chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Cough, Dysgeusia, Fatigue, Oropharyngeal discomfort
Clinical narrative: woke up coughing; chest just did not feel right; extremely fatigued; tingling/ weird sensation in my mouth; Metally taste; vision didn't feel right; windpipe felt funny; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (tingling/ weird sensation in my mouth), DYSGEUSIA (Metally taste), VISUAL IMPAIRMENT (vision didn't feel right), OROPHARYNGEAL DISCOMFORT (windpipe felt funny) and COUGH (woke up coughing) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included CPAP (On CPAP machine for unknown history).    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced PARAESTHESIA ORAL (tingling/ weird sensation in my mouth), DYSGEUSIA (Metally taste), VISUAL IMPAIRMENT (vision didn't feel right), OROPHARYNGEAL DISCOMFORT (windpipe felt funny) and FATIGUE (extremely fatigued). On 07-Jan-2021 at 2:00 AM, the patient experienced COUGH (woke up coughing) and CHEST DISCOMFORT (chest just did not feel right). At the time of the report, PARAESTHESIA ORAL (tingling/ weird sensation in my mouth), DYSGEUSIA (Metally taste), VISUAL IMPAIRMENT (vision didn't feel right), OROPHARYNGEAL DISCOMFORT (windpipe felt funny), COUGH (woke up coughing), CHEST DISCOMFORT (chest just did not feel right) and FATIGUE (extremely fatigued) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 06 Jan 2021, within first few minutes after receiving the vaccine, the patient had a tingly/weird sensation in her mouth, a metally taste and was extremely fatigued.  After 15 minutes, her vision just didn't feel right and her windpipe felt funny.  She stated that she wasn't really short of breath and asked the person who gave the vaccine if she should use her inhaler. After 15 more minutes, she went home.  On 07 Jan 2021, at about 2:00am, the patient woke up coughing and felt something in her chest just did not feel right, but it wasn't her heart.  Treatment included one Benadryl (diphenhydramine) which did help.   Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Visual impairment
Clinical narrative: woke up coughing; chest just did not feel right; extremely fatigued; tingling/ weird sensation in my mouth; Metally taste; vision didn't feel right; windpipe felt funny; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (tingling/ weird sensation in my mouth), DYSGEUSIA (Metally taste), VISUAL IMPAIRMENT (vision didn't feel right), OROPHARYNGEAL DISCOMFORT (windpipe felt funny) and COUGH (woke up coughing) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included CPAP (On CPAP machine for unknown history).    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced PARAESTHESIA ORAL (tingling/ weird sensation in my mouth), DYSGEUSIA (Metally taste), VISUAL IMPAIRMENT (vision didn't feel right), OROPHARYNGEAL DISCOMFORT (windpipe felt funny) and FATIGUE (extremely fatigued). On 07-Jan-2021 at 2:00 AM, the patient experienced COUGH (woke up coughing) and CHEST DISCOMFORT (chest just did not feel right). At the time of the report, PARAESTHESIA ORAL (tingling/ weird sensation in my mouth), DYSGEUSIA (Metally taste), VISUAL IMPAIRMENT (vision didn't feel right), OROPHARYNGEAL DISCOMFORT (windpipe felt funny), COUGH (woke up coughing), CHEST DISCOMFORT (chest just did not feel right) and FATIGUE (extremely fatigued) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 06 Jan 2021, within first few minutes after receiving the vaccine, the patient had a tingly/weird sensation in her mouth, a metally taste and was extremely fatigued.  After 15 minutes, her vision just didn't feel right and her windpipe felt funny.  She stated that she wasn't really short of breath and asked the person who gave the vaccine if she should use her inhaler. After 15 more minutes, she went home.  On 07 Jan 2021, at about 2:00am, the patient woke up coughing and felt something in her chest just did not feel right, but it wasn't her heart.  Treatment included one Benadryl (diphenhydramine) which did help.   Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Nausea, Pyrexia
Clinical narrative: Diarrhea; Fever (101°F); Chills; headache; Nausea; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DIARRHOEA (Diarrhea), PYREXIA (Fever (101°F)), CHILLS (Chills), HEADACHE (headache) and NAUSEA (Nausea) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02552E) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced DIARRHOEA (Diarrhea), PYREXIA (Fever (101°F)), CHILLS (Chills), HEADACHE (headache) and NAUSEA (Nausea). At the time of the report, DIARRHOEA (Diarrhea), PYREXIA (Fever (101°F)), CHILLS (Chills), HEADACHE (headache) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment for the event included Chameamelum.  Based on the established safety profile and a strong temporal association between the reported events and administration of mRNA-1273 vaccine, a causal association cannot be excluded. Nausea, headache, pyrexia and chills are consistent with the known safety profile of the vaccine; Reporter's Comments: Based on the established safety profile and a strong temporal association between the reported events and administration of mRNA-1273 vaccine, a causal association cannot be excluded. Nausea, headache, pyrexia and chills are consistent with the known safety profile of the vaccine
