chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: swelling on the injection site; tenderness on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swelling on the injection site) and VACCINATION SITE PAIN (tenderness on the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (swelling on the injection site) and VACCINATION SITE PAIN (tenderness on the injection site). At the time of the report, VACCINATION SITE SWELLING (swelling on the injection site) and VACCINATION SITE PAIN (tenderness on the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information was provided by the reporter.  No treatment information was provided.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received doses from vials that had exceeded the 30 day refrigeration limit; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received doses from vials that had exceeded the 30 day refrigeration limit) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received doses from vials that had exceeded the 30 day refrigeration limit). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received doses from vials that had exceeded the 30 day refrigeration limit) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Sex: U
Vaccine: COVID19
Symptoms: Blepharospasm
Clinical narrative: left eye has been twitching on & off; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of BLEPHAROSPASM (left eye has been twitching on & off) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BLEPHAROSPASM (left eye has been twitching on & off). At the time of the report, BLEPHAROSPASM (left eye has been twitching on & off) outcome was unknown.            no concomitant and treatment drug was used
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Vaccination site pruritus
Clinical narrative: Itching at the injection site after receiving the first dose; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PRURITUS (Itching at the injection site after receiving the first dose) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Dec-2020, the patient experienced VACCINATION SITE PRURITUS (Itching at the injection site after receiving the first dose). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form every four hours. At the time of the report, VACCINATION SITE PRURITUS (Itching at the injection site after receiving the first dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 antibody test: positive (Positive) IgG qualitative test after the first dose and was positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were provided.   This case was linked to MOD-2021-015600 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Email On 01-Jun-2021: Initial Additional-2 : Translated Document
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Lethargy, Pain in extremity
Clinical narrative: Back pain; Leg pain; Lethargic; Pain in hip; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced BACK PAIN (Back pain). At the time of the report, BACK PAIN (Back pain) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The concomitant medications were not reported.  The treatment information was not provided.  The action taken with mRNA 1273 with the events was considered as not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site discharge, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: The place of the vaccine can weep at times; The place of the vaccine is still a little red; The place of the vaccine itches; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCHARGE (The place of the vaccine can weep at times), VACCINATION SITE ERYTHEMA (The place of the vaccine is still a little red) and VACCINATION SITE PRURITUS (The place of the vaccine itches) in a patient of an unknown age and gender 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) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced VACCINATION SITE DISCHARGE (The place of the vaccine can weep at times), VACCINATION SITE ERYTHEMA (The place of the vaccine is still a little red) and VACCINATION SITE PRURITUS (The place of the vaccine itches). At the time of the report, VACCINATION SITE DISCHARGE (The place of the vaccine can weep at times), VACCINATION SITE ERYTHEMA (The place of the vaccine is still a little red) and VACCINATION SITE PRURITUS (The place of the vaccine itches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medication was reported.  Treatment information was not provided.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received doses from vials that had exceeded the 30 day refrigeration limit; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received doses from vials that had exceeded the 30 day refrigeration limit) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-May-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 25-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received doses from vials that had exceeded the 30 day refrigeration limit). On 25-May-2021, EXPIRED PRODUCT ADMINISTERED (Received doses from vials that had exceeded the 30 day refrigeration limit) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication list was not provided. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable. The reporter states that the vials were placed in the refrigerator on 21 Apr 2021 and stayed in the same location until their administration date on 25 May 2021.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: My side efffect; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (My side efffect) in a patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (My side efffect). At the time of the report, VACCINATION COMPLICATION (My side efffect) outcome was unknown.            No concomitant medication and treatment information was reported.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cold sweat, Dizziness, Fatigue, Heart rate
