chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Still nauseous but not vomiting anymore; Vomiting the entire day; A spontaneous report was received from a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vomiting the entire day and was nauseous.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 29 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly (lot number 011L20A) for prophylaxis of COVID-19 infection.    On 30 Dec 2020, the day after administration, the patient was vomiting the entire day and was not able to go to work.  On 31 Dec 2020, the patient stated that she was still nauseous, but was not vomiting anymore. No treatment information was provided.   Action taken with mRNA-1273 vaccine was unknown.  The outcome of event, vomiting the entire day, was resolved on 30 Dec 2020.  The outcome of the event, nauseous, 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
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Ultrasound scan
Clinical narrative: 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 28-year-old female patient (gravida 3, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. The patient's past medical history included Alcohol use (Prior use to pregnancy). Concurrent medical conditions included Type 1 diabetes mellitus since November 2014, Latex allergy and Penicillin allergy. Concomitant products included INSULIN LISPRO (HUMALOG) for Type 1 diabetes mellitus, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Vitamin supplementation. On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 16-Sep-2020 and the estimated date of delivery was 23-Jun-2021. On 07-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  sixteenth 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 07-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Dec-2020, Ultrasound scan: normal (normal) normal.     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 medications were reported. This is a case of product exposure during pregnancy with no associated AEs for this 28-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.  This is a case of product exposure during pregnancy with no associated AEs for this 28-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 07-Jan-2021: Internal review on 23-Jul-3021 resulted in updates to pregnancy details.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 28-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, SARS-CoV-2 test, Throat irritation
Clinical narrative: Scratchy; Feeling tired; Headache; Chills; A spontaneous report was received from a healthcare professional concerning a 54-year-old female patient, who was also the patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced tiredness, headache,  scratchy throat, and chills.   The patient's medical history was not provided.  Concomitant medication included blood pressure medication.  On 31 Dec 2020, the patient received their first of two planned doses of mRNA-1273 in her left arm for prophylaxis of COVID-19 infection.   On an unknown date, the patient experienced tiredness, headache, fatigue, scratchy throat, and chills.  The patient also tested negative for COVID-19.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events tiredness, headache, fatigue, scratchy throat, and chills was considered were not recovered/resolved on an unknown date.; 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: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: Sore arm; A spontaneous report was received from a consumer concerning a 71-year-old, male patient who received Moderna (mRNA-1273) and experienced sore arm.   The patient's medical history included high blood pressure. Relevant concomitant medications included Warfarin (blood thinning treatment) and unknown blood pressure medicine.   On 06 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot: 25LA0E) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 06 Jan 2021, after administration, the patient experienced a sore arm, but denied adverse events, stated that he was very well. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was unknown.   The outcome of the event sore arm was unknown.; Reporter's Comments: This case concerns a 71-year-old male who experienced a NS unexpected event of Limb discomfort.  Event onset occurred the same day after the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Rash
Clinical narrative: Rashes; Chills; Tiredness; Muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rashes), CHILLS (Chills), FATIGUE (Tiredness) and MYALGIA (Muscle aches) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history provided).    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2021, the patient experienced RASH (Rashes), CHILLS (Chills), FATIGUE (Tiredness) and MYALGIA (Muscle aches). At the time of the report, RASH (Rashes), CHILLS (Chills), FATIGUE (Tiredness) and MYALGIA (Muscle aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.   Reporter did not allow further contact; Reporter's Comments: This case concerns a male of unknown age who experienced NS expected events of rash, fatigue, chills, and myalgia.  Event onset occurred on Day 2 after the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during breast feeding