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site rash, Pain, Pyrexia, Rash
Clinical narrative: large rash all over her body; big, humongous, distinguished rash; achiness; fever; headache; This spontaneous case was reported by a nurse and describes the occurrence of PAIN (achiness), RASH (large rash all over her body), PYREXIA (fever), HEADACHE (headache) and INJECTION SITE RASH (big, humongous, distinguished rash) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event history).    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced PAIN (achiness), PYREXIA (fever) and HEADACHE (headache). On 06-Jan-2021, the patient experienced RASH (large rash all over her body) and INJECTION SITE RASH (big, humongous, distinguished rash). On 30-Dec-2020, PYREXIA (fever) had resolved. At the time of the report, PAIN (achiness), RASH (large rash all over her body), HEADACHE (headache) and INJECTION SITE RASH (big, humongous, distinguished rash) 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 product history was not provided. Treatments for these events include Zyrtec and her migraine medication for the headaches.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Reporter did not allow further contact; 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: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Pyrexia, Vaccination site pain
Clinical narrative: 101°F fever; Severe headache; Fatigue; Injection site soreness; A spontaneous report ( was received from a consumer concerning a 56-year-old, male patient who received Moderna's Covid-19 vaccine (mRNA-1273) and experienced soreness around the injection site, fever, severe headache, severe fatigue.  The patient's medical history was not provided. Concomitant product use was not provided.  On 29 Dec 2020 the patient received his first of two planned doses of mRNA-1273 (Lot number: 011J20A) for prophylaxis of COVID-19 infection.   On 29 Dec 2020 , the patient experienced soreness at the injection site but no other symptoms.   On 04 Jan 2021, the patient experienced fever of 101°F, severe headache, severe fatigue and exhaustion.   Treatment for the event included ibuprofen, Vitamin C, Vitamin D, and Zinc.   Action taken with mRNA-1273 in response to the events was unknown.   The soreness around the injection site, fever, severe headache, severe fatigue, were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Pruritus, Skin warm, Swelling
Clinical narrative: Redness; swelling; Itching; Pain in arm; Heat in the arm; A spontaneous report was received from a nurse  concerning a 60 year old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced redness, swelling, itching, pain in the arm, and heat in the arm.  The patient's medical history was not provided. Products known to have been used by the patient were not provided.  On 23 Dec 2020, prior to the onset of the events, the patient received one of two planned doses of mRNA-1273 (Lot number: unknown) via unknown route at unknown anatomical location for prophylaxis of COVID-19 infection.    On an unknown date, the patient experienced delayed adverse reaction reported redness, swelling, itching, pain in the arm, and heat in the arm.   Consent obtained for follow up.  Treatment information was not provided.    Action taken with mRNA-1273 in response was not reported.   The outcome of the events, redness, swelling, itching, pain in the arm, heat in the arm were not reported.; Reporter's Comments: This case concerns a 60-year-old patient of unknown gender who experienced NS unexpected events of pain in extremity, pruritus, swelling and skin warmth and NS expected events of erythema. Event onset occurred the same day as the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-003304: US-MODERNATX, INC.-MOD-2021-003308:
