chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: tingling in fingers/ 3 fingers of right hand; numb/only 3 fingers of right hand; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling in fingers/ 3 fingers of right hand) and HYPOAESTHESIA (numb/only 3 fingers of right hand) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In September 2021, the patient experienced PARAESTHESIA (tingling in fingers/ 3 fingers of right hand) and HYPOAESTHESIA (numb/only 3 fingers of right hand). At the time of the report, PARAESTHESIA (tingling in fingers/ 3 fingers of right hand) and HYPOAESTHESIA (numb/only 3 fingers of right hand) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported  No treatment information was provided
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered dose more than 12 hours after vial puncture; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered dose more than 12 hours after vial puncture) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered dose more than 12 hours after vial puncture). On 23-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Administered dose more than 12 hours after vial puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant drugs were reported. No treatment drugs were reported.   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2021: New reporter added.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Influenza like illness, Myalgia, Pyrexia
Clinical narrative: flu like symptoms; slight body ache; slight fever; slight chills; This spontaneous case was reported by an other health care professional and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), MYALGIA (slight body ache), PYREXIA (slight fever) and CHILLS (slight chills) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), MYALGIA (slight body ache), PYREXIA (slight fever) and CHILLS (slight chills). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), MYALGIA (slight body ache), PYREXIA (slight fever) and CHILLS (slight chills) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product included blood pressure medication and diabetic medication the patient chose not to disclose the names of the medications.  No treatment medication information was provided   This case was linked to MOD-2021-329305, MOD-2021-329306 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: at first declined having any side effects then said a headache that resolved on its own; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (at first declined having any side effects then said a headache that resolved on its own) 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 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (at first declined having any side effects then said a headache that resolved on its own). At the time of the report, HEADACHE (at first declined having any side effects then said a headache that resolved on its own) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-328744 (Patient Link).
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: A patient received a Moderna vaccine this am from a vial that was punctured at 3pm on 22Sep2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A patient received a Moderna vaccine this am from a vial that was punctured at 3pm on 22Sep2021) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Sep-2021 at 9:52 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In September 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (A patient received a Moderna vaccine this am from a vial that was punctured at 3pm on 22Sep2021). In September 2021, EXPIRED PRODUCT ADMINISTERED (A patient received a Moderna vaccine this am from a vial that was punctured at 3pm on 22Sep2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter. No treatment information was provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Significant followup received & updated patient demographics and updated suspect details
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Logorrhoea, Malaise
Clinical narrative: yappy feeling; felt lousy/not feeling good; headaches; This spontaneous case was reported by a consumer and describes the occurrence of LOGORRHOEA (yappy feeling), MALAISE (felt lousy/not feeling good) and HEADACHE (headaches) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 041L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN, ASPIRIN [ACETYLSALICYLIC ACID], CALCIUM, DILTIAZEM, DULOXETINE, GABAPENTIN, LETROZOLE, LEVOTHYROXINE, MODAFINIL, MELATONIN, INSULIN ASPART (NOVOLOG), OLMESARTAN MEDOXOMIL (BENICAR), OMEPRAZOLE, OXYCODONE, INSULIN GLARGINE (TOUJEO), EICOSAPENTAENOIC ACID ETHYL ESTER (VASCEPA), LIRAGLUTIDE (VICTOZA) and RIVAROXABAN (XARELTO) for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced MALAISE (felt lousy/not feeling good) and HEADACHE (headaches). On an unknown date, the patient experienced LOGORRHOEA (yappy feeling). On 13-Feb-2021, MALAISE (felt lousy/not feeling good) and HEADACHE (headaches) had resolved. At the time of the report, LOGORRHOEA (yappy feeling) outcome was unknown.            Other concomitant medications include over-the-counter fiber supplement, over-the-counter multivitamin. No treatment medications were reported.   This case was linked to MOD-2021-329130 (Patient Link).
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Inappropriate age at vaccine administration; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) in a 13-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Sep-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant and Treatment was not specified.
