chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Dyspepsia, Dyspnoea, Ear pain
Clinical narrative: breaks out in a sweat; Runny nose; headache; fatigue; shortness of breath; stomach issues; diarrhea; stomach feels like it's burning; my ears have been hurting; congestion; sore throat; A spontaneous report was received from a healthcare professional for a 37-year-old, female patient who received Moderna's COVID-19 (mRNA-1273) vaccine and developed fatigue, shortness of breath (dyspnoea), stomach issues (abdominal discomfort), diarrhea (diarrhoea), burning feeling in the stomach (dyspepsia), ear pain, headache, congestion (nasal congestion), runny nose (rhinorrhoea), sore throat (oropharyngeal pain) and breaking out in a sweat while doing the dishes (hyperhidrosis).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 28 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 039K20-2A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.     On 29 Dec 2020, one day after receiving the vaccine, the patient reported fatigue, shortness of breath, stomach issues, diarrhea, stomach feels like it's burning, ears have been hurting, headache, congestion, runny nose and sore throat. The patient reported exposure to COVID-19 as she was caring for someone who had tested positive.  They were awaiting COVID test results.    On 31 Dec 2020, the patient reported breaking out in a sweat and has shortness of breath even doing the dishes. They reported that sore throat was not as bad.  Treatment for the events included ibuprofen, omeprazole and bismuth salicylate.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The outcome for the events,  fatigue, shortness of breath, stomach issues, diarrhea, burning feeling in the stomach, ear pain, headache, congestion, runny nose, and  breaking out in a sweat while doing the dishes were considered not recovered/not resolved.   The outcome for the event, sore throat, was considered recovering/resolving.; Reporter's Comments: This case concerns a 37-year-old female who had NS events of unexpected dyspnea, abdominal discomfort, dyspepsia, diarrhea, nasal congestion, rhinorrhea, oropharyngeal pain, ear pain, hyperhidrosis and expected headache and fatigue.  Event onset occurred Day 1 after the first dose of mRNA-1273. Treated with ibuprofen, omeprazole. 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.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hyperhidrosis, Nasal congestion, Oropharyngeal pain
Clinical narrative: breaks out in a sweat; Runny nose; headache; fatigue; shortness of breath; stomach issues; diarrhea; stomach feels like it's burning; my ears have been hurting; congestion; sore throat; A spontaneous report was received from a healthcare professional for a 37-year-old, female patient who received Moderna's COVID-19 (mRNA-1273) vaccine and developed fatigue, shortness of breath (dyspnoea), stomach issues (abdominal discomfort), diarrhea (diarrhoea), burning feeling in the stomach (dyspepsia), ear pain, headache, congestion (nasal congestion), runny nose (rhinorrhoea), sore throat (oropharyngeal pain) and breaking out in a sweat while doing the dishes (hyperhidrosis).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 28 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 039K20-2A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.     On 29 Dec 2020, one day after receiving the vaccine, the patient reported fatigue, shortness of breath, stomach issues, diarrhea, stomach feels like it's burning, ears have been hurting, headache, congestion, runny nose and sore throat. The patient reported exposure to COVID-19 as she was caring for someone who had tested positive.  They were awaiting COVID test results.    On 31 Dec 2020, the patient reported breaking out in a sweat and has shortness of breath even doing the dishes. They reported that sore throat was not as bad.  Treatment for the events included ibuprofen, omeprazole and bismuth salicylate.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The outcome for the events,  fatigue, shortness of breath, stomach issues, diarrhea, burning feeling in the stomach, ear pain, headache, congestion, runny nose, and  breaking out in a sweat while doing the dishes were considered not recovered/not resolved.   The outcome for the event, sore throat, was considered recovering/resolving.; Reporter's Comments: This case concerns a 37-year-old female who had NS events of unexpected dyspnea, abdominal discomfort, dyspepsia, diarrhea, nasal congestion, rhinorrhea, oropharyngeal pain, ear pain, hyperhidrosis and expected headache and fatigue.  Event onset occurred Day 1 after the first dose of mRNA-1273. Treated with ibuprofen, omeprazole. 