chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Nasopharyngeal swab
Clinical narrative: Nasal Swab date 29Aug2022: Positive; Nasal Swab date 29Aug2022: Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old male patient received BNT162b2 (BNT162B2), on 04Nov2021 at 20:00 as dose 1, single (Lot number: 320308d), in left arm and on 18Dec2021 at 20:00 as dose 2, single (Lot number: 331808a) at the age of 38 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Gastritis" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 29Aug2022, outcome "unknown" and all described as "Nasal Swab date 29Aug2022: Positive". The patient underwent the following laboratory tests and procedures: Nasopharyngeal swab: (29Aug2022) Positive, notes: Nasal Swab.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201212992 Same patient/drug, different AE, different dose of vaccine;
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Anxiety, Dyspnoea, Inappropriate schedule of product administration, Limb discomfort, Malaise
Clinical narrative: Nasal Swab date 29Aug2022: Positive; Nasal Swab date 29Aug2022: Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old male patient received BNT162b2 (BNT162B2), on 04Nov2021 at 20:00 as dose 1, single (Lot number: 320308d), in left arm and on 18Dec2021 at 20:00 as dose 2, single (Lot number: 331808a) at the age of 38 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Gastritis" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 29Aug2022, outcome "unknown" and all described as "Nasal Swab date 29Aug2022: Positive". The patient underwent the following laboratory tests and procedures: Nasopharyngeal swab: (29Aug2022) Positive, notes: Nasal Swab.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201212992 Same patient/drug, different AE, different dose of vaccine;
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Nasopharyngeal swab, Skin burning sensation
Clinical narrative: Nasal Swab date 29Aug2022: Positive; Nasal Swab date 29Aug2022: Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old male patient received BNT162b2 (BNT162B2), on 04Nov2021 at 20:00 as dose 1, single (Lot number: 320308d), in left arm and on 18Dec2021 at 20:00 as dose 2, single (Lot number: 331808a) at the age of 38 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Gastritis" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 29Aug2022, outcome "unknown" and all described as "Nasal Swab date 29Aug2022: Positive". The patient underwent the following laboratory tests and procedures: Nasopharyngeal swab: (29Aug2022) Positive, notes: Nasal Swab.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201212992 Same patient/drug, different AE, different dose of vaccine;
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Hypoxia
Clinical narrative: She tested positive for covid 11-18-2021 and deceased 11-21-21.   Admitted to hospital with dx of copd exacerbation, acute on chronic resp failure with hypoxia and hypercapnia and sat of 60 percent reported by hospice(she was on hospice for dnr care).  Had pneumonia and acute kidney injury as well.  given dexamethasone, vanco, cefipime and more treatment that I do not have records on.
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acute kidney injury, Acute respiratory failure, COVID-19, Chronic obstructive pulmonary disease, Condition aggravated
Clinical narrative: She tested positive for covid 11-18-2021 and deceased 11-21-21.   Admitted to hospital with dx of copd exacerbation, acute on chronic resp failure with hypoxia and hypercapnia and sat of 60 percent reported by hospice(she was on hospice for dnr care).  Had pneumonia and acute kidney injury as well.  given dexamethasone, vanco, cefipime and more treatment that I do not have records on.
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Death, Hypercapnia, Hypoxia, Pneumonia, SARS-CoV-2 test positive
Clinical narrative: She tested positive for covid 11-18-2021 and deceased 11-21-21.   Admitted to hospital with dx of copd exacerbation, acute on chronic resp failure with hypoxia and hypercapnia and sat of 60 percent reported by hospice(she was on hospice for dnr care).  Had pneumonia and acute kidney injury as well.  given dexamethasone, vanco, cefipime and more treatment that I do not have records on.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Heart rate increased
Clinical narrative: high fever, brain shaking, ringing in ears, headache
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cerebral disorder, Headache, Pyrexia, Tinnitus, Tremor
Clinical narrative: high fever, brain shaking, ringing in ears, headache
Age: 61.0
Sex: M
Vaccine: HEP, HEP, PNC20
Symptoms: Bell's palsy, Facial paralysis, Neck pain
Clinical narrative: Received shot around 4:30 in the afternoon and woke up the next morning with face paralysis on my right side of face, sharp unmanageable pain up the right side of my neck to the back of ear.  Went to the ER that morning and had a CT done to rule out stroke. The ER Dr. gave some pain meds and said he could not be put on antibiotics because of diabetes. Diagnosed with Bell's palsy due to recent vaccinations. Went back to ER because the pain was unbearable but nothing else was done. Went to my Primary care DR and he reiterated what the ER DR said and also took bloodwork. As of today 10/12/2022 there has been no change in condition neither worse nor better.
