chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: Back pain; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history).    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced BACK PAIN (Back pain). At the time of the report, BACK PAIN (Back pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medications was not provided by the reporter. Treatment information was not provided. Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Injection site swelling
Clinical narrative: Injection site hardness; Injection site swelling; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE INDURATION (Injection site hardness) and INJECTION SITE SWELLING (Injection site swelling) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 05004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced INJECTION SITE INDURATION (Injection site hardness) and INJECTION SITE SWELLING (Injection site swelling). At the time of the report, INJECTION SITE INDURATION (Injection site hardness) and INJECTION SITE SWELLING (Injection site swelling) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; 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: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: Fast heart rate; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Fast heart rate) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced HEART RATE INCREASED (Fast heart rate). At the time of the report, HEART RATE INCREASED (Fast heart rate) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Follow-up received on 16-APR-2021, and no new information added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Headache, Heart rate increased, Inflammation
Clinical narrative: needles and pin pokes in her arms, hands and scalp; mild chill; Mild headaches; physical pain in arms and back, severe body ache (not typical as flu) was not able to lean on her side, severe pain through back, legs; severe pain through neck; itchy skin; chest pain; Increased heart beat; Something similar to inflammation in the soft tissue of the chest, sharpness, low grade chest pain; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain), HEART RATE INCREASED (Increased heart beat), INFLAMMATION (Something similar to inflammation in the soft tissue of the chest, sharpness, low grade chest pain), PAIN IN EXTREMITY (needles and pin pokes in her arms, hands and scalp) and NECK PAIN (severe pain through neck) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025G20A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in March 2020.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Feb-2021, the patient experienced CHEST PAIN (chest pain), HEART RATE INCREASED (Increased heart beat), INFLAMMATION (Something similar to inflammation in the soft tissue of the chest, sharpness, low grade chest pain), NECK PAIN (severe pain through neck), PRURITUS (itchy skin) and MYALGIA (physical pain in arms and back, severe body ache (not typical as flu) was not able to lean on her side, severe pain through back, legs). On 18-Feb-2021, the patient experienced PAIN IN EXTREMITY (needles and pin pokes in her arms, hands and scalp), CHILLS (mild chill) and HEADACHE (Mild headaches). The patient was treated with PARACETAMOL (TYLENOL) on 16-Feb-2021 for Myalgia, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 18-Feb-2021 for Itching, at an unspecified dose and frequency. On 16-Feb-2021, CHEST PAIN (chest pain), HEART RATE INCREASED (Increased heart beat), INFLAMMATION (Something similar to inflammation in the soft tissue of the chest, sharpness, low grade chest pain), NECK PAIN (severe pain through neck) and MYALGIA (physical pain in arms and back, severe body ache (not typical as flu) was not able to lean on her side, severe pain through back, legs) had resolved. At the time of the report, PAIN IN EXTREMITY (needles and pin pokes in her arms, hands and scalp), PRURITUS (itchy skin), CHILLS (mild chill) and HEADACHE (Mild headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Neck pain, Pain in extremity, Pruritus
Clinical narrative: needles and pin pokes in her arms, hands and scalp; mild chill; Mild headaches; physical pain in arms and back, severe body ache (not typical as flu) was not able to lean on her side, severe pain through back, legs; severe pain through neck; itchy skin; chest pain; Increased heart beat; Something similar to inflammation in the soft tissue of the chest, sharpness, low grade chest pain; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain), HEART RATE INCREASED (Increased heart beat), INFLAMMATION (Something similar to inflammation in the soft tissue of the chest, sharpness, low grade chest pain), PAIN IN EXTREMITY (needles and pin pokes in her arms, hands and scalp) and NECK PAIN (severe pain through neck) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025G20A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in March 2020.