chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Facial pain, Lip swelling, Rash, Swelling face, Swollen tongue
Clinical narrative: Face, lips and tongue swelling after 2nd dose; Face, lips and tongue swelling after 2nd dose; Face, lips and tongue swelling after 2nd dose; facial pain is worse at the injection sites; red r ash; A spontaneous report was received from a healthcare professional concerning a 34-years-old  female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events face, lips and tongue swelling after 2nd dose, a red rash,facial pain is worse at the injection sites/facial pain.  The patient's medical history was not provided.  concomitant product usage was not provided by the reporter.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 013l20a) via unknown route on left arm for prophylaxis of COVID-19 infection. On unknown date, prior to the onset of the events the patient received second of two planned doses of mRNA-1273 (lot/batch013m20a) via unknown route on left arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) Face, lips and tongue swelling after 2nd dose, a red rash, facial pain is worse at the injection sites.She does receive Botox and said the facial pain is worse at the injection sites. She went to the doctor the following Monday. She was put on a topical and oral steroid, but told to wait on the oral steroid until 11 days after vaccine .  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore  Action taken with mRNA-1273 in response to the events was not applicable.  Treatment information included was Botox injection, topical and oral steroid.   The outcome of event(s), face, lips and tongue swelling after 2nd dose, a red rash, facial pain is worse at the injection sites  was unknown.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded.  Rash and facial swelling is consistent with the known safety profile of mRNA-1273. Swelling of the face may occur in patients who have had facial cosmetic injections. Patient is known to have had Botox
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Tooth infection
Clinical narrative: Tooth infection; This spontaneous case was reported by a consumer and describes the occurrence of TOOTH INFECTION (Tooth infection) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No Historical Condition was provided).    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced TOOTH INFECTION (Tooth infection). At the time of the report, TOOTH INFECTION (Tooth infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This spontaneous case was reported by a consumer and describes the occurrence of TOOTH INFECTION (Tooth infection) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No Historical Condition was provided).    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced TOOTH INFECTION (Tooth infection). At the time of the report, TOOTH INFECTION (Tooth infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       15 days post vaccination, the patient reported that he had a tooth infection. The patient stated that the symptoms were ongoing.   Treatment information included an unknown dosage of Amoxicillin   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: No specific follow-up information recorded.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: No specific follow-up information recorded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Mild rash; Itchy; Red; A spontaneous report was received from a consumer concerning a 79-years-old  female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events mild rash/vaccination site rash, itchy/vaccination site pruritus, red/vaccination site erythema.  The patient's medical history was not provided.  concomitant product use was not reported by the reporter.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 010M20A) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the events,  mild rash, itchy, red. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), mild rash, itchy, red, seems to be going away was resolving.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. The reported events are consistent with the known safety profile of mRNA-1273.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Adverse reaction, Chills, Feeling abnormal, Feeling of body temperature change, Headache
Clinical narrative: Experienced series of drastic adverse reactions; Body feeling hot and cold alternatively; Whole bodyaches and pain; Felt like he was going to die; fever (103 degrees); Chills; Headaches all day; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Experienced series of drastic adverse reactions), FEELING OF BODY TEMPERATURE CHANGE (Body feeling hot and cold alternatively), PAIN (Whole bodyaches and pain), FEELING ABNORMAL (Felt like he was going to die) and PYREXIA (fever (103 degrees)) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 011520A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by reporter.  No concomitant medication reported.    On 16-Feb-2021 at 6:00 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced ADVERSE REACTION (Experienced series of drastic adverse reactions), FEELING OF BODY TEMPERATURE CHANGE (Body feeling hot and cold alternatively), PAIN (Whole bodyaches and pain), FEELING ABNORMAL (Felt like he was going to die), PYREXIA (fever (103 degrees)), CHILLS (Chills) and HEADACHE (Headaches all day). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 17-Feb-2021, ADVERSE REACTION (Experienced series of drastic adverse reactions), FEELING OF BODY TEMPERATURE CHANGE (Body feeling hot and cold alternatively), PAIN (Whole bodyaches and pain), FEELING ABNORMAL (Felt like he was going to die), PYREXIA (fever (103 degrees)), CHILLS (Chills) and HEADACHE (Headaches all day) had resolved.       Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: TCR received
