chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Feeling abnormal, Injection site pain, Pyrexia
Clinical narrative: her knees feel wobbly, feet are dragging aroudn the house; fever 100.4; chills; feeling terrible; Soreness in the left arm at the injection site; This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (fever 100.4) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 026L20A) for COVID-19 vaccination.     The patient's past medical history included Hypertension (Controlled) since an unknown date and GERD since an unknown date. Concurrent medical conditions included Seasonal allergy. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Allergy, TELMISARTAN (MICARDIS) for Hypertension, FAMOTIDINE (PEPCID AC), MULTIVITAMIN [VITAMINS NOS] and VITAMIN C [ASCORBIC ACID] for an unknown indication.   On 22-Dec-2020 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021 at 1:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Dec-2020, the patient experienced PYREXIA (fever 100.4). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at a dose of 400 mg. On 27-Dec-2020, PYREXIA (fever 100.4) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 98.8 98.8.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: The patient information, patient's medical history, additional event and event outcome, vaccine information (dose 2) and treatment drug were provided.; Sender's Comments: This case concerns a 59-year-old, female patient,  who experienced non-serious expected events of injection site pain, chills and  non-serious unexpected events of feeling abnormal and asthenia .The event of injection site pain occurred 1 day (same day) after the first dose of mRNA-1273, COVID -19 Vaccine. The events of chills and feeling abnormal occurred 5 days after the first dose of mRNA-1273, COVID -19 Vaccine. The event of asthenia  occurred 6 days after the first dose of mRNA-1273, COVID -19 Vaccine. 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.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested Positive for Covid-19; A spontaneous report was received from nurse a concerning a 48-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) was tested positive for Covid-19.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 24 Dec 2020, the patient received their first of two planned doses of mRNA-1273, intramuscularly for prophylaxis of COVID-19 infection.  On 25 Dec 2020, the patient reported positive for COVID-19. No information about the patient's symptoms was provided.   On 30 Dec 2020, the treatment information included, Bamlanivimab.  The nurse stated that since the patient received medication, they will wait 90 days and then proceed with the second dose of the Moderna vaccine.   Action taken with mRNA-1273 in response to the event was dose delayed.  The outcome for the event positive for Covid-19 was unknown.; Reporter's Comments: This case concerns a 48-years-old male patient, who experienced a non-serious unexpected event of SARS-CoV-2 test positive. The events occurred 2 days after first dose of mRNA-1273, lot # unknown. Treatment included Bamalanivimab. Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Nausea
Clinical narrative: Chills; muscle pain; nausea; Head was about to explode/headache; A spontaneous report was received from a health care provider who received Moderna's COVID-19 vaccine (mRNA-1273) and had chills, muscle pain, nausea, and  headache.  The patient's medical history was not provided. No relevant concomitant medications were reported.   The patient received their first of two planned doses of mRNA-1273 on 23 Dec 2020 intramuscularly for prophylaxis of COVID-19 infection. On 23 Dec 2020, the patient experienced chills, muscle pain, nausea, and felt like her head was going to explode.  On 24 Dec 2020, the symptoms were not as bad, but on 25 Dec 2020, they became worse before ending that night.  On 26 Dec 2020, she only had a slight headache.    Treatment included a heating pad and Advil.  Action taken with mRNA-1273 in response to the event was not reported.  The events, chills, muscle pain, and nausea, were considered recovered/resolved on 25 Dec 2020.  The event, headache, was considered recovering/resolving.; Reporter's Comments: This case concerns female patient of unknown age, who experienced a non-serious expected events of chills, myalgia, nausea, and headache.  All events occurred at the same day of the first dose of mRNA-1273 vaccine. Treatment included a heating pad and Advil, and all events resolved two days later. The events were assessed as related to mRNA-1273 vaccine due to temporal association.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Injection site pain, Myalgia