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Feb-2021, the patient experienced CHEST PAIN (chest pain), HEART RATE INCREASED (Increased heart beat), INFLAMMATION (Something similar to inflammation in the soft tissue of the chest, sharpness, low grade chest pain), NECK PAIN (severe pain through neck), PRURITUS (itchy skin) and MYALGIA (physical pain in arms and back, severe body ache (not typical as flu) was not able to lean on her side, severe pain through back, legs). On 18-Feb-2021, the patient experienced PAIN IN EXTREMITY (needles and pin pokes in her arms, hands and scalp), CHILLS (mild chill) and HEADACHE (Mild headaches). The patient was treated with PARACETAMOL (TYLENOL) on 16-Feb-2021 for Myalgia, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 18-Feb-2021 for Itching, at an unspecified dose and frequency. On 16-Feb-2021, CHEST PAIN (chest pain), HEART RATE INCREASED (Increased heart beat), INFLAMMATION (Something similar to inflammation in the soft tissue of the chest, sharpness, low grade chest pain), NECK PAIN (severe pain through neck) and MYALGIA (physical pain in arms and back, severe body ache (not typical as flu) was not able to lean on her side, severe pain through back, legs) had resolved. At the time of the report, PAIN IN EXTREMITY (needles and pin pokes in her arms, hands and scalp), PRURITUS (itchy skin), CHILLS (mild chill) and HEADACHE (Mild headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal distension, Decreased appetite, Diarrhoea, Fatigue
Clinical narrative: loose bowels; flu like; abdominal discomfort; bloating; loss of apetite; headache; tiredness; This spontaneous case was reported by an other and describes the occurrence of DIARRHOEA (loose bowels), INFLUENZA LIKE ILLNESS (flu like), ABDOMINAL DISCOMFORT (abdominal discomfort), ABDOMINAL DISTENSION (bloating) and DECREASED APPETITE (loss of apetite) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A-214) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension. Concomitant products included FAMOTIDINE for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced DIARRHOEA (loose bowels). 21-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like), ABDOMINAL DISCOMFORT (abdominal discomfort), ABDOMINAL DISTENSION (bloating), DECREASED APPETITE (loss of apetite), HEADACHE (headache) and FATIGUE (tiredness). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at a dose of 500 milligram. On 25-Jan-2021, DIARRHOEA (loose bowels), INFLUENZA LIKE ILLNESS (flu like), ABDOMINAL DISCOMFORT (abdominal discomfort), ABDOMINAL DISTENSION (bloating), DECREASED APPETITE (loss of apetite), HEADACHE (headache) and FATIGUE (tiredness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient also used Blood pressure medications concomitantly.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Influenza like illness
Clinical narrative: loose bowels; flu like; abdominal discomfort; bloating; loss of apetite; headache; tiredness; This spontaneous case was reported by an other and describes the occurrence of DIARRHOEA (loose bowels), INFLUENZA LIKE ILLNESS (flu like), ABDOMINAL DISCOMFORT (abdominal discomfort), ABDOMINAL DISTENSION (bloating) and DECREASED APPETITE (loss of apetite) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A-214) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension. Concomitant products included FAMOTIDINE for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced DIARRHOEA (loose bowels). 21-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like), ABDOMINAL DISCOMFORT (abdominal discomfort), ABDOMINAL DISTENSION (bloating), DECREASED APPETITE (loss of apetite), HEADACHE (headache) and FATIGUE (tiredness). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at a dose of 500 milligram. On 25-Jan-2021, DIARRHOEA (loose bowels), INFLUENZA LIKE ILLNESS (flu like), ABDOMINAL DISCOMFORT (abdominal discomfort), ABDOMINAL DISTENSION (bloating), DECREASED APPETITE (loss of apetite), HEADACHE (headache) and FATIGUE (tiredness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient also used Blood pressure medications concomitantly.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nausea, Pain in extremity
Clinical narrative: Sore arm for 3-4 days; felt puny that lingered for 4-5 days; Nausea that lingered for 4-5 days; Chills that lingered for 4-5 days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm for 3-4 days), FATIGUE (felt puny that lingered for 4-5 days), NAUSEA (Nausea that lingered for 4-5 days) and CHILLS (Chills that lingered for 4-5 days) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm for 3-4 days), FATIGUE (felt puny that lingered for 4-5 days), NAUSEA (Nausea that lingered for 4-5 days) and CHILLS (Chills that lingered for 4-5 days). At the time of the report, PAIN IN EXTREMITY (Sore arm for 3-4 days), FATIGUE (felt puny that lingered for 4-5 days), NAUSEA (Nausea that lingered for 4-5 days) and CHILLS (Chills that lingered for 4-5 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       . No relevant concomitant medications were reported. No treatment information was provided.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Discomfort, Fatigue