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Experienced series of drastic adverse reactions; Body feeling hot and cold alternatively; Whole bodyaches and pain; Felt like he was going to die; fever (103 degrees); Chills; Headaches all day; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Experienced series of drastic adverse reactions), FEELING OF BODY TEMPERATURE CHANGE (Body feeling hot and cold alternatively), PAIN (Whole bodyaches and pain), FEELING ABNORMAL (Felt like he was going to die) and PYREXIA (fever (103 degrees)) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 011520A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by reporter.  No concomitant medication reported.    On 16-Feb-2021 at 6:00 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced ADVERSE REACTION (Experienced series of drastic adverse reactions), FEELING OF BODY TEMPERATURE CHANGE (Body feeling hot and cold alternatively), PAIN (Whole bodyaches and pain), FEELING ABNORMAL (Felt like he was going to die), PYREXIA (fever (103 degrees)), CHILLS (Chills) and HEADACHE (Headaches all day). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 17-Feb-2021, ADVERSE REACTION (Experienced series of drastic adverse reactions), FEELING OF BODY TEMPERATURE CHANGE (Body feeling hot and cold alternatively), PAIN (Whole bodyaches and pain), FEELING ABNORMAL (Felt like he was going to die), PYREXIA (fever (103 degrees)), CHILLS (Chills) and HEADACHE (Headaches all day) had resolved.       Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: TCR received
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Fast heartbeat all day; A spontaneous report () was received from a consumer concerning a 74-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events fast heartbeat all day/palpitation.  The patient's medical history was not provided.  concomitant products use were not provided by reporter. On 26 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 007M20A) via unknown route for prophylaxis of COVID-19 infection.  On 7 Feb 2021, the patient experienced the event(s) fast heartbeat all day.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  On 7 Feb 2021 the outcome of event,  fast heartbeat all day was resolved.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: Report an adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (Report an adverse reaction) 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 (history not 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 ADVERSE DRUG REACTION (Report an adverse reaction). At the time of the report, ADVERSE DRUG REACTION (Report an adverse reaction) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Very limited information regarding this event has been provided at this time. Further information has been requested.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Hyperaesthesia, Vaccination site erythema
Clinical narrative: little sensation when she touches arm; flat, pinkish to dark red 2x3 mark; A spontaneous report was received from a consumer concerning a 80-years-old female  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events flat, pinkish to dark red 2x3 mark/vaccination site erythema, little sensation when she touches arm/hyperesthesia.  The patient's medical history was not provided. Concomitant medications reported were dabigatran, Metoprolol for drug use for unknown indication.  On 17 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 022M20A) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the events, flat, pinkish to dark red 2x3 mark, little sensation when she touches arm.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, flat, pinkish to dark red 2x3 mark, little sensation when she touches arm was unknown.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Vaccination site erythema is consistent with the known safety profile of mRNA-1273.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Hypertension, Oropharyngeal discomfort, Sensory disturbance, Throat tightness
Clinical narrative: sensation on forehead that turned between eyes; high blood pressure; mental sensation on the throat; throat clamed down and lose air breath; throat clamed down; A spontaneous report was received from a consumer concerning his twin brother a 51-year-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sensation on forehead that turned between eyes, blood pressure went high, mental sensation on the throat, throat clamed down and lose air breath.  The patient's medical history was not reported. Concomitant medications included metformin.  On 13 JAN 2021, prior to the onset of events the patient received first dose of their two planned doses of mRNA-1273 (Batch No: unknown) for prophylaxis of covid 19 infection.  On 13 Jan 2021, the patient experienced, Sensation on forehead that turned between eyes, blood pressure went high, mental sensation on the throat. He at 11 minute throat clamed down, loose air breath and they were told not to receive the second shot.   Treatment received included steroid and Benadryl.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of event(s), sensation on forehead that turned between eyes, blood pressure went high, mental sensation on the throat, throat clamed down and lose air breath were considered resolved 6 hours after the vaccine on 13 Jan 2021.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: a circle the size of 50cent piece is red and hard; A spontaneous report was received from a consumer concerning a female patient of 70 years of age,who was administered with Moderna's covid-19 vaccine and experienced a circle the size of 50cent piece as red and hard.  Patient's medical history was not provided .No relevant concomitant medications were mentioned.  On 28-JAN-2021, patient received the first of two planned doses of mRNA-1273 vaccine(Lot number:012M20A) for prophylaxis of covid-19 infection.  On 29-JAN-2021,patient experienced a circle the size of 50cent piece  as red and hard. No treatment information was provided.  Action taken with second dose of mRNA-1273 in response to the event was not reported.  Outcome for the event was considered not resolved.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded.  The reported events are consistent with the known safety profile of mRNA-1273.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Headache, Injection site pain, Myalgia
Clinical narrative: anxiety; dizziness; headache; Injection Site Pain; Myalgia; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (anxiety), DIZZINESS (dizziness), HEADACHE (headache), INJECTION SITE PAIN (Injection Site Pain) and MYALGIA (Myalgia) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included BENAZEPRIL, HYDRALAZINE, OMEPRAZOLE and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced ANXIETY (anxiety), DIZZINESS (dizziness), HEADACHE (headache), INJECTION SITE PAIN (Injection Site Pain) and MYALGIA (Myalgia). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, ANXIETY (anxiety), DIZZINESS (dizziness), HEADACHE (headache), INJECTION SITE PAIN (Injection Site Pain) and MYALGIA (Myalgia) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Headache, injection site pain and myalgia are consistent with the known safety profile of mRNA-1273.
