chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Sneezing
Clinical narrative: SORE THROAT; STUFFY NOSE; SNEEZING; COUGHING; FEELING HOT; HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced sore throat, stuffy nose, sneezing, coughing, feeling hot, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore throat, stuffy nose, sneezing, coughing, headache and feeling hot was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORE ARM; This spontaneous report received from a parent via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced sore arm. The action taken with covid-19 vaccine was not applicable. The outcome of sore arm was not reported. This report was non-serious. This case, from the same reporter is linked to 20210815700 and 20210815185.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: ACHY; FEVER; TIRED NAPPED FOR TWO DAYS ON AND OFF; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced achy, fever, and tired napped for two days on and off. The action taken with covid-19 vaccine was not applicable. The outcome of the fever, achy and tired napped for two days on and off was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Injection site hypoaesthesia, SARS-CoV-2 test
Clinical narrative: INJECTION ARM NUMBNESS; SLIGHT WEAKNESS; This spontaneous report received from a patient concerned a 55 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient never had any reaction to injections before, patient got a flu shot every year was exposed to COVID-19 multiple times and never got COVID-19 and was in good health, not overweight. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 31-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 05-AUG-2021, the patient experienced injection arm numbness. On 05-AUG-2021, the patient experienced slight weakness. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the injection arm numbness and slight weakness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Body temperature, Fatigue, Headache
Clinical narrative: I lost my sense of smell; sense of taste is diminished; head congestion; fever; fatigue; body aches; flu-like symptoms; headache; A spontaneous report was received from a healthcare professional (HCP) concerning a female patient of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced headache, head congestion/nasopharyngitis, fever, fatigue, body aches/pain, flu-like symptoms, lost sense of smell/anosmia and sense of taste diminished/ageusia.  The patient's medical history was not provided. No concomitant medications were reported.  On 24 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot# Unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 25 Dec 2020, the patient experienced a headache.  On 26 Dec 2020, the patient experienced head congestion, fever (number is not reported) , fatigue, body aches and flu-like symptoms.  On 30 Dec 2020, the patient experienced lost sense of smell and sense of taste diminished. The fever was 99.7 F.  Treatment of the events included Advil.  The Action taken with mRNA-1273 in response to the events was unknown.  The outcome for the events, headache, head congestion, fever, fatigue, body aches, flu-like symptoms were considered unknown.  The outcome for the events, lost sense of smell and sense of taste diminished were considered not recovered/not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Nasopharyngitis, Pain, Pyrexia
Clinical narrative: I lost my sense of smell; sense of taste is diminished; head congestion; fever; fatigue; body aches; flu-like symptoms; headache; A spontaneous report was received from a healthcare professional (HCP) concerning a female patient of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced headache, head congestion/nasopharyngitis, fever, fatigue, body aches/pain, flu-like symptoms, lost sense of smell/anosmia and sense of taste diminished/ageusia.  The patient's medical history was not provided. No concomitant medications were reported.  On 24 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot# Unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 25 Dec 2020, the patient experienced a headache.  On 26 Dec 2020, the patient experienced head congestion, fever (number is not reported) , fatigue, body aches and flu-like symptoms.  On 30 Dec 2020, the patient experienced lost sense of smell and sense of taste diminished. The fever was 99.7 F.  Treatment of the events included Advil.  The Action taken with mRNA-1273 in response to the events was unknown.  The outcome for the events, headache, head congestion, fever, fatigue, body aches, flu-like symptoms were considered unknown.  The outcome for the events, lost sense of smell and sense of taste diminished were considered not recovered/not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Cough, Dyspnoea, Fatigue, Myalgia
Clinical narrative: Short of breath; Cough; Fatigue; Fever 103.8; Body hurt; A spontaneous report was received from a healthcare professional for a 40-year-old, female patient who received Moderna's COVID-19 vaccine and experienced fever of 103.8, body pain, fatigue, cough and shortness of breath.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 26 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch#:037K20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.     On 28 Dec 2020, the patient awoke with a fever of 103.8, body pain, and fatigue.   On 29 Dec 2020 she developed a cough and shortness of breath. She states all symptoms are still ongoing. Treatment for the event included acetaminophen and guaifenesin.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The outcome of the event(s), fever of 103.8, body pain, fatigue, cough and shortness of breath, were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Myalgia, fatigue and pyrexia are listed events in CCDS.