Clinical narrative: baseball size swelling under her left arm; baseball size swelling under her left arm likely a swollen lymph node; pain in the top of the shoulder down to armpit; discomfort; low-grade fever of 99 F that went to 100.2 F then back down; fatigue; chills; muscles aches, soreness; headache; nausea; slight arm pain through the day; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (slight arm pain through the day), PERIPHERAL SWELLING (baseball size swelling under her left arm), DISCOMFORT (discomfort), PYREXIA (low-grade fever of 99 F that went to 100.2 F then back down) and FATIGUE (fatigue) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma, Migraine and Sinusitis. Concomitant products included MONTELUKAST SODIUM (SINGULAIR) and ALBUTEROL [SALBUTAMOL] for Asthma, IBUPROFEN for Migraine.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Feb-2021, the patient experienced PAIN IN EXTREMITY (slight arm pain through the day). On 02-Feb-2021, the patient experienced DISCOMFORT (discomfort), PYREXIA (low-grade fever of 99 F that went to 100.2 F then back down), FATIGUE (fatigue), CHILLS (chills), MYALGIA (muscles aches, soreness), HEADACHE (headache) and NAUSEA (nausea). 02-Feb-2021, the patient experienced ARTHRALGIA (pain in the top of the shoulder down to armpit). On 03-Feb-2021, the patient experienced PERIPHERAL SWELLING (baseball size swelling under her left arm) and LYMPHADENOPATHY (baseball size swelling under her left arm likely a swollen lymph node). The patient was treated with IBUPROFEN for Fever, at an unspecified dose and frequency and MONTELUKAST SODIUM (SINGULAIR) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (slight arm pain through the day), PERIPHERAL SWELLING (baseball size swelling under her left arm), DISCOMFORT (discomfort), PYREXIA (low-grade fever of 99 F that went to 100.2 F then back down), FATIGUE (fatigue), CHILLS (chills), MYALGIA (muscles aches, soreness), HEADACHE (headache), NAUSEA (nausea), LYMPHADENOPATHY (baseball size swelling under her left arm likely a swollen lymph node) and ARTHRALGIA (pain in the top of the shoulder down to armpit) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Feb-2021, Body temperature: 99-100.2 (High) temperature elevated from 99 to 100.2F. On 03-Feb-2021, Body temperature: 98 f-99f (normal) Temperature elevated between 98 F and 99 F.         Concomitant medications Ibuprofen, Singulair, albuterol inhaler.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Updated the outcome of event
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy, Myalgia, Nausea, Pain in extremity
Clinical narrative: baseball size swelling under her left arm; baseball size swelling under her left arm likely a swollen lymph node; pain in the top of the shoulder down to armpit; discomfort; low-grade fever of 99 F that went to 100.2 F then back down; fatigue; chills; muscles aches, soreness; headache; nausea; slight arm pain through the day; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (slight arm pain through the day), PERIPHERAL SWELLING (baseball size swelling under her left arm), DISCOMFORT (discomfort), PYREXIA (low-grade fever of 99 F that went to 100.2 F then back down) and FATIGUE (fatigue) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma, Migraine and Sinusitis. Concomitant products included MONTELUKAST SODIUM (SINGULAIR) and ALBUTEROL [SALBUTAMOL] for Asthma, IBUPROFEN for Migraine.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Feb-2021, the patient experienced PAIN IN EXTREMITY (slight arm pain through the day). On 02-Feb-2021, the patient experienced DISCOMFORT (discomfort), PYREXIA (low-grade fever of 99 F that went to 100.2 F then back down), FATIGUE (fatigue), CHILLS (chills), MYALGIA (muscles aches, soreness), HEADACHE (headache) and NAUSEA (nausea). 02-Feb-2021, the patient experienced ARTHRALGIA (pain in the top of the shoulder down to armpit). On 03-Feb-2021, the patient experienced PERIPHERAL SWELLING (baseball size swelling under her left arm) and LYMPHADENOPATHY (baseball size swelling under her left arm likely a swollen lymph node). The patient was treated with IBUPROFEN for Fever, at an unspecified dose and frequency and MONTELUKAST SODIUM (SINGULAIR) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (slight arm pain through the day), PERIPHERAL SWELLING (baseball size swelling under her left arm), DISCOMFORT (discomfort), PYREXIA (low-grade fever of 99 F that went to 100.2 F then back down), FATIGUE (fatigue), CHILLS (chills), MYALGIA (muscles aches, soreness), HEADACHE (headache), NAUSEA (nausea), LYMPHADENOPATHY (baseball size swelling under her left arm likely a swollen lymph node) and ARTHRALGIA (pain in the top of the shoulder down to armpit) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Feb-2021, Body temperature: 99-100.2 (High) temperature elevated from 99 to 100.2F. On 03-Feb-2021, Body temperature: 98 f-99f (normal) Temperature elevated between 98 F and 99 F.         Concomitant medications Ibuprofen, Singulair, albuterol inhaler.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Updated the outcome of event
