chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dry mouth, Palpitations, Paraesthesia
Clinical narrative: heart racing; light headed; dry mouth; fingers and feet tingling with sharp pain; A spontaneous report was received from a consumer concerning a 54-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced heart racing/palpitations, lightheaded/dizziness, mouth dry/dry mouth, and fingers and feet tingling with sharp pain/paraesthesia.  The patient's medical history included cancer. Concomitant medication included tamoxifen.   On 04 JAN 2021, the patient received the first of two planned doses of mRNA-1273 (batch number: unknown) intramuscularly on her right arm for prophylaxis of COVID-19 infection.  On 04 JAN 2021, the patient experienced heart racing, lightheaded, mouth dry, fingers and feet tingling with sharp pain.  Treatment for the events included acetaminophen.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, heart racing, lightheaded, mouth dry, fingers and feet tingling with sharp pain was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Cough, Headache, Painful respiration
Clinical narrative: cough; headache; fever 98.7F; chills; right lung started to hurt when she exhaled; salivating; runny nose; itchy throat; A spontaneous report was received from a consumer concerning a 40 -years -old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced her right lung started to hurt when she exhaled and had a fever 98.7F and was salivating and had chills, runny nose and itchy throat, next  morning the fever was 102.5 F, had cough and headache.  The patient's medical history as reported by the reporter as she had allergies to almonds, beets, peaches, figs and seasonal allergies. Concomitant medication was not reported.  On 02 Jan 2021 7 pm, two days prior to the onset of the events, patient received their first two doses of mRNA-1273 (Lot number: 025J20-2A) through an unknown route at right shoulder for prophylaxis of COVID-19 infection.  On 04 Jan 2021 morning, her right lung started to hurt when she exhaled and had a fever 98.7F. She could not sleep at night because of the lung pain and was salivating and had chills,runny nose and itchy throat. On 05 J an 2021 morning the fever was 102.5 F. She also had cough and headache. She had not taken any treatment medications.  Treatment activities for event was reported as none.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of events,experienced her right lung started to hurt when she exhaled and had a fever 98.7F, she could not sleep at night because of the lung pain and was salivating and had chills, runny nose and itchy throat, next  morning the fever was 102.5 F, had cough and headache was unknown.  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: Pyrexia, Rhinorrhoea, Salivary hypersecretion, Throat irritation
Clinical narrative: cough; headache; fever 98.7F; chills; right lung started to hurt when she exhaled; salivating; runny nose; itchy throat; A spontaneous report was received from a consumer concerning a 40 -years -old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced her right lung started to hurt when she exhaled and had a fever 98.7F and was salivating and had chills, runny nose and itchy throat, next  morning the fever was 102.5 F, had cough and headache.  The patient's medical history as reported by the reporter as she had allergies to almonds, beets, peaches, figs and seasonal allergies. Concomitant medication was not reported.  On 02 Jan 2021 7 pm, two days prior to the onset of the events, patient received their first two doses of mRNA-1273 (Lot number: 025J20-2A) through an unknown route at right shoulder for prophylaxis of COVID-19 infection.  On 04 Jan 2021 morning, her right lung started to hurt when she exhaled and had a fever 98.7F. She could not sleep at night because of the lung pain and was salivating and had chills,runny nose and itchy throat. On 05 J an 2021 morning the fever was 102.5 F. She also had cough and headache. She had not taken any treatment medications.  Treatment activities for event was reported as none.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of events,experienced her right lung started to hurt when she exhaled and had a fever 98.7F, she could not sleep at night because of the lung pain and was salivating and had chills, runny nose and itchy throat, next  morning the fever was 102.5 F, had cough and headache was unknown.  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: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Injection site pain, Lymphadenopathy, Myalgia