Age: 61.0
Sex: M
Vaccine: HEP, HEP, PNC20
Symptoms: Bell's palsy, Blood test, Computerised tomogram, Ear pain, Facial paralysis
Clinical narrative: Received shot around 4:30 in the afternoon and woke up the next morning with face paralysis on my right side of face, sharp unmanageable pain up the right side of my neck to the back of ear.  Went to the ER that morning and had a CT done to rule out stroke. The ER Dr. gave some pain meds and said he could not be put on antibiotics because of diabetes. Diagnosed with Bell's palsy due to recent vaccinations. Went back to ER because the pain was unbearable but nothing else was done. Went to my Primary care DR and he reiterated what the ER DR said and also took bloodwork. As of today 10/12/2022 there has been no change in condition neither worse nor better.
Age: 61.0
Sex: M
Vaccine: HEP, HEP, PNC20
Symptoms: Immunisation reaction, Neck pain
Clinical narrative: Received shot around 4:30 in the afternoon and woke up the next morning with face paralysis on my right side of face, sharp unmanageable pain up the right side of my neck to the back of ear.  Went to the ER that morning and had a CT done to rule out stroke. The ER Dr. gave some pain meds and said he could not be put on antibiotics because of diabetes. Diagnosed with Bell's palsy due to recent vaccinations. Went back to ER because the pain was unbearable but nothing else was done. Went to my Primary care DR and he reiterated what the ER DR said and also took bloodwork. As of today 10/12/2022 there has been no change in condition neither worse nor better.
Age: 65.0
Sex: M
Vaccine: PNC20, PNC20
Symptoms: Arthralgia, Joint range of motion decreased
Clinical narrative: Patient had severe arm/ shoulder pain for  one month.  Patient said his pain resolved after taking Ibuprofen 600mg for 2 days.
Age: 65.0
Sex: M
Vaccine: PNC20, PNC20
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Patient had severe arm/ shoulder pain for  one month.  Patient said his pain resolved after taking Ibuprofen 600mg for 2 days.
Age: 37.0
Sex: M
Vaccine: FLUC4, FLUC4
Symptoms: Tinnitus
Clinical narrative: Tinnitus
Age: 37.0
Sex: M
Vaccine: FLUC4, FLUC4
Symptoms: Acoustic stimulation tests abnormal, Tinnitus
Clinical narrative: Tinnitus
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Injection site pain
Clinical narrative: Pain has never subsided, and or dissipated since the time of the covid booster on 05/24/2022. Three weeks of physical therapy has not worked to alleviate the pain.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Pain
Clinical narrative: Pain has never subsided, and or dissipated since the time of the covid booster on 05/24/2022. Three weeks of physical therapy has not worked to alleviate the pain.
