chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Severe itching; A spontaneous report was received from a consumer concerning a  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events severe itching/pruritus.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) severe itching.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), severe itching was unknown.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Constipation, Disorientation, Electric shock sensation, Fatigue, Gait disturbance
Clinical narrative: constipation got worse; Both legs swelled up; Stings like electric shocks; Disoriented; wobbly on her feet (unstable); Fatigue; A spontaneous report was received from a consumer concerning a 84 year old, female patient who developed fatigue, disorientation, wobbly on her feet (unstable), both her legs swelled and got stings like electric shocks and constipation.  The patient's medical history was not provided.  Products known to have been used by the patient, within two weeks prior to the events, included Novastix, Amitiza, thyroxine, Nexium, calcium, vit d3, Blood thinner Aggrenox. Patient was allergic to codeine.   The patient received their first of two planned doses of mRNA-1273 (Batch number: 030M20A) on 16 Feb 2021 intramuscularly in the injection site for prophylaxis of COVID-19 infection.   On 16 Feb 2021 she had her 1st shot of moderna covid- 19 vaccination from that day onwards she had fatigue that lasted for 2 days. On 18 Feb 2021 she was disoriented dizzy and wobbly on her feet (unstable). On 20 Feb 2021 both her legs swelled and got stings like electric shocks. She usually had trouble with her bowels (constipation) but got worsen on 21 Feb 2021. Treatment for the event included Tylenol.  Action taken with mRNA-1273 in response to the events was not provided.  The events, fatigue, disorientation, wobbly on her feet (unstable), both her legs swelled and got stings like electric shocks and constipation, was considered resolved.    The reported event, fatigue was considered related to mRNA- 1273.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-020371:Same reporter, reporter's sister US-MODERNATX, INC.-MOD-2021-020515:Same reporter, reporter's son
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: constipation got worse; Both legs swelled up; Stings like electric shocks; Disoriented; wobbly on her feet (unstable); Fatigue; A spontaneous report was received from a consumer concerning a 84 year old, female patient who developed fatigue, disorientation, wobbly on her feet (unstable), both her legs swelled and got stings like electric shocks and constipation.  The patient's medical history was not provided.  Products known to have been used by the patient, within two weeks prior to the events, included Novastix, Amitiza, thyroxine, Nexium, calcium, vit d3, Blood thinner Aggrenox. Patient was allergic to codeine.   The patient received their first of two planned doses of mRNA-1273 (Batch number: 030M20A) on 16 Feb 2021 intramuscularly in the injection site for prophylaxis of COVID-19 infection.   On 16 Feb 2021 she had her 1st shot of moderna covid- 19 vaccination from that day onwards she had fatigue that lasted for 2 days. On 18 Feb 2021 she was disoriented dizzy and wobbly on her feet (unstable). On 20 Feb 2021 both her legs swelled and got stings like electric shocks. She usually had trouble with her bowels (constipation) but got worsen on 21 Feb 2021. Treatment for the event included Tylenol.  Action taken with mRNA-1273 in response to the events was not provided.  The events, fatigue, disorientation, wobbly on her feet (unstable), both her legs swelled and got stings like electric shocks and constipation, was considered resolved.    The reported event, fatigue was considered related to mRNA- 1273.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-020371:Same reporter, reporter's sister US-MODERNATX, INC.-MOD-2021-020515:Same reporter, reporter's son
