chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site swelling
Clinical narrative: Very inflamed area beneath my injection site; fever of upto 102.2; 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 SITE SWELLING (Very inflamed area beneath my injection site) and PYREXIA (fever of upto 102.2) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (Very inflamed area beneath my injection site) and PYREXIA (fever of upto 102.2). At the time of the report, VACCINATION SITE SWELLING (Very inflamed area beneath my injection site) and PYREXIA (fever of upto 102.2) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: fever of upto 102.2 (High) fever of upto 102.2.         Treatment information not reported.   Concomitant medication not reported.   Reporter did not allow further contact
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Irritability, Pain in extremity, Peripheral swelling, Urticaria
Clinical narrative: right arm swelling; right arm burning; right arm irritated and hurting; right arm irritated and hurting; severe hives  in right hand; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (severe hives  in right hand), PERIPHERAL SWELLING (right arm swelling), BURNING SENSATION (right arm burning), IRRITABILITY (right arm irritated and hurting) and PAIN IN EXTREMITY (right arm irritated and hurting) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009c21a) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LINACLOTIDE (LINZESS) for an unknown indication.    On 24-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced URTICARIA (severe hives  in right hand). On 01-May-2021, the patient experienced PERIPHERAL SWELLING (right arm swelling), BURNING SENSATION (right arm burning), IRRITABILITY (right arm irritated and hurting) and PAIN IN EXTREMITY (right arm irritated and hurting). At the time of the report, URTICARIA (severe hives  in right hand), PERIPHERAL SWELLING (right arm swelling), BURNING SENSATION (right arm burning), IRRITABILITY (right arm irritated and hurting) and PAIN IN EXTREMITY (right arm irritated and hurting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       treatment included ice placing on the swelling.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Nodule, Pruritus, Sleep disorder, Urticaria
Clinical narrative: Hives primarily on back; He first noticed the bumps appearing primarily on his back; itching; difficulty with sleep interruption; Occasional Chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (Hives primarily on back), NODULE (He first noticed the bumps appearing primarily on his back), PRURITUS (itching), SLEEP DISORDER (difficulty with sleep interruption) and CHILLS (Occasional Chills) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 030M20A) for COVID-19 vaccination.     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 17-Mar-2021, the patient experienced URTICARIA (Hives primarily on back), NODULE (He first noticed the bumps appearing primarily on his back), PRURITUS (itching), SLEEP DISORDER (difficulty with sleep interruption) and CHILLS (Occasional Chills). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Difficulty sleeping, at a dose of 1 dosage form. At the time of the report, URTICARIA (Hives primarily on back), NODULE (He first noticed the bumps appearing primarily on his back), PRURITUS (itching), SLEEP DISORDER (difficulty with sleep interruption) and CHILLS (Occasional Chills) outcome was unknown.            The concomitant medication was not provided. The patient experienced hives for nearly 2 months after second dose.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: "There was a little round, red place" (injection site); "it hurt a little." (injection site); This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA ("There was a little round, red place" (injection site)) and INJECTION SITE PAIN ("it hurt a little." (injection site)) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA ("There was a little round, red place" (injection site)) and INJECTION SITE PAIN ("it hurt a little." (injection site)). On 28-Jan-2021, INJECTION SITE ERYTHEMA ("There was a little round, red place" (injection site)) and INJECTION SITE PAIN ("it hurt a little." (injection site)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications include blood pressure and thyroid medication were reported.  No Treatment medication was provided.  patient reported that she was doing physical therapy and it's improving.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Follow-up information received on 21-JUN-2021; contains No Significant information
Sex: U
Vaccine: COVID19
Symptoms: Chills, Erythema, Hyperhidrosis, Muscle spasms, Myalgia
