chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Condition aggravated, Diarrhoea, Nausea, Salivary hypersecretion
Clinical narrative: Began experiencing persistent nausea; This is a spontaneous report from a contactable consumer. A 41-year-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. The concomitant medications of the patient included lithium taken for an unspecified indication. The patient historical vaccine includes first dose of BNT162B2 on an unspecified date as single dose for COVID-19 immunisation and experienced nausea, a big loss of appetite for a few days and indigestion/stomach bug. The patient reported that 3 weeks after second COVID vaccine dose, she experienced persistent nausea. She had the nausea for 24 days. She stated this was exactly what happened after her first vaccine dose (which she also reported on 22 days of nausea). The outcome of the event was reported as unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea
Clinical narrative: Began experiencing persistent nausea; This is a spontaneous report from a contactable consumer. A 41-year-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. The concomitant medications of the patient included lithium taken for an unspecified indication. The patient historical vaccine includes first dose of BNT162B2 on an unspecified date as single dose for COVID-19 immunisation and experienced nausea, a big loss of appetite for a few days and indigestion/stomach bug. The patient reported that 3 weeks after second COVID vaccine dose, she experienced persistent nausea. She had the nausea for 24 days. She stated this was exactly what happened after her first vaccine dose (which she also reported on 22 days of nausea). The outcome of the event was reported as unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fall, Head injury, Pain in extremity, Paraesthesia, Peripheral coldness
Clinical narrative: Syncope approx 15 minutes after vaccine administration. Brief LOC and no sequelae.
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Syncope
Clinical narrative: Syncope approx 15 minutes after vaccine administration. Brief LOC and no sequelae.
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram normal, Loss of consciousness, Syncope
Clinical narrative: Syncope approx 15 minutes after vaccine administration. Brief LOC and no sequelae.
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: Error: Patient Too Young for Vaccine Administered-
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Error: Patient Too Young for Vaccine Administered-
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain lower, Dyspepsia
Clinical narrative: Site: Redness at Injection Site-Mild
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Injection site erythema
Clinical narrative: Site: Redness at Injection Site-Mild
Age: 62.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Ageusia, Blood test normal, Chest X-ray normal, Chills, Headache
Clinical narrative: I have been sick ever since and I am still sick; Nausea, terrible nausea; Fever; Chills; Headache; Shaking; Body aches; Losing weight consistently; This is a spontaneous report from a contactable consumer (patient). A 62-year-old patient of an unspecified gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported) via an unspecified route of administration, administered in arm right on 29May2021 09:30 (at the age of 62-year-old) as dose 2, single for COVID-19 immunization. Medical history was none provided. Concomitant medication included steroid (They put me on steroid for 4 days). The patient previously received first dose of BNT162B2 on Mar2021 for COVID-19 immunization (I don't have my first one on my hand. That was 3 weeks prior). Prior Vaccination (4 weeks prior) was no reported. Patient did not have family medical history. Patient stated, I had my second COVID shot Pfizer on the 29May and I had been sick ever since and I was still sick. I mean I still have nausea, terrible nausea, fever, chills, body aches, headaches and shaking and I was losing weight consistently and I cannot afford to lose weight (2021). My doctors, who had been treating me and they cannot figure it out. Stated, "I do not know why I am still sick." Patient stated, "I told you 29May. That was my second shot. I do not have my first one on my hand. That was 3 weeks prior." Patient used steroids for the treatment of adverse events. Time of Administration: Patient stated, "Oh, kind a day, it was in the morning. I do not know like 9:30." Therapeutic measures were taken as a result of I have been sick ever since and I am still sick, nausea, terrible nausea, fever, chills, headache, shaking, body aches, losing weight consistently. There was no investigation assessment and no laboratory test. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Age: 62.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pain, Thyroid function test normal, Tremor