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site mass, Vaccination site pruritus
Clinical narrative: Left arm hurt for 2 days; Bump at injection site; Itching at injection site; Red at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Left arm hurt for 2 days), VACCINATION SITE MASS (Bump at injection site), VACCINATION SITE PRURITUS (Itching at injection site) and VACCINATION SITE ERYTHEMA (Red at injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's medical history was not provided.  Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA), ACETYLSALICYLIC ACID (DISPRIN), METOPROLOL and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Left arm hurt for 2 days), VACCINATION SITE MASS (Bump at injection site), VACCINATION SITE PRURITUS (Itching at injection site) and VACCINATION SITE ERYTHEMA (Red at injection site). On 20-Jan-2021, PAIN IN EXTREMITY (Left arm hurt for 2 days) had resolved. On 28-Jan-2021, VACCINATION SITE MASS (Bump at injection site) and VACCINATION SITE PRURITUS (Itching at injection site) had resolved. On 29-Jan-2021, VACCINATION SITE ERYTHEMA (Red at injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Email-id updated and Email Document Attached
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Myalgia, Pyrexia
Clinical narrative: fever 100.5F; Headache; weakness; muscle aches; chills; A spontaneous report was received from consumer concerning herself of 50 years old age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced high fever /pyrexia 100.5 F, headache, weakness/asthenia, muscle ache/myalgia, chills.  On 05 JAN 2021, patient was diagnosed with COVID-19 as reported. Concomitant medications were not reported.  On 22 JAN 2021, prior to onset of events, the patient received a first dose of two planned doses of mRNA-1273 (Lot number: 012L20A) via intramuscular route in left arm for prophylaxis of COVID-19 infection.  On 23 JAN 2021, the patient experienced very high fever to 100.5 F, headache, weakness, muscle ache, chills. Tylenol and Ibuprofen treatment medication was reported.  Action taken with mRNA-1273 in response to events were not provided.  The outcome of the events very high fever to 100.5 F, headache, weakness, muscle ache, chills were resolving at the time of this report.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Chest pain, Chills, Dysphagia
Clinical narrative: Fever; Chills; Green discharge from nose; Pain in spine; Mid chest pain; Mid back pain; Lost sensation in left hand; Arm weakness; High heart rate when standing; Trouble swallowing; Day by day got more tired; Weak; Loss of feeling; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills), RHINORRHOEA (Green discharge from nose), SPINAL PAIN (Pain in spine) and CHEST PAIN (Mid chest pain) 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.     The patient's past medical history included No adverse event (No medical history provided).   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced PYREXIA (Fever), CHILLS (Chills), RHINORRHOEA (Green discharge from nose), SPINAL PAIN (Pain in spine), CHEST PAIN (Mid chest pain), BACK PAIN (Mid back pain), SENSORY LOSS (Lost sensation in left hand), MUSCULAR WEAKNESS (Arm weakness), HEART RATE INCREASED (High heart rate when standing), DYSPHAGIA (Trouble swallowing), FATIGUE (Day by day got more tired), ASTHENIA (Weak) and FEELING ABNORMAL (Loss of feeling). At the time of the report, PYREXIA (Fever), CHILLS (Chills), RHINORRHOEA (Green discharge from nose), SPINAL PAIN (Pain in spine), CHEST PAIN (Mid chest pain), BACK PAIN (Mid back pain), SENSORY LOSS (Lost sensation in left hand), MUSCULAR WEAKNESS (Arm weakness), HEART RATE INCREASED (High heart rate when standing), DYSPHAGIA (Trouble swallowing), FATIGUE (Day by day got more tired), ASTHENIA (Weak) and FEELING ABNORMAL (Loss of feeling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported   No treatment medication reported   This case was linked to MOD-2021-041495 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Heart rate increased, Muscular weakness, Pyrexia
