chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pain
Clinical narrative: muscle aches; achy; a little tired, had a very slight fatigue/really fatigued, really really exhausted, extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (achy), FATIGUE (a little tired, had a very slight fatigue/really fatigued, really really exhausted, extreme fatigue) and MYALGIA (muscle aches) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Heart disorder.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced PAIN (achy) and FATIGUE (a little tired, had a very slight fatigue/really fatigued, really really exhausted, extreme fatigue). On 18-Mar-2021, the patient experienced MYALGIA (muscle aches). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. At the time of the report, PAIN (achy) outcome was unknown and FATIGUE (a little tired, had a very slight fatigue/really fatigued, really really exhausted, extreme fatigue) and MYALGIA (muscle aches) had not resolved.            No relevant concomitant medications reported.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable     This case was linked to MOD-2021-049603 (Patient Link).
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Feeling abnormal, Feeling hot, Headache
Clinical narrative: Felt Worse; Weird Neurological Sensations; Warm Sensation; Weakness; Tired; Headache; Achiness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achiness), FEELING ABNORMAL (Weird Neurological Sensations), FEELING HOT (Warm Sensation), ASTHENIA (Weakness) and FEELING ABNORMAL (Felt Worse) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002ZAZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced PAIN (Achiness), FATIGUE (Tired) and HEADACHE (Headache). On 14-Mar-2021, the patient experienced FEELING ABNORMAL (Weird Neurological Sensations), FEELING HOT (Warm Sensation) and ASTHENIA (Weakness). On 18-Mar-2021, the patient experienced FEELING ABNORMAL (Felt Worse). At the time of the report, PAIN (Achiness), FEELING ABNORMAL (Weird Neurological Sensations), FEELING HOT (Warm Sensation), ASTHENIA (Weakness), FEELING ABNORMAL (Felt Worse), FATIGUE (Tired) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Felt Worse; Weird Neurological Sensations; Warm Sensation; Weakness; Tired; Headache; Achiness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achiness), FEELING ABNORMAL (Weird Neurological Sensations), FEELING HOT (Warm Sensation), ASTHENIA (Weakness) and FEELING ABNORMAL (Felt Worse) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002ZAZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced PAIN (Achiness), FATIGUE (Tired) and HEADACHE (Headache). On 14-Mar-2021, the patient experienced FEELING ABNORMAL (Weird Neurological Sensations), FEELING HOT (Warm Sensation) and ASTHENIA (Weakness). On 18-Mar-2021, the patient experienced FEELING ABNORMAL (Felt Worse). At the time of the report, PAIN (Achiness), FEELING ABNORMAL (Weird Neurological Sensations), FEELING HOT (Warm Sensation), ASTHENIA (Weakness), FEELING ABNORMAL (Felt Worse), FATIGUE (Tired) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Abscess limb, Blue toe syndrome, Pain in extremity, Skin discharge
Clinical narrative: toes became reddened, swollen, and achy; substance similar to earwax started seeping out of the skin of the big toes; Pain in extremity; both of big toes turned Purple; Sore Arm; This spontaneous case was reported by a physician and describes the occurrence of BLUE TOE SYNDROME (both of big toes turned Purple), SKIN DISCHARGE (substance similar to earwax started seeping out of the skin of the big toes), PAIN IN EXTREMITY (Sore Arm), ABSCESS LIMB (toes became reddened, swollen, and achy) and PAIN IN EXTREMITY (Pain in extremity) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 012M20A) for COVID-19 vaccination.     The patient's past medical history included Atrial fibrillation in 2000, Hypertension in 2000, Obesity in 1990, Prostate cancer in 2017 and Barrett's esophagus in 2015. Concomitant products included APIXABAN for Atrial fibrillation, OMEPRAZOLE for Barrett's esophagus, ROSUVASTATIN for Cholesterol, DILTIAZEM HCL and METOPROLOL TARTRATE for Hypertension.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm). On 12-Mar-2021, the patient experienced BLUE TOE SYNDROME (both of big toes turned Purple) and PAIN IN EXTREMITY (Pain in extremity). On 13-Mar-2021, the patient experienced SKIN DISCHARGE (substance similar to earwax started seeping out of the skin of the big toes). On an unknown date, the patient experienced ABSCESS LIMB (toes became reddened, swollen, and achy). On 29-Apr-2021, SKIN DISCHARGE (substance similar to earwax started seeping out of the skin of the big toes) had resolved. On 30-Apr-2021, PAIN IN EXTREMITY (Pain in extremity) had resolved. At the time of the report, BLUE TOE SYNDROME (both of big toes turned Purple), PAIN IN EXTREMITY (Sore Arm) and ABSCESS LIMB (toes became reddened, swollen, and achy) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events was not applicable.   This case was linked.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Patient demographics,  other relevant history, concomitant medications were added and event details and outcome was updated.; Sender's Comments:  Cross link;Wife case