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Short of breath; Cough; Fatigue; Fever 103.8; Body hurt; A spontaneous report was received from a healthcare professional for a 40-year-old, female patient who received Moderna's COVID-19 vaccine and experienced fever of 103.8, body pain, fatigue, cough and shortness of breath.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 26 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch#:037K20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.     On 28 Dec 2020, the patient awoke with a fever of 103.8, body pain, and fatigue.   On 29 Dec 2020 she developed a cough and shortness of breath. She states all symptoms are still ongoing. Treatment for the event included acetaminophen and guaifenesin.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The outcome of the event(s), fever of 103.8, body pain, fatigue, cough and shortness of breath, were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Myalgia, fatigue and pyrexia are listed events in CCDS.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of pregnancy in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.     The patient's past medical history included No adverse event (No reported medical history.).   On an unknown date, the patient received first dose of MRNA-1273 (Moderna covid-19 vaccine) (intramuscular).   Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced exposure during pregnancy (pregnancy).   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  At the time of the report, exposure during pregnancy (pregnancy) had resolved.; 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: U
Vaccine: COVID19
Symptoms: Gait disturbance, Paraesthesia
Clinical narrative: Difficulty walking; Tingling all over body; A spontaneous report was received from a consumer who is an unidentified patient that received Moderna's COVID-19 vaccine and experienced tingling all over the body and difficulty walking.   The patient's medical history was not provided. No relevant concomitant medications were reported   On an unknown date in Dec 2020, the patient received their first of two planned doses of mRNA-1273 via unknown route for prophylaxis of COVID-19 infection.   On an unknown date in Dec-2020, the patient reports having tingling all over the body, one week after receiving the vaccine. The patient also reports difficulty walking since 28-Dec-2020.   No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, tingling all over the body and difficulty walking, was unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Maternal exposure during pregnancy, Pregnancy test, Vaccination site pain
Clinical narrative: Fatigue; Headache; Pregnancy; Soreness at the site of injection; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy), VACCINATION SITE PAIN (Soreness at the site of injection), FATIGUE (Fatigue) and HEADACHE (Headache) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Dilaudid) and Drug allergy (Imitrex).    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 on 07-Nov-2020 and the estimated date of delivery was 11-Aug-2021. On 29-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) and VACCINATION SITE PAIN (Soreness at the site of injection). On 30-Dec-2020, the patient experienced FATIGUE (Fatigue) and HEADACHE (Headache). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  seventh week of the pregnancy.  The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 29-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) had resolved. At the time of the report, VACCINATION SITE PAIN (Soreness at the site of injection), FATIGUE (Fatigue) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Dec-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.   Concomitant product was not provided. Estimated date of conception 17 Nov 2020 was reported.; Sender's Comments: This is a report of product exposure during pregnancy with associated AEs (soreness at the injection site, headache and fatigue) in a 38-year-old female consumer. Patient will continue to be contacted for further monitoring of AEs during the pregnancy. Based on the current available information and temporal association between the use of the product and the start date of the events (vaccination site pain, headache, fatigue) a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site pain
Clinical narrative: Bump on my left arm; Soreness and pain in the injection site; A spontaneous report  was received from a consumer concerning a female patient, who received Moderna's covid-19 vaccine(mRNA-1273) and experienced bump on the left arm, pain and soreness at injection site.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 23 Dec 2020, the patient received their dose of mRNA-1273 (Batch Number: Unknown) in left arm for prophylaxis of COVID-19 infection.  On an unspecified date, a week after vaccination in Dec 2020, the patient developed a bump on the left arm, soreness and pain in the injection site.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events a bump on the left arm, soreness and pain in the injection site was not reported.  The outcome of the event a bump on the left arm, soreness and pain in the injection site was not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Fatigue, Flushing
