chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain
Clinical narrative: severe lower back pain; pain going into hips; pain going into knees; A spontaneous report was received from a consumer concerning a patient who received the mRNA-1273 and experienced severe lower back pain going into hips and knees.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   The patient received their first of two planned doses of mRNA-1273 on 29-Dec-2020 intramuscularly for prophylaxis of COVID-19 infection.   Patient reported that they received the Moderna vaccine on 29-Dec-2020 at 8 a.m.  She said that by midnight that night, she began to experience severe lower back pain going into hips and knees.  Patient reported that they had been taking paracetamol, naproxen and ibuprofen along with application of a heating pad; none of which provided any relief.    Treatment for the event included paracetamol, naproxen, ibuprofen and application of a heating pad.   Action taken with mRNA-1273 in response to the events, severe lower back pain going into hips and knees, was not provided.    The outcome of the events, severe lower back pain going into hips and knees, was not reported.   The reporter did not provide a causality assessment of the events, severe lower back pain going into hips and knees.; 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, Headache, Myalgia
Clinical narrative: Chills; Headache; Body aches; A spontaneous report was received from a consumer for a 60-year-old female patient who experienced chills, headache, and body aches.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.    On 30 Dec 2020, the patient received his first of two planned doses of mRNA-1273 intramuscularly in her left arm for prophylaxis of COVID-19 infection.   On 30 Dec 2020, the patient experienced chills, headache and body ache.  She took Tylenol and the headache improved.  Action taken with mRNA-1273 in response to the event, chills, headache, and body aches, was not provided.  The outcome for the event, chills and body ache, was not recovered/resolved.  The outcome for the event, headache, was recovering/resolving.; Reporter's Comments: This case concerns a 60-year-old female with nonserious events of expected chills, headache, myalgia.  Event onset the same day as the first dose of mRNA-1273. Treatment with Tylenol. Headache resolved, but chills and myalgia ongoing. 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: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Rash on injection site; A spontaneous report was received from a 43 year old female consumer who was participating in the mRNA-1273 Emergency Use Program and developed rash at injection site.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 23 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot# 027KWA) intramuscularly in the left for prophylaxis of COVID-19 infection.   On 30 Dec 2020, the patient started having a rash at injection site. Patient treated the injection site rash with ibuprofen with no effect.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, rash at injection site, was not known.  The reporter did not provide an assessment 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 of rash, a causal relationship cannot be excluded.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Pregnancy; This spontaneous prospective pregnancy case was reported by a physician and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) in a 30-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) 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. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 15-Jun-2021. On 30-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy). On 30-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (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.   No concomitant medications reported by investigator No treatment medications provided by the reporter.  This is a case of product exposure during pregnancy with no associated AEs for this 30-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 30-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Rash, Vaccination site erythema, Vaccination site pain, Vaccination site reaction
Clinical narrative: Fatigue; Redness around injection site; Tenderness at injection site; Swollen and tiny bit raised at injection site; Arm is rashy and velvety; Defined dark circle at injection site; A spontaneous report  was received from a consumer concerning a female patient who experienced fatigue, injection site erythema, injection site pain, injection site swelling, rash and injection site discoloration.   The patient's medical history and concomitant product use were not provided by the reporter.  On 30 Dec 2020, several hours prior to onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 30 Dec 2020 the patient developed a fatigue; redness, tenderness, discoloration, and swelling around the injection site; and rash.  She treated the events with Tylenol.  At the time of the report the outcome for the events was unknown.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events were 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 events, a causal relationship cannot be excluded.