chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort, Lymphadenopathy, Non-cardiac chest pain, Painful respiration, Pyrexia
Clinical narrative: Heavy sensation feeling in arm; sharp achy pains left side of chest pectoral region; sharp pinch pain while taking breath; Fever; Achiness and soreness; Severe swelling in axillary lymphnodes the size of a baseball on the same side of the injection site; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of LIMB DISCOMFORT (Heavy sensation feeling in arm), NON-CARDIAC CHEST PAIN (sharp achy pains left side of chest pectoral region), PAINFUL RESPIRATION (sharp pinch pain while taking breath), PYREXIA (Fever) and VACCINATION SITE PAIN (Achiness and soreness) in a 36-year-old male 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 Hypothyroidism and COVID-19 virus test positive on 15-Sep-2020. Concomitant products included LEVOTHYROXINE and ATORVASTATIN for an unknown indication.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced LIMB DISCOMFORT (Heavy sensation feeling in arm), NON-CARDIAC CHEST PAIN (sharp achy pains left side of chest pectoral region), PAINFUL RESPIRATION (sharp pinch pain while taking breath), PYREXIA (Fever), VACCINATION SITE PAIN (Achiness and soreness) and LYMPHADENOPATHY (Severe swelling in axillary lymphnodes the size of a baseball on the same side of the injection site). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. At the time of the report, LIMB DISCOMFORT (Heavy sensation feeling in arm), NON-CARDIAC CHEST PAIN (sharp achy pains left side of chest pectoral region), PAINFUL RESPIRATION (sharp pinch pain while taking breath), PYREXIA (Fever), VACCINATION SITE PAIN (Achiness and soreness) and LYMPHADENOPATHY (Severe swelling in axillary lymphnodes the size of a baseball on the same side of the injection site) had not resolved.        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.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Heavy sensation feeling in arm; sharp achy pains left side of chest pectoral region; sharp pinch pain while taking breath; Fever; Achiness and soreness; Severe swelling in axillary lymphnodes the size of a baseball on the same side of the injection site; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of LIMB DISCOMFORT (Heavy sensation feeling in arm), NON-CARDIAC CHEST PAIN (sharp achy pains left side of chest pectoral region), PAINFUL RESPIRATION (sharp pinch pain while taking breath), PYREXIA (Fever) and VACCINATION SITE PAIN (Achiness and soreness) in a 36-year-old male 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 Hypothyroidism and COVID-19 virus test positive on 15-Sep-2020. Concomitant products included LEVOTHYROXINE and ATORVASTATIN for an unknown indication.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced LIMB DISCOMFORT (Heavy sensation feeling in arm), NON-CARDIAC CHEST PAIN (sharp achy pains left side of chest pectoral region), PAINFUL RESPIRATION (sharp pinch pain while taking breath), PYREXIA (Fever), VACCINATION SITE PAIN (Achiness and soreness) and LYMPHADENOPATHY (Severe swelling in axillary lymphnodes the size of a baseball on the same side of the injection site). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. At the time of the report, LIMB DISCOMFORT (Heavy sensation feeling in arm), NON-CARDIAC CHEST PAIN (sharp achy pains left side of chest pectoral region), PAINFUL RESPIRATION (sharp pinch pain while taking breath), PYREXIA (Fever), VACCINATION SITE PAIN (Achiness and soreness) and LYMPHADENOPATHY (Severe swelling in axillary lymphnodes the size of a baseball on the same side of the injection site) had not resolved.        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.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pyrexia
Clinical narrative: Low grade fever (around 100°); Little bit of nausea; Fatigue; A spontaneous report was received from a caregiver on behalf of a patient concerning an 87-year-old male patient who experienced a little bit of nausea, fatigue and a low grade fever.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.     On 02 Jan 2021, approximately one day prior to the onset of the symptoms, the patient received their dose of mRNA-1273 (Batch number not provided) in the left arm for prophylaxis of COVID-19 infection.    A day after the vaccination shot, on 03 Jan 2021, the patient experienced a little bit of nausea and fatigue. The nausea subsided but the fatigue persisted. On 07 Jan 2021, he experienced a low-grade fever.  Treatment information was not provided/unknown.    Action taken with mRNA-1273 in response to the event(s) was not provided/unknown.  The event, [little bit of nausea], was considered recovered/resolved on 04 Jan 2021.   The outcome of the events, [fatigue and low-grade fever], were considered unknown.   Reporter causality for the events was not provided. This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Little bit of nausea), FATIGUE (Fatigue) and PYREXIA (Low grade fever (around 100°)) in an 87-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 (No medical history reported).    On 02-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jan-2021, the patient experienced NAUSEA (Little bit of nausea) and FATIGUE (Fatigue). On 07-Jan-2021, the patient experienced PYREXIA (Low grade fever (around 100°)). On 04-Jan-2021, NAUSEA (Little bit of nausea) had resolved. At the time of the report, FATIGUE (Fatigue) and PYREXIA (Low grade fever (around 100°)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Contusion, Erythema, Feeling hot