Clinical narrative: I have been sick ever since and I am still sick; Nausea, terrible nausea; Fever; Chills; Headache; Shaking; Body aches; Losing weight consistently; This is a spontaneous report from a contactable consumer (patient). A 62-year-old patient of an unspecified gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported) via an unspecified route of administration, administered in arm right on 29May2021 09:30 (at the age of 62-year-old) as dose 2, single for COVID-19 immunization. Medical history was none provided. Concomitant medication included steroid (They put me on steroid for 4 days). The patient previously received first dose of BNT162B2 on Mar2021 for COVID-19 immunization (I don't have my first one on my hand. That was 3 weeks prior). Prior Vaccination (4 weeks prior) was no reported. Patient did not have family medical history. Patient stated, I had my second COVID shot Pfizer on the 29May and I had been sick ever since and I was still sick. I mean I still have nausea, terrible nausea, fever, chills, body aches, headaches and shaking and I was losing weight consistently and I cannot afford to lose weight (2021). My doctors, who had been treating me and they cannot figure it out. Stated, "I do not know why I am still sick." Patient stated, "I told you 29May. That was my second shot. I do not have my first one on my hand. That was 3 weeks prior." Patient used steroids for the treatment of adverse events. Time of Administration: Patient stated, "Oh, kind a day, it was in the morning. I do not know like 9:30." Therapeutic measures were taken as a result of I have been sick ever since and I am still sick, nausea, terrible nausea, fever, chills, headache, shaking, body aches, losing weight consistently. There was no investigation assessment and no laboratory test. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Age: 62.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Chills, Headache, Illness, Nausea, Pain
Clinical narrative: I have been sick ever since and I am still sick; Nausea, terrible nausea; Fever; Chills; Headache; Shaking; Body aches; Losing weight consistently; This is a spontaneous report from a contactable consumer (patient). A 62-year-old patient of an unspecified gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported) via an unspecified route of administration, administered in arm right on 29May2021 09:30 (at the age of 62-year-old) as dose 2, single for COVID-19 immunization. Medical history was none provided. Concomitant medication included steroid (They put me on steroid for 4 days). The patient previously received first dose of BNT162B2 on Mar2021 for COVID-19 immunization (I don't have my first one on my hand. That was 3 weeks prior). Prior Vaccination (4 weeks prior) was no reported. Patient did not have family medical history. Patient stated, I had my second COVID shot Pfizer on the 29May and I had been sick ever since and I was still sick. I mean I still have nausea, terrible nausea, fever, chills, body aches, headaches and shaking and I was losing weight consistently and I cannot afford to lose weight (2021). My doctors, who had been treating me and they cannot figure it out. Stated, "I do not know why I am still sick." Patient stated, "I told you 29May. That was my second shot. I do not have my first one on my hand. That was 3 weeks prior." Patient used steroids for the treatment of adverse events. Time of Administration: Patient stated, "Oh, kind a day, it was in the morning. I do not know like 9:30." Therapeutic measures were taken as a result of I have been sick ever since and I am still sick, nausea, terrible nausea, fever, chills, headache, shaking, body aches, losing weight consistently. There was no investigation assessment and no laboratory test. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Age: 62.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Tremor, Weight, Weight decreased
Clinical narrative: I have been sick ever since and I am still sick; Nausea, terrible nausea; Fever; Chills; Headache; Shaking; Body aches; Losing weight consistently; This is a spontaneous report from a contactable consumer (patient). A 62-year-old patient of an unspecified gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported) via an unspecified route of administration, administered in arm right on 29May2021 09:30 (at the age of 62-year-old) as dose 2, single for COVID-19 immunization. Medical history was none provided. Concomitant medication included steroid (They put me on steroid for 4 days). The patient previously received first dose of BNT162B2 on Mar2021 for COVID-19 immunization (I don't have my first one on my hand. That was 3 weeks prior). Prior Vaccination (4 weeks prior) was no reported. Patient did not have family medical history. Patient stated, I had my second COVID shot Pfizer on the 29May and I had been sick ever since and I was still sick. I mean I still have nausea, terrible nausea, fever, chills, body aches, headaches and shaking and I was losing weight consistently and I cannot afford to lose weight (2021). My doctors, who had been treating me and they cannot figure it out. Stated, "I do not know why I am still sick." Patient stated, "I told you 29May. That was my second shot. I do not have my first one on my hand. That was 3 weeks prior." Patient used steroids for the treatment of adverse events. Time of Administration: Patient stated, "Oh, kind a day, it was in the morning. I do not know like 9:30." Therapeutic measures were taken as a result of I have been sick ever since and I am still sick, nausea, terrible nausea, fever, chills, headache, shaking, body aches, losing weight consistently. There was no investigation assessment and no laboratory test. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Limb injury, Paraesthesia
Clinical narrative: Site: Pain at Injection Site-Severe
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Severe
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain, Asymptomatic COVID-19, Cholecystectomy, Cholecystitis, Condition aggravated
Clinical narrative: Pt is fully vaccinated, receiving 2 doses of the Moderna vaccine on 4/15/2021 and 5/13/2021. Pt presented to local ED and needed emergent cholecystectomy.  Routine admission screening showed patient was COVID+.  Pt was asymptomatic for COVID.