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.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: breaks out in a sweat; Runny nose; headache; fatigue; shortness of breath; stomach issues; diarrhea; stomach feels like it's burning; my ears have been hurting; congestion; sore throat; A spontaneous report was received from a healthcare professional for a 37-year-old, female patient who received Moderna's COVID-19 (mRNA-1273) vaccine and developed fatigue, shortness of breath (dyspnoea), stomach issues (abdominal discomfort), diarrhea (diarrhoea), burning feeling in the stomach (dyspepsia), ear pain, headache, congestion (nasal congestion), runny nose (rhinorrhoea), sore throat (oropharyngeal pain) and breaking out in a sweat while doing the dishes (hyperhidrosis).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 28 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 039K20-2A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.     On 29 Dec 2020, one day after receiving the vaccine, the patient reported fatigue, shortness of breath, stomach issues, diarrhea, stomach feels like it's burning, ears have been hurting, headache, congestion, runny nose and sore throat. The patient reported exposure to COVID-19 as she was caring for someone who had tested positive.  They were awaiting COVID test results.    On 31 Dec 2020, the patient reported breaking out in a sweat and has shortness of breath even doing the dishes. They reported that sore throat was not as bad.  Treatment for the events included ibuprofen, omeprazole and bismuth salicylate.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The outcome for the events,  fatigue, shortness of breath, stomach issues, diarrhea, burning feeling in the stomach, ear pain, headache, congestion, runny nose, and  breaking out in a sweat while doing the dishes were considered not recovered/not resolved.   The outcome for the event, sore throat, was considered recovering/resolving.; Reporter's Comments: This case concerns a 37-year-old female who had NS events of unexpected dyspnea, abdominal discomfort, dyspepsia, diarrhea, nasal congestion, rhinorrhea, oropharyngeal pain, ear pain, hyperhidrosis and expected headache and fatigue.  Event onset occurred Day 1 after the first dose of mRNA-1273. Treated with ibuprofen, omeprazole. 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: Maternal exposure during pregnancy
Clinical narrative: 20 weeks pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (20 weeks pregnant) 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 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 30-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (20 weeks pregnant). On 30-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (20 weeks pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnant; A spontaneous report was received from consumer who is a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was pregnant when vaccinated.   The patient's medical and pregnancy history was not provided. Concomitant medications not provided.  On an unknown date, the patient received the first dose of mRNA-1273 via unknown route for prophylaxis of COVID-19 infection.   The date of the patient's positive pregnancy test and first day of the last menstrual period were not reported. The estimated date of conception and due date were not reported.  The patient received Moderna vaccine and was pregnant, also stated that she received the Tdap vaccine 19 days ago as well.  Action taken with mRNA-1273 was not reported.  The outcome for the event exposure during pregnancy is resolved/recovered.; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for this unknown age female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chills, Dizziness, Headache
Clinical narrative: back pain; toes and hands are really cold; mild dizziness; some chills; joint aches; headache; A spontaneous report was received from a female consumer of unknown age, who received Moderna's COVID-19 vaccine and experienced back pain, toes and hands are really cold, mild dizziness, some chills, joint aches, and headache.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.    On an 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: Unknown) for prophylaxis of COVID-19 infection.   On an unknown date, the patient was experiencing back pain, toes and hands are really cold, mild dizziness, some chills, joint aches, and headache. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the  events, back pain, toes and hands are really cold, mild dizziness, some chills, joint aches, and headache were considered not recovered.; 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: U