Sex: U
Vaccine: COVID19
Symptoms: Axillary pain
Clinical narrative: 2 other people had the same pain on the side of the breast where they got the shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of AXILLARY PAIN (2 other people had the same pain on the side of the breast where they got the 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AXILLARY PAIN (2 other people had the same pain on the side of the breast where they got the shot). At the time of the report, AXILLARY PAIN (2 other people had the same pain on the side of the breast where they got the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   No treatment information was provided.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Loss of consciousness, Myalgia, Pain in extremity, Vaccination complication
Clinical narrative: colapsed to the ground; it was very serious / very serious reaction; just a little bit of a sore arm / just a tiny tiny of a sore arm; passed out cold with no warning / suddenly she blacked out; Myalgia; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out cold with no warning / suddenly she blacked out), FALL (colapsed to the ground), VACCINATION COMPLICATION (it was very serious / very serious reaction), PAIN IN EXTREMITY (just a little bit of a sore arm / just a tiny tiny of a sore arm) and MYALGIA (Myalgia) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced MYALGIA (Myalgia). On 06-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out cold with no warning / suddenly she blacked out). On an unknown date, the patient experienced FALL (colapsed to the ground), VACCINATION COMPLICATION (it was very serious / very serious reaction) and PAIN IN EXTREMITY (just a little bit of a sore arm / just a tiny tiny of a sore arm). At the time of the report, LOSS OF CONSCIOUSNESS (passed out cold with no warning / suddenly she blacked out), FALL (colapsed to the ground), VACCINATION COMPLICATION (it was very serious / very serious reaction), PAIN IN EXTREMITY (just a little bit of a sore arm / just a tiny tiny of a sore arm) and MYALGIA (Myalgia) outcome was unknown.            No concomitant medication was reported.  No treatment medication use was reported.   This case was linked to MOD-2021-328631.; Sender's Comments: This case concerns a 77-year-old, female patient with no relevant medical history, who experienced the unexpected non-serious event of loss of consciousness among other non-serious adverse events. The event occurred on the same day after the second dose of Spikevax (Moderna COVID-19 vaccine). The rechallenge was not applicable since the event occurred exclusively after the second dose. The age of the patient could be a potential confounder to the event. The benefit-risk relationship of Spikevax (Moderna COVID-19 vaccine) is not affected by this report. Case seriousness downgraded due to lack of evidence of seriousness from a regulatory or clinical standpoint according to source document
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: adverse event; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of ADVERSE EVENT (adverse event) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (adverse event). At the time of the report, ADVERSE EVENT (adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug information was provided. No treatment information was reported.   Reporter did not allow further contact
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered dose more than 12 hours after vial puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered dose more than 12 hours after vial puncture) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Sep-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered dose more than 12 hours after vial puncture). On 20-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Administered dose more than 12 hours after vial puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient is taking unknown concomitant medication. Treatment medication was not reported. The vial was initially punctured on Friday 17-Sep-2021 at 8:00 AM.  The patient received vaccine 67 hours after the 12 hours expiry. Therefore, the patient received the vaccine 79 hours after the vials was punctured. The vaccine did had any particulates or discoloration. The accumulative time the vaccine was at room temperature was 15 minutes.   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2021: New reporter added. On 24-Sep-2021: Patient demographics added, added information in I narrative.
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Limb discomfort, Musculoskeletal discomfort
Clinical narrative: down her arm, and her whole left arm; she had discomfort in the back of her skull; in the back of her neck, she had to go for medical treatment, she is still going through physical therapy; This spontaneous case was reported by a nurse and describes the occurrence of LIMB DISCOMFORT (down her arm, and her whole left arm), HEAD DISCOMFORT (she had discomfort in the back of her skull) and MUSCULOSKELETAL DISCOMFORT (in the back of her neck, she had to go for medical treatment, she is still going through physical therapy) in a female 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (down her arm, and her whole left arm), HEAD DISCOMFORT (she had discomfort in the back of her skull) and MUSCULOSKELETAL DISCOMFORT (in the back of her neck, she had to go for medical treatment, she is still going through physical therapy). The patient was treated with Physical therapy for Musculoskeletal discomfort. At the time of the report, LIMB DISCOMFORT (down her arm, and her whole left arm), HEAD DISCOMFORT (she had discomfort in the back of her skull) and MUSCULOSKELETAL DISCOMFORT (in the back of her neck, she had to go for medical treatment, she is still going through physical therapy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported.  No treatment medications reported.   This case was linked to MOD-2021-329313 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Suspected COVID-19