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Infection, Nausea, SARS-CoV-2 test positive
Clinical narrative: Pt is fully vaccinated, receiving 2 doses of the Moderna vaccine on 4/15/2021 and 5/13/2021. Pt presented to local ED and needed emergent cholecystectomy.  Routine admission screening showed patient was COVID+.  Pt was asymptomatic for COVID.
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Pt is fully vaccinated, receiving 2 doses of the Moderna vaccine on 4/15/2021 and 5/13/2021. Pt presented to local ED and needed emergent cholecystectomy.  Routine admission screening showed patient was COVID+.  Pt was asymptomatic for COVID.
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Syncope
Clinical narrative: Patient was a 13 y/o who presented at center with his mother at 9:15 am for vaccination. Mom confirmed pt has several food allergies which include nuts and shellfish. Pt received the covid-19 Pfizer vaccine on the right arm . The patient leaned back on the chair shaking, pale. Mother administered EpiPen @0923, 0.3mg. Pt opened his eyes talking, HR 80-86, RR 24. Patient was encouraged to drink cold water. 911 call ambulance on the way.0930 ambulance arrived patient pink/pale 02 sats. 80s, sats. rechecked on thumb 02 sats. 98.Squard arrived. reports given to them, pediatric 02 monitors applied 02 was 98%, oxygen applied, BP within normal limits. About 9:38 patient was put on the stretcher in the company of mother to Emergency Department.
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pallor, Tremor
Clinical narrative: Patient was a 13 y/o who presented at center with his mother at 9:15 am for vaccination. Mom confirmed pt has several food allergies which include nuts and shellfish. Pt received the covid-19 Pfizer vaccine on the right arm . The patient leaned back on the chair shaking, pale. Mother administered EpiPen @0923, 0.3mg. Pt opened his eyes talking, HR 80-86, RR 24. Patient was encouraged to drink cold water. 911 call ambulance on the way.0930 ambulance arrived patient pink/pale 02 sats. 80s, sats. rechecked on thumb 02 sats. 98.Squard arrived. reports given to them, pediatric 02 monitors applied 02 was 98%, oxygen applied, BP within normal limits. About 9:38 patient was put on the stretcher in the company of mother to Emergency Department.