Clinical narrative: appears to look brusied; Redness in arm; Swelling in the arm; Arm hot to the touch; Lymphnode pain; Pain in the armpit; Pain in the right side of the body; Headache; Pain in the shoulder; Poke of pins and needles; A spontaneous report was received from other healthcare professional concerning a 48-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced poke of pins and needles (paraesthesia), pain in the shoulder(arthralgia), little bit of a headache, pain on the right side of the body (pain), pain in the arm pit (axillary pain), lymph node pain (lymph node pain), redness in the arm(erythema), swelling in the arm(peripheral swelling), arm hot to touch (feeling hot) and bruised (contusion).  The patient's medical history was not provided. Concomitant medications were not reported.  On 29 DEC 2020, approximately 10 minutes prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 039K20-2A) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection.  On 29 DEC 2020, after receiving the vaccine, the patient felt different poke of pins and needles occurred at different parts of her body (fingers, toes and cheek) and experienced pain in the shoulder, little bit of a headache. During that evening because of the shoulder pain she could not get any proper sleep. On 03 JAN 2021, the patient developed a pain on the right side of the body and started to have pain in the arm pit, described as lymph node pain. On 04Jan2021 she developed redness and swelling in the arm which was hot to touch. On 05 JAN 2021, it was reported that the surface area that was red got much bigger, the swelling was more visible, and the pain was still there and to touch it was very hot. The circumference of the right arm was measured 2 centimeters bigger than the left arm. On 08 JAN 2021, the reddened area appeared to look bruised.   Treatment for the events included, topical cream clobetasol 0.05, IBU 600mg qTID.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of poke of pins and needles was considered resolved on 29 DEC 2020 and the outcome of the events, pain in the shoulder, little bit of a headache, pain on the right side of the body, pain in the arm pit, lymph node pain, redness in the arm, swelling in the arm, arm hot to touch and bruised were considered recovering.  Follow up was received on 07 Jan 2021. Events and treatment details were updated.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymph node pain, Pain, Paraesthesia, Peripheral swelling
Clinical narrative: appears to look brusied; Redness in arm; Swelling in the arm; Arm hot to the touch; Lymphnode pain; Pain in the armpit; Pain in the right side of the body; Headache; Pain in the shoulder; Poke of pins and needles; A spontaneous report was received from other healthcare professional concerning a 48-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced poke of pins and needles (paraesthesia), pain in the shoulder(arthralgia), little bit of a headache, pain on the right side of the body (pain), pain in the arm pit (axillary pain), lymph node pain (lymph node pain), redness in the arm(erythema), swelling in the arm(peripheral swelling), arm hot to touch (feeling hot) and bruised (contusion).  The patient's medical history was not provided. Concomitant medications were not reported.  On 29 DEC 2020, approximately 10 minutes prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 039K20-2A) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection.  On 29 DEC 2020, after receiving the vaccine, the patient felt different poke of pins and needles occurred at different parts of her body (fingers, toes and cheek) and experienced pain in the shoulder, little bit of a headache. During that evening because of the shoulder pain she could not get any proper sleep. On 03 JAN 2021, the patient developed a pain on the right side of the body and started to have pain in the arm pit, described as lymph node pain. On 04Jan2021 she developed redness and swelling in the arm which was hot to touch. On 05 JAN 2021, it was reported that the surface area that was red got much bigger, the swelling was more visible, and the pain was still there and to touch it was very hot. The circumference of the right arm was measured 2 centimeters bigger than the left arm. On 08 JAN 2021, the reddened area appeared to look bruised.   