chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: I am 27 weeks pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (I am 27 weeks pregnant) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 04-Apr-2021. On 04-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (I am 27 weeks pregnant). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 04-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (I am 27 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 and treatment medications were not reported.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 32-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Feeling hot, Injection site swelling, Vomiting
Clinical narrative: Arm  started to swell up around injection site; Arm  is warm to touch; Diarrhea; Vomiting; A spontaneous report was received from a 61 year old female nurse who was participating in the mRNA-1273 Emergency Use Program and experienced diarrhea, vomiting, and arm started to swell up around injection site and was warm to touch.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 29 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot 026L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 31 Dec 2020, patient had diarrhea and vomiting lasting for 1.5 hours. On 5 Jan 2020, patient experienced arm swelling around injection site and warm to touch.   Treatment for the event included Benadryl.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events diarrhea and vomiting, were considered resolved. The outcome of the event  arm started to swell up around injection site and was warm to touch was unknown.  The reporter did not provide an assessment for the events.; Reporter's Comments: This case concerns a 61 year old female patient, who experienced non-serious unexpected events of diarrhoea, feeling hot, and non-serious expected events of vomiting and injection site swelling. The event of diarrhoea and vomiting occurred 2 day after mRNA-1273 (lot # 026L20A) administration. The event of injection site swelling and feeling hot occurred 8 days after mRNA-1273 (lot # 026L20A) administration. The treatment included Benadryl. Based on temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Dysuria, Fatigue, Incontinence, Pollakiuria, Pyrexia
Clinical narrative: Frequent urination; Incontinence; Discomfort urinating; Urinary Tract Infection; Fever; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of POLLAKIURIA (Frequent urination), INCONTINENCE (Incontinence), DYSURIA (Discomfort urinating), URINARY TRACT INFECTION (Urinary Tract Infection) and PYREXIA (Fever) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Bacteremia (Streptococcus) in April 2000. Concurrent medical conditions included Type 2 diabetes mellitus and Heart disease, unspecified.    On 01-Jan-2021 at 1:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jan-2021, the patient experienced FATIGUE (Fatigue). On 03-Jan-2021, the patient experienced POLLAKIURIA (Frequent urination), INCONTINENCE (Incontinence), DYSURIA (Discomfort urinating), URINARY TRACT INFECTION (Urinary Tract Infection) and PYREXIA (Fever). At the time of the report, POLLAKIURIA (Frequent urination), INCONTINENCE (Incontinence), DYSURIA (Discomfort urinating), URINARY TRACT INFECTION (Urinary Tract Infection), PYREXIA (Fever) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Urinary tract infection: positive (Positive) tested positive for a urinary tract infection.     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 also taking acetoaminophen after aver 4 hrs for fever and sulphamethoxazole for urinary tract infection   Most recent FOLLOW-UP information incorporated above includes: On 08-Apr-2021: Patient reported- I have not experienced a recurrence of the symptoms I reported following the first shot of Covid 19 vaccine; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: Frequent urination; Incontinence; Discomfort urinating; Urinary Tract Infection; Fever; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of POLLAKIURIA (Frequent urination), INCONTINENCE (Incontinence), DYSURIA (Discomfort urinating), URINARY TRACT INFECTION (Urinary Tract Infection) and PYREXIA (Fever) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Bacteremia (Streptococcus) in April 2000. Concurrent medical conditions included Type 2 diabetes mellitus and Heart disease, unspecified.    On 01-Jan-2021 at 1:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jan-2021, the patient experienced FATIGUE (Fatigue). On 03-Jan-2021, the patient experienced POLLAKIURIA (Frequent urination), INCONTINENCE (Incontinence), DYSURIA (Discomfort urinating), URINARY TRACT INFECTION (Urinary Tract Infection) and PYREXIA (Fever). At the time of the report, POLLAKIURIA (Frequent urination), INCONTINENCE (Incontinence), DYSURIA (Discomfort urinating), URINARY TRACT INFECTION (Urinary Tract Infection), PYREXIA (Fever) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Urinary tract infection: positive (Positive) tested positive for a urinary tract infection.     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 also taking acetoaminophen after aver 4 hrs for fever and sulphamethoxazole for urinary tract infection   Most recent FOLLOW-UP information incorporated above includes: On 08-Apr-2021: Patient reported- I have not experienced a recurrence of the symptoms I reported following the first shot of Covid 19 vaccine; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Fatigue, Headache, Myalgia