Clinical narrative: Breast feeding; A spontaneous report was received from a consumer concerning female patient of an unknown age who received Moderna's COVID-19 Vaccine, and who experienced maternal exposure during breast feeding.  The patient's medical history was not provided. Concomitant product use was not provided.  The patient received their first of two planned doses of mRNA-1273 (Batch number unknown) on 07 Jan 2021 intramuscularly in the for prophylaxis of COVID-19 infection.  On 07 Jan 2021, the patient reported maternal exposure during breast feeding. Treatment for the event was not provided.  At the time of the report no additional information was provided.   Action taken with mRNA-1273 in response to the event was unknown.; Reporter's Comments: This is a case of product exposure during breastfeeding with no associated AEs. Patient will continue to be contacted for further monitoring of AEs.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: tingling sensation on toes; A spontaneous report was received from a consumer (medical student), reporting on self and concerns a 26-year-old male patient who received Moderna's COVID-19 Vaccine and experienced tingling sensation on toes.   The patient's medical history was not provided. No relevant concomitant medications were reported.    On 02 Jan 2021, approximately 2 days prior to the onset of symptoms, the patient received his first of two planned doses of mRNA-1273 (Lot number 026L20A) through an unknown route in an unknown arm  for prophylaxis of COVID-19 infection.  On 03 Jan 2021, the patient had tingling sensation on toes. Treatment information for the event was not provided.                                                           Action taken with mRNA-1273 in response to the event was not reported.  Outcome of the event, tingling sensation on toes was unknown.; Reporter's Comments: This case concerns a 26-year-old male who had a nonserious unexpected event of paraesthesia, described as tingling sensation on toes.  Event onset occurred 2 days after the first dose of mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the paraesthesia, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: large welt that is itchy, raised, hot; large welt that is itchy, raised, hot; large welt that is itchy, raised, hot; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE WARMTH (large welt that is itchy, raised, hot), VACCINATION SITE PRURITUS (large welt that is itchy, raised, hot) and VACCINATION SITE SWELLING (large welt that is itchy, raised, hot) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J202A) for COVID-19 vaccination.     The patient's past medical history included Intra-uterine contraceptive device insertion since an unknown date. Concomitant products included LEVONORGESTREL for Prevention, ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.    On 27-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced VACCINATION SITE WARMTH (large welt that is itchy, raised, hot), VACCINATION SITE PRURITUS (large welt that is itchy, raised, hot) and VACCINATION SITE SWELLING (large welt that is itchy, raised, hot). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (large welt that is itchy, raised, hot), VACCINATION SITE PRURITUS (large welt that is itchy, raised, hot) and VACCINATION SITE SWELLING (large welt that is itchy, raised, hot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   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: Breast pain, Maternal exposure during breast feeding, Vaccination site rash
Clinical narrative: Painful breast; Breastfeeding; Rash in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of BREAST PAIN (Painful breast), MATERNAL EXPOSURE DURING BREAST FEEDING (Breastfeeding) and VACCINATION SITE RASH (Rash in the injection site) 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 29-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 BREAST PAIN (Painful breast), MATERNAL EXPOSURE DURING BREAST FEEDING (Breastfeeding) and VACCINATION SITE RASH (Rash in the injection site). At the time of the report, BREAST PAIN (Painful breast), MATERNAL EXPOSURE DURING BREAST FEEDING (Breastfeeding) and VACCINATION SITE RASH (Rash in the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: This is a case of product exposure during breastfeeding, who experienced vaccination site rash and breast pain.  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.  The causality for maternal exposure during breast feeding is assessed as not applicable. Patient will continue to be contacted for further monitoring of AEs.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Headache, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Arm is really warm; Arm soreness; Redness; Swelling; Headaches; Body aches; Runny nose; A spontaneous report was received from a consumer who was a 25-year-old, female patient who received Moderna's Covid-19 vaccine (mRNA-1273) and experienced arm soreness, redness, swelling, headache, body aches, runny nose and her arm was really warm.   