chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received an expired second dose) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 091B21A and 047B21A) for COVID-19 vaccination.     medical History not reported.  Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.   On 24-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (received an expired second dose). On 24-Sep-2021, EXPIRED PRODUCT ADMINISTERED (received an expired second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   NO treatment Drug was reported
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Limb discomfort, Pain
Clinical narrative: discomfort in her hands; pains; very tired; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (discomfort in her hands), PAIN (pains) and FATIGUE (very tired) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (discomfort in her hands), PAIN (pains) and FATIGUE (very tired). At the time of the report, LIMB DISCOMFORT (discomfort in her hands), PAIN (pains) and FATIGUE (very tired) outcome was unknown.            No concomitant medications were not reported. No treatment medications were not provided.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     Concomitant products included TELMISARTAN, ROSUVASTATIN CALCIUM, DUTASTERIDE, ALFUZOSIN HYDROCHLORIDE, VITAMIN D NOS, ZINC and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment medications were reported.   This case was linked to MOD-2021-330549, MOD-2021-330449 (Patient Link).
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain, Pain in extremity, Vaccination site pain
Clinical narrative: Pain in my upper right arm, shoulder, and into my neck; Pain in my upper right arm, shoulder, and into my neck; Pain in my upper right arm, shoulder, and into my neck; Soreness around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness around the injection site), PAIN IN EXTREMITY (Pain in my upper right arm, shoulder, and into my neck), ARTHRALGIA (Pain in my upper right arm, shoulder, and into my neck) and NECK PAIN (Pain in my upper right arm, shoulder, and into my neck) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Soreness around the injection site). On 19-Sep-2021, the patient experienced PAIN IN EXTREMITY (Pain in my upper right arm, shoulder, and into my neck), ARTHRALGIA (Pain in my upper right arm, shoulder, and into my neck) and NECK PAIN (Pain in my upper right arm, shoulder, and into my neck). The patient was treated with HYDROCODONE at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Soreness around the injection site), PAIN IN EXTREMITY (Pain in my upper right arm, shoulder, and into my neck), ARTHRALGIA (Pain in my upper right arm, shoulder, and into my neck) and NECK PAIN (Pain in my upper right arm, shoulder, and into my neck) outcome was unknown.            No relevant concomitant medications were reported.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Urticaria
Clinical narrative: All covered in hives/doctor said that it was the worse case of hives doctor had seen; Awful; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (All covered in hives/doctor said that it was the worse case of hives doctor had seen) and FEELING ABNORMAL (Awful) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2021, the patient experienced URTICARIA (All covered in hives/doctor said that it was the worse case of hives doctor had seen) and FEELING ABNORMAL (Awful). At the time of the report, URTICARIA (All covered in hives/doctor said that it was the worse case of hives doctor had seen) and FEELING ABNORMAL (Awful) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.   Patient took 2 medicines orally and 1 injection to treat symptoms .   Patient did not know what was taken but one of these was an antihistamine.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Vaccination complication
Clinical narrative: how long side effects last; patient pregnant received the vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (how long side effects last) and MATERNAL EXPOSURE DURING PREGNANCY (patient pregnant received the vaccine) 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) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced VACCINATION COMPLICATION (how long side effects last) and MATERNAL EXPOSURE DURING PREGNANCY (patient pregnant received the vaccine). At the time of the report, VACCINATION COMPLICATION (how long side effects last) outcome was unknown and MATERNAL EXPOSURE DURING PREGNANCY (patient pregnant received the vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication list was not provided. Treatment information was not provided.  