Clinical narrative: terrible sleep; cold sweat / still feeling cold sweat; been feeling really bad; dizziness; rash on the stomach; fatigue; chills; heart beats too fast; legs are purple and under the left feet; blurry vision; This spontaneous case was reported by a patient and describes the occurrence of SOMNOLENCE (terrible sleep), VISION BLURRED (blurry vision), COLD SWEAT (cold sweat / still feeling cold sweat), HEART RATE INCREASED (heart beats too fast) and SKIN DISCOLOURATION (legs are purple and under the left feet) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, the patient experienced VISION BLURRED (blurry vision). On an unknown date, the patient experienced SOMNOLENCE (terrible sleep), COLD SWEAT (cold sweat / still feeling cold sweat), HEART RATE INCREASED (heart beats too fast), SKIN DISCOLOURATION (legs are purple and under the left feet), MALAISE (been feeling really bad), DIZZINESS (dizziness), RASH (rash on the stomach), CHILLS (chills) and FATIGUE (fatigue). The patient was treated with ACETYLSALICYLIC ACID (BABY ASPIRIN) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, SOMNOLENCE (terrible sleep), VISION BLURRED (blurry vision), COLD SWEAT (cold sweat / still feeling cold sweat), SKIN DISCOLOURATION (legs are purple and under the left feet), MALAISE (been feeling really bad), DIZZINESS (dizziness), RASH (rash on the stomach) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: (High) Heart rate increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medicine include Acetaminophen, Baby Aspirin, Water Action taken with mRNA-1273 in response to the event was unknown     Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: significant doc received on 03-JUN-2021, additional events Heartbeats too fast, Fatigue, chills, and legs are purple, and under the left feet were added
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Malaise, Rash, Skin discolouration, Somnolence
Clinical narrative: terrible sleep; cold sweat / still feeling cold sweat; been feeling really bad; dizziness; rash on the stomach; fatigue; chills; heart beats too fast; legs are purple and under the left feet; blurry vision; This spontaneous case was reported by a patient and describes the occurrence of SOMNOLENCE (terrible sleep), VISION BLURRED (blurry vision), COLD SWEAT (cold sweat / still feeling cold sweat), HEART RATE INCREASED (heart beats too fast) and SKIN DISCOLOURATION (legs are purple and under the left feet) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, the patient experienced VISION BLURRED (blurry vision). On an unknown date, the patient experienced SOMNOLENCE (terrible sleep), COLD SWEAT (cold sweat / still feeling cold sweat), HEART RATE INCREASED (heart beats too fast), SKIN DISCOLOURATION (legs are purple and under the left feet), MALAISE (been feeling really bad), DIZZINESS (dizziness), RASH (rash on the stomach), CHILLS (chills) and FATIGUE (fatigue). The patient was treated with ACETYLSALICYLIC ACID (BABY ASPIRIN) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, SOMNOLENCE (terrible sleep), VISION BLURRED (blurry vision), COLD SWEAT (cold sweat / still feeling cold sweat), SKIN DISCOLOURATION (legs are purple and under the left feet), MALAISE (been feeling really bad), DIZZINESS (dizziness), RASH (rash on the stomach) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: (High) Heart rate increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medicine include Acetaminophen, Baby Aspirin, Water Action taken with mRNA-1273 in response to the event was unknown     Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: significant doc received on 03-JUN-2021, additional events Heartbeats too fast, Fatigue, chills, and legs are purple, and under the left feet were added
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: terrible sleep; cold sweat / still feeling cold sweat; been feeling really bad; dizziness; rash on the stomach; fatigue; chills; heart beats too fast; legs are purple and under the left feet; blurry vision; This spontaneous case was reported by a patient and describes the occurrence of SOMNOLENCE (terrible sleep), VISION BLURRED (blurry vision), COLD SWEAT (cold sweat / still feeling cold sweat), HEART RATE INCREASED (heart beats too fast) and SKIN DISCOLOURATION (legs are purple and under the left feet) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, the patient experienced VISION BLURRED (blurry vision). On an unknown date, the patient experienced SOMNOLENCE (terrible sleep), COLD SWEAT (cold sweat / still feeling cold sweat), HEART RATE INCREASED (heart beats too fast), SKIN DISCOLOURATION (legs are purple and under the left feet), MALAISE (been feeling really bad), DIZZINESS (dizziness), RASH (rash on the stomach), CHILLS (chills) and FATIGUE (fatigue). The patient was treated with ACETYLSALICYLIC ACID (BABY ASPIRIN) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, SOMNOLENCE (terrible sleep), VISION BLURRED (blurry vision), COLD SWEAT (cold sweat / still feeling cold sweat), SKIN DISCOLOURATION (legs are purple and under the left feet), MALAISE (been feeling really bad), DIZZINESS (dizziness), RASH (rash on the stomach) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: (High) Heart rate increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medicine include Acetaminophen, Baby Aspirin, Water Action taken with mRNA-1273 in response to the event was unknown     Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: significant doc received on 03-JUN-2021, additional events Heartbeats too fast, Fatigue, chills, and legs are purple, and under the left feet were added