Vaccine: COVID19
Symptoms: Peripheral coldness
Clinical narrative: back pain; toes and hands are really cold; mild dizziness; some chills; joint aches; headache; A spontaneous report was received from a female consumer of unknown age, who received Moderna's COVID-19 vaccine and experienced back pain, toes and hands are really cold, mild dizziness, some chills, joint aches, and headache.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.    On an 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: Unknown) for prophylaxis of COVID-19 infection.   On an unknown date, the patient was experiencing back pain, toes and hands are really cold, mild dizziness, some chills, joint aches, and headache. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the  events, back pain, toes and hands are really cold, mild dizziness, some chills, joint aches, and headache were considered not recovered.; 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: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Positive for Covid-19; A spontaneous report was received from a patient who is also nurse of unknown age and gender. The patient is participating in the mRNA-1273 Emergency Use Program and had a  positive for Covid-19 after vaccination.    There was no relevant medical history or concomitant medications provided.  On 29 Dec 2020, the patient received the first of two planned doses of mRNA-1273 (Lot # unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 29 Dec 2020, the patient was tested positive for Covid-19. The patient reports she received the Covid-19 vaccine on 29 Dec 2020 and after 24 hours started to have a fever and aches. There was no treatment information provided.  Relevant laboratory test on 30 Dec 2020 included a positive SARS-CoV-2 by RT-PCR nasopharyngeal swab.   Action taken with mRNA-1273 in response to the event of Positive for Covid-19 not reported.   The outcome for the event of Positive for Covid-19 was unknown at the time of this report.  Causality was not provided for the event of Positive for Covid-19.; 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: Ageusia, Headache, Hypogeusia, Pyrexia, Upper-airway cough syndrome
Clinical narrative: post nasal drip; start losing taste; Have no taste; Arm hurt worse than tetanus shot; vomiting; fever; really bad headache; A spontaneous report was received from a nurse concerning a 70 year- old, female patient who received Moderna's COVID-19 vaccine and experienced arm pain, postnasal drip, loss of taste, vomiting, fever and headache.   The patient's medical history was not provided. Concomitant medications reported included levothyroxine sodium.   On 23 Dec 2020, approximately three hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (025-J202A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On 23 Dec 2020, the patient states reported arm pain ("worse than tetanus shot") lasting 36 hours, postnasal drip, lost of taste, vomiting, fever and a bad headache. On 30 Dec 2020, the patient reports "starting to feel better". No treatment information was provided.   Action taken with mRNA-1273 in response to the event(s) was not reported.   The outcome of the events, arm pain, postnasal drip, loss of taste, vomiting, fever and headache were considered recovering/resolving.; Reporter's Comments: This case concerns a 70-year-old female who experienced nonserious events of unexpected upper-airway cough syndrome, hypogeusia, ageusia, and expected vaccination site pain, fever, headache, vomiting. Event onset occurred the same day as the first dose of mRNA-1273. Treatment not reported. Events resolving. 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: Vaccination site pain, Vomiting
Clinical narrative: post nasal drip; start losing taste; Have no taste; Arm hurt worse than tetanus shot; vomiting; fever; really bad headache; A spontaneous report was received from a nurse concerning a 70 year- old, female patient who received Moderna's COVID-19 vaccine and experienced arm pain, postnasal drip, loss of taste, vomiting, fever and headache.   The patient's medical history was not provided. Concomitant medications reported included levothyroxine sodium.   On 23 Dec 2020, approximately three hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (025-J202A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On 23 Dec 2020, the patient states reported arm pain ("worse than tetanus shot") lasting 36 hours, postnasal drip, lost of taste, vomiting, fever and a bad headache. On 30 Dec 2020, the patient reports "starting to feel better". No treatment information was provided.   Action taken with mRNA-1273 in response to the event(s) was not reported.   The outcome of the events, arm pain, postnasal drip, loss of taste, vomiting, fever and headache were considered recovering/resolving.; Reporter's Comments: This case concerns a 70-year-old female who experienced nonserious events of unexpected upper-airway cough syndrome, hypogeusia, ageusia, and expected vaccination site pain, fever, headache, vomiting. Event onset occurred the same day as the first dose of mRNA-1273. Treatment not reported. Events resolving. 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: Maternal exposure during pregnancy