Clinical narrative: really fatigue/tired; chills; JOINT PAIN; MUSCLE PAIN; pain at injecton site; fever; A spontaneous report was received from a consumer concerning a 26 year-old, female patient participating in the mRNA-1273 Emergency Use Program and experienced fatigue, chills, joint pain, muscle pain, pain at the site of injection, and fever.   The patient's medical history, as provided by the reporter, included COVID-19. No relevant concomitant medications were reported.   On 24 Dec 2020 at 11:30 am, approximately 10 hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot #039K20A) intramuscularly for prophylaxis of COVID-19 infection.   On 24 Dec 2020 at about 9:30 pm, the patient started to feel really fatigue and started to get chills, joint pain, and muscle pain. It was reported that the pain first started at the site of injection and then spread to other parts "just like when you workout". Fever was reported at 99.9F. On 26 Dec 2020, the patient reports that "most of symptoms resolved just feeling tired". Treatment for the event included acetaminophen and ibuprofen.   Action taken with mRNA-1273 in response to the events was not reported.   The events, chills, joint pain, muscle pain, pain at the site of injection, and fever, were considered recovered/resolved on 26 Dec 2020. The event, fatigue, was considered recovering/resolving.    The reporter did not provide assessment of the event in relation to study drug.; Reporter's Comments: This case concerns a 26-years-old female patient, with a history of COVID-19 (2 months prior to event onset), who experienced a non-serious expected event of fatigue, chills, pyrexia, arthralgia, myalgia, and injection site pain. The events occurred 1 days (same day) after first dose of mRNA-1273, lot # 039K20A.  Treatment included Tylenol and Aleve. Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: really fatigue/tired; chills; JOINT PAIN; MUSCLE PAIN; pain at injecton site; fever; A spontaneous report was received from a consumer concerning a 26 year-old, female patient participating in the mRNA-1273 Emergency Use Program and experienced fatigue, chills, joint pain, muscle pain, pain at the site of injection, and fever.   The patient's medical history, as provided by the reporter, included COVID-19. No relevant concomitant medications were reported.   On 24 Dec 2020 at 11:30 am, approximately 10 hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot #039K20A) intramuscularly for prophylaxis of COVID-19 infection.   On 24 Dec 2020 at about 9:30 pm, the patient started to feel really fatigue and started to get chills, joint pain, and muscle pain. It was reported that the pain first started at the site of injection and then spread to other parts "just like when you workout". Fever was reported at 99.9F. On 26 Dec 2020, the patient reports that "most of symptoms resolved just feeling tired". Treatment for the event included acetaminophen and ibuprofen.   Action taken with mRNA-1273 in response to the events was not reported.   The events, chills, joint pain, muscle pain, pain at the site of injection, and fever, were considered recovered/resolved on 26 Dec 2020. The event, fatigue, was considered recovering/resolving.    The reporter did not provide assessment of the event in relation to study drug.; Reporter's Comments: This case concerns a 26-years-old female patient, with a history of COVID-19 (2 months prior to event onset), who experienced a non-serious expected event of fatigue, chills, pyrexia, arthralgia, myalgia, and injection site pain. The events occurred 1 days (same day) after first dose of mRNA-1273, lot # 039K20A.  Treatment included Tylenol and Aleve. Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort, Neck pain, Pain, Swelling, Vaccination site pain
Clinical narrative: Right side of her neck was swollen, tender, and painful to touch; Right side of her neck was swollen, tender, and painful to touch; Right side of her neck was swollen, tender, and painful to touch; Hurts upon movement; Tenderness of the site; A spontaneous report was received from a nurse concerning a 38-years-old female patient who experienced right side of her neck was swollen, tender and painful to touch, hurts upon movement and tenderness of the site.   The patient's medical history included diabetes. Concomitant medications included unspecified medications for diabetes.  On 24 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Batch number: 025J20A) in the left arm for prophylaxis of COVID-19 infection.  On 24 Dec 2020, the patient had usual tenderness of the site. On 25 Dec 2020, the patient experienced the right side of her neck was swollen, tender and painful to touch. It hurts upon movement. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events right side of her neck was swollen, tender and painful to touch, hurts upon movement and tenderness of the was not reported. The outcome of the event hurts upon movement was not recovered (still hurts).; Reporter's Comments: This case concerns a 38-year-old female who experienced NS unexpected events of pain, neck pain, neck swelling, musculoskeletal discomfort and NS expected event of injection site pain.  Event onset occurred the same day as the first dose of mRNA-1273. Treatment not reported. Pain event ongoing, other 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: Arthralgia
Clinical narrative: Shoulder started getting sore; A spontaneous report was received from a physician who is a male that received Moderna's COVID-19 vaccine (mRNA-1273) and experienced shoulder getting sore.  The patients' medical history was not provided. No concomitant medications list was provided.  On 23-DEC-2020, prior to the onset of symptoms, patient received the first of two planned doses of mRNA-1273 (BATCH: -unknown) for the prophylaxis of COVID -19 infection.   The patient felt nothing after receiving the vaccine, but 6 hours later he experienced his shoulder started getting sore.   Treatment for the event, shoulder soreness was not provided.    Action taken with planned second dose of mRNA-1273 in response to the event was not provided.  The outcome of the event, shoulder soreness 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 event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Malaise, Nausea