Clinical narrative: Fever; Chills; Green discharge from nose; Pain in spine; Mid chest pain; Mid back pain; Lost sensation in left hand; Arm weakness; High heart rate when standing; Trouble swallowing; Day by day got more tired; Weak; Loss of feeling; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills), RHINORRHOEA (Green discharge from nose), SPINAL PAIN (Pain in spine) and CHEST PAIN (Mid chest pain) 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.     The patient's past medical history included No adverse event (No medical history provided).   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced PYREXIA (Fever), CHILLS (Chills), RHINORRHOEA (Green discharge from nose), SPINAL PAIN (Pain in spine), CHEST PAIN (Mid chest pain), BACK PAIN (Mid back pain), SENSORY LOSS (Lost sensation in left hand), MUSCULAR WEAKNESS (Arm weakness), HEART RATE INCREASED (High heart rate when standing), DYSPHAGIA (Trouble swallowing), FATIGUE (Day by day got more tired), ASTHENIA (Weak) and FEELING ABNORMAL (Loss of feeling). At the time of the report, PYREXIA (Fever), CHILLS (Chills), RHINORRHOEA (Green discharge from nose), SPINAL PAIN (Pain in spine), CHEST PAIN (Mid chest pain), BACK PAIN (Mid back pain), SENSORY LOSS (Lost sensation in left hand), MUSCULAR WEAKNESS (Arm weakness), HEART RATE INCREASED (High heart rate when standing), DYSPHAGIA (Trouble swallowing), FATIGUE (Day by day got more tired), ASTHENIA (Weak) and FEELING ABNORMAL (Loss of feeling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported   No treatment medication reported   This case was linked to MOD-2021-041495 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Rhinorrhoea, Sensory loss, Spinal pain
Clinical narrative: Fever; Chills; Green discharge from nose; Pain in spine; Mid chest pain; Mid back pain; Lost sensation in left hand; Arm weakness; High heart rate when standing; Trouble swallowing; Day by day got more tired; Weak; Loss of feeling; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills), RHINORRHOEA (Green discharge from nose), SPINAL PAIN (Pain in spine) and CHEST PAIN (Mid chest pain) 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.     The patient's past medical history included No adverse event (No medical history provided).   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced PYREXIA (Fever), CHILLS (Chills), RHINORRHOEA (Green discharge from nose), SPINAL PAIN (Pain in spine), CHEST PAIN (Mid chest pain), BACK PAIN (Mid back pain), SENSORY LOSS (Lost sensation in left hand), MUSCULAR WEAKNESS (Arm weakness), HEART RATE INCREASED (High heart rate when standing), DYSPHAGIA (Trouble swallowing), FATIGUE (Day by day got more tired), ASTHENIA (Weak) and FEELING ABNORMAL (Loss of feeling). At the time of the report, PYREXIA (Fever), CHILLS (Chills), RHINORRHOEA (Green discharge from nose), SPINAL PAIN (Pain in spine), CHEST PAIN (Mid chest pain), BACK PAIN (Mid back pain), SENSORY LOSS (Lost sensation in left hand), MUSCULAR WEAKNESS (Arm weakness), HEART RATE INCREASED (High heart rate when standing), DYSPHAGIA (Trouble swallowing), FATIGUE (Day by day got more tired), ASTHENIA (Weak) and FEELING ABNORMAL (Loss of feeling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported   No treatment medication reported   This case was linked to MOD-2021-041495 (Patient Link).