Clinical narrative: Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 30-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On 30-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during breast feeding
Clinical narrative: breastfeeding and received vaccine; A spontaneous report was received from a consumer concerning a female patient who was breastfeeding: Maternal exposure during breast feeding  The patient's medical history and concomitant product use were not provided/unknown by the reporter.  In Dec-2020 the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 30-Dec-2020 the patient reported having had a baby on 01-Sep-2020 and was breastfeeding as the time first dose was received.  At the time of the report the outcome for the events was unknown.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events were not reported.   The reporter did not provide causality for the events.; Reporter's Comments: This is a case of product exposure during breastfeeding with no associated AEs. Patient will continue to be contacted for further monitoring of AEs.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnancy; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnancy) 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 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 31-Dec-2020, the patient experienced EXPOSURE DURING PREGNANCY (Pregnancy). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Delivered NOS. Patient delivered baby and have no adverse event for both mother and baby. On 31-Dec-2020, EXPOSURE DURING PREGNANCY (Pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient delivered baby and have no issues and have no adverse events for mother and baby. No relevant concomitant medications reported. No treatment information was provided.  Company Comment: This is a case of product exposure during pregnancy with no associated AEs for this female with an unknown age. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Follow-up information received on 03-Jun-2021: Added delivery notes and updated pregnancy outcome was updated to retrospective.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female with an unknown age. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Limb discomfort, Pain, Tenderness
Clinical narrative: A spontaneous report  was received from a health care professional concerning a 24 year old, female patient who received Moderna's Covid-19 vaccine (mRNA-1273) and experienced limb discomfort, tenderness, pain, and discomfort.  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 # 026L20A) on 30 Dec 2020 for in the left arm for prophylaxis of COVID-19 infection.   Health care professional called to report she received the Moderna Covid-19 vaccine today, 30 Dec 2020 at 6:30PM, and her upper left arm is hurting. She reported that there is soreness, tenderness and uncomfortable pain on her upper left arm that she feels will persist.   Treatment information was not provided but stated she plans on taking ibuprofen.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events,  limb discomfort, tenderness, pain, and discomfort, were considered as unknown.; Reporter's Comments: This case concerns a 24-year-old female who experienced NS events of unexpected discomfort and limb discomfort and expected tenderness and pain.  Event onset occurred the same day as the first dose of mRNA-1273. Treatment included ibuprofen. 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: Rash pruritic
Clinical narrative: itchy rash; A spontaneous case was received from a customer who is a female patient (unkown age) that received Moderna's COVID-19 vaccine (mRNA-1273) and experienced itchy rashes on her neck.  The patients' medical history is reported as allergy to antibiotics and cold medications. No relevant concomitant medications were reported.  On 24-Dec-2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch:unknown) unkown route and location for prophylaxis of COVID-19 infection.  On 25-Dec-2020, the patient developed itchy rashes on her neck and  called in to inquire if she should visit her physician immediately or wait until the next day to visit her doctor.   The action taken with mRNA-1273 in response to the adverse event was not reported. No treatment information was provided.  The outcome of this event is unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Blood pressure measurement, Dysgeusia, Heart rate, Heart rate increased
