chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: Adverse reaction to the shot; A spontaneous report was received from a consumer, concerning a female patient of unspecified age, who received Moderna's COVID-19 vaccine and experienced an adverse reaction to the shot.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On an unspecified date, prior to the onset of events, the patient received their first dose of mRNA-1273 (lot number unknown) via unknown route for COVID-19 infection prophylaxis.   No treatment medication was reported.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the event, an adverse reaction was considered to be unknown at the time of this report.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: tested positive for COVID; A SPONTANEOUS report was received concerning a 78Years old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) on 26JAN2021 in left upper arm (non-dominant)     The patient's medical history included is unknown. Event or Problem :Patient got first dose of Moderna vaccine on 26 Jan 2021 in left upper arm (non-dominant). The lot is #029L20A. No reactions when received his shot. On 5 Feb 2021 patient tested positive for COVID and has quarantined for 17 days. Both he and his wife got COVID around the same time(wife has had no injections). All of the COVID symptoms are gone except for a little taste and smell not return. Patient stated ok for safety to contact . Patient is due for second shot on 10 March which would be 42.5 days  Treatment information was unknown.  Action taken with mRNA-1273 in response to the events was not provided.   On feb 5 2021 he tested for positive for COVID outcome is unknown  a little taste and smell not return its outcome is also unknown  The outcome of the events were unknown ITS A NON-SERIOUS CASE
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history provided). Concomitant products included METFORMIN, OMEPRAZOLE and ALPRAZOLAM for an unknown indication.    On 22-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 PAIN IN EXTREMITY (Arm was sore). At the time of the report, PAIN IN EXTREMITY (Arm was sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported taking ibuprofen approximately 6 hours after receiving the vaccine.
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Injection site erythema, Injection site pain, Musculoskeletal stiffness, Neck pain
Clinical narrative: Injection site redness; having a little trouble on the same arm of the injection; neck pain; arm pain; stiff still; some redness about 2 inches length wise and 1.5 inches in width; pink color; A SPONTANOUS REPORT was received concerning a 68Years old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273)   he and his brother received the first dose of the Moderna Covid-19 vaccine yesterday morning at medical in Caller is not having an adverse event but his brother who received the vaccine in his left arm is having a little trouble on the same arm of the injection and his neck kind of bothers him. His brother's arm bothers him, stiff still, pain, some redness about 2 inches length wise and 1.5 inches in width. Pink color. He has not taken anything for his arm. Lot number reported is 029L20A for both of the patients. Caller is a 71 year old male and he takes Lisinopril, Methadone, Over the Counter Allergy relief His brother is a 68 year old male who takes Diphenhydramine, Hydroxyzine, Ibuprofen, Nortriptyline, Topiramate (stopped on Friday 19FEB2021), Lisinopril, Methadone, Sertraline, Lactulose, Docusate  Treatment information was unknown.  Action taken with mRNA-1273 in response to the events was not provided.    The outcome of the events were UNKNOWN
Sex: M
Vaccine: COVID19
Symptoms: Pain, Photosensitivity reaction
Clinical narrative: Injection site redness; having a little trouble on the same arm of the injection; neck pain; arm pain; stiff still; some redness about 2 inches length wise and 1.5 inches in width; pink color; A SPONTANOUS REPORT was received concerning a 68Years old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273)   he and his brother received the first dose of the Moderna Covid-19 vaccine yesterday morning at medical in Caller is not having an adverse event but his brother who received the vaccine in his left arm is having a little trouble on the same arm of the injection and his neck kind of bothers him. His brother's arm bothers him, stiff still, pain, some redness about 2 inches length wise and 1.5 inches in width. Pink color. He has not taken anything for his arm. Lot number reported is 029L20A for both of the patients. Caller is a 71 year old male and he takes Lisinopril, Methadone, Over the Counter Allergy relief His brother is a 68 year old male who takes Diphenhydramine, Hydroxyzine, Ibuprofen, Nortriptyline, Topiramate (stopped on Friday 19FEB2021), Lisinopril, Methadone, Sertraline, Lactulose, Docusate  Treatment information was unknown.  Action taken with mRNA-1273 in response to the events was not provided.    The outcome of the events were UNKNOWN
