chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Vaccination site coldness
Clinical narrative: tingling in her fingers immediately after receiving the vaccine; feeling of coldness on the shoulder of the site where the shot was   given; This spontaneous case was reported by a health care professional and describes the occurrence of PARAESTHESIA (tingling in her fingers immediately after receiving the vaccine) and VACCINATION SITE COLDNESS (feeling of coldness on the shoulder of the site where the shot was   given) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (tingling in her fingers immediately after receiving the vaccine) and VACCINATION SITE COLDNESS (feeling of coldness on the shoulder of the site where the shot was   given). At the time of the report, PARAESTHESIA (tingling in her fingers immediately after receiving the vaccine) and VACCINATION SITE COLDNESS (feeling of coldness on the shoulder of the site where the shot was   given) outcome was unknown.        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.   the patient had this symptoms with a flu vaccine 4 years ago but no other time, was pretty quick and went away quickly too.  No concomitant medications reported by investigator No treatment medications provided by the reporter.    This case was linked to MOD-2021-058974, MOD-2021-009606, MOD-2021-005584, MOD-2021-063094 (Patient Link).; 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: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Dizziness, Dysphonia, Dyspnoea, Feeling abnormal
Clinical narrative: Tongue Tingling; Felt a little off; had trouble breathing; started trembling and shaking; neck in both sides is sensitive to the touch, sore; voice is raspy; blood pressure was high; felt warm heat throughout the whole body; Dizziness; heart skyrocketed; A spontaneous report was received from a consumer concerning a fifty-one-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced feeling of warmth, dizziness, heart skyrocketed, tongue tingling, blood pressure was high, felt a little off, had trouble breathing, started trembling and shaking, neck in both sides is sensitive to the touch, sore and voice is raspy.   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# 025L20A) on 14 Jan 2021 intramuscularly in the left arm for prophylaxis of COVID-19 infection.   Consumer received the Moderna COVID-19 vaccine on 14 Jan 2021 around eight-thirty am (ante-meridian) in the left arm (non-dominant) and immediately after getting vaccine felt warm heat throughout the whole body and dizziness, heart skyrocketed and tongue tingling. Paramedics attended to them. Once she got the shot it was not even a minute until she felt warm, people talked to her and they felt far away. Their blood pressure was high and heart rate elevated from sixty-two to one-hundred and twenty-two. Consumer stayed for forty-five minutes in the facility and then felt better and drove home. Took Benadryl and slept the whole day and night. On 18 Jan 2021 consumer felt a little off, and going to work had trouble breathing, tongue tingling, feeling dizzy, started trembling and shaking. Reporter took some more Benadryl while they waited for ambulance, at the hospital received Benadryl injection. 18 Jan 2021 their neck in both sides is sensitive to the touch, it is sore, and voice is raspy.  Treatment for events included Benadryl.  Action taken with RNA-1273 in response to the event was unknown.  The outcome of the events was unknown.  The reporter did not provide an assessment for the events, feeling of warmth, dizziness, heart skyrocketed, tongue tingling, blood pressure was high, felt a little off, had trouble breathing, started trembling and shaking, neck in both sides is sensitive to the touch, sore and voice is raspy.  Follow-up received on 14 Jan 2021 included, reporter stated they reported adverse event after getting vaccine.; 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: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Heart rate increased, Neck pain, Paraesthesia oral, Tremor
