chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Arm was swelling pretty bad; This spontaneous case was reported by an other health care professional and describes the occurrence of   in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.; 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: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Tested positive for COVID-19; A spontaneous report was received from a pharmacist for a nurse who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a positive COVID test.   The patient's medical history was not provided.  No concomitant medications were reported.  On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Batch # 025J202A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On an unknown date after vaccination, the patient tested positive for COVID-19 through a routine, weekly test.  The patient was reportedly already exposed to COVID-19.  No treatment was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, a positive COVID test, was not resolved.; Reporter's Comments: Based on the natural history of COVID-19, and the established information about the mRNA-1273 vaccine, a causal association between the event of positive COVID test and the product use is assessed as unlikely.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Chest discomfort, Cough, Fatigue
Clinical narrative: Positive Covid test; Persistent cough; Fatigue; Muscle ache; Headache; Low graded fever; Back Pain; Tightness of chest; A spontaneous report was received from a consumer concerning himself, a 47-year-old, male patient who experienced back pain, tightness of chest, persistent cough, fatigue, muscle aches, headache, low graded fever and a positive Covid test [SARS-CoV-2 test positive].   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 26-Dec-2020, a few hours prior to the onset of the symptoms, the patient received his first of two planned doses of mRNA-1273 (Lot 037K20A) intramuscularly in an unknown injection site for prophylaxis of COVID-19 infection.   A few hours after receiving the Covid-19 vaccine, the patient experienced side effects including persistent cough, muscle ache, back pain, tightness of chest, fatigue, headache and low graded fever (99.1F-100.1F).   He reported that the side effects were mild on 26-Dec-2020 (day of vaccination) but increased in intensity to severe on 27-Dec-2020 and 28-Dec-2020.   Treatment for the events included tizanidine for muscle aches.   Action taken with mRNA-1273 in response to the events was unknown.   The outcomes of the events were not reported.; 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. However, the event of Covid-19 positive is Unlikely related to mRNA-1273 and a very limited information regarding this event  has been provided.  Further information has been requested
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pyrexia, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Positive Covid test; Persistent cough; Fatigue; Muscle ache; Headache; Low graded fever; Back Pain; Tightness of chest; A spontaneous report was received from a consumer concerning himself, a 47-year-old, male patient who experienced back pain, tightness of chest, persistent cough, fatigue, muscle aches, headache, low graded fever and a positive Covid test [SARS-CoV-2 test positive].   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 26-Dec-2020, a few hours prior to the onset of the symptoms, the patient received his first of two planned doses of mRNA-1273 (Lot 037K20A) intramuscularly in an unknown injection site for prophylaxis of COVID-19 infection.   A few hours after receiving the Covid-19 vaccine, the patient experienced side effects including persistent cough, muscle ache, back pain, tightness of chest, fatigue, headache and low graded fever (99.1F-100.1F).   He reported that the side effects were mild on 26-Dec-2020 (day of vaccination) but increased in intensity to severe on 27-Dec-2020 and 28-Dec-2020.   Treatment for the events included tizanidine for muscle aches.   Action taken with mRNA-1273 in response to the events was unknown.   The outcomes of the events were not reported.; 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. However, the event of Covid-19 positive is Unlikely related to mRNA-1273 and a very limited information regarding this event  has been provided.  Further information has been requested
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Cheilitis, Chills, Eyelid rash, Headache, Pyrexia
Clinical narrative: Rash on lips; Rash on left eye lids; Rash on face and nose; Chills; High Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of CHEILITIS (Rash on lips), EYELID RASH (Rash on left eye lids), CHILLS (Chills), PYREXIA (High Fever) and HEADACHE (Headache) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No concomitant medications were reported.  The patient's past medical history included Herpes simplex.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced CHILLS (Chills), PYREXIA (High Fever) and HEADACHE (Headache). On 07-Feb-2021, the patient experienced CHEILITIS (Rash on lips), EYELID RASH (Rash on left eye lids) and RASH (Rash on face and nose). At the time of the report, CHEILITIS (Rash on lips), EYELID RASH (Rash on left eye lids), CHILLS (Chills), PYREXIA (High Fever), HEADACHE (Headache) and RASH (Rash on face and nose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication use was provided by the reporter.  No treatment of events was reported.Patient was vaccinated 6FEB2021. That same day, had chills, high fever and a headache. The next day 7FEB2021, had a rash on her face, nose , lip, and left eye. Has a history of herpes simplex.