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspepsia, Pain, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: injection site hot to the touch; injection site swelling; injection site itching profusely; Heartburn; sore; This spontaneous case was reported by a consumer and describes the occurrence of DYSPEPSIA (Heartburn), PAIN (sore), VACCINATION SITE WARMTH (injection site hot to the touch), VACCINATION SITE SWELLING (injection site swelling) and VACCINATION SITE PRURITUS (injection site itching profusely) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced DYSPEPSIA (Heartburn) and PAIN (sore). On 06-Jan-2021, the patient experienced VACCINATION SITE WARMTH (injection site hot to the touch), VACCINATION SITE SWELLING (injection site swelling) and VACCINATION SITE PRURITUS (injection site itching profusely). At the time of the report, DYSPEPSIA (Heartburn), PAIN (sore), VACCINATION SITE WARMTH (injection site hot to the touch), VACCINATION SITE SWELLING (injection site swelling) and VACCINATION SITE PRURITUS (injection site itching profusely) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  Treatment for the event included Tylenol (paracetamol).  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Reporter did not allow further contact; 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: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Nasopharyngitis, Stress
Clinical narrative: Stress; Rapid heart beat; Cold; This spontaneous case was reported by an other health care professional and describes the occurrence of NASOPHARYNGITIS (Cold), STRESS (Stress) and HEART RATE INCREASED (Rapid heart beat) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced NASOPHARYNGITIS (Cold) and HEART RATE INCREASED (Rapid heart beat). On an unknown date, the patient experienced STRESS (Stress). At the time of the report, NASOPHARYNGITIS (Cold), STRESS (Stress) and HEART RATE INCREASED (Rapid heart beat) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jan-2021, Heart rate: 105-107 (abnormal) 105-107 BPM (beats per minute).     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient's medical history was not provided. No concomitant medications were provided.  The patient was lying in dark calm environment to reduce stress. Treatment for the cold included cough medicine and steroid.   Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Lymphadenopathy, Nausea, Rash, Vaccination site erythema
Clinical narrative: dizzy; mild rash on her chest and arm; nausea; arm was inflamed; hives; injection site redness; injection site swelling; injection site pain; lymph node swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INFLAMMATION (arm was inflamed) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On 26-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jan-2021, the patient experienced VACCINATION SITE INFLAMMATION (arm was inflamed). At the time of the report, VACCINATION SITE INFLAMMATION (arm was inflamed) 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.   Concomitant product use was not provided by the reporter. She took Benadryl 25 mg to help with the hives on day 7.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the se events, a causal relationship cannot be excluded.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the se events, a causal relationship cannot be excluded.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site inflammation, Vaccination site pain, Vaccination site swelling, Vaccination site urticaria
Clinical narrative: dizzy; mild rash on her chest and arm; nausea; arm was inflamed; hives; injection site redness; injection site swelling; injection site pain; lymph node swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INFLAMMATION (arm was inflamed) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On 26-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jan-2021, the patient experienced VACCINATION SITE INFLAMMATION (arm was inflamed). At the time of the report, VACCINATION SITE INFLAMMATION (arm was inflamed) 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.   Concomitant product use was not provided by the reporter. She took Benadryl 25 mg to help with the hives on day 7.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the se events, a causal relationship cannot be excluded.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the se events, a causal relationship cannot be excluded.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: runny nose; slight cough; COVID-19; A spontaneous report  was received from a nurse concerning a 90-year old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced COVID-19, runny nose and slight cough.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 28 Dec 2020, approximately 9 days 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 05 Jan 2021, the patient tested positive for COVID-19 by polymerase chain reaction (PCR) analysis. She was experiencing a runny nose and slight cough. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcomes of the events of COVID-19, runny nose and slight cough was unknown.; Reporter's Comments: Based on the known causative agent of COVID-19 infection, the event COVID-19 is assessed as unlikely related to mRNA-1273. It is likely that the patient was already infected with the virus but asymptomatic before being administered with the mRNA-1273 vaccine.A causal relationship cannot be excluded between the vaccine and the events rhinorrhea and cough.