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: C-reactive protein increased, Chest pain, Ejection fraction decreased, Electrocardiogram ST segment elevation, Magnetic resonance imaging abnormal
Clinical narrative: myocarditis, pericarditis, and gum inflammation
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myocarditis, Red blood cell sedimentation rate increased, Tachycardia, White blood cell count increased
Clinical narrative: myocarditis, pericarditis, and gum inflammation
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myocarditis, Noninfective gingivitis, Pericarditis
Clinical narrative: myocarditis, pericarditis, and gum inflammation
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19
Clinical narrative: Despite being fully vaccinated, patient was hospitalized for breakthrough infection on 7/10/21. On 7/28/21, patient died. He received dose #1 of Moderna on 2/10/21 and dose #2 on 3/12/21.  Discharge summary below (copied from chart): Patient is a vaccinated (2 doses of Moderna) 74 y.o. male with PMH of T2DM, HTN, CML who who is admitted for management of acute hypoxic respiratory failure 2/2 to COVID PNA complicated by secondary bacterial pneumonia and AKI.    He originally presented with shortness of breath on 07/10/2021 and tested positive for COVID. He was admitted to hospital for management of acute hypoxic resp failure intially requring HFNC. During his admission- he was started on methylprednisone on 07/11/2021. Patient had increasing oxygen requirement and was transitioned to nasal BiPAP. Patient emergently intubated with lung protective settings and admitted to ICU on 7/12.    In the ICU, he was started on statin, remdesevir and tocilizumab x1 after admission. He was extubated to HFNC on 7/19. Patient re-intubated on 7/20 due to increasing oxygen requirements.  Despite ongoing therapy, patient continued to decline with family electing DNR. On 07/28/2021 patient went acutely bradycardiac. He was given atropine and epinephrine, however soon went into asystole.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acute kidney injury, Acute respiratory failure, Bilevel positive airway pressure, Bradycardia, COVID-19
Clinical narrative: Despite being fully vaccinated, patient was hospitalized for breakthrough infection on 7/10/21. On 7/28/21, patient died. He received dose #1 of Moderna on 2/10/21 and dose #2 on 3/12/21.  Discharge summary below (copied from chart): Patient is a vaccinated (2 doses of Moderna) 74 y.o. male with PMH of T2DM, HTN, CML who who is admitted for management of acute hypoxic respiratory failure 2/2 to COVID PNA complicated by secondary bacterial pneumonia and AKI.    He originally presented with shortness of breath on 07/10/2021 and tested positive for COVID. He was admitted to hospital for management of acute hypoxic resp failure intially requring HFNC. During his admission- he was started on methylprednisone on 07/11/2021. Patient had increasing oxygen requirement and was transitioned to nasal BiPAP. Patient emergently intubated with lung protective settings and admitted to ICU on 7/12.    In the ICU, he was started on statin, remdesevir and tocilizumab x1 after admission. He was extubated to HFNC on 7/19. Patient re-intubated on 7/20 due to increasing oxygen requirements.  Despite ongoing therapy, patient continued to decline with family electing DNR. On 07/28/2021 patient went acutely bradycardiac. He was given atropine and epinephrine, however soon went into asystole.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac arrest, Death, Dyspnoea, Endotracheal intubation, Extubation
Clinical narrative: Despite being fully vaccinated, patient was hospitalized for breakthrough infection on 7/10/21. On 7/28/21, patient died. He received dose #1 of Moderna on 2/10/21 and dose #2 on 3/12/21.  Discharge summary below (copied from chart): Patient is a vaccinated (2 doses of Moderna) 74 y.o. male with PMH of T2DM, HTN, CML who who is admitted for management of acute hypoxic respiratory failure 2/2 to COVID PNA complicated by secondary bacterial pneumonia and AKI.    He originally presented with shortness of breath on 07/10/2021 and tested positive for COVID. He was admitted to hospital for management of acute hypoxic resp failure intially requring HFNC. During his admission- he was started on methylprednisone on 07/11/2021. Patient had increasing oxygen requirement and was transitioned to nasal BiPAP. Patient emergently intubated with lung protective settings and admitted to ICU on 7/12.    