This prospective pregnancy spontaneous case concerns a female patient of unknown age with no relevant medical history reported, who experienced unexpected event of maternal exposure during pregnancy with associated unexpected event of vaccination complication, described as side effects. The associated event occurred after Spikevax however, the exact time to onset was unknown since there is lack of information regarding number of doses and dates of administration. Rechallenge was unknown due to lack of key information regarding Spikevax administration (number of doses and exact dates of administration). The benefit-risk relationship of drug is not affected by this report   Reporter did not allow further contact; Sender's Comments: This prospective pregnancy spontaneous case concerns a female patient of unknown age with no relevant medical history reported, who experienced unexpected event of maternal exposure during pregnancy with associated unexpected event of vaccination complication, described as side effects. The associated event occurred after Spikevax however, the exact time to onset was unknown since there is lack of information regarding number of doses and dates of administration. Rechallenge was unknown due to lack of key information regarding Spikevax administration (number of doses and exact dates of administration). The benefit-risk relationship of drug is not affected by this report
Sex: M
Vaccine: COVID19
Symptoms: Headache, Malaise, Myalgia, Pain in extremity, Pruritus
Clinical narrative: Itching in different parts of the body/Itching started/other arm/now it is on the waist; Arm Hurt; Did not feel well; Headache; General Aches/Pain; Itching in arm below the elbow; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching in different parts of the body/Itching started/other arm/now it is on the waist), PAIN IN EXTREMITY (Arm Hurt), MALAISE (Did not feel well), HEADACHE (Headache) and MYALGIA (General Aches/Pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced PRURITUS (Itching in different parts of the body/Itching started/other arm/now it is on the waist), PAIN IN EXTREMITY (Arm Hurt), MALAISE (Did not feel well), HEADACHE (Headache), MYALGIA (General Aches/Pain) and VACCINATION SITE PRURITUS (Itching in arm below the elbow). At the time of the report, PRURITUS (Itching in different parts of the body/Itching started/other arm/now it is on the waist) had not resolved and PAIN IN EXTREMITY (Arm Hurt), MALAISE (Did not feel well), HEADACHE (Headache), MYALGIA (General Aches/Pain) and VACCINATION SITE PRURITUS (Itching in arm below the elbow) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication list was not provided. Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: Itching in different parts of the body/Itching started/other arm/now it is on the waist; Arm Hurt; Did not feel well; Headache; General Aches/Pain; Itching in arm below the elbow; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching in different parts of the body/Itching started/other arm/now it is on the waist), PAIN IN EXTREMITY (Arm Hurt), MALAISE (Did not feel well), HEADACHE (Headache) and MYALGIA (General Aches/Pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced PRURITUS (Itching in different parts of the body/Itching started/other arm/now it is on the waist), PAIN IN EXTREMITY (Arm Hurt), MALAISE (Did not feel well), HEADACHE (Headache), MYALGIA (General Aches/Pain) and VACCINATION SITE PRURITUS (Itching in arm below the elbow). At the time of the report, PRURITUS (Itching in different parts of the body/Itching started/other arm/now it is on the waist) had not resolved and PAIN IN EXTREMITY (Arm Hurt), MALAISE (Did not feel well), HEADACHE (Headache), MYALGIA (General Aches/Pain) and VACCINATION SITE PRURITUS (Itching in arm below the elbow) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication list was not provided. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Palpitations
Clinical narrative: palpitations; hard time breathing; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (palpitations) and DYSPNOEA (hard time breathing) 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 PALPITATIONS (palpitations) and DYSPNOEA (hard time breathing). At the time of the report, PALPITATIONS (palpitations) and DYSPNOEA (hard time breathing) had not resolved. Not Provided          no concomitant mediations are provided. treatment to the events not reported. patient experienced having a hard time breathing and palpitation for 2 days, until now.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea
Clinical narrative: Diarrhea; Stomach distress; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) and ABDOMINAL DISCOMFORT (Stomach distress) in a 77-year-old female patient 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and 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 DIARRHOEA (Diarrhea) and ABDOMINAL DISCOMFORT (Stomach distress). At the time of the report, DIARRHOEA (Diarrhea) and ABDOMINAL DISCOMFORT (Stomach distress) outcome was unknown.            Concomitant product use was not provided. Treatment information was not provided.   This case was linked to MOD-2021-331183 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Sinus pain