Sex: F
Vaccine: COVID19
Symptoms: Eye irritation, Eye pain, Vaccination site pain
Clinical narrative: pain in her right eye; eye was irritated; sore arm; A spontaneous report was received from a consumer  concerning her wife, a 71-years-old  female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events pain in her right eye, sore arm/vaccination site pain, eye was irritated.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 17 Feb 2021, prior to the onset of the events the patient received second of two planned doses of mRNA-1273 (lot/batch: 02AL20A) intramuscularly for prophylaxis of COVID-19 infection.  On 17 Feb 2021, the patient experienced the events,  pain in her right eye, sore arm, eye was irritated. Thursday, she went to the HCP who says her eye was irritated and it might or might not be related to the vaccine. HCP prescribed her an antibiotic ointment. On Sunday and Monday, she forgot to use it, but remembered Monday night and Tuesday the pain in the eye came back.  Treatment details included antibiotic ointment.  The patient received both scheduled doses of mRNA 1237 before the events, therefore, action taken with mRNA-1273 in response to the events was not applicable   The outcome of event, pain in her right eye, sore arm, eye was irritated was unknown.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pain, Pyrexia
Clinical narrative: Body Aches; Feverish (Normal 97.0, recorded 98.5); This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body Aches) and PYREXIA (Feverish (Normal 97.0, recorded 98.5)) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 31H20A) for COVID-19 vaccination.    MEDICAL HISTORY (Parent): Unknown.     MEDICAL HISTORY (Patient): Concurrent medical conditions included Diabetes.   On 22-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced PAIN (Body Aches) and PYREXIA (Feverish (Normal 97.0, recorded 98.5)). At the time of the report, PAIN (Body Aches) and PYREXIA (Feverish (Normal 97.0, recorded 98.5)) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Feb-2021, Body temperature: 97 (normal) recorded 98.5.         Patient took Advil as treatment medication for unknown use. No concomitant products were reported.   For mRNA-1273 (COVID 19 Vaccine Moderna ) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: significant FU attached which contain AE outcome
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Headache, Hyperhidrosis, Pain, Pain in extremity
Clinical narrative: sore arms; sweat; body aches; eyes are hurting and blurring; eyes are hurting and blurring; fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arms), HYPERHIDROSIS (sweat), PAIN (body aches), EYE PAIN (eyes are hurting and blurring) and VISION BLURRED (eyes are hurting and blurring) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in October 2020 and Pneumonia in October 2020. Concomitant products included CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP) and ZINC for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arms), HYPERHIDROSIS (sweat), PAIN (body aches), EYE PAIN (eyes are hurting and blurring), VISION BLURRED (eyes are hurting and blurring), PYREXIA (fever) and HEADACHE (headache). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arms), HYPERHIDROSIS (sweat), PAIN (body aches), EYE PAIN (eyes are hurting and blurring), VISION BLURRED (eyes are hurting and blurring), PYREXIA (fever) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Added treatment medication from initial source. FU amended.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Headache and fever are consistent with the known safety profile of mRNA-1273.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vision blurred
Clinical narrative: sore arms; sweat; body aches; eyes are hurting and blurring; eyes are hurting and blurring; fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arms), HYPERHIDROSIS (sweat), PAIN (body aches), EYE PAIN (eyes are hurting and blurring) and VISION BLURRED (eyes are hurting and blurring) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in October 2020 and Pneumonia in October 2020. Concomitant products included CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP) and ZINC for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arms), HYPERHIDROSIS (sweat), PAIN (body aches), EYE PAIN (eyes are hurting and blurring), VISION BLURRED (eyes are hurting and blurring), PYREXIA (fever) and HEADACHE (headache). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arms), HYPERHIDROSIS (sweat), PAIN (body aches), EYE PAIN (eyes are hurting and blurring), VISION BLURRED (eyes are hurting and blurring), PYREXIA (fever) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Added treatment medication from initial source. FU amended.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Headache and fever are consistent with the known safety profile of mRNA-1273.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-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 28-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy). The delivery occurred on an unknown date.  At the time of the report, EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were reported. No treatment information provided by reporter.  This is a case of product exposure during pregnancy with no associated AEs for this 35-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy (or "patient declined further contact).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Internal review on 24-JUN-2021 resulted in updates to pregnancy details.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 35-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy (or "patient declined further contact).