Clinical narrative: Tongue Tingling; Felt a little off; had trouble breathing; started trembling and shaking; neck in both sides is sensitive to the touch, sore; voice is raspy; blood pressure was high; felt warm heat throughout the whole body; Dizziness; heart skyrocketed; A spontaneous report was received from a consumer concerning a fifty-one-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced feeling of warmth, dizziness, heart skyrocketed, tongue tingling, blood pressure was high, felt a little off, had trouble breathing, started trembling and shaking, neck in both sides is sensitive to the touch, sore and voice is raspy.   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# 025L20A) on 14 Jan 2021 intramuscularly in the left arm for prophylaxis of COVID-19 infection.   Consumer received the Moderna COVID-19 vaccine on 14 Jan 2021 around eight-thirty am (ante-meridian) in the left arm (non-dominant) and immediately after getting vaccine felt warm heat throughout the whole body and dizziness, heart skyrocketed and tongue tingling. Paramedics attended to them. Once she got the shot it was not even a minute until she felt warm, people talked to her and they felt far away. Their blood pressure was high and heart rate elevated from sixty-two to one-hundred and twenty-two. Consumer stayed for forty-five minutes in the facility and then felt better and drove home. Took Benadryl and slept the whole day and night. On 18 Jan 2021 consumer felt a little off, and going to work had trouble breathing, tongue tingling, feeling dizzy, started trembling and shaking. Reporter took some more Benadryl while they waited for ambulance, at the hospital received Benadryl injection. 18 Jan 2021 their neck in both sides is sensitive to the touch, it is sore, and voice is raspy.  Treatment for events included Benadryl.  Action taken with RNA-1273 in response to the event was unknown.  The outcome of the events was unknown.  The reporter did not provide an assessment for the events, feeling of warmth, dizziness, heart skyrocketed, tongue tingling, blood pressure was high, felt a little off, had trouble breathing, started trembling and shaking, neck in both sides is sensitive to the touch, sore and voice is raspy.  Follow-up received on 14 Jan 2021 included, reporter stated they reported adverse event after getting vaccine.; 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: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Presyncope, Pyrexia
Clinical narrative: consumer took her temperature and it read 100.6 F; Felt like going to black out; Woozy; headache; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (Felt like going to black out), DIZZINESS (Woozy), HEADACHE (headache) and PYREXIA (consumer took her temperature and it read 100.6 F) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042120A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 18-Jan-2021, the patient experienced PRESYNCOPE (Felt like going to black out), DIZZINESS (Woozy) and HEADACHE (headache). On 20-Jan-2021, the patient experienced PYREXIA (consumer took her temperature and it read 100.6 F). At the time of the report, PRESYNCOPE (Felt like going to black out), DIZZINESS (Woozy), HEADACHE (headache) and PYREXIA (consumer took her temperature and it read 100.6 F) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) 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.; 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: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Lid lag, Vaccination site pain
Clinical narrative: Right lid started lagging (lid stutter before returning to the normal position, it doesnot open correctly); Vaccination site pain; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain) and LID LAG (right lid started lagging (lid stutter before returning to the normal position, it doesnot open correctly)) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.  Concurrent medical conditions included Glaucoma.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). On 07-Jan-2021, the patient experienced LID LAG (right lid started lagging (lid stutter before returning to the normal position, it doesnot open correctly)). On 08-Jan-2021, VACCINATION SITE PAIN (Vaccination site pain) had resolved. In January 2021, LID LAG (right lid started lagging (lid stutter before returning to the normal position, it doesnot open correctly)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was eyedrops for glaucoma in both eyes.  No treatment information was provided.; 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: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Nasal congestion, Pain in extremity, SARS-CoV-2 test
Clinical narrative: COVID-19 virus test positive; Lost my sense of taste; Lost my sense of smell; Nasal congestion/runny nose; Arm was sore for 24 hrs; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Jan-2021. The most recent information was received on 22-Jun-2021 and was forwarded to Moderna on 22-Jun-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Arm was sore for 24 hrs), SARS-COV-2 TEST POSITIVE (COVID-19 virus test positive), AGEUSIA (Lost my sense of taste), ANOSMIA (Lost my sense of smell) and NASAL CONGESTION (Nasal congestion/runny nose) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. o25L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 03-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore for 24 hrs). On 05-Jan-2021, the patient