Clinical narrative: Sinuses hurting; This spontaneous case was reported by a consumer and describes the occurrence of SINUS PAIN (Sinuses hurting) 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 20-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced SINUS PAIN (Sinuses hurting). At the time of the report, SINUS PAIN (Sinuses hurting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, SARS-CoV-2 test: positive (Positive) Positive.         No Concomitant medication was reported No treatment Drug was reported
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Tremor
Clinical narrative: Shaking of legs; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaking of legs) and NAUSEA (Nausea) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID, ASCORBIC ACID (ASPIRIN COMPOUND [ACETYLSALICYLIC ACID;ASCORBIC ACID]) for Anticoagulant therapy, ATORVASTATIN for Cholesterol, FUROSEMIDE (FUROSIMIDE) for Hypertension.    On 25-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Sep-2021, the patient experienced TREMOR (Shaking of legs) and NAUSEA (Nausea). At the time of the report, TREMOR (Shaking of legs) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Carbetolol is used as concomitant medication for hypertension.  No treatment information is provided.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Myalgia, Pyrexia, Rash, Tenderness
Clinical narrative: Fever; Soreness in the muscles of the left upper arm; Covid arm; Tenderness in the left upper arm; Lethargic; Rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Covid arm), TENDERNESS (Tenderness in the left upper arm), LETHARGY (Lethargic), RASH (Rash) and PYREXIA (Fever) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Sep-2021, the patient experienced VACCINATION SITE REACTION (Covid arm), TENDERNESS (Tenderness in the left upper arm), LETHARGY (Lethargic), RASH (Rash), PYREXIA (Fever) and MYALGIA (Soreness in the muscles of the left upper arm). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE REACTION (Covid arm), TENDERNESS (Tenderness in the left upper arm), LETHARGY (Lethargic), RASH (Rash), PYREXIA (Fever) and MYALGIA (Soreness in the muscles of the left upper arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant drug was not reported. Treatment medication included topical spray of all natural mint and eucalyptus and anti-allergic medications to alleviate the symptoms.  It was reported that patient was supposed to take second dose on 26-SEP-2021.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: Fever; Soreness in the muscles of the left upper arm; Covid arm; Tenderness in the left upper arm; Lethargic; Rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Covid arm), TENDERNESS (Tenderness in the left upper arm), LETHARGY (Lethargic), RASH (Rash) and PYREXIA (Fever) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Sep-2021, the patient experienced VACCINATION SITE REACTION (Covid arm), TENDERNESS (Tenderness in the left upper arm), LETHARGY (Lethargic), RASH (Rash), PYREXIA (Fever) and MYALGIA (Soreness in the muscles of the left upper arm). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE REACTION (Covid arm), TENDERNESS (Tenderness in the left upper arm), LETHARGY (Lethargic), RASH (Rash), PYREXIA (Fever) and MYALGIA (Soreness in the muscles of the left upper arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant drug was not reported. Treatment medication included topical spray of all natural mint and eucalyptus and anti-allergic medications to alleviate the symptoms.  It was reported that patient was supposed to take second dose on 26-SEP-2021.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received dose from a vial that was punctured for more than 12hs; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received dose from a vial that was punctured for more than 12hs) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Aug-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 24-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received dose from a vial that was punctured for more than 12hs). On 24-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Received dose from a vial that was punctured for more than 12hs) had resolved. Not Provided   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported.  it was reported that Moderna COVID-19 vaccine was given outside the recommended time frame, more than 12 hours post vial puncture. vial was kept at recommended temperature of 2-8 C before administration.  No treatment medication reported by the reporter.   This case was linked to MOD-2021-295452, MOD-2021-331621 (Patient Link).