Clinical narrative: swollen glands were on the same side where you had the injection; muscle aches; joint pain; swollen lynph node under her arm which eventually went away; soreness in left arm at injection site; was very tired; supra clavicular node which has not gone away; discoloration on 2 of her of bottom teeth on the left side; This spontaneous case was reported by an other health care professional and describes the occurrence of LYMPHADENOPATHY (supra clavicular node which has not gone away), TOOTH DISCOLOURATION (discoloration on 2 of her of bottom teeth on the left side), LYMPHADENOPATHY (swollen glands were on the same side where you had the injection), MYALGIA (muscle aches) and ARTHRALGIA (joint pain) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-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 TOOTH DISCOLOURATION (discoloration on 2 of her of bottom teeth on the left side). On an unknown date, the patient experienced LYMPHADENOPATHY (supra clavicular node which has not gone away), LYMPHADENOPATHY (swollen glands were on the same side where you had the injection), MYALGIA (muscle aches), ARTHRALGIA (joint pain), LYMPHADENOPATHY (swollen lynph node under her arm which eventually went away), INJECTION SITE PAIN (soreness in left arm at injection site) and FATIGUE (was very tired). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK, prn and IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of UNK, prn. At the time of the report, LYMPHADENOPATHY (supra clavicular node which has not gone away) had not resolved, TOOTH DISCOLOURATION (discoloration on 2 of her of bottom teeth on the left side), MYALGIA (muscle aches), ARTHRALGIA (joint pain), INJECTION SITE PAIN (soreness in left arm at injection site) and FATIGUE (was very tired) outcome was unknown and LYMPHADENOPATHY (swollen glands were on the same side where you had the injection) and LYMPHADENOPATHY (swollen lynph node under her arm which eventually went away) 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.   Most recent FOLLOW-UP information incorporated above includes: On 10-Jan-2021: No specific follow-up information recorded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Tooth discolouration
Clinical narrative: swollen glands were on the same side where you had the injection; muscle aches; joint pain; swollen lynph node under her arm which eventually went away; soreness in left arm at injection site; was very tired; supra clavicular node which has not gone away; discoloration on 2 of her of bottom teeth on the left side; This spontaneous case was reported by an other health care professional and describes the occurrence of LYMPHADENOPATHY (supra clavicular node which has not gone away), TOOTH DISCOLOURATION (discoloration on 2 of her of bottom teeth on the left side), LYMPHADENOPATHY (swollen glands were on the same side where you had the injection), MYALGIA (muscle aches) and ARTHRALGIA (joint pain) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-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 TOOTH DISCOLOURATION (discoloration on 2 of her of bottom teeth on the left side). On an unknown date, the patient experienced LYMPHADENOPATHY (supra clavicular node which has not gone away), LYMPHADENOPATHY (swollen glands were on the same side where you had the injection), MYALGIA (muscle aches), ARTHRALGIA (joint pain), LYMPHADENOPATHY (swollen lynph node under her arm which eventually went away), INJECTION SITE PAIN (soreness in left arm at injection site) and FATIGUE (was very tired). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK, prn and IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of UNK, prn. At the time of the report, LYMPHADENOPATHY (supra clavicular node which has not gone away) had not resolved, TOOTH DISCOLOURATION (discoloration on 2 of her of bottom teeth on the left side), MYALGIA (muscle aches), ARTHRALGIA (joint pain), INJECTION SITE PAIN (soreness in left arm at injection site) and FATIGUE (was very tired) outcome was unknown and LYMPHADENOPATHY (swollen glands were on the same side where you had the injection) and LYMPHADENOPATHY (swollen lynph node under her arm which eventually went away) 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.   Most recent FOLLOW-UP information incorporated above includes: On 10-Jan-2021: No specific follow-up information recorded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Somnolence, Vertigo
Clinical narrative: Woke up with a horrible vertigo; Woke up with a horrible headache; Slept most of the day; Had sore arm; A spontaneous report was received from a healthcare professional concerning a 66-year old, female patient who received Moderna's COVID-19 vaccine and experienced sore arm, horrible headache, horrible vertigo and slept most of the day.    The patient's medical history included Lyme disease. Concomitant medications included Carvedilol, Escitalopram and Hydrochlorothiazide.  On 31 Dec 20, Thursday, approximately one day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (011J20A) intramuscularly for prophylaxis of COVID-19 infection.   