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Neck pain, Pain in extremity
Clinical narrative: sore arm; then the soreness went to the neck, back and shoulders; then the soreness went to the neck, back and shoulders; then the soreness went to the neck, back and shoulders; A spontaneous report was received from a consumer concerning a Drug Start Date-1-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore arm/pain in extremity then the soreness went to the neck/neck pain, back /back pain and shoulders/arthralgia.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 030M20A) via unknown route for prophylaxis of COVID-19 infection.  On 11 Feb 2021, the patient experienced the event(s) sore arm. On an unknown date, the patient experienced the event(s) then the soreness went to the neck, back and shoulders.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), sore arm, then the soreness went to the neck, back and shoulders was unknown.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Erythema, Headache, Pain in extremity
Clinical narrative: severe pain in right arm; mild erythema; diarrhea; headache; severe shaking chills; fever of 105.9 maximum; A spontaneous report was received from a healthcare professional who is also a 69-years-old male patient that received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events fever of 105.9 maximum, severe shaking chills, severe pain in right arm, mild erythema, headache and diarrhea.  The patient's past medical history was not provided. Concomitant product use was not provided.  The patient received their first of two planned doses of mRNA-1273 (lot # 013L20A) on 20 Jan 2021.  On 17 Feb 2021, four hours prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (010M20A) intramuscularly in the left arm for prophylaxis of covid-19 infection.  On 17 Feb 2021, post vaccination, the patient began having low grade fever that rose to 105.9 that night.  The patient took Tylenol and it decreased to 103.  On 18 Feb 2021, the patient again developed night fever of 105 as well as severe shaking chills.  On 19 Feb 2021, patient's fever was 102 and they experienced Headache, severe pain in right arm, mild erthymea and diarrhea.  On 20 Feb 2021, patient had fever of 101.  On 21 Feb 2021, the patient's fever was 100 in the morning and decreased to 98-99 in the afternoon.  In the morning of 22 Feb 2021, the patient had fever of 99.1 with continued headaches and diarrhea.    Treatment details included Tylenol every 6 hours during the second and third day. Also, the patient's been drinking a lot of cold water and trying to keep themself in a cold environment.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events was not Applicable.  Outcome of events: On 22-feb-2021 Patient with fever outcome was resolved and recovered . 18-feb-2021 event Severe shaking chills was resolved and recovered. Headache, severe pain in right arm, mild erythema, diarrhea and pain in right arm outcome was not unknown or not provided.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: severe pain in right arm; mild erythema; diarrhea; headache; severe shaking chills; fever of 105.9 maximum; A spontaneous report was received from a healthcare professional who is also a 69-years-old male patient that received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events fever of 105.9 maximum, severe shaking chills, severe pain in right arm, mild erythema, headache and diarrhea.  The patient's past medical history was not provided. Concomitant product use was not provided.  The patient received their first of two planned doses of mRNA-1273 (lot # 013L20A) on 20 Jan 2021.  On 17 Feb 2021, four hours prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (010M20A) intramuscularly in the left arm for prophylaxis of covid-19 infection.  On 17 Feb 2021, post vaccination, the patient began having low grade fever that rose to 105.9 that night.  The patient took Tylenol and it decreased to 103.  On 18 Feb 2021, the patient again developed night fever of 105 as well as severe shaking chills.  On 19 Feb 2021, patient's fever was 102 and they experienced Headache, severe pain in right arm, mild erthymea and diarrhea.  On 20 Feb 2021, patient had fever of 101.  On 21 Feb 2021, the patient's fever was 100 in the morning and decreased to 98-99 in the afternoon.  In the morning of 22 Feb 2021, the patient had fever of 99.1 with continued headaches and diarrhea.    Treatment details included Tylenol every 6 hours during the second and third day. Also, the patient's been drinking a lot of cold water and trying to keep themself in a cold environment.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events was not Applicable.  Outcome of events: On 22-feb-2021 Patient with fever outcome was resolved and recovered . 18-feb-2021 event Severe shaking chills was resolved and recovered. Headache, severe pain in right arm, mild erythema, diarrhea and pain in right arm outcome was not unknown or not provided.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site pain, Vaccination site pruritus, Vaccination site urticaria, Vaccination site warmth