Clinical narrative: Super fatigued; Post nasal drip; Lateral ankle joint pain; Headache; Paroxysmal fever; Face started to flushing; injection site pain that radiates through left arm; Chills; A spontaneous report was received from a healthcare facility staff member concerning a 30 year old, female patient who experienced fever, chills, face started to flush, injection site pain that radiates through her left arm, lateral ankle joint pain, super fatigued, headache and post nasal drip.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   The patient received her first of two planned doses of mRNA-1273 (LOT:  011L20A) on 29 Dec 2020 intramuscularly in the left arm for prophylaxis of COVID-19 infection.    After being vaccinated, The patient experienced injection site pain that radiated through her left arm. At 18:00 the same day as the vaccine, the patient reported she experienced a fever (described as paroxysmal) and chills. At 18:30, her face started to flush. At 19:45, she experienced lateral ankle joint pain, described as being isolated to just that bone. The patient reported headache on 29 Dec 2020 and 30 Dec 2020. On 30 Dec 2020, patient reported  another spike in fever at 17:30 and felt super fatigued and had postnasal drip.   Patient stated that postnasal drip was relieved by the allergy medication.  Treatment for the events included allergy medication for the postnasal drip. and denied taking treatment for the fever as she did not want to mask any symptoms.    Action taken with mRNA-1273 in response to the events was not provided.   The out come of the events, fever, chills, face started to flush, injection site pain that radiates through her left arm, lateral ankle joint pain, super fatigued, headache, were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events,a causal relationship cannot be excluded.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia, Upper-airway cough syndrome, Vaccination site pain
Clinical narrative: Super fatigued; Post nasal drip; Lateral ankle joint pain; Headache; Paroxysmal fever; Face started to flushing; injection site pain that radiates through left arm; Chills; A spontaneous report was received from a healthcare facility staff member concerning a 30 year old, female patient who experienced fever, chills, face started to flush, injection site pain that radiates through her left arm, lateral ankle joint pain, super fatigued, headache and post nasal drip.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   The patient received her first of two planned doses of mRNA-1273 (LOT:  011L20A) on 29 Dec 2020 intramuscularly in the left arm for prophylaxis of COVID-19 infection.    After being vaccinated, The patient experienced injection site pain that radiated through her left arm. At 18:00 the same day as the vaccine, the patient reported she experienced a fever (described as paroxysmal) and chills. At 18:30, her face started to flush. At 19:45, she experienced lateral ankle joint pain, described as being isolated to just that bone. The patient reported headache on 29 Dec 2020 and 30 Dec 2020. On 30 Dec 2020, patient reported  another spike in fever at 17:30 and felt super fatigued and had postnasal drip.   Patient stated that postnasal drip was relieved by the allergy medication.  Treatment for the events included allergy medication for the postnasal drip. and denied taking treatment for the fever as she did not want to mask any symptoms.    Action taken with mRNA-1273 in response to the events was not provided.   The out come of the events, fever, chills, face started to flush, injection site pain that radiates through her left arm, lateral ankle joint pain, super fatigued, headache, were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events,a causal relationship cannot be excluded.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Asthenia, Back pain, Fatigue
Clinical narrative: Upper shoulder pain; Weakness, Feels like she has no energy; Fatigue; Epigastric pain; Pain in legs; Severe lower back pain going into hips and; A spontaneous report was received from a 56 year old  nurse who experienced severe lower back pain going into hips and knees, upper shoulder pain, weakness, fatigue, epigastric pain, pain in her lower back and legs, and feels like she has no energy.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 29 Dec 2020, approximately 16 hours prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot/Batch number not provided) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   The patient reports that she received the Moderna COVID-19 vaccine on 29 Dec 2020 at 08:00. By 24:00 that night she experienced severe lower back pain going into hips and knees. She also reported experiencing some upper shoulder pain, weakness, fatigue, epigastric pain, pain in lower back and legs, and feels like she has no energy.   Treatment for the event included paracetamol, naproxen sodium, and ibuprofen.  Action taken with mRNA-1273 in response to the event(s) was not provided.    The outcome of the events, severe lower back pain going into hips and knees, upper shoulder pain, weakness, fatigue, epigastric pain, pain in her lower back and legs, and feels like she has no energy were 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: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Upper shoulder pain; Weakness, Feels like she has no energy; Fatigue; Epigastric pain; Pain in legs; Severe lower back pain going into hips and; A spontaneous report was received from a 56 year old  nurse who experienced severe lower back pain going into hips and knees, upper shoulder pain, weakness, fatigue, epigastric pain, pain in her lower back and legs, and feels like she has no energy.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 29 Dec 2020, approximately 16 hours prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot/Batch number not provided) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   The patient reports that she received the Moderna COVID-19 vaccine on 29 Dec 2020 at 08:00. By 24:00 that night she experienced severe lower back pain going into hips and knees. She also reported experiencing some upper shoulder pain, weakness, fatigue, epigastric pain, pain in lower back and legs, and feels like she has no energy.   Treatment for the event included paracetamol, naproxen sodium, and ibuprofen.  Action taken with mRNA-1273 in response to the event(s) was not provided.    The outcome of the events, severe lower back pain going into hips and knees, upper shoulder pain, weakness, fatigue, epigastric pain, pain in her lower back and legs, and feels like she has no energy were 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: Back pain, Fatigue, Pain