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on lips; Rash on left eye lids; Rash on face and nose; Chills; High Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of CHEILITIS (Rash on lips), EYELID RASH (Rash on left eye lids), CHILLS (Chills), PYREXIA (High Fever) and HEADACHE (Headache) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No concomitant medications were reported.  The patient's past medical history included Herpes simplex.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced CHILLS (Chills), PYREXIA (High Fever) and HEADACHE (Headache). On 07-Feb-2021, the patient experienced CHEILITIS (Rash on lips), EYELID RASH (Rash on left eye lids) and RASH (Rash on face and nose). At the time of the report, CHEILITIS (Rash on lips), EYELID RASH (Rash on left eye lids), CHILLS (Chills), PYREXIA (High Fever), HEADACHE (Headache) and RASH (Rash on face and nose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication use was provided by the reporter.  No treatment of events was reported.Patient was vaccinated 6FEB2021. That same day, had chills, high fever and a headache. The next day 7FEB2021, had a rash on her face, nose , lip, and left eye. Has a history of herpes simplex.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination complication
Clinical narrative: Tested postive for COVID-19; Vaccination complication; A spontaneous report was received from a consumer  concerning a 69-year-old, male patient who received Moderna COVID-19 vaccine (mRNA-1273) and developed a vaccine reaction (PT Vaccination Complication) and tested positive for Covid-19.    The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.  On 22-DEC-2020, 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, he developed a vaccine reaction.  Finally, on 27-DEC-2020, the patient was tested and was positive for Covid-19.    Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not reported.     The outcome of the events developed a vaccine reaction and tested positive for Covid-19, was unknown.; 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: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Erythema, Feeling cold, Limb discomfort, Tachycardia
Clinical narrative: Whole bodyredness; shaking; coldness; tachycardia; shortness of breath; heaviness in lower extremities; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of ERYTHEMA (Whole bodyredness), FEELING COLD (coldness), TACHYCARDIA (tachycardia), DYSPNOEA (shortness of breath) and LIMB DISCOMFORT (heaviness in lower extremities) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced ERYTHEMA (Whole bodyredness), FEELING COLD (coldness), TACHYCARDIA (tachycardia), DYSPNOEA (shortness of breath) and LIMB DISCOMFORT (heaviness in lower extremities). The patient was treated with ROSUVASTATIN CALCIUM (CRESTOR) at an unspecified dose and frequency; ALLOPURINOL at an unspecified dose and frequency and LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency. At the time of the report, ERYTHEMA (Whole bodyredness), FEELING COLD (coldness), TACHYCARDIA (tachycardia), DYSPNOEA (shortness of breath) and LIMB DISCOMFORT (heaviness in lower extremities) 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.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Whole bodyredness; shaking; coldness; tachycardia; shortness of breath; heaviness in lower extremities; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of ERYTHEMA (Whole bodyredness), FEELING COLD (coldness), TACHYCARDIA (tachycardia), DYSPNOEA (shortness of breath) and LIMB DISCOMFORT (heaviness in lower extremities) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced ERYTHEMA (Whole bodyredness), FEELING COLD (coldness), TACHYCARDIA (tachycardia), DYSPNOEA (shortness of breath) and LIMB DISCOMFORT (heaviness in lower extremities). The patient was treated with ROSUVASTATIN CALCIUM (CRESTOR) at an unspecified dose and frequency; ALLOPURINOL at an unspecified dose and frequency and LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency. At the time of the report, ERYTHEMA (Whole bodyredness), FEELING COLD (coldness), TACHYCARDIA (tachycardia), DYSPNOEA (shortness of breath) and LIMB DISCOMFORT (heaviness in lower extremities) 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.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dysgeusia, Erythema, Fatigue, Pruritus
Clinical narrative: Severe joint pain, most noticeable in wrists; Large red circle about 3-4 inches belowthe injection site; The redness patch increased in size and became itchy.; Metal taste in mouth; Very tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Very tired), ERYTHEMA (Large red circle about 3-4 inches belowthe injection site), PRURITUS (The redness patch increased in size and became itchy.), ARTHRALGIA (Severe joint pain, most noticeable in wrists) and DYSGEUSIA (Metal taste in mouth) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 030L20A) for COVID-19 vaccination.     no medical history is reported by reporter.  The patient's past medical history included Thyroidectomy. Previously administered products included for Shingles: Shingles vaccine and Shingles vaccine. Past adverse reactions to the above products included Redness with Shingles vaccine; and Swelling with Shingles vaccine. Concurrent medical conditions included Hypertension (Controlled with medication) since June 2001, Thyroid disorder (Thyroid removed / medication) since May 2001, Environmental allergy, Allergy to surgical sutures, Drug allergy, Vitamin D low and Bone disorder. Concomitant products included CALCIUM for Bone disorder, OLMESARTAN for Hypertension, LEVOTHYROXINE SODIUM (LEVOXYL) for Thyroidectomy, VITAMIN D3 for Vitamin D low.   