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: baseball size swelling under her left arm; baseball size swelling under her left arm likely a swollen lymph node; pain in the top of the shoulder down to armpit; discomfort; low-grade fever of 99 F that went to 100.2 F then back down; fatigue; chills; muscles aches, soreness; headache; nausea; slight arm pain through the day; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (slight arm pain through the day), PERIPHERAL SWELLING (baseball size swelling under her left arm), DISCOMFORT (discomfort), PYREXIA (low-grade fever of 99 F that went to 100.2 F then back down) and FATIGUE (fatigue) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma, Migraine and Sinusitis. Concomitant products included MONTELUKAST SODIUM (SINGULAIR) and ALBUTEROL [SALBUTAMOL] for Asthma, IBUPROFEN for Migraine.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Feb-2021, the patient experienced PAIN IN EXTREMITY (slight arm pain through the day). On 02-Feb-2021, the patient experienced DISCOMFORT (discomfort), PYREXIA (low-grade fever of 99 F that went to 100.2 F then back down), FATIGUE (fatigue), CHILLS (chills), MYALGIA (muscles aches, soreness), HEADACHE (headache) and NAUSEA (nausea). 02-Feb-2021, the patient experienced ARTHRALGIA (pain in the top of the shoulder down to armpit). On 03-Feb-2021, the patient experienced PERIPHERAL SWELLING (baseball size swelling under her left arm) and LYMPHADENOPATHY (baseball size swelling under her left arm likely a swollen lymph node). The patient was treated with IBUPROFEN for Fever, at an unspecified dose and frequency and MONTELUKAST SODIUM (SINGULAIR) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (slight arm pain through the day), PERIPHERAL SWELLING (baseball size swelling under her left arm), DISCOMFORT (discomfort), PYREXIA (low-grade fever of 99 F that went to 100.2 F then back down), FATIGUE (fatigue), CHILLS (chills), MYALGIA (muscles aches, soreness), HEADACHE (headache), NAUSEA (nausea), LYMPHADENOPATHY (baseball size swelling under her left arm likely a swollen lymph node) and ARTHRALGIA (pain in the top of the shoulder down to armpit) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Feb-2021, Body temperature: 99-100.2 (High) temperature elevated from 99 to 100.2F. On 03-Feb-2021, Body temperature: 98 f-99f (normal) Temperature elevated between 98 F and 99 F.         Concomitant medications Ibuprofen, Singulair, albuterol inhaler.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Updated the outcome of event
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache
Clinical narrative: weak; Chills; HEADACHE/ Head was hurting her going through her eyes; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weak), CHILLS (Chills) and HEADACHE (HEADACHE/ Head was hurting her going through her eyes) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included Planning to become pregnant since an unknown date. Concurrent medical conditions included Asthma and Graves' disease.    On 28-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced ASTHENIA (weak), CHILLS (Chills) and HEADACHE (HEADACHE/ Head was hurting her going through her eyes). At the time of the report, ASTHENIA (weak), CHILLS (Chills) and HEADACHE (HEADACHE/ Head was hurting her going through her eyes) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product use was reported No treatment information was provided; 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.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Slight rash in her arm; A spontaneous report was received from a consumer who is a 67-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced slight rash in her arm.  The patient's medical history included hypothyroidism. Concomitant medications reported were medication for hypothyroidism.  On 23-Jan-2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: 042L20A) intramuscularly in her arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the slight rash. The reporter indicated other for seriousness but this is not consistent with the presentation of the event slight rash.  No lab data was provided.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was Unknown  On an unknown date the outcome of slight rash was considered to be recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. This event is not serious.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Dizziness, Feeling abnormal, Nausea, Pyrexia