On 01 Jan 21, Friday, the patient experienced had a sore arm which had resolved by the time of report. On 02 Jan 21, Saturday, the patient reported woke up with a horrible headache and slept most of the day. On 03 Jan 21, she woke up with horrible vertigo.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event sore arm was considered resolved. The outcome of event vertigo was considered not resolved. The outcome of the events, headache and slept most of the day was not reported.; Reporter's Comments: This case concerns a 66-year-old female with medical history of Lyme disease who had NS unexpected events of somnolence, vertigo, pain in extremity and NS expected event of headache.  Event onset occurred 2 days after the first dose of mRNA-1273. Treatment not reported. Vertigo ongoing, sore arm resolved, but other outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Defaecation urgency, Feeling cold, Flatulence, Headache
Clinical narrative: Soreness of the arm; Slight Headache; Chills; Nauseous; Freezing; Sweating; Gassy; I had a feeling that i had to run to the bathroom but nothing ever came out; ASpontaneous report was received from a Healthcare Professional concerning a 63-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced freezing, chills, sweating, nauseous, gassy, had a feeling that I had to run to the bathroom but nothing came out, slight headache and soreness of the arm.  The patient's medical history was not provided. Concomitant medications reported included paracetamol.   On 29 Dec 2020, approximately 1 day prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 29 Dec 2020, the patient woke up that evening freezing, had chills, was sweating, nauseous, gassy, and had a feeling she had to run to the bathroom but nothing came out. These symptoms only lasted the night.   On 30 Dec 2020, she had a slight headache and soreness of the arm. Treatment for the event included paracetamol.   Action taken with mRNA-1273 in response to the events was not reported.  The event(s) freezing, chills, sweating, nauseous, gassy, and had a feeling that I had to run to the bathroom but nothing came out, were considered resolved on 29 Dec 2020. The outcome of the event(s) slight headache and soreness of the arm were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Nausea, Vaccination site pain
Clinical narrative: Soreness of the arm; Slight Headache; Chills; Nauseous; Freezing; Sweating; Gassy; I had a feeling that i had to run to the bathroom but nothing ever came out; ASpontaneous report was received from a Healthcare Professional concerning a 63-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced freezing, chills, sweating, nauseous, gassy, had a feeling that I had to run to the bathroom but nothing came out, slight headache and soreness of the arm.  The patient's medical history was not provided. Concomitant medications reported included paracetamol.   On 29 Dec 2020, approximately 1 day prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 29 Dec 2020, the patient woke up that evening freezing, had chills, was sweating, nauseous, gassy, and had a feeling she had to run to the bathroom but nothing came out. These symptoms only lasted the night.   On 30 Dec 2020, she had a slight headache and soreness of the arm. Treatment for the event included paracetamol.   Action taken with mRNA-1273 in response to the events was not reported.  The event(s) freezing, chills, sweating, nauseous, gassy, and had a feeling that I had to run to the bathroom but nothing came out, were considered resolved on 29 Dec 2020. The outcome of the event(s) slight headache and soreness of the arm were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm at the injection site; This spontaneous case was reported by an other and describes the occurrence of VACCINATION SITE PAIN (Sore arm at the injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history provided).    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore arm at the injection site). At the time of the report, VACCINATION SITE PAIN (Sore arm at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   Treatment for the event is 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.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: pregnant and received vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (pregnant and received vaccine) in a female patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnant and received vaccine). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (pregnant and received vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not reported. Treatment information was not provided.; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for this  female of unknown age. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Hyperhidrosis, Injection site pain