Clinical narrative: Back very sore; ankle ache, back, knees and hips sore; Headache; Fatigue/exhausted,Weakness; injection arm, thigh and calfs sore / body aches; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back very sore), ARTHRALGIA (ankle ache, back, knees and hips sore), HEADACHE (Headache), FATIGUE (Fatigue/exhausted,Weakness) and MYALGIA (injection arm, thigh and calfs sore / body aches) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2021 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced BACK PAIN (Back very sore). 04-Jan-2021, the patient experienced ARTHRALGIA (ankle ache, back, knees and hips sore), HEADACHE (Headache), FATIGUE (Fatigue/exhausted,Weakness) and MYALGIA (injection arm, thigh and calfs sore / body aches). On 08-Jan-2021, BACK PAIN (Back very sore), ARTHRALGIA (ankle ache, back, knees and hips sore), HEADACHE (Headache), FATIGUE (Fatigue/exhausted,Weakness) and MYALGIA (injection arm, thigh and calfs sore / body aches) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No relevant concomitant medication were reported  Treatment was not reported  The vaccine recipient stated that " On Sunday I moved many heavy bags up the 3 flights of stairs to my apartment and took several trips so my legs may have been slightly sore before that and the shot just exacerbated the soreness."     Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Follow-up received and reporter information updated, patient demographics updated, vaccine information updated, new event added, and event outcome updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Erythema, Fatigue, Injection site pain, Injection site rash, Pruritus
Clinical narrative: pink area is bright red...now a solid red color; arm felt very itchy; Fever; her arm was very sore; faint pink splotchy rash size of half dollar inch below where injection occurred; Fatigue; A spontaneous report was received from a consumer concerning a 61-year-old, female patient who was participating in the mRNA-1273 Emergency Use Program and who developed a sore arm, a faint pink splotchy rash, fatigue, fever, arm felt very itchy and now pink area is bright red, patchy looking and bigger.   The patient's medical history included asthma, osteoporosis, cardiac arrythmias, seasonal allergies and hematuria.   Products known to have been used by the patient, within two weeks prior to the event, included salmeterol inhaler, budesonide inhaler, montelukast sodium, guaifenesin, levothyroxine sodium, ubidecarenone, tolterodine L-tartrate, vitamin D, biotin and cetirizine.    The patient received their first of two planned doses of mRNA-1273 (LOT# 037K20A) on 28-Dec-2020 intramuscularly in the left arm for prophylaxis of COVID-19 infection.   Patient received the Moderna vaccine on 28-Dec-2020 in the left arm at approximately 1300.  She reported that 12 hours later, her arm was very sore, however, she had expected that.  On 29-Dec-2020, she reported that there was a half-dollar sized, pink, splotchy rash about 1 inch below the injection site. She said that is was raised but did not itch.  Additionally on 29-Dec-2020, she reported having fatigue.  Patient reported that the fatigue resolved over the course of a week and that the rash began to disappear.  However, one week later, on 04-Jan-2021, her arm felt very itchy and the area that used to be pink had become red and patchy looking and continued to increase in size and become more reddened. Patient wished to know if this was normal.   Treatment for the event included diphenhydramine.   Action taken with mRNA-1273 in response to the events, developed a sore arm, a faint pink splotchy rash, fatigue, fever, arm felt very itchy and now pink area is bright red, patchy looking and bigger, was not provided.  The outcome of the events, developed a sore arm, a faint pink splotchy rash, fatigue, fever, arm felt very itchy and now pink area is bright red, patchy looking and bigger, was not reported.   The reporter did not provide a causality assessment for the events, developed a sore arm, a faint pink splotchy rash, fatigue, fever, arm felt very itchy and now pink area is bright red, patchy looking and bigger.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pyrexia