Age: 75.0
Sex: F
Vaccine: COVID19-2, COVID19, COVID19, COVID19
Symptoms: Erythema, Feeling abnormal, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: feeling uncomfortable; her arm is red/arm is hilarious red; her arm is sore; arm is puffy; has a slight temperature; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (feeling uncomfortable), ERYTHEMA (her arm is red/arm is hilarious red), PAIN IN EXTREMITY (her arm is sore), PERIPHERAL SWELLING (arm is puffy) and PYREXIA (has a slight temperature) in a 75-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     The patient never had COVID-19 positive test or diagnosis.  No medical history relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination. The patient had no other vaccine within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Drug allergy (Sulfa) and Penicillin allergy. Concomitant products included LOSARTAN POTASSIUM (LOSARTIN) and ATORVASTATIN for an unknown indication.    On 06-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (feeling uncomfortable), ERYTHEMA (her arm is red/arm is hilarious red), PAIN IN EXTREMITY (her arm is sore), PERIPHERAL SWELLING (arm is puffy) and PYREXIA (has a slight temperature). At the time of the report, FEELING ABNORMAL (feeling uncomfortable), ERYTHEMA (her arm is red/arm is hilarious red), PAIN IN EXTREMITY (her arm is sore), PERIPHERAL SWELLING (arm is puffy) and PYREXIA (has a slight temperature) had not resolved.            Patient received the two primary series doses and a booster dose. The patient experienced a similar event in the past after receiving the vaccines. The treatment medication was not reported.   This case was linked to MOD-2022-656521, MOD-2022-656523, MOD-2022-656524 (Patient Link).   Reporter did not allow further contact
Age: 75.0
Sex: F
Vaccine: COVID19-2, COVID19, COVID19, COVID19
Symptoms: Bedridden, Immunisation reaction
Clinical narrative: feeling uncomfortable; her arm is red/arm is hilarious red; her arm is sore; arm is puffy; has a slight temperature; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (feeling uncomfortable), ERYTHEMA (her arm is red/arm is hilarious red), PAIN IN EXTREMITY (her arm is sore), PERIPHERAL SWELLING (arm is puffy) and PYREXIA (has a slight temperature) in a 75-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     The patient never had COVID-19 positive test or diagnosis.  No medical history relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination. The patient had no other vaccine within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Drug allergy (Sulfa) and Penicillin allergy. Concomitant products included LOSARTAN POTASSIUM (LOSARTIN) and ATORVASTATIN for an unknown indication.    On 06-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (feeling uncomfortable), ERYTHEMA (her arm is red/arm is hilarious red), PAIN IN EXTREMITY (her arm is sore), PERIPHERAL SWELLING (arm is puffy) and PYREXIA (has a slight temperature). At the time of the report, FEELING ABNORMAL (feeling uncomfortable), ERYTHEMA (her arm is red/arm is hilarious red), PAIN IN EXTREMITY (her arm is sore), PERIPHERAL SWELLING (arm is puffy) and PYREXIA (has a slight temperature) had not resolved.            Patient received the two primary series doses and a booster dose. The patient experienced a similar event in the past after receiving the vaccines. The treatment medication was not reported.   This case was linked to MOD-2022-656521, MOD-2022-656523, MOD-2022-656524 (Patient Link).   Reporter did not allow further contact
Age: 75.0
Sex: F
Vaccine: COVID19-2, COVID19, COVID19, COVID19
Symptoms: Fatigue
Clinical narrative: feeling uncomfortable; her arm is red/arm is hilarious red; her arm is sore; arm is puffy; has a slight temperature; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (feeling uncomfortable), ERYTHEMA (her arm is red/arm is hilarious red), PAIN IN EXTREMITY (her arm is sore), PERIPHERAL SWELLING (arm is puffy) and PYREXIA (has a slight temperature) in a 75-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     The patient never had COVID-19 positive test or diagnosis.  No medical history relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination. The patient had no other vaccine within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Drug allergy (Sulfa) and Penicillin allergy. Concomitant products included LOSARTAN POTASSIUM (LOSARTIN) and ATORVASTATIN for an unknown indication.    On 06-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (feeling uncomfortable), ERYTHEMA (her arm is red/arm is hilarious red), PAIN IN EXTREMITY (her arm is sore), PERIPHERAL SWELLING (arm is puffy) and PYREXIA (has a slight temperature). At the time of the report, FEELING ABNORMAL (feeling uncomfortable), ERYTHEMA (her arm is red/arm is hilarious red), PAIN IN EXTREMITY (her arm is sore), PERIPHERAL SWELLING (arm is puffy) and PYREXIA (has a slight temperature) had not resolved.            Patient received the two primary series doses and a booster dose. The patient experienced a similar event in the past after receiving the vaccines. The treatment medication was not reported.   This case was linked to MOD-2022-656521, MOD-2022-656523, MOD-2022-656524 (Patient Link).   Reporter did not allow further contact
Age: 75.0
Sex: F
Vaccine: COVID19-2, COVID19, COVID19, COVID19