Clinical narrative: Sore throat; Diarrhea; Sweats; was shaking bad; Head was killing her; had cold chills; Vomited; Left arm was sore arm where received the injection; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), DIARRHOEA (Diarrhea), HYPERHIDROSIS (Sweats), TREMOR (was shaking bad) and HEADACHE (Head was killing her) in a 43-year-old female patient 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 Allergy NOS.    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 OROPHARYNGEAL PAIN (Sore throat), DIARRHOEA (Diarrhea), HYPERHIDROSIS (Sweats), TREMOR (was shaking bad), HEADACHE (Head was killing her), CHILLS (had cold chills), VOMITING (Vomited) and INJECTION SITE PAIN (Left arm was sore arm where received the injection). At the time of the report, OROPHARYNGEAL PAIN (Sore throat), DIARRHOEA (Diarrhea), HYPERHIDROSIS (Sweats), TREMOR (was shaking bad), CHILLS (had cold chills), VOMITING (Vomited) and INJECTION SITE PAIN (Left arm was sore arm where received the injection) had resolved and HEADACHE (Head was killing her) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Company comment: This case concerns a 43-year-old female who experienced NS events of unexpected tremor, oropharyngeal pain, diarrhea, hyperhidrosis, tremor, and expected injection site pain, headache, chills, vomiting. Event onset occurred the same day as the first dose of mRNA-1273. Treated with paracetamol. Based on 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: This case concerns a 43-year-old female who experienced NS events of unexpected tremor, oropharyngeal pain, diarrhea, hyperhidrosis, tremor, and expected injection site pain, headache, chills, vomiting. Event onset occurred the same day as the first dose of mRNA-1273. Treated with paracetamol. Based on current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Tremor, Vomiting
Clinical narrative: Sore throat; Diarrhea; Sweats; was shaking bad; Head was killing her; had cold chills; Vomited; Left arm was sore arm where received the injection; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), DIARRHOEA (Diarrhea), HYPERHIDROSIS (Sweats), TREMOR (was shaking bad) and HEADACHE (Head was killing her) in a 43-year-old female patient 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 Allergy NOS.    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 OROPHARYNGEAL PAIN (Sore throat), DIARRHOEA (Diarrhea), HYPERHIDROSIS (Sweats), TREMOR (was shaking bad), HEADACHE (Head was killing her), CHILLS (had cold chills), VOMITING (Vomited) and INJECTION SITE PAIN (Left arm was sore arm where received the injection). At the time of the report, OROPHARYNGEAL PAIN (Sore throat), DIARRHOEA (Diarrhea), HYPERHIDROSIS (Sweats), TREMOR (was shaking bad), CHILLS (had cold chills), VOMITING (Vomited) and INJECTION SITE PAIN (Left arm was sore arm where received the injection) had resolved and HEADACHE (Head was killing her) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Company comment: This case concerns a 43-year-old female who experienced NS events of unexpected tremor, oropharyngeal pain, diarrhea, hyperhidrosis, tremor, and expected injection site pain, headache, chills, vomiting. Event onset occurred the same day as the first dose of mRNA-1273. Treated with paracetamol. Based on 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: This case concerns a 43-year-old female who experienced NS events of unexpected tremor, oropharyngeal pain, diarrhea, hyperhidrosis, tremor, and expected injection site pain, headache, chills, vomiting. Event onset occurred the same day as the first dose of mRNA-1273. Treated with paracetamol. Based on 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: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: heat; Swelling; redness; itchy on the injection site; 2 inch wide tenderness; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (heat), VACCINATION SITE SWELLING (Swelling), VACCINATION SITE ERYTHEMA (redness), VACCINATION SITE PRURITUS (itchy on the injection site) and VACCINATION SITE PAIN (2 inch wide tenderness) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026120A and 030L20A) for an unknown indication.     The patient's past medical history included GERD (No medical history reported) and Shingles. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], OMEPRAZOLE, ASA, VITAMINS NOS and BOSWELLIA SERRATA RESIN, COLECALCIFEROL, COLLAGEN (OSTEO BI-FLEX EASE).   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On 04-Jan-2021, the patient experienced VACCINATION SITE WARMTH (heat), VACCINATION SITE SWELLING (Swelling), VACCINATION SITE ERYTHEMA (redness), VACCINATION SITE PRURITUS (itchy on the injection site) and VACCINATION SITE PAIN (2 inch wide tenderness). On 11-Jan-2021, VACCINATION SITE ERYTHEMA (redness) had resolved. At the time of the report, VACCINATION SITE WARMTH (heat) and VACCINATION SITE PAIN (2 inch wide tenderness) outcome was unknown, VACCINATION SITE SWELLING (Swelling) had resolved and VACCINATION SITE PRURITUS (itchy on the injection site) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 03-Apr-2021: FUP information included, updated patient information and concomitant medications, dose 2 details.; 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; 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: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Cough, Headache, Myalgia