Clinical narrative: Arm got very hot; Arm rash; Arm itching; Hives on arm; Arm got sore; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (Arm got very hot), RASH (Arm rash), VACCINATION SITE PRURITUS (Arm itching), VACCINATION SITE URTICARIA (Hives on arm) and VACCINATION SITE PAIN (Arm got sore) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Arm got very hot), RASH (Arm rash), VACCINATION SITE PRURITUS (Arm itching), VACCINATION SITE URTICARIA (Hives on arm) and VACCINATION SITE PAIN (Arm got sore). On 28-Jan-2021, VACCINATION SITE WARMTH (Arm got very hot), RASH (Arm rash), VACCINATION SITE URTICARIA (Hives on arm) and VACCINATION SITE PAIN (Arm got sore) had resolved and VACCINATION SITE PRURITUS (Arm itching) had resolved with sequelae.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient went to urgent care but didn't received any treatment.  Concomitant products were not provided/unknown. Treatment medication includes Witch hazel for itching.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Induration, Pruritus
Clinical narrative: Arm was red size of palm; Arm was hot; Arm was itchy; Arm was hard; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Arm was red size of palm), FEELING HOT (Arm was hot), PRURITUS (Arm was itchy) and INDURATION (Arm was hard) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021 at 12:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Arm was red size of palm), FEELING HOT (Arm was hot), PRURITUS (Arm was itchy) and INDURATION (Arm was hard). At the time of the report, ERYTHEMA (Arm was red size of palm), FEELING HOT (Arm was hot), PRURITUS (Arm was itchy) and INDURATION (Arm was hard) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information not provided. Treatment information not provided.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Sensitive skin, Vaccination site erythema, Vaccination site pain
Clinical narrative: sensitive to touch; itchy sensation if touched; Redness on arm; arm sore; This spontaneous case was reported by a consumer and describes the occurrence of SENSITIVE SKIN (sensitive to touch), PRURITUS (itchy sensation if touched), VACCINATION SITE ERYTHEMA (Redness on arm) and VACCINATION SITE PAIN (arm sore) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) 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 an unknown date, the patient experienced SENSITIVE SKIN (sensitive to touch), PRURITUS (itchy sensation if touched), VACCINATION SITE ERYTHEMA (Redness on arm) and VACCINATION SITE PAIN (arm sore). At the time of the report, SENSITIVE SKIN (sensitive to touch), PRURITUS (itchy sensation if touched) and VACCINATION SITE ERYTHEMA (Redness on arm) outcome was unknown and VACCINATION SITE PAIN (arm sore) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details were reported. No treatment medication details were reported.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Lacrimation increased, Rash
Clinical narrative: Eyes water a lot; Rash; This spontaneous case was reported by a consumer and describes the occurrence of LACRIMATION INCREASED (Eyes water a lot) and RASH (Rash) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No medical history reported by the reporter.  Concomitant products included MONTELUKAST SODIUM (SINGULAIR), VITAMIN C [ASCORBIC ACID], VITAMIN D NOS, VITAMIN B NOS, CALCIUM and ZINC for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced LACRIMATION INCREASED (Eyes water a lot) and RASH (Rash). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 25 mg. At the time of the report, LACRIMATION INCREASED (Eyes water a lot) and RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications are there Concomitant medications provided in initial source document which is submitted, but they are not captured, but captured in follow-up 1.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Added concomitant medication, treatment medication and anatomical location.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Eyelid ptosis, Rash
Clinical narrative: left side of face red; eye lid droop; bumps left side face (breakouts); This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (left side of face red), EYELID PTOSIS (eye lid droop) and RASH (bumps left side face (breakouts)) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced EYELID PTOSIS (eye lid droop) and RASH (bumps left side face (breakouts)). On 22-Apr-2021, the patient experienced ERYTHEMA (left side of face red). At the time of the report, ERYTHEMA (left side of face red), EYELID PTOSIS (eye lid droop) and RASH (bumps left side face (breakouts)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and concomitant medications were not provided by reporter.