The patient's medical history was not provided. Concomitant product use was not provided.  On 30 Dec 2020, the patient received her first dose of mRNA-1273 (Lot number: 011J20A) intramuscularly in her left arm for prophylaxis of COVID-19 infection.   On 30 Dec 2020, after receiving the mRNA-1273 vaccine, she had a small amount of soreness, redness and swelling for two to three days and disappeared. However, she experienced them again on 06 Jan 2021.  On 08 Jan 2021 her arm was more swollen and her arm was really warm on that day.   On unreported date, she experienced headache, body aches and runny nose.   Treatment information was not provided.  Action taken with mRNA-1273 in response to the events were not provided.   The outcome of the events, arm soreness, redness, swelling, headache, body aches, runny nose and feeling of warm were not reported.; Reporter's Comments: This case concerns a 25-year-old, female patient. The patient's medical history was not provided. The patient experienced BS expected event of injection site pain, erythema, swelling, headache,  and unexpected event of Ache NOS, rhinorrhea and injection site warmth. The events of injection site pain, erythema and swelling after 1 day, injection site warmth after 8 days and headache, Ache NOS, rhinorrhea on unspecified date after the first dose of mRNA-1273 (Lot number: 011J20A) administration. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rhinorrhoea
Clinical narrative: Arm is really warm; Arm soreness; Redness; Swelling; Headaches; Body aches; Runny nose; A spontaneous report was received from a consumer who was a 25-year-old, female patient who received Moderna's Covid-19 vaccine (mRNA-1273) and experienced arm soreness, redness, swelling, headache, body aches, runny nose and her arm was really warm.   The patient's medical history was not provided. Concomitant product use was not provided.  On 30 Dec 2020, the patient received her first dose of mRNA-1273 (Lot number: 011J20A) intramuscularly in her left arm for prophylaxis of COVID-19 infection.   On 30 Dec 2020, after receiving the mRNA-1273 vaccine, she had a small amount of soreness, redness and swelling for two to three days and disappeared. However, she experienced them again on 06 Jan 2021.  On 08 Jan 2021 her arm was more swollen and her arm was really warm on that day.   On unreported date, she experienced headache, body aches and runny nose.   Treatment information was not provided.  Action taken with mRNA-1273 in response to the events were not provided.   The outcome of the events, arm soreness, redness, swelling, headache, body aches, runny nose and feeling of warm were not reported.; Reporter's Comments: This case concerns a 25-year-old, female patient. The patient's medical history was not provided. The patient experienced BS expected event of injection site pain, erythema, swelling, headache,  and unexpected event of Ache NOS, rhinorrhea and injection site warmth. The events of injection site pain, erythema and swelling after 1 day, injection site warmth after 8 days and headache, Ache NOS, rhinorrhea on unspecified date after the first dose of mRNA-1273 (Lot number: 011J20A) administration. 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: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Pain
Clinical narrative: Felt very uncomfortable this morning; Sore arm and Back is really sore this morning; Achy all over; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy all over), DISCOMFORT (Felt very uncomfortable this morning) and PAIN (Sore arm and Back is really sore this morning) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Back discomfort (Back issues off and on) and Hypertension. Concomitant products included ATENOLOL for Hypertension.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced PAIN (Achy all over). On 07-Jan-2021, the patient experienced DISCOMFORT (Felt very uncomfortable this morning) and PAIN (Sore arm and Back is really sore this morning). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (Achy all over), DISCOMFORT (Felt very uncomfortable this morning) and PAIN (Sore arm and Back is really sore this morning) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Son having a fever; A spontaneous report was received from a consumer concerning of an unknown age male patient, who received Moderna's COVID-19 vaccine and developed a fever.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unknown date, prior to the onset of the event, the patient received their first of two doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.     On 01 Jan 2021, after receiving his vaccination, the patient began to develop a fever. The exact temperature of the fever was not provided. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome for the event, fever, was 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 event of fever, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Vaccination site pain, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: A large rash on my left arm that was itchy; Arm tightness; Warm to the touch; Had pain on injection site; Big rash on the injection site; Swollen rash on injection site; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PRURITUS (A large rash on my left arm that was itchy), LIMB DISCOMFORT (Arm tightness), VACCINATION SITE WARMTH (Warm to the touch), VACCINATION SITE PAIN (Had pain on injection site) and VACCINATION SITE RASH (Big rash on the injection site) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included VITAMIN D3 for an unknown indication.    On 27-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (A large rash on my left arm that was itchy), LIMB DISCOMFORT (Arm tightness), VACCINATION SITE WARMTH (Warm to the touch), VACCINATION SITE PAIN (Had pain on injection site), VACCINATION SITE RASH (Big rash on the injection site) and VACCINATION SITE SWELLING (Swollen rash on injection site). On 08-Jan-2021, VACCINATION SITE PRURITUS (A large rash on my left arm that was itchy), LIMB DISCOMFORT (Arm tightness), VACCINATION SITE WARMTH (Warm to the touch), VACCINATION SITE PAIN (Had pain on injection site), VACCINATION SITE RASH (Big rash on the injection site) and VACCINATION SITE SWELLING (Swollen rash on injection site) 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.   It was reported that the patient was prescribed a topical cream (unspecified). The patient received the second dose of mRNA-1273 (Moderna COVID-19 Vaccine) on 24-Jan-2021 in right arm.   This case was linked to MOD-2021-082291 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: FUP obtained included: new events after dose 1, second dose details and adverse events associated with it.; Reporter's Comments: This case concerns a female of unknown age who experienced NS events of unexpected limb discomfort and expected injection site pain, Injection site swelling, Injection site rash.  Event onset occurred on Day 2 after the first dose of mRNA-1273, followed by other events on Day 8. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: A large rash on my left arm that was itchy; Arm tightness; Warm to the touch; Had pain on injection site; Big rash on the injection site; Swollen rash on injection site; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PRURITUS (A large rash on my left arm that was itchy), LIMB DISCOMFORT (Arm tightness), VACCINATION SITE WARMTH (Warm to the touch), VACCINATION SITE PAIN (Had pain on injection site) and VACCINATION SITE RASH (Big rash on the injection site) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included VITAMIN D3 for an unknown indication.    On 27-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (A large rash on my left arm that was itchy), LIMB DISCOMFORT (Arm tightness), VACCINATION SITE WARMTH (Warm to the touch), VACCINATION SITE PAIN (Had pain on injection site), VACCINATION SITE RASH (Big rash on the injection site) and VACCINATION SITE SWELLING (Swollen rash on injection site). On 08-Jan-2021, VACCINATION SITE PRURITUS (A large rash on my left arm that was itchy), LIMB DISCOMFORT (Arm tightness), VACCINATION SITE WARMTH (Warm to the touch), VACCINATION SITE PAIN (Had pain on injection site), VACCINATION SITE RASH (Big rash on the injection site) and VACCINATION SITE SWELLING (Swollen rash on injection site) 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.   It was reported that the patient was prescribed a topical cream (unspecified). The patient received the second dose of mRNA-1273 (Moderna COVID-19 Vaccine) on 24-Jan-2021 in right arm.   This case was linked to MOD-2021-082291 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: FUP obtained included: new events after dose 1, second dose details and adverse events associated with it.; Reporter's Comments: This case concerns a female of unknown age who experienced NS events of unexpected limb discomfort and expected injection site pain, Injection site swelling, Injection site rash.  Event onset occurred on Day 2 after the first dose of mRNA-1273, followed by other events on Day 8. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: swelling in arm; Redness in the arm; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE SWELLING (swelling in arm) and VACCINATION SITE ERYTHEMA (Redness in the arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02SJ20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history provided). Concomitant products included LISINOPRIL for an unknown indication.    On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jan-2021, the patient experienced VACCINATION SITE SWELLING (swelling in arm) and VACCINATION SITE ERYTHEMA (Redness in the arm). At the time of the report, VACCINATION SITE SWELLING (swelling in arm) and VACCINATION SITE ERYTHEMA (Redness in the 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.   Reportedly, Red swollen injection site a week after vaccination is an expected effect and resolved in all the participants after a week or so.   Most recent FOLLOW-UP information incorporated above includes: On 24-Mar-2021: Outcome updated,information added to the narrative; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnancy; This spontaneous prospective pregnancy case was reported by a health care professional and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnancy) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K202A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Medical history not provided).    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnancy). At the time of the report, EXPOSURE DURING PREGNANCY (Pregnancy) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.; 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: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Back pain, Burning sensation, Fatigue