Clinical narrative: pink area is bright red...now a solid red color; arm felt very itchy; Fever; her arm was very sore; faint pink splotchy rash size of half dollar inch below where injection occurred; Fatigue; A spontaneous report was received from a consumer concerning a 61-year-old, female patient who was participating in the mRNA-1273 Emergency Use Program and who developed a sore arm, a faint pink splotchy rash, fatigue, fever, arm felt very itchy and now pink area is bright red, patchy looking and bigger.   The patient's medical history included asthma, osteoporosis, cardiac arrythmias, seasonal allergies and hematuria.   Products known to have been used by the patient, within two weeks prior to the event, included salmeterol inhaler, budesonide inhaler, montelukast sodium, guaifenesin, levothyroxine sodium, ubidecarenone, tolterodine L-tartrate, vitamin D, biotin and cetirizine.    The patient received their first of two planned doses of mRNA-1273 (LOT# 037K20A) on 28-Dec-2020 intramuscularly in the left arm for prophylaxis of COVID-19 infection.   Patient received the Moderna vaccine on 28-Dec-2020 in the left arm at approximately 1300.  She reported that 12 hours later, her arm was very sore, however, she had expected that.  On 29-Dec-2020, she reported that there was a half-dollar sized, pink, splotchy rash about 1 inch below the injection site. She said that is was raised but did not itch.  Additionally on 29-Dec-2020, she reported having fatigue.  Patient reported that the fatigue resolved over the course of a week and that the rash began to disappear.  However, one week later, on 04-Jan-2021, her arm felt very itchy and the area that used to be pink had become red and patchy looking and continued to increase in size and become more reddened. Patient wished to know if this was normal.   Treatment for the event included diphenhydramine.   Action taken with mRNA-1273 in response to the events, developed a sore arm, a faint pink splotchy rash, fatigue, fever, arm felt very itchy and now pink area is bright red, patchy looking and bigger, was not provided.  The outcome of the events, developed a sore arm, a faint pink splotchy rash, fatigue, fever, arm felt very itchy and now pink area is bright red, patchy looking and bigger, was not reported.   The reporter did not provide a causality assessment for the events, developed a sore arm, a faint pink splotchy rash, fatigue, fever, arm felt very itchy and now pink area is bright red, patchy looking and bigger.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pruritus (itchy) and erythema (red) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 309K209) for COVID-19 immunization. The patient's past medical history included no reported medical event. On Dec 28, 2020, patient received the first dose of mRNA-1273 (Moderna COVID-19  vaccine), intramuscular; 1 dosage form. On Dec 31, 2020, patient experienced pruritus (itchy) and erythema (red). At the time of the report, pruritus (itchy) and erythema (red) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. The reporter did not provide any causality assessments. No concomitant medications reported. Treatment for the events included diphenhydramine hydrochloride cream. Most recent follow-up information incorporated above included: Mar 29, 2021: No new information. 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: Eye pruritus, Injection site rash, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Arm  pain..site of injection; Itchiness at site of injection; Bullseye shaped rash around injection site which was diffuse and red; Itchy eyes; Soreness around injection site; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PAIN (Arm  pain..site of injection), EYE PRURITUS (Itchy eyes), VACCINATION SITE PAIN (Soreness around injection site), VACCINATION SITE PRURITUS (Itchiness at site of injection) and INJECTION SITE RASH (Bullseye shaped rash around injection site which was diffuse and red) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Hay fever and Allergy (tuberculin test).    On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Dec-2020, the patient experienced EYE PRURITUS (Itchy eyes) and VACCINATION SITE PAIN (Soreness around injection site). On 31-Dec-2020, the patient experienced VACCINATION SITE PAIN (Arm  pain..site of injection), VACCINATION SITE PRURITUS (Itchiness at site of injection) and INJECTION SITE RASH (Bullseye shaped rash around injection site which was diffuse and red). On 26-Dec-2020, EYE PRURITUS (Itchy eyes) and VACCINATION SITE PAIN (Soreness around injection site) had resolved. On 04-Jan-2021, VACCINATION SITE PRURITUS (Itchiness at site of injection) and INJECTION SITE RASH (Bullseye shaped rash around injection site which was diffuse and red) had resolved. At the time of the report, VACCINATION SITE PAIN (Arm  pain.site of injection) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment of events was reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Patient declined follow-up. No new information.; 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: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Glucose tolerance test, Maternal exposure during pregnancy, Pregnancy test, Ultrasound abdomen