Treatment for the events included, topical cream clobetasol 0.05, IBU 600mg qTID.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of poke of pins and needles was considered resolved on 29 DEC 2020 and the outcome of the events, pain in the shoulder, little bit of a headache, pain on the right side of the body, pain in the arm pit, lymph node pain, redness in the arm, swelling in the arm, arm hot to touch and bruised were considered recovering.  Follow up was received on 07 Jan 2021. Events and treatment details were updated.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Myalgia
Clinical narrative: Aches; Chills; Dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), MYALGIA (Aches) and CHILLS (Chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On 31-Dec-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jan-2021, the patient experienced DIZZINESS (Dizzy). On an unknown date, the patient experienced MYALGIA (Aches) and CHILLS (Chills). At the time of the report, DIZZINESS (Dizzy), MYALGIA (Aches) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication was reported.; Reporter's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia
Clinical narrative: Lost sense of taste; A spontaneous report was received from a consumer, concerning herself, a 25-year-old, female patient, who received Moderna's COVID-19 Vaccine and experienced lost sense of taste.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 04 Jan 2021, the patient received her first of two planned doses of mRNA-1273 (Lot number 011L20A) via unknown route in her left arm for prophylaxis of COVID-19 infection.    On 04 Jan 2021 at 19:00, after vaccination, the patient had lost her sense of taste. The patient has not taken any treatment for the event.   Action taken with mRNA-1273 in response to the event was unknown.   The event, lost sense of taste was considered not resolved as it was ongoing at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037KZ0A) for COVID-19 vaccination.     Concurrent medical conditions included Pregnant. Concomitant products included VITAMINS NOS.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 06-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy). On 06-Jan-2021, EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dysgeusia, Headache, Influenza like illness, Myalgia
Clinical narrative: body ache; chills; muscle aches; flu like symptoms; metallic taste in her mouth and throat; sharp headache; A report was received from a healthcare professional  who was also a 49-year- old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a sharp headache, metallic taste in her mouth and throat (dysgeusia), flu-like symptoms (influenza like illness), body aches (pain), muscle aches (myalgia), and chills.   The patient's medical history and relevant concomitant medications were not reported.   On 31 Dec 2020, approximately one hour prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 025L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   The patient began experiencing a severe headache and a metallic taste in her mouth and throat about an hour after receiving vaccine.    On 01 Jan 2021 the patient experienced flu-like symptoms, body aches, muscle aches, and chills.  She treated the events with ibuprofen.  Action taken with mRNA-1273 in response to the events was not provided .   The events  of headache and metallic taste in her mouth and throat were resolved on 31 Dec 2020.  The events of flu-like symptoms, body aches, muscle aches, and chills were resolved on 02 Jan 2021.  Reporter causality for the events was not provided.; Reporter's Comments: This case concerns a 49-year-old female who experienced NS events of unexpected influenza-like illness, dysgeusia, pain and expected headache, myalgia, chills.  Event onset occurred the same day as the first dose of mRNA-1273. Treatment with ibuprofen. Events resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: body ache; chills; muscle aches; flu like symptoms; metallic taste in her mouth and throat; sharp headache; A report was received from a healthcare professional  who was also a 49-year- old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a sharp headache, metallic taste in her mouth and throat (dysgeusia), flu-like symptoms (influenza like illness), body aches (pain), muscle aches (myalgia), and chills.   The patient's medical history and relevant concomitant medications were not reported.   On 31 Dec 2020, approximately one hour prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 025L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   The patient began experiencing a severe headache and a metallic taste in her mouth and throat about an hour after receiving vaccine.    