Sex: M
Vaccine: COVID19
Symptoms: Injection site discolouration, Injection site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE DISCOLOURATION (Pink spot at the injection site) and INJECTION SITE PAIN (Sore left arm) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.  Concurrent medical conditions included Cholesterol blood excessive. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for Cholesterol blood excessive. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced INJECTION SITE PAIN (Sore left arm). On 21-Feb-2021, the patient experienced INJECTION SITE DISCOLOURATION (Pink spot at the injection site). On 14-Feb-2021, INJECTION SITE PAIN (Sore left arm) outcome was unknown. At the time of the report, INJECTION SITE DISCOLOURATION (Pink spot at the injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient stated that after the injection, he experienced a sore left arm that resolved in two days. On 21-Feb-2021, the patient stated that his left arm became sore again. No treatment medications reported. Reporter did not allow further contact
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Slight dizziness; A spontaneous report was received from a consumer concerning a 73-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events slight dizziness/dizziness.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 10 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 024M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 11 Feb 2021, the patient experienced the event(s) slight dizziness.  Treatment details included None.  Action taken with mRNA-1273 in response to the events was not reported.  On 12 Feb 2021 the outcome of event(s), slight dizziness was resolved.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in arm) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     The patient's past medical history included Neck surgery (September 2020 neck surgery that had repercussion on her arm.). Concurrent medical conditions included Drug allergy (Lyrica), Hypertension, Cholesterol and Cardiovascular disease, unspecified.   On 17-Feb-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 PAIN IN EXTREMITY (pain in arm). At the time of the report, PAIN IN EXTREMITY (pain in arm) outcome was unknown.            Prior vaccine include shingle's vaccine some years ago, she had a really bad reaction with the 1st dose, but did not last that long. Concomitant medications include blood pressure medication, cholesterol medication, heart medication. Treatment medication include paracetamol, Diphenhydramine for every 5 or 6 hours.   This case was linked to MOD-2021-020466 (E2B Linked Report).; Sender's Comments:  MOD-2021-020466:2nd dose for patient
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema
Clinical narrative: Redness (Injection Site); A spontaneous report was received from a consume concerning a 67 year old, female patient who experienced redness on the injection site.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.     On 13-Feb-2021, approximately 8 days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 006M20A) intramuscularly unspecified location for prophylaxis of COVID-19 infection.    On 20-Feb-2021, the patient experienced injection site redness. Treatment information was not provided.    Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event injection site redness was not reported.  The reporter assessed the event injection site redness related to the study drug was unknown.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Nausea
Clinical narrative: fatigue; nausea; diarrhea; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (fatigue), NAUSEA (nausea) and DIARRHOEA (diarrhea) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL, AMLODIPINE and ATORVASTATIN for an unknown indication.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced FATIGUE (fatigue), NAUSEA (nausea) and DIARRHOEA (diarrhea). At the time of the report, FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypoaesthesia, Lymphadenopathy, Somnolence, Vaccination site mass
Clinical narrative: numbness in pinky finger and finger next to pinky finger; Lymph node swollen; Very fatigued; slept all day; Felt hot on injection site; Knot located at injection site; Pain in injection arm; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (slept all day), HYPOAESTHESIA (numbness in pinky finger and finger next to pinky finger), VACCINATION SITE WARMTH (Felt hot on injection site), VACCINATION SITE MASS (Knot located at injection site) and VACCINATION SITE PAIN (Pain in injection arm) in a 54-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.     Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Felt hot on injection site), VACCINATION SITE MASS (Knot located at injection site) and VACCINATION SITE PAIN (Pain in injection arm). On 21-Feb-2021, the patient experienced SOMNOLENCE (slept all day), LYMPHADENOPATHY (Lymph node swollen) and FATIGUE (Very fatigued). On 24-Feb-2021, the patient experienced HYPOAESTHESIA (numbness in pinky finger and finger next to pinky finger). On 22-Feb-2021, VACCINATION SITE WARMTH (Felt hot on injection site), VACCINATION SITE MASS (Knot located at injection site), LYMPHADENOPATHY (Lymph node swollen) and FATIGUE (Very fatigued) had resolved. At the time of the report, SOMNOLENCE (slept all day) and HYPOAESTHESIA (numbness in pinky finger and finger next to pinky finger) outcome was unknown and VACCINATION SITE PAIN (Pain in injection arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 18-Mar-2021: Follow up received on 18-Mar-2021, event details Hypoaesthesia was updated.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site warmth