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Fatigue; Redness around injection site; Tenderness at injection site; Swollen and tiny bit raised at injection site; Arm is rashy and velvety; Defined dark circle at injection site; A spontaneous report  was received from a consumer concerning a female patient who experienced fatigue, injection site erythema, injection site pain, injection site swelling, rash and injection site discoloration.   The patient's medical history and concomitant product use were not provided by the reporter.  On 30 Dec 2020, several hours prior to onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 30 Dec 2020 the patient developed a fatigue; redness, tenderness, discoloration, and swelling around the injection site; and rash.  She treated the events with Tylenol.  At the time of the report the outcome for the events was unknown.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events were 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 events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Myalgia, Pyrexia
Clinical narrative: A spontaneous report was received from a consumer concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced multiple events body aches, fever and conscious but very weak.  The patient's medical history was not provided. No Concomitant medications were reported.  On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection  On 31 Dec 2020, the patient experienced body aches, fever and conscious but very weak. No treatment information was reported.  The Action taken with mRNA-1273 in response to the events was unknown.  The outcome for the events, body aches, fever and conscious but very weak was not reported.; Reporter's Comments: This case concerns a male of unknown age who experienced NS events of unexpected asthenia and expected pyrexia, myalgia.  Event onset occurred on Day 2 after 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: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia
Clinical narrative: Chills; Body aches; A spontaneous reportwas received from a Consumer for a 50-year-old, female patient who received Moderna's COVID-19 vaccine and developed chills and body aches.  The patient's medical history, as provided by the reporter, included fibromyalgia. Concomitant medications was not provided.  On 30 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.     On 31 Dec 2020, the patient awoke with chills and body aches. Treatment for the events included acetaminophen, quetiapine and gabapentin.  Action taken with the second dose of mRNA-1273 in response to the events was not reported.  The outcome of the event(s) chills and body aches were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded. However, patient's significant medical history of fibromyalgia may have been contributory.
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Eye pain
Clinical narrative: A lot of pain around right eye; Right inner ear pain; A spontaneous report was received from a consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a lot of pain around right eye and right inner ear.  The patient's medical history was not provided. No concomitant medications were reported.  On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot# unknown).   On an unknown date, the patient experienced a lot of pain around right eye and right inner ear. No treatment information was reported.  The Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events, a lot of pain around right eye and right inner ear was considered as unknown.; Reporter's Comments: This case concerns a patient of unknown age and gender. The patient's medical history was not provided. The patient experienced an unexpected event of right eye pain and ear pain. The event occurred on unspecified date after the first dose of mRNA-1273 administration. Very limited information regarding this event has been provided at this time.  Based on 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: Exposure during pregnancy
Clinical narrative: A spontaneous report was received from a consumer concerning a female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) while pregnant.  The patient's medical and pregnancy history was not provided. No concomitant medications were reported.  On 30 Dec 2020 , the patient received the first dose of mRNA-1273 for prophylaxis of COVID-19 infection.   The date of the patient's positive pregnancy test and first day of the last menstrual period were not reported. The estimated date of conception and due date were not reported.  Action taken with mRNA-1273 was unknown.  The event exposure during pregnancy was considered resolved on 30 Dec 2020.; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Pregnancy test
Clinical narrative: Pregnant at time of vaccination; A spontaneous report was received from a Healthcare professional concerning a 34-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and got pregnant.  The patient's medical history was not provided. The pregnancy history of the patient included 4 prior pregnancies with latest pregnancy details were: live birth, full term birth. No concomitant medications were reported.  On 30 Dec 2020, the patient received the first dose of mRNA-1273 (Lot#: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On Dec 21 2020, the patient had a positive pregnancy test. The first day of the patient's last menstrual period was 24 Nov 2020. The estimated date of conception was 08 Dec 2020 and the due date was estimated as 30 Aug 2021.  Action taken with mRNA-1273 was not applicable.  The event Pregnant at time of vaccination was considered resolved on 30 Dec 2020.; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 34-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site urticaria