Sex: U
Vaccine: COVID19
Symptoms: Condition aggravated, Contusion, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Bruise; Symptoms worsening; Redness at injection site; Swelling at injection site; Pain at injection site; A spontaneous report was received from a pharmacist concerning a patient who received Moderna's COVID-19 Vaccine, and experienced bruise/ contusion, symptoms worsening/ condition aggravated, redness at injection site/ vaccination site erythema, swelling at injection site/ vaccination site swelling, pain at injection site/ vaccination site pain.  The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 (LOT# 011J20A) on an undisclosed date intramuscularly for prophylaxis of COVID-19 infection.   A pharmacist called to report that 70 patients received their Moderna vaccine.  He stated that the patients reported redness, swelling and pain at the injection site and bruising Additionally, pharmacist said that some of the patients have stated that their symptoms have worsened. Treatment information was not provided.  Action taken with mRNA-1273 in response to the events were not provided.  The outcome of the events, bruise, symptoms worsening, redness at injection site, swelling at injection site, pain at injection site 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.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: got worse soreness and swelling got worse on day 7-8, presenting redness, swelling and feel heat; got worse soreness and swelling on day 7-8, presenting redness and feel heat; Soreness 2-3 days after vaccination; Swelling 2-3 days after vaccination; A spontaneous report was received from a consumer concerning a 34-years-old, female patient who received Moderna's COVID-19 Vaccine, and who experienced soreness, swelling, redness, heat, and worsening of the soreness and swelling.  The patient's medical history was not provided.  Concomitant medication were not provided.   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 025G20A) intramuscularly in her left arm for prophylaxis of COVID-19 infection.   On 31 Dec 2020, the patient experienced soreness and swelling 2 - 3 days after the COVID-19 vaccine.   On 05 Jan 2021 the patient experienced vaccination site erythema, vaccination site warmth. Then on days 7  8 (05 Jan 2021 - 06 Jan 2021) the injection sited presented with redness, heat, and the soreness and swelling had worsened.    Treatment for the events included hydrocortisone cream twice once on 05 Jan 2021 and once on the morning of 06 Jan 2021.  Action taken with mRNA-1273 in response to the events was unknown.  Seriousness criteria for all event was reported as non serious.  The outcome of the events soreness, swelling, redness, heat, and worsening of the soreness and swelling were not resolved at the time of the report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Breast pain, Chills, Dizziness, Feeling cold
Clinical narrative: Dizziness; Super weak; Heart palpitation; Burning sensation in her lungs; Super cold; Pain in left arm; Pain in breast; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Super cold) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in April 2020.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2021, the patient experienced FEELING COLD (Super cold). At the time of the report, FEELING COLD (Super cold) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.  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.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Palpitations, Respiratory tract irritation
Clinical narrative: Dizziness; Super weak; Heart palpitation; Burning sensation in her lungs; Super cold; Pain in left arm; Pain in breast; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Super cold) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in April 2020.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2021, the patient experienced FEELING COLD (Super cold). At the time of the report, FEELING COLD (Super cold) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.  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.; 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: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Dizziness, Insomnia, Tremor
Clinical narrative: Shoulder throbbing; Chest throbbing; Shaking; Dizzy in the head; Could not sleep; A spontaneous report was received from a consumer concerning a 57-year old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced shoulder throbbing, chest throbbing, shaking, dizzy in the head and could not sleep.  The patient's medical history, as provided by the reporter, included chronic obstructive pulmonary disease (COPD), asthma, blood pressure and bronchitis. Concomitant medications reported included unspecified blood pressure medication.   On 05 Jan 2021 at 11:00, approximately 11 hours and 30 minutes prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 via unknown route for prophylaxis of COVID-19 infection.  On 05 Jan 2021 at 22:30, the patient began to experience shoulder and chest throbbing, shaking, dizziness, and insomnia.   No treatment was received in response to the events.   Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, shoulder throbbing, chest throbbing, shaking, dizzy in the head and could not sleep was unknown.; Reporter's Comments: Based on the information provided, a strong temporal association between the reported events and administration of mRNA-1273 vaccine, and excluding any other etiology, a causal association cannot be excluded.  Arthralgia is consistent with the mRNA-1273  safety profile.