Clinical narrative: burning pain in back of legs; Painful lymph nodes under arms/swelling in armpit glands; Headache; Swollen and painful neck lymph node, supraclavicular; muscle pain; Pain in back and legs; pain in legs; Bad pain behind right knee/Joint pains; Fatigue; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Pain in back and legs), PAIN IN EXTREMITY (pain in legs), BURNING SENSATION (burning pain in back of legs), AXILLARY PAIN (Painful lymph nodes under arms/swelling in armpit glands) and ARTHRALGIA (Bad pain behind right knee/Joint pains) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Endometriosis.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 12-Dec-2020, the patient experienced VACCINATION SITE PAIN (sore arm). On 29-Dec-2020, the patient experienced BACK PAIN (Pain in back and legs), PAIN IN EXTREMITY (pain in legs), ARTHRALGIA (Bad pain behind right knee/Joint pains), FATIGUE (Fatigue) and MYALGIA (muscle pain). On 07-Jan-2021, the patient experienced LYMPHADENOPATHY (Swollen and painful neck lymph node, supraclavicular). On an unknown date, the patient experienced BURNING SENSATION (burning pain in back of legs), AXILLARY PAIN (Painful lymph nodes under arms/swelling in armpit glands) and HEADACHE (Headache). At the time of the report, BACK PAIN (Pain in back and legs), PAIN IN EXTREMITY (pain in legs), BURNING SENSATION (burning pain in back of legs), AXILLARY PAIN (Painful lymph nodes under arms/swelling in armpit glands), HEADACHE (Headache) and VACCINATION SITE PAIN (sore arm) outcome was unknown and ARTHRALGIA (Bad pain behind right knee/Joint pains), FATIGUE (Fatigue), MYALGIA (muscle pain) and LYMPHADENOPATHY (Swollen and painful neck lymph node, supraclavicular) had not resolved.            concomitant medication was not provided.  Treatment information was not provided.   This case was linked to MOD-2021-108110 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Patient demographics, medical history updated, therapy details of Moderna vaccine, additional events reported (burning pain in back of legs, muscle pain, Swollen and painful neck lymph node, supraclavicular).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy, Myalgia, Pain in extremity, Vaccination site pain
Clinical narrative: burning pain in back of legs; Painful lymph nodes under arms/swelling in armpit glands; Headache; Swollen and painful neck lymph node, supraclavicular; muscle pain; Pain in back and legs; pain in legs; Bad pain behind right knee/Joint pains; Fatigue; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Pain in back and legs), PAIN IN EXTREMITY (pain in legs), BURNING SENSATION (burning pain in back of legs), AXILLARY PAIN (Painful lymph nodes under arms/swelling in armpit glands) and ARTHRALGIA (Bad pain behind right knee/Joint pains) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Endometriosis.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 12-Dec-2020, the patient experienced VACCINATION SITE PAIN (sore arm). On 29-Dec-2020, the patient experienced BACK PAIN (Pain in back and legs), PAIN IN EXTREMITY (pain in legs), ARTHRALGIA (Bad pain behind right knee/Joint pains), FATIGUE (Fatigue) and MYALGIA (muscle pain). On 07-Jan-2021, the patient experienced LYMPHADENOPATHY (Swollen and painful neck lymph node, supraclavicular). On an unknown date, the patient experienced BURNING SENSATION (burning pain in back of legs), AXILLARY PAIN (Painful lymph nodes under arms/swelling in armpit glands) and HEADACHE (Headache). At the time of the report, BACK PAIN (Pain in back and legs), PAIN IN EXTREMITY (pain in legs), BURNING SENSATION (burning pain in back of legs), AXILLARY PAIN (Painful lymph nodes under arms/swelling in armpit glands), HEADACHE (Headache) and VACCINATION SITE PAIN (sore arm) outcome was unknown and ARTHRALGIA (Bad pain behind right knee/Joint pains), FATIGUE (Fatigue), MYALGIA (muscle pain) and LYMPHADENOPATHY (Swollen and painful neck lymph node, supraclavicular) had not resolved.            concomitant medication was not provided.  Treatment information was not provided.   This case was linked to MOD-2021-108110 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Patient demographics, medical history updated, therapy details of Moderna vaccine, additional events reported (burning pain in back of legs, muscle pain, Swollen and painful neck lymph node, supraclavicular).; 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: Axillary pain, Erythema