Clinical narrative: bone pain/ unbearable femur pain; awoke with fever; nausea; dizziness; could not keep it down; Feel odd; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feel odd) and BONE PAIN (bone pain/ unbearable femur pain) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (had Covid over thanksgiving weekend) in November 2020.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced FEELING ABNORMAL (Feel odd). On 02-Feb-2021 at 1:00 AM, the patient experienced BONE PAIN (bone pain/ unbearable femur pain). The patient was treated with BENZYL NICOTINATE, CAMPHOR, GLYCOL SALICYLATE, MENTHOL, METHYL SALICYLATE (SALONPAS TOPICAL) ongoing since an unknown date for Pain, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (Feel odd) and BONE PAIN (bone pain/ unbearable femur pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.; 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: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: bone pain/ unbearable femur pain; awoke with fever; nausea; dizziness; could not keep it down; Feel odd; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feel odd) and BONE PAIN (bone pain/ unbearable femur pain) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (had Covid over thanksgiving weekend) in November 2020.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced FEELING ABNORMAL (Feel odd). On 02-Feb-2021 at 1:00 AM, the patient experienced BONE PAIN (bone pain/ unbearable femur pain). The patient was treated with BENZYL NICOTINATE, CAMPHOR, GLYCOL SALICYLATE, MENTHOL, METHYL SALICYLATE (SALONPAS TOPICAL) ongoing since an unknown date for Pain, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (Feel odd) and BONE PAIN (bone pain/ unbearable femur pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.; 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: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pain in extremity
Clinical narrative: General body pain; Pain in arm; Fatigue; Chills; This spontaneous case was reported by a nurse and describes the occurrence of PAIN (General body pain), PAIN IN EXTREMITY (Pain in arm), FATIGUE (Fatigue) and CHILLS (Chills) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Jan-2021, the patient experienced PAIN (General body pain), PAIN IN EXTREMITY (Pain in arm), FATIGUE (Fatigue) and CHILLS (Chills). At the time of the report, PAIN (General body pain), PAIN IN EXTREMITY (Pain in arm), FATIGUE (Fatigue) and CHILLS (Chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication use was not provided by reporter.  Patient used topical Salonpas  for soreness of arm
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: little sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (little sore arm) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K702A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced PAIN IN EXTREMITY (little sore arm). At the time of the report, PAIN IN EXTREMITY (little sore arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient reported that she should take Lipitor daily but she didn't take it near the time of the vaccination or afterwards. No treatment medications were reported.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: pain and a sore arm; slight fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain and a sore arm) and PYREXIA (slight fever) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy and Seasonal allergy. Concomitant products included MONTELUKAST SODIUM (SINGULAIR) for an unknown indication.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2021, the patient experienced PAIN IN EXTREMITY (pain and a sore arm) and PYREXIA (slight fever). At the time of the report, PAIN IN EXTREMITY (pain and a sore arm) and PYREXIA (slight fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: felt like she was going to get an allergy; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (felt like she was going to get an allergy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030MZ0A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to arthropod bite (allergy to bees).    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (felt like she was going to get an allergy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) in February 2021 for Allergic reaction, at an unspecified dose and frequency. At the time of the report, HYPERSENSITIVITY (felt like she was going to get an allergy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Patient took diphenhydramine because she felt like she would get allergic reaction 20 minutes after the shot, and she did not allow it to happen, she took it for 2 days and she was fine.