Clinical narrative: 2 raised red hives on my arm below the vaccine injection site; Whole deltoid area was firm; Whole deltoid area was warm; Whole deltoid area was red; Bad pain in her armpit; armpit burning; Soreness at the injection site; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced multiple events of soreness at injection site, bad pain in her armpit, armpit felt full, armpit felt uncomfortable, armpit burning, armpit has achy feeling, whole deltoid area was red, whole deltoid area was warm, whole deltoid area was firm and 2 raised red hives on my arm below the vaccine injection site.   The patient's medical history was not provided. No concomitant medications were reported.  On 22 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot# 011J20A). On the same day, the patient experienced soreness at injection site. The treatment information included advil.   On 25 Dec 2020, the patient experienced bad pain in her armpit, armpit felt full, armpit felt uncomfortable, armpit burning, and armpit has achy feeling. No treatment information was reported.   On 29 Dec 2020, the patient experienced whole deltoid area was red, whole deltoid area was warm, and whole deltoid area was firm. No treatment information was reported.   On 30 Dec 2020, the patient experienced 2 raised red hives on my arm below the vaccine injection site. No treatment information was reported.   The Action taken with mRNA-1273 in response to the events was unknown.  The outcome for the event, soreness at injection site was considered as resolved on 24 Dec 2020.  The outcome for the events, bad pain in her armpit, armpit felt full, armpit felt uncomfortable and armpit has achy feeling was considered as resolved on 27 Dec 2020.  The outcome for the events, whole deltoid area was red, whole deltoid area was warm, and whole deltoid area was firm was considered as resolved on 30 Dec 2020.  The outcome for the events, armpit burning and 2 raised red hives on my arm below the vaccine injection site was considered as not recovered/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 event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: 2 raised red hives on my arm below the vaccine injection site; Whole deltoid area was firm; Whole deltoid area was warm; Whole deltoid area was red; Bad pain in her armpit; armpit burning; Soreness at the injection site; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced multiple events of soreness at injection site, bad pain in her armpit, armpit felt full, armpit felt uncomfortable, armpit burning, armpit has achy feeling, whole deltoid area was red, whole deltoid area was warm, whole deltoid area was firm and 2 raised red hives on my arm below the vaccine injection site.   The patient's medical history was not provided. No concomitant medications were reported.  On 22 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot# 011J20A). On the same day, the patient experienced soreness at injection site. The treatment information included advil.   On 25 Dec 2020, the patient experienced bad pain in her armpit, armpit felt full, armpit felt uncomfortable, armpit burning, and armpit has achy feeling. No treatment information was reported.   On 29 Dec 2020, the patient experienced whole deltoid area was red, whole deltoid area was warm, and whole deltoid area was firm. No treatment information was reported.   On 30 Dec 2020, the patient experienced 2 raised red hives on my arm below the vaccine injection site. No treatment information was reported.   The Action taken with mRNA-1273 in response to the events was unknown.  The outcome for the event, soreness at injection site was considered as resolved on 24 Dec 2020.  The outcome for the events, bad pain in her armpit, armpit felt full, armpit felt uncomfortable and armpit has achy feeling was considered as resolved on 27 Dec 2020.  The outcome for the events, whole deltoid area was red, whole deltoid area was warm, and whole deltoid area was firm was considered as resolved on 30 Dec 2020.  The outcome for the events, armpit burning and 2 raised red hives on my arm below the vaccine injection site was considered as not recovered/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 event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Headache, SARS-CoV-2 test
Clinical narrative: Tested weakly positive for COVID-19; Pretty bad headache; A spontaneous report was received from a female consumer who received Moderna's COVID-19 vaccine and experienced a weakly positive COVID-19 test and headache.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 26 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch: unknown) for prophylaxis of COVID-19 infection.     On 26 Dec 2020, the patient received her vaccine. On 29 Dec 2020, the Tuesday after she developed a pretty bad headache. The patient also was tested for COVID-19 on an unknown date. The results showed weakly positive for COVID-19 virus. No treatment information was provided.  Action taken with the second dose of mRNA-1273 in response to the event was unknown.   The outcome for the events, a weakly positive COVID-19 test and headache was not provided.; Reporter's Comments: Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the events of Covid-19 is assessed as unlikely related.  The causality for the event of headache remains possible.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Muscle tightness, Vaccination site erythema, Vaccination site warmth