On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 24-Dec-2020, the patient experienced FATIGUE (Very tired) and DYSGEUSIA (Metal taste in mouth). On 31-Dec-2020, the patient experienced ERYTHEMA (Large red circle about 3-4 inches belowthe injection site) and PRURITUS (The redness patch increased in size and became itchy.). On 02-Jan-2021, the patient experienced ARTHRALGIA (Severe joint pain, most noticeable in wrists). On 25-Dec-2020, FATIGUE (Very tired) and DYSGEUSIA (Metal taste in mouth) had resolved. On 04-Jan-2021, ARTHRALGIA (Severe joint pain, most noticeable in wrists) had resolved. On 07-Jan-2021, PRURITUS (The redness patch increased in size and became itchy.) 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.   conmeds added    Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2021: No specific follow-up information recorded.; 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: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site pain, Malaise
Clinical narrative: Chilling; Overall not feeling very well; Arm was really sore and hurts; A spontaneous report was received from a consumer, who was also a 36-year-old, female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced chilling, her arm  was really sore and hurts, she was overall not feeling well.  The patient's medical history was not provided by the reporter. Concomitant medications reported included Coreg, Taxol, Buspar, Protonix.  On 07 Jan 2021, prior to the onset of the events, the patient received their first two planned doses of mRNA-1273 (batch number: 026L20A) intramuscularly on her right arm for prophylaxis of COVID-19 infection.  The patient experienced chilling, arm  was really sore and hurts and was overall not feeling well.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events were not reported.   The outcome of events, chilling, arm  was really sore and hurts and was overall not feeling well, were not reported.; Reporter's Comments: This case concerns a 36-year-old, female, patient, who experienced non-serious unexpected event of Malaise and non-serious expected events of Injection site pain, and Chills. The events occurred after first dose of mRNA-1273, lot # 026L20A. Treatment information was not provided. Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Threw up; Severe headache; Chills; Body aches; Temperature is at 101; Arm started hurting; Really tired; A report was received from a consumer concerning a 54 year old male patient who was participating in the mRNA-1273 trial and developed upper arm pain, headache, feeling tired, fever, chills, body aches, and vomiting.     The patient's medical history, as provided by the reporter, included COVID-19.  No relevant concomitant medications were reported.   On 05 Jan 2021, approximately two hours prior to the onset of the events, the patient received his first of two planned doses of mRNA-1273 intramuscularly in his upper left arm for prophylaxis of COVID-19 infection.   The patient's arm started hurting on 05 Jan 2021.  On 06 Jan 2021 the patient experienced a severe headache, a temperature of 101 degrees Fahrenheit, chills, and body aches.  On 07 Jan 2021 the patient vomited and his fever continued.  He treated the events with Tylenol, and ibuprofen, and an ice pack.  Action taken with mRNA-1273 in response to the events was not provided .   The outcome of the events headache, fever, feeling tired, chills, body aches, and vomiting were not reported. The event upper arm pain was recovering.; 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: Pyrexia, Vaccination site pain, Vomiting
Clinical narrative: Threw up; Severe headache; Chills; Body aches; Temperature is at 101; Arm started hurting; Really tired; A report was received from a consumer concerning a 54 year old male patient who was participating in the mRNA-1273 trial and developed upper arm pain, headache, feeling tired, fever, chills, body aches, and vomiting.     The patient's medical history, as provided by the reporter, included COVID-19.  No relevant concomitant medications were reported.   On 05 Jan 2021, approximately two hours prior to the onset of the events, the patient received his first of two planned doses of mRNA-1273 intramuscularly in his upper left arm for prophylaxis of COVID-19 infection.   The patient's arm started hurting on 05 Jan 2021.  On 06 Jan 2021 the patient experienced a severe headache, a temperature of 101 degrees Fahrenheit, chills, and body aches.  On 07 Jan 2021 the patient vomited and his fever continued.  He treated the events with Tylenol, and ibuprofen, and an ice pack.  Action taken with mRNA-1273 in response to the events was not provided .   The outcome of the events headache, fever, feeling tired, chills, body aches, and vomiting were not reported. The event upper arm pain was recovering.; 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: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Heart rate, Heart rate increased, Throat irritation
Clinical narrative: Itchy throat; BP 161/107 > 149/87; increased heart rate; A spontaneous report was received from a pharmacist concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced itchy throat, increased heart rate and blood pressure increased.   The patient's medical history included hypertension, allergy to shellfish and seasonal allergies. Concomitant medication as per the reporter was amlodipine.  On 08 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 08 Jan 2021, the patient experienced itchy throat, increased heart rate and blood pressure increased. No treatment information was reported.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome for the events, itchy throat, increased heart rate and blood pressure increased was considered resolved on an unknown date.; 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: Urticaria