Clinical narrative: Feeling sick; Nauseas; Cold chills; Fever; General weakness; Body aches; headache that felt like a "hand wrapped around her head"; A spontaneous report was received from nurse concerning a 53 year old, female patient who experienced feeling sick, nausea, cold chills, fever, general weakness, body aches, and a headache that felt like a "hand wrapped around her head."   The patient's medical history included a positive COVID-19 test in Aug 2020. Concomitant product use was not provided/unknown by the reporter.   On 26 Dec 2020, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch# 039K20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  Treatment for the event included paracetamol.  Action taken with mRNA-1273 in response to the event(s) was not provided/unknown.   The outcome of the events, feeling sick; nausea, cold chills, fever, general weakness, body aches, and a headache that felt like a "hand wrapped around her head," were not reported.    The reporter did not provide causality assessment for the events, feeling sick; nausea, cold chills, fever, general weakness, body aches, and a headache that felt like a "hand wrapped around her head."; Reporter's Comments: This case concerns a 53-year-old female patient with medical history of COVID-19 in Aug 2020,  who received their first of two planned doses of mRNA-1273 (Lot 039K20A), and who experienced the non-serious listed events of nausea, chills, fever and headache, and the non-serious unlisted events of feeling sick, general weakness, and body aches.  Based on the current available information and temporal association between the use of the product and the onset of events on the day of vaccination, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Feeling sick; Nauseas; Cold chills; Fever; General weakness; Body aches; headache that felt like a "hand wrapped around her head"; A spontaneous report was received from nurse concerning a 53 year old, female patient who experienced feeling sick, nausea, cold chills, fever, general weakness, body aches, and a headache that felt like a "hand wrapped around her head."   The patient's medical history included a positive COVID-19 test in Aug 2020. Concomitant product use was not provided/unknown by the reporter.   On 26 Dec 2020, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch# 039K20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  Treatment for the event included paracetamol.  Action taken with mRNA-1273 in response to the event(s) was not provided/unknown.   The outcome of the events, feeling sick; nausea, cold chills, fever, general weakness, body aches, and a headache that felt like a "hand wrapped around her head," were not reported.    The reporter did not provide causality assessment for the events, feeling sick; nausea, cold chills, fever, general weakness, body aches, and a headache that felt like a "hand wrapped around her head."; Reporter's Comments: This case concerns a 53-year-old female patient with medical history of COVID-19 in Aug 2020,  who received their first of two planned doses of mRNA-1273 (Lot 039K20A), and who experienced the non-serious listed events of nausea, chills, fever and headache, and the non-serious unlisted events of feeling sick, general weakness, and body aches.  Based on the current available information and temporal association between the use of the product and the onset of events on the day of vaccination, a causal relationship cannot be excluded.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Oropharyngeal discomfort, Swollen tongue
Clinical narrative: Swelling in tongue; Nausea; Throat scratchy; This spontaneous report was received from a consumer of 60-year-old, female patient who was participating in the mRNA-1273 Emergency Use Program and experienced multiple events of swelling in tongue, nausea and feel like throat scratchy.  The patient's medical history was not provided. No Concomitant medications were reported.  On 23 Dec 2020 at 10:30, the patient received their first of two planned doses of mRNA-1273 (Lot# not reported) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 23 Dec 2020, the patient experienced swelling in tongue, nausea and feel like throat scratchy. No treatment was administered.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome for the events, swelling in tongue, nausea and feel like throat scratchy was unknown.  The reporter did not provide an assessment for the events.; Reporter's Comments: This case concerns a female patient, who experienced a non-serious unexpected event of swollen tongue, oropharyngeal discomfort and non-serious expected event of nausea. The events occurred on an unspecified date after first dose of mRNA-1273, lot # unknown. Treatment details was no provided. Very limited information regarding these events has been provided at this time. Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded. Additional information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: Temperature excursion administered up to 57 patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion administered up to 57 patients) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion administered up to 57 patients). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion administered up to 57 patients) 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.   No relevant concomitant medications were provided. No treatment information was provided.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Bone pain, Chills, Myalgia