Clinical narrative: Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 33-year-old female patient (gravida 1, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (on weekends). Concurrent medical conditions included Ovarian cancer, Drug hypersensitivity (Sulfa Drugs), Blood pressure high and Lymphedema. Concomitant products included UBIDECARENONE (COQ10 [UBIDECARENONE]), MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 05-Jan-2021 at 7:15 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 22-Jun-2020 and the estimated date of delivery was 29-Mar-2021. On 05-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-eighth week of the pregnancy. The delivery occurred  on 13-Mar-2021, which was reported as Normal Pregnancy Outcome. For neonate 1, The outcome was reported as Delivered NOS. The patient was induced early for hypertension. On 05-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Aug-2020, Pregnancy test: positive (Positive) Positive. On an unknown date, Glucose tolerance test: positive (Positive) 2 weeks ago, Passed. On an unknown date, Ultrasound abdomen: normal (normal) at 12 and 20 weeks.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not reported.  Company comment: This is a case of product exposure during pregnancy with no associated AEs for this 33-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.   Most recent FOLLOW-UP information incorporated above includes: On 15-May-2021: Updated patient delivery details.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 33-year-old female patient. Patient gave birth to a healthy baby but the delivery date was moved earlier because the patient had Increased in BP
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 39K20-2) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 04-Dec-2020 and the estimated date of delivery was 10-Sep-2021. On 24-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fifth week of the pregnancy.  On 24-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jan-2021, Pregnancy: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not reported . Treatment history was not reported .  This is a case of product exposure during pregnancy with no associated AEs for this 33-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jan-2021: Pregnancy form attached contains, LMP, Due date, Gestation period , Pregnancy test details On 06-Jan-2021: TCR received contains Email address of patient and consented to follow up with her after her due date.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 33-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis, Headache, Nasal discomfort
Clinical narrative: Nose started to feel weird; Nosebleed; Headache; This spontaneous case was reported by a consumer and describes the occurrence of NASAL DISCOMFORT (Nose started to feel weird), EPISTAXIS (Nosebleed) and HEADACHE (Headache) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 030L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jan-2021, the patient experienced NASAL DISCOMFORT (Nose started to feel weird), EPISTAXIS (Nosebleed) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) on 04-Jan-2021 for Headache, at an unspecified dose and frequency. On 04-Jan-2021, NASAL DISCOMFORT (Nose started to feel weird) and EPISTAXIS (Nosebleed) had resolved. On 06-Jan-2021, HEADACHE (Headache) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications provided.  After the first shot of moderna covid-19 vaccine he suffered a nose bleed 30-45minutes after receiving the shot. He then had a headache that evening.  Treatment information was not provided.   This case was linked to MOD-2021-033454 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: follow up received: reporter address was updated, dosing details were updated, race and ethicity was updated, narrative information was updated; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: received vaccine while 36 weeks pregnant; This spontaneous prospective pregnancy case was reported by a physician and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (received vaccine while 36 weeks pregnant) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Pregnant.    On an unknown date, 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 an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (received vaccine while 36 weeks pregnant). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (received vaccine while 36 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.   No concomitant medications reported by investigator  No treatment medications provided by the reporter.; Sender'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.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site pruritus