Clinical narrative: Covid symptoms; after second vaccine patient had fever for about a week; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (Covid symptoms) and PYREXIA (after second vaccine patient had fever for about a week) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 010A21A) for COVID-19 vaccination.     The patient's past medical history included Bullous disorder and Acid reflux (esophageal). Concurrent medical conditions included COPD and Emphysema. Concomitant products included ALBUTEROL [SALBUTAMOL] for an unknown indication.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-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 SUSPECTED COVID-19 (Covid symptoms) and PYREXIA (after second vaccine patient had fever for about a week). At the time of the report, SUSPECTED COVID-19 (Covid symptoms) outcome was unknown and PYREXIA (after second vaccine patient had fever for about a week) had resolved.            Concomitant medication also include trilogy once daily. Treatment includes antibiotics and steroid pack Patient also had both lungs altered, a third of each was taken out. Patient stated that her doctor said to her that she had the same Covid symptoms as the doctor had, when the doctor had Covid. The patient had two Covid tests done on 06June2021.  Patient stated results were that she had no antibodies.; Sender's Comments: This case concerns a female patient with relevant medical history of COPD, Emphysema, Bullous disorder and Acid reflux (esophageal)., who experienced the unexpected event of suspected COVID 19 and expected event of pyrexia. The event of suspected COVID 19 occurred on an unknown date while pyrexia occurred after the second dose of Moderna COVID-19 Vaccine. Patient stated that her doctor said to her that she had the same Covid symptoms as the doctor had, when the doctor had Covid. The patient had two Covid tests done and results were that she had no antibodies. The rechallenge was not applicable. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Reactions within 1-2 days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of VACCINATION COMPLICATION (Reactions within 1-2 days) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Reactions within 1-2 days). At the time of the report, VACCINATION COMPLICATION (Reactions within 1-2 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Shortly after receiving 2nd dose, his lungs cleared up, He doesnt need to use stabilizer,doing good with lungs,could breathee really gooddoesnt have any gurgling in lungs; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Shortly after receiving 2nd dose, his lungs cleared up, He doesnt need to use stabilizer,doing good with lungs,could breathee really gooddoesnt have any gurgling in lungs) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 062E21A and 059E21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included MIRABEGRON (MYRBETRIQ) and SERTRALINE for an unknown indication.   On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Aug-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 THERAPEUTIC RESPONSE UNEXPECTED (Shortly after receiving 2nd dose, his lungs cleared up, He doesnt need to use stabilizer,doing good with lungs,could breathee really gooddoesnt have any gurgling in lungs). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Shortly after receiving 2nd dose, his lungs cleared up, He doesnt need to use stabilizer,doing good with lungs,could breathee really gooddoesnt have any gurgling in lungs) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was reported.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Headache, Influenza like illness, Malaise
Clinical narrative: patient was mentally foggy/mental fogginess; patient experienced headaches; chills; patient experienced fever; uncomfortable flu-like symptoms; patient started to feel off; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (uncomfortable flu-like symptoms), DEPRESSED MOOD (patient started to feel off), FEELING ABNORMAL (patient was mentally foggy/mental fogginess), HEADACHE (patient experienced headaches) and CHILLS (chills) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (uncomfortable flu-like symptoms), FEELING ABNORMAL (patient was mentally foggy/mental fogginess), HEADACHE (patient experienced headaches), CHILLS (chills) and PYREXIA (patient experienced fever). In March 2021, the patient experienced DEPRESSED MOOD (patient started to feel off). In March 2021, INFLUENZA LIKE ILLNESS (uncomfortable flu-like symptoms), DEPRESSED MOOD (patient started to feel off), FEELING ABNORMAL (patient was mentally foggy/mental fogginess), HEADACHE (patient experienced headaches), CHILLS (chills) and PYREXIA (patient experienced fever) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no concomitant medications are provided. treatment to the events not reported. Patient gave a more detailed description: second shot was administered at 9 o'clock. By 11 o'clock patient started to feel off, by 12 o'clock patient had a headache, by 1 o'clock patient had chills, headache, and uncomfortable flu-like symptoms. As patient said, these lasted around 36 hours, and the mental fogginess for 8 hours more.   This case was linked to MOD-2021-329486 (Patient Link).