Clinical narrative: Severe body pain; Neck pain; Shin pain; Chills; Joint pain; Both legs are hurting/ Mild aching in the arms/ Thigh pain; Back hurting; Muscle pain; A spontaneous report was received from a 49-years-old female, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced muscle pain/ myalgia, joint pain/ arthralgia, thigh pain/ both legs hurting/ mild aching in the arms/ pain in extremity, back hurting/ back pain, neck pain, shin pain/bone pain, chills, and severe body pain/ general body pain.   The patient's medical history included COVID-19 virus. No relevant concomitant medications were reported.  On 23 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: 011J208) intramuscularly, for prophylaxis of COVID-19 infection.  On 23 Dec 2020, the patient had mild aching in the arms, muscle pain, thigh pain, and joint pain. She reported that both legs and back were hurting.   On 25 Dec 2020, the symptoms continued along with chills. The patient stated that maybe the chills were due to the severe body pain. The patient also had neck pain and shin pain. Treatment for the events included paracetamol.   Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, muscle pain, joint pain, thigh pain, both legs hurting, back hurting, chills, mild aching in the arms, neck pain, shin pain, and severe body pain, were considered unknown.; 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: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain, Pain in extremity
Clinical narrative: Severe body pain; Neck pain; Shin pain; Chills; Joint pain; Both legs are hurting/ Mild aching in the arms/ Thigh pain; Back hurting; Muscle pain; A spontaneous report was received from a 49-years-old female, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced muscle pain/ myalgia, joint pain/ arthralgia, thigh pain/ both legs hurting/ mild aching in the arms/ pain in extremity, back hurting/ back pain, neck pain, shin pain/bone pain, chills, and severe body pain/ general body pain.   The patient's medical history included COVID-19 virus. No relevant concomitant medications were reported.  On 23 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: 011J208) intramuscularly, for prophylaxis of COVID-19 infection.  On 23 Dec 2020, the patient had mild aching in the arms, muscle pain, thigh pain, and joint pain. She reported that both legs and back were hurting.   On 25 Dec 2020, the symptoms continued along with chills. The patient stated that maybe the chills were due to the severe body pain. The patient also had neck pain and shin pain. Treatment for the events included paracetamol.   Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, muscle pain, joint pain, thigh pain, both legs hurting, back hurting, chills, mild aching in the arms, neck pain, shin pain, and severe body pain, were considered unknown.; 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.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: Arm Pain; Sore; red; hard; Feeling tired; little fever with 2 readings (99.8 & 100.1 F); A spontaneous report was received from a healthcare facility staff member concerning a 29-year-old, female patient who was participating in the mRNA-1273 Emergency Use Program and who experienced arm pain, sore, red and hard on the injection site, feeling tired and had a little fever with 2 readings (99.8 & 100.1 F).   The patient's medical history includes Covid-19. Dates were undisclosed. Products known to have been used by the patient, within two weeks prior to the event, included vitamins B, C and zinc.    The patient received their first of two planned doses of mRNA-1273 on 26-Dec-2020 intramuscularly in the right deltoid for prophylaxis of COVID-19 infection.   Patient received the Moderna vaccine on the evening of 26-Dec-2020.  Following vaccine administration, she experienced arm pain and soreness as well as redness and hardness at the injection site.  Additionally, she reported feeling tired and had fever with 2 readings (99.8 & 100.1 F).  Patient admitted to taking paracetamol for pain.   Treatment for the event included paracetamol for pain.   Action taken with mRNA-1273 in response to the events, experienced arm pain, sore, red and hard on the injection site, feeling tired and had a little fever with 2 readings (99.8 & 100.1 F), was not provided.   The outcome of the events, experienced arm pain, sore, red and hard on the injection site, feeling tired and had a little fever with 2 readings (99.8 & 100.1 F), was not provided.   