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness
Clinical narrative: Weakness; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness) and DIZZINESS (Dizziness) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     The patient's past medical history included No adverse event.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced ASTHENIA (Weakness) and DIZZINESS (Dizziness).        For mRNA-1273 (Moderna COVID-19 Vaccine), the reporter did not provide any causality assessments.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Dizziness, Headache, Pain in extremity, Rash pruritic
Clinical narrative: Welty rash on her left and right thigh/welty rash on her belly button; dizziness; itching welty rash; Headache; Soreness in arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (Welty rash on her left and right thigh/welty rash on her belly button), DIZZINESS (dizziness), PAIN IN EXTREMITY (Soreness in arm), RASH PRURITIC (itching welty rash) and HEADACHE (Headache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced PAIN IN EXTREMITY (Soreness in arm) and HEADACHE (Headache). On 15-Feb-2021, the patient experienced URTICARIA (Welty rash on her left and right thigh/welty rash on her belly button), DIZZINESS (dizziness) and RASH PRURITIC (itching welty rash). At the time of the report, URTICARIA (Welty rash on her left and right thigh/welty rash on her belly button), DIZZINESS (dizziness), PAIN IN EXTREMITY (Soreness in arm), RASH PRURITIC (itching welty rash) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy: rare (Inconclusive) It was a drug reaction and rare esoinophils..         Patient went to dermatologist and had a biopsy , the result was that it was a drug reaction and there was a rare  eosinophil.  No concomitant medications were provided.  No treatment medications were provided.   This case was linked to MOD21-041652 (E2B Linked Report). This case was linked to MOD-2021-017202 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Mar-2021: Follow up was received on 01 March 2021. Primary dosage regimen was changed from first to second dose and action taken changed from unknown to not applicable.; Sender's Comments:  MOD21-041652:CROSS-LINKED
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Welty rash on her left and right thigh/welty rash on her belly button; dizziness; itching welty rash; Headache; Soreness in arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (Welty rash on her left and right thigh/welty rash on her belly button), DIZZINESS (dizziness), PAIN IN EXTREMITY (Soreness in arm), RASH PRURITIC (itching welty rash) and HEADACHE (Headache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced PAIN IN EXTREMITY (Soreness in arm) and HEADACHE (Headache). On 15-Feb-2021, the patient experienced URTICARIA (Welty rash on her left and right thigh/welty rash on her belly button), DIZZINESS (dizziness) and RASH PRURITIC (itching welty rash). At the time of the report, URTICARIA (Welty rash on her left and right thigh/welty rash on her belly button), DIZZINESS (dizziness), PAIN IN EXTREMITY (Soreness in arm), RASH PRURITIC (itching welty rash) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy: rare (Inconclusive) It was a drug reaction and rare esoinophils..         Patient went to dermatologist and had a biopsy , the result was that it was a drug reaction and there was a rare  eosinophil.  No concomitant medications were provided.  No treatment medications were provided.   This case was linked to MOD21-041652 (E2B Linked Report). This case was linked to MOD-2021-017202 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Mar-2021: Follow up was received on 01 March 2021. Primary dosage regimen was changed from first to second dose and action taken changed from unknown to not applicable.; Sender's Comments:  MOD21-041652:CROSS-LINKED
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Erythema, Headache, Vaccination site erythema, Vaccination site pain
Clinical narrative: Redness is covering a big zone of almost the half of her upper arm; Arm of the vaccine red; Arm of the vaccine hurting; Arm of the vaccine swollen; Had fever in the arm of the vaccine; Feeling dizzy; Headaches; A spontaneous report was received from a consumer concerning a 57-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced erythema (erythema redness in the arm, redness is covering a big zone of almost the half of her upper arm), vaccination site erythema ( arm of the vaccine red), vaccination site pain (  arm of the vaccine hurting), vaccination site swelling (arm of the vaccine swollen), vaccination site warmth (had fever in the arm of the vaccine), dizziness ( feeling dizzy) and headache.  The patient's medical history was not provided. Concomitant medications reported were Vitamins for unknown indication.  On 6 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 007MZ04) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 20 Feb 2021, the patient stated experiencing arm of the vaccine red, arm of the vaccine swollen, had fever in the arm of the vaccine, arm of the vaccine hurting. On 6 Feb 2021, the patient experienced redness in the arm, redness is covering a big zone of almost the half of her upper arm, feeling dizzy, headaches.  Treatment details included Tylenol.  Action taken with mRNA-1273 in response to the events was not reported.   On 8 Feb 2021 the outcome of event, redness in the arm was resolved. The outcome of other events was unknown.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Headache, vaccination site erythema, vaccination site swelling and vaccination site pain is consistent with the known safety profile of mRNA-1273..