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Pyrexia
Clinical narrative: Very weak; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Very weak) and PYREXIA (Fever) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced ASTHENIA (Very weak) and PYREXIA (Fever). At the time of the report, ASTHENIA (Very weak) and PYREXIA (Fever) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient experienced side effect few hour after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine).  The patient took Ibuprofen 400mg and Tylenol 800 mg as the treatment medications.  The patients symptoms persisted and the patient was planning to call emergency number and visit emergency room since she was scared.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Rash
Clinical narrative: rash and sore; rash and sore; A Spontaneous Report was received concerning a 82 Years old, Female patient who received Moderna's COVID-19 vaccine (mRNA-1273) 2 doses and experienced rash, sore,red rash, itchiness,      The patient's medical history is unknown     On 22/jan/2021 patient received first dose of mRNA-1273 of batch number-013L20A, and on 19/feb/2021 she received second dose of vaccination   Event or Problem With the first dose she got a rash and sore. The rash had the size of a quarter. Appeared a week after the first dose and lasted a couple of days. With the second dose had a red rash, sore, itching and it's bigger/ larger (3x3) than with the first shot. Noticed it on Saturday. rash is still there, the soreness is little less follow Up directly: Yes     Treatment information was given as With a hot compress it seems to be relieved  Action taken with mRNA-1273 in response to the events was not provided.     The outcome of the events were unknown
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on face, arm, chest, and back; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on face, arm, chest, and back) 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 20-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 RASH (Rash on face, arm, chest, and back). At the time of the report, RASH (Rash on face, arm, chest, and back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Constipation, Dehydration, Fatigue
Clinical narrative: so weak and so tired; cannot go poop for 2 days; not very clear, cloudy mind; he has to use the walker; he did not drink and was dehydrated; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (so weak and so tired), CONSTIPATION (cannot go poop for 2 days), VISION BLURRED (not very clear, cloudy mind), GAIT INABILITY (he has to use the walker) and DEHYDRATION (he did not drink and was dehydrated) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history povided).    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 FATIGUE (so weak and so tired), CONSTIPATION (cannot go poop for 2 days), VISION BLURRED (not very clear, cloudy mind), GAIT INABILITY (he has to use the walker) and DEHYDRATION (he did not drink and was dehydrated). At the time of the report, FATIGUE (so weak and so tired), CONSTIPATION (cannot go poop for 2 days), VISION BLURRED (not very clear, cloudy mind), GAIT INABILITY (he has to use the walker) and DEHYDRATION (he did not drink and was dehydrated) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jan-2021, Blood test: measured blood test and it's due to his he cannot go poop for 2 days. On 27-Jan-2021, Computerised tomogram: normal ct scan looked normol.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Gait inability, Vision blurred
Clinical narrative: so weak and so tired; cannot go poop for 2 days; not very clear, cloudy mind; he has to use the walker; he did not drink and was dehydrated; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (so weak and so tired), CONSTIPATION (cannot go poop for 2 days), VISION BLURRED (not very clear, cloudy mind), GAIT INABILITY (he has to use the walker) and DEHYDRATION (he did not drink and was dehydrated) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history povided).    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 FATIGUE (so weak and so tired), CONSTIPATION (cannot go poop for 2 days), VISION BLURRED (not very clear, cloudy mind), GAIT INABILITY (he has to use the walker) and DEHYDRATION (he did not drink and was dehydrated). At the time of the report, FATIGUE (so weak and so tired), CONSTIPATION (cannot go poop for 2 days), VISION BLURRED (not very clear, cloudy mind), GAIT INABILITY (he has to use the walker) and DEHYDRATION (he did not drink and was dehydrated) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jan-2021, Blood test: measured blood test and it's due to his he cannot go poop for 2 days. On 27-Jan-2021, Computerised tomogram: normal ct scan looked normol.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Influenza like illness, Myalgia, Pyrexia, Vaccination site pruritus