Symptoms: Immunisation reaction
Clinical narrative: feeling uncomfortable; her arm is red/arm is hilarious red; her arm is sore; arm is puffy; has a slight temperature; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (feeling uncomfortable), ERYTHEMA (her arm is red/arm is hilarious red), PAIN IN EXTREMITY (her arm is sore), PERIPHERAL SWELLING (arm is puffy) and PYREXIA (has a slight temperature) in a 75-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     The patient never had COVID-19 positive test or diagnosis.  No medical history relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination. The patient had no other vaccine within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Drug allergy (Sulfa) and Penicillin allergy. Concomitant products included LOSARTAN POTASSIUM (LOSARTIN) and ATORVASTATIN for an unknown indication.    On 06-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (feeling uncomfortable), ERYTHEMA (her arm is red/arm is hilarious red), PAIN IN EXTREMITY (her arm is sore), PERIPHERAL SWELLING (arm is puffy) and PYREXIA (has a slight temperature). At the time of the report, FEELING ABNORMAL (feeling uncomfortable), ERYTHEMA (her arm is red/arm is hilarious red), PAIN IN EXTREMITY (her arm is sore), PERIPHERAL SWELLING (arm is puffy) and PYREXIA (has a slight temperature) had not resolved.            Patient received the two primary series doses and a booster dose. The patient experienced a similar event in the past after receiving the vaccines. The treatment medication was not reported.   This case was linked to MOD-2022-656521, MOD-2022-656523, MOD-2022-656524 (Patient Link).   Reporter did not allow further contact
Age: 75.0
Sex: F
Vaccine: COVID19-2, COVID19, COVID19, COVID19
Symptoms: Erythema, Feeling abnormal, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Worse reaction; Was in a bed for  a day; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Worse reaction) and BEDRIDDEN (Was in a bed for  a day) in a 75-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Patient has never had COVID positive test or diagnosis. Patient had no medical history relating to adverse event and did not have both acute and chronic illnesses at the time of vaccination. Patient did not receive any other vaccine one month prior to vaccination.  Concurrent medical conditions included Drug allergy (sulfa) and Penicillin allergy. Concomitant products included LOSARTAN POTASSIUM (LOSARTIN) and ATORVASTATIN for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Worse reaction) and BEDRIDDEN (Was in a bed for  a day). At the time of the report, IMMUNISATION REACTION (Worse reaction) had not resolved and BEDRIDDEN (Was in a bed for  a day) had resolved.        mRNA-1273 (Spikevax) (Unknown) dosing remained unchanged.       Patient did not seek any medical care for the adverse event. No treatment medications were reported.   This case was linked to MOD-2022-656523, MOD-2022-656524, MOD-2022-656528.   Reporter did not allow further contact
Age: 75.0
Sex: F
Vaccine: COVID19-2, COVID19, COVID19, COVID19
Symptoms: Bedridden, Immunisation reaction
Clinical narrative: Worse reaction; Was in a bed for  a day; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Worse reaction) and BEDRIDDEN (Was in a bed for  a day) in a 75-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Patient has never had COVID positive test or diagnosis. Patient had no medical history relating to adverse event and did not have both acute and chronic illnesses at the time of vaccination. Patient did not receive any other vaccine one month prior to vaccination.  Concurrent medical conditions included Drug allergy (sulfa) and Penicillin allergy. Concomitant products included LOSARTAN POTASSIUM (LOSARTIN) and ATORVASTATIN for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Worse reaction) and BEDRIDDEN (Was in a bed for  a day). At the time of the report, IMMUNISATION REACTION (Worse reaction) had not resolved and BEDRIDDEN (Was in a bed for  a day) had resolved.        mRNA-1273 (Spikevax) (Unknown) dosing remained unchanged.       Patient did not seek any medical care for the adverse event. No treatment medications were reported.   This case was linked to MOD-2022-656523, MOD-2022-656524, MOD-2022-656528.   Reporter did not allow further contact
Age: 75.0
Sex: F
Vaccine: COVID19-2, COVID19, COVID19, COVID19
Symptoms: Fatigue
Clinical narrative: Worse reaction; Was in a bed for  a day; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Worse reaction) and BEDRIDDEN (Was in a bed for  a day) in a 75-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Patient has never had COVID positive test or diagnosis. Patient had no medical history relating to adverse event and did not have both acute and chronic illnesses at the time of vaccination. Patient did not receive any other vaccine one month prior to vaccination.  Concurrent medical conditions included Drug allergy (sulfa) and Penicillin allergy. Concomitant products included LOSARTAN POTASSIUM (LOSARTIN) and ATORVASTATIN for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Worse reaction) and BEDRIDDEN (Was in a bed for  a day). At the time of the report, IMMUNISATION REACTION (Worse reaction) had not resolved and BEDRIDDEN (Was in a bed for  a day) had resolved.        mRNA-1273 (Spikevax) (Unknown) dosing remained unchanged.       Patient did not seek any medical care for the adverse event. No treatment medications were reported.   This case was linked to MOD-2022-656523, MOD-2022-656524, MOD-2022-656528.   Reporter did not allow further contact