Clinical narrative: flu-like symptoms; it was hard; extremely itchy; soreness; redness to the area; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), VACCINATION SITE INDURATION (it was hard), VACCINATION SITE PRURITUS (extremely itchy), VACCINATION SITE PAIN (soreness) and VACCINATION SITE ERYTHEMA (redness to the area) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), VACCINATION SITE INDURATION (it was hard), VACCINATION SITE PRURITUS (extremely itchy), VACCINATION SITE PAIN (soreness) and VACCINATION SITE ERYTHEMA (redness to the area). The patient was treated with DIPHENHYDRAMINE CITRATE, IBUPROFEN (ADVIL COLD & FLU [DIPHENHYDRAMINE CITRATE;IBUPROFEN]) for Flu-like symptoms, at an unspecified dose and frequency and LORATADINE (CLARITIN [LORATADINE]) on 04-Jan-2021 at a dose of 20 mg. At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms), VACCINATION SITE INDURATION (it was hard), VACCINATION SITE PRURITUS (extremely itchy), VACCINATION SITE PAIN (soreness) and VACCINATION SITE ERYTHEMA (redness to the area) 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.   This case was linked to MOD-2021-003367 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Jan-2021: Upon review, start date of the vaccine was not provided, so it was updated to regulatory authority. On 04-Jun-2021: Follow-up via telephone received from patient. No new information for coworker. refused to fill out form.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Swelling
Clinical narrative: Pain in left arm; Redness; Swelling; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in left arm), ERYTHEMA (Redness) and SWELLING (Swelling) 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 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in left arm), ERYTHEMA (Redness) and SWELLING (Swelling). At the time of the report, PAIN IN EXTREMITY (Pain in left arm), ERYTHEMA (Redness) and SWELLING (Swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Follow up information was received: Updated contact information. No new information; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site mass
Clinical narrative: Lump at injection site; A spontaneous report was received from a consumer concerning a 36-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced lump at injection site.  The patient's medical history, was not provided by the reporter. No Concomitant medications were  reported.  On 06 Jan 2021, few hours prior to the onset of the events, the patient received his first of two planned doses of mRNA-1273 (Lot number: unknown) in the left arm for prophylaxis of COVID-19 infection.   On 06 Jan 2021, the patient experienced  lump at injection site. It went away soon. Treatment for the events included  ibuprofen.   Action taken with mRNA-1273 in response to the events was not reported.    Follow up: Follow-up received on 11 Jan 2021 included lump at injection site.  On 11 Jan 2021, lump at the injection site came back. Treatment included using a cold press, topical steroid cream, and an antibiotic for his side effect.  The outcome of the event, lump at injection site 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: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: pain at the injection site; injection site red; injection site itching; A spontaneous report was received from a  36 year old female consumer who was participating in the mRNA-1273 Emergency Use Program and developed injection site pain, redness and itching.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On 30 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot 025L20A) intramuscularly in the arm for prophylaxis of COVID-19 infection.   After the vaccine was administered, the patient developed injection site pain, redness and itching. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events developed injection site pain, redness and itching, were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Fatigue, Injection site pain, Pyrexia
Clinical narrative: Tested positive for covid-19; Bad chills; Fever; Tired; Pain in the arm where she got the injection; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for covid-19) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     Concomitant products included ORAL CONTRACEPTIVE NOS for an unknown indication.    On 07-Jan-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced COVID-19 (tested positive for covid-19). At the time of the report, COVID-19 (tested positive for covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jan-2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jan-2021: On 14 Jan 2021, due to the COVID-19 symptoms, patient took the test and tested positive. Patient wanted to know whether this will affect her ability to get the second shot On 04-Jun-2021: Non-significant follow-up appended.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Tested positive for covid-19; Bad chills; Fever; Tired; Pain in the arm where she got the injection; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for covid-19) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     Concomitant products included ORAL CONTRACEPTIVE NOS for an unknown indication.    On 07-Jan-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced COVID-19 (tested positive for covid-19). At the time of the report, COVID-19 (tested positive for covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jan-2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jan-2021: On 14 Jan 2021, due to the COVID-19 symptoms, patient took the test and tested positive. Patient wanted to know whether this will affect her ability to get the second shot On 04-Jun-2021: Non-significant follow-up appended.
