chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: very itchy; injection site is red; chills; swelling at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (very itchy), VACCINATION SITE SWELLING (swelling at injection site), VACCINATION SITE ERYTHEMA (injection site is red) and CHILLS (chills) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE SWELLING (swelling at injection site) and CHILLS (chills). On 28-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (very itchy) and VACCINATION SITE ERYTHEMA (injection site is red). At the time of the report, VACCINATION SITE PRURITUS (very itchy) and VACCINATION SITE ERYTHEMA (injection site is red) outcome was unknown and VACCINATION SITE SWELLING (swelling at injection site) and CHILLS (chills) 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 medications were not reported.   Treatment information was not provided.     Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Additional information include contains non significant information.Email updated On 07-Jul-2021: Additional information include patient initials got updated. On 12-Jul-2021: Additional information include patient initial corrected as per query response.; 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: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Fatigue, Vaccination site pain
Clinical narrative: stomach ache; soreness on injection site; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach ache), VACCINATION SITE PAIN (soreness on injection site) and FATIGUE (fatigue) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach ache), VACCINATION SITE PAIN (soreness on injection site) and FATIGUE (fatigue). At the time of the report, ABDOMINAL PAIN UPPER (stomach ache), VACCINATION SITE PAIN (soreness on injection site) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: arm got a little bit sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm got a little bit sore) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     Concurrent medical conditions included Heart disorder (The patient was on unspecified heart medication.).    On 02-Jan-2021, 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 (arm got a little bit sore). The patient was treated with PARACETAMOL (TYLENOL) for Vaccination site pain, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (arm got a little bit sore) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic, Vaccination site erythema, Vaccination site rash
Clinical narrative: Rash on her arm, that is very itchy, red, and is spreading; Rash on her arm, that is very itchy, red, and is spreading; Rash on her arm, that is very itchy, red, and is spreading; A spontaneous report was received from a healthcare professional concerning a 76 -years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events rash on her arm/vaccination site rash, that is very itchy/ rash pruritic, red/vaccination site erythema, and is spreading.  The patient's medical history was not provided. Concomitant medications reported were naproxen, gabapentin, metformin, ceresin, rosuvastatin, methimazole, losartan, vitamin B12, over the counter vitamins, acid reflux tablets. On unknown date of Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 024M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 20 Feb 2021, the patient experienced the events rash on her arm, that is very itchy, red, and is spreading.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, rash on her arm, that is very itchy, red, and is spreading was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: vaccinated on 20Jan2021 and didn't know she was pregnant at the time; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (vaccinated on 20Jan2021 and didn't know she was pregnant at the time) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 20-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (vaccinated on 20Jan2021 and didn't know she was pregnant at the time). On 20-Jan-2021, EXPOSURE DURING PREGNANCY (vaccinated on 20Jan2021 and didn't know she was pregnant at the time) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Feb-2021: Internal review on 24-Jun-21 resulted in updates to pregnancy details.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Vaccination site pain
Clinical narrative: Chills; Sore arm at the injection site; a low grade temperature; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), VACCINATION SITE PAIN (Sore arm at the injection site) and PYREXIA (a low grade temperature) in a 21-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 reaction.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced CHILLS (Chills), VACCINATION SITE PAIN (Sore arm at the injection site) and PYREXIA (a low grade temperature). At the time of the report, CHILLS (Chills), VACCINATION SITE PAIN (Sore arm at the injection site) and PYREXIA (a low grade temperature) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided. No treatment medication information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: email updated. The reporter was changed from health care professional to consumer on follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Pyrexia, Rash
Clinical narrative: fever of 99.8°F; Face was red; face warm; Rash on torso; A spontaneous report was received from a Consumer concerning a 29 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever of 99.8°F, her face became red and warm and she had a rash on her torso.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 20/Jan/2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection.  On 20/Jan/2021The patient experienced the events fever of 99.8°F, her face became red and warm and she had a rash on her torso. The symptoms are not ongoing.  Laboratory details were not provided. Patient was treated with Benadryl and Tylenol . Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event was resolved. Patient suffered the symptoms and would like to know whether she can take the next dose. Consent for follow-up is given.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Insomnia, Vision blurred