Clinical narrative: sweating when sleeping to the point of being soaked; extreme muscle cramps in all my muscles was very painful; arm is red; has a huge bump the size of a tennis ball; Body aches; chills; 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 HYPERHIDROSIS (sweating when sleeping to the point of being soaked), MUSCLE SPASMS (extreme muscle cramps in all my muscles was very painful), ERYTHEMA (arm is red), SWELLING (has a huge bump the size of a tennis ball) and MYALGIA (Body aches) in a  patient of an unknown age and gender 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 19-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (sweating when sleeping to the point of being soaked), MUSCLE SPASMS (extreme muscle cramps in all my muscles was very painful), ERYTHEMA (arm is red), SWELLING (has a huge bump the size of a tennis ball), MYALGIA (Body aches) and CHILLS (chills). At the time of the report, HYPERHIDROSIS (sweating when sleeping to the point of being soaked), MUSCLE SPASMS (extreme muscle cramps in all my muscles was very painful), ERYTHEMA (arm is red), SWELLING (has a huge bump the size of a tennis ball), MYALGIA (Body aches) and CHILLS (chills) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications were reported. Treatment information was unknown.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: sweating when sleeping to the point of being soaked; extreme muscle cramps in all my muscles was very painful; arm is red; has a huge bump the size of a tennis ball; Body aches; chills; 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 HYPERHIDROSIS (sweating when sleeping to the point of being soaked), MUSCLE SPASMS (extreme muscle cramps in all my muscles was very painful), ERYTHEMA (arm is red), SWELLING (has a huge bump the size of a tennis ball) and MYALGIA (Body aches) in a  patient of an unknown age and gender 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 19-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (sweating when sleeping to the point of being soaked), MUSCLE SPASMS (extreme muscle cramps in all my muscles was very painful), ERYTHEMA (arm is red), SWELLING (has a huge bump the size of a tennis ball), MYALGIA (Body aches) and CHILLS (chills). At the time of the report, HYPERHIDROSIS (sweating when sleeping to the point of being soaked), MUSCLE SPASMS (extreme muscle cramps in all my muscles was very painful), ERYTHEMA (arm is red), SWELLING (has a huge bump the size of a tennis ball), MYALGIA (Body aches) and CHILLS (chills) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications were reported. Treatment information was unknown.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Condition aggravated, Hypokinesia, Injection site erythema, Injection site pain
Clinical narrative: pain progressive got worse; I wasn't able to move the left shoulder joint and arm so much, I ended up "freezing up; neck was so painful.; "There was a little round, red place" (injection site); "it hurt a little." (injection site); (left) shoulder joint was so painful.; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (pain progressive got worse), HYPOKINESIA (I wasn't able to move the left shoulder joint and arm so much, I ended up "freezing up), NECK PAIN (neck was so painful.), INJECTION SITE ERYTHEMA ("There was a little round, red place" (injection site)) and INJECTION SITE PAIN ("it hurt a little." (injection site)) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced CONDITION AGGRAVATED (pain progressive got worse), HYPOKINESIA (I wasn't able to move the left shoulder joint and arm so much, I ended up "freezing up), NECK PAIN (neck was so painful.) and ARTHRALGIA ((left) shoulder joint was so painful.). 21-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA ("There was a little round, red place" (injection site)) and INJECTION SITE PAIN ("it hurt a little." (injection site)). On 28-Jan-2021, INJECTION SITE PAIN ("it hurt a little." (injection site)) outcome was unknown. At the time of the report, CONDITION AGGRAVATED (pain progressive got worse), HYPOKINESIA (I wasn't able to move the left shoulder joint and arm so much, I ended up "freezing up), NECK PAIN (neck was so painful.) and ARTHRALGIA ((left) shoulder joint was so painful.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment details were provided. Patient is doing physical therapy and it's improving.   This case was linked to MOD-2021-163454 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Neck pain
Clinical narrative: pain progressive got worse; I wasn't able to move the left shoulder joint and arm so much, I ended up "freezing up; neck was so painful.; "There was a little round, red place" (injection site); "it hurt a little." (injection site); (left) shoulder joint was so painful.; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (pain progressive got worse), HYPOKINESIA (I wasn't able to move the left shoulder joint and arm so much, I ended up "freezing up), NECK PAIN (neck was so painful.), INJECTION SITE ERYTHEMA ("There was a little round, red place" (injection site)) and INJECTION SITE PAIN ("it hurt a little." (injection site)) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced CONDITION AGGRAVATED (pain progressive got worse), HYPOKINESIA (I wasn't able to move the left shoulder joint and arm so much, I ended up "freezing up), NECK PAIN (neck was so painful.) and ARTHRALGIA ((left) shoulder joint was so painful.). 21-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA ("There was a little round, red place" (injection site)) and INJECTION SITE PAIN ("it hurt a little." (injection site)). On 28-Jan-2021, INJECTION SITE PAIN ("it hurt a little." (injection site)) outcome was unknown. At the time of the report, CONDITION AGGRAVATED (pain progressive got worse), HYPOKINESIA (I wasn't able to move the left shoulder joint and arm so much, I ended up "freezing up), NECK PAIN (neck was so painful.) and ARTHRALGIA ((left) shoulder joint was so painful.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment details were provided. Patient is doing physical therapy and it's improving.   This case was linked to MOD-2021-163454 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: fever of 102.1; 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 PYREXIA (fever of 102.1) 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 PYREXIA (fever of 102.1). At the time of the report, PYREXIA (fever of 102.1) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102.1 (High) fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information was unknown.   Reporter did not allow further contact