Clinical narrative: Cough; head was killing her; Fever (101); Muscle pain; Chilled; Joint pain, knees hurt; A spontaneous report was received from a healthcare professional, a female patient,  who experienced fever (pyrexia), muscle pain (myalgia), cough, headache, chills, and joint pain in knees (arthralgia).  The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter.   On 23 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   The patient, a medical researcher, reported that she received the Moderna Covid-19 vaccine on 23 Dec 2020. She did not experience any side effects until 02 Jan 2021. The patient experienced a fever of 101.7, muscle pain, cough, headache, chills, and joint pain and knees hurt.   Treatment for the event included paracetamol and dextromethorphan hydrobromide for pain and cough.    Action taken with mRNA-1273 in response to the events was not provided/unknown.   The outcome of the events, fever, muscle pain, cough, headache, chills, and joint pain in knees were unknown/not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Cough; head was killing her; Fever (101); Muscle pain; Chilled; Joint pain, knees hurt; A spontaneous report was received from a healthcare professional, a female patient,  who experienced fever (pyrexia), muscle pain (myalgia), cough, headache, chills, and joint pain in knees (arthralgia).  The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter.   On 23 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   The patient, a medical researcher, reported that she received the Moderna Covid-19 vaccine on 23 Dec 2020. She did not experience any side effects until 02 Jan 2021. The patient experienced a fever of 101.7, muscle pain, cough, headache, chills, and joint pain and knees hurt.   Treatment for the event included paracetamol and dextromethorphan hydrobromide for pain and cough.    Action taken with mRNA-1273 in response to the events was not provided/unknown.   The outcome of the events, fever, muscle pain, cough, headache, chills, and joint pain in knees were unknown/not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Arm was sore; A spontaneous report was received from a consumer concerning a female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm was sore.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Batch Number: D11L20A) intramuscularly in right arm for prophylaxis of COVID-19 infection.   On unknown date, the patient experienced arm was sore.  No treatment was information was provided.   Action taken with mRNA-1273 in response to the event arm was sore was not reported.   The outcome of event arm was sore was not reported.; Reporter's Comments: This case concerns a female who experienced a nonserious expected event of injection site pain.  Event onset occurred with unknown latency after the first dose of mRNA-1273. Treatment not reported. Event outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Gait disturbance, Headache, Musculoskeletal discomfort
Clinical narrative: Left knee went out; Had trouble walking last night with right knee; Pain starting on the top of her head and moved down to her ear; Pain starting on the top of her head and moved down to her ear; A spontaneous report was received from a physician, concerning herself, a 70-year-old female patient, who received Moderna's Covid-19 vaccine (mRNA-1273) and experienced pain starting on the top of her head and it moved down to her ear/headache/ear pain, had trouble walking last night with right knee and left knee went out.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 29 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot # not provided) via unknown route in the left arm for prophylaxis of COVID-19 infection.   On an unspecified date, the patient noticed a pain starting on the top of her head and it moved down to her ear and she was unsure of when this started, It could have been before the vaccine or after. Additionally, patient had self-diagnosed herself with trigeminal neuralgia on the left side of her face. On 03 Jan 2021, she started having trouble with her right knee, but got better on the same night. On 04 Jan 2021, her left knee went out, but resolved quickly on the same date. Treatment for the event trigeminal neuralgia on left side of her face included acyclovir. No treatment information was provided for other events.  Action taken with mRNA-1273 in response to the events were not appplicable.   