) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant details were provide
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness in her right arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness in her right arm) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Soreness in her right arm). At the time of the report, VACCINATION SITE PAIN (Soreness in her right arm) outcome was unknown. Not Provided          No concomitant medication provided. No treatment information mentioned.  Action taken with respect to mRNA-1273 was not applicable.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Eye pain, Headache, Myalgia, SARS-CoV-2 test
Clinical narrative: COVID-19; Eyes were sore; Headaches; Body aches; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19), EYE PAIN (Eyes were sore), HEADACHE (Headaches) and MYALGIA (Body aches) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced EYE PAIN (Eyes were sore), HEADACHE (Headaches) and MYALGIA (Body aches). On 02-Apr-2021, the patient experienced COVID-19 (COVID-19). On 13-Apr-2021, COVID-19 (COVID-19) had resolved. At the time of the report, EYE PAIN (Eyes were sore), HEADACHE (Headaches) and MYALGIA (Body aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, SARS-CoV-2 test: positive (Positive) Positive. On 13-Apr-2021, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications was reported.  Treatment information was not provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Sore Left Arm on movement, from Fingertips to the Shoulder; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Left Arm on movement, from Fingertips to the Shoulder) and FATIGUE (Fatigue) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048821A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore Left Arm on movement, from Fingertips to the Shoulder) and FATIGUE (Fatigue). The patient was treated with IBUPROFEN (oral) at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (Sore Left Arm on movement, from Fingertips to the Shoulder) and FATIGUE (Fatigue) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not reported.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure measurement, Body temperature, Chest pain, Chills
Clinical narrative: Experienced chest pain and chest burning; Weak; Felt dizzy; Felt very sick; Ear pain; Shivering; Experienced pain all over her body; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Experienced chest pain and chest burning), ASTHENIA (Weak), DIZZINESS (Felt dizzy), ILLNESS (Felt very sick) and EAR PAIN (Ear pain) in a 63-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 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced CHEST PAIN (Experienced chest pain and chest burning), ASTHENIA (Weak), DIZZINESS (Felt dizzy), EAR PAIN (Ear pain), CHILLS (Shivering) and MYALGIA (Experienced pain all over her body). 06-Mar-2021, the patient experienced ILLNESS (Felt very sick). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and ESSENTIAL OILS NOS at an unspecified dose and frequency. On 12-Mar-2021, EAR PAIN (Ear pain), CHILLS (Shivering) and MYALGIA (Experienced pain all over her body) had resolved. At the time of the report, CHEST PAIN (Experienced chest pain and chest burning), ASTHENIA (Weak), DIZZINESS (Felt dizzy) and ILLNESS (Felt very sick) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Mar-2021, Blood pressure measurement: normal (normal) Reported to be normal. On 06-Mar-2021, Body temperature: normal (normal) Reported to be normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Ear pain, Illness, Myalgia
Clinical narrative: Experienced chest pain and chest burning; Weak; Felt dizzy; Felt very sick; Ear pain; Shivering; Experienced pain all over her body; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Experienced chest pain and chest burning), ASTHENIA (Weak), DIZZINESS (Felt dizzy), ILLNESS (Felt very sick) and EAR PAIN (Ear pain) in a 63-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 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced CHEST PAIN (Experienced chest pain and chest burning), ASTHENIA (Weak), DIZZINESS (Felt dizzy), EAR PAIN (Ear pain), CHILLS (Shivering) and MYALGIA (Experienced pain all over her body). 06-Mar-2021, the patient experienced ILLNESS (Felt very sick). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and ESSENTIAL OILS NOS at an unspecified dose and frequency. On 12-Mar-2021, EAR PAIN (Ear pain), CHILLS (Shivering) and MYALGIA (Experienced pain all over her body) had resolved. At the time of the report, CHEST PAIN (Experienced chest pain and chest burning), ASTHENIA (Weak), DIZZINESS (Felt dizzy) and ILLNESS (Felt very sick) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Mar-2021, Blood pressure measurement: normal (normal) Reported to be normal. On 06-Mar-2021, Body temperature: normal (normal) Reported to be normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient scheduled for second dose after 46 day window; This spontaneous case was reported by a physician and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient scheduled for second dose after 46 day window) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 28-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient scheduled for second dose after 46 day window). On 28-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient scheduled for second dose after 46 day window) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided/unknown. Treatment medication were not reported/unknown.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache, Influenza like illness, Vaccination site erythema
Clinical narrative: Flu like symptoms; Weakness; Red circle at injection site; Headache; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), ASTHENIA (Weakness), VACCINATION SITE ERYTHEMA (Red circle at injection site) and HEADACHE (Headache) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 002B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), ASTHENIA (Weakness), VACCINATION SITE ERYTHEMA (Red circle at injection site) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (DAYQUIL) at an unspecified dose and frequency. On 24-Apr-2021, INFLUENZA LIKE ILLNESS (Flu like symptoms), ASTHENIA (Weakness), VACCINATION SITE ERYTHEMA (Red circle at injection site) and HEADACHE (Headache) had resolved.            Concomitant product use was not provided.   Action taken with mRNA-1273 in response to the events was  not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 29-May-2021: Follow up information was  received  contains significant information, the outcome of the events were changed from unknown to recovered.