Age: 55.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: second dose was improperly stored and administered; second dose was improperly stored and administered; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (second dose was improperly stored and administered) and EXPIRED PRODUCT ADMINISTERED (second dose was improperly stored and administered) in a 55-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A Í¾ 20Sep2021) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced PRODUCT STORAGE ERROR (second dose was improperly stored and administered) and EXPIRED PRODUCT ADMINISTERED (second dose was improperly stored and administered). On 12-Mar-2021, PRODUCT STORAGE ERROR (second dose was improperly stored and administered) and EXPIRED PRODUCT ADMINISTERED (second dose was improperly stored and administered) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details were provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: <strong>Moderna</strong> <p>Side Effects Reporting Form</p>; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of VACCINATION COMPLICATION (<strong>Moderna</strong> <p>Side Effects Reporting Form</p>) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) 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 VACCINATION COMPLICATION (<strong>Moderna</strong> <p>Side Effects Reporting Form</p>). At the time of the report, VACCINATION COMPLICATION (<strong>Moderna</strong> <p>Side Effects Reporting Form</p>) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication and treatment medications are reported
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: I received my first Moderna shot April 11th and am not allowed my second shot until August 1; 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I received my first Moderna shot April 11th and am not allowed my second shot until August 1) 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 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I received my first Moderna shot April 11th and am not allowed my second shot until August 1). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I received my first Moderna shot April 11th and am not allowed my second shot until August 1) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Feeling jittery
Clinical narrative: jitters in the face; This spontaneous case was reported by a consumer and describes the occurrence of FEELING JITTERY (jitters in the face) 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 FEELING JITTERY (jitters in the face). At the time of the report, FEELING JITTERY (jitters in the face) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information was unknown.   Reporter did not allow further contact
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: swollen arm ( COVID arm); This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen arm ( COVID arm)) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 010A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Irritable bowel syndrome. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and VITAMIN D NOS for an unknown indication.   On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. On 31-Jan-2021, the patient experienced PERIPHERAL SWELLING (swollen arm ( COVID arm)). The patient was treated with IBUPROFEN ongoing since an unknown date for Fever, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. On 06-Feb-2021, PERIPHERAL SWELLING (swollen arm ( COVID arm)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication include The omegas, rosacea medications     This case was linked to MOD-2021-163465 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: having issues with high heart rate still after 8 weeks of the last shot; 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 HEART RATE INCREASED (having issues with high heart rate still after 8 weeks of the last shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (having issues with high heart rate still after 8 weeks of the last shot). At the time of the report, HEART RATE INCREASED (having issues with high heart rate still after 8 weeks of the last shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient's medical history was not provided.  patient lab tests data not provided. Concomitant product use was not provided. Treatment information was not provided.   Reporter did not allow further contact
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Body temperature, Chills, Nausea, Peripheral swelling