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: Redness is covering a big zone of almost the half of her upper arm; Arm of the vaccine red; Arm of the vaccine hurting; Arm of the vaccine swollen; Had fever in the arm of the vaccine; Feeling dizzy; Headaches; A spontaneous report was received from a consumer concerning a 57-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced erythema (erythema redness in the arm, redness is covering a big zone of almost the half of her upper arm), vaccination site erythema ( arm of the vaccine red), vaccination site pain (  arm of the vaccine hurting), vaccination site swelling (arm of the vaccine swollen), vaccination site warmth (had fever in the arm of the vaccine), dizziness ( feeling dizzy) and headache.  The patient's medical history was not provided. Concomitant medications reported were Vitamins for unknown indication.  On 6 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 007MZ04) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 20 Feb 2021, the patient stated experiencing arm of the vaccine red, arm of the vaccine swollen, had fever in the arm of the vaccine, arm of the vaccine hurting. On 6 Feb 2021, the patient experienced redness in the arm, redness is covering a big zone of almost the half of her upper arm, feeling dizzy, headaches.  Treatment details included Tylenol.  Action taken with mRNA-1273 in response to the events was not reported.   On 8 Feb 2021 the outcome of event, redness in the arm was resolved. The outcome of other events was unknown.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Headache, vaccination site erythema, vaccination site swelling and vaccination site pain is consistent with the known safety profile of mRNA-1273..
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity
Clinical narrative: Pain in her arm; Swollen Lymphnodes underneath her armpit; A spontaneous report was received from a consumer, concerning a 72-year-old female patient, who received Moderna's COVID-19 vaccine and experienced pain in her arm, swollen lymph nodes underneath her armpit.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 19 FEB 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (lot/batch: Unknown) via unknown route on the left arm for prophylaxis of COVID-19 infection.   On 21 FEB 2021, the patient experienced pain in her arm, swollen lymph nodes underneath her armpit.  Treatment details was not reported.  Action taken with mRNA-1273 in response to the events was not reported.    At the time of the report, the outcome of event was unknown.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Axillary lymphadenopathy is consistent with the known safety profile of mRNA-1273.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Hyperhidrosis, Vaccination site erythema, Vaccination site pain
Clinical narrative: red mark at the injection site that's about 6 inches long; felt like somebody grabbed me in the chest; I started pouring sweat; I could hardly catch my breath; Arm was sore at the injection site; A spontaneous report  was received from a Consumer concerning a 87 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events- chest discomfort, hyperhidrosis, dyspnea, vaccination site pain and vaccination site erythema.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 16/Jan/2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 011J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 16 Jan 2021, the patient experienced that her arm was sore at the injection site that night. She also reported that on Tuesday night (02Feb2021), she bent over to pick something up and had a cardiac episode. She describes it as if "somebody grabbed me in the chest and I started pouring sweat, and I could hardly catch my breath." She reported 2 such episodes that same evening (02Feb2021). She also reported that she currently has a red mark at the injection site that's about 6 inches long (4 Feb 2021)  Laboratory details were not provided.  No treatment information was provided. The patient did not go to the hospital, but did inform her doctor and set an appointment.    Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the events- chest discomfort, hyperhidrosis, dyspnoea, vaccination site pain and vaccination site erythema was considered unknown.; Reporter's Comments: This case concerns a 87 Years-old, female patient who experienced events of chest discomfort, hyperhidrosis, dyspnea,  vaccination site pain and vaccination site erythema. 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.  Further information has been requested.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Lymphadenopathy, Rash, Swelling