Age: 75.0
Sex: F
Vaccine: COVID19-2, COVID19, COVID19, COVID19
Symptoms: Immunisation reaction
Clinical narrative: Worse reaction; Was in a bed for  a day; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Worse reaction) and BEDRIDDEN (Was in a bed for  a day) in a 75-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Patient has never had COVID positive test or diagnosis. Patient had no medical history relating to adverse event and did not have both acute and chronic illnesses at the time of vaccination. Patient did not receive any other vaccine one month prior to vaccination.  Concurrent medical conditions included Drug allergy (sulfa) and Penicillin allergy. Concomitant products included LOSARTAN POTASSIUM (LOSARTIN) and ATORVASTATIN for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Worse reaction) and BEDRIDDEN (Was in a bed for  a day). At the time of the report, IMMUNISATION REACTION (Worse reaction) had not resolved and BEDRIDDEN (Was in a bed for  a day) had resolved.        mRNA-1273 (Spikevax) (Unknown) dosing remained unchanged.       Patient did not seek any medical care for the adverse event. No treatment medications were reported.   This case was linked to MOD-2022-656523, MOD-2022-656524, MOD-2022-656528.   Reporter did not allow further contact
Age: 75.0
Sex: F
Vaccine: COVID19-2, COVID19, COVID19, COVID19
Symptoms: Erythema, Feeling abnormal, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: was very tired the next day; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (was very tired the next day) in a 75-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Patient has never had COVID positive test or diagnosis. Patient had no medical history relating to adverse event and did not have both acute and chronic illnesses at the time of vaccination. Patient did not receive any other vaccine one month prior to vaccination.  Concurrent medical conditions included Penicillin allergy and Drug allergy (Sulfa drugs). Concomitant products included LOSARTAN POTASSIUM (LOSARTIN) and ATORVASTATIN for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (was very tired the next day). At the time of the report, FATIGUE (was very tired the next day) outcome was unknown.            No treatment medications were reported.   This case was linked to MOD-2022-656521, MOD-2022-656524, MOD-2022-656528 (Patient Link).   Reporter did not allow further contact
Age: 75.0
Sex: F
Vaccine: COVID19-2, COVID19, COVID19, COVID19
Symptoms: Bedridden, Immunisation reaction
Clinical narrative: was very tired the next day; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (was very tired the next day) in a 75-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Patient has never had COVID positive test or diagnosis. Patient had no medical history relating to adverse event and did not have both acute and chronic illnesses at the time of vaccination. Patient did not receive any other vaccine one month prior to vaccination.  Concurrent medical conditions included Penicillin allergy and Drug allergy (Sulfa drugs). Concomitant products included LOSARTAN POTASSIUM (LOSARTIN) and ATORVASTATIN for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (was very tired the next day). At the time of the report, FATIGUE (was very tired the next day) outcome was unknown.            No treatment medications were reported.   This case was linked to MOD-2022-656521, MOD-2022-656524, MOD-2022-656528 (Patient Link).   Reporter did not allow further contact
Age: 75.0
Sex: F
Vaccine: COVID19-2, COVID19, COVID19, COVID19
Symptoms: Fatigue
Clinical narrative: was very tired the next day; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (was very tired the next day) in a 75-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Patient has never had COVID positive test or diagnosis. Patient had no medical history relating to adverse event and did not have both acute and chronic illnesses at the time of vaccination. Patient did not receive any other vaccine one month prior to vaccination.  Concurrent medical conditions included Penicillin allergy and Drug allergy (Sulfa drugs). Concomitant products included LOSARTAN POTASSIUM (LOSARTIN) and ATORVASTATIN for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (was very tired the next day). At the time of the report, FATIGUE (was very tired the next day) outcome was unknown.            No treatment medications were reported.   This case was linked to MOD-2022-656521, MOD-2022-656524, MOD-2022-656528 (Patient Link).   Reporter did not allow further contact
Age: 75.0
Sex: F
Vaccine: COVID19-2, COVID19, COVID19, COVID19
Symptoms: Immunisation reaction