Age: 63.0
Sex: U
Vaccine: COVID19
Symptoms: Cough, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Covid-19 test positive; Lowgrade fever; Cough got worse; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Covid-19 test positive), COUGH (Cough got worse) and PYREXIA (Lowgrade fever) in a 63-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     Concurrent medical conditions included Breast cancer and Hypertension. Concomitant products included HYDROCHLOROTHIAZIDE for Hypertension.    On 11-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced COUGH (Cough got worse). On 12-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Covid-19 test positive) and PYREXIA (Lowgrade fever). At the time of the report, SARS-COV-2 TEST POSITIVE (Covid-19 test positive), COUGH (Cough got worse) and PYREXIA (Lowgrade fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jan-2021, SARS-CoV-2 test positive: positive (Positive) Positive.     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 Treatment information was reported; Sender's Comments: Based on the information provided, a causal association between the event of Covid-19 and the administration of mRNA-1273 vaccine is assessed as unlikely related.  Based n available information. the event pre-existed vaccine administration and the other events of cough and fever are symptoms of the disease.  Hence also assessed as unlikely related.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Ultrasound foetal
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 30-year-old female patient (gravida 3, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included Idiopathic urticaria, Bell's palsy in October 2016, Subfertility, Anxiety and Alcohol use on 15-Aug-2020. Previously administered products included for an unreported indication: LETROZOLE from 2016 to 2018. Concurrent medical conditions included Sulfonamide allergy. Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for Anxiety, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Prenatal care, PROBIOTICS NOS for Probiotic therapy, VITAMIN C [ASCORBIC ACID] and VITAMIN D [VITAMIN D NOS] for Vitamin supplementation.    On 07-Jan-2021 at 4:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 15-Jul-2020 and the estimated date of delivery was 24-May-2021. On 07-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-fifth week of the pregnancy.  On 07-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Ultrasound foetal: abnormal (abnormal) concern regarding femur length. On an unknown date, Ultrasound foetal: abnormal (abnormal) At 20 weeks (concern regarding femur length) and normal (normal) At 8 weeks: everything was fine.     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.   Treatment information was not provided. 17-Mar-2018: Patient had Miscarriage 02-Jul-2019: Patient had live-full time birth, infant's cord was wrapped around the neck and heart rate was dropping; 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.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site rash
Clinical narrative: Discolored rash at the area of the vaccine; Arm felt a bit sore; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of INJECTION SITE RASH (Discolored rash at the area of the vaccine) and INJECTION SITE PAIN (Arm felt a bit sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 30-Dec-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2021, the patient experienced INJECTION SITE RASH (Discolored rash at the area of the vaccine) and INJECTION SITE PAIN (Arm felt a bit sore). At the time of the report, INJECTION SITE RASH (Discolored rash at the area of the vaccine) and INJECTION SITE PAIN (Arm felt a bit sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient's medical history was not provided. No relevant concomitant medications were reported.   No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site infection, Vaccination site inflammation
Clinical narrative: She had a moderate reaction on her arms for about 24 hours. It started to get inflamed.; Possible bacterial infection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INFLAMMATION (She had a moderate reaction on her arms for about 24 hours. It started to get inflamed.) and VACCINATION SITE INFECTION (Possible bacterial infection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE INFLAMMATION (She had a moderate reaction on her arms for about 24 hours. It started to get inflamed.) and VACCINATION SITE INFECTION (Possible bacterial infection). At the time of the report, VACCINATION SITE INFLAMMATION (She had a moderate reaction on her arms for about 24 hours. It started to get inflamed.) and VACCINATION SITE INFECTION (Possible bacterial infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; 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: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Decreased appetite, Fatigue, Nausea