Clinical narrative: Arm feels tight on the side; It had gotten much worse; Arm was red; Arm was warm; A spontaneous report was received from a nurse,  a 48-year old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced  a red arm, arm was warm, and arm feels tight on side.  The patient's medical history was not provided. Concomitant medications reported included ascorbic acid and cholecalciferol.   On 22 Dec 2020, approximately 2 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 ([LOT# 025520-2A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 24 Dec 2020, the patient noticed her arm was red and warm. By 31 Dec 2020, it had gotten worse as her arm was redder and warmer, and it felt tight on the side. She was concerned about how long the reaction lasted and reports never having a reaction like this to previous vaccines. She has rotated warm and cold compresses on the arm but has not taken treatment yet, though her primary care provider advised her to take Claritin. Treatment for the event included warm and cold compresses.   Action taken with mRNA-1273 in response to the events was not reported.  The outcome of events, arm was red, arm was warm, and arm feels tight on side, 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 the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: A spontaneous report was received from a consumer concerning a female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273)  and developed arm pain.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 30 Dec 2020, the patient received their dose of mRNA-1273 (Batch Number: Unknown) for prophylaxis of COVID-19 infection, and shortly after developed arm pain (Vaccination site pain).  Treatment for the event included ibuprofen.  Action taken with mRNA-1273 in response to the event arm pain was not reported.  The outcome of the event arm pain was 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 event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Covid-19; A spontaneous report was received from a consumer concerning a female patient who experienced COVID-19/MedDRA PT: COVID-19.  The patient's medical history and concomitant product use were not provided/unknown by the reporter.  On an unknown date the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 30-Dec-2020 the patient tested positive for COVID-19.  At the time of the report the outcome for the events was unknown.   Action taken with mRNA-1273 in response to the event was not provided/unknown.  The outcome of the event were unknown/not reported.   The reporter did not provide causality for the event.; 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 tested positive for COVID and the product use is assessed as unlikely,
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Vaccination site movement impairment
Clinical narrative: arm is swollen really bad to the point she can almost not lift it; arm is swollen really bad to the point she can almost not lift it; A spontaneous report was received from a consumer who is an adult female patient of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe arm is swelling and inability to lift/move the vaccinated arm.    The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unknown date in 2020, the patient received the first of two planned doses of mRNA-1273 (Lot # unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date in 2020, after the vaccine administration, the patient experienced severe arm is swelling and inability to lift/move the vaccinated arm. There was no treatment information provided.  There were no relevant laboratory tests provided.  Action taken with mRNA-1273 in response to the event of arm is swollen really bad to the point she can almost not lift it was not reported.   The outcome for the events, severe arm is swelling and inability to lift/move the vaccinated arm, was unknown at the time of this report.  Causality was not provided for the events, severe arm is swelling and inability to lift/move the vaccinated arm.; 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: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Vaccination site pain
Clinical narrative: Joint ache; Arms aching at the site of injection; feeling tired; A spontaneous report was received from a healthcare professional concerning a 75-year-old, female consumer who received Moderna's COVID-19 vaccine and experienced arms aching at site of injection, joint ache and feeling tired after the vaccine.  The patient's medical history, as provided by the reporter, included a bladder instillation and cystoscopy. Concomitant medications reported included betamethasone acetate/betamethasone sodium phosphate.   On 30 Dec 2020 at 0700AM, 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 29 Dec 2020, the patient underwent a cystoscopy for a prior bladder instillation procedure. During, the cystoscopy the patient was administered betamethasone acetate/betamethasone sodium phosphate, intravenously for one hour.  The next day 30 Dec 2020 at 0700AM, she received her mRNA-1273 vaccination. She began to experience her arms aching at site of injection, joint ache and feeling tired after the vaccine. Treatment for the events included tramadol and clovinol, on 31 Dec 2020 at 0630AM.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.    The outcome for the events, arms aching at site of injection, joint ache and feeling tired after the vaccine, are considered resolving.  The reporter's assessment of 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: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Fatigue, SARS-CoV-2 test