experienced AGEUSIA (Lost my sense of taste), ANOSMIA (Lost my sense of smell) and NASAL CONGESTION (Nasal congestion/runny nose). On 06-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (COVID-19 virus test positive). The patient was treated with VITAMIN C [ASCORBIC ACID] (oral) from 06-Jan-2021 to 16-Jan-2021 for COVID-19, at an unspecified dose and frequency and GUAIFENESIN (MUCINEX) from 06-Jan-2021 to 12-Jan-2021 for COVID-19, at a dose of UNK, bid. On 06-Jan-2021, NASAL CONGESTION (Nasal congestion/runny nose) outcome was unknown. On 10-Jan-2021, AGEUSIA (Lost my sense of taste) and ANOSMIA (Lost my sense of smell) was resolving. At the time of the report, PAIN IN EXTREMITY (Arm was sore for 24 hrs) had resolved and SARS-COV-2 TEST POSITIVE (COVID-19 virus test positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jan-2021, SARS-CoV-2 test: positive (Positive) PCR.     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.   Concomitant product use was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Treatment medications of Vitamin C and Mucinex were reported, nasal congestion and runny nose was reported. Patient reported that she received the second dose of vaccine within the recommended time frame.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: COVID-19 virus test positive; Lost my sense of taste; Lost my sense of smell; Nasal congestion/runny nose; Arm was sore for 24 hrs; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Jan-2021. The most recent information was received on 22-Jun-2021 and was forwarded to Moderna on 22-Jun-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Arm was sore for 24 hrs), SARS-COV-2 TEST POSITIVE (COVID-19 virus test positive), AGEUSIA (Lost my sense of taste), ANOSMIA (Lost my sense of smell) and NASAL CONGESTION (Nasal congestion/runny nose) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. o25L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 03-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore for 24 hrs). On 05-Jan-2021, the patient experienced AGEUSIA (Lost my sense of taste), ANOSMIA (Lost my sense of smell) and NASAL CONGESTION (Nasal congestion/runny nose). On 06-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (COVID-19 virus test positive). The patient was treated with VITAMIN C [ASCORBIC ACID] (oral) from 06-Jan-2021 to 16-Jan-2021 for COVID-19, at an unspecified dose and frequency and GUAIFENESIN (MUCINEX) from 06-Jan-2021 to 12-Jan-2021 for COVID-19, at a dose of UNK, bid. On 06-Jan-2021, NASAL CONGESTION (Nasal congestion/runny nose) outcome was unknown. On 10-Jan-2021, AGEUSIA (Lost my sense of taste) and ANOSMIA (Lost my sense of smell) was resolving. At the time of the report, PAIN IN EXTREMITY (Arm was sore for 24 hrs) had resolved and SARS-COV-2 TEST POSITIVE (COVID-19 virus test positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jan-2021, SARS-CoV-2 test: positive (Positive) PCR.     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.   Concomitant product use was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Treatment medications of Vitamin C and Mucinex were reported, nasal congestion and runny nose was reported. Patient reported that she received the second dose of vaccine within the recommended time frame.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash 24 hours after vaccination; This spontaneous case was reported by a dentist and describes the occurrence of RASH (rash 24 hours after vaccination) in a  patient of an unknown age and gender 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (rash 24 hours after vaccination). At the time of the report, RASH (rash 24 hours after vaccination) outcome was unknown.        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.   No concomitant medications reported by investigator o No treatment medications provided by the reporter.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Nausea, Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Achy arm), PERIPHERAL SWELLING (arm swollen), ERYTHEMA (Red patch), PRURITUS (Itchy patch/its itchy) and SOFT TISSUE SWELLING (Swollen patch/its a little bigger than a baseball in circumference) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. D25L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 02-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jan-2021, the patient experienced PAIN IN EXTREMITY (Achy arm). On 10-Jan-2021, the patient experienced PERIPHERAL SWELLING (arm swollen) and ERYTHEMA (Red patch). On 11-Jan-2021, the patient experienced PRURITUS (Itchy patch/its itchy), SOFT TISSUE SWELLING (Swollen patch/its a little bigger than a baseball in circumference), FATIGUE (Tired) and NAUSEA (Nauseated). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Achy arm), PERIPHERAL SWELLING (arm swollen), ERYTHEMA (Red patch), PRURITUS (Itchy patch/its itchy), SOFT TISSUE SWELLING (Swollen patch/its a little bigger than a baseball in circumference), FATIGUE (Tired) and NAUSEA (Nauseated) outcome was unknown.        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.   Concomitant product use was not provided by the reporter.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Soft tissue swelling