Clinical narrative: numbness in pinky finger and finger next to pinky finger; Lymph node swollen; Very fatigued; slept all day; Felt hot on injection site; Knot located at injection site; Pain in injection arm; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (slept all day), HYPOAESTHESIA (numbness in pinky finger and finger next to pinky finger), VACCINATION SITE WARMTH (Felt hot on injection site), VACCINATION SITE MASS (Knot located at injection site) and VACCINATION SITE PAIN (Pain in injection arm) in a 54-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.     Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Felt hot on injection site), VACCINATION SITE MASS (Knot located at injection site) and VACCINATION SITE PAIN (Pain in injection arm). On 21-Feb-2021, the patient experienced SOMNOLENCE (slept all day), LYMPHADENOPATHY (Lymph node swollen) and FATIGUE (Very fatigued). On 24-Feb-2021, the patient experienced HYPOAESTHESIA (numbness in pinky finger and finger next to pinky finger). On 22-Feb-2021, VACCINATION SITE WARMTH (Felt hot on injection site), VACCINATION SITE MASS (Knot located at injection site), LYMPHADENOPATHY (Lymph node swollen) and FATIGUE (Very fatigued) had resolved. At the time of the report, SOMNOLENCE (slept all day) and HYPOAESTHESIA (numbness in pinky finger and finger next to pinky finger) outcome was unknown and VACCINATION SITE PAIN (Pain in injection arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 18-Mar-2021: Follow up received on 18-Mar-2021, event details Hypoaesthesia was updated.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Night sweats
Clinical narrative: Nightsweats; Chills; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (Nightsweats) and CHILLS (Chills) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, the patient experienced NIGHT SWEATS (Nightsweats) and CHILLS (Chills). At the time of the report, NIGHT SWEATS (Nightsweats) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment and concomitant medications were not provided by reporter.   This case was linked to MOD-2021-020538 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  MOD-2021-020538:MOD21-035367: Same reporter, reporter's husband
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Pain in extremity, Pyrexia, Vaccination site erythema
Clinical narrative: Redness/ the injection site is pink; Hurting at injection site; Fever; Dizziness; Chills; left arm sore; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (left arm sore), CHILLS (Chills), VACCINATION SITE ERYTHEMA (Redness/ the injection site is pink), VACCINATION SITE PAIN (Hurting at injection site) and PYREXIA (Fever) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042M20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical reported history).   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (left arm sore). On 17-Feb-2021, the patient experienced CHILLS (Chills), VACCINATION SITE PAIN (Hurting at injection site), PYREXIA (Fever) and DIZZINESS (Dizziness). On 22-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness/ the injection site is pink). On 17-Feb-2021, CHILLS (Chills) had resolved. At the time of the report, PAIN IN EXTREMITY (left arm sore), VACCINATION SITE ERYTHEMA (Redness/ the injection site is pink), VACCINATION SITE PAIN (Hurting at injection site), PYREXIA (Fever) and DIZZINESS (Dizziness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment and concomitant medications were not provided by reporter.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Redness/ the injection site is pink; Hurting at injection site; Fever; Dizziness; Chills; left arm sore; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (left arm sore), CHILLS (Chills), VACCINATION SITE ERYTHEMA (Redness/ the injection site is pink), VACCINATION SITE PAIN (Hurting at injection site) and PYREXIA (Fever) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042M20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical reported history).   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (left arm sore). On 17-Feb-2021, the patient experienced CHILLS (Chills), VACCINATION SITE PAIN (Hurting at injection site), PYREXIA (Fever) and DIZZINESS (Dizziness). On 22-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness/ the injection site is pink). On 17-Feb-2021, CHILLS (Chills) had resolved. At the time of the report, PAIN IN EXTREMITY (left arm sore), VACCINATION SITE ERYTHEMA (Redness/ the injection site is pink), VACCINATION SITE PAIN (Hurting at injection site), PYREXIA (Fever) and DIZZINESS (Dizziness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment and concomitant medications were not provided by reporter.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Pain, Rash erythematous