Clinical narrative: blurry vision; She feels weak; She feels tired; She has been sleeping around the clock; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (She has been sleeping around the clock), VISION BLURRED (blurry vision), ASTHENIA (She feels weak) and FATIGUE (She feels tired) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced INSOMNIA (She has been sleeping around the clock), ASTHENIA (She feels weak) and FATIGUE (She feels tired). On an unknown date, the patient experienced VISION BLURRED (blurry vision). On 21-Feb-2021, INSOMNIA (She has been sleeping around the clock), ASTHENIA (She feels weak) and FATIGUE (She feels tired) had resolved. At the time of the report, VISION BLURRED (blurry vision) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   prescribed antibiotics for 7 days.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Follow-up received on 27-04-2021: one newevent added and treatment details added.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test negative, SARS-CoV-2 test positive
Clinical narrative: Patient tested positive for COVID-19; A spontaneous report was received from a consumer concerning a 59-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event, tested positive for covid-19.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 25 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: D04M20A) intramuscularly in left upper arm for prophylaxis of COVID-19 infection.  On 20 Feb 2021, the patient experienced the event, patient tested positive for covid-19.She reported that her husband tested positive 01FEB2021, and son tested positive 05FEB2021 but  tested negative 10FEB2021,02FEB2021,05FEB2021 respectively. Treatment details included not provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event , patient tested positive for covid-19 was unknown.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Lymphadenopathy, Myalgia
Clinical narrative: Tenderness in her forehead; Lymph node swelling in the base of her scalp on her right side; Pain in her forehead; Rash; Headache; Muscle pain; Joint pain; Chills; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Feb-2021 and was forwarded to Moderna on 23-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Tenderness in her forehead), LYMPHADENOPATHY (Lymph node swelling in the base of her scalp on her right side), HEADACHE (Headache), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Shingles.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced HEADACHE (Headache), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and CHILLS (Chills). On 15-Feb-2021, the patient experienced TENDERNESS (Tenderness in her forehead), LYMPHADENOPATHY (Lymph node swelling in the base of her scalp on her right side), HEADACHE (Pain in her forehead) and RASH (Rash). The patient was treated with NAPROXEN (NAPROSYN E) for Lymph nodes enlarged, at a dose of 200 milligram. On 16-Feb-2021, LYMPHADENOPATHY (Lymph node swelling in the base of her scalp on her right side), HEADACHE (Headache), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and CHILLS (Chills) had resolved. On 20-Feb-2021, TENDERNESS (Tenderness in her forehead), HEADACHE (Pain in her forehead) and RASH (Rash) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided  It was reported that the treatment received on Monday but it didn't diminished the lymph node symptom.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow up information received on 29-JUN-2021 contains no significant information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Tenderness
Clinical narrative: Tenderness in her forehead; Lymph node swelling in the base of her scalp on her right side; Pain in her forehead; Rash; Headache; Muscle pain; Joint pain; Chills; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Feb-2021 and was forwarded to Moderna on 23-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Tenderness in her forehead), LYMPHADENOPATHY (Lymph node swelling in the base of her scalp on her right side), HEADACHE (Headache), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Shingles.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced HEADACHE (Headache), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and CHILLS (Chills). On 15-Feb-2021, the patient experienced TENDERNESS (Tenderness in her forehead), LYMPHADENOPATHY (Lymph node swelling in the base of her scalp on her right side), HEADACHE (Pain in her forehead) and RASH (Rash). The patient was treated with NAPROXEN (NAPROSYN E) for Lymph nodes enlarged, at a dose of 200 milligram. On 16-Feb-2021, LYMPHADENOPATHY (Lymph node swelling in the base of her scalp on her right side), HEADACHE (Headache), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and CHILLS (Chills) had resolved. On 20-Feb-2021, TENDERNESS (Tenderness in her forehead), HEADACHE (Pain in her forehead) and RASH (Rash) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided  It was reported that the treatment received on Monday but it didn't diminished the lymph node symptom.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow up information received on 29-JUN-2021 contains no significant information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events a sore arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unspecified date( 7 or 9th Feb2021) prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event a sore arm.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event, sore arm was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache, Myalgia, Nausea
Clinical narrative: headache; nausea; sore arm; feels weak; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), NAUSEA (nausea), MYALGIA (sore arm) and ASTHENIA (feels weak) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced HEADACHE (headache), NAUSEA (nausea), MYALGIA (sore arm) and ASTHENIA (feels weak). At the time of the report, HEADACHE (headache), NAUSEA (nausea), MYALGIA (sore arm) and ASTHENIA (feels weak) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Counterfeit product administered