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Achy arm), PERIPHERAL SWELLING (arm swollen), ERYTHEMA (Red patch), PRURITUS (Itchy patch/its itchy) and SOFT TISSUE SWELLING (Swollen patch/its a little bigger than a baseball in circumference) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. D25L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 02-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jan-2021, the patient experienced PAIN IN EXTREMITY (Achy arm). On 10-Jan-2021, the patient experienced PERIPHERAL SWELLING (arm swollen) and ERYTHEMA (Red patch). On 11-Jan-2021, the patient experienced PRURITUS (Itchy patch/its itchy), SOFT TISSUE SWELLING (Swollen patch/its a little bigger than a baseball in circumference), FATIGUE (Tired) and NAUSEA (Nauseated). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Achy arm), PERIPHERAL SWELLING (arm swollen), ERYTHEMA (Red patch), PRURITUS (Itchy patch/its itchy), SOFT TISSUE SWELLING (Swollen patch/its a little bigger than a baseball in circumference), FATIGUE (Tired) and NAUSEA (Nauseated) outcome was unknown.        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.   Concomitant product use was not provided by the reporter.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: painful injection site; swelling muscle at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swelling muscle at the injection site) and VACCINATION SITE PAIN (painful injection site) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced VACCINATION SITE SWELLING (swelling muscle at the injection site). On 11-Jan-2021, the patient experienced VACCINATION SITE PAIN (painful injection site). At the time of the report, VACCINATION SITE SWELLING (swelling muscle at the injection site) and VACCINATION SITE PAIN (painful injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment details were not provided.    Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2021: 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.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
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 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 18-Jan-2021, 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 18-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy). On 18-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant products were provided by reporter.  No treatment information was provided. She was 20 weeks pregnant.; 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.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection site soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection site soreness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Injection site soreness). At the time of the report, VACCINATION SITE PAIN (Injection site soreness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. Treatment details was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-028624 (E2B Linked Report).; 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. US-MODERNATX, INC.-MOD-2021-028624:same reporter, different patient - MOD21-04067
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia, Fatigue, Influenza like illness, Myalgia, Nausea
Clinical narrative: "flu like" symptoms; Body aches; fever; fatigue; nausea; Weird voice; Sensation that something is stuck on her back throat; Back throat felt warm/ burning; Constriction in throat; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of THROAT IRRITATION (Back throat felt warm/ burning), THROAT TIGHTNESS (Constriction in throat), PAIN (Body aches), INFLUENZA LIKE ILLNESS ("flu like" symptoms) and DYSPHONIA (Weird voice) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Addison's disease and Food allergy (several; unspecified). Concomitant products included HYDROCORTISONE for Addison's disease, LEVOTHYROXINE for Hypothyroidism, FLUDROCORTISONE for an unknown indication.    On 04-Jan-2021 at 12:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced THROAT IRRITATION (Back throat felt warm/ burning), THROAT TIGHTNESS (Constriction in throat), DYSPHONIA (Weird voice), OROPHARYNGEAL DISCOMFORT (Sensation that something is stuck on her back throat) and NAUSEA (nausea). On 05-Jan-2021, the patient experienced PAIN (Body aches), INFLUENZA LIKE ILLNESS ("flu like" symptoms), PYREXIA (fever) and FATIGUE (fatigue). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 04-Jan-2021, THROAT TIGHTNESS (Constriction in throat) had resolved. On 08-Jan-2021, PAIN (Body aches), INFLUENZA LIKE ILLNESS ("flu like" symptoms), PYREXIA (fever) and NAUSEA (nausea) had resolved. On 11-Jan-2021, THROAT IRRITATION (Back throat felt warm/ burning), DYSPHONIA (Weird voice) and FATIGUE (fatigue) had resolved. At the time of the report, OROPHARYNGEAL DISCOMFORT (Sensation that something is stuck on her back throat) 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.; 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: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal discomfort, Pyrexia, Throat irritation, Throat tightness
Clinical narrative: "flu like" symptoms; Body aches; fever; fatigue; nausea; Weird voice; Sensation that something is stuck on her back throat; Back throat felt warm/ burning; Constriction in throat; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of THROAT IRRITATION (Back throat felt warm/ burning), THROAT TIGHTNESS (Constriction in throat), PAIN (Body aches), INFLUENZA LIKE ILLNESS ("flu like" symptoms) and DYSPHONIA (Weird voice) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Addison's disease and Food allergy (several; unspecified). Concomitant products included HYDROCORTISONE for Addison's disease, LEVOTHYROXINE for Hypothyroidism, FLUDROCORTISONE for an unknown indication.    On 04-Jan-2021 at 12:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced THROAT IRRITATION (Back throat felt warm/ burning), THROAT TIGHTNESS (Constriction in throat), DYSPHONIA (Weird voice), OROPHARYNGEAL DISCOMFORT (Sensation that something is stuck on her back throat) and NAUSEA (nausea). On 05-Jan-2021, the patient experienced PAIN (Body aches), INFLUENZA LIKE ILLNESS ("flu like" symptoms), PYREXIA (fever) and FATIGUE (fatigue). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 04-Jan-2021, THROAT TIGHTNESS (Constriction in throat) had resolved. On 08-Jan-2021, PAIN (Body aches), INFLUENZA LIKE ILLNESS ("flu like" symptoms), PYREXIA (fever) and NAUSEA (nausea) had resolved. On 11-Jan-2021, THROAT IRRITATION (Back throat felt warm/ burning), DYSPHONIA (Weird voice) and FATIGUE (fatigue) had resolved. At the time of the report, OROPHARYNGEAL DISCOMFORT (Sensation that something is stuck on her back throat) 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.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: A spontaneous report was received from a physician on 18-Jan-2021 concerning a female patient of an unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) while pregnant.    The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On an unknown date, during pregnancy patient received their first of two planned doses of mRNA-1273 (batch number not provided) via an unknown route for COVID-19 infection.   On an unknown date, the patient became pregnant. LMP and estimated delivery date was not reported.    Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the event pregnant was unknown.  The reporter did not provide causality assessment for event pregnant with mRNA-1273 vaccine.; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient of an unknown age. Patient will continue to be contacted for further monitoring of AEs during the pregnancy. The causality of pregnancy was assessed as not applicable.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Headache
Clinical narrative: terrible headache; Very tired; very weak; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (terrible headache), FATIGUE (Very tired) and ASTHENIA (very weak) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025JZ0A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced HEADACHE (terrible headache), FATIGUE (Very tired) and ASTHENIA (very weak). The patient was treated with PARACETAMOL (TYLENOL) on 20-Jan-2021 at an unspecified dose and frequency. At the time of the report, HEADACHE (terrible headache), FATIGUE (Very tired) and ASTHENIA (very weak) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Erythema, Feeling abnormal, Feeling hot, Hypotension