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Numbness outside of the face; Numbness inside of the cheeks; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-Mar-2021 and was forwarded to Moderna on 17-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness inside of the cheeks) and HYPOAESTHESIA (Numbness outside of the face) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced HYPOAESTHESIA (Numbness inside of the cheeks). On 17-Mar-2021, the patient experienced HYPOAESTHESIA (Numbness outside of the face). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 16-Mar-2021 at a dose of 50 milligram. At the time of the report, HYPOAESTHESIA (Numbness inside of the cheeks) and HYPOAESTHESIA (Numbness outside of the face) 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.   ?
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Herpes virus infection, Swelling
Clinical narrative: Harpies on right side of the body; Redness and little bump; Redness and little bump; This spontaneous case was reported by a consumer and describes the occurrence of HERPES VIRUS INFECTION (Harpies on right side of the body), SWELLING (Redness and little bump) and ERYTHEMA (Redness and little bump) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 16M20A) for COVID-19 vaccination.     No medical history reported by the reporter.  Concomitant products included VITAMIN C [ASCORBIC ACID], CALCIUM and ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced HERPES VIRUS INFECTION (Harpies on right side of the body), SWELLING (Redness and little bump) and ERYTHEMA (Redness and little bump). At the time of the report, HERPES VIRUS INFECTION (Harpies on right side of the body), SWELLING (Redness and little bump) and ERYTHEMA (Redness and little bump) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information reported included valacyclovir.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.    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 (arm was sore). At the time of the report, PAIN IN EXTREMITY (arm was sore) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were provided by the reporter.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Fatigue, Illness, Myalgia
Clinical narrative: has continued to itch; Red area the size of an apple; Exhausted; Too sick to get up; Fever; Chills; Body pain; Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Too sick to get up), PRURITUS (has continued to itch), PAIN IN EXTREMITY (Arm pain), ERYTHEMA (Red area the size of an apple) and CHILLS (Chills) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm pain), CHILLS (Chills), MYALGIA (Body pain) and PYREXIA (Fever). On 14-Mar-2021, the patient experienced ILLNESS (Too sick to get up), ERYTHEMA (Red area the size of an apple) and FATIGUE (Exhausted). On an unknown date, the patient experienced PRURITUS (has continued to itch). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and ACETYLSALICYLIC ACID (BABY ASPIRIN) at an unspecified dose and frequency. On 16-Feb-2021, PAIN IN EXTREMITY (Arm pain) had resolved. On 17-Feb-2021, CHILLS (Chills), MYALGIA (Body pain) and PYREXIA (Fever) had resolved. On 16-Mar-2021, ERYTHEMA (Red area the size of an apple) had resolved. On 17-Mar-2021, ILLNESS (Too sick to get up) and FATIGUE (Exhausted) had resolved. At the time of the report, PRURITUS (has continued to itch) had not resolved.            No concomitant medications were reported.   This case was linked.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Pyrexia