Clinical narrative: stomach pain; Blotchy; rosacea; stomachache; fever; nausea; chills; swollen arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ABDOMINAL PAIN UPPER (stomachache), RASH MACULAR (Blotchy), ROSACEA (rosacea), PERIPHERAL SWELLING (swollen arm) and ABDOMINAL PAIN UPPER (stomach pain) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and VITAMIN D NOS for an unknown indication.    On 28-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, the patient experienced PERIPHERAL SWELLING (swollen arm). On 04-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (stomachache), PYREXIA (fever), NAUSEA (nausea) and CHILLS (chills). On 07-Mar-2021, the patient experienced RASH MACULAR (Blotchy) and ROSACEA (rosacea). On 23-May-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach pain). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of UNK dosage form and IBUPROFEN for Pain, at an unspecified dose and frequency. On 06-Mar-2021, PERIPHERAL SWELLING (swollen arm) had resolved. At the time of the report, ABDOMINAL PAIN UPPER (stomachache), RASH MACULAR (Blotchy), ROSACEA (rosacea), ABDOMINAL PAIN UPPER (stomach pain), PYREXIA (fever), NAUSEA (nausea) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 101.1 (High) The patient body temperature was 101.1.         Concomitant medication included omegas.  Further treatment information was not provided.  The patient also reported that her both arms were swollen after the both shots. and mentioned that people called it as COVID arm.   This case was linked to MOD-2021-163463 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash macular, Rosacea
Clinical narrative: stomach pain; Blotchy; rosacea; stomachache; fever; nausea; chills; swollen arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ABDOMINAL PAIN UPPER (stomachache), RASH MACULAR (Blotchy), ROSACEA (rosacea), PERIPHERAL SWELLING (swollen arm) and ABDOMINAL PAIN UPPER (stomach pain) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and VITAMIN D NOS for an unknown indication.    On 28-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, the patient experienced PERIPHERAL SWELLING (swollen arm). On 04-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (stomachache), PYREXIA (fever), NAUSEA (nausea) and CHILLS (chills). On 07-Mar-2021, the patient experienced RASH MACULAR (Blotchy) and ROSACEA (rosacea). On 23-May-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach pain). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of UNK dosage form and IBUPROFEN for Pain, at an unspecified dose and frequency. On 06-Mar-2021, PERIPHERAL SWELLING (swollen arm) had resolved. At the time of the report, ABDOMINAL PAIN UPPER (stomachache), RASH MACULAR (Blotchy), ROSACEA (rosacea), ABDOMINAL PAIN UPPER (stomach pain), PYREXIA (fever), NAUSEA (nausea) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 101.1 (High) The patient body temperature was 101.1.         Concomitant medication included omegas.  Further treatment information was not provided.  The patient also reported that her both arms were swollen after the both shots. and mentioned that people called it as COVID arm.   This case was linked to MOD-2021-163463 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Bedridden, Decreased appetite, Fatigue, Headache
Clinical narrative: felt very lethargic; barely unable to get out bed; no energy/extreme weakness; no appetite; low grade fever; extreme fatigue; throbbing pain in her arm which increased in intensity; very bad headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (throbbing pain in her arm which increased in intensity), LETHARGY (felt very lethargic), BEDRIDDEN (barely unable to get out bed), ASTHENIA (no energy/extreme weakness) and DECREASED APPETITE (no appetite) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 032B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced PAIN (throbbing pain in her arm which increased in intensity) and HEADACHE (very bad headache). On 12-Mar-2021, the patient experienced LETHARGY (felt very lethargic), BEDRIDDEN (barely unable to get out bed), ASTHENIA (no energy/extreme weakness), DECREASED APPETITE (no appetite), PYREXIA (low grade fever) and FATIGUE (extreme fatigue). At the time of the report, PAIN (throbbing pain in her arm which increased in intensity), LETHARGY (felt very lethargic), BEDRIDDEN (barely unable to get out bed), ASTHENIA (no energy/extreme weakness), DECREASED APPETITE (no appetite), PYREXIA (low grade fever), HEADACHE (very bad headache) and FATIGUE (extreme fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   On her second dose, patient felt less tired right after the vaccination. It was noon when it happened and she only felt slight headache. The next day she felt tired but went to the salon for her hair appointment. Said she still felt tired and drove slowly back home. When she got out from her car in their garage, she felt freezing cold and her teeth were chattering hard. Said she rushed upstairs, turned on the heater and used the electric blanket. Said her temperature was 101 degrees Fahrenheit and she had  very bad headache. She rechecked her temperature and it became 102, lymph nodes were tender and painful to touch, ears were throbbing and there was shooting arthritic pain everywhere; like a Ping-Pong ball response. Her thighs and legs felt they were on fire, air felt like hurting her skin and felt head was exploding. Patient she only took the migraine pill again for the symptoms and it subsided but fatigue went on for 7 days.  no concomitant medications and treatment details reported.   This case was linked to MOD-2021-163478 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Pain, Pyrexia