Clinical narrative: Full body hives six days after vaccination; A spontaneous report was received from a 41-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced full body hives six days after vaccination.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot: 025J20-2A) intramuscularly in left arm for prophylaxis of COVID-19 infection.  On unknown date, 6 days later the patient developed full body hives six days after vaccination. Treatment provided included diphenhydramine hydrochloride and prednisone.    Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, full body hives six days after vaccination, was considered unknown.; 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: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chills, Heart rate, Myalgia
Clinical narrative: Chills; Sore Arm; A spontaneous report was received from a 55-year-old, female consumer who received Moderna's COVID-19 vaccine and experienced soreness in the arm and chills.  The patient's medical history was not provided. Concomitant medications were Metoprolol 25mg PO daily.  On 31st 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 right Deltoid for prophylaxis of COVID-19 infection.  On 31 Dec 2020, after receiving the vaccine, the patient experienced sore arm and chills. Her BP was 145/74 and HR 136. Treatment for the events were Acetaminophen and she took Zequill for sleeping.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The outcome for the events soreness in the arm and chills were not reported.; Reporter's Comments: This case concerns a 55 year old female patient who received her first of two planned doses of mRNA-1273 (Lot number: Unknown) intramuscularly in the right Deltoid for prophylaxis of COVID-19 infection and experienced non-serious listed events of soreness in the arm and chills.  Treatment included Tylenol and zequill. 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 and the non-serious listed events are possibly related to the vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: dizziness; I couldn't lift my arm; feeling very very bad; very fatigued; muscular pain; fever; felt lot of chills; A spontaneous report was received from a 49 year-old, female consumer, who was also the patient, who received Moderna's COVID-19 vaccine and experienced dizziness, couldn't lift my arm, feeling very very bad, very fatigued, muscular pain, fever, and felt lot of chills.   The patient's medical history was not provided. Concomitant product use was not provided.    On 02 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: Unknown) for prophylaxis of COVID-19 infection.   On the morning of 03 Jan 2021, the patient started feeling very very bad. The patient felt dizzy and had a 100.2 °F fever. They took 2 units of paracetamol and the fever dropped and never went up again. The patient was very fatigued, had a lot of muscular pain, and couldn't lift their arm. The patient also had a lot of chills. On the night of 03 Jan 2021, the patient took 2 more paracetamol, but didn't take anything on 04 Jan 2021 due to feeling much better. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events dizziness, couldn't lift my arm, feeling very very bad, very fatigued, muscular pain, and felt lot of chills was unknown. The event fever was considered recovered/resolved on 03 Jan 2021.  Reporter causality for the events was not provided.; 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: Movement disorder, Myalgia, Pyrexia
Clinical narrative: dizziness; I couldn't lift my arm; feeling very very bad; very fatigued; muscular pain; fever; felt lot of chills; A spontaneous report was received from a 49 year-old, female consumer, who was also the patient, who received Moderna's COVID-19 vaccine and experienced dizziness, couldn't lift my arm, feeling very very bad, very fatigued, muscular pain, fever, and felt lot of chills.   The patient's medical history was not provided. Concomitant product use was not provided.    On 02 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: Unknown) for prophylaxis of COVID-19 infection.   On the morning of 03 Jan 2021, the patient started feeling very very bad. The patient felt dizzy and had a 100.2 °F fever. They took 2 units of paracetamol and the fever dropped and never went up again. The patient was very fatigued, had a lot of muscular pain, and couldn't lift their arm. The patient also had a lot of chills. On the night of 03 Jan 2021, the patient took 2 more paracetamol, but didn't take anything on 04 Jan 2021 due to feeling much better. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events dizziness, couldn't lift my arm, feeling very very bad, very fatigued, muscular pain, and felt lot of chills was unknown. The event fever was considered recovered/resolved on 03 Jan 2021.  Reporter causality for the events was not provided.; 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: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Lymph node pain, Pain in extremity