Clinical narrative: has continued to itch; Red area the size of an apple; Exhausted; Too sick to get up; Fever; Chills; Body pain; Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Too sick to get up), PRURITUS (has continued to itch), PAIN IN EXTREMITY (Arm pain), ERYTHEMA (Red area the size of an apple) and CHILLS (Chills) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm pain), CHILLS (Chills), MYALGIA (Body pain) and PYREXIA (Fever). On 14-Mar-2021, the patient experienced ILLNESS (Too sick to get up), ERYTHEMA (Red area the size of an apple) and FATIGUE (Exhausted). On an unknown date, the patient experienced PRURITUS (has continued to itch). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and ACETYLSALICYLIC ACID (BABY ASPIRIN) at an unspecified dose and frequency. On 16-Feb-2021, PAIN IN EXTREMITY (Arm pain) had resolved. On 17-Feb-2021, CHILLS (Chills), MYALGIA (Body pain) and PYREXIA (Fever) had resolved. On 16-Mar-2021, ERYTHEMA (Red area the size of an apple) had resolved. On 17-Mar-2021, ILLNESS (Too sick to get up) and FATIGUE (Exhausted) had resolved. At the time of the report, PRURITUS (has continued to itch) had not resolved.            No concomitant medications were reported.   This case was linked.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Pyrexia, Swelling
Clinical narrative: Weakness; Swelling; Joint pain; Fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), SWELLING (Swelling), ARTHRALGIA (Joint pain) and PYREXIA (Fever) in a patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (Weakness), SWELLING (Swelling), ARTHRALGIA (Joint pain) and PYREXIA (Fever). At the time of the report, ASTHENIA (Weakness), SWELLING (Swelling), ARTHRALGIA (Joint pain) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were provided. No concomitant medications were reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Product dose omission issue
Clinical narrative: Had Covid after first dose; Past 42 days after first dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Had Covid after first dose) and PRODUCT DOSE OMISSION ISSUE (Past 42 days after first dose) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Had Covid after first dose) and PRODUCT DOSE OMISSION ISSUE (Past 42 days after first dose). At the time of the report, COVID-19 (Had Covid after first dose) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Past 42 days after first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Ban Therapy for COVID.  Concomitant information not provided
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Diarrhoea, Dizziness, Dysgeusia, Flatulence
Clinical narrative: Muscle pain; Metallic taste; Diarrhea; Gas; Itching; Dizziness; Swelling; 100.4 degree fever; Vomiting; Nausea; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Metallic taste), DIARRHOEA (Diarrhea), FLATULENCE (Gas), PRURITUS (Itching) and DIZZINESS (Dizziness) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced DYSGEUSIA (Metallic taste), DIARRHOEA (Diarrhea), FLATULENCE (Gas), PRURITUS (Itching), DIZZINESS (Dizziness), SWELLING (Swelling), PYREXIA (100.4 degree fever), VOMITING (Vomiting), NAUSEA (Nausea) and VACCINATION SITE PAIN (Sore arm). On an unknown date, the patient experienced MYALGIA (Muscle pain). At the time of the report, DYSGEUSIA (Metallic taste), DIARRHOEA (Diarrhea), FLATULENCE (Gas), PRURITUS (Itching), DIZZINESS (Dizziness), SWELLING (Swelling), PYREXIA (100.4 degree fever), VOMITING (Vomiting), NAUSEA (Nausea), VACCINATION SITE PAIN (Sore arm) and MYALGIA (Muscle pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Feb-2021, Body temperature: 100.4 (High) 100.4 degree fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medications included IV fluids , pain killers.   Most recent FOLLOW-UP information incorporated above includes: On 18-Mar-2021: No specific follow-up information recorded. On 23-Jun-2021: Follow-up information received on 23-JUN-2021 contains no new information.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pruritus, Pyrexia, Swelling
Clinical narrative: Muscle pain; Metallic taste; Diarrhea; Gas; Itching; Dizziness; Swelling; 100.4 degree fever; Vomiting; Nausea; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Metallic taste), DIARRHOEA (Diarrhea), FLATULENCE (Gas), PRURITUS (Itching) and DIZZINESS (Dizziness) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced DYSGEUSIA (Metallic taste), DIARRHOEA (Diarrhea), FLATULENCE (Gas), PRURITUS (Itching), DIZZINESS (Dizziness), SWELLING (Swelling), PYREXIA (100.4 degree fever), VOMITING (Vomiting), NAUSEA (Nausea) and VACCINATION SITE PAIN (Sore arm). On an unknown date, the patient experienced MYALGIA (Muscle pain). At the time of the report, DYSGEUSIA (Metallic taste), DIARRHOEA (Diarrhea), FLATULENCE (Gas), PRURITUS (Itching), DIZZINESS (Dizziness), SWELLING (Swelling), PYREXIA (100.4 degree fever), VOMITING (Vomiting), NAUSEA (Nausea), VACCINATION SITE PAIN (Sore arm) and MYALGIA (Muscle pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Feb-2021, Body temperature: 100.4 (High) 100.4 degree fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medications included IV fluids , pain killers.   Most recent FOLLOW-UP information incorporated above includes: On 18-Mar-2021: No specific follow-up information recorded. On 23-Jun-2021: Follow-up information received on 23-JUN-2021 contains no new information.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vomiting