Clinical narrative: felt very lethargic; barely unable to get out bed; no energy/extreme weakness; no appetite; low grade fever; extreme fatigue; throbbing pain in her arm which increased in intensity; very bad headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (throbbing pain in her arm which increased in intensity), LETHARGY (felt very lethargic), BEDRIDDEN (barely unable to get out bed), ASTHENIA (no energy/extreme weakness) and DECREASED APPETITE (no appetite) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 032B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced PAIN (throbbing pain in her arm which increased in intensity) and HEADACHE (very bad headache). On 12-Mar-2021, the patient experienced LETHARGY (felt very lethargic), BEDRIDDEN (barely unable to get out bed), ASTHENIA (no energy/extreme weakness), DECREASED APPETITE (no appetite), PYREXIA (low grade fever) and FATIGUE (extreme fatigue). At the time of the report, PAIN (throbbing pain in her arm which increased in intensity), LETHARGY (felt very lethargic), BEDRIDDEN (barely unable to get out bed), ASTHENIA (no energy/extreme weakness), DECREASED APPETITE (no appetite), PYREXIA (low grade fever), HEADACHE (very bad headache) and FATIGUE (extreme fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   On her second dose, patient felt less tired right after the vaccination. It was noon when it happened and she only felt slight headache. The next day she felt tired but went to the salon for her hair appointment. Said she still felt tired and drove slowly back home. When she got out from her car in their garage, she felt freezing cold and her teeth were chattering hard. Said she rushed upstairs, turned on the heater and used the electric blanket. Said her temperature was 101 degrees Fahrenheit and she had  very bad headache. She rechecked her temperature and it became 102, lymph nodes were tender and painful to touch, ears were throbbing and there was shooting arthritic pain everywhere; like a Ping-Pong ball response. Her thighs and legs felt they were on fire, air felt like hurting her skin and felt head was exploding. Patient she only took the migraine pill again for the symptoms and it subsided but fatigue went on for 7 days.  no concomitant medications and treatment details reported.   This case was linked to MOD-2021-163478 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; 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 HERPES ZOSTER (shingles) 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 HERPES ZOSTER (shingles). At the time of the report, HERPES ZOSTER (shingles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information was unknown.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: Side Effects; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Side Effects) 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 ADVERSE REACTION (Side Effects). At the time of the report, ADVERSE REACTION (Side Effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information was unknown.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Headache, Mouth swelling, Nausea
Clinical narrative: tired; nauseated; headache; fever; redness in the area; swollen mouth; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness in the area), MOUTH SWELLING (swollen mouth), FATIGUE (tired), NAUSEA (nauseated) and HEADACHE (headache) in a male 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 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, the patient experienced ERYTHEMA (redness in the area) and MOUTH SWELLING (swollen mouth). On an unknown date, the patient experienced FATIGUE (tired), NAUSEA (nauseated), HEADACHE (headache) and PYREXIA (fever). At the time of the report, ERYTHEMA (redness in the area), MOUTH SWELLING (swollen mouth), FATIGUE (tired), NAUSEA (nauseated), HEADACHE (headache) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided. No treatment information provided.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: tired; nauseated; headache; fever; redness in the area; swollen mouth; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness in the area), MOUTH SWELLING (swollen mouth), FATIGUE (tired), NAUSEA (nauseated) and HEADACHE (headache) in a male 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 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, the patient experienced ERYTHEMA (redness in the area) and MOUTH SWELLING (swollen mouth). On an unknown date, the patient experienced FATIGUE (tired), NAUSEA (nauseated), HEADACHE (headache) and PYREXIA (fever). At the time of the report, ERYTHEMA (redness in the area), MOUTH SWELLING (swollen mouth), FATIGUE (tired), NAUSEA (nauseated), HEADACHE (headache) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided. No treatment information provided.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Pain in extremity