The outcome of event pain starting on the top of her head and it moved down to her ear/ headache was considered not resolved at the time of this report. The outcome of event pain starting on the top of her head and it moved down to her ear/ ear pain was considered resolved at the time of this report. The outcome of event trigeminal neuralgia on left side of her face and had trouble walking last night with right knee was resolved on 03 Jan 2021. The outcome of event left knee went out was resolved on 04 Jan 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Received vaccine while pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Received vaccine while pregnant) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No medical history reported.     On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 18-May-2021. On 07-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Received vaccine while pregnant). On 07-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Received vaccine while pregnant) 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 medications were not provided.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2021: No new information.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 32-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test
Clinical narrative: Pregnant women received the first dose of the moderna vaccine/ pregnant; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant women received the first dose of the moderna vaccine/ pregnant) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 26-Aug-2020 and the estimated date of delivery was 02-Jun-2021. On 31-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant women received the first dose of the moderna vaccine/ pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  eighteenth week of the pregnancy.  On 31-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant women received the first dose of the moderna vaccine/ pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Sep-2020, Pregnancy test: 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 Concomitant information  provided. No Treatment information  provided; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 33-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: high fever; A spontaneous report was received from a consumer concerning a male patient  of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a  heavy reaction/adverse reaction and high fever/pyrexia.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (lot# unknown) intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, the patient reported having a "heavy reaction" to the vaccine, including a high fever.   No treatment information was reported.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the events, adverse reaction and pyrexia 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 event of pyrexia, a causal relationship cannot be excluded.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Disorientation
Clinical narrative: Feeling disoriented; Inability to recall; A report was received from a consumer concerning a 72 years old elderly female patient MOD21-01139 who experienced disorientation and inability to recall after receiving the Moderna COVID-19 vaccine. The patient's medical history was not provided. No relevant concomitant medications were reported but expressed that the patient regularly takes supplements (unnamed).  The patient received her first of two planned doses of mRNA-1273 on 31 DEC 2020 intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 01 JAN 2021, she reported that she had experienced disorientation after receiving the vaccine. The patient stated that she gave her neighbor's phone number to her sister but could not recall doing that. The exact time interval between the vaccine administration and the event was not provided. The patient's disorientation was said to have lasted for 75 minutes before resolution. No action was reported to have been taken to aid resolution. No treatment information was provided.  Any action taken with mRNA-1273 in response to the events was not reported.   The events were considered recovered/resolved. There is no information regarding a recurrence of the event, or any residual effects of the event on the patient. The patient consented to follow-up with Safety.; 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: Exposure during pregnancy
Clinical narrative: 24 weeks pregnant; A spontaneous report was received from a consumer concerning a 31-years-old, female patient who received Moderna's COVID-19 Vaccine, and who is 24 weeks pregnant.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.    On 04 Jan 2021, the patient received the vaccine while 24 weeks pregnant and would like to enroll in the pregnancy exposure registry. Treatment information was unknown.   Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the event 24 weeks pregnant was not reported.; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 31-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy (or "patient declined further contact).