Clinical narrative: Muscle pain; Metallic taste; Diarrhea; Gas; Itching; Dizziness; Swelling; 100.4 degree fever; Vomiting; Nausea; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Metallic taste), DIARRHOEA (Diarrhea), FLATULENCE (Gas), PRURITUS (Itching) and DIZZINESS (Dizziness) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced DYSGEUSIA (Metallic taste), DIARRHOEA (Diarrhea), FLATULENCE (Gas), PRURITUS (Itching), DIZZINESS (Dizziness), SWELLING (Swelling), PYREXIA (100.4 degree fever), VOMITING (Vomiting), NAUSEA (Nausea) and VACCINATION SITE PAIN (Sore arm). On an unknown date, the patient experienced MYALGIA (Muscle pain). At the time of the report, DYSGEUSIA (Metallic taste), DIARRHOEA (Diarrhea), FLATULENCE (Gas), PRURITUS (Itching), DIZZINESS (Dizziness), SWELLING (Swelling), PYREXIA (100.4 degree fever), VOMITING (Vomiting), NAUSEA (Nausea), VACCINATION SITE PAIN (Sore arm) and MYALGIA (Muscle pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Feb-2021, Body temperature: 100.4 (High) 100.4 degree fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medications included IV fluids , pain killers.   Most recent FOLLOW-UP information incorporated above includes: On 18-Mar-2021: No specific follow-up information recorded. On 23-Jun-2021: Follow-up information received on 23-JUN-2021 contains no new information.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: Heart rate got raised; This spontaneous case was reported by a patient family member or friend and describes the occurrence of HEART RATE INCREASED (Heart rate got raised) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (Heart rate got raised). At the time of the report, HEART RATE INCREASED (Heart rate got raised) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was provided.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Wrong product administered
Clinical narrative: Sore Arm; Received the Pfizer Covid-19 vaccine as the first dose and Moderna as the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm) and WRONG PRODUCT ADMINISTERED (Received the Pfizer Covid-19 vaccine as the first dose and Moderna as the second dose) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. CO11321A) for COVID-19 vaccination.    Co-suspect product included non-company product COVID-19 VACCINE MRNA (BNT162B2) for COVID-19 vaccination.    Concomitant products included TAMSULOSIN, LISINOPRIL, METOPROLOL, RIVAROXABAN (XARELTO), PRAVASTATIN and ACETAMINOPHEN for an unknown indication.   On 16-Feb-2021, the patient started COVID-19 VACCINE MRNA (BNT162B2) (unknown route) 1 dosage form. On 16-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced WRONG PRODUCT ADMINISTERED (Received the Pfizer Covid-19 vaccine as the first dose and Moderna as the second dose). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore Arm). On 16-Mar-2021, WRONG PRODUCT ADMINISTERED (Received the Pfizer Covid-19 vaccine as the first dose and Moderna as the second dose) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore Arm) outcome was unknown.            No treatment information was provided.  Pfizer vaccine was given in left arm.  Upon internal review on 30 Jun 2021, event coding was updated.  Based on the current available information and temporal association between the use of the product and the start date of the event of pain in extremity, a causal relationship cannot be excluded.   The causality for the event of wrong product administered remains as not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Follow up information received on 28-JUNE-2021, included no new information; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event of pain in extremity, a causal relationship cannot be excluded.   The causality for the event of wrong product administered remains as not applicable.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site pain
Clinical narrative: little sore arm but not enough to complain; itching in stomach front upper part / itching arm / really itching all over body, even on her butt; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (itching in stomach front upper part / itching arm / really itching all over body, even on her butt) and VACCINATION SITE PAIN (little sore arm but not enough to complain) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) 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) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced PRURITUS (itching in stomach front upper part / itching arm / really itching all over body, even on her butt). On 14-Mar-2021, the patient experienced VACCINATION SITE PAIN (little sore arm but not enough to complain). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) in March 2021 for Itching, at an unspecified dose and frequency. At the time of the report, PRURITUS (itching in stomach front upper part / itching arm / really itching all over body, even on her butt) and VACCINATION SITE PAIN (little sore arm but not enough to complain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment for the event included Benadryl, which did not relieve her symptoms. The patient sought medical attention at Urgent Care and she was recommended 24 hour allergy relief but that didn't help. The patient went to doctor who prescribed "Hydrocondis" lotion.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Event outcome updated
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Peripheral swelling
Clinical narrative: swelling got worse; Swelling in right foot; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling in right foot) and CONDITION AGGRAVATED (swelling got worse) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) 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) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced PERIPHERAL SWELLING (Swelling in right foot). On an unknown date, the patient experienced CONDITION AGGRAVATED (swelling got worse). At the time of the report, PERIPHERAL SWELLING (Swelling in right foot) and CONDITION AGGRAVATED (swelling got worse) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Antibody test abnormal
Clinical narrative: Antibodies less 0.02% after two shots; This spontaneous case was reported by a consumer and describes the occurrence of ANTIBODY TEST ABNORMAL (Antibodies less 0.02% after two shots) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-A) for COVID-19 vaccination.     Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], ACETYLSALICYLIC ACID (ECOTRIN), DUTASTERIDE (AVODART), MAGNESIUM, MECLOZINE HYDROCHLORIDE (ANTIVERT [MECLOZINE HYDROCHLORIDE]), NYSTATIN (MICOSTATIN), ROSUVASTATIN CALCIUM (CRESTOR), HYDROCHLOROTHIAZIDE, VALSARTAN (DIOVAN HCT), RIVAROXABAN (XARELTO), AMLODIPINE and METOPROLOL SUCCINATE (TOPROL) for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ANTIBODY TEST ABNORMAL (Antibodies less 0.02% after two shots). At the time of the report, ANTIBODY TEST ABNORMAL (Antibodies less 0.02% after two shots) outcome was unknown.            No treatment medications were provided.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Vaccination site erythema
Clinical narrative: chills; the injection site had a circle of red around it the size of a half dollar; knee pain; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), VACCINATION SITE ERYTHEMA (the injection site had a circle of red around it the size of a half dollar) and ARTHRALGIA (knee pain) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 05-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 CHILLS (chills), VACCINATION SITE ERYTHEMA (the injection site had a circle of red around it the size of a half dollar) and ARTHRALGIA (knee pain). At the time of the report, CHILLS (chills) and ARTHRALGIA (knee pain) had resolved and VACCINATION SITE ERYTHEMA (the injection site had a circle of red around it the size of a half dollar) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Diarrhoea, Fatigue, Headache
Clinical narrative: shakes; cough; arm was sore; body aches from head to toe with a severe headache; some diarrhea; sore throat; chills; fatigue; body aches from head to toe with a severe headache; fever of 101.1 degrees F; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shakes), COUGH (cough), PAIN IN EXTREMITY (arm was sore), PAIN (body aches from head to toe with a severe headache) and DIARRHOEA (some diarrhea) 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 26-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 TREMOR (shakes), COUGH (cough), PAIN IN EXTREMITY (arm was sore), PAIN (body aches from head to toe with a severe headache), DIARRHOEA (some diarrhea), OROPHARYNGEAL PAIN (sore throat), CHILLS (chills), FATIGUE (fatigue), HEADACHE (body aches from head to toe with a severe headache) and PYREXIA (fever of 101.1 degrees F). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. On 28-Feb-2021, TREMOR (shakes), COUGH (cough), PAIN (body aches from head to toe with a severe headache), DIARRHOEA (some diarrhea), OROPHARYNGEAL PAIN (sore throat), CHILLS (chills), FATIGUE (fatigue), HEADACHE (body aches from head to toe with a severe headache) and PYREXIA (fever of 101.1 degrees F) had resolved. At the time of the report, PAIN IN EXTREMITY (arm was sore) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medication was reported.