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: patient was mentally foggy/mental fogginess; patient experienced headaches; chills; patient experienced fever; uncomfortable flu-like symptoms; patient started to feel off; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (uncomfortable flu-like symptoms), DEPRESSED MOOD (patient started to feel off), FEELING ABNORMAL (patient was mentally foggy/mental fogginess), HEADACHE (patient experienced headaches) and CHILLS (chills) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (uncomfortable flu-like symptoms), FEELING ABNORMAL (patient was mentally foggy/mental fogginess), HEADACHE (patient experienced headaches), CHILLS (chills) and PYREXIA (patient experienced fever). In March 2021, the patient experienced DEPRESSED MOOD (patient started to feel off). In March 2021, INFLUENZA LIKE ILLNESS (uncomfortable flu-like symptoms), DEPRESSED MOOD (patient started to feel off), FEELING ABNORMAL (patient was mentally foggy/mental fogginess), HEADACHE (patient experienced headaches), CHILLS (chills) and PYREXIA (patient experienced fever) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no concomitant medications are provided. treatment to the events not reported. Patient gave a more detailed description: second shot was administered at 9 o'clock. By 11 o'clock patient started to feel off, by 12 o'clock patient had a headache, by 1 o'clock patient had chills, headache, and uncomfortable flu-like symptoms. As patient said, these lasted around 36 hours, and the mental fogginess for 8 hours more.   This case was linked to MOD-2021-329486 (Patient Link).
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Fatigue, Pyrexia, Vaccination site pain
Clinical narrative: sore arm; low grade fever; fatigue; chest congestion; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (chest congestion), VACCINATION SITE PAIN (sore arm), PYREXIA (low grade fever) and FATIGUE (fatigue) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050E21A, 013L20A and 025J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Sep-2021, the patient experienced VACCINATION SITE PAIN (sore arm). In September 2021, the patient experienced CHEST DISCOMFORT (chest congestion), PYREXIA (low grade fever) and FATIGUE (fatigue). At the time of the report, CHEST DISCOMFORT (chest congestion), VACCINATION SITE PAIN (sore arm), PYREXIA (low grade fever) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Patient tested negative 3 times..         The patient was immunocompromised. No concomitant medications were provided. No treatment medications were provided.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pruritus, Vaccination site pruritus
Clinical narrative: nauseous; her entire body is very itchy; left arm (where the vaccine was administered) became very itchy/entire body; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (left arm (where the vaccine was administered) became very itchy/entire body) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PRURITUS (left arm (where the vaccine was administered) became very itchy/entire body) (seriousness criterion medically significant). On 20-Sep-2021, the patient experienced NAUSEA (nauseous) and PRURITUS (her entire body is very itchy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Vaccination site pruritus, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (left arm (where the vaccine was administered) became very itchy/entire body), NAUSEA (nauseous) and PRURITUS (her entire body is very itchy) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided.  It was reported that within 3 minutes after the administration of the vaccine, the patient's left arm (where the vaccine was administered) became very itchy. She was advised by the pharmacist to go tot the emergency room (ER) where she was given Benadryl shot and was advised to continue Benadryl. As of today, her entire body is very itchy and she is still nauseous (started last 20Sep2021).  The patient wants to know if she should proceed with the 2nd dose because her pharmacist told her not to get the 2nd dose while the ER doctor told her to have it.  Company comment: This case concerns a 35-year-old, female patient with no previous relevant medical history, who experienced the unexpected event of vaccination site pruritus. The event occurred on the same day after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.; Sender's Comments: This case concerns a 35-year-old, female patient with no previous relevant medical history, who experienced the unexpected event of vaccination site pruritus. The event occurred on the same day after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) 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 EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.            No concomitant medication was reported. No treatment medication use was reported. Assistant Office Manger called found out today they storage container was not okay for use with the thermometers Goal storage in freezer LOT 050C21A Expiration Date 6Nov2021 20 vial 280Doses Patient did not mention any other symptoms and not sure about other medications.