Clinical narrative: Aches; lower back pain in the lower right side like in the kidney area; Fatigue; A spontaneous report was received from a nurse, concerning a female patient who experienced aches, fatigue, and lower back pain in the lower right side like in the kidney area.   The patient's medical history included a Covid-19 diagnosis in Oct 2020. Concomitant product use was not provided/unknown by the reporter.   On 29 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number unknown) via unknown route for prophylaxis of COVID-19 infection.   The patient reported that she received the vaccination on 29 Dec 2020 in the afternoon and had been having what appeared to be normal reactions to it.   She reported experiencing aches and fatigue. The lower back pain in the lower right side, like in the kidney area. She reported that she did not recall doing anything to her back. The pain appeared overnight and she woke up in the middle of the night with this weird pain out of nowhere.   Treatment information was not provided/unknown.   Action taken with mRNA-1273 in response to the event(s) was not provided/unknown.   The outcome of the events, aches, fatigue, and lower back pain in the lower right side were unknown/not reported.; Reporter's Comments: This case concerns a female of unknown age who had NS unexpected pain, low back pain, and NS expected fatigue. 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: F
Vaccine: COVID19
Symptoms: Injection site pain, Mobility decreased
Clinical narrative: Unable to lift her arm at all/I cannot lift arm without screaming; Its more than just pain at the injection site; A spontaneous report was received from a healthcare professional concerning a female patient of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) experienced unable to lift her arm at all/I cannot lift arm without screaming and its more than just pain at the injection site.  The patient's medical history was not provided. No concomitant medications were reported.  On 29 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) for prophylaxis of COVID-19 infection.   On 30 Dec 2020, the patient experienced unable to lift her arm at all/I cannot lift arm without screaming and its more than just pain at the injection site. No treatment information was reported.  The action taken with mRNA-1273 in response to the events was unknown.  The outcome for the events, unable to lift her arm at all/I cannot lift arm without screaming and its more than just pain at the injection site was considered as 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: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (Patient was using 1 glass per month.) in June 2020. Concurrent medical conditions included Mitral valve prolapse since 2010 and Social anxiety disorder (Social Anxiety). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMIN [MINERALS NOS;VITAMINS NOS]) from June 2020 to an unknown date for Pregnancy, FLUOXETINE HYDROCHLORIDE (PROZAC) from June 2017 to an unknown date and PROPRANOLOL HYDROCHLORIDE (PROPRANOL) from June 2020 to an unknown date for Social anxiety disorder.    On 30-Dec-2020 at 10:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 18-May-2021. On 30-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). On 30-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (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.   Patient was pregnant on 12-Aug-2020 and at the time of vaccine administration patient was 20 weeks pregnant.  Treatment information was not provided.; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 36-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Feeling cold, Nausea
Clinical narrative: Freezing; Stomach cramps; Nausea; A spontaneous report was received from a consumer who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced freezing, nausea and stomach cramps.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 29 Dec 2020, the patient received the first of two planned doses of mRNA-1273 (Batch#: unknown) for COVID-19 infection prophylaxis.  On 30 Dec 2020, next day after receiving vaccine, the patient stated that they experienced freezing, nausea, and stomach cramps. No additional information available at this time. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, freezing, nausea, and stomach cramps were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Injection site pain, Pyrexia
Clinical narrative: sore arm; fatigue; feeling dizzy; chills; low grade fever around 100 degrees; A spontaneous report was received from a nurse concerning a 51 year old, female patient who received Moderna's COVID-19 vaccine and experienced chills, low-grade fever, dizziness, arm soreness, and fatigue.    The patient's medical history, as provided by the reporter, included COVID-19. No relevant concomitant medications were reported.   On 28 Dec 2020, the patient received their 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 started to have chills and a low-grade fever around 100F. The patient stated she felt like she "had COVID again". Patient also reported feeling dizzy. On 30 Dec 2020, patient still had chills and reported arm soreness and fatigue. Treatment for the event included ibuprofen and paracetamol.   Action taken with mRNA-1273 in response to the event(s) was not reported.   The event, arm soreness, was considered recovered/resolved. The outcome of the events, chills, low-grade fever, dizziness, and fatigue were unknown/not reported.; Reporter's Comments: This case concerns a 51-year-old female, with PMH of COVID-19, who had NS unexpected dizziness, and NS expected chills, low-grade fever, arm soreness, and fatigue.  Event onset occurred on Day 2 after the first dose of mRNA-1273. Treatment included ibuprofen and paracetamol. Arm pain resolved, but other event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Nausea