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-May-2021 and was forwarded to Moderna on 28-May-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: he got Covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (he got Covid) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 immunisation.     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 COVID-19 (he got Covid). At the time of the report, COVID-19 (he got Covid) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment and concomitant medications were reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: 2 months since my first moderne shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (2 months since my first moderne shot) in a patient of an unknown age and gender 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 PRODUCT DOSE OMISSION ISSUE (2 months since my first moderne shot). At the time of the report, PRODUCT DOSE OMISSION ISSUE (2 months since my first moderne shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were provided
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received Expired Dose of Vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose of Vaccine) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-May-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 25-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose of Vaccine). On 25-May-2021, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose of Vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was reported. No concomitant medication was reported.  It was reported that patient received second dose of vaccine from vials that had exceeded the 30 day refrigeration limit. The vials were placed in the refrigerator on 21-Apr-2021 and stayed in the same location until their administration date on 25-May-2021.
Sex: U
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: I had a nose bleed; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 27-May-2021 and was forwarded to Moderna on 27-May-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (I had a nose bleed) in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EPISTAXIS (I had a nose bleed). At the time of the report, EPISTAXIS (I had a nose bleed) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment drug were used
Sex: U
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: Small nosebleed; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-May-2021 and was forwarded to Moderna on 30-May-2021.    This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-May-2021 and was forwarded to Moderna on 30-May-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (Small nosebleed) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 27-May-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 27-May-2021, the patient experienced EPISTAXIS (Small nosebleed). At the time of the report, EPISTAXIS (Small nosebleed) outcome was unknown.            no treatment information was provided no concomitant medication were reported   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pyrexia
Clinical narrative: Headaches; Fever 101.8; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headaches) and PYREXIA (Fever 101.8) in a  patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headaches) and PYREXIA (Fever 101.8). At the time of the report, HEADACHE (Headaches) and PYREXIA (Fever 101.8) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.8 (High) High.         For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  Concomitant product use was not provided by the reporter.  Treatment medication use was not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Not Provided) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, 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.
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: I feel really sick; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (I feel really sick) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (I feel really sick). At the time of the report, MALAISE (I feel really sick) outcome was unknown.            Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Source document received on 28/5/2021 does not contain any new information
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Oral pain
Clinical narrative: Top lip was numb; Sore in mouth; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (Top lip was numb) and ORAL PAIN (Sore in mouth) in a patient of an unknown age and gender 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 HYPOAESTHESIA ORAL (Top lip was numb) and ORAL PAIN (Sore in mouth). At the time of the report, HYPOAESTHESIA ORAL (Top lip was numb) and ORAL PAIN (Sore in mouth) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   Reporter did not allow further contact
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Dyspnoea, Hyperhidrosis, Wheezing
Clinical narrative: wheezing; breathing hard for every step; sweating a lot / perspiration; dizzy/Light headed; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (breathing hard for every step), HYPERHIDROSIS (sweating a lot / perspiration), DIZZINESS (dizzy/Light headed) and WHEEZING (wheezing) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     The patient's past medical history included Pacemaker insertion (cardiac) (had Pacemaker surgery in his heart) on 12-Apr-2021. Concurrent medical conditions included Lung cancer and Cholesterol. Concomitant products included DICLOFENAC for Arthritis, ROSUVASTATIN for Cholesterol, FINASTERIDE, VITAMIN D3, CURCUMA LONGA (TURMERIC CURCUMIN [CURCUMA LONGA]), FISH OIL (OMEGA 3 FISH OILS) and APPLE CIDER VINEGAR for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced DYSPNOEA (breathing hard for every step), HYPERHIDROSIS (sweating a lot / perspiration) and DIZZINESS (dizzy/Light headed). On an unknown date, the patient experienced WHEEZING (wheezing). The patient was treated with PREDNISONE from 11-May-2021 to 16-May-2021 at a dose of 50 milligram and GENTAMICIN from 11-May-2021 to 16-May-2021 at a dose of 250 milligram. At the time of the report, DYSPNOEA (breathing hard for every step), HYPERHIDROSIS (sweating a lot / perspiration), DIZZINESS (dizzy/Light headed) and WHEEZING (wheezing) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 97.7 (normal) Body temperature recorded as 97.7.     