Clinical narrative: armpit pain; Redness; A report was received from a consumer concerning a female patient who experienced pain and redness in her armpit after receiving the Moderna COVID-19 vaccine.   The patient's medical history was not provided. No relevant concomitant medications were reported.   The patient received their first of two planned doses of mRNA-1273 (batch# was not provided) for prophylaxis of COVID-19 infection on 30 Dec 2020. She expressed that she experienced axillary pain and noticed also that her axillary area had a reddish discoloration. The patient informed that she felt pain in her arm when it rested on her side.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, axillary pain and redness, is unknown.   The reporter did not provide an assessment for the events of axillary pain and redness.; Sender's Comments: This case concerns a female of unknown age who experienced NS events of unexpected Erythema and expected Axillary pain.  Erythema occurred Day 1 after the first dose of mRNA-1273, followed by Axillary pain Day 8. 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. US-MODERNATX, INC.-MOD-2021-002918:case invalid US-MODERNATX, INC.-MOD-2021-002925:
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy, Pain in extremity, Vaccination site pain
Clinical narrative: sore arm; swollen and retractable lymph node above the collar bone; pain at the injection site; fatigue; A spontaneous report was received from a consumer/pharmacist concerning a 40 year old patient who developed pain in the injection site, swollen and retractable lymph nodes, fatigue, and a sore arm.   The patient's medical history and relevant concomitant medications were not reported.   On 28 Dec 2020, the same day as onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.   The patient experienced pain at the injection site beginning on 28 Dec 2020. On 30 Dec 2020 the patient developed a swollen and retractable lymph node, fatigue and a sore arm. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events pain in the injection site, swollen and retractable lymph node, fatigue and sore arm were not reported.  Reporter causality for the events was not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Pain, Skin discolouration, Vaccination site pain
Clinical narrative: color was going down arms; hurts to the bone; hurts really deep; localized swelling; Redness; A spontaneous report was received from a consumer who was a 44-year old female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced localized swelling, redness, huge lump underneath, color is going down my arms, hurts really deep, hurts to the bone which was getting worse and not better.   The patient's medical history was not provided. Concomitant medications reported included diphenhydramine citrate, ibuprofen and melatonin.  On 29 Dec 2020, prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 in the left upper arm for prophylaxis of COVID-19 infection.  On 29 Dec 2020, the patient experienced localized swelling and redness.   On 07 Jan 2021, she reported that the redness was much worse, she developed a huge lump underneath, the color was going down her arms and it hurt really deep and to the bone. The condition was worsening and not getting better. Treatment for the events included Advil and Benadryl.   Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, localized swelling, redness, huge lump underneath, color is going down my arms, hurts really deep and hurts to the bone which was getting worse and not better were not reported.; Reporter's Comments: This case concerns a 44-year old, female patient. The patient's medical history was not provided. The patient experienced NS, expected event of injection site swelling, erythema, injection site pain and unexpected event of Pain NOS, skin coloration. The events of injection site swelling , erythema occurred on the same day, events of Injection site pain, Pain NOS, skin discoloration occurred 10 days after the first dose of mRNA-1273. Treatment for the events included Advil and Benadryl.  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: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Bone pain, Fatigue, Headache, Heart rate increased, Myalgia
Clinical narrative: heart rate going faster (ka-bunk, ka-bunk); muscles and bones aching; muscles and bones aching; very very very very tired; slight headache; A spontaneous report was received from a consumer who was a 68-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced muscles and bones aching, slight headache, heart rate going faster (ka-bunk, ka-bunk) and felt very tired.  The patient's medical history was not provided. No concomitant medications were reported.   On 06 Jan 2021, approximately one day prior to the onset of the events, the patient received his first of two planned doses of mRNA-1273 (Lot number: 026L20A) intramuscularly on the left arm for prophylaxis of COVID-19 infection.   On the morning of 07 Jan 2021, the patient woke up feeling very tired with muscles and bones aching and a slight headache. He also noticed that his heart rate was going faster (ka-bunk, ka-bunk) one hour prior to reporting the events. Treatment for the events included ibuprofen.   