Clinical narrative: Stomach Cramps; nausea, almost vomiting; freezing; A spontaneous report was received from a female consumer of unknown age, who was also the patient, who received Moderna's COVID-19 vaccine and experienced stomach cramps (abdominal pain upper), freezing (chills), and nausea, almost vomiting (nausea).   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 number: unknown) for prophylaxis of COVID-19 infection.   On an unknown date, the patient was freezing, had nausea, almost vomiting, and stomach cramps. The patient did not have a fever. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was unknown.    The outcome for the events stomach cramps, freezing, and nausea, almost vomiting 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 of nausea, chills and abdominal pain, a causal relationship cannot be excluded.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever at 100.0 F; A spontaneous report was received from a consumer (patient's husband) and concerning 50-year-old, female patient who was administered Moderna's COVID-19 vaccine(mRNA-1273) and experienced a fever of 100.0 F (Pyrexia).    The patient's medical history was not provided. No relevant concomitant medications were reported.  On 30-Dec-2020, 1 day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot 011J205A) intramuscularly in the right arm, for prophylaxis of COVID-19 infection.   On 31-Dec-2020, the patient had a fever of 100.0 F.  The patient had not received any treatment for the event at the time of this report.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event of fever of 100.0 F was not resolved.; Reporter's Comments: This case concerns a 50-year-old female with a NS expected event of Pyrexia. Event onset occurred on Day 2 after the first dose of mRNA-1273. Treatment not reported. Event ongoing. Based on the current available information and temporal association between 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: Lip swelling, Vaccination site pain
Clinical narrative: Lip Swelling; Mild Sore Arm; A spontaneous report was received from a nurse concerning a 32-year-old, female consumer who received Moderna's COVID-19 vaccine and experienced a mild sore arm (pain in extremity) and lip swelling.  The patient's medical history was not provided. Concomitant medications reported included certolizumab pegol.  On 29 Dec 2020 at 0800AM, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026-L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.     The patient reported to be symptom free for 2 days after receiving the vaccine. However, she developed a mild sore arm and lip swelling on an unknown date.  Treatment for the event included 2 diphenhydramine tablets.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.    The outcome for the events, a mild sore arm and lip, were not provided.  The reporter's assessment of causality for the events was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Vaccination site pain
Clinical narrative: Partial loss of smell; Loss of taste; Arm is sore; A spontaneous report  was received from a consumer concerning herself, a 50-year-old female patient, who was administered Moderna's COVID-19 vaccine (mRNA-1273) and experienced partial loss of smell [Anosmia], loss of taste [Ageusia] and a sore arm [Injection site pain].   The patient's medical history included high blood pressure, Graves' disease and an autoimmune system "that is too high or too low". Concomitant product use included lisinopril 20 mg daily.   On 30-Dec-2020, approximately one day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot 025L30A) intramuscularly in an unknown injection site for prophylaxis of COVID-19 infection.   On 31-Dec-2020, the patient reported experiencing a partial loss of smell and loss of taste.  She reported she could smell beans that her husband opened but could not smell the coffee in the morning. Additionally, she reported that her arm was sore. Treatment for the events was not provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events 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: Pain in extremity
Clinical narrative: Arm hurt; A spontaneous report was received from a consumer concerning a female patient who was administered Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm hurt.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter   On 31-DEC-2020, the patient received their first of two planned doses of mRNA-1273 (batch unknown), Intramuscular for prophylaxis of COVID-19 infection.   On 31-DEC-2020, after vaccination, the patient's arm had hurt.  As a treatment the patient had taken a pain reliever.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event her arm hurt 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 event, a causal relationship cannot be excluded.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Not doing good, In bed all morning; A spontaneous report was received from a wife, concerning an 80-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and is not doing well, and was in bed all morning.   The patient's medical history was not provided. Concomitant medications reported was apixaban, metoprolol tartrate, losartan potassium, atorvastatin and acetylsalicylic acid.   On 30 Dec 2020, the patient received his  first of two planned doses of mRNA-1273 intramuscularly (lot number 011L20A) for prophylaxis of COVID-19 infection.    On 30 Dec 2020, several hours after the administration of the vaccine, the patient received a positive result from her covid test taken on 21 Dec 2020.   The patient stated she is not doing well, and he is in bed all morning. Treatment information was not reported.   Action taken with mRNA-1273 vaccine was not reported.  The outcome of event, not doing well, in bed all morning, 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 event, a causal relationship cannot be excluded.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema
Clinical narrative: Small very very red area raised with visible blood underneath, around 3 inches next to injection site; A spontaneous report was received from a consumer concerning a 73-years-old, male patient who received Moderna's Covid-19 vaccine (mRNA-1273) and developed a small very very red area raised, with visible blood underneath.  The patient's medical history included heart issues. No concomitant medications were reported.   On 30 Dec 2020 , approximately six hours prior to onset of the event, the patient received his first of two planned doses of mRNA-1273 (lot/batch number: unknown) in the right arm for prophylaxis of COVID-19 infection.   On 30 Dec 2020, he experienced a small very very red area raised and you can see blood underneath. It was around 3 inches next to the injection site. The patient did not receive any treatment to treat the symptoms.   Action taken with mRNA-1273 in response to the event was not provided.   The outcome of the event a small very very red area raised, with visible blood underneath was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Polymerase chain reaction
Clinical narrative: Coughing a lot; A spontaneous report was received from a health care provider who was a 51 year-old female patient that received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced a lot.of coughing.   The patient's medical history was not provided. Concomitant medications reported included montelukast and vitamins.   On 30 Dec 2020, the patient received the first of two planned doses of mRNA-1273 (batch number: 025L20A) Intramuscular, in her left arm for prophylaxis of COVID-19 infection.  On 31 Dec 2020, the patient reported that she received the vaccine on 30 Dec 2020 and about an hour later she started coughing a lot. She also stated that she had taken a Covid PCR test on Monday and the results received on 31 Dec 2020 were positive. Treatment for the events included a lozenge.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the events, coughing a lot, was considered not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; A spontaneous report was received from a consumer concerning a 89-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a sore arm.  The patient's medical history and concomitant product use were not provided.  In 28 Dec 2020, two days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 29 Dec 2020, the patient developed a sore arm which was treated with a heat pad. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the event sore arm was unknown.; Reporter's Comments: This case concerns an 89-year-old female who experienced a NS unexpected event of pain in extremity.  Event onset occurred on Day 2 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.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Feeling abnormal, Pyrexia
Clinical narrative: Feeling like crap; Fever of 101; A spontaneous report was received from a male patient of unknown age concerning himself, who received their first of two planned doses of mRNA-1273 and experienced a fever of 101 and feeling bad.   The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter.   On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot/Batch number unknown) via unknown route at unknown anatomical location for prophylaxis of COVID-19 infection.   On an unknown date in Dec 2020, the patient experienced  fever of 101 and felt bad. Treatment information was not provided/unknown.   Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the events, a fever of 101 and feeling bad were unknown.    The reporter did not provide causality for the events.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Tenderness, Vaccination site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: Warmth at the injection site; Redness at the injection site; a lot of pain; Tenderness; A spontaneous report was received from a 54-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experience tenderness, a lot of pain, injection site is red and warm.   The patient's medical history was not provided. Concomitant medications reported were levothyroxine sodium, liothyronine sodium, somatropin, and liraglutide.    On 29-Dec-2020, the patient received their first of two planned doses of mRNA-1273 (Lot 011J208A) intramuscularly for prophylaxis of COVID-19 infection.  On 29-Dec-2020, the patient experienced tenderness. That evening, she experienced a lot of pain.  She took ibuprofen 200 milligrams (took 4 units) for treatment and the next morning she was fine.   On the evening of 30-Dec-2020, she started experiencing a lot pain again and stated that the injection site is red and warm. No additional treatment information was provided.   Action taken with mRNA-1273 in response to the event was unknown.   The outcome of the events, tenderness, a lot of pain, injection site is red and warm, 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: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Red rash at the injection site; Itching at the injection site; Tenderness at injection site; Red rash at the injection site; A spontaneous report was received from a 57-year-old female patient who received Moderna's COVID-19 Vaccine and experienced itching, tenderness, and red rash at the injection site.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 29 Dec 2020, the patient received the first of two planned doses of mRNA-1273 (Batch number: 026L20A) in her left arm for COVID-19 infection prophylaxis.  On 29 Dec 2020, the patient experienced itching, tenderness and a red rash at the injection site. Treatment for the events included hydrocortisone cream.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event(s) itching, tenderness, and red rash at the injection site 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. Further information has been requested.