In the ICU, he was started on statin, remdesevir and tocilizumab x1 after admission. He was extubated to HFNC on 7/19. Patient re-intubated on 7/20 due to increasing oxygen requirements.  Despite ongoing therapy, patient continued to decline with family electing DNR. On 07/28/2021 patient went acutely bradycardiac. He was given atropine and epinephrine, however soon went into asystole.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Intensive care, Pneumonia bacterial, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Despite being fully vaccinated, patient was hospitalized for breakthrough infection on 7/10/21. On 7/28/21, patient died. He received dose #1 of Moderna on 2/10/21 and dose #2 on 3/12/21.  Discharge summary below (copied from chart): Patient is a vaccinated (2 doses of Moderna) 74 y.o. male with PMH of T2DM, HTN, CML who who is admitted for management of acute hypoxic respiratory failure 2/2 to COVID PNA complicated by secondary bacterial pneumonia and AKI.    He originally presented with shortness of breath on 07/10/2021 and tested positive for COVID. He was admitted to hospital for management of acute hypoxic resp failure intially requring HFNC. During his admission- he was started on methylprednisone on 07/11/2021. Patient had increasing oxygen requirement and was transitioned to nasal BiPAP. Patient emergently intubated with lung protective settings and admitted to ICU on 7/12.    In the ICU, he was started on statin, remdesevir and tocilizumab x1 after admission. He was extubated to HFNC on 7/19. Patient re-intubated on 7/20 due to increasing oxygen requirements.  Despite ongoing therapy, patient continued to decline with family electing DNR. On 07/28/2021 patient went acutely bradycardiac. He was given atropine and epinephrine, however soon went into asystole.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: May 2021 moderate rash over chest, back and shoulders. Was given an rx of steroid cream which is working to get rid of the rash.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Sensory loss
Clinical narrative: left side of face decreased sensation and tingling
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: Tingling and numbness in right big toe and up the foot.  Sometimes sharp pain when touched.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Eczema, Pruritus
Clinical narrative: Itchiness,  eczema
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Back pain, Blood test, Breast pain, Chest X-ray, Chest pain
Clinical narrative: CHEST PAIN / BACK PAIN / JAW PAIN / BREAST PAIN / FOOT PAIN / HIVES / COUGHING / SENSATION OF CHEST BACK BREAST FOOT SWELLING / Treated with Advil Tylenol Simethicone CA MG / Treatment somewhat helpful / SHARP CHEST BACK & JAW PAIN RESOLVED INTO GENERAL OVERALL CHEST BACK BREAST PAIN / RECENTLY SHARP CHEST BACK JAW PAIN RETURNED / OVERALL CHEST BACK BREAST PAIN COUGHING CONTINUES AFTER TWO MONTHS
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cough, Electrocardiogram, Pain in extremity, Pain in jaw, Sensory disturbance
Clinical narrative: CHEST PAIN / BACK PAIN / JAW PAIN / BREAST PAIN / FOOT PAIN / HIVES / COUGHING / SENSATION OF CHEST BACK BREAST FOOT SWELLING / Treated with Advil Tylenol Simethicone CA MG / Treatment somewhat helpful / SHARP CHEST BACK & JAW PAIN RESOLVED INTO GENERAL OVERALL CHEST BACK BREAST PAIN / RECENTLY SHARP CHEST BACK JAW PAIN RETURNED / OVERALL CHEST BACK BREAST PAIN COUGHING CONTINUES AFTER TWO MONTHS
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: CHEST PAIN / BACK PAIN / JAW PAIN / BREAST PAIN / FOOT PAIN / HIVES / COUGHING / SENSATION OF CHEST BACK BREAST FOOT SWELLING / Treated with Advil Tylenol Simethicone CA MG / Treatment somewhat helpful / SHARP CHEST BACK & JAW PAIN RESOLVED INTO GENERAL OVERALL CHEST BACK BREAST PAIN / RECENTLY SHARP CHEST BACK JAW PAIN RETURNED / OVERALL CHEST BACK BREAST PAIN COUGHING CONTINUES AFTER TWO MONTHS
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Axillary pain, Back pain, Breast tenderness, Chest discomfort, Chest pain
Clinical narrative: CHEST PAIN / BACK PAIN / JAW PAIN / BREAST PAIN / FOOT PAIN / HIVES / COUGHING / SENSATION OF CHEST BACK BREAST FOOT SWELLING / Treated with Advil Tylenol Simethicone CA MG / Treatment somewhat helpful / SHARP CHEST BACK & JAW PAIN RESOLVED INTO GENERAL OVERALL CHEST BACK BREAST PAIN / RECENTLY SHARP CHEST BACK JAW PAIN RETURNED / OVERALL CHEST BACK BREAST PAIN COUGHING CONTINUES AFTER TWO MONTHS