Age: 73.0
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness at the injection site) in a 73-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced VACCINATION SITE PAIN (Soreness at the injection site). At the time of the report, VACCINATION SITE PAIN (Soreness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported Treatment medications was not provided; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced HEADACHE (headache). At the time of the report, 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 medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: reaction to 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (reaction to 1st dose) 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 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (reaction to 1st dose). At the time of the report, ADVERSE REACTION (reaction to 1st dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications taken by the patient were not provided. Treatment information was not provided.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Sleep apnoea syndrome
Clinical narrative: Feeling faint and light headed; Number of episodes on his sleep apnea machine increased from 1 episode per hour to 28; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Feeling faint and light headed) and SLEEP APNOEA SYNDROME (Number of episodes on his sleep apnea machine increased from 1 episode per hour to 28) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012MZ0A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and High cholesterol. Concomitant products included ATENOLOL, HYDROCHLOROTHIAZIDE, ALOPURINOL and ROSUVASTATIN for an unknown indication.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced DIZZINESS (Feeling faint and light headed) and SLEEP APNOEA SYNDROME (Number of episodes on his sleep apnea machine increased from 1 episode per hour to 28). On 02-Feb-2021, DIZZINESS (Feeling faint and light headed) had resolved. At the time of the report, SLEEP APNOEA SYNDROME (Number of episodes on his sleep apnea machine increased from 1 episode per hour to 28) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included Not provided   Most recent FOLLOW-UP information incorporated above includes: On 29-Mar-2021: On 19-Apr-2021: Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Feeling hot, Malaise, Pain in extremity
Clinical narrative: arm was extremely sore from the distance of the shot; t was also red, hot; t was also red, hot; severe chills, fever all day; severe chills, fever all day; she's been sick all day; she hasn't been able to get out of her bed; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (she's been sick all day; she hasn't been able to get out of her bed), PAIN IN EXTREMITY (arm was extremely sore from the distance of the shot), ERYTHEMA (t was also red, hot), FEELING HOT (t was also red, hot) and PYREXIA (severe chills, fever all day) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Jan-2021, the patient experienced MALAISE (she's been sick all day; she hasn't been able to get out of her bed), PYREXIA (severe chills, fever all day) and CHILLS (severe chills, fever all day). On an unknown date, the patient experienced PAIN IN EXTREMITY (arm was extremely sore from the distance of the shot), ERYTHEMA (t was also red, hot) and FEELING HOT (t was also red, hot). At the time of the report, MALAISE (she's been sick all day; she hasn't been able to get out of her bed), FEELING HOT (t was also red, hot), PYREXIA (severe chills, fever all day) and CHILLS (severe chills, fever all day) had resolved and PAIN IN EXTREMITY (arm was extremely sore from the distance of the shot) and ERYTHEMA (t was also red, hot) was resolving.            No relevant concomitant medications were reported. Treatment details included Not provided