Clinical narrative: Slight tightness in the chest; Fatigue; A spontaneous report was received from a consumer, concerning himself, a 52-year-old, male patient, who received Moderna's COVID-19 vaccine and experienced slight tightness in the chest and fatigue.  The patient's medical history reported included COVID-19. No relevant concomitant medications were reported.  On 31 Dec 2020 at 11:00 AM, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot number not provided) via unknown route for prophylaxis of COVID-19 infection.     On 31 Dec 2020 at 02:30 PM, after vaccination, the patient was notified to be positive for COVID-19, which was tested on 29 Dec 2020. The patient experienced fatigue and slight tightness in the chest. No treatment information was provided.   Action taken with mRNA-1273 in response to the events were not reported.  The outcome for the events, slight tightness in the chest and fatigue were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Blepharitis, Dizziness, Fatigue, Headache, Pruritus
Clinical narrative: Angular blepharitis; Itching; Fatigue intermittent; Light headedness and dizziness; Sleepiness; Swelling at the injection site; He got the shot on Tuesday (Dec 29) and it is still sore today; Headache; A spontaneous report was received from consumer concerning a 52 years old male patient, who received Moderna's COVID-19 vaccine and experienced lightheadedness, dizziness, sleepiness, headache, sore injection site area, swelling at injection site, Angular blepharitis, Itching and Fatigue intermittent.  The patient's medical history, as provided by the reporter, included temporomandibular joint (TMJ) and allergies. 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 number: 039K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 29 Dec 2020, the patient experienced headache, swelling and soreness in the site of vaccination, fatigue intermittent. He also experienced lightheadedness, dizziness and sleepiness the same day as vaccination. The patient developed itching from 1 Jan 2021. The patient experienced Angular blepharitis since 04 Jan 2021.  The patient is unsure if his headache is due to the vaccine or his TMJ.  Treatment information included Claiiten once a day and Pepcid both since 13 Jan 2021 till 15 Jan 2021 for an unknown indication. Lab details were not reported.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.    The outcome for the events, swelling, lightheadedness, dizziness, sleepiness, sore injection site area and swelling at injection site, angular blepharitis, itching and fatigue intermittent were considered as unknown. The outcome of the event headache was resolved on 15 Jan 2021.  The reporter's assessment of causality for the events was not provided.  Follow up: Follow-up received on 15 Jan 2021 included Batch number of the vaccine, treatment details and event headache details including start date and stop date. Other events were also reported included, angular blepharitis, itching and fatigue intermittent.; 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.  The patient's medical history of allergies and TMJ syndrome is a risk factor for headache and pruritus.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence, Vaccination site pain, Vaccination site swelling
Clinical narrative: Angular blepharitis; Itching; Fatigue intermittent; Light headedness and dizziness; Sleepiness; Swelling at the injection site; He got the shot on Tuesday (Dec 29) and it is still sore today; Headache; A spontaneous report was received from consumer concerning a 52 years old male patient, who received Moderna's COVID-19 vaccine and experienced lightheadedness, dizziness, sleepiness, headache, sore injection site area, swelling at injection site, Angular blepharitis, Itching and Fatigue intermittent.  The patient's medical history, as provided by the reporter, included temporomandibular joint (TMJ) and allergies. 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 number: 039K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 29 Dec 2020, the patient experienced headache, swelling and soreness in the site of vaccination, fatigue intermittent. He also experienced lightheadedness, dizziness and sleepiness the same day as vaccination. The patient developed itching from 1 Jan 2021. The patient experienced Angular blepharitis since 04 Jan 2021.  The patient is unsure if his headache is due to the vaccine or his TMJ.  Treatment information included Claiiten once a day and Pepcid both since 13 Jan 2021 till 15 Jan 2021 for an unknown indication. Lab details were not reported.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.    The outcome for the events, swelling, lightheadedness, dizziness, sleepiness, sore injection site area and swelling at injection site, angular blepharitis, itching and fatigue intermittent were considered as unknown. The outcome of the event headache was resolved on 15 Jan 2021.  