Clinical narrative: was very tired the next day; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (was very tired the next day) in a 75-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Patient has never had COVID positive test or diagnosis. Patient had no medical history relating to adverse event and did not have both acute and chronic illnesses at the time of vaccination. Patient did not receive any other vaccine one month prior to vaccination.  Concurrent medical conditions included Penicillin allergy and Drug allergy (Sulfa drugs). Concomitant products included LOSARTAN POTASSIUM (LOSARTIN) and ATORVASTATIN for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (was very tired the next day). At the time of the report, FATIGUE (was very tired the next day) outcome was unknown.            No treatment medications were reported.   This case was linked to MOD-2022-656521, MOD-2022-656524, MOD-2022-656528 (Patient Link).   Reporter did not allow further contact
Age: 75.0
Sex: F
Vaccine: COVID19-2, COVID19, COVID19, COVID19
Symptoms: Erythema, Feeling abnormal, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: A little bit of a reaction; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (A little bit of a reaction) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     It was reported that patient has never been diagnosed/tested positive for COVID-19. It was reported patient did not had  acute illness at the time of vaccination and up to one month before and chronic or long-standing health conditions. No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Drug allergy (Sulfa) and Penicillin allergy. Concomitant products included LOSARTAN POTASSIUM (LOSARTIN) and ATORVASTATIN for an unknown indication.    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 IMMUNISATION REACTION (A little bit of a reaction). At the time of the report, IMMUNISATION REACTION (A little bit of a reaction) had not resolved.            On an unknown date, the patient received the fist booster dose of Moderna COVID-19 vaccine.  No treatment medications were reported.   This case was linked to MOD-2022-656521, MOD-2022-656523, MOD-2022-656528 (Patient Link).   Reporter did not allow further contact
Age: 75.0
Sex: F
Vaccine: COVID19-2, COVID19, COVID19, COVID19
Symptoms: Bedridden, Immunisation reaction
Clinical narrative: A little bit of a reaction; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (A little bit of a reaction) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     It was reported that patient has never been diagnosed/tested positive for COVID-19. It was reported patient did not had  acute illness at the time of vaccination and up to one month before and chronic or long-standing health conditions. No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Drug allergy (Sulfa) and Penicillin allergy. Concomitant products included LOSARTAN POTASSIUM (LOSARTIN) and ATORVASTATIN for an unknown indication.    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 IMMUNISATION REACTION (A little bit of a reaction). At the time of the report, IMMUNISATION REACTION (A little bit of a reaction) had not resolved.            On an unknown date, the patient received the fist booster dose of Moderna COVID-19 vaccine.  No treatment medications were reported.   This case was linked to MOD-2022-656521, MOD-2022-656523, MOD-2022-656528 (Patient Link).   Reporter did not allow further contact
Age: 75.0
Sex: F
Vaccine: COVID19-2, COVID19, COVID19, COVID19
Symptoms: Fatigue
Clinical narrative: A little bit of a reaction; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (A little bit of a reaction) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     It was reported that patient has never been diagnosed/tested positive for COVID-19. It was reported patient did not had  acute illness at the time of vaccination and up to one month before and chronic or long-standing health conditions. No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Drug allergy (Sulfa) and Penicillin allergy. Concomitant products included LOSARTAN POTASSIUM (LOSARTIN) and ATORVASTATIN for an unknown indication.    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 IMMUNISATION REACTION (A little bit of a reaction). At the time of the report, IMMUNISATION REACTION (A little bit of a reaction) had not resolved.            On an unknown date, the patient received the fist booster dose of Moderna COVID-19 vaccine.  No treatment medications were reported.   This case was linked to MOD-2022-656521, MOD-2022-656523, MOD-2022-656528 (Patient Link).   Reporter did not allow further contact
Age: 75.0
Sex: F
Vaccine: COVID19-2, COVID19, COVID19, COVID19
Symptoms: Immunisation reaction
Clinical narrative: A little bit of a reaction; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (A little bit of a reaction) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     It was reported that patient has never been diagnosed/tested positive for COVID-19. It was reported patient did not had  acute illness at the time of vaccination and up to one month before and chronic or long-standing health conditions. No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Drug allergy (Sulfa) and Penicillin allergy. Concomitant products included LOSARTAN POTASSIUM (LOSARTIN) and ATORVASTATIN for an unknown indication.    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 IMMUNISATION REACTION (A little bit of a reaction). At the time of the report, IMMUNISATION REACTION (A little bit of a reaction) had not resolved.            On an unknown date, the patient received the fist booster dose of Moderna COVID-19 vaccine.  No treatment medications were reported.   This case was linked to MOD-2022-656521, MOD-2022-656523, MOD-2022-656528 (Patient Link).   Reporter did not allow further contact