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site swelling
Clinical narrative: Reporter states that after second shot patient had high fever and the arm swelled up,; Reporter states that after second shot patient had high fever and the arm swelled up,; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Reporter states that after second shot patient had high fever and the arm swelled up,) and VACCINATION SITE SWELLING (Reporter states that after second shot patient had high fever and the arm swelled up,) in an 81-year-old male patient 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 PYREXIA (Reporter states that after second shot patient had high fever and the arm swelled up,) and VACCINATION SITE SWELLING (Reporter states that after second shot patient had high fever and the arm swelled up,). At the time of the report, PYREXIA (Reporter states that after second shot patient had high fever and the arm swelled up,) and VACCINATION SITE SWELLING (Reporter states that after second shot patient had high fever and the arm swelled up,) outcome was unknown.            No concomitant medications were reported. No treatment information was provided.    This case was linked to MOD-2021-331759 (Patient Link).
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Peripheral swelling, Pneumonitis, Pyrexia
Clinical narrative: Lungs inflammation/it's swelling all around the heart; Arm swelled up; High fever; Not immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONITIS (Lungs inflammation/it's swelling all around the heart), PERIPHERAL SWELLING (Arm swelled up), PYREXIA (High fever) and EXTRA DOSE ADMINISTERED (Not immunocompromised) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Sep-2021, the patient experienced PNEUMONITIS (Lungs inflammation/it's swelling all around the heart), PERIPHERAL SWELLING (Arm swelled up), PYREXIA (High fever) and EXTRA DOSE ADMINISTERED (Not immunocompromised). On 22-Sep-2021, EXTRA DOSE ADMINISTERED (Not immunocompromised) had resolved. At the time of the report, PNEUMONITIS (Lungs inflammation/it's swelling all around the heart) and PERIPHERAL SWELLING (Arm swelled up) outcome was unknown and PYREXIA (High fever) had resolved.            No concomitant medications were provided. No treatment medications were reported. The patient had high fever last only one day arm swelled up and lungs inflammation. The doctor thought it was pneumonia, but the fever went away after one day, it was swelling all around the heart.   This case was linked to MOD-2021-331716 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Dizziness, Hypersomnia, Pain in extremity
Clinical narrative: Dizziness; My arm hurt hurt real good; Loss of appetite; I wanted to sleep a lot; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), PAIN IN EXTREMITY (My arm hurt hurt real good), DECREASED APPETITE (Loss of appetite) and HYPERSOMNIA (I wanted to sleep a lot) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017E21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Diabetes. Concomitant products included INSULIN for Diabetes.   On 27-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Aug-2021, the patient experienced DIZZINESS (Dizziness), PAIN IN EXTREMITY (My arm hurt hurt real good), DECREASED APPETITE (Loss of appetite) and HYPERSOMNIA (I wanted to sleep a lot). At the time of the report, DIZZINESS (Dizziness), PAIN IN EXTREMITY (My arm hurt hurt real good), DECREASED APPETITE (Loss of appetite) and HYPERSOMNIA (I wanted to sleep a lot) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   The patient has a lot of side effects with medicines. Moreover, when she take her insulin shot, it puts her out and go right to sleep.  No treatment information was provided. Sender's Comments: This case concerns a 73-year-old, female patient with history of hypertension and diabetes non relevant for the case, who experienced the unexpected non-serious adverse event of special interest of hypersomnia. The event occurred on the same day after the first dose of Spikevax (Moderna COVID-19 vaccine). The rechallenge was unknown since the event occurred after the first dose and there is no information about the second. The benefit-risk relationship of Spikevax (Moderna COVID-19 vaccine) is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: Pharmacies gives the 3rd dose to not immunocompromised people; 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 OFF LABEL USE (Pharmacies gives the 3rd dose to not immunocompromised people) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and 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 OFF LABEL USE (Pharmacies gives the 3rd dose to not immunocompromised people). At the time of the report, OFF LABEL USE (Pharmacies gives the 3rd dose to not immunocompromised people) had resolved.            No concomitant product information was provided. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: Product temperature excursion issue; vaccine administered to patients that was exposed to temperatures outside of the recommended storage per Fact Sheet; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and EXPIRED PRODUCT ADMINISTERED (vaccine administered to patients that was exposed to temperatures outside of the recommended storage per Fact Sheet) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) 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. In September 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and EXPIRED PRODUCT ADMINISTERED (vaccine administered to patients that was exposed to temperatures outside of the recommended storage per Fact Sheet). In September 2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and EXPIRED PRODUCT ADMINISTERED (vaccine administered to patients that was exposed to temperatures outside of the recommended storage per Fact Sheet) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were not reported. No treatment medications were not provided. Frozen vaccine stored Minimum: -12  degree C, Maximum: -23 degree C. Multiple episodes of temperature fluctuation for 15-90 minutes each day from 01-Sep-2021 to 16-Sep-2021 due to freezer cycling and needing defrosted. Expired vaccine was used on 02-Sep2021 for 11 patients and on 16-Sep-2021 for 18 patients. This lot expires 24-Sep2021.