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction, Injection site swelling
Clinical narrative: Delayed reaction; Localized raised area at the injection site; A spontaneous report was received from a physician concerning  a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced localized raised area at the injection site and delayed reaction.  The patient's medical history was not provided. No concomitant medications were reported.  On 30 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, the patient developed localized raised area at the injection site and delayed reaction. The treatment information was not provided. The reporter stated that the patient was doing fine and had no fever.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome of events localized raised area at the injection site  and delayed reaction were considered resolved.  Reporter causality for the events was not provided.; Reporter's Comments: This case concerns a female of unknown age who experienced nonserious expected events of injection site reaction and injection site swelling.  Event onset occurred with unknown latency after the first dose of mRNA-1273. Treatment not reported. Events resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test
Clinical narrative: vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) in a 35-year-old female patient (gravida 3, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 27L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event reported). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 15-Aug-2020 and the estimated date of delivery was 22-May-2021. On 05-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twentieth week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 05-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Sep-2021, Pregnancy test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       There was no treatment medication reported. No maternal history of subfertility was reported.  On 01-Sep-2020, it was reported as the estimated date of conception. On 24-MAY-2014 it was reported that 1st pregnancy ended with live, full-term birth. On 06-DEC-2016 it was reported that 2st pregnancy ended with live, full-term birth. There was no family history of congenital anomalies/genetic disease.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the event a causal relationship cannot be excluded.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Feeling abnormal, Headache, Pain
Clinical narrative: Bad headache; Chills; Feeling really bad; Aches; Temperature 105F; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling really bad), PAIN (Aches), PYREXIA (Temperature 105F), HEADACHE (Bad headache) and CHILLS (Chills) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Dec-2020, the patient experienced FEELING ABNORMAL (Feeling really bad), PAIN (Aches), PYREXIA (Temperature 105F) and CHILLS (Chills). On 01-Jan-2021, the patient experienced HEADACHE (Bad headache). On 03-Jan-2021, FEELING ABNORMAL (Feeling really bad), PAIN (Aches), PYREXIA (Temperature 105F), HEADACHE (Bad headache) and CHILLS (Chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Dec-2020, Body temperature: 105 °F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 04-Apr-2021: No specific follow-up information recorded.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Bad headache; Chills; Feeling really bad; Aches; Temperature 105F; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling really bad), PAIN (Aches), PYREXIA (Temperature 105F), HEADACHE (Bad headache) and CHILLS (Chills) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Dec-2020, the patient experienced FEELING ABNORMAL (Feeling really bad), PAIN (Aches), PYREXIA (Temperature 105F) and CHILLS (Chills). On 01-Jan-2021, the patient experienced HEADACHE (Bad headache). On 03-Jan-2021, FEELING ABNORMAL (Feeling really bad), PAIN (Aches), PYREXIA (Temperature 105F), HEADACHE (Bad headache) and CHILLS (Chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Dec-2020, Body temperature: 105 °F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 04-Apr-2021: No specific follow-up information recorded.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity
Clinical narrative: felt a bump about the size of a marble in my armpit under my left arm.; soreness under my left arm; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (soreness under my left arm) and LYMPHADENOPATHY (felt a bump about the size of a marble in my armpit under my left arm.) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PROBIOTICS NOS from 01-Jun-2019 to an unknown date for an unknown indication.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 06-Jan-2021 at 8:00 AM, the patient experienced PAIN IN EXTREMITY (soreness under my left arm). On 07-Jan-2021, the patient experienced LYMPHADENOPATHY (felt a bump about the size of a marble in my armpit under my left arm.). On 07-Jan-2021, PAIN IN EXTREMITY (soreness under my left arm) had resolved. On 08-Jan-2021, LYMPHADENOPATHY (felt a bump about the size of a marble in my armpit under my left arm.) 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 stated that he was using Men's Multivitamin for vitamin supplement  orally2 chewables/day and probiotic for digestive supplement as a concomitant medication. Treatment details was not reported .   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Added  Concomitant medications. Updated  Reporter email address,patient demographics and event onset date for pain in extremity.; 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: Maternal exposure during pregnancy, Pregnancy test
Clinical narrative: Patient is pregnant and received the 1st dose of Moderna vaccine; This spontaneous prospective pregnancy case was reported by a health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Patient is pregnant and received the 1st dose of Moderna vaccine) in a 30-year-old female patient (gravida 3, para 1) who received mRNA-1273 (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included Spontaneous abortion on 15-Apr-2017 and Delivery (Live full-term birth) on 18-Jan-2018. Concurrent medical conditions included Drug allergy (to augmentin) and Shellfish allergy. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]).    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. The patient's last menstrual period was on 24-Sep-2020 and the estimated date of delivery was 01-Jul-2021. On 06-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Patient is pregnant and received the 1st dose of Moderna vaccine). The patient received mRNA-1273 beginning around the  fifteenth week of the pregnancy.  On 06-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Patient is pregnant and received the 1st dose of Moderna vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Oct-2020, Pregnancy test: poitive (Positive) positive.     The action taken with mRNA-1273 (Intramuscular) was unknown.   For mRNA-1273 (Intramuscular), the reporter did not provide any causality assessments.   This is a case of product exposure during pregnancy with no associated AEs for this 30-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 30-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.