The reporter's assessment of causality for the events was not provided.  Follow up: Follow-up received on 15 Jan 2021 included Batch number of the vaccine, treatment details and event headache details including start date and stop date. Other events were also reported included, angular blepharitis, itching and fatigue intermittent.; 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.  The patient's medical history of allergies and TMJ syndrome is a risk factor for headache and pruritus.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Arm which is sore; A spontaneous report was received from a consumer concerning a female patient, who received Moderna's covid-19 vaccine(mRNA-1273) and experienced arm was sore.   The patient's medical history included back issues. No relevant concomitant medications were reported.   On an unspecified date, the patient received their first dose of mRNA-1273 (Batch Number: Unknown) for prophylaxis of COVID-19 infection.  On an unspecified date, the patient received Moderna COVID-19 Vaccine and experienced arm was sore (Pain in arm).  Treatment details included three Ibuprofen for an evet arm was sore.  Action taken with mRNA-1273 in response to the event arm was sore was not reported.  The outcome of the event arm was sore was 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 event, a causal relationship cannot be excluded.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Insomnia, Nasopharyngitis
Clinical narrative: Dry cough; Feels like he was coming down with a cold; Could not go to sleep; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Could not go to sleep), COUGH (Dry cough) and NASOPHARYNGITIS (Feels like he was coming down with a cold) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included COPD.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Dec-2020, the patient experienced INSOMNIA (Could not go to sleep) and NASOPHARYNGITIS (Feels like he was coming down with a cold). On an unknown date, the patient experienced COUGH (Dry cough). At the time of the report, INSOMNIA (Could not go to sleep), COUGH (Dry cough) and NASOPHARYNGITIS (Feels like he was coming down with a cold) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medications included unspecified cold medicine. Concomitant therapy included an oxygen tank.  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.   Most recent FOLLOW-UP information incorporated above includes: On 09-Apr-2021: updated event outcome and action taken (received second dose); 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: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Epistaxis, Headache, Pain in extremity
Clinical narrative: Nose bleeding; Chest hurting; Having a headache getting worse in head; Arm sore; A spontaneous report was received from a consumer concerning a female patient who received Moderna's Covid-19 vaccine (mRNA-1273) and experiencing a headache right now, arm sore for a couple of days, nose is bleeding when blowing nose, and chest hurting.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   The patient received their first of two planned doses of mRNA-1273 (Lot # 0111-20A) on 24 Dec 2020 in the left arm intramuscularly for prophylaxis of COVID-19 infection.   The consumer called stating she received the Moderna COVID-19 vaccine on 24 Dec 2020 at a nursing home. Patient stated people says getting headache. Patient is having headache right now, getting worse in head, arm sore for a couple of days, nose is bleeding when blowing nose, chest hurting, no other symptoms.    Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not provided.   The event, a headache right now, arm sore for a couple of days, nose is bleeding when blowing nose, and chest hurting, was considered unknown.   The reporter did not provide an assessment of the event, a headache right now, arm sore for a couple of days, nose is bleeding when blowing nose, and chest hurting.; 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: Maternal exposure during pregnancy
Clinical narrative: Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Pregnancy.    On an unknown date, 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 an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information was not provided.  Treatment information was not provided.; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for a pregnant female of unknown age. The consumer will continue to be contacted for further monitoring of AEs during the pregnancy.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness in arm; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (Soreness in arm) 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 medical history reported.).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Soreness in arm). At the time of the report, VACCINATION SITE PAIN (Soreness in arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant and treatment information not provided  Company comment: Based on the current available information and temporal association between the use of the product and the onset date of the reported event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-002685 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Decreased appetite, Malaise