Clinical narrative: typical vaccine side effects; itchiness, muscle pains, flu-like symptoms; itchiness, muscle pains, flu-like symptoms; itchiness, muscle pains, flu-like symptoms; progressed into neck pain, joint pain, fever; progressed into neck pain, joint pain, fever; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE REACTION (typical vaccine side effects), VACCINATION SITE PRURITUS (itchiness, muscle pains, flu-like symptoms), MYALGIA (itchiness, muscle pains, flu-like symptoms), INFLUENZA LIKE ILLNESS (itchiness, muscle pains, flu-like symptoms) and ARTHRALGIA (progressed into neck pain, joint pain, fever) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced VACCINATION SITE REACTION (typical vaccine side effects), VACCINATION SITE PRURITUS (itchiness, muscle pains, flu-like symptoms), MYALGIA (itchiness, muscle pains, flu-like symptoms), INFLUENZA LIKE ILLNESS (itchiness, muscle pains, flu-like symptoms), ARTHRALGIA (progressed into neck pain, joint pain, fever) and PYREXIA (progressed into neck pain, joint pain, fever). At the time of the report, VACCINATION SITE REACTION (typical vaccine side effects), VACCINATION SITE PRURITUS (itchiness, muscle pains, flu-like symptoms), MYALGIA (itchiness, muscle pains, flu-like symptoms), INFLUENZA LIKE ILLNESS (itchiness, muscle pains, flu-like symptoms), ARTHRALGIA (progressed into neck pain, joint pain, fever) and PYREXIA (progressed into neck pain, joint pain, fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: typical vaccine side effects; itchiness, muscle pains, flu-like symptoms; itchiness, muscle pains, flu-like symptoms; itchiness, muscle pains, flu-like symptoms; progressed into neck pain, joint pain, fever; progressed into neck pain, joint pain, fever; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE REACTION (typical vaccine side effects), VACCINATION SITE PRURITUS (itchiness, muscle pains, flu-like symptoms), MYALGIA (itchiness, muscle pains, flu-like symptoms), INFLUENZA LIKE ILLNESS (itchiness, muscle pains, flu-like symptoms) and ARTHRALGIA (progressed into neck pain, joint pain, fever) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced VACCINATION SITE REACTION (typical vaccine side effects), VACCINATION SITE PRURITUS (itchiness, muscle pains, flu-like symptoms), MYALGIA (itchiness, muscle pains, flu-like symptoms), INFLUENZA LIKE ILLNESS (itchiness, muscle pains, flu-like symptoms), ARTHRALGIA (progressed into neck pain, joint pain, fever) and PYREXIA (progressed into neck pain, joint pain, fever). At the time of the report, VACCINATION SITE REACTION (typical vaccine side effects), VACCINATION SITE PRURITUS (itchiness, muscle pains, flu-like symptoms), MYALGIA (itchiness, muscle pains, flu-like symptoms), INFLUENZA LIKE ILLNESS (itchiness, muscle pains, flu-like symptoms), ARTHRALGIA (progressed into neck pain, joint pain, fever) and PYREXIA (progressed into neck pain, joint pain, fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Pruritus, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Allergic reaction; Left arm started to itch (incredibly itchy); Left arm became swollen; Left arm became red at injection site and 5" below; Her back on the left side became incredibly itchy; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Allergic reaction), PRURITUS (Her back on the left side became incredibly itchy), VACCINATION SITE PRURITUS (Left arm started to itch (incredibly itchy)), VACCINATION SITE SWELLING (Left arm became swollen) and VACCINATION SITE ERYTHEMA (Left arm became red at injection site and 5" below) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (Amoxicillin) and Leg pain. Concomitant products included GABAPENTIN for Leg pain.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced PRURITUS (Her back on the left side became incredibly itchy). On 25-Jan-2021, the patient experienced HYPERSENSITIVITY (Allergic reaction), VACCINATION SITE PRURITUS (Left arm started to itch (incredibly itchy)), VACCINATION SITE SWELLING (Left arm became swollen) and VACCINATION SITE ERYTHEMA (Left arm became red at injection site and 5" below). On 19-Jan-2021, PRURITUS (Her back on the left side became incredibly itchy) had resolved. At the time of the report, HYPERSENSITIVITY (Allergic reaction), VACCINATION SITE PRURITUS (Left arm started to itch (incredibly itchy)), VACCINATION SITE SWELLING (Left arm became swollen) and VACCINATION SITE ERYTHEMA (Left arm became red at injection site and 5" below) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Pain in extremity