Clinical narrative: Patients were given a possible counterfeit; A spontaneous report was received from a consumer concerning fifty or sixty people, who received Moderna's COVID-19 vaccine (mRNA-1273) and it was noticied that the patients were given a possible counterfeit / counterfeit product administered.  The patient's medical history, were not provided. Concomitant medications were not reported.   On 29-Jan-2021, approximately fifty or sixty patients received their first of two planned doses of mRNA-1273 (Lot number: 012M20A) for prophylaxis of COVID-19 infection. It was noticed that the patients were given a possible counterfeit and was considered as a medication error. The route of administration were unknown.   The reporter states that the patients have recieved the first of two planned doses of mRNA-1273 vaccine on 29-Jan-2021 and the second dose has been scheduled while the site suspiciously was not answering and deleted all information about the advertising and everything regarding the vaccination.  The repoter was concerned to get a list of approved places that have the moderna covid-19 vaccine. Upon follow up the reporter added additional information of two patients among the group. The patient details were hidden while the lot number was reported as 012M20A.  Treatment information were not provided.  Action taken with mRNA-1273 in response to the events was considered not applicable.  The outcome of event, counterfeit product administration, were considered resolved.; Reporter's Comments: This report refers to a case of counterfeit production administered for mRNA-1273, lot #012M20A with no associated AEs.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Erythema, Feeling hot, Vaccination site erythema, Vaccination site induration
Clinical narrative: Turned into a bruise; Injection site SWelling; It's hard; It became itchy; Redness around the site/baseball size redness; Ear became very hot; Redness of external ear; Site become very hot; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FEELING HOT (Ear became very hot), CONTUSION (Turned into a bruise), ERYTHEMA (Redness of external ear), VACCINATION SITE WARMTH (Site become very hot) and VACCINATION SITE PRURITUS (It became itchy) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Jan-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced FEELING HOT (Ear became very hot) and VACCINATION SITE WARMTH (Site become very hot). 22-Jan-2021, the patient experienced ERYTHEMA (Redness of external ear). On 23-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness around the site/baseball size redness). On 28-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (It became itchy). On 29-Jan-2021, the patient experienced VACCINATION SITE INDURATION (It's hard). On an unknown date, the patient experienced CONTUSION (Turned into a bruise) and VACCINATION SITE SWELLING (Injection site SWelling). At the time of the report, FEELING HOT (Ear became very hot), CONTUSION (Turned into a bruise), ERYTHEMA (Redness of external ear), VACCINATION SITE WARMTH (Site become very hot), VACCINATION SITE PRURITUS (It became itchy), VACCINATION SITE INDURATION (It's hard) and VACCINATION SITE SWELLING (Injection site SWelling) outcome was unknown and VACCINATION SITE ERYTHEMA (Redness around the site/baseball size redness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment medication use was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: No new information
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Turned into a bruise; Injection site SWelling; It's hard; It became itchy; Redness around the site/baseball size redness; Ear became very hot; Redness of external ear; Site become very hot; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FEELING HOT (Ear became very hot), CONTUSION (Turned into a bruise), ERYTHEMA (Redness of external ear), VACCINATION SITE WARMTH (Site become very hot) and VACCINATION SITE PRURITUS (It became itchy) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Jan-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced FEELING HOT (Ear became very hot) and VACCINATION SITE WARMTH (Site become very hot). 22-Jan-2021, the patient experienced ERYTHEMA (Redness of external ear). On 23-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness around the site/baseball size redness). On 28-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (It became itchy). On 29-Jan-2021, the patient experienced VACCINATION SITE INDURATION (It's hard). On an unknown date, the patient experienced CONTUSION (Turned into a bruise) and VACCINATION SITE SWELLING (Injection site SWelling). At the time of the report, FEELING HOT (Ear became very hot), CONTUSION (Turned into a bruise), ERYTHEMA (Redness of external ear), VACCINATION SITE WARMTH (Site become very hot), VACCINATION SITE PRURITUS (It became itchy), VACCINATION SITE INDURATION (It's hard) and VACCINATION SITE SWELLING (Injection site SWelling) outcome was unknown and VACCINATION SITE ERYTHEMA (Redness around the site/baseball size redness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment medication use was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: No new information
Age: 51.0
Sex: U
Vaccine: COVID19
Symptoms: Migraine, Pain
Clinical narrative: Migranes; Body aches; A spontaneous report  was received from a consumer concerning a 51-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events body aches, migranes.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 9 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 012M20A) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the events body aches, migranes.  Treatment details included Ubrogepant  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, body aches, migranes was unknown.