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Pruritus
Clinical narrative: fatigue 2-3 days; Red spot on inside of bicep, same arm but not on injection site, opposite side of the bone, against rib cage, size of palm print; Itching; A spontaneous report was received from a consumer concerning a 30 year old, female patient who received Moderna's Covid-19 vaccine (mRNA-1273) and experienced fatigue, pruritus and erythema.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   The patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20-2A) on 29 Dec 2020 intramuscularly for prophylaxis of COVID-19 infection.   The consumer called to report she had received the Moderna COVID-19 vaccine on 29 Dec 2020. She stated she had fatigue for 2-3 days, unknown start date. Started itching on 04 Jan 2021. On 05 Jan 2021, she stated there was a red spot on the inside of her bicep, same arm but not on the injection site, opposite side of the bone, against her rib cage, the size of a palm print.   Treatment for the events was not provided.   Action taken with mRNA-1273 in response to the events was not provided.   The event, fatigue, was considered resolved. The events, pruritus and erythema, were considered unknown.  The reporter did not provide an assessment of the events, fatigue, pruritus and erythema.; Reporter's Comments: This case concerns a 30-year-old female who experienced NS events of unexpected pruritus and erythema and expected fatigue.  Event onset occurred on day 7 after the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Feeling hot, Hyperhidrosis, Palmar erythema, Paraesthesia
Clinical narrative: vasovagal reaction; diarrhea; she started feeling tingly; her entire body was on fire,she was hot; palms were blood red; hot and sweating; A spontaneous report was received from a consumer who was a 59-year-old, female patient who experienced a vasovagal reaction, feeling tingly, feeling like her entire body was on fire, palms were red, hot and sweating, and diarrhea.   The patient's medical history included malignant hyperthermia and Bell's Palsy following the flu vaccine. Concomitant product use was not provided/unknown by the reporter.   On 08 Jan 2021, approximately 40-50 mins prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number 0126201A) intramuscularly for prophylaxis of COVID-19 infection.   The patient stated that she received her first dose of the Moderna Covid-19 vaccine and about 40-50 minutes after she received the vaccine, she started feeling tingly, her entire body as on fire, he palms were blood red, she was hot and was sweating. The symptoms would come and go in 10 minute cycles. As her husband drove her home, she decided to return to a medical facility where she was diagnosed to be vasovagal. Per the patient, the treatment given weakened the symptoms, but also made he tired and sleepy. She reported that she had diarrhea once she got home. Treatment for the event included hydroxyzine 25mg.    Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events, vasovagal reaction, feeling tingly, feeling like her entire body was on fire, palms were red, hot and sweating, and diarrhea were unknown/not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Presyncope
Clinical narrative: vasovagal reaction; diarrhea; she started feeling tingly; her entire body was on fire,she was hot; palms were blood red; hot and sweating; A spontaneous report was received from a consumer who was a 59-year-old, female patient who experienced a vasovagal reaction, feeling tingly, feeling like her entire body was on fire, palms were red, hot and sweating, and diarrhea.   The patient's medical history included malignant hyperthermia and Bell's Palsy following the flu vaccine. Concomitant product use was not provided/unknown by the reporter.   On 08 Jan 2021, approximately 40-50 mins prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number 0126201A) intramuscularly for prophylaxis of COVID-19 infection.   The patient stated that she received her first dose of the Moderna Covid-19 vaccine and about 40-50 minutes after she received the vaccine, she started feeling tingly, her entire body as on fire, he palms were blood red, she was hot and was sweating. The symptoms would come and go in 10 minute cycles. As her husband drove her home, she decided to return to a medical facility where she was diagnosed to be vasovagal. Per the patient, the treatment given weakened the symptoms, but also made he tired and sleepy. She reported that she had diarrhea once she got home. Treatment for the event included hydroxyzine 25mg.    Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events, vasovagal reaction, feeling tingly, feeling like her entire body was on fire, palms were red, hot and sweating, and diarrhea were unknown/not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm is sore; A spontaneous report  was received from a consumer concerning a 56 year-old female patient who received Moderna's COVID-19 Vaccine and experienced sore arm .  The patient's reported medical history was not provided. No relevant concomitant medications were reported.   On 30 Dec 2020, the patient received the first of two planned doses of mRNA-1273 intramuscularly for COVID-19 for infection prophylaxis.  On 04 Jan 2021, the patient stated that her arm was sore and that it was probably because of the weather. The patient would get the second injection on 22 Jan 2021. No treatment information was provided.  Action taken with mRNA-1273 in response to the events is not applicable. The outcome of the event, arm is sore, was considered unknown.  The reporter did not provide causality for the event.; 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: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: Fever; Chills; Achy; A spontaneous report was received from a 50-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever, chills and being achy.    The patient's medical history was not provided. Relevant concomitant medication included atorvastatin.   On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot: 011J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 04 Jan 2021, the evening of administration, the patient experienced fever, chills, and being achy. No treatment provided.    Action taken with mRNA-1273 in response to the event was not reported.   The seriousness criteria of all the events was reported as non-serious.  The outcome of the events, fever, chills and being achy, 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. Further information has been requested.