The reporter did not provide an assessment for the events, experienced arm pain, sore, red and hard on the injection site, feeling tired and had a little fever with 2 readings (99.8 & 100.1 F).; Reporter's Comments: This case concerns 29-year-old, female patient experienced non-serious, expected  injection site pain, injection site rash, injection site swelling, fever and fatigue, as well as non-serious unexpected event of arm pain events following administration of the 1st dose of the Moderna vaccine mRNA-1273. Treatment for the events included paracetamol for pain, however outcome was not reported. All events were assessed as possibly related due to temporal plausibility.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Arm Pain; Sore; red; hard; Feeling tired; little fever with 2 readings (99.8 & 100.1 F); A spontaneous report was received from a healthcare facility staff member concerning a 29-year-old, female patient who was participating in the mRNA-1273 Emergency Use Program and who experienced arm pain, sore, red and hard on the injection site, feeling tired and had a little fever with 2 readings (99.8 & 100.1 F).   The patient's medical history includes Covid-19. Dates were undisclosed. Products known to have been used by the patient, within two weeks prior to the event, included vitamins B, C and zinc.    The patient received their first of two planned doses of mRNA-1273 on 26-Dec-2020 intramuscularly in the right deltoid for prophylaxis of COVID-19 infection.   Patient received the Moderna vaccine on the evening of 26-Dec-2020.  Following vaccine administration, she experienced arm pain and soreness as well as redness and hardness at the injection site.  Additionally, she reported feeling tired and had fever with 2 readings (99.8 & 100.1 F).  Patient admitted to taking paracetamol for pain.   Treatment for the event included paracetamol for pain.   Action taken with mRNA-1273 in response to the events, experienced arm pain, sore, red and hard on the injection site, feeling tired and had a little fever with 2 readings (99.8 & 100.1 F), was not provided.   The outcome of the events, experienced arm pain, sore, red and hard on the injection site, feeling tired and had a little fever with 2 readings (99.8 & 100.1 F), was not provided.   The reporter did not provide an assessment for the events, experienced arm pain, sore, red and hard on the injection site, feeling tired and had a little fever with 2 readings (99.8 & 100.1 F).; Reporter's Comments: This case concerns 29-year-old, female patient experienced non-serious, expected  injection site pain, injection site rash, injection site swelling, fever and fatigue, as well as non-serious unexpected event of arm pain events following administration of the 1st dose of the Moderna vaccine mRNA-1273. Treatment for the events included paracetamol for pain, however outcome was not reported. All events were assessed as possibly related due to temporal plausibility.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Positive COVID Test; A Spontaneous report was received from a Physician and concerns a 95-year-old male patient who experienced positive COVID test.  The patient's medical history included chronic obstructive pulmonary disease, arthritis, chronic kidney disease, hyperlipidemia, hypertension, atrial fibrillation (A-Fib), chronic heart failure, benign prostatic hyperplasia (BPH), hydronephrosis, chronic low back pain, hematuria, Alzheimer's, essential tremor, peripheral vascular disease and heart valve replace.  No relevant concomitant medications were reported.  On 19 Dec 2020, the patient had negative COVID-19 PCR test.  On 25 Dec 2020, the patient received his first of two planned doses of mRNA-1273 (batch no: unknown) intramuscularly, for prophylaxis of COVID-19 infection.  On 25 Dec 2020, the same day of receiving vaccination, the patient tested positive for COVID-19. Symptoms included sore throat.  No relevant treatment information was provided.  Action taken with mRNA-1273 in response to the event, positive COVID test was not provided.  The outcome for the event, positive COVID test was not reported.; Reporter's Comments: This case concerns a 95 year old male with medical history of COPD, arthritis, CKD/hydronephrosis, hyperlipidemia, hypertension, A-Fib, CHF/heart valve replacement, BPH, chronic low back pain, hematuria, Alzheimer's, essential tremor, PVD. Baseline COVID-19 test was negative on 19 Dec 2020. On 25 Dec 2020, the same day as first dose mRNA-1273 administration, he tested positive for COVID-19. Symptoms included sore throat.  Based on available evidence at the time of this report and the temporal association of positive COVID-19 test occurring the same day as the mRNA-1273 first dose, the nonserious event of SARS-CoV-2 test positive,  a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Diarrhoea, Dizziness, Headache, Nausea