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.   Additional Treatment information includes patient taking Nebulizer 2-3 times a day.A  Additional lab data includes numerous tests such as CT Head & Brain w/o Contrast, Chest x-ray(2 views), CT chest w/o contrast, CT Head and neck, HbA1C, B-Type natriuretic peptide, Lipid Panel, MRI Brain, TSH, INR, Hepatic function panel, Basic metabolic panel, CBC with differential, SARS-COV 2 Ag, ECG all for an Unknown dates with Inconclusive results. Patient provided information for a particular adverse event on 14 March 2021 saying he did not felt right and still continues.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jun-2021: Follow up document received on 12-JUN-2021 contains No New Information. On 18-Jun-2021: Followup document received on 18-jun-2021 contains No New Information. On 24-Jul-2021: Follow-up received on 24 July 2021 and contains significant information where Patient details, Medical history, Treatment information, concomitant product information, Laboratory data all were provided.
Sex: U
Vaccine: COVID19
Symptoms: Skin mass
Clinical narrative: little bumps on my arm; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of SKIN MASS (little bumps on my arm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history provided by the reporter.     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 SKIN MASS (little bumps on my arm). At the time of the report, SKIN MASS (little bumps on my arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information provided by the reporter. No  concomitant medical  provided by the reporter.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Burning feeling in chest; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Burning feeling in chest) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (Burning feeling in chest). At the time of the report, CHEST PAIN (Burning feeling in chest) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient had  a burning feeling in chest after getting Moderna vaccine on 27 MAY 2021. Relevant concomitant medications were not reported.  Treatment medication was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: reaction; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (reaction) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 Vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (reaction). At the time of the report, VACCINATION SITE PAIN (reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication history not provided. Treatment information was unknown.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Missed second dose; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed second dose) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant drugd provided. No treatment drugs provided. Patient was scheduled for second dose but missed it. It has now been 8 weeks and no second dose.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever of 104 F; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 104 F) in a patient of an unknown age and gender 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 28-May-2021, the patient experienced PYREXIA (Fever of 104 F). At the time of the report, PYREXIA (Fever of 104 F) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications were provided No treatment medications were provided   Reporter did not allow further contact
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Feeling abnormal, Insomnia, Myalgia, Pruritus
Clinical narrative: problems sleeping at night because of the itching; uncomfortable; feel like something still isn't right; itching; rashes all over my body; muscle aches; This spontaneous case was reported by a patient and describes the occurrence of INSOMNIA (problems sleeping at night because of the itching), DISCOMFORT (uncomfortable), FEELING ABNORMAL (feel like something still isn't right), PRURITUS (itching) and RASH (rashes all over my body) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-May-2021, the patient experienced INSOMNIA (problems sleeping at night because of the itching), DISCOMFORT (uncomfortable), FEELING ABNORMAL (feel like something still isn't right), PRURITUS (itching), RASH (rashes all over my body) and MYALGIA (muscle aches). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency and DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) at an unspecified dose and frequency. At the time of the report, INSOMNIA (problems sleeping at night because of the itching), DISCOMFORT (uncomfortable), FEELING ABNORMAL (feel like something still isn't right), PRURITUS (itching), RASH (rashes all over my body) and MYALGIA (muscle aches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant drug were used. Benadryl, Nyquil,steroids were used. steroids were not coded