Sex: U
Vaccine: COVID19
Symptoms: Lymphatic disorder
Clinical narrative: patients that had lymphatic issues were having aggravated lymphatic issues after receiving the Moderna vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of LYMPHATIC DISORDER (patients that had lymphatic issues were having aggravated lymphatic issues after receiving the Moderna vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Lymphatic disorder.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced LYMPHATIC DISORDER (patients that had lymphatic issues were having aggravated lymphatic issues after receiving the Moderna vaccine). At the time of the report, LYMPHATIC DISORDER (patients that had lymphatic issues were having aggravated lymphatic issues after receiving the Moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.  The doctor (specialist) recommending the patients with lymphatic issues, not to get the Moderna vaccine.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Breast cancer
Clinical narrative: Breast Cancer; This spontaneous case was reported by a consumer and describes the occurrence of BREAST CANCER (Breast Cancer) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M2019 and 030L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced BREAST CANCER (Breast Cancer) (seriousness criterion medically significant). At the time of the report, BREAST CANCER (Breast Cancer) outcome was unknown.            Patient  was asking if she can get Moderna booster dose, as she was over (age given) and fixing to do radiation for cancer.  She was diagnosed with breast cancer in her left breast in May.  She was not certain what type, but thinks it is noninvasive.  Concomitant product use was not provided by reporter.  Treatment information was not provided.  Company comment: This case concerns a    66 years-old, female subject without significant clinical history, who experienced the unexpected  event of BREAST CANCER. The event occurred approximately three months after the first dose and  two months  after the second dose of [Spikevax]. The rechallenge was not applicable. The event was considered unlikely related to the study drug per the reporter's assessment. The benefit-risk relationship of the vaccine is not affected by this report.; Sender's Comments: This case concerns a    66 years-old, female subject without significant clinical history, who experienced the unexpected  event of BREAST CANCER. The event occurred approximately three months after the first dose and  two months  after the second dose of [Spikevax]. The rechallenge was not applicable The event was considered unlikely related to the study drug per the reporter's assessment The benefit-risk relationship of the vaccine is not affected by this report
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, General physical health deterioration, Head discomfort, Headache, Oropharyngeal discomfort
Clinical narrative: Had warmness in his throat that went away; Started having pressure headaches in the upper back of his head; His resistance felt low; He felt stoned; pressure headaches; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL DISCOMFORT (Had warmness in his throat that went away), HEAD DISCOMFORT (Started having pressure headaches in the upper back of his head), GENERAL PHYSICAL HEALTH DETERIORATION (His resistance felt low), FEELING ABNORMAL (He felt stoned) and HEADACHE (pressure headaches) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced OROPHARYNGEAL DISCOMFORT (Had warmness in his throat that went away), HEAD DISCOMFORT (Started having pressure headaches in the upper back of his head), GENERAL PHYSICAL HEALTH DETERIORATION (His resistance felt low), FEELING ABNORMAL (He felt stoned) and HEADACHE (pressure headaches). At the time of the report, OROPHARYNGEAL DISCOMFORT (Had warmness in his throat that went away) had resolved and HEAD DISCOMFORT (Started having pressure headaches in the upper back of his head), GENERAL PHYSICAL HEALTH DETERIORATION (His resistance felt low), FEELING ABNORMAL (He felt stoned) and HEADACHE (pressure headaches) outcome was unknown.            No Concomitant  medication was reported No treatment medication was reported
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: had a big red arm; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE ERYTHEMA (had a big red arm) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced VACCINATION SITE ERYTHEMA (had a big red arm). In 2021, VACCINATION SITE ERYTHEMA (had a big red arm) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient was taking unspecified blood pressure medication and diabetic medication.  The patient reported taking first dose in Feb-2021 and a third dose on 20-Sep-2021.    This case was linked to MOD-2021-329087, MOD-2021-329306 (Patient Link).
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased, Body temperature increased, Chills, Headache, Influenza like illness
Clinical narrative: flu like symptoms; warm at the site, and hot; lay down, heart palpitation; headache; fever, high fever; chills; site was red and swollen; body aches and pains; nausea; site pain/arm pain; swollen around the injection site; itches; This spontaneous case was reported by a nurse and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), VACCINATION SITE WARMTH (warm at the site, and hot), PALPITATIONS (lay down, heart palpitation), HEADACHE (headache) and PYREXIA (fever, high fever) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes and Hypertension.    On 20-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), VACCINATION SITE WARMTH (warm at the site, and hot), PALPITATIONS (lay down, heart palpitation), HEADACHE (headache), PYREXIA (fever, high fever), CHILLS (chills), VACCINATION SITE ERYTHEMA (site was red and swollen), MYALGIA (body aches and pains), NAUSEA (nausea), VACCINATION SITE PAIN (site pain/arm pain), VACCINATION SITE SWELLING (swollen around the injection site) and VACCINATION SITE PRURITUS (itches). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), VACCINATION SITE WARMTH (warm at the site, and hot), PALPITATIONS (lay down, heart palpitation), HEADACHE (headache), PYREXIA (fever, high fever), CHILLS (chills), VACCINATION SITE ERYTHEMA (site was red and swollen), MYALGIA (body aches and pains), NAUSEA (nausea), VACCINATION SITE PAIN (site pain/arm pain), VACCINATION SITE SWELLING (swollen around the injection site) and VACCINATION SITE PRURITUS (itches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose increased: high (High) high. On an unknown date, Body temperature increased: high (High) high.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The blood sugar and blood pressure was up, patient took an extra high blood pressure pill and an extra diabetic medication. caller chose not to disclose the names of the medications.   This case was linked to MOD-2021-329305, MOD-2021-329087 (Patient Link).