Clinical narrative: Rapid heart rate of 80BPM; Mettalic taste in mouth; Diaphoretic; Low back ache; Blood pressure shoot up to 163/93; numbness of tongue and lips; Tingling of the tongue; Rash; A spontaneous report was received from a nurse concerning a 60 year-old, female patient who received Moderna's COVID-19 vaccine and experienced rash, became diaphoretic, rapid heart rate, metallic taste, tongue and lip numbness, tongue tingling, low back ache and high blood pressure.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 26 Dec 2020, approximately 10 minutes prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (025J20-2A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 26 Dec 2020, the patient developed a rash and became diaphoretic shortly after receiving the vaccination, She developed a heart rate of 80 beats per min (BPM) from baseline 60 BPM. She reported metallic taste in her mouth, her tongue and lips were numb, and she had tongue tingling. She also noted that she developed low back pain and her blood pressure increase to 163/93. Treatment for the event included diphenhydramine hydrochloride.  Action taken with mRNA-1273 in response to the events was not reported.   The event, rash, was considered recovering/resolving. The outcome of the events, diaphoretic, rapid heart rate, metallic taste, tongue and lip numbness, tongue tingling, low back ache and high blood pressure was unknown/not reported.; Reporter's Comments: This case concerns a 60 Y/O F who had NS unexpected heart rate increased, blood pressure high, hypoaesthesia oral, paraesthesia oral, dysgeusia, diaphoresis, back pain and NS expected rash.  Event onset occurred 10 minutes after the first dose of mRNA-1273. Treatment included diphenhydramine. Rash resolving, 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: Hyperhidrosis, Hypertension, Hypoaesthesia oral, Paraesthesia oral, Rash
Clinical narrative: Rapid heart rate of 80BPM; Mettalic taste in mouth; Diaphoretic; Low back ache; Blood pressure shoot up to 163/93; numbness of tongue and lips; Tingling of the tongue; Rash; A spontaneous report was received from a nurse concerning a 60 year-old, female patient who received Moderna's COVID-19 vaccine and experienced rash, became diaphoretic, rapid heart rate, metallic taste, tongue and lip numbness, tongue tingling, low back ache and high blood pressure.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 26 Dec 2020, approximately 10 minutes prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (025J20-2A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 26 Dec 2020, the patient developed a rash and became diaphoretic shortly after receiving the vaccination, She developed a heart rate of 80 beats per min (BPM) from baseline 60 BPM. She reported metallic taste in her mouth, her tongue and lips were numb, and she had tongue tingling. She also noted that she developed low back pain and her blood pressure increase to 163/93. Treatment for the event included diphenhydramine hydrochloride.  Action taken with mRNA-1273 in response to the events was not reported.   The event, rash, was considered recovering/resolving. The outcome of the events, diaphoretic, rapid heart rate, metallic taste, tongue and lip numbness, tongue tingling, low back ache and high blood pressure was unknown/not reported.; Reporter's Comments: This case concerns a 60 Y/O F who had NS unexpected heart rate increased, blood pressure high, hypoaesthesia oral, paraesthesia oral, dysgeusia, diaphoresis, back pain and NS expected rash.  Event onset occurred 10 minutes after the first dose of mRNA-1273. Treatment included diphenhydramine. Rash resolving, 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: Headache, Myalgia, Pyrexia
Clinical narrative: Fever; headache; Body ache; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever, headache and body aches.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On 26 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (batch number: 039K20A) intramuscularly for prophylaxis of COVID-19 infection.   On 26 Dec 2020, the patient began to have a fever, headache and body aches. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, fever, headache and body aches was unknown.; Reporter's Comments: This case concerns a female of unknown age who had NS expected fever, headaches, myalgia. 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.