Sex: F
Vaccine: COVID19-2
Symptoms: Maternal exposure during breast feeding, No adverse event
Clinical narrative: Bivalent booster when patient was breastfeeding; No adverse event; This spontaneous case was reported by a patient and describes the occurrence of MATERNAL EXPOSURE DURING BREAST FEEDING (Bivalent booster when patient was breastfeeding) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Bivalent booster when patient was breastfeeding) and NO ADVERSE EVENT (No adverse event). At the time of the report, MATERNAL EXPOSURE DURING BREAST FEEDING (Bivalent booster when patient was breastfeeding) had resolved and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant and treatment medications were reported   This case was linked to MOD-2022-656355 (Patient Link).
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: NO other issues or concerns noted.; Caller reported that she was given MMRII IM instead of SQ.; This spontaneous report was received from a pharmacist, reporting on herself, a female patient of unknown age. There was no information regarding the patient's medical history, concurrent conditions and concomitant medications provided.  On 09-SEP-2022, the patient was vaccinated with measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) injection, administered intramuscularly (strength, dose, dose number, anatomical location, lot # and expiration date were not reported) for prophylaxis (incorrect route of product administration). There were no other issues or concerns noted. No PQC.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Transcription medication error
Clinical narrative: No additional AE reported; while Separate Nurse had incorrectly documented the same corresponding immunization as VARIVAX; This spontaneous report was received from an advanced practice registered nurse (APRN) concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided.   On 30-MAR-2022, the patient was vaccinated with a dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live recombinant human albumin (rHA) (M-M-R II) administered as prophylaxis, lot number T027935 with expiration date 18-AUG-2022 (dosage regimen and route of administration were not reported). The reporter stated that she correctly documented corresponding immunization as Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live recombinant human albumin (rHA) (M-M-R II) within patient's medical record, however, separate nurse had incorrectly documented the same corresponding immunization as varicella virus vaccine live (Oka/Merck) (VARIVAX) administered as prophylaxis (dosage regimen, route of administration, lot number and expiration date were not provided) (Transcription medication error). No additional adverse events were reported. Reporter gave permission to be contacted in future regarding the event.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AEs were reported; The physician reported that a patient received improperly stored vaccine.  No additional AEs were reported, no further information provided.  Names of vaccines involved (including lot/exp) VARIVAX (u024221   8/4/2023) Temperature: -12.5C Time frame:; This spontaneous report was received from a physician regarding a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications.   On 06-SEP-2022, the patient was vaccinated with an improperly stored vaccine of varicella virus vaccine live (Oka/Merck) (VARIVAX) for prophylaxis, lot # U024221 with expiration date on 04-AUG-2023 (strength, dose number, anatomical location and route of administration). The temperature storage was -12.5 C for a time frame of 1 hour, without a previous temperature excursion.  No additional adverse events were reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs were reported; expired MMR II vaccine was given to a patient; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender.  The patient's pertinent medical history, current conditions, drug reactions or allergies and concomitant medications were not reported.  On 03-OCT-2022, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant human albumin (rHA) (M-M-R II) subcutaneous injection, 1 dose, lot #T031436, expiration date: 15-SEP-2022, administered for prophylaxis (strength, and route of administration were not provided) (expired product administered). No additional adverse events details or product quality complaints were reported (no adverse event).
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events reported.; VARIVAX that had undergone temperature excursion was administered to a patient.; This spontaneous report was received from a nurse regarding a 12-month-old patient of an unspecified gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 26-SEP-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot #W002601, expiration date: 24-JAN-2024, product quantity 1, (strength, dosage regimen, anatomical location, and route of administration were not provided) administered as prophylaxis (Product storage error).  The improperly stored vaccine underwent a temperature excursion of -11.8 degrees Celsius (C) for 1 hour and 45 minutes without previous excursions (also reported as "with previous temperature excursion", conflicting information). No adverse events were reported.