Clinical narrative: had a loss of appetite; Malaise; Soreness in my upper right arm in the deltoid muscle that prevents him from sleeping on his right side/covers went on and off throughout the night; Alternating chills and fever; Alternating chills and fever; Soreness in my upper right arm in the deltoid muscle that prevents him from sleeping on his right side; A spontaneous report was received from a 62 year-old, male nurse, who is also the patient, who received Moderna's COVID-19 vaccine and experienced loss of appetite, malaise, soreness in my upper right arm in the deltoid muscle that prevents him from sleeping on his right side, covers went on and off throughout the night, and alternating chills and fever.   The patient's medical history included receiving Varicella Zoster Vaccine in 2018. The patient received the first dose on Friday, and he was down on Saturday.   Concomitant product use was not provided by the reporter.    On 29 Dec 2020 at 14:00, approximately three hours prior to the onset of symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number: Unknown) for prophylaxis of COVID-19 infection.   On 29 Dec 2020, around dinner time, the patient had a loss of appetite and malaise. He went to bed early, and felt alternating chills and fever throughout the night. The patient did not take his temperature, but believed he was probably in the subclinical range, 99 degree range. The patient was not diaphoretic or sweating. The patient's covers went on and off throughout the night which is unusual for him. The patient still had soreness in his upper right arm in the deltoid muscle that prevented him from sleeping on his right side at the time of reporting.  Action taken with mRNA-1273 in response to the event was unknown. The patient has his next vaccination scheduled on 26 Jan 2021.   The outcome of the events loss of appetite, malaise, covers went on and off throughout the night, and alternating chills and fever was unknown.   The event soreness in my upper right arm in the deltoid muscle that prevents him from sleeping on his right side was considered not recovered/not resolved.; Reporter's Comments: This case concerns a 62-year-old male who experienced NS events of unexpected malaise, decrease appetite, poor quality sleep and expected fever, chills, arthralgia.  Event onset occurred the same day as the first dose of mRNA-1273. Treatment not reported.  Arthralgia ongoing, other 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.
Sex: M
Vaccine: COVID19
Symptoms: Poor quality sleep, Pyrexia
Clinical narrative: had a loss of appetite; Malaise; Soreness in my upper right arm in the deltoid muscle that prevents him from sleeping on his right side/covers went on and off throughout the night; Alternating chills and fever; Alternating chills and fever; Soreness in my upper right arm in the deltoid muscle that prevents him from sleeping on his right side; A spontaneous report was received from a 62 year-old, male nurse, who is also the patient, who received Moderna's COVID-19 vaccine and experienced loss of appetite, malaise, soreness in my upper right arm in the deltoid muscle that prevents him from sleeping on his right side, covers went on and off throughout the night, and alternating chills and fever.   The patient's medical history included receiving Varicella Zoster Vaccine in 2018. The patient received the first dose on Friday, and he was down on Saturday.   Concomitant product use was not provided by the reporter.    On 29 Dec 2020 at 14:00, approximately three hours prior to the onset of symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number: Unknown) for prophylaxis of COVID-19 infection.   On 29 Dec 2020, around dinner time, the patient had a loss of appetite and malaise. He went to bed early, and felt alternating chills and fever throughout the night. The patient did not take his temperature, but believed he was probably in the subclinical range, 99 degree range. The patient was not diaphoretic or sweating. The patient's covers went on and off throughout the night which is unusual for him. The patient still had soreness in his upper right arm in the deltoid muscle that prevented him from sleeping on his right side at the time of reporting.  Action taken with mRNA-1273 in response to the event was unknown. The patient has his next vaccination scheduled on 26 Jan 2021.   The outcome of the events loss of appetite, malaise, covers went on and off throughout the night, and alternating chills and fever was unknown.   The event soreness in my upper right arm in the deltoid muscle that prevents him from sleeping on his right side was considered not recovered/not resolved.; Reporter's Comments: This case concerns a 62-year-old male who experienced NS events of unexpected malaise, decrease appetite, poor quality sleep and expected fever, chills, arthralgia.  Event onset occurred the same day as the first dose of mRNA-1273. Treatment not reported.  Arthralgia ongoing, other 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.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 immunisation.     No Medical History information was reported.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 28-Dec-2020, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). On 28-Dec-2020, EXPOSURE DURING PREGNANCY (Pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  Treatment information was not provided.  This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.