Clinical narrative: Lethargic; Legs began feeling heavy; Couldn't focus/felt like I wasn't sober/felt like she was on medication; Felt hot; Itching; Cotton mouth; Blood pressure became really low; red; Firm; Uncontrollable laughing; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LETHARGY (Lethargic), LIMB DISCOMFORT (Legs began feeling heavy), FEELING ABNORMAL (Couldn't focus/felt like I wasn't sober/felt like she was on medication), FEELING HOT (Felt hot) and PRURITUS (Itching) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Allergic to Sulfa.).    On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2020, the patient experienced LETHARGY (Lethargic), LIMB DISCOMFORT (Legs began feeling heavy), FEELING ABNORMAL (Couldn't focus/felt like I wasn't sober/felt like she was on medication), FEELING HOT (Felt hot), PRURITUS (Itching), DRY MOUTH (Cotton mouth), HYPOTENSION (Blood pressure became really low), ERYTHEMA (red), FEELING ABNORMAL (Firm) and INAPPROPRIATE AFFECT (Uncontrollable laughing). On 23-Dec-2020, LETHARGY (Lethargic), LIMB DISCOMFORT (Legs began feeling heavy), FEELING ABNORMAL (Couldn't focus/felt like I wasn't sober/felt like she was on medication), FEELING HOT (Felt hot), PRURITUS (Itching), DRY MOUTH (Cotton mouth), ERYTHEMA (red), FEELING ABNORMAL (Firm) and INAPPROPRIATE AFFECT (Uncontrollable laughing) had resolved. At the time of the report, HYPOTENSION (Blood pressure became really low) 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.; Sender's Comments: This case concerns a 43-year-old female with a nonserious unexpected events of hypotension, pruritus, erythema, dry mouth, lethargy, feeling hot, feeling abnormal, inappropriate affect, and limb discomfort. Event onset the same day as first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate affect, Lethargy, Limb discomfort, Pruritus
Clinical narrative: Lethargic; Legs began feeling heavy; Couldn't focus/felt like I wasn't sober/felt like she was on medication; Felt hot; Itching; Cotton mouth; Blood pressure became really low; red; Firm; Uncontrollable laughing; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LETHARGY (Lethargic), LIMB DISCOMFORT (Legs began feeling heavy), FEELING ABNORMAL (Couldn't focus/felt like I wasn't sober/felt like she was on medication), FEELING HOT (Felt hot) and PRURITUS (Itching) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Allergic to Sulfa.).    On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2020, the patient experienced LETHARGY (Lethargic), LIMB DISCOMFORT (Legs began feeling heavy), FEELING ABNORMAL (Couldn't focus/felt like I wasn't sober/felt like she was on medication), FEELING HOT (Felt hot), PRURITUS (Itching), DRY MOUTH (Cotton mouth), HYPOTENSION (Blood pressure became really low), ERYTHEMA (red), FEELING ABNORMAL (Firm) and INAPPROPRIATE AFFECT (Uncontrollable laughing). On 23-Dec-2020, LETHARGY (Lethargic), LIMB DISCOMFORT (Legs began feeling heavy), FEELING ABNORMAL (Couldn't focus/felt like I wasn't sober/felt like she was on medication), FEELING HOT (Felt hot), PRURITUS (Itching), DRY MOUTH (Cotton mouth), ERYTHEMA (red), FEELING ABNORMAL (Firm) and INAPPROPRIATE AFFECT (Uncontrollable laughing) had resolved. At the time of the report, HYPOTENSION (Blood pressure became really low) 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.; Sender's Comments: This case concerns a 43-year-old female with a nonserious unexpected events of hypotension, pruritus, erythema, dry mouth, lethargy, feeling hot, feeling abnormal, inappropriate affect, and limb discomfort. Event onset the same day as first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Musculoskeletal stiffness, Nasal congestion, Oropharyngeal pain
Clinical narrative: Sore throat; drainage (stuffy nose); Stiff neck a muscle thing; Cramps in her neck; This spontaneous case was reported by a physician and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiff neck a muscle thing), MUSCLE SPASMS (Cramps in her neck), NASAL CONGESTION (drainage (stuffy nose)) and OROPHARYNGEAL PAIN (Sore throat) in a 90-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 adverse event history).    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiff neck a muscle thing) and MUSCLE SPASMS (Cramps in her neck). On 10-Jan-2021, the patient experienced NASAL CONGESTION (drainage (stuffy nose)). On 11-Jan-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiff neck a muscle thing), MUSCLE SPASMS (Cramps in her neck), NASAL CONGESTION (drainage (stuffy nose)) and OROPHARYNGEAL PAIN (Sore throat) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication includes blood pressure, something for cholesterol, weekly something for bones.; Sender's Comments: This case concerns a 90-year-old female with nonserious unexpected events of nasal congestion, oropharyngeal pain, musculoskeletal stiffness, and muscle spasms. Event onset 2 days after first dose mRNA-1273. Events ongoing. 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: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Euphoric mood, Fatigue, Feeling abnormal, Head discomfort