Clinical narrative: pain in injection site; Felt Nauseas; Felt Dizzy; had the runs; woke up with a slight headache on the right side of head; pain in the middle of her chest radiating to right axillary side of chest / When she inhales deeply, she experiences pain in her chest; A spontaneous report was received from a pharmacist concerning a 48-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pain in injection site, felt nauseas, felt dizzy, had the runs, woke up with a slight headache on the right side of head and pain in the middle of her chest radiating to right axillary side of chest/When she inhales deeply, she experiences pain in her chest.    The patient's medical history included hysterectomy, myomectomy, IBS, anxiety, depression, partial liver removal due to hemangiomas, 2 lumps removed from left breast and melanoma on the abdomen. Concomitant medications reported included duloxetine hydrochloride, progesterone, dicycloverine hydrochloride, metoprolol succinate, metformin, probiotics nos and gabapentin.   On 23 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (batch number: 025J20A) intramuscularly for prophylaxis of COVID-19 infection.   On 23 Dec 2020, during vaccine administration the patient experienced pain at injection site. She went back to home and when in home she felt nauseas, dizzy and she had runs. The patient was not sure if this was because she hadn't eaten. The patient took a nap and woke up with a slight headache on the right side of head and pain in the middle of her chest radiating to right axillary side of her chest. When she inhaled deeply, she experienced pain in her chest. The patient was not sure if her chest pain was muscular. Treatment for the event included acetylsalicylic acid.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, experienced pain in injection site, felt nauseas, felt dizzy, had the runs, woke up with a slight headache on the right side of head and pain in the middle of her chest radiating to right axillary side of chest / When she inhales deeply, she experiences pain in her chest  was not provided.; Reporter's Comments: This case concerns a 48 year old female with medical history of hysterectomy, myomectomy, IBS, anxiety, depression, liver hemangiomas, left breast lumps and melanoma, who experienced listed nonserious events of injection site pain, nausea, headache and unlisted nonserious events of chest pain, dizziness, diarrhea, and respiration abnormal, all occurring after mRNA-1273 administration to the right arm on 23-Dec-2020.  Event duration and outcome were not reported for any of the events. Based on the current available information and temporal association beteeen 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: pain in injection site; Felt Nauseas; Felt Dizzy; had the runs; woke up with a slight headache on the right side of head; pain in the middle of her chest radiating to right axillary side of chest / When she inhales deeply, she experiences pain in her chest; A spontaneous report was received from a pharmacist concerning a 48-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pain in injection site, felt nauseas, felt dizzy, had the runs, woke up with a slight headache on the right side of head and pain in the middle of her chest radiating to right axillary side of chest/When she inhales deeply, she experiences pain in her chest.    The patient's medical history included hysterectomy, myomectomy, IBS, anxiety, depression, partial liver removal due to hemangiomas, 2 lumps removed from left breast and melanoma on the abdomen. Concomitant medications reported included duloxetine hydrochloride, progesterone, dicycloverine hydrochloride, metoprolol succinate, metformin, probiotics nos and gabapentin.   On 23 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (batch number: 025J20A) intramuscularly for prophylaxis of COVID-19 infection.   On 23 Dec 2020, during vaccine administration the patient experienced pain at injection site. She went back to home and when in home she felt nauseas, dizzy and she had runs. The patient was not sure if this was because she hadn't eaten. The patient took a nap and woke up with a slight headache on the right side of head and pain in the middle of her chest radiating to right axillary side of her chest. When she inhaled deeply, she experienced pain in her chest. The patient was not sure if her chest pain was muscular. Treatment for the event included acetylsalicylic acid.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, experienced pain in injection site, felt nauseas, felt dizzy, had the runs, woke up with a slight headache on the right side of head and pain in the middle of her chest radiating to right axillary side of chest / When she inhales deeply, she experiences pain in her chest  was not provided.; Reporter's Comments: This case concerns a 48 year old female with medical history of hysterectomy, myomectomy, IBS, anxiety, depression, liver hemangiomas, left breast lumps and melanoma, who experienced listed nonserious events of injection site pain, nausea, headache and unlisted nonserious events of chest pain, dizziness, diarrhea, and respiration abnormal, all occurring after mRNA-1273 administration to the right arm on 23-Dec-2020.  Event duration and outcome were not reported for any of the events. Based on the current available information and temporal association beteeen the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Diarrhoea, Nausea, Vaccination site pain, Vomiting