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain, Pain in extremity, Pyrexia, Tremor
Clinical narrative: shakes; cough; arm was sore; body aches from head to toe with a severe headache; some diarrhea; sore throat; chills; fatigue; body aches from head to toe with a severe headache; fever of 101.1 degrees F; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shakes), COUGH (cough), PAIN IN EXTREMITY (arm was sore), PAIN (body aches from head to toe with a severe headache) and DIARRHOEA (some diarrhea) 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 26-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 TREMOR (shakes), COUGH (cough), PAIN IN EXTREMITY (arm was sore), PAIN (body aches from head to toe with a severe headache), DIARRHOEA (some diarrhea), OROPHARYNGEAL PAIN (sore throat), CHILLS (chills), FATIGUE (fatigue), HEADACHE (body aches from head to toe with a severe headache) and PYREXIA (fever of 101.1 degrees F). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. On 28-Feb-2021, TREMOR (shakes), COUGH (cough), PAIN (body aches from head to toe with a severe headache), DIARRHOEA (some diarrhea), OROPHARYNGEAL PAIN (sore throat), CHILLS (chills), FATIGUE (fatigue), HEADACHE (body aches from head to toe with a severe headache) and PYREXIA (fever of 101.1 degrees F) had resolved. At the time of the report, PAIN IN EXTREMITY (arm was sore) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medication was reported.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Redness; Itchiness; Swelling; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness), PRURITUS (Itchiness) and SWELLING (Swelling) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced ERYTHEMA (Redness), PRURITUS (Itchiness) and SWELLING (Swelling). The patient was treated with HYDROCORTISONE (CORTISONE [HYDROCORTISONE]) at an unspecified dose and frequency. At the time of the report, ERYTHEMA (Redness), PRURITUS (Itchiness) and SWELLING (Swelling) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Additional Information received and Reporter details were updated.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: hardness; redness; swelling; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE INDURATION (hardness), INJECTION SITE ERYTHEMA (redness) and INJECTION SITE SWELLING (swelling) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) 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 an unknown date, the patient experienced INJECTION SITE INDURATION (hardness), INJECTION SITE ERYTHEMA (redness) and INJECTION SITE SWELLING (swelling). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. At the time of the report, INJECTION SITE INDURATION (hardness), INJECTION SITE ERYTHEMA (redness) and INJECTION SITE SWELLING (swelling) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Vaccination site erythema, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Occasional discomfort; Itching at the rash site; Pinkish/reddish circular rash around the injection site; pinkish/reddish circular rash around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (Occasional discomfort), VACCINATION SITE PRURITUS (Itching at the rash site), VACCINATION SITE RASH (Pinkish/reddish circular rash around the injection site) and VACCINATION SITE ERYTHEMA (pinkish/reddish circular rash around the injection site) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010a27a) for COVID-19 vaccination.     The patient's medical history was not provided.  Concomitant products included ROSUVASTATIN, VITAMIN D NOS, VITAMIN B COMPLEX (B COMPLEX (B50)), FISH OIL (OMEGA 3 FISH OIL [FISH OIL]) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itching at the rash site), VACCINATION SITE RASH (Pinkish/reddish circular rash around the injection site) and VACCINATION SITE ERYTHEMA (pinkish/reddish circular rash around the injection site). On an unknown date, the patient experienced DISCOMFORT (Occasional discomfort). At the time of the report, DISCOMFORT (Occasional discomfort), VACCINATION SITE PRURITUS (Itching at the rash site), VACCINATION SITE RASH (Pinkish/reddish circular rash around the injection site) and VACCINATION SITE ERYTHEMA (pinkish/reddish circular rash around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient did not take any treatment for events.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Caught COVID after first dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (Caught COVID after first dose) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 05-Mar-2021, the patient experienced COVID-19 (Caught COVID after first dose). At the time of the report, COVID-19 (Caught COVID after first dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, SARS-CoV-2 test: unknown (Positive) COVID-19 Positive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing was delayed on an unknown date.       No concomitant medication were provided. No treatment information were given by the reporter.