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: arm was extremely sore from the distance of the shot; t was also red, hot; t was also red, hot; severe chills, fever all day; severe chills, fever all day; she's been sick all day; she hasn't been able to get out of her bed; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (she's been sick all day; she hasn't been able to get out of her bed), PAIN IN EXTREMITY (arm was extremely sore from the distance of the shot), ERYTHEMA (t was also red, hot), FEELING HOT (t was also red, hot) and PYREXIA (severe chills, fever all day) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Jan-2021, the patient experienced MALAISE (she's been sick all day; she hasn't been able to get out of her bed), PYREXIA (severe chills, fever all day) and CHILLS (severe chills, fever all day). On an unknown date, the patient experienced PAIN IN EXTREMITY (arm was extremely sore from the distance of the shot), ERYTHEMA (t was also red, hot) and FEELING HOT (t was also red, hot). At the time of the report, MALAISE (she's been sick all day; she hasn't been able to get out of her bed), FEELING HOT (t was also red, hot), PYREXIA (severe chills, fever all day) and CHILLS (severe chills, fever all day) had resolved and PAIN IN EXTREMITY (arm was extremely sore from the distance of the shot) and ERYTHEMA (t was also red, hot) was resolving.            No relevant concomitant medications were reported. Treatment details included Not provided
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Very itchy rash in injection site; Big rash in injection site, Skin Rash covering whole upper left arm injection site; Normal ache pains; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Normal ache pains), VACCINATION SITE PRURITUS (Very itchy rash in injection site) and VACCINATION SITE RASH (Big rash in injection site, Skin Rash covering whole upper left arm injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Drug allergy (NSAIDs Allergy) and Acid reflux (oesophageal) since 1997. Concomitant products included FAMOTIDINE (PEPCID AC) for Acid reflux (esophageal), PENICILLIN N from 24-Jan-2021 to an unknown date for Tooth extraction.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced PAIN (Normal ache pains). On 23-Jan-2021, the patient experienced VACCINATION SITE RASH (Big rash in injection site, Skin Rash covering whole upper left arm injection site). On 25-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Very itchy rash in injection site). The patient was treated with LORATADINE (CLARITINE) for Rash, at an unspecified dose and frequency. On 06-Feb-2021, VACCINATION SITE RASH (Big rash in injection site, Skin Rash covering whole upper left arm injection site) had resolved. At the time of the report, PAIN (Normal ache pains) outcome was unknown and VACCINATION SITE PRURITUS (Very itchy rash in injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-080634 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Apr-2021: Reporter address, patient demographics, allergies, history, concomitant medicines, rechallenge information were updated.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm soreness; 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 PAIN IN EXTREMITY (Arm soreness) 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 PAIN IN EXTREMITY (Arm soreness). At the time of the report, PAIN IN EXTREMITY (Arm soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The Concomitant medications were not reported.  No treatment information was provided
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Muscular weakness, Pain
Clinical narrative: Soreness; Injection site feels warm to the touch; Injection site is swollen; Injection site is painful; He cannot move his hand all the way up; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Soreness), INJECTION SITE WARMTH (Injection site feels warm to the touch), INJECTION SITE SWELLING (Injection site is swollen), INJECTION SITE PAIN (Injection site is painful) and MUSCULAR WEAKNESS (He cannot move his hand all the way up) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced PAIN (Soreness), INJECTION SITE WARMTH (Injection site feels warm to the touch), INJECTION SITE SWELLING (Injection site is swollen), INJECTION SITE PAIN (Injection site is painful) and MUSCULAR WEAKNESS (He cannot move his hand all the way up). At the time of the report, PAIN (Soreness), INJECTION SITE WARMTH (Injection site feels warm to the touch), INJECTION SITE SWELLING (Injection site is swollen), INJECTION SITE PAIN (Injection site is painful) and MUSCULAR WEAKNESS (He cannot move his hand all the way up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided; 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.