Clinical narrative: Sensitivity to light; Tenderness in lymph nodes in neck and groin; Bad headache; Dizziness; Soreness in right arm; Fatigue; Mild headache; A spontaneous report was received from a nurse who was a 61-year-old female patient who received Moderna's COVID-19 Vaccine, and who experienced soreness in arm, dizziness, fatigue, mild / bad headache, sensitivity to light, tenderness in lymph nodes in neck and groin.   The patient's medical history was not provided. Concomitant product included Effexor and Sertraline for depression.  On 30-Dec-2020, approximately 24 hours prior to the onset of the symptoms, the patient received her first of two planned doses of mRNA-1273 (LOT 039K20A) intramuscularly for prophylaxis of COVID-19 infection.   A nurse reported that she received the Moderna vaccine on 30-Dec-2020. On 31-Dec-2020, she experienced soreness in her arm, dizziness, fatigue and a mild headache. She stated that these symptoms improved over the next two days but then on 03-Jan-2021, she experienced a bad headache, light sensitivity and lymph node tenderness in the neck and groin. She stated that she was feeling better on 04-Jan-2021 and was no longer taking any pain-relieving medications. The patient was concerned about the duration and intensity of her symptoms and she was also concerned because she stated that she did not usually get headaches. Additionally, she wanted to know if she should get the second dose because she understood that the second dose may cause more side effects that the first dose.   Treatment for the event included paracetamol, plenty of water and rest.   Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the events soreness in arm, dizziness, mild / bad headache, sensitivity to light, tenderness in lymph nodes in neck and groin was recovered and of event fatigue was unknown.; 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: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Photophobia
Clinical narrative: Sensitivity to light; Tenderness in lymph nodes in neck and groin; Bad headache; Dizziness; Soreness in right arm; Fatigue; Mild headache; A spontaneous report was received from a nurse who was a 61-year-old female patient who received Moderna's COVID-19 Vaccine, and who experienced soreness in arm, dizziness, fatigue, mild / bad headache, sensitivity to light, tenderness in lymph nodes in neck and groin.   The patient's medical history was not provided. Concomitant product included Effexor and Sertraline for depression.  On 30-Dec-2020, approximately 24 hours prior to the onset of the symptoms, the patient received her first of two planned doses of mRNA-1273 (LOT 039K20A) intramuscularly for prophylaxis of COVID-19 infection.   A nurse reported that she received the Moderna vaccine on 30-Dec-2020. On 31-Dec-2020, she experienced soreness in her arm, dizziness, fatigue and a mild headache. She stated that these symptoms improved over the next two days but then on 03-Jan-2021, she experienced a bad headache, light sensitivity and lymph node tenderness in the neck and groin. She stated that she was feeling better on 04-Jan-2021 and was no longer taking any pain-relieving medications. The patient was concerned about the duration and intensity of her symptoms and she was also concerned because she stated that she did not usually get headaches. Additionally, she wanted to know if she should get the second dose because she understood that the second dose may cause more side effects that the first dose.   Treatment for the event included paracetamol, plenty of water and rest.   Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the events soreness in arm, dizziness, mild / bad headache, sensitivity to light, tenderness in lymph nodes in neck and groin was recovered and of event fatigue was unknown.; 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: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Gene mutation identification test, Glucose tolerance test, Ultrasound antenatal screen
Clinical narrative: Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnancy) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039k20-2A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (Live, full-term birth) on 18-May-2019, Alcohol use and Nicotine dependence. Concurrent medical conditions included Drug hypersensitivity (Hives, swelling). Concomitant products included COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) from 01-May-2020 to an unknown date, FISH OIL (DHA NATAL) from 01-May-2020 to an unknown date and MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 01-May-2020 to an unknown date for an unknown indication.    On 30-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-May-2020 and the estimated date of delivery was 07-Feb-2021. On 30-Dec-2020, the patient experienced EXPOSURE DURING PREGNANCY (Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-fourth week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 30-Dec-2020, EXPOSURE DURING PREGNANCY (Pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-May-2020, Gene mutation identification test: normal (normal) normal. On 05-May-2020, Ultrasound antenatal screen: normal (normal) normal. On an unknown date, Glucose tolerance test: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication details was reported.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 32-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, SARS-CoV-2 test positive, Vaccination site erythema
Clinical narrative: Injection site erythema; tested positive for COVID-19; COVID-19 symptoms; A spontaneous report was received from a physician who was a 67 year old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed Covid-19 symptoms, injection site erythema, and tested positive for Covid-19.    The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter.  On 26 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number 039K20A) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection.   The physician called to report that he received his first dose of Moderna Covid-19 vaccine on 26 Dec 2020. On 31 Dec 2020, he developed Covid-19 symptoms (unspecified) and tested positive for Covid-19 on 04 Jan 2021. He stated that after developed Covid-19 symptoms, he also developed a 3-5cm ring of erythema at the injection site. The patient provided that he did not have any reaction or tenderness at the injection site on the day of vaccination. Treatment information was not provided/unknown.   Action taken with mRNA-1273 in response to the events was not provided/unknown.   The outcome of the events, Covid-19 symptoms, injection site erythema, and tested positive for Covid-19 were unknown/not reported.  The reporter did not provide causality for the events.; 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 except for the events of COVID-19 and SAR-COV-2  test positive. The event of COVID-19 and SAR-COV-2 test positive is unlikely related to mRNA-1273 since the vaccine does not contain virus capable of causing infection.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea
Clinical narrative: Diarrhea; Nausea; A spontaneous report was received from a 68 year-old female patient who was administered Moderna's COVID-19 vaccine (mRNA-1273) and developed diarrhea and nausea.  The patient's medical history was not provided. Concomitant medications included vitamin D, multivitamin magnesium and zinc, pill for circulation, and muscle relaxer.  On 30-DEC-2020, prior to onset of the events, the patient received her dose of mRNA-1273 (lot#: unknown) intramuscularly in the left arm for the prophylaxis of COVID-19 infection.  On an unknown date, the patient developed diarrhea and nausea. Treatment included loperamide.  Action taken with mRNA-1273 in response to the events was not reported.  The outcomes of the events, diarrhea and nausea, were resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Really really dizzy like walking on a boat; A spontaneous report was received from a 53-year old female patient concerning herself who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced really really dizzy like walking on a boat.   The patient's medical history was not provided. No relevant concomitant medications were reported.  On 30 Dec 2020, approximately 3 days prior to the onset of the event, 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.  On 02 Jan 2021, after receiving the first dose of  mRNA-1273, the patient started to feel dizzy, when she gets up and walks, she feels really, really dizzy, like walking on a boat. She denied nausea, and reports that she was good when she sits down.   On 03 Jan 2021, the patient went to the emergency room but all tests were normal. Treatment for the event included cleaning out ears, Dramamine and oral Pedialyte.   Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, really really dizzy like walking on a boat, was unknown.; Reporter's Comments: This case concerns a 53-year-old female who experienced NS events of unexpected dizziness.  Event onset occurred on Day 4 after the first dose of mRNA-1273. Treatment with dramamine. 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: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Area of the injection site is swollen and warm to the touch; Spot of injection is red; Area of injection is swollen and warm to the touch; Soreness at the injection site; A spontaneous report was received from a 64-year-old, female consumer who received Moderna's COVID-19 vaccine and experienced soreness at the area of injection, spot of the injection is red, swollen and warm to the touch.   The patient's medical history was not provided. No relevant concomitant medications were reported.  On 28 Dec 2020 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number:026L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 28th Dec 2020, after receiving the vaccine, the patient experienced soreness at the vaccine site which resolved next day. On 3rd Jan 2021, day 7  after vaccination the  soreness at the vaccine site reoccurred with redness, swelling and warmth. She did not take any medications to alleviate the events.   Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The outcome for the events was unknown.; 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: Dizziness, Fatigue, Feeling cold, Headache, Hot flush
Clinical narrative: Unable to produce milk; headache; tiredness; woke up with dizziness; arm was in pain and sitll sore; body aches; I was breast feeding 5 month old  baby boy; hot and cold flashes; hot and cold flashes; A spontaneous report was received from a 42 year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm in pain, dizziness, body aches, hot & cold flashes, headache, breastfeeding my 5 month old baby boy, unable to produce milk and still very tired.  The patient's medical history included Covid-19. No relevant concomitant medications were reported.  On 24 Dec 2020, at 9:30 am  10am, the patient received their first of two planned doses of mRNA-1273 intramuscularly (lot number unknown) in her left arm for prophylaxis of COVID-19 infection.    On 25 Dec 2020, at midnight, the patient stated that her arm was in pain and that she woke up with dizziness, body aches. She experienced hot and cold flashes (3 - 4 days after) and headache. Treatment included paracetamol.  The patient noted she was still experiencing dizziness and headache. The body aches were coming and going. Her arm was still sore. She was breastfeeding her 5-month-old baby boy, but was unable to produce milk at the time of this report, and was still very tired.  Action taken with mRNA-1273 vaccine was not provided. The events dizziness, headache, body aches, arm pain and sore, and still very tired were still ongoing and the outcome hot & cold flashes, breastfeeding her 5 month old baby boy, and unable to produce milk were unknown.; Reporter's Comments: This is a case of product exposure during breastfeeding with some associated AEs. Patient will continue to be contacted for further monitoring of AEs.