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: problems sleeping at night because of the itching; uncomfortable; feel like something still isn't right; itching; rashes all over my body; muscle aches; This spontaneous case was reported by a patient and describes the occurrence of INSOMNIA (problems sleeping at night because of the itching), DISCOMFORT (uncomfortable), FEELING ABNORMAL (feel like something still isn't right), PRURITUS (itching) and RASH (rashes all over my body) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-May-2021, the patient experienced INSOMNIA (problems sleeping at night because of the itching), DISCOMFORT (uncomfortable), FEELING ABNORMAL (feel like something still isn't right), PRURITUS (itching), RASH (rashes all over my body) and MYALGIA (muscle aches). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency and DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) at an unspecified dose and frequency. At the time of the report, INSOMNIA (problems sleeping at night because of the itching), DISCOMFORT (uncomfortable), FEELING ABNORMAL (feel like something still isn't right), PRURITUS (itching), RASH (rashes all over my body) and MYALGIA (muscle aches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant drug were used. Benadryl, Nyquil,steroids were used. steroids were not coded
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Vision blurred
Clinical narrative: Fleshy eyes/like little clouds in the eye on the left side/sees like cobwebs; Bothering; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Fleshy eyes/like little clouds in the eye on the left side/sees like cobwebs) and FEELING ABNORMAL (Bothering) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 008BA1) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Blood pressure high. Concomitant products included METFORMIN for an unknown indication.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, 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 experienced VISION BLURRED (Fleshy eyes/like little clouds in the eye on the left side/sees like cobwebs) and FEELING ABNORMAL (Bothering). The patient was treated with MATRICARIA RECUTITA (CHAMOMILEN) at an unspecified dose and frequency. At the time of the report, VISION BLURRED (Fleshy eyes/like little clouds in the eye on the left side/sees like cobwebs) and FEELING ABNORMAL (Bothering) outcome was unknown.            Concomitant medication include high blood pressure medication.  Patient experienced  fleshy (like little clouds in the eye on the left side) he sees like cobwebs, for a week.  Action taken with mRNA-1273 in response to the events were not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: TCR Received. Non significant Fu / scheduled surgery for retinol detachment on 17-Jun-21.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Diarrhoea
Clinical narrative: I just got injected with Moderna and I'm noticing that I got the runs and a few chills; I just got injected with Moderna and I'm noticing that I got the runs and a few chills; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (I just got injected with Moderna and I'm noticing that I got the runs and a few chills) and CHILLS (I just got injected with Moderna and I'm noticing that I got the runs and a few chills) in a patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (I just got injected with Moderna and I'm noticing that I got the runs and a few chills) and CHILLS (I just got injected with Moderna and I'm noticing that I got the runs and a few chills). At the time of the report, DIARRHOEA (I just got injected with Moderna and I'm noticing that I got the runs and a few chills) and CHILLS (I just got injected with Moderna and I'm noticing that I got the runs and a few chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were mentioned. Treatment medications not provided
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: light fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (light fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, the patient experienced PYREXIA (light fever). At the time of the report, PYREXIA (light fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medication was reported , No treatment medication was reported .   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Headache, Musculoskeletal stiffness
Clinical narrative: headache at the base of my skull; I have had a stiff neck; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-May-2021 and was forwarded to Moderna on 30-May-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of MUSCULOSKELETAL STIFFNESS (I have had a stiff neck) and HEADACHE (headache at the base of my skull) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 21-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-May-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (I have had a stiff neck). On an unknown date, the patient experienced HEADACHE (headache at the base of my skull). At the time of the report, MUSCULOSKELETAL STIFFNESS (I have had a stiff neck) and HEADACHE (headache at the base of my skull) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant drugs included no treatment drugs included
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: I feel very tired; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (I feel very tired) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (I feel very tired). At the time of the report, FATIGUE (I feel very tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication included.  No treatment medication included.
Sex: U
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: Cold; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-May-2021, the patient experienced NASOPHARYNGITIS (Cold). At the time of the report, NASOPHARYNGITIS (Cold) outcome was unknown.            Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable. Concomitant product use was not provided by the reporter. Treatment information was not provided.    Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever is 102.2; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever is 102.2) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever is 102.2). At the time of the report, PYREXIA (Fever is 102.2) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102.2 (High) High.     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.