Age: 78.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Lip swelling
Clinical narrative: lip swelling; A spontaneous report was received from a healthcare professional concerning a 78-year-old, female  patient who experienced lip swelling.  The patient's medical history included rheumatoid arthritis. Concomitant medications reported were Remicade.  On 29 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 0131204) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 3 Feb 2021, the patient experienced lip swelling, especially on the bottom lip.  Treatment details included prednisone 20mg once a day for 5 days.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event, lip swelling was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Nervous system disorder
Clinical narrative: Neurological sequela; A spontaneous report was received from a healthcare professional concerning a  female patient of unspecified age  who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events neurological sequela, started on the left side of the face and spread all over the body/neurological disorder.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 21 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.  On 29 Jan 2021, the patient experienced the event(s) neurological sequela, started on the left side of the face and spread all over the body.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), neurological sequela, started on the left side of the face and spread all over the body was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site erythema, Injection site pruritus
Clinical narrative: itching at the injection site; red at the injection site; redness is less but cover more space; red size like a 2 silver dollar coin; A spontaneous report was received from a Consumer concerning a 84 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced red size like a 2 silver dollar coin, red at the injection site, itching at the injection site, redness is less but cover more space.  The patient's medical history was not provided. The patient took blood pressure pills, cholesterol pills, Nexium, vitamins, allergies pills as concomitant medication.    On 15-01-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 batch no: 013L20A intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 16-01-2021, The patient experienced red size like a 2 silver dollar coin.  On 27-01-2021, the patient experienced red at the injection site, itching at the injection site, redness is less but cover more space. Laboratory details are not provided.  The patient put Benadryl as the treatment medication.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events red size like a 2 silver dollar coin, red at the injection site, itching at the injection site, redness is less but cover more space is unknown.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Decreased appetite, Diarrhoea, Dyspnoea, Erythema
Clinical narrative: she's so tired; really bad low backache; diarrhea; I slept all day; didn't eat; She feels she has less appetite; Real bad allergy; she couldn't breathe very well; her arm was red; her arm was swollen; her arm was hard; 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 real bad allergy, she couldn't breathe very well, her arm was red, her arm was swollen, her arm was hard, slept all day, didn't eat, she's so tired, really bad low backache, diarrhea, and she feels she has less appetite.  The patient's medical history was not provided. Concomitant medications reported were losartan, atorvastatin, bupropion for drug use for unknown indication.  On 19 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 011J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 19 Feb 2021, the patient experienced the events real bad allergy, she couldn't breathe very well, her arm was red, her arm was swollen, and her arm was hard. On 20 Feb 2021, the patient experienced the events I slept all day, and didn't eat. On 21 Feb 2021, the patient experienced the events she's so tired, really bad low backache, diarrhea, and she feels she has less appetite.  Treatment details included Tylenol.  Action taken with mRNA-1273 in response to the events was not reported.   On 21 Feb 2021, the outcome of events real bad allergy and she couldn't breathe very well was resolved. On 20 Feb 2021, the outcome of events, slept all day, didn't eat and diarrhea was resolved. The outcome of events her arm was red, her arm was swollen, her arm was hard, she's so tired, really bad low backache, and she feels she has less appetite was unknown.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypersensitivity, Induration, Somnolence, Swelling