On 01 Jan 2021 the patient experienced flu-like symptoms, body aches, muscle aches, and chills.  She treated the events with ibuprofen.  Action taken with mRNA-1273 in response to the events was not provided .   The events  of headache and metallic taste in her mouth and throat were resolved on 31 Dec 2020.  The events of flu-like symptoms, body aches, muscle aches, and chills were resolved on 02 Jan 2021.  Reporter causality for the events was not provided.; Reporter's Comments: This case concerns a 49-year-old female who experienced NS events of unexpected influenza-like illness, dysgeusia, pain and expected headache, myalgia, chills.  Event onset occurred the same day as the first dose of mRNA-1273. Treatment with ibuprofen. Events resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Rash
Clinical narrative: Rash that extended to her chest and torso; Chills; Pain; A spontaneous report was received from a Health care professional concerning a 50-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced rash that extended to chest and torso/rash, chills and pain.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 04 Jan 2021, Monday, approximately 2 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 039k20a) for prophylaxis of COVID-19 infection.  On 04 Jan 2021, the patient experienced chills and pain. On 06 Jan 2021, the patient experienced rash that extended to chest and torso.  Treatment details included capsules of diphenhydramine  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, rash that extended to chest and torso, chills and pain was resolving (helped with her symptoms).; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: hot around injection site; redness, red around injection site; injection site tenderness; This spontaneous case was reported by a consumer and describes the occurrence of   in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.  Case comment: This case concerns a female of unknown age who experienced NS events of unexpected injection site warmth and expected injection site pain, injection site erythema.  Event onset occurred the same day as the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Reporter's Comments: This case concerns a female of unknown age who experienced NS events of unexpected injection site warmth and expected injection site pain, injection site erythema.  Event onset occurred the same day as the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Inflammation, Pain in extremity, Pyrexia, Tenderness
Clinical narrative: Fever; Head is tender to the touch/head hurt but not like a headache/cannot raise forehead without hurting; Water hitting the head hurts like inflammed hair follicles; Arm hurt; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN IN EXTREMITY (Arm hurt), TENDERNESS (Head is tender to the touch/head hurt but not like a headache/cannot raise forehead without hurting), INFLAMMATION (Water hitting the head hurts like inflammed hair follicles) and PYREXIA (Fever) in a 54-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 (No medical history was reported).    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2020, the patient experienced PAIN IN EXTREMITY (Arm hurt). On 30-Dec-2020, the patient experienced TENDERNESS (Head is tender to the touch/head hurt but not like a headache/cannot raise forehead without hurting) and INFLAMMATION (Water hitting the head hurts like inflammed hair follicles). On 05-Jan-2021, the patient experienced PYREXIA (Fever). At the time of the report, PAIN IN EXTREMITY (Arm hurt), TENDERNESS (Head is tender to the touch/head hurt but not like a headache/cannot raise forehead without hurting), INFLAMMATION (Water hitting the head hurts like inflammed hair follicles) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.8 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication includes Blood pressure medication. Treatment for the events was Acetaminophen.  Case comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nasal congestion, Nasal dryness, Paraesthesia, Paraesthesia oral
Clinical narrative: stuffy nose/congestion; chills; swollen lymp nodes on left arm injection site; nose always dry; arm pain; erythema around the vaccine site; tingly sensation on the lips; tingly sensation on the tip of nose; A spontaneous report  was received from a 38 year old female consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced tingly sensation on tip of nose (paraesthesia) and lips (paraesthesia oral), weird stuffy nose (nasal congestion) and dryness (nasal dryness), arm pain (pain in extremity), swollen lymph nodes on left arm injections site (injection site lymphadenopathy), chills, and erythema around injection site (injection site erythema).    The patient's medical history was not provided.  