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site mass, Paraesthesia, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Warm to touch; Hives reaction similar to the reaction from a bee stung; Red line which is swelled on the site of injection; Like an egg; itchy; injection site turn red / A line and the area turned a little pink; Tingly; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingly), VACCINATION SITE WARMTH (Warm to touch), INJECTION SITE MASS (Like an egg), VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE URTICARIA (Hives reaction similar to the reaction from a bee stung) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypothyroidism. Concomitant products included LEVOTHYROXINE for Hypothyroidism.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PARAESTHESIA (Tingly) and VACCINATION SITE ERYTHEMA (injection site turn red / A line and the area turned a little pink ). On 12-Mar-2021, the patient experienced INJECTION SITE MASS (Like an egg) and VACCINATION SITE PRURITUS (itchy). On 17-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE URTICARIA (Hives reaction similar to the reaction from a bee stung) and VACCINATION SITE SWELLING (Red line which is swelled on the site of injection). At the time of the report, PARAESTHESIA (Tingly), VACCINATION SITE WARMTH (Warm to touch), INJECTION SITE MASS (Like an egg), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE URTICARIA (Hives reaction similar to the reaction from a bee stung), VACCINATION SITE ERYTHEMA (injection site turn red / A line and the area turned a little pink ) and VACCINATION SITE SWELLING (Red line which is swelled on the site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment was reported for the events.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site urticaria, Vaccination site warmth
Clinical narrative: Warm to touch; Hives reaction similar to the reaction from a bee stung; Red line which is swelled on the site of injection; Like an egg; itchy; injection site turn red / A line and the area turned a little pink; Tingly; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingly), VACCINATION SITE WARMTH (Warm to touch), INJECTION SITE MASS (Like an egg), VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE URTICARIA (Hives reaction similar to the reaction from a bee stung) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypothyroidism. Concomitant products included LEVOTHYROXINE for Hypothyroidism.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PARAESTHESIA (Tingly) and VACCINATION SITE ERYTHEMA (injection site turn red / A line and the area turned a little pink ). On 12-Mar-2021, the patient experienced INJECTION SITE MASS (Like an egg) and VACCINATION SITE PRURITUS (itchy). On 17-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE URTICARIA (Hives reaction similar to the reaction from a bee stung) and VACCINATION SITE SWELLING (Red line which is swelled on the site of injection). At the time of the report, PARAESTHESIA (Tingly), VACCINATION SITE WARMTH (Warm to touch), INJECTION SITE MASS (Like an egg), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE URTICARIA (Hives reaction similar to the reaction from a bee stung), VACCINATION SITE ERYTHEMA (injection site turn red / A line and the area turned a little pink ) and VACCINATION SITE SWELLING (Red line which is swelled on the site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment was reported for the events.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Got symptoms only after the second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Got symptoms only after the second dose) in a  patient of an unknown age and gender 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Got symptoms only after the second dose). At the time of the report, VACCINATION COMPLICATION (Got symptoms only after the second dose) outcome was unknown.            No relevant concomitant medications were reported.  Treatment medications not reported.   This case was linked.   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Follow-up received on 17 Jun 2021 included no new information.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Vein collapse
Clinical narrative: He feels his veins around his heart are trying to collapse, it is constantly going on and off; This spontaneous case was reported by a consumer and describes the occurrence of VEIN COLLAPSE (He feels his veins around his heart are trying to collapse, it is constantly going on and off) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced VEIN COLLAPSE (He feels his veins around his heart are trying to collapse, it is constantly going on and off). At the time of the report, VEIN COLLAPSE (He feels his veins around his heart are trying to collapse, it is constantly going on and off) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient experienced events after couple of drinks. Concomitant products include Blood pressure pill and Thyroid medication. Treatment information was not provided.