Clinical narrative: Nausea; I felt tired; My stomach hurt constantly; Loss appetite; A spontaneous report  was received from a consumer who was an 60-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced nausea, loss of appetite, stomach pain and felt tired.  The patient's medical history was not provided. No concomitant medications were reported.  On 31 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. On the same day, the patient experienced, nausea and felt tired.   On 31DEC2020, the patient experienced, loss of appetite and stomach pain which she assumed was due to taking ibuprofen with out food. The patient reported that she is healthy, she runs and is a vegan and also that she wasn't ill before the vaccination.   The treatment for the events included ibuprofen.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome for the events, nausea, loss of appetite, stomach pain and felt tired was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation
Clinical narrative: Feet started burning up to knees; A spontaneous report was received from a consumer concerning a 76-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and feet started burning up to knees.  The patient's medical history included hypothyroidism, hypertension, gout and was allergic to latex. Concomitant medication included levothyroxine sodium, lovastatin, losartan and metoprolol.  On 06 Jan 2021 at 02:30 PM, approximately three hours prior to onset of the event, the patient received their first of two planned doses of mRNA-1273 (batch number: 026L20A) on left shoulder area for prophylaxis of COVID-19 infection.  On 06 Jan 2021, the patient experienced that her feet started burning up to her knees. Treatment for the event included cherry pills.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event feet started burning up to knees was not reported.; Reporter's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm now hurts; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm now hurts) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included High cholesterol. Concurrent medical conditions included Hypertension. Concomitant products included SIMVASTATIN, AMLODIPINE, DIAZEPAM, METOPROLOL and CANDESARTAN for an unknown indication.    On 05-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 05-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm now hurts). At the time of the report, PAIN IN EXTREMITY (arm now hurts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded   Reporter did not allow further contact; 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: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Body temperature decreased, Cold sweat, Decreased appetite
Clinical narrative: No desire to eat or drink; Joint ache; Exhausted; Nausesous; Lightheaded; I was hot; Face was flush looking; Tip of her tongue was feeling numb, Lips were feeling numb; Mouth kept salivating; Temperature 92.5F; Felt clammy; A report was received from a [consumer/physician/nurse/pharmacist/healthcare facility staff member] concerning a 61 year- old patient who was participating in the mRNA-1273 Emergency Use Program and developed lightheadedness, felt hot, felt clammy, face was flush, tip of her tongue and lips were numb, exhaustion, nausea, salivating, decreased body temperature, joint ache, and no appetite or thirst.  The patient's medical history, as provided by the reporter, included autoimmune disorder. No relevant concomitant medications were reported.   On 05 Jan 2021, immediately prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the right arm for prophylaxis of COVID-19 infection.   The patient began feeling lightheaded, hot, her face was flush looking, and the tip of her tongue and lips became numb.  Approximately three hours after receiving the vaccine she became nauseous, she was salivating, her temperature was 92.5° F, she felt clammy, and exhausted.  On 06 Jan 2021 her nausea continued, her temperature was 93° F, salivating continued, and her joints ached.  On 07 Jan 2021 her nausea continued and she had no desire to eat or drink. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not provided .   The outcome of the events lightheadedness, felt hot, face was flush, nausea, salivating, decreased body temperature, joint ache, and no appetite or thirst were not reported.  The outcome of the events tip of her tongue and lips were numb were recovered/resolved.  Reporter causality for the events was not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Feeling hot, Flushing, Hypoaesthesia oral