No relevant concomitant medications were reported.   On 23 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot 011J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 23 Dec 2020 after the vaccine was administered, the patient reports that she had immediate reaction, tingly sensation on the tip of nose and lips. After, the patient experienced weird stuff nose, not congested but dry, arm pain, swollen lymph nodes on left arm injection site and chills. On 30 Dec 2020, the patient experienced erythema around the vaccine site. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events of weird stuffy nose and dryness, arm pain, swollen lymph nodes on left arm injections site, chills and erythema around injection site, were unknown.  The events of tingly sensation on tip of nose and lips was resolved on 23 Dec 2020.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site lymphadenopathy, Vaccination site pain
Clinical narrative: stuffy nose/congestion; chills; swollen lymp nodes on left arm injection site; nose always dry; arm pain; erythema around the vaccine site; tingly sensation on the lips; tingly sensation on the tip of nose; A spontaneous report  was received from a 38 year old female consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced tingly sensation on tip of nose (paraesthesia) and lips (paraesthesia oral), weird stuffy nose (nasal congestion) and dryness (nasal dryness), arm pain (pain in extremity), swollen lymph nodes on left arm injections site (injection site lymphadenopathy), chills, and erythema around injection site (injection site erythema).    The patient's medical history was not provided.  No relevant concomitant medications were reported.   On 23 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot 011J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 23 Dec 2020 after the vaccine was administered, the patient reports that she had immediate reaction, tingly sensation on the tip of nose and lips. After, the patient experienced weird stuff nose, not congested but dry, arm pain, swollen lymph nodes on left arm injection site and chills. On 30 Dec 2020, the patient experienced erythema around the vaccine site. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events of weird stuffy nose and dryness, arm pain, swollen lymph nodes on left arm injections site, chills and erythema around injection site, were unknown.  The events of tingly sensation on tip of nose and lips was resolved on 23 Dec 2020.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Joint range of motion decreased, Vaccination site pain
Clinical narrative: Barely able to move his arm up and down; Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of JOINT RANGE OF MOTION DECREASED (Barely able to move his arm up and down) and VACCINATION SITE PAIN (Arm pain) in a 64-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 (No medical history reported.).    On 30-Dec-2020 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced VACCINATION SITE PAIN (Arm pain). On 01-Jan-2021, the patient experienced JOINT RANGE OF MOTION DECREASED (Barely able to move his arm up and down). At the time of the report, JOINT RANGE OF MOTION DECREASED (Barely able to move his arm up and down) and VACCINATION SITE PAIN (Arm pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient stated in the follow up that the arm pain he had was due to administration of vaccine in the joint between arm shoulder. Treatment included ice, ibuprofen and Toradol(which was two years old).   Most recent FOLLOW-UP information incorporated above includes: On 25-Mar-2021: FU received updated
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Sore arm; More tired than usual; A spontaneous report was received from a consumer concerning a  60-year-old, female patient who received Moderna's COVID-19 vaccine and experienced sore arm/injection site pain and was more tired than usual/fatigue.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 23 Dec 2020 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: Unknown) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On 23 Dec 2020, after receiving the vaccine, the patient experienced sore arm and was more tired than usual. She stated that her symptoms did not last longer than 24hrs.  Treatment for the events included Motrin.   Action taken with the second dose of mRNA-1273 in response to the event was not reported.   The outcome for the events, injection site pain and fatigue were  recovered/resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Liquid product physical issue