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cough, Cyst, Depression, Headache, Insomnia
Clinical narrative: CHEST PAIN / BACK PAIN / JAW PAIN / BREAST PAIN / FOOT PAIN / HIVES / COUGHING / SENSATION OF CHEST BACK BREAST FOOT SWELLING / Treated with Advil Tylenol Simethicone CA MG / Treatment somewhat helpful / SHARP CHEST BACK & JAW PAIN RESOLVED INTO GENERAL OVERALL CHEST BACK BREAST PAIN / RECENTLY SHARP CHEST BACK JAW PAIN RETURNED / OVERALL CHEST BACK BREAST PAIN COUGHING CONTINUES AFTER TWO MONTHS
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Lethargy, Malaise, Pain in extremity, Pain in jaw, Premenstrual pain
Clinical narrative: CHEST PAIN / BACK PAIN / JAW PAIN / BREAST PAIN / FOOT PAIN / HIVES / COUGHING / SENSATION OF CHEST BACK BREAST FOOT SWELLING / Treated with Advil Tylenol Simethicone CA MG / Treatment somewhat helpful / SHARP CHEST BACK & JAW PAIN RESOLVED INTO GENERAL OVERALL CHEST BACK BREAST PAIN / RECENTLY SHARP CHEST BACK JAW PAIN RETURNED / OVERALL CHEST BACK BREAST PAIN COUGHING CONTINUES AFTER TWO MONTHS
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pruritus, Swelling, Urticaria, Weight abnormal
Clinical narrative: CHEST PAIN / BACK PAIN / JAW PAIN / BREAST PAIN / FOOT PAIN / HIVES / COUGHING / SENSATION OF CHEST BACK BREAST FOOT SWELLING / Treated with Advil Tylenol Simethicone CA MG / Treatment somewhat helpful / SHARP CHEST BACK & JAW PAIN RESOLVED INTO GENERAL OVERALL CHEST BACK BREAST PAIN / RECENTLY SHARP CHEST BACK JAW PAIN RETURNED / OVERALL CHEST BACK BREAST PAIN COUGHING CONTINUES AFTER TWO MONTHS
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Sensation of foreign body, Throat tightness
Clinical narrative: 62 year old male presented for 1st dose COVID vaccine with pfizer. 15-minutes post-vaccination the patient complained of having a minor headache. At this time he expressed no other concerns or symptoms. The patient was moved to a shaded area and provided water. Upon further questioning in Spanish the patient reported that his HA was progressively worsening since onset and he had an associated "tightness" and sensation of a growing lump in his throat. Patient denied SOB, chest tightness, difficulty breathing, itching, hives, lightheadedness, N/V. At this time the decision was made to contact EMS. EMS arrived at 1804 and evaluated the patient. During evaluation the patient reported improvement of his HA and throat discomfort. EMS instructed patient to be evaluated at the local ER. However, the patient refused and signed to leave AMA. Patient left the site at 1825 and stated he would take the bus home. Education was provided and patient instructed to follow-up in ER if symptoms re-emerge.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Bedridden, Chills, Decreased appetite, Electrocardiogram, Magnetic resonance imaging
Clinical narrative: Bedridden for 9 days. Chills high fever loss of appetite. Hospitalized for 10 days on oxygen remdesivir and antibiotics
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, X-ray
Clinical narrative: Bedridden for 9 days. Chills high fever loss of appetite. Hospitalized for 10 days on oxygen remdesivir and antibiotics
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Piercing chest pains at 6:20pm and 12:05am.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Skin warm, Swelling, Tenderness, Urticaria, Vaccination site reaction
Clinical narrative: COVID arm, swollen, hot, huge red welt, tender, spreading
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster, Neuralgia, Rash
Clinical narrative: (reporting as I read about other inflammatory conditions in another that caused adverse events). It might not be related - I contracted a very bad case of Shingles on June 21st with slight nerve symptoms occurring through today (July 18th). With the rash showing by June 25th at 8p.  End result, on June 26th ~2P,  I went to urgent care and was prescribed Valacylovir for 10 days to help reduce severity of symptoms
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Syncope
Clinical narrative: pt fainted 5 minutes after dose, had high temperature. had to have 1 shot of 0.3mg epipen, used ice packs to cool down temperature. pt regained consciousness after 10 seconds, was able to answer questions, was pale looking. called 911, was taken to hospital by paramedics for further testing