Clinical narrative: No desire to eat or drink; Joint ache; Exhausted; Nausesous; Lightheaded; I was hot; Face was flush looking; Tip of her tongue was feeling numb, Lips were feeling numb; Mouth kept salivating; Temperature 92.5F; Felt clammy; A report was received from a [consumer/physician/nurse/pharmacist/healthcare facility staff member] concerning a 61 year- old patient who was participating in the mRNA-1273 Emergency Use Program and developed lightheadedness, felt hot, felt clammy, face was flush, tip of her tongue and lips were numb, exhaustion, nausea, salivating, decreased body temperature, joint ache, and no appetite or thirst.  The patient's medical history, as provided by the reporter, included autoimmune disorder. No relevant concomitant medications were reported.   On 05 Jan 2021, immediately prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the right arm for prophylaxis of COVID-19 infection.   The patient began feeling lightheaded, hot, her face was flush looking, and the tip of her tongue and lips became numb.  Approximately three hours after receiving the vaccine she became nauseous, she was salivating, her temperature was 92.5° F, she felt clammy, and exhausted.  On 06 Jan 2021 her nausea continued, her temperature was 93° F, salivating continued, and her joints ached.  On 07 Jan 2021 her nausea continued and she had no desire to eat or drink. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not provided .   The outcome of the events lightheadedness, felt hot, face was flush, nausea, salivating, decreased body temperature, joint ache, and no appetite or thirst were not reported.  The outcome of the events tip of her tongue and lips were numb were recovered/resolved.  Reporter causality for the events was not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Salivary hypersecretion
Clinical narrative: No desire to eat or drink; Joint ache; Exhausted; Nausesous; Lightheaded; I was hot; Face was flush looking; Tip of her tongue was feeling numb, Lips were feeling numb; Mouth kept salivating; Temperature 92.5F; Felt clammy; A report was received from a [consumer/physician/nurse/pharmacist/healthcare facility staff member] concerning a 61 year- old patient who was participating in the mRNA-1273 Emergency Use Program and developed lightheadedness, felt hot, felt clammy, face was flush, tip of her tongue and lips were numb, exhaustion, nausea, salivating, decreased body temperature, joint ache, and no appetite or thirst.  The patient's medical history, as provided by the reporter, included autoimmune disorder. No relevant concomitant medications were reported.   On 05 Jan 2021, immediately prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the right arm for prophylaxis of COVID-19 infection.   The patient began feeling lightheaded, hot, her face was flush looking, and the tip of her tongue and lips became numb.  Approximately three hours after receiving the vaccine she became nauseous, she was salivating, her temperature was 92.5° F, she felt clammy, and exhausted.  On 06 Jan 2021 her nausea continued, her temperature was 93° F, salivating continued, and her joints ached.  On 07 Jan 2021 her nausea continued and she had no desire to eat or drink. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not provided .   The outcome of the events lightheadedness, felt hot, face was flush, nausea, salivating, decreased body temperature, joint ache, and no appetite or thirst were not reported.  The outcome of the events tip of her tongue and lips were numb were recovered/resolved.  Reporter causality for the events was not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: warm at  injection site; Itchy at injection site; red at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm at  injection site), VACCINATION SITE PRURITUS (Itchy at injection site) and VACCINATION SITE ERYTHEMA (red at injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION SITE WARMTH (warm at  injection site), VACCINATION SITE PRURITUS (Itchy at injection site) and VACCINATION SITE ERYTHEMA (red at injection site). At the time of the report, VACCINATION SITE WARMTH (warm at  injection site), VACCINATION SITE PRURITUS (Itchy at injection site) and VACCINATION SITE ERYTHEMA (red at injection site) 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 concomitant medication and treatment provided; 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.