Clinical narrative: couldn't swallow very well at all - had to bend down to be able to swallow; lymph nodes were swollen; rash; swelling of the arm; A spontaneous report was received from a healthcare professional concerning a 72-years-old  female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced dysphagia (couldn't swallow very well at all - had to bend down to be able to swallow), lymphadenopathy ( lymph nodes were swollen), rash and swelling (swelling of the arm)  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 4 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 013L20A) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient stated experiencing swelling of the arm, rash, lymph nodes were swollen, she also stated that she couldn't swallow very well at all - had to bend down to be able to swallow.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events was unknown.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Rash is consistent with the known safety profile of mRNA-1273.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: injection site red and spread; A spontaneous report was received from a  concerning a 79-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vaccination site erythema (injection site red and spread).  The patient's medical history was not provided. Concomitant medications reported were High blood pressure, high cholesterol, thyroid C3 for unknown indication.  27 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 004M20A) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced injection site red and spread.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event was unknown.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Injection site erythema is consistent with the known safety profile of mRNA-1273.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Vaccination site erythema
Clinical narrative: Pregnant (20 weeks gestation); Redness on injection site; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant (20 weeks gestation)) and VACCINATION SITE ERYTHEMA (Redness on injection site) in a 31-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (one week prior use.) on 10-Aug-2020. Concurrent medical conditions included High cholesterol (The same) since 2018, Drug allergy (claritin for allergy) and Bone disorder (vitamin D for bones). Concomitant products included CLARITHROMYCIN from an unknown date to 08-Nov-2020 for Allergy, VITAMIN D [VITAMIN D NOS] from 08-Dec-2020 to an unknown date for Bone disorder, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) and FISH OIL for an unknown indication.    On 09-Feb-2021 at 4:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 07-Oct-2020 and the estimated date of delivery was 14-Jul-2021. On 09-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant (20 weeks gestation)) and VACCINATION SITE ERYTHEMA (Redness on injection site). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  seventeenth week of the pregnancy.  On 09-Feb-2021, EXPOSURE DURING PREGNANCY (Pregnant (20 weeks gestation)) had resolved. On 12-Feb-2021, VACCINATION SITE ERYTHEMA (Redness 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.   Pregnancy test was positive on 10-Nov-2020.; Reporter's Comments: This is a case of product exposure during pregnancy with vaccination site erythema for this 31-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site pruritus, Injection site swelling
Clinical narrative: itching; swollen; very red; 5 inches long; 3 inches wide; A spontaneous report was received from a consumer concerning a 65-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events, itching , swollen, very red , 5 inches long, 3 inches wide.  The patient's medical history was not provided. Concomitant medications was not reported.  On 13 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch:011M20A ) intramuscularly for prophylaxis of COVID-19 infection.  On 19 Feb  2021, the patient experienced the events, itching, swollen, very red, 5 inches long, 3 inches wide.  Treatment details was not included.  Action taken with mRNA-1273 in response to the events was unknown.  Outcomes of the events was unknown.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Injection site erythema, injection site swelling and injection site itching are consistent with the known safety profile of mRNA-1273.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea
Clinical narrative: nausea; body and muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea) and MYALGIA (body and muscle aches) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     The patient's past medical history included Ulcer stomach (By taking ibuprofen). Concomitant products included LOSARTAN, SIMVASTATIN, FISH OIL and COLECALCIFEROL (D3) for an unknown indication.   On 22-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced NAUSEA (nausea) and MYALGIA (body and muscle aches). At the time of the report, NAUSEA (nausea) and MYALGIA (body and muscle aches) outcome 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.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Myalgia, Pain
Clinical narrative: stabbing pain; Fever; Chills; Headache; muscle aches , back in knots; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of PAIN (stabbing pain), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache) and MYALGIA (muscle aches , back in knots) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History was provided by the reporter.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 05-Feb-2021, the patient experienced PAIN (stabbing pain), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache) and MYALGIA (muscle aches , back in knots).   At the time of the report, PAIN (stabbing pain), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache) and MYALGIA (muscle aches , back in knots) 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.   Concomitant product use was not provided by the reporter. No treatment information was provided.