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient is 16 years old. Was provided vaccine without guardian being present.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Deep vein thrombosis, Optic ischaemic neuropathy, Peripheral embolism, Ultrasound Doppler, Visual impairment
Clinical narrative: I did get "moderna arm" following 2nd dose but it is the aforementioned issues (VASCULAR) with my LEFT EYE and blood clot in LEFT LEG
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Nasal congestion, SARS-CoV-2 test positive
Clinical narrative: Cough and nasal congestion developed on 7/25/2021.  Tested positive for COVID on 7/26/2021
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac failure congestive, Catheterisation cardiac abnormal, Chest pain, Chronic left ventricular failure, Coronary arterial stent insertion
Clinical narrative: The symptoms were ever pain in my chest, great discomfort allowing only one sitting position on the ground, inability to walk more than about 50 feet without resting.  After three attempts to walk, I could no longer continue.  I was the beginning  of a myocardial infarction.  It was four hours before a rescue team could get me to the hospital.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Ejection fraction decreased, Gait disturbance, Ischaemia, Myocardial infarction
Clinical narrative: The symptoms were ever pain in my chest, great discomfort allowing only one sitting position on the ground, inability to walk more than about 50 feet without resting.  After three attempts to walk, I could no longer continue.  I was the beginning  of a myocardial infarction.  It was four hours before a rescue team could get me to the hospital.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Fatigue, Headache, Oropharyngeal pain
Clinical narrative: patient developed cough, fatigue, body aches, headache, sore throat, and a fever on 07/25/21.  He tested positive for COVID on 07/26/21
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: patient developed cough, fatigue, body aches, headache, sore throat, and a fever on 07/25/21.  He tested positive for COVID on 07/26/21
Age: 31.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Cough, Dyspnoea, Pyrexia
Clinical narrative: Fever, chills, cough, shortness of breath.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Cough, Fatigue
Clinical narrative: patient develop symptoms beginning on 7/23/2021, including cough, new loss of taste or smell, body aches, sore throat, nasal congestion, fever up to 101.2, and fatigue.  Tested positive for COVID on 7/26/2021
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Oropharyngeal pain, Pain, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: patient develop symptoms beginning on 7/23/2021, including cough, new loss of taste or smell, body aches, sore throat, nasal congestion, fever up to 101.2, and fatigue.  Tested positive for COVID on 7/26/2021
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Fatigue, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: Patient reports that he was vaccinated for COVID in March.   I do not have documentation of the type of vaccine or lot number, he was to send that information to his PCP's office. Patient developed cough, fatigue, sore throat, and runny nose on 07/22/2021.  He tested positive for COVID on 7/26/2021
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Allergy test positive, Hypersensitivity, Rash, Rash pruritic
Clinical narrative: Approximately two weeks after each dose, I broke out in a full body rash.  I had an appointment with my dermatologist who prescribed Prednisone. This cleared up the rash, but as soon as the prescription was over, the rash came back. A topical cream was prescribed to use which is more safe. My dermatologist recommended I see an Allergist. I saw an allergist who tested me for several types of allergens. I have never in my 37 years of living had any type of allergy; food or environmental. Ultimately, the scratch test showed that I am now allergic to every single environmental allergen. This rash will not go away. It is the most uncomfortable full body rash that itches endlessly. There has been no outcome as of yet. I have been dealing with trying to manage this rash since mid March of 2021 after receiving the first Moderna dose.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: Sensation of throat tightness started at 9 pm, persistent at least several hours (while in emergency department). Advised to take Benadryl. Discharged to home from emergency department.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspepsia, Insomnia