Sex: M
Vaccine: COVID19
Symptoms: Oedema
Clinical narrative: Very bad edma; This spontaneous case was reported by a nurse and describes the occurrence of OEDEMA (Very bad edma) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OEDEMA (Very bad edma). At the time of the report, OEDEMA (Very bad edma) 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 were provided. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Sep-2021: Follow up received on 30 sep 2021: contains no new information.
Sex: U
Vaccine: FLUX
Symptoms: Extra dose administered, Medication error, No adverse event
Clinical narrative: me too i dd twice this year with no adverse event; Initial information received on 27-Sep-2021 regarding an unsolicited valid non-serious case received from via consumer non health care professional (under reference number: US-SA-SAC20210929000207).  This case involves Adult and unknown gender patient who was administered an extra dose INFLUENZA VACCINE (extra dose administered).  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  It was case of an actual medication error due to extra dose administered (latency: same day).  It was reported that "Hello, The following potential OSF has been found as a public comment on an Influencer post related to Flu Shot Fridays. Product name was not provided. Since this is a public post on the Sanofi flu shot campaign Flu Shot Friday we are assuming the consumer is referring to the Sanofi flu vaccine".  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.)
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: first dose leaked during administration with no adverse event; vaccine leaked between the syringe and needle during administration( plunger rob) with no adverse event; Initial information was received on 28-Sep-2021 regarding an unsolicited valid non-serious case from other health professional Information (under reference-00788891).  This case involves a female patient (over the age of 65) who was vaccinated INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT], but first dose leaked during administration and vaccine leaked between the syringe and needle during administration (plunger rob) (underdose and syringe issue).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On 23-Sep-2021, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ704AA, expiry date-30-Jun-2022) via intramuscular route in the deltoid NOS.  It was an actual medication error due to vaccine underdose and syringe leak (same day latency).  It was reported "a female patient over the age of 65 received a second dose of Fluzone High-Dose, as the first dose leaked during administration. The patient received a second dose of the vaccine, as she received a partial dose. The vaccine leaked between the syringe and needle during administration (plunger rob). She stated that the needle was attached properly, with no apparent defects to the syringe".  At time of reporting, no adverse event was reported.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness unilateral, Tinnitus
Clinical narrative: Severe tinnitus and loss of hearing in right ear.  Moderate tinnitus in left ear.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Cold sweat, Dizziness, Dysstasia
Clinical narrative: 1:00am  headache body and joint pain dizziness cold and clammy temperature 100.2 weakness unable to stand.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Headache, Pain
Clinical narrative: 1:00am  headache body and joint pain dizziness cold and clammy temperature 100.2 weakness unable to stand.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Palpitations, Sleep disorder
Clinical narrative: waking up abruptly with an extremely high heart rate and heart palpitations.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Electrocardiogram normal, Fatigue, Full blood count normal, Metabolic function test
Clinical narrative: Shortness of breath, heart palpitations, extreme fatigue, migraine.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Palpitations, Thyroid function test normal
Clinical narrative: Shortness of breath, heart palpitations, extreme fatigue, migraine.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper, Dehydration, Electrocardiogram normal, Muscle spasms
Clinical narrative: Nausea, vomiting, hands and feet cramped and stiff, stomach tightness and pain, dehydrated, ended up in ER
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Nausea, Vomiting
Clinical narrative: Nausea, vomiting, hands and feet cramped and stiff, stomach tightness and pain, dehydrated, ended up in ER
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bone pain, Dyspepsia, Fatigue, Headache
Clinical narrative: Significant Right arm pain Deep bone/joint pain Muscle pain Fatigue Mild headache Heartburn