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Contusion, Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: barely hurt(when received injection); Feels like a permanent bruise; Big, hardened knot; Arm was sore to touch; Ring of discoloration around the knot; Itching sensation; Swelling arm; Arm was red; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling arm), ERYTHEMA (Arm was red), PRURITUS (Itching sensation), AXILLARY MASS (Big, hardened knot) and PAIN IN EXTREMITY (Arm was sore to touch) in a female patient of an unknown age 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-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced PERIPHERAL SWELLING (Swelling arm) and ERYTHEMA (Arm was red). On 15-Apr-2021, the patient experienced PRURITUS (Itching sensation). On 16-Apr-2021, the patient experienced AXILLARY MASS (Big, hardened knot), PAIN IN EXTREMITY (Arm was sore to touch) and SKIN DISCOLOURATION (Ring of discoloration around the knot). On 18-Apr-2021, the patient experienced CONTUSION (Feels like a permanent bruise). On an unknown date, the patient experienced VACCINATION SITE PAIN (barely hurt(when received injection)). At the time of the report, PERIPHERAL SWELLING (Swelling arm), ERYTHEMA (Arm was red), PRURITUS (Itching sensation), AXILLARY MASS (Big, hardened knot), PAIN IN EXTREMITY (Arm was sore to touch), SKIN DISCOLOURATION (Ring of discoloration around the knot), CONTUSION (Feels like a permanent bruise) and VACCINATION SITE PAIN (barely hurt(when received injection)) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Skin discolouration, Vaccination site pain
Clinical narrative: barely hurt(when received injection); Feels like a permanent bruise; Big, hardened knot; Arm was sore to touch; Ring of discoloration around the knot; Itching sensation; Swelling arm; Arm was red; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling arm), ERYTHEMA (Arm was red), PRURITUS (Itching sensation), AXILLARY MASS (Big, hardened knot) and PAIN IN EXTREMITY (Arm was sore to touch) in a female patient of an unknown age 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-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced PERIPHERAL SWELLING (Swelling arm) and ERYTHEMA (Arm was red). On 15-Apr-2021, the patient experienced PRURITUS (Itching sensation). On 16-Apr-2021, the patient experienced AXILLARY MASS (Big, hardened knot), PAIN IN EXTREMITY (Arm was sore to touch) and SKIN DISCOLOURATION (Ring of discoloration around the knot). On 18-Apr-2021, the patient experienced CONTUSION (Feels like a permanent bruise). On an unknown date, the patient experienced VACCINATION SITE PAIN (barely hurt(when received injection)). At the time of the report, PERIPHERAL SWELLING (Swelling arm), ERYTHEMA (Arm was red), PRURITUS (Itching sensation), AXILLARY MASS (Big, hardened knot), PAIN IN EXTREMITY (Arm was sore to touch), SKIN DISCOLOURATION (Ring of discoloration around the knot), CONTUSION (Feels like a permanent bruise) and VACCINATION SITE PAIN (barely hurt(when received injection)) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Pain in arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: inappropriate age at vaccine administration; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (inappropriate age at vaccine administration) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (inappropriate age at vaccine administration). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (inappropriate age at vaccine administration) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medicines reported. No treatment medication reported.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Erythema, Fatigue, Headache, Nausea
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRESYNCOPE (felt that she was going to pass out), PAIN IN EXTREMITY (sore arm), ERYTHEMA (red face), DIZZINESS (Dizzy/felt dizzy) and FATIGUE (Tired) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 08B21A and 044B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced PRESYNCOPE (felt that she was going to pass out), PAIN IN EXTREMITY (sore arm), ERYTHEMA (red face), DIZZINESS (Dizzy/felt dizzy), FATIGUE (Tired), HEADACHE (Headache/had headache) and NAUSEA (nausea). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and PREDNISONE at an unspecified dose and frequency. On 27-Mar-2021, ERYTHEMA (red face), DIZZINESS (Dizzy/felt dizzy) and FATIGUE (Tired) outcome was unknown. At the time of the report, PRESYNCOPE (felt that she was going to pass out), PAIN IN EXTREMITY (sore arm), HEADACHE (Headache/had headache) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported. Treatment medications taken were antibiotics and steroid shot.   This case was linked to MOD-2021-094686 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Follow up document was attached on 05-May-2021 which contains added events : Presyncope, Headache, Dizzy, Nausea, Pain in extremity.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Presyncope