Sex: U
Vaccine: COVID19
Symptoms: Exposure via breast milk
Clinical narrative: Breast feeding; A spontaneous report was received from Other Health Professional concerning a unknown patient of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) while breastfeeding (Vaccine exposure via breast milk).  The patients medical history was not provided. No relevant concomitant medications were reported.  On 26 Dec 2020, the patient received dose of mRNA-1273 via transmammary route (lot number: 037K20A).   The patients mother stated that she received the vaccine and wanted to sign up for the pregnancy registry. The patients mother was not pregnant but she was breastfeeding (Vaccine exposure via breast milk).  Action taken with mRNA-1273 in response to the event was not applicable at the time of reporting.  The outcome for the event was not recovered.; Reporter's Comments: This is a case of product exposure during breastfeeding with no associated AEs. Patient will continue to be contacted for further monitoring of AEs.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Pain in extremity, Vaccination site pain
Clinical narrative: my left hand, hip and toward my back, from a scale of 1-10 felt like an 8-9 for the last 24 hours; my left hand, hip and toward my back, from a scale of 1-10 felt like an 8-9 for the last 24 hours; injection site is tender and the tenderness seems to be lasting longer than other vaccines; my left hand, hip and toward my back, from a scale of 1-10 felt like an 8-9 for the last 24 hours; A spontaneous report was received from a consumer, who is a male patient of an unknown age that received Moderna's COVID-19 Vaccine and experienced pain in left hand, hip, toward his back, and vaccine injection site tenderness.  The patient's medical history included an unspecified disorder related to back pain. Concomitant product use included unspecified pain medication.   On 22-Dec-2020 at around 2 o'clock, the patient received his first of two planned doses of mRNA-1273 (Lot number unknown) intramuscularly in his left upper arm for prophylaxis of COVID-19 infection.    That day, at around 4 o'clock, the patient had experienced pain on his left hand, hip and toward his back, pain intensity 8-9/10 for the last 24 hours.  The vaccine injection site was tender which had seemed to last longer than any other vaccines that he had received in the past.   Treatment for the events was not provided.   Action taken with mRNA-1273 in response to the events were unknown.   The events, back pain aggravated, pain in hip, pain in hand and vaccination site tenderness, is 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: Pain
Clinical narrative: A spontaneous report was received from a consumer concerning themselves, a male patient of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and developed body aches.  The patient's medical history was not provided. Concomitant product use was not provided.  The patient received one of two planned doses of mRNA-1273, injection site was not reported, for prophylaxis of COVID-19 infection.  The patient called in to report that they had body aches after administration of this vaccine.   Treatment for the event was not reported.   Action taken with mRNA-1273 was also not provided.  The outcome was unknown for event.; Reporter's Comments: This case concerns a male of unknown age who experienced NS unexpected event of pain. Event onset occurred with unknown latency after the first dose of mRNA-1273. Treatment not reported. Pain 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.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site swelling, Myalgia, Pain, Vaccination site movement impairment
Clinical narrative: Headache; Muscle pain; Right arm pain from the injection site; Difficulty to move and stretch the arm; Swelling from the injection site; A spontaneous report was received from a consumer concerning a 52-year-old female who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced headache, pain, swelling to the arm, muscle pain and difficulty to move and stretch the arm.   The patient's medical history was not provided. Concomitant product use was not provided.   On 30-dec-2020, The patient received their first of two planned doses of mRNA-1273 (Batch number: Unknown) intramuscularly in the right arm  for prophylaxis of COVID-19 infection.    On 30-dec-2020, the patient experienced headache, pain, and swelling to the arm.   Action taken with the second dose of mRNA-1273 in response to the events is not applicable.  The outcome of the events headache,injection site pain and swelling to the arm, pain from injection site to the elbow,  muscle pain and difficulty to move and stretch the arm were considered resolving.; 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: Maternal exposure during pregnancy
Clinical narrative: Pregnant and received the COVID-19 Vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and received the COVID-19 Vaccine) in a 37-year-old female patient (gravida 3, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension (Has been under control and not treated for 10 years) and Nickel sensitivity. Concomitant products included ASA for Pre-eclampsia, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) and DOCUSATE SODIUM (STOOL SOFTENER) for an unknown indication.    On 29-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 in May 2020 and the estimated date of delivery was 29-Jan-2021. On 29-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and received the COVID-19 Vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  On 29-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and received the COVID-19 Vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient had 2 previous pregnancies. The first pregnancy was full term birth in 2017 and second pregnancy was full term birth in 2019.   Reporter did not allow further contact; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 37-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: 29 1/2 weeks pregnant; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (29 1/2 weeks pregnant) 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 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 29-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (29 1/2 weeks pregnant). On 29-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (29 1/2 weeks 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 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 unknown age female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Exposure during pregnancy, Ultrasound scan