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Injection site pain, Pain
Clinical narrative: the third dose/shot being being very painful/a lot of stinging at the injection site; She thought she was going to pass out; This spontaneous report was received from a consumer via company representative and refers to an approximately 22-year-old female patient. Her medical history and concomitant therapies details were not reported. Concurrent condition included a mental disorder.  On an unknown date, the patient was vaccinated with third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On an unknown date, the patient had a lot of stinging at the injection site and she also experienced dizziness, she thought she was going to pass out, but she also got worked up over shots. The third shot of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was very painful. No additional information was provided. No additional adverse event or product quality complaint was reported. No further information was provided. The outcome of the events was reported as recovered.  The causal relationship between the events and suspected therapies was not reported.
Age: 0.42
Sex: U
Vaccine: RV5
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: No additional AE; patient age 20 weeks received an initial dose of ROTATEQ on 9/19/2022; This spontaneous report was received from medical assistant and refers to a 20-week-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 19-SEP-2022, the patient was vaccinated with initial dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 milliliter, lot #W004502, expiration date: 09-OCT-2023, administered orally for prophylaxis (strength was not provided) (product administered to patient of inappropriate age).  There was no adverse event reported.
Sex: F
Vaccine: PNC15, PPV
Symptoms: Vaccination site pain
Clinical narrative: The caller reports her sister received an unspecified Pneumonia vaccine and her arm "still hurts"; This spontaneous report was received from a patient's relative referring to a female patient of unknown age. No information regarding the patient's medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications was provided.  On an unknown date, the patient was vaccinated with an unspecified vaccine against pneumonia, (no information of the vaccine names were provided) pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) administered as prophylaxis ((strength, doses, frequencies, anatomical sites of injection, lot numbers, expiration dates, and indications were not provided). The patient's sister reported that the arm of the patient "still hurts" (vaccination site pain)The outcome of the adverse event as well as the action taken with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) and the causality assessment were not provided.
Sex: M
Vaccine: PPV
Symptoms: Cardiac disorder, Diabetes mellitus
Clinical narrative: Patient now has diabetes and heart condition.; Patient now has diabetes and heart condition.; This spontaneous report was received from customer and refers to a male patient before the age of 65. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On an unknown date, the patient started therapy with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, quantity: 1, for prophylaxis (lot #, expiry date, anatomical location, and route of administration were not provided).  On an unknown date, the patient experienced diabetes and heart condition. The reporter asked if the patient (he) could get another pneumonia vaccine. The causal relationship between the events diabetes and heart disease, unspecified pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not reported.  Upon internal review, the event diabetes was determined to be medically significant.
Sex: M
Vaccine: FLUN3
Symptoms: Burning sensation, Nasal discomfort
Clinical narrative: NOTE: FLUMIST DEMONSTRATION BLANK - PHARMACIST TESTED FLUMIST DEMONSTRATION BLANK BY SELF ADMINISTERING IN NOSE. IMMEDIATELY COMPLAINED OF BURNING SENSATION IN NOSE.; A spontaneous report has been received from a pharmacist. The report concerns a male patient (age not provided).    No medical history was reported.    No concomitant products were reported.    The patient received Flumist (influenza vaccine live reassort 3v) (batch number Unknown), via nasal route, on an unknown date.    No malfunction has been reported for FLUMIST.    On an unknown date, the patient experienced note: flumist demonstration blank - pharmacist tested flumist demonstration blank by self administering in nose. immediately complained of burning sensation in nose. (preferred term: Nasal discomfort).    Treatment with Flumist was not changed.    The patient recovered from the event on an unspecified date.    The event was considered non-serious.    The reporter considered  that there was a reasonable possibility of a causal relationship between Flumist and the following event: Note: flumist demonstration blank - pharmacist tested flumist demonstration blank by self administering in nose. immediately complained of burning sensation in nose.    Device Information:     Combination Product Report: Yes    Product As Reported: FLUMIST  Common Device Name: Nasal Spray  Procode: CCQ  Product Role: Suspect