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRESYNCOPE (felt that she was going to pass out), PAIN IN EXTREMITY (sore arm), ERYTHEMA (red face), DIZZINESS (Dizzy/felt dizzy) and FATIGUE (Tired) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 08B21A and 044B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced PRESYNCOPE (felt that she was going to pass out), PAIN IN EXTREMITY (sore arm), ERYTHEMA (red face), DIZZINESS (Dizzy/felt dizzy), FATIGUE (Tired), HEADACHE (Headache/had headache) and NAUSEA (nausea). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and PREDNISONE at an unspecified dose and frequency. On 27-Mar-2021, ERYTHEMA (red face), DIZZINESS (Dizzy/felt dizzy) and FATIGUE (Tired) outcome was unknown. At the time of the report, PRESYNCOPE (felt that she was going to pass out), PAIN IN EXTREMITY (sore arm), HEADACHE (Headache/had headache) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported. Treatment medications taken were antibiotics and steroid shot.   This case was linked to MOD-2021-094686 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Follow up document was attached on 05-May-2021 which contains added events : Presyncope, Headache, Dizzy, Nausea, Pain in extremity.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat, Diarrhoea
Clinical narrative: loose stools; cold sweats; This spontaneous case was reported by a nurse and describes the occurrence of DIARRHOEA (loose stools) and COLD SWEAT (cold sweats) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, the patient experienced DIARRHOEA (loose stools) and COLD SWEAT (cold sweats). At the time of the report, DIARRHOEA (loose stools) and COLD SWEAT (cold sweats) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications provided. No treatment information provided.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Pruritus, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: face, chin, forehead, redness and itching; face, chin, forehead, redness and itching; redness and swelling on the left arm; injection site redness; injection site redness and itching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (face, chin, forehead, redness and itching), ERYTHEMA (face, chin, forehead, redness and itching), PERIPHERAL SWELLING (redness and swelling on the left arm), VACCINATION SITE PRURITUS (injection site redness and itching) and VACCINATION SITE ERYTHEMA (injection site redness) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 048B21A) for COVID-19 vaccination.     Concurrent medical conditions included Shellfish allergy.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (injection site redness and itching). On an unknown date, the patient experienced PRURITUS (face, chin, forehead, redness and itching), ERYTHEMA (face, chin, forehead, redness and itching), PERIPHERAL SWELLING (redness and swelling on the left arm) and VACCINATION SITE ERYTHEMA (injection site redness). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 2 doses. On 29-Mar-2021, VACCINATION SITE PRURITUS (injection site redness and itching) had resolved. At the time of the report, PRURITUS (face, chin, forehead, redness and itching), ERYTHEMA (face, chin, forehead, redness and itching), PERIPHERAL SWELLING (redness and swelling on the left arm) and VACCINATION SITE ERYTHEMA (injection site redness) outcome was unknown.            No relevant concomitant medications were provided. The action taken for mRNA-1273 was not applicable.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 years of age patient received a Moderna vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years of age patient received a Moderna vaccine) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years of age patient received a Moderna vaccine). On 27-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years of age patient received a Moderna vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were provided. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain
Clinical narrative: excruciating back pain; hip pain; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (excruciating back pain) and ARTHRALGIA (hip pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BACK PAIN (excruciating back pain) and ARTHRALGIA (hip pain). At the time of the report, BACK PAIN (excruciating back pain) and ARTHRALGIA (hip pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-094702 (Patient Link).
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhoea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhoea) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FOLIC ACID, CYANOCOBALAMIN (VITAMIN B 12 [CYANOCOBALAMIN]) and CARVEDILOL for an unknown indication.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced DIARRHOEA (Diarrhoea). At the time of the report, DIARRHOEA (Diarrhoea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant products includes Heart medication and Statin Treatment was not received by the patient. Patient took crackers and drank coffee