Clinical narrative: she had trouble raising my arm, had to make a big effort to raise my arm; She had also trouble swallowing her vitamins; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (she had trouble raising my arm, had to make a big effort to raise my arm) and DYSPHAGIA (She had also trouble swallowing her vitamins) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (she had trouble raising my arm, had to make a big effort to raise my arm). On 29-Jan-2021, the patient experienced DYSPHAGIA (She had also trouble swallowing her vitamins). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (she had trouble raising my arm, had to make a big effort to raise my arm) was resolving and DYSPHAGIA (She had also trouble swallowing her vitamins) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the events was not applicable.  Concomitant medications included vitamins A, B, C, D.  Patient put ice on arm.   Most recent FOLLOW-UP information incorporated above includes: On 05-Jul-2021: Follow up information received on 05-JUL-2021 and contains non significant information. Race information added.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity, Swelling
Clinical narrative: Swollen Armpit; Sore Arm; Bump under armpit was getting bigger and hurting her; A spontaneous report was received from a consumer concerning his wife a 41-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced swollen armpit/ swelling, sore arm/ pain in extremity and bump under her armpit was getting bigger and hurting her/ lymphadenopathy.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 15 Feb 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (batch: 0322L20A) via unknown route for prophylaxis of COVID-19 infection.  On 16 Feb 2021, the patient developed swollen armpit, sore arm and bump under her armpit was getting bigger and hurting her. Treatment for the event included tylenol.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of events, swollen armpit, sore arm and bump under her armpit was getting bigger and hurting her were resolving.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Skin warm, Vaccination site erythema
Clinical narrative: arm was red, a little warm, and itchy like crazy. redness is the size of a tennis ball. the redness is down below the injection site; arm was red, a little warm, and itchy like crazy; arm was red, a little warm, and itchy like crazy.; only had a little redness around it the size of a quarter; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (arm was red, a little warm, and itchy like crazy. redness is the size of a tennis ball. the redness is down below the injection site), SKIN WARM (arm was red, a little warm, and itchy like crazy), PRURITUS (arm was red, a little warm, and itchy like crazy.) and VACCINATION SITE ERYTHEMA (only had a little redness around it the size of a quarter) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: SMALLPOX VACCINE.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (only had a little redness around it the size of a quarter). On 28-Jan-2021, the patient experienced ERYTHEMA (arm was red, a little warm, and itchy like crazy. redness is the size of a tennis ball. the redness is down below the injection site), SKIN WARM (arm was red, a little warm, and itchy like crazy) and PRURITUS (arm was red, a little warm, and itchy like crazy.). The patient was treated with CEFALEXIN (CEPHALEXINE) at a dose of 750 milligram twice a day. At the time of the report, ERYTHEMA (arm was red, a little warm, and itchy like crazy. redness is the size of a tennis ball. the redness is down below the injection site), SKIN WARM (arm was red, a little warm, and itchy like crazy), PRURITUS (arm was red, a little warm, and itchy like crazy.) and VACCINATION SITE ERYTHEMA (only had a little redness around it the size of a quarter) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product was reported.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Follow up received on 16-Apr-2021, no new information was recorded
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Fatigue, Headache, Injection site erythema, Myalgia
Clinical narrative: Ice cold legs; Circular itchy rash on top of chest; Throat felt swollen; burning sensation on both legs and underside of the arms; tingling sensation on both legs and underside of the arms; stinging sensation on both legs and underside of the arms; Injection site red and hot; Felt fatigued; body aches and pains; Extreme headache; Ached all over; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Ached all over), PERIPHERAL COLDNESS (Ice cold legs), RASH PRURITIC (Circular itchy rash on top of chest), PHARYNGEAL SWELLING (Throat felt swollen) and BURNING SENSATION (burning sensation on both legs and underside of the arms) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, the patient experienced PAIN (Ached all over), MYALGIA (body aches and pains) and HEADACHE (Extreme headache). On an unknown date, the patient experienced PERIPHERAL COLDNESS (Ice cold legs), RASH PRURITIC (Circular itchy rash on top of chest), PHARYNGEAL SWELLING (Throat felt swollen), BURNING SENSATION (burning sensation on both legs and underside of the arms), PARAESTHESIA (tingling sensation on both legs and underside of the arms), PAIN (stinging sensation on both legs and underside of the arms), INJECTION SITE ERYTHEMA (Injection site red and hot) and FATIGUE (Felt fatigued). The patient was treated with PREDNISONE at a dose of 120 mg. On 26-Jan-2021, PAIN (Ached all over) and HEADACHE (Extreme headache) had resolved, MYALGIA (body aches and pains) outcome was unknown. At the time of the report, PERIPHERAL COLDNESS (Ice cold legs), RASH PRURITIC (Circular itchy rash on top of chest), PHARYNGEAL SWELLING (Throat felt swollen), BURNING SENSATION (burning sensation on both legs and underside of the arms), PARAESTHESIA (tingling sensation on both legs and underside of the arms), PAIN (stinging sensation on both legs and underside of the arms), INJECTION SITE ERYTHEMA (Injection site red and hot) and FATIGUE (Felt fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications details were not reported by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Paraesthesia, Peripheral coldness, Pharyngeal swelling, Rash pruritic
Clinical narrative: Ice cold legs; Circular itchy rash on top of chest; Throat felt swollen; burning sensation on both legs and underside of the arms; tingling sensation on both legs and underside of the arms; stinging sensation on both legs and underside of the arms; Injection site red and hot; Felt fatigued; body aches and pains; Extreme headache; Ached all over; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Ached all over), PERIPHERAL COLDNESS (Ice cold legs), RASH PRURITIC (Circular itchy rash on top of chest), PHARYNGEAL SWELLING (Throat felt swollen) and BURNING SENSATION (burning sensation on both legs and underside of the arms) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, the patient experienced PAIN (Ached all over), MYALGIA (body aches and pains) and HEADACHE (Extreme headache). On an unknown date, the patient experienced PERIPHERAL COLDNESS (Ice cold legs), RASH PRURITIC (Circular itchy rash on top of chest), PHARYNGEAL SWELLING (Throat felt swollen), BURNING SENSATION (burning sensation on both legs and underside of the arms), PARAESTHESIA (tingling sensation on both legs and underside of the arms), PAIN (stinging sensation on both legs and underside of the arms), INJECTION SITE ERYTHEMA (Injection site red and hot) and FATIGUE (Felt fatigued). The patient was treated with PREDNISONE at a dose of 120 mg. On 26-Jan-2021, PAIN (Ached all over) and HEADACHE (Extreme headache) had resolved, MYALGIA (body aches and pains) outcome was unknown. At the time of the report, PERIPHERAL COLDNESS (Ice cold legs), RASH PRURITIC (Circular itchy rash on top of chest), PHARYNGEAL SWELLING (Throat felt swollen), BURNING SENSATION (burning sensation on both legs and underside of the arms), PARAESTHESIA (tingling sensation on both legs and underside of the arms), PAIN (stinging sensation on both legs and underside of the arms), INJECTION SITE ERYTHEMA (Injection site red and hot) and FATIGUE (Felt fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications details were not reported by the reporter.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Redness (Injection Site); Itchiness (Injection site); This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Redness (Injection Site)) and INJECTION SITE PRURITUS (Itchiness (Injection site)) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (Redness (Injection Site)) and INJECTION SITE PRURITUS (Itchiness (Injection site)). At the time of the report, INJECTION SITE ERYTHEMA (Redness (Injection Site)) and INJECTION SITE PRURITUS (Itchiness (Injection site)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: Arm a little sensitive; warm red good sized spot appeared around the injection site which has gotten larger; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm a little sensitive) and VACCINATION SITE ERYTHEMA (warm red good sized spot appeared around the injection site which has gotten larger) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029620A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included Blood pressure medication for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE PAIN (Arm a little sensitive) and VACCINATION SITE ERYTHEMA (warm red good sized spot appeared around the injection site which has gotten larger). At the time of the report, VACCINATION SITE PAIN (Arm a little sensitive) and VACCINATION SITE ERYTHEMA (warm red good sized spot appeared around the injection site which has gotten larger) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Shaking more than usual; A spontaneous report was received from a consumer concerning a 78-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed Tremor.   The patient's medical history included Parkinson's disease.. Products known to have been used by the patient, within two weeks prior to the event, not reported.  On 27 Feb 2021, prior to the onset of the event, the patient received their second of two planned doses of mRNA-1273 (Lot 007ML0A) intramuscularly in the right  arm for prophylaxis of COVID-19 infection.   On 27 Feb 2021, the patient developed Tremor.  Treatment for the event, was not reported.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, tremor was considered unknown.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm for the 1st vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm for the 1st vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    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 (sore arm for the 1st vaccine). At the time of the report, PAIN IN EXTREMITY (sore arm for the 1st vaccine) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment and concomitant medications were provided by reporter.   Reporter did not allow further contact