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Significant Right arm pain Deep bone/joint pain Muscle pain Fatigue Mild headache Heartburn
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain of skin, Rash
Clinical narrative: Symptoms of Shingles started two days after vaccination. The symptoms started with skin pain on abdomen which spread around to back over next two days. At 5 days after vaccination, a rash started and progressed over next 3 days also around back. I visited an Urgent Care at 7 days after vaccination where the Nurse Practitioner diagnosed Shingles. Started anti-viral at 8 days after vaccination (6 days after initial skin pain, and 3 days after rash started). The rash does not appear to be spreading further but is still in-progress toward blistering, etc...
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Throwing up, fever.
Age: 50.0
Sex: F
Vaccine: UNK
Symptoms: Body temperature increased
Clinical narrative: 103 Temp
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Additional Details: Red swollen lump at injection site. Very tender. She is going to doctor to make sure its not a blood clot.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Dizziness, Flushing, Hyperhidrosis
Clinical narrative: Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Chills, Pain
Clinical narrative: Chest pain, body aches, chills. Advil helped the chills and body aches but not the chest pain.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headaches
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too Low-
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site pain, Injection site pruritus, Lymph node pain, Pain
Clinical narrative: Red arm rash size of baseball. Itching and pain at injection site, pain in lymp node under arm, body aches, fever and chills. Still not resolved after 4 days
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash erythematous
Clinical narrative: Red arm rash size of baseball. Itching and pain at injection site, pain in lymp node under arm, body aches, fever and chills. Still not resolved after 4 days
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Cold sweat, Dizziness, Dysphagia
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventilation-Mild, Systemic: Nausea-Medium, Additional Details: Approximately 5 minutes after administration patient appeared "clammy" upon asking patient how she felt she reported feeling very hot and nauseous. Patient initially reported reservations about getting the shot prior to administration and was "very nervous about having to get it."  Roughly 10 minutes after administration patient was getting short of breath, breathing rapidly, and appeared very distraught. Told patient epipen was available and patient requested it, breathing became easier after.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Feeling hot, Flushing, Hyperhidrosis, Hyperventilation
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventilation-Mild, Systemic: Nausea-Medium, Additional Details: Approximately 5 minutes after administration patient appeared "clammy" upon asking patient how she felt she reported feeling very hot and nauseous. Patient initially reported reservations about getting the shot prior to administration and was "very nervous about having to get it."  Roughly 10 minutes after administration patient was getting short of breath, breathing rapidly, and appeared very distraught. Told patient epipen was available and patient requested it, breathing became easier after.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Nervousness, Throat tightness
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventilation-Mild, Systemic: Nausea-Medium, Additional Details: Approximately 5 minutes after administration patient appeared "clammy" upon asking patient how she felt she reported feeling very hot and nauseous. Patient initially reported reservations about getting the shot prior to administration and was "very nervous about having to get it."  Roughly 10 minutes after administration patient was getting short of breath, breathing rapidly, and appeared very distraught. Told patient epipen was available and patient requested it, breathing became easier after.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Asthenia, Dizziness, Flushing, Hyperhidrosis
Clinical narrative: Systemic: Abdominal Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Weakness-Medium
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)-
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Induration, Lymphadenopathy, Muscular weakness, Oral herpes