Clinical narrative: she's so tired; really bad low backache; diarrhea; I slept all day; didn't eat; She feels she has less appetite; Real bad allergy; she couldn't breathe very well; her arm was red; her arm was swollen; her arm was hard; 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 real bad allergy, she couldn't breathe very well, her arm was red, her arm was swollen, her arm was hard, slept all day, didn't eat, she's so tired, really bad low backache, diarrhea, and she feels she has less appetite.  The patient's medical history was not provided. Concomitant medications reported were losartan, atorvastatin, bupropion for drug use for unknown indication.  On 19 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 011J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 19 Feb 2021, the patient experienced the events real bad allergy, she couldn't breathe very well, her arm was red, her arm was swollen, and her arm was hard. On 20 Feb 2021, the patient experienced the events I slept all day, and didn't eat. On 21 Feb 2021, the patient experienced the events she's so tired, really bad low backache, diarrhea, and she feels she has less appetite.  Treatment details included Tylenol.  Action taken with mRNA-1273 in response to the events was not reported.   On 21 Feb 2021, the outcome of events real bad allergy and she couldn't breathe very well was resolved. On 20 Feb 2021, the outcome of events, slept all day, didn't eat and diarrhea was resolved. The outcome of events her arm was red, her arm was swollen, her arm was hard, she's so tired, really bad low backache, and she feels she has less appetite was unknown.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; A spontaneous report was received from a healthcare professional concerning a 86-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events fever.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received second of two planned doses of mRNA-1273 (lot/batch: 010M20A and expiration date 12/31/2021) unknown route in the right arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event, fever.She provided consent to follow up with her.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of event, fever was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: Sore arm for a few days; Left foot starting to feel numb/tingling; A spontaneous report was received from a consumer concerning a  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore arm for a few days, left foot starting to feel numb tingling.  The patient's medical history was not provided. Concomitant medications reported were Claritin Allergies for drug use for unknown indication.  On 11 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) Sore arm for a few days, Left foot starting to feel numb tingling.  Treatment details included None.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), sore arm for a few days, left foot starting to feel numb tingling was unknown.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Headache, Nasal congestion
Clinical narrative: COVID-19; More tired than usual; Mild headaches; Stuffy nose; A spontaneous report was received from a Consumer concerning a 64 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced COVID-19, Fatigue, Headache and Nasal congestion.  The patient's medical history was not provided. Relevant concomitant medications were reported as supplements, vitamin D and B, fish oil, Calcium, Multivitamin, CoQ 10 and red yeast rice.  On 13-JAN-2021, prior to the onset of the events, the patient received their first dose of two planned dose of mRNA-1273 (lot/batch: 037K20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 15 JAN 2021, the patient experienced Fatigue, Headache and Nasal congestion. On 20-JAN-2021, the patient confirmed COVID-19. These events are medically significant.  Laboratory details were provided as COVID-19 test and the result was positive. Treatment information was provided as an aspirin a day to prevent blood clothing.  Action taken with mRNA-1273 in response to the events was unknown.  At the time of this report, the outcome of the event's COVID-19, Fatigue, Headache and Nasal congestion was considered as unknown.
Age: 93.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness; A spontaneous report was received from a consumer who was also a 93-years-old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced dizziness.   The patient's current condition included acid reflux. Products known to have been used by the patient, within two weeks prior to the event, included losartan not specific.  On 18 Jan 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) via an unknown route for prophylaxis of COVID-19 infection.  On an unspecified date patient started to experience dizziness.   No treatment was provided.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.  The outcome of the event was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema
Clinical narrative: redness at injection site; A spontaneous report was received from a Health care professional concerning a 70 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced redness in injection site and it started to grow larger.  The patient's medical history was not provided. Concomitant medications included Estrogen patch, Klonopin and Atorvastatin with unknown-indication were reported.   On 14/Jan/2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection.  On 20/Jan/2021, The patient experienced redness in injection site and it started to grow larger.  Laboratory details were not provided.  Patient was treated with Keflex 500mg twice a day, Zyrtec and warm compress.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event was resolved with the antibiotic. Patient would like to know whether she can take up the second dose and also would like to know the adverse event from clinical trials.