Clinical narrative: Diarrhea; Nausea; Vomiting; Soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), NAUSEA (Nausea), VOMITING (Vomiting) and VACCINATION SITE PAIN (Soreness at the injection site) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Diabetes. Concomitant products included INSULIN for Diabetes, APIXABAN (ELIQUIS) for an unknown indication.    On 27-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Dec-2020, the patient experienced DIARRHOEA (Diarrhea), NAUSEA (Nausea), VOMITING (Vomiting) and VACCINATION SITE PAIN (Soreness at the injection site). At the time of the report, DIARRHOEA (Diarrhea), NAUSEA (Nausea) and VACCINATION SITE PAIN (Soreness at the injection site) was resolving and VOMITING (Vomiting) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: above 200 mg/dl abnormal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2021: Follow-up received on 07 Apr 2021 included non significant information. Patient email address information was updated.; 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.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Cough, Injection site pain, Pyrexia
Clinical narrative: Tested positive for Covid-19; Dry cough; Fever; A little arm pain; freezing and cold not warm up; A report was received from a health care professional concerning a patient female who was participating in the mRNA-1273 Emergency Use Program and experienced multiple events of little arm pain, fever, dry cough and freezing and cold not warm up.  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 (Lot# 026L20A). Soon after they experienced multiple events of little arm pain, fever, dry cough and freezing and cold not warm up. The treatment information included Tylenol.   On 08 Jan 2021, Patient called to inquire as to whether she can receive the second dose of the vaccine or not. Patient tested positive for Covid-19 on 06 Jan 2021. Her doctor does not know and told her to call Moderna. Caller angry and frustrated. Verbal Consent given.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome for the events, little arm pain and dry cough was considered recovered/ resolved.  The outcome for the events, fever and freezing and cold not warm up was considered not recovered/ not resolved.  The reporter did not provide an assessment for the events.; Reporter's Comments: This case concerns a 52 Y/O F who had a NS unexpected SARS-CoV-2 test positive, cough and NS expected fever, chills, injection site pain. Event onset occurred on Day 1 after first dose mRNA-1273, with SARS-CoV-2 test positive on Day 10.  Treatment not reported. Arm pain and dry cough resolved, and fever and chills ongoing. 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: SARS-CoV-2 test positive
Clinical narrative: Tested positive for Covid-19; Dry cough; Fever; A little arm pain; freezing and cold not warm up; A report was received from a health care professional concerning a patient female who was participating in the mRNA-1273 Emergency Use Program and experienced multiple events of little arm pain, fever, dry cough and freezing and cold not warm up.  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 (Lot# 026L20A). Soon after they experienced multiple events of little arm pain, fever, dry cough and freezing and cold not warm up. The treatment information included Tylenol.   On 08 Jan 2021, Patient called to inquire as to whether she can receive the second dose of the vaccine or not. Patient tested positive for Covid-19 on 06 Jan 2021. Her doctor does not know and told her to call Moderna. Caller angry and frustrated. Verbal Consent given.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome for the events, little arm pain and dry cough was considered recovered/ resolved.  The outcome for the events, fever and freezing and cold not warm up was considered not recovered/ not resolved.  The reporter did not provide an assessment for the events.; Reporter's Comments: This case concerns a 52 Y/O F who had a NS unexpected SARS-CoV-2 test positive, cough and NS expected fever, chills, injection site pain. Event onset occurred on Day 1 after first dose mRNA-1273, with SARS-CoV-2 test positive on Day 10.  Treatment not reported. Arm pain and dry cough resolved, and fever and chills ongoing. 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: COVID-19, Chest discomfort, Cough, Headache, Hypoaesthesia
Clinical narrative: Numbness on her feet; Positive for Covid 19; Severe headache; Low grade fever; Chest tightness; Body aches; Sore throat; Congestion; Cough; A spontaneous report was received from female patient who is also a nurse. This case concerns an adult female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore throat, congestion, cough, low grade fever, severe headache, chest tightness, body aches, numbness on her feet, and COVID-19 positive with the use of mRNA-1273.   There was no medical history provided. No relevant concomitant medications were reported.   On 23-Dec-2020, the patient received the first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 25-Dec-2020 the patient experienced the non-serious events of a sore throat, congestion, and a cough. On 26-Dec-2020 the patient developed a low grade fever, severe headache, chest tightness, and body aches.  On 27-Dec-2020 the patient developed numbness on her feet and tested positive for COVID-19.  Treatment included with paracetamol and and salbuterol.    Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events of sore throat, congestion, cough, low grade fever, severe headache, chest tightness, body aches, numbness on her feet, and COVID-19 positive was unknown.; Reporter's Comments: This case concerns a female of unknown age, who experienced non-serious unexpected events of sore throat, congestion, cough, chest tightness, body aches, numbness on her feet, and COVID-19  and non-serious expected events of low-grade fever and severe headache. The events began 2 days after the first dose of mRNA-1273 and progressed until she tested positive for COVID-19 at 5 days after mRNA-1273 administration. Treatment included paracetamol and and salbuterol. Based on the current available information and temporal association between the use of mRNA-1273 and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Numbness on her feet; Positive for Covid 19; Severe headache; Low grade fever; Chest tightness; Body aches; Sore throat; Congestion; Cough; A spontaneous report was received from female patient who is also a nurse. This case concerns an adult female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore throat, congestion, cough, low grade fever, severe headache, chest tightness, body aches, numbness on her feet, and COVID-19 positive with the use of mRNA-1273.   There was no medical history provided. No relevant concomitant medications were reported.   On 23-Dec-2020, the patient received the first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 25-Dec-2020 the patient experienced the non-serious events of a sore throat, congestion, and a cough. On 26-Dec-2020 the patient developed a low grade fever, severe headache, chest tightness, and body aches.  On 27-Dec-2020 the patient developed numbness on her feet and tested positive for COVID-19.  Treatment included with paracetamol and and salbuterol.    Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events of sore throat, congestion, cough, low grade fever, severe headache, chest tightness, body aches, numbness on her feet, and COVID-19 positive was unknown.; Reporter's Comments: This case concerns a female of unknown age, who experienced non-serious unexpected events of sore throat, congestion, cough, chest tightness, body aches, numbness on her feet, and COVID-19  and non-serious expected events of low-grade fever and severe headache. The events began 2 days after the first dose of mRNA-1273 and progressed until she tested positive for COVID-19 at 5 days after mRNA-1273 administration. Treatment included paracetamol and and salbuterol. Based on the current available information and temporal association between the use of mRNA-1273 and the start date of the events, a causal relationship cannot be excluded.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular, Premenstrual pain
Clinical narrative: delayed menstrual cycle; pre-cramping feeling; A spontaneous report was received from a 37-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced delayed menstrual cycle and pre-cramping feeling.   The patient's medical history included seizure disorder, allergies, depression and anxiety. Concomitant medication was not reported.   On 23 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (batch #039K20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 23 Dec 2020,  the patient experienced delayed menstrual cycle. The patient stated she has the symptoms as if she's going to have her period, pre-cramping feeling, but it hasn't come yet. No treatment information provided.  Action taken with mRNA-1273 in response to the events were not reported.  The outcome of events, delayed menstrual cycle and pre-cramping feeling, were not reported.; Reporter's Comments: This case concerns a 37-year-old female patient with medical history of seizures, anxiety, and depression,  who received their first of two planned doses of mRNA-1273 (Lot 039K20A), and who experienced the non-serious unlisted events of delayed menstrual cycle and pre-cramping feeling.  Based on the current available information and temporal association between the use of the product and the onset of events on the day of vaccination, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Fatigue, Headache
Clinical narrative: Very bad headache; Extremely tired; Had metallic taste that lasted 24 hours; A spontaneous report was received from a nurse concerning a 42-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced very bad headache, extremely tired, and metallic taste.  The patient's medical history was not provided. Concomitant medication included unspecified birth control.  On 22 Dec 2020, the patient received the first of two planned doses of mRNA-1273 (Lot# 011J20A, Exp. unknown).   On 23 Dec 2020, the patient experienced very bad headache, extremely tired, and metallic taste. It was reported the patient's physician was not aware of the reported events. The patient denied any treatment.   Action taken with mRNA-1273 in response to the reported events was not reported.  The outcome for the events very bad headache, extremely tired and metallic taste considered as recovered/resolved.; Reporter's Comments: This case concerns a 42-year-old female who experienced NS unexpected events of dysgeusia and NS expected events of headache, fatigue.  Event onset occurred 2 days after the first dose of mRNA-1273. No treatment reported. Events resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.