Clinical narrative: Vaccine looked cloudy milky,vial was still frozen or not thawed properly; iInitial discomfort in the left arm after receiving vaccine; A spontaneous report was received from a consumer concerning a 57 --year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced initial discomfort in the left arm and vaccine appeared to be cloudy milky in color and was not thawed properly.   The patient's medical history and relevant concomitant medications were not reported.   On 13 Jan 2021, the same time as the onset of the events, the patient received their first of two planned doses of mRNA-1273  (Lot number: 025J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   The patient experienced initial discomfort in the left arm after receiving the vaccine. The patient also felt the vaccine appeared cloudy milky. After removing the vaccine vial from the freezer, the pharmacist only warmed the vial in his hands for a couple minutes prior to administering the dose. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not provided .   The outcome of the events initial discomfort in the left arm and vaccine appeared to be cloudy milky in color were not reported.; Reporter's Comments: This report refers to a case of a 57-year-old female patient who experienced non-serious events of experienced initial discomfort in the left arm and vaccine appeared to be cloudy milky in color and was not thawed properly (Product appearance cloudy) during administration of mRNA-1273 (lot # 25J20A, Exp date-unknown). There were no reported AEs associated with the events of experienced initial discomfort in the left arm and vaccine appeared to be cloudy milky in color and was not thawed properly
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site rash
Clinical narrative: rash that covered from shoulder to elbow; intense itches in the left arm; pain at the injection site; A spontaneous report was received from a 73-year-old male physician who was participating in the mRNA-1273 Emergency Use Program and experienced tenderness and pain at the injection site, intense itchiness on left arm and rash that covered from the shoulder to elbow.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 29 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot 039K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 30 Dec 2020, the patient reports he experienced tenderness and pain at the injection site that lasted one day. On 5 Jan 2021, the patient experienced intense itches in the left arm and on 6 Jan 2021, he woke up with a rash that covered from the shoulder to the elbow. Treatment for the event included liquid loratadine and corticosteroids.    Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, tenderness and pain at the injection site were considered resolved on 31 Dec 2020. The outcome of the events, intense itchiness on left arm and rash that covered from the shoulder to elbow, were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Hyperhidrosis, Influenza like illness, Lethargy
Clinical narrative: flu like symptoms; lethargy; Sweats; Chills; Fever but no temperature; red, itching arm; itching arm; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of HYPERHIDROSIS (Sweats), CHILLS (Chills), PYREXIA (Fever but no temperature), ERYTHEMA (red, itching arm) and PRURITUS (itching arm) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cold on 15-Dec-2020. Concurrent medical conditions included CHRON'S DISEASE since 01-Jan-2000 and Crohn's since 01-Jan-2000. Concomitant products included 6-MERCAPTOPURINE MONOHYDRATE for Crohn's disease.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Dec-2020, the patient experienced PYREXIA (Fever but no temperature), ERYTHEMA (red, itching arm) and PRURITUS (itching arm). On 01-Jan-2021, the patient experienced HYPERHIDROSIS (Sweats), CHILLS (Chills) and LETHARGY (lethargy). On 27-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms). The patient was treated with DIPHENHYDRAMINE for Itching, at an unspecified dose and frequency. On 04-Jan-2021, ERYTHEMA (red, itching arm) and PRURITUS (itching arm) had resolved. On 07-Jan-2021, HYPERHIDROSIS (Sweats), CHILLS (Chills) and LETHARGY (lethargy) had resolved. On 27-Jan-2021, INFLUENZA LIKE ILLNESS (flu like symptoms) had resolved. At the time of the report, PYREXIA (Fever but no temperature) 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.   Most recent FOLLOW-UP information incorporated above includes: On 24-Mar-2021: the follow  up  was received at 24-3-21 in general tab the reporter address and fax number was updated, patients height weight race and  patient's current history Crohn's disease, historical condition lingering cold symptoms was updated. the Concomitant medicine 6-MERCAPTOPURINE was updated, in events outcome was updated from unknown to recovered and resolved,events like severe redness and itching at site of injection and alternating severe sweats and chills and lethargy this events was recovered and resolved On 07-Apr-2021: No specific follow-up information recorded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia