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Somnolence, Vaccination site pain
Clinical narrative: felt sleepy; soreness; pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (felt sleepy), PAIN (soreness) and VACCINATION SITE PAIN (pain at the injection site) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 19-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 SOMNOLENCE (felt sleepy), PAIN (soreness) and VACCINATION SITE PAIN (pain at the injection site). At the time of the report, SOMNOLENCE (felt sleepy), PAIN (soreness) and VACCINATION SITE PAIN (pain at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications included Tylenol. No concomitant medications were provided by reporter.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Injection site pain; Injection site swelling; A spontaneous report  was received from a consumer concerning about a 81 years old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events injection site pain and injection site swelling.  The patient's medical history was not reported.  Concomitant medications were reported as acetylsalicylic acid, metoprolol, isosorbide, losartan and fenofibrate.  On 16 Feb 2021, prior to the onset of the events the patient received their second planned doses of mRNA-1273 (Batch number: unknown) via intramuscular in right upper arm for the prophylaxis of COVID-19 infection.  Later the patient experienced events injection site pain and injection site swelling.  Laboratory details was not mentioned.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the event are unknown.  The outcomes of the events injection site pain and injection site swelling remain unknown.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Shoulder is still sore; A spontaneous report was received from a consumer concerning a 80-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and patient's shoulder was sore/ arthralgia.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 12 Feb 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (batch: 039K20A) intramuscularly for prophylaxis of COVID-19 infection.  On 12 Feb 2021, the patient's shoulder was sore. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not provided.  The outcome of event, shoulder was sore was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Fever; Chills; Body aches; Headache; Fatigue; A spontaneous report was received from a reporter(consumer) concerning unknown age, male patient , who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever,chills, body aches, headache, fatigue and temperature was about 103 degree fahrenheit. The patient medical history was not provided.  The relevant concomitant medications were also not provided. On unknown date , prior to the consent of the events, the patients received their second of two planned doses of mRNA-1273(batch number: not provided) through the unknown route of administration for prophylaxis of COVID-19 injection. On unknown date the patient experienced pyrexia, chills, myalgia, headache, fatigue and temperature was about 103 degree Fahrenheit. Patient was feeling better Laboratory details not provided.  No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events were unknown.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: left arm pain; slight headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (left arm pain) and HEADACHE (slight headache) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. o28l20a) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced PAIN IN EXTREMITY (left arm pain) and HEADACHE (slight headache). At the time of the report, PAIN IN EXTREMITY (left arm pain) and HEADACHE (slight headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications and treatment medications were reported.   Reporter did not allow further contact
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus
Clinical narrative: Itching on arm; Transient pain on arm; A spontaneous report was received from a Consumer concerning a 70 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Itching on arm (Pruritus), Transient pain on arm (Pain in extremity).  The patient's medical history was not provided.  Relevant concomitant medication was reported ELIQUIS.  On 11 FEB 2021, prior to the onset of the events the patient received their planned dose of mRNA-1273 (lot/batch: 031M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 18 FEB 2021, the patient experienced Itching on arm (Pruritus), Transient pain on arm (Pain in extremity).  Laboratory details were not provided. Treatment information was provided as antibiotic.  Action taken with mRNA-1273 in response to the events was not reported. At the of this report, the outcome of the event's Itching on arm (Pruritus), Transient pain on arm (Pain in extremity) was considered as unknown.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Amblyopia, Chills, Eye swelling, Hypoaesthesia, Limb discomfort