Sex: F
Vaccine: COVID19
Symptoms: Lactation disorder, Maternal exposure during breast feeding, Pain, Pain in extremity
Clinical narrative: Unable to produce milk; headache; tiredness; woke up with dizziness; arm was in pain and sitll sore; body aches; I was breast feeding 5 month old  baby boy; hot and cold flashes; hot and cold flashes; A spontaneous report was received from a 42 year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm in pain, dizziness, body aches, hot & cold flashes, headache, breastfeeding my 5 month old baby boy, unable to produce milk and still very tired.  The patient's medical history included Covid-19. No relevant concomitant medications were reported.  On 24 Dec 2020, at 9:30 am  10am, the patient received their first of two planned doses of mRNA-1273 intramuscularly (lot number unknown) in her left arm for prophylaxis of COVID-19 infection.    On 25 Dec 2020, at midnight, the patient stated that her arm was in pain and that she woke up with dizziness, body aches. She experienced hot and cold flashes (3 - 4 days after) and headache. Treatment included paracetamol.  The patient noted she was still experiencing dizziness and headache. The body aches were coming and going. Her arm was still sore. She was breastfeeding her 5-month-old baby boy, but was unable to produce milk at the time of this report, and was still very tired.  Action taken with mRNA-1273 vaccine was not provided. The events dizziness, headache, body aches, arm pain and sore, and still very tired were still ongoing and the outcome hot & cold flashes, breastfeeding her 5 month old baby boy, and unable to produce milk were unknown.; Reporter's Comments: This is a case of product exposure during breastfeeding with some associated AEs. Patient will continue to be contacted for further monitoring of AEs.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chills, Confusional state, Fatigue, Feeling abnormal
Clinical narrative: Not feeling well; Tingling in her hands and feet; Fatigue; Nausea; Chills; Confusion; Brain fogginess; Cold hands; Very anxious about having; A spontaneous report was received from a nurse concerning a 56-year-old female patient who experienced confusion [confusion], brain fogginess [foggy feeling in head], not feeling well [malaise], cold hands, are intermittent or waxing and waning, and mostly noticed when going to bed [cold hands], very anxious about having received the vaccine [anxiety], tingling in her hands and feet [tingling feet/hands], fatigue [fatigue], nausea [nausea] and chills [chills].  The patient's medical history was not provided. Concomitant medication use was not provided by the reporter.   On 29-Dec-2020, approximately one day prior to the onset of symptoms, the patient received one of two planned doses of mRNA-1273 (Lot number unknown) intramuscularly in an unknown injection site for prophylaxis of COVID-19 infection.   Since 30-Dec-2020 she has been experiencing fatigue, confusion, brain fogginess, "not feeling well," nausea, chills, and tingling in her hands and feet. The tingling in her hands and feet are accompanied by cold hands, are intermittent and mostly noticed when the patient is going to bed. The caller believes the recipient is also very anxious about having received the vaccine and experiences these symptoms most noticeably before bed due the anxiety. Fatigue has improved somewhat but her other symptoms continue to occur every night. She received negative covid-19 test results on 01-Jan-2021.   Treatment for the events was unknown.    Action taken with mRNA-1273 in response to the events was not applicable.   The event, fatigue, was resolving. The outcomes of the remaining events were not 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.