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: Experienced whole body itching and redness; Experienced whole body itching and redness; A spontaneous report was received from a consumer, concerning a male patient 65-year-old, who received Moderna's COVID-19 vaccine and experienced whole-body itching and redness.  The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (lot/batch: Unknown) via unknown route for prophylaxis of COVID-19 infection.  On 17 FEB 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (lot/batch: 023M20A) via unknown route for prophylaxis of COVID-19 infection   On 23 FEB 2021, the patient experienced whole-body itching and redness. Treatment details included Benadryl. 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.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Neck mass
Clinical narrative: a small slightly sore lump appeared on right side of lower neck, above collar bone; Swollen lymph nodes; This spontaneous case was reported by a patient and describes the occurrence of NECK MASS (a small slightly sore lump appeared on right side of lower neck, above collar bone) and LYMPHADENOPATHY (Swollen lymph nodes) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 039K20A) for COVID-19 vaccination.     The patient's past medical history included Blood pressure high, Kidney stones, Osteopenia and High cholesterol. Concurrent medical conditions included Allergy to antibiotic (Bactrim) and Contrast media allergy (IVP dye). Concomitant products included AMLODIPINE, METOPROLOL SUCCINATE, CHLORTHALIDONE from 2018 to an unknown date, POTASSIUM CHLORIDE and ROSUVASTATIN for an unknown indication.   On 12-Jan-2021 at 7:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021 at 7:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced NECK MASS (a small slightly sore lump appeared on right side of lower neck, above collar bone) and LYMPHADENOPATHY (Swollen lymph nodes). In February 2021, NECK MASS (a small slightly sore lump appeared on right side of lower neck, above collar bone) and LYMPHADENOPATHY (Swollen lymph nodes) had resolved.            It was reported that the patient called an endocrinologist who confirmed it was probably a swollen lymph node. Swelling disappeared within a couple of days.  No treatment medication was reported.   This case was linked to MOD-2021-021697, MOD-2021-023928 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Email address updated On 29-Apr-2021: Followreceived on 29-04-2021 and contains No NewInformation On 07-Jul-2021: Patient demographics were updated. The patient's medical history and allergies were added. Suspect dosing details were updated. Concomitant medication was added. Events start date was updated. Outcome of events was updated.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Pain in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in the arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, the patient experienced PAIN IN EXTREMITY (Pain in the arm). At the time of the report, PAIN IN EXTREMITY (Pain in the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment details were not provided.   This case was linked to MOD-2021-022058 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Report: non safety info, updated address and email of the reporter
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test positive
Clinical narrative: Pregnant patient received 1st dose of the vaccine; This spontaneous prospective pregnancy case was reported by a health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received 1st dose of the vaccine) in a 38-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031m20a) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to animal (Allergy to bees reported.). Concomitant products included MULTIVITAMIN [VITAMINS NOS] and ASA for an unknown indication.    On 20-Feb-2021 at 3:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 02-Jul-2020 and the estimated date of delivery was 08-Apr-2021. On 20-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received 1st dose of the vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-third week of the pregnancy.  On 20-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received 1st dose of the vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Jul-2020, Pregnancy test positive: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information not reported. Estimated date of conception 14 Jul 2021.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Received first dose of the vaccine and was pregnant; A spontaneous report was received from a other healthcare professional concerning 29 years old, pregnant female patient, who received Moderna's Covid-19 Vaccine (mRNA-1273) during pregnancy (Vaccine exposure during pregnancy).  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 17 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 011M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 17 Feb 2021, the pregnant patient was exposed to the mRNA-1273 vaccine. Her last menstrual period and conception date was unknown. The patient's estimated due date is on date. The patient's treatment included prenatal vitamins and baby aspirin.  Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event received first dose of the vaccine and was pregnant was considered resolved on 17-Feb-2021.; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 29-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Felt really bad that day, the next day he was fine.; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Feb-2021 and was forwarded to Moderna on 23-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Felt really bad that day, the next day he was fine.) in a male 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 MALAISE (Felt really bad that day, the next day he was fine.). At the time of the report, MALAISE (Felt really bad that day, the next day he was fine.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD21-036175, MOD21-036103 (E2B Linked Report).; Sender's Comments:  MOD21-036175: MOD21-036103:
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Somnolence
Clinical narrative: Slept for 17 hours; Arm hurt; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-Jan-2021 and was forwarded to Moderna on 29-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt) and SOMNOLENCE (Slept for 17 hours) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0137K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jan-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2020, the patient experienced PAIN IN EXTREMITY (Arm hurt). On 02-Jan-2021, the patient experienced SOMNOLENCE (Slept for 17 hours). On 31-Dec-2020, PAIN IN EXTREMITY (Arm hurt) had resolved. On 03-Jan-2021, SOMNOLENCE (Slept for 17 hours) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.