Clinical narrative: Eyes Swollen almost shut; weak; dead arm; Itchy rash all over the body; chills; soreness in arm; tingling in arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itchy rash all over the body), EYE SWELLING (Eyes Swollen almost shut), AMBLYOPIA (weak), CHILLS (chills) and LIMB DISCOMFORT (soreness in arm) in a 77-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.     The patient's past medical history included No adverse event.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced CHILLS (chills), LIMB DISCOMFORT (soreness in arm) and PARAESTHESIA (tingling in arm). On 19-Feb-2021, the patient experienced RASH PRURITIC (Itchy rash all over the body). On an unknown date, the patient experienced EYE SWELLING (Eyes Swollen almost shut), AMBLYOPIA (weak) and HYPOAESTHESIA (dead arm). At the time of the report, RASH PRURITIC (Itchy rash all over the body), AMBLYOPIA (weak), CHILLS (chills), LIMB DISCOMFORT (soreness in arm) and HYPOAESTHESIA (dead arm) outcome was unknown.            Treatment and concomitant medications were not provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 22-Feb-2021: Adverse events were updated.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Rash pruritic
Clinical narrative: Eyes Swollen almost shut; weak; dead arm; Itchy rash all over the body; chills; soreness in arm; tingling in arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itchy rash all over the body), EYE SWELLING (Eyes Swollen almost shut), AMBLYOPIA (weak), CHILLS (chills) and LIMB DISCOMFORT (soreness in arm) in a 77-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.     The patient's past medical history included No adverse event.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced CHILLS (chills), LIMB DISCOMFORT (soreness in arm) and PARAESTHESIA (tingling in arm). On 19-Feb-2021, the patient experienced RASH PRURITIC (Itchy rash all over the body). On an unknown date, the patient experienced EYE SWELLING (Eyes Swollen almost shut), AMBLYOPIA (weak) and HYPOAESTHESIA (dead arm). At the time of the report, RASH PRURITIC (Itchy rash all over the body), AMBLYOPIA (weak), CHILLS (chills), LIMB DISCOMFORT (soreness in arm) and HYPOAESTHESIA (dead arm) outcome was unknown.            Treatment and concomitant medications were not provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 22-Feb-2021: Adverse events were updated.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Headache, Lethargy, Tinnitus
Clinical narrative: A spontaneous report was received from a consumer concerning a 68-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events headache, ringing in ears/tinnitus, dull discomfort upon movement/discomfort, lethargy.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 3 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 038K20A) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) headache, ringing in ears, dull discomfort upon movement, lethargy.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), headache, ringing in ears, dull discomfort upon movement, lethargy was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Pain in extremity
Clinical narrative: pain in the arm; Back pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in the arm) and BACK PAIN (Back pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A. and 025K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, 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 experienced PAIN IN EXTREMITY (pain in the arm) and BACK PAIN (Back pain). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (pain in the arm) and BACK PAIN (Back pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications were provided by reporter.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose increased, Illness
Clinical narrative: Very sick; high blood sugar; This spontaneous case was reported by a pharmacist and describes the occurrence of ILLNESS (Very sick) and BLOOD GLUCOSE INCREASED (high blood sugar) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 virus test positive. Concurrent medical conditions included Diabetes mellitus (type 1 diabetes). Concomitant products included MONOCLONAL ANTIBODY 17-1A for COVID-19, INSULIN for an unknown indication.    On 29-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 ILLNESS (Very sick) and BLOOD GLUCOSE INCREASED (high blood sugar). At the time of the report, ILLNESS (Very sick) and BLOOD GLUCOSE INCREASED (high blood sugar) 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.   The treatment medication was not provided.