Clinical narrative: blood clot in his left lower calf; pain in lower left calf; This spontaneous case was reported by a consumer and describes the occurrence of DEEP VEIN THROMBOSIS (blood clot in his left lower calf) and PAIN IN EXTREMITY (pain in lower left calf) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history provided by the reporter.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-May-2021, the patient experienced PAIN IN EXTREMITY (pain in lower left calf). On 20-May-2021, the patient experienced DEEP VEIN THROMBOSIS (blood clot in his left lower calf). The patient was treated with ACETAMINOPHEN ongoing since an unknown date at an unspecified dose and frequency and RIVAROXABAN (XARELTO) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, DEEP VEIN THROMBOSIS (blood clot in his left lower calf) and PAIN IN EXTREMITY (pain in lower left calf) outcome was unknown.            No concomitant medications reported by investigator Action taken with mRNA-1273 in response to the events was not Applicable.  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.; 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: U
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (shortness of breath). At the time of the report, DYSPNOEA (shortness of breath) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information was unknown.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Myalgia
Clinical narrative: stomach cramps; pain; 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 ABDOMINAL PAIN UPPER (stomach cramps ) and MYALGIA (pain) 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 ABDOMINAL PAIN UPPER (stomach cramps ) and MYALGIA (pain). At the time of the report, ABDOMINAL PAIN UPPER (stomach cramps ) and MYALGIA (pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information was unknown.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: joint pain; 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 ARTHRALGIA (joint pain) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (joint pain). At the time of the report, ARTHRALGIA (joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication provided. No concomitant medication provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Abdominal discomfort, Anxiety, Feeling abnormal, Pain
Clinical narrative: feel something wrong in my body; anxiety; Princks in my body muscles; My stomach was no well/My stomach sometimes is still a bit weird; 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 FEELING ABNORMAL (feel something wrong in my body), ANXIETY (anxiety), PAIN (Princks in my body muscles) and ABDOMINAL DISCOMFORT (My stomach was no well/My stomach sometimes is still a bit weird) 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 FEELING ABNORMAL (feel something wrong in my body), ANXIETY (anxiety), PAIN (Princks in my body muscles) and ABDOMINAL DISCOMFORT (My stomach was no well/My stomach sometimes is still a bit weird). At the time of the report, FEELING ABNORMAL (feel something wrong in my body), ANXIETY (anxiety), PAIN (Princks in my body muscles) and ABDOMINAL DISCOMFORT (My stomach was no well/My stomach sometimes is still a bit weird) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information was unknown.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Burning sensation, Chills, Ear pain, Exploding head syndrome
Clinical narrative: lymph nodes were tender and painful to touch; ears were throbbing; thighs and legs felt they were on fire; air felt like hurting her skin; felt head was exploding; shooting  pain everywhere / painful to touch; felt freezing cold; shooting arthritic pain everywhere; teeth were chattering hard; temperature of 101-102 degrees Fahrenheit; felt less tired/ fatigue; felt slight headache / very bad headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 24-May-2021 and was forwarded to Moderna on 24-May-2021.    This spontaneous case was reported by a patient and describes the occurrence of LYMPH NODE PAIN (lymph nodes were tender and painful to touch), EAR PAIN (ears were throbbing), BURNING SENSATION (thighs and legs felt they were on fire), PAIN OF SKIN (air felt like hurting her skin) and EXPLODING HEAD SYNDROME (felt head was exploding) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 08-Apr-2021, the patient experienced HEADACHE (felt slight headache / very bad headache) and FATIGUE (felt less tired/ fatigue). On 09-Apr-2021, the patient experienced LYMPH NODE PAIN (lymph nodes were tender and painful to touch), EAR PAIN (ears were throbbing), BURNING SENSATION (thighs and legs felt they were on fire), PAIN OF SKIN (air felt like hurting her skin), EXPLODING HEAD SYNDROME (felt head was exploding), PAIN (shooting  pain everywhere / painful to touch), FEELING COLD (felt freezing cold), ARTHRALGIA (shooting arthritic pain everywhere), CHILLS (teeth were chattering hard) and PYREXIA (temperature of 101-102 degrees Fahrenheit). At the time of the report, LYMPH NODE PAIN (lymph nodes were tender and painful to touch), EAR PAIN (ears were throbbing), BURNING SENSATION (thighs and legs felt they were on fire), PAIN OF SKIN (air felt like hurting her skin), EXPLODING HEAD SYNDROME (felt head was exploding), PAIN (shooting  pain everywhere / painful to touch), FEELING COLD (felt freezing cold), ARTHRALGIA (shooting arthritic pain everywhere), HEADACHE (felt slight headache / very bad headache), CHILLS (teeth were chattering hard), PYREXIA (temperature of 101-102 degrees Fahrenheit) and FATIGUE (felt less tired/ fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported , No treatment medication was reported .   This case was linked to MOD-2021-163466 (Patient Link).   Reporter did not allow further contact