Clinical narrative: pressure on their head; memory loss when thinking at words; Vertigo; Missed dose; Mild fatigue; mild headache; Brain fog, cloud feeling, foggy feeling; high feeling; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Brain fog, cloud feeling, foggy feeling), EUPHORIC MOOD (high feeling), HEAD DISCOMFORT (pressure on their head), APHASIA (memory loss when thinking at words) and VERTIGO (Vertigo) in a 23-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.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced FEELING ABNORMAL (Brain fog, cloud feeling, foggy feeling), EUPHORIC MOOD (high feeling), FATIGUE (Mild fatigue) and HEADACHE (mild headache). On an unknown date, the patient experienced HEAD DISCOMFORT (pressure on their head), APHASIA (memory loss when thinking at words), VERTIGO (Vertigo) and PRODUCT DOSE OMISSION ISSUE (Missed dose). The patient was treated with AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for Adverse event, at a dose of 5 mg; CAFFEINE on 13-Jan-2021 for Headache, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) on 13-Jan-2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (Brain fog, cloud feeling, foggy feeling), HEAD DISCOMFORT (pressure on their head), APHASIA (memory loss when thinking at words) and VERTIGO (Vertigo) had not resolved, EUPHORIC MOOD (high feeling), FATIGUE (Mild fatigue) and HEADACHE (mild headache) had resolved and PRODUCT DOSE OMISSION ISSUE (Missed dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Additional treatment for the events included steroids and Physical therapy.   This case was linked to MOD-2021-013493 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Mar-2021: Additional information on events and treatment. On 23-Jun-2021: Significant Follow-up; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.  .
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Product dose omission issue, Vertigo
Clinical narrative: pressure on their head; memory loss when thinking at words; Vertigo; Missed dose; Mild fatigue; mild headache; Brain fog, cloud feeling, foggy feeling; high feeling; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Brain fog, cloud feeling, foggy feeling), EUPHORIC MOOD (high feeling), HEAD DISCOMFORT (pressure on their head), APHASIA (memory loss when thinking at words) and VERTIGO (Vertigo) in a 23-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.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced FEELING ABNORMAL (Brain fog, cloud feeling, foggy feeling), EUPHORIC MOOD (high feeling), FATIGUE (Mild fatigue) and HEADACHE (mild headache). On an unknown date, the patient experienced HEAD DISCOMFORT (pressure on their head), APHASIA (memory loss when thinking at words), VERTIGO (Vertigo) and PRODUCT DOSE OMISSION ISSUE (Missed dose). The patient was treated with AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for Adverse event, at a dose of 5 mg; CAFFEINE on 13-Jan-2021 for Headache, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) on 13-Jan-2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (Brain fog, cloud feeling, foggy feeling), HEAD DISCOMFORT (pressure on their head), APHASIA (memory loss when thinking at words) and VERTIGO (Vertigo) had not resolved, EUPHORIC MOOD (high feeling), FATIGUE (Mild fatigue) and HEADACHE (mild headache) had resolved and PRODUCT DOSE OMISSION ISSUE (Missed dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Additional treatment for the events included steroids and Physical therapy.   This case was linked to MOD-2021-013493 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Mar-2021: Additional information on events and treatment. On 23-Jun-2021: Significant Follow-up; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.  .
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: On the side where she received tha vaccine the area was red and itchy; On the side where she received tha vaccine the area was red and itchy; Nausea; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PRURITUS (On the side where she received tha vaccine the area was red and itchy), VACCINATION SITE ERYTHEMA (On the side where she received tha vaccine the area was red and itchy) and NAUSEA (Nausea) in a 36-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, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (On the side where she received tha vaccine the area was red and itchy), VACCINATION SITE ERYTHEMA (On the side where she received tha vaccine the area was red and itchy) and NAUSEA (Nausea). At the time of the report, VACCINATION SITE PRURITUS (On the side where she received tha vaccine the area was red and itchy), VACCINATION SITE ERYTHEMA (On the side where she received tha vaccine the area was red and itchy) and NAUSEA (Nausea) outcome was unknown.        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.   Concomitant product use was not provided by the reporter. 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.; 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.