Action taken with mRNA-1273 in response to the events was not reported.  The outcome for the events, very tired, muscles and bones aching, slight headache and heart rate going faster was not reported.; Reporter's Comments: This case concerns a 68 year old male who experienced nonserious  unexpected events of heart rate increase and bone pain, as wells as nonserious listed events of fatigue, myalgia, and headache. The events occurred approximately 1 day after first dose of mRNA-1273 administration. Treatment for the events included ibuprofen.  Based on the current available information and temporal association between the use of mRNA-1273 and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Experienced swelling, burning, and slight itching at the injection spot; Experienced swelling, burning, and slight itching at the injection spot; Experienced swelling, burning, and slight itching at the injection spot; A spontaneous report was received from a consumer, concerning herself, a 64-year-old female patient, who received Moderna's COVID-19 vaccine and experienced swelling, burning, and itching at the injection spot.  The patient's medical history was not provided. Concomitant product use was not provided.  On 23-Dec-2020, approximately seven days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot number 025J20-2A) intramuscularly in the upper left arm for prophylaxis of COVID-19 infection.   On 30-Dec-2020, 7 days after the shot of vaccine, the patient experienced swelling, burning and slight itching at the injection spot (not too bad). Hence, she was treated with ibuprofen and the first dose of which helped patient 50% and the second dose provided full relief from the symptoms. These event had lasted for two days.   Action taken with mRNA-1273 in response to the events were not reported.   The outcome of the events, experienced swelling, burning and itching at the injection spot was resolved on 01-Jan-2021.; Reporter's Comments: This case concerns a 64 year old, female patient, who experienced a non-serious expected event of injection site pruritus, injection site pain, and injection site swelling. The events occurred 8 days after first dose of mRNA-1273, lot # 039K20A. Treatment included Advil. Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Eye irritation, Swelling face
Clinical narrative: Burning eyes; swelling in face; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of EYE IRRITATION (Burning eyes) and SWELLING FACE (swelling in face) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No Medical History reported). Concomitant products included CARVEDILOL, HYDROCHLOROTHIAZIDE, BETAHISTINE, POTASSIUM CHLORIDE and TIMOLOL MALEATE (TIMOPTIC) for an unknown indication.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jan-2021, the patient experienced EYE IRRITATION (Burning eyes) and SWELLING FACE (swelling in face). The patient was treated with PREDNISONE at a dose of 20 mg. At the time of the report, EYE IRRITATION (Burning eyes) outcome was unknown and SWELLING FACE (swelling in face) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.; 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: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site swelling
Clinical narrative: bump is bigger this time and it doesn't look like it's gonna go away; hardness; redness; swelling; regular pain at the injection site; This spontaneous case was reported by a physician and describes the occurrence of CONDITION AGGRAVATED (bump is bigger this time and it doesn't look like it's gonna go away), VACCINATION SITE INDURATION (hardness), VACCINATION SITE PAIN (regular pain at the injection site), VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE SWELLING (swelling) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 077K204) for COVID-19 vaccination.     Concomitant products included PANTOPRAZOLE, METFORMIN, CALCIUM, SODIUM CITRATE (CITRATE), ZINC and VITAMINS NOS for an unknown indication.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced VACCINATION SITE PAIN (regular pain at the injection site). On 31-Dec-2020, the patient experienced VACCINATION SITE INDURATION (hardness), VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE SWELLING (swelling). On 06-Jan-2021, the patient experienced CONDITION AGGRAVATED (bump is bigger this time and it doesn't look like it's gonna go away). At the time of the report, CONDITION AGGRAVATED (bump is bigger this time and it doesn't look like it's gonna go away), VACCINATION SITE INDURATION (hardness), VACCINATION SITE PAIN (regular pain at the injection site), VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE SWELLING (swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were reported.; Sender's Comments: This case concerns a 41-year-old female who experienced NS events of unexpected condition aggravated and expected vaccination site pain, vaccination site erythema, vaccination site swelling, vaccination site induration. 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 use of the product and the start date of the event, a causal relationship cannot be excluded.