Clinical narrative: PREGNANT; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (PREGNANT) in a 37-year-old female patient (gravida 4, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 029K20A) for COVID-19 vaccination.     Patient had prior use of nicotine. No known allergies were reported.  The patient's past medical history included Alcohol use (occasional) from 1998 to 2019, Marijuana use (Rarely), Spontaneous abortion (on 2017 and 2008 (very early ectopic no intervention needed)) and Live birth on 29-Apr-2020.   On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 20-Oct-2020 and the estimated date of delivery was 27-Jul-2021. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (PREGNANT). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  ninth week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (PREGNANT) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Apr-2021, Blood glucose: normal. On 14-Apr-2021, Ultrasound scan: normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   concomitant medication was not provided.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Followup information was received on 23-Apr-2021: Pregnancy dates (Date of LMP, delivery expected date) added, para and gravida added with previous pregnancy details.; Reporter's Comments: This is a case of vaccine exposure during pregnancy with no associated AEs for this female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Nausea
Clinical narrative: feeling a bit hostile; nausea; A spontaneous report was received from a consumer concerning a male patient who received Moderna's COVID-19 Vaccine, and who experienced nausea and feeling a bit hostile.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 22 Dec 2020, approximately ten minutes prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (batch unknown) intramuscularly for prophylaxis of COVID-19 infection.    On 22 Dec 2020, the patient felt nauseous after receiving the vaccine. Treatment information was not provided.   On 24 Dec 2020, the patient started feeling hostile.  Action taken with mRNA-1273 in response to the event was not reported.    The outcome of the events nausea and feeling a bit hostile was unknown.; Reporter's Comments: This case concerns a male of unknown age who experienced a NS unexpected event of anxiety and NS expected events of nausea.  Event onset occurred 10 minutes after the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Malaise, Nausea, Pain
Clinical narrative: A spontaneous report was received from a  Consumer) concerning a 30-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced feeling terrible with body ache, nausea, fever, chills and headache.  The patient's medical history was not provided. No relevant concomitant medications were reported.     On 21-JAN-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch: 043L20A ) intramuscularly in the left arm  for prophylaxis of COVID-19 infection.  On 21-JAN-2021, the patient experienced feeling terrible, body ache, nausea, fever, chills and headache.  No treatment information was provided.    Action taken with mRNA-1273 in response to the events was not reported.    The outcome of the event was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: A spontaneous report was received from a  Consumer) concerning a 30-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced feeling terrible with body ache, nausea, fever, chills and headache.  The patient's medical history was not provided. No relevant concomitant medications were reported.     On 21-JAN-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch: 043L20A ) intramuscularly in the left arm  for prophylaxis of COVID-19 infection.  On 21-JAN-2021, the patient experienced feeling terrible, body ache, nausea, fever, chills and headache.  No treatment information was provided.    Action taken with mRNA-1273 in response to the events was not reported.    The outcome of the event 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.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Soreness at the injection site; redness in the area of the injection spreading toward the chest; Fever (101° F degrees); This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever (101° F degrees)), INJECTION SITE PAIN (Soreness at the injection site) and INJECTION SITE ERYTHEMA (redness in the area of the injection spreading toward the chest) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced PYREXIA (Fever (101° F degrees)). On an unknown date, the patient experienced INJECTION SITE PAIN (Soreness at the injection site) and INJECTION SITE ERYTHEMA (redness in the area of the injection spreading toward the chest). At the time of the report, PYREXIA (Fever (101° F degrees)), INJECTION SITE PAIN (Soreness at the injection site) and INJECTION SITE ERYTHEMA (redness in the area of the injection spreading toward the chest) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Jan-2021, Body temperature: 101 (High) 101.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment medication included acetaminophen.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain in extremity, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain), PYREXIA (101 Fever) and CHILLS (Chills) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm pain). On 11-Feb-2021, the patient experienced PYREXIA (101 Fever) and CHILLS (Chills). At the time of the report, PAIN IN EXTREMITY (Arm pain), PYREXIA (101 Fever) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Feb-2021, Body temperature: 101.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.