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (big large red circular spot underneath the injection site exactly one week after getting the vaccine/Redness/erythema), PAIN (just a little ache) and HYPERSENSITIVITY (Hypersensitivity reaction) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039k20 and 029L20) for COVID-19 vaccination.  The patient's past medical history included Hay fever. Previously administered products included for an unreported indication: Bisacodyl on 12-May-2004. Past adverse reactions to the above products included Paresthesia oral with Bisacodyl. Concurrent medical conditions included Birth control, Hypothyroidism and Allergy. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) from 01-Jan-2004 to an unknown date for Allergy, ETHINYLESTRADIOL, LEVONORGESTREL (AVIANE) from 01-Jan-2004 to an unknown date for Birth control, LEVOTHYROXINE SODIUM (SYNTHROID) from 08-Jan-2015 to an unknown date for Hypothyroidism. On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH ERYTHEMATOUS (big large red circular spot underneath the injection site exactly one week after getting the vaccine/Redness/erythema), PAIN (just a little ache) and HYPERSENSITIVITY (Hypersensitivity reaction). At the time of the report, RASH ERYTHEMATOUS (big large red circular spot underneath the injection site exactly one week after getting the vaccine/Redness/erythema) and HYPERSENSITIVITY (Hypersensitivity reaction) outcome was unknown and PAIN (just a little ache) had resolved.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information were not provided. This case was linked to MOD-2021-023115, US-MODERNATX, INC.-MOD-2021-023115. Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Follow up received on 19 Apr 2021 contains no new information. On 27-Jul-2021: Significant follow up received on 27-JUL-2021 updated patient demographics, suspect dosage regimens, relevant medical history, concomitant medications and new event Hypersensitivity reaction.; Sender's Comments: MOD-2021-023115:Crosslinked: Same reporter/different patient (Reporter's case) US-MODERNATX, INC.-MOD-2021-023115:Same reporter/ Different patient (Neighbor case).
Sex: F
Vaccine: COVID19
Symptoms: Bed rest, Dyspnoea, Myalgia, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: Covid like symptoms; Breathing issues; Complete bed rest; Body aches; A spontaneous report was received on 25-Jan-2021 from a consumer regarding his mother, a female patient of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Covid like symptoms, body aches, and breathing issues and complete bed rest.  The patient medical history was not reported. The information about concomitant medication was not reported.  On an unknown date in Jan-2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date in Jan-2021, about 2 weeks ago to the day, the patient experienced Covid like symptoms and had been tested negative several times. The patient was not able to do everyday activities, had body aches, and breathing issues. The patient was on complete bed rest and does not seem to be getting better and also informed that it was very severe. The patient visited the hospital. Information about the treatment was not provided.  Action taken with mRNA-1273 in response to the events were not provided.  The outcome of the events Covid like symptoms, body aches, and breathing issues were not provided. The outcome of event complete bed rest was considered to be not resolved at the time of this report.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Injected limb mobility decreased, Pain in extremity, Swelling
Clinical narrative: Couldn't move or lift the arm; Might have some swelling; Severe pain in the arm; A spontaneous report was received from a consumer concerning a 69 year old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pain in extremity, injected limb mobility decreased and swelling.  The patient's medical history was not provided. No Concomitant medications were reported .  On 18 Feb 2021,thursday, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 030L20A) via unknown route in the left arm for prophylaxis of COVID-19 infection. After receiving the vaccine she developed extreme severe pain in her vaccinated arm from joint to elbow and she was not able to move or lift her arm. Also patient experienced swelling. All the events lasted for three days.The patient used lidocaine patch for the events.  The treatment for the events was reported as lidocaine patch.  Action taken with mRNA-1273 in response to the events was unknown.  All the events were reported as resolved and the event couldn't move or lift arm was reported as resolving.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: tenderness in her arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (tenderness in her arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Urinary tract infection. Concomitant products included NITROFURANTOIN (NITROFURABTOIN) for Urinary tract infection.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (tenderness in her arm). At the time of the report, PAIN IN EXTREMITY (tenderness in her arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not provided by reporter.