Clinical narrative: flu like symptoms; lethargy; Sweats; Chills; Fever but no temperature; red, itching arm; itching arm; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of HYPERHIDROSIS (Sweats), CHILLS (Chills), PYREXIA (Fever but no temperature), ERYTHEMA (red, itching arm) and PRURITUS (itching arm) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cold on 15-Dec-2020. Concurrent medical conditions included CHRON'S DISEASE since 01-Jan-2000 and Crohn's since 01-Jan-2000. Concomitant products included 6-MERCAPTOPURINE MONOHYDRATE for Crohn's disease.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Dec-2020, the patient experienced PYREXIA (Fever but no temperature), ERYTHEMA (red, itching arm) and PRURITUS (itching arm). On 01-Jan-2021, the patient experienced HYPERHIDROSIS (Sweats), CHILLS (Chills) and LETHARGY (lethargy). On 27-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms). The patient was treated with DIPHENHYDRAMINE for Itching, at an unspecified dose and frequency. On 04-Jan-2021, ERYTHEMA (red, itching arm) and PRURITUS (itching arm) had resolved. On 07-Jan-2021, HYPERHIDROSIS (Sweats), CHILLS (Chills) and LETHARGY (lethargy) had resolved. On 27-Jan-2021, INFLUENZA LIKE ILLNESS (flu like symptoms) had resolved. At the time of the report, PYREXIA (Fever but no temperature) 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.   Most recent FOLLOW-UP information incorporated above includes: On 24-Mar-2021: the follow  up  was received at 24-3-21 in general tab the reporter address and fax number was updated, patients height weight race and  patient's current history Crohn's disease, historical condition lingering cold symptoms was updated. the Concomitant medicine 6-MERCAPTOPURINE was updated, in events outcome was updated from unknown to recovered and resolved,events like severe redness and itching at site of injection and alternating severe sweats and chills and lethargy this events was recovered and resolved On 07-Apr-2021: No specific follow-up information recorded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Gout
Clinical narrative: gout attack; red as a beet; A spontaneous report was received from a consumer concerning a male patient of unknown age, who received Moderna's COVID-19 vaccine (mRNA-1273)  experienced gout and redness.   The patient's medical history and relevant concomitant medications were not reported.   On 05 Jan 2021, approximately one day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.   The patient experienced a gout attack and was red as a beet on 06 Jan 2021.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events gout and redness were not reported.; Reporter's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02552024) for COVID-19 vaccination.  Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]).   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 05-Sep-2020 and the estimated date of delivery was 11-Jun-2021. On 31-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the sixteenth week of the pregnancy. On 31-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved.   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.  It was reported that the estimated date of conception was 14 Sep 2020.  Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 28-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Fatigue, Nausea, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), TACHYCARDIA (Fast heartbeat), PYREXIA (Fever of 103.9), NAUSEA (Nausea) and VOMITING (Vomiting) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02612OA) 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 reported medical history).    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced DIZZINESS (Dizziness), TACHYCARDIA (Fast heartbeat), PYREXIA (Fever of 103.9), NAUSEA (Nausea), VOMITING (Vomiting) and FATIGUE (Fatigue). At the time of the report, DIZZINESS (Dizziness), TACHYCARDIA (Fast heartbeat), PYREXIA (Fever of 103.9), NAUSEA (Nausea), VOMITING (Vomiting) and FATIGUE (Fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103.9 (High) 103.9.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Tachycardia, Vomiting
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), TACHYCARDIA (Fast heartbeat), PYREXIA (Fever of 103.9), NAUSEA (Nausea) and VOMITING (Vomiting) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02612OA) 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 reported medical history).    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced DIZZINESS (Dizziness), TACHYCARDIA (Fast heartbeat), PYREXIA (Fever of 103.9), NAUSEA (Nausea), VOMITING (Vomiting) and FATIGUE (Fatigue). At the time of the report, DIZZINESS (Dizziness), TACHYCARDIA (Fast heartbeat), PYREXIA (Fever of 103.9), NAUSEA (Nausea), VOMITING (Vomiting) and FATIGUE (Fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103.9 (High) 103.9.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.