Clinical narrative: Extreme swelling to left underarm(lymph node) hardness and swelling noted first evening of shot. Tenderness to left groin area Numbness and weakness to left hand and fingers especially fifth finger. Fever blister formed On bottom lip.  Underarm swollen and warm. No low grade temp notes but I do not experience elevated temps when sick as a general rule.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Skin warm, Tenderness
Clinical narrative: Extreme swelling to left underarm(lymph node) hardness and swelling noted first evening of shot. Tenderness to left groin area Numbness and weakness to left hand and fingers especially fifth finger. Fever blister formed On bottom lip.  Underarm swollen and warm. No low grade temp notes but I do not experience elevated temps when sick as a general rule.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Severe lump, redness and itching at injection site. Hot to the touch and extremely sore. No other side effects. Tylenol for arm pain.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Oedema peripheral, Rash pruritic
Clinical narrative: Entire body red confluent pruritic rash which began about 12 hours after the vaccine and progressed. Includes lips and base of penis. Some edema of lower extremities. No SOB, tongue swelling, hypotension or other signs of anaphylaxis. Outcome is that I started him on a 5-day course of prednisone 40mg qd.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Lethargy, Nausea
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Medium, Systemic: Weakness-Medium
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Medium, Systemic: Weakness-Medium
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Lichen planus, Loss of personal independence in daily activities, Oral lichen planus, Oral pain, Pain
Clinical narrative: Formed painful, erosive, Oral Lichen Planus lesions in my mouth. Can't eat without severe, burning pain. Can't talk. Can't open my mouth completely without ripping apart these lesions.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Speech disorder
Clinical narrative: Formed painful, erosive, Oral Lichen Planus lesions in my mouth. Can't eat without severe, burning pain. Can't talk. Can't open my mouth completely without ripping apart these lesions.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too Low-
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Chills, Dizziness, Tremor
Clinical narrative: Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Shakiness-Mild;
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (temperature)-
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Ear discomfort, Magnetic resonance imaging, Tinnitus, Vertigo
Clinical narrative: After the second  dose I developed clogged ears and severe vertigo that would occur every week or so for several months, gradually getting better and less severe.  It finally resolved and then  I received the third shot and in less than a week had severely clogged ears and now tinnitus which has lasted for a full week now.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Injection site pain, Presyncope
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Additional Details: pt had near syniscope per emt.  pt did not sit and wait the 15 minute waiting period was walking around after 2 minutes of recieving the vacinne pt almost fainted called emt and was taken to er and released with diagnois of near syniscope no pain at the injection site just dizzy
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests normal, Deafness, Ear, nose and throat examination, Sleep disorder, Tinnitus
Clinical narrative: Started getting ringing in my left ear and woke me up in the middle of the night.  Cannot sleep due to loud noise.  Constant noise.  Sometimes it dulls out but in the night, the noise is very intense. I made a appointment with my primary care physicians and she said  that I did not have ear infections and referred me to ENT. I made the appointment with the ENT and they conducted a hearing test.  They did not see anything that stood out unusual.  Ears appeared fine with small amount of earing loss.  No infections to indicate why I am having this issue.  ENT prescribed a Z Pak for 6 days.  First day appear to have some relief, however the Tinnitus came back.  I have 2 days left of taking this medication
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling, Tenderness
Clinical narrative: Swelling and tenderness in both armpits.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, Delivery, Exposure during pregnancy, SARS-CoV-2 test positive
Clinical narrative: Patient was admitted on 9/29/2021 to hospital at 38 weeks for spontaneous delivery. Patient reports testing positive for COVID-19 on 9/23/2021. Patient was asymptomatic for COVID-19 infection during admission.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Oropharyngeal pain, Pain
Clinical narrative: Felt achy, tired, chills (no fever), sore throat.  Last one day and am fine today.