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Palpitations, Pyrexia, Vaccination site erythema
Clinical narrative: flu like symptoms; warm at the site, and hot; lay down, heart palpitation; headache; fever, high fever; chills; site was red and swollen; body aches and pains; nausea; site pain/arm pain; swollen around the injection site; itches; This spontaneous case was reported by a nurse and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), VACCINATION SITE WARMTH (warm at the site, and hot), PALPITATIONS (lay down, heart palpitation), HEADACHE (headache) and PYREXIA (fever, high fever) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes and Hypertension.    On 20-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), VACCINATION SITE WARMTH (warm at the site, and hot), PALPITATIONS (lay down, heart palpitation), HEADACHE (headache), PYREXIA (fever, high fever), CHILLS (chills), VACCINATION SITE ERYTHEMA (site was red and swollen), MYALGIA (body aches and pains), NAUSEA (nausea), VACCINATION SITE PAIN (site pain/arm pain), VACCINATION SITE SWELLING (swollen around the injection site) and VACCINATION SITE PRURITUS (itches). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), VACCINATION SITE WARMTH (warm at the site, and hot), PALPITATIONS (lay down, heart palpitation), HEADACHE (headache), PYREXIA (fever, high fever), CHILLS (chills), VACCINATION SITE ERYTHEMA (site was red and swollen), MYALGIA (body aches and pains), NAUSEA (nausea), VACCINATION SITE PAIN (site pain/arm pain), VACCINATION SITE SWELLING (swollen around the injection site) and VACCINATION SITE PRURITUS (itches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose increased: high (High) high. On an unknown date, Body temperature increased: high (High) high.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The blood sugar and blood pressure was up, patient took an extra high blood pressure pill and an extra diabetic medication. caller chose not to disclose the names of the medications.   This case was linked to MOD-2021-329305, MOD-2021-329087 (Patient Link).
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: flu like symptoms; warm at the site, and hot; lay down, heart palpitation; headache; fever, high fever; chills; site was red and swollen; body aches and pains; nausea; site pain/arm pain; swollen around the injection site; itches; This spontaneous case was reported by a nurse and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), VACCINATION SITE WARMTH (warm at the site, and hot), PALPITATIONS (lay down, heart palpitation), HEADACHE (headache) and PYREXIA (fever, high fever) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes and Hypertension.    On 20-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), VACCINATION SITE WARMTH (warm at the site, and hot), PALPITATIONS (lay down, heart palpitation), HEADACHE (headache), PYREXIA (fever, high fever), CHILLS (chills), VACCINATION SITE ERYTHEMA (site was red and swollen), MYALGIA (body aches and pains), NAUSEA (nausea), VACCINATION SITE PAIN (site pain/arm pain), VACCINATION SITE SWELLING (swollen around the injection site) and VACCINATION SITE PRURITUS (itches). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), VACCINATION SITE WARMTH (warm at the site, and hot), PALPITATIONS (lay down, heart palpitation), HEADACHE (headache), PYREXIA (fever, high fever), CHILLS (chills), VACCINATION SITE ERYTHEMA (site was red and swollen), MYALGIA (body aches and pains), NAUSEA (nausea), VACCINATION SITE PAIN (site pain/arm pain), VACCINATION SITE SWELLING (swollen around the injection site) and VACCINATION SITE PRURITUS (itches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose increased: high (High) high. On an unknown date, Body temperature increased: high (High) high.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The blood sugar and blood pressure was up, patient took an extra high blood pressure pill and an extra diabetic medication. caller chose not to disclose the names of the medications.   This case was linked to MOD-2021-329305, MOD-2021-329087 (Patient Link).