Clinical narrative: Insomnia and indigestion
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea
Clinical narrative: Chest pain, shortness of breath
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstruation irregular
Clinical narrative: heavy bleeding; Changes on  menstruation; This is a spontaneous report from a contactable consumer. A 35-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: Unknown) via an unspecified route of administration in the arm left on 21Apr2021 at 23:00 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history and concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: Unknown) via an unspecified route of administration in the  left arm on 31Mar2021 at 11:00 as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 23Apr2021 at 09:00, the patient experienced heavy bleeding and change on menstruation(irregular menstruation). The clinical outcome of the event heavy bleeding and change on  menstruation were recovering at the time of this report.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypersensitivity, Pruritus, SARS-CoV-2 test, Swelling face
Clinical narrative: I had an allergic reaction after the first dose, swollen face, itchy body and face. Headache.; I had an allergic reaction after the first dose, swollen face, itchy body and face. Headache.; I had an allergic reaction after the first dose, swollen face, itchy body and face. Headache.; I had an allergic reaction after the first dose, swollen face, itchy body and face. Headache.; This is a spontaneous report from a contactable consumer (Patient). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date: was not reported ), dose 1 via an unspecified route of administration, administered in Arm Right on 19May2021 at 13:30 ( Age at vaccination: 50 years) as dose 1, single for covid-19 immunisation. Patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not received any other medications within 2 weeks of vaccination. The patient was previously diagnosed with COVID-19, and since the vaccination the patient tested for COVID-19. Concomitant medications were not reported. The patient previously took Penicillin, Codeine phosphate (CDOEIN) and acetylsalicylic acid (ASPIRIN E.C) and had Drug allergy. It was reported that she had an allergic reaction after the first dose, swollen face, itchy body and face and headache on 19May2021 at 17:00. The patient underwent lab tests and procedures which included sars-cov-2 test which was negative on 06Apr2021 Nasal Swab. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Bone pain, Dysphagia, Dyspnoea, Headache
Clinical narrative: excruciating pain in the bones; sharp neck pain; Headache; sore throat; Difficulty swallowing and breathing; Difficulty swallowing and breathing; Swollen and blistered on the right leg; Swollen and blistered on the right leg; itch and hurt; itch and hurt; This is a spontaneous report from a contactable consumer (patient). A 60-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) dose 2 via an unspecified route of administration in Arm Right on 04May2021 10:00 (at the age of 60 years old) as single for COVID-19 immunisation at Hospital. Medical history included lupus erythematosus, rheumatoid arthritis, fibromyalgia. Concomitant medication received within two weeks included baclofen (SOLOFEN), clonazepam (KLONOPIN), trazodone hydrochloride (TRAZODON) all taken for an unspecified indication, start and stop date were not reported and Plasma Capilar. The patient previously took tramadol and experienced allergies, ultacit and experienced allergies, ultram and experienced allergies. The patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in Arm Right on 13Apr2021 08:00 (at the age of 60 years old) as single for COVID-19 immunisation. Patient did not have COVID prior to vaccination. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced excruciating pain in the bones, sharp neck pain, headache, sore throat, difficulty swallowing and breathing, swollen and blistered on the right leg, itch and hurt on 06May2021 16:00. Event reported as, After three days excruciating pain in the bones. Still sharp neck pain. Headache and sore throat. Difficulty swallowing and breathing. Swollen and blistered on the right leg. They itch and hurt. The pain in the neck is excruciating. Adverse events resulted in emergency room/department or urgent care. Treatment given for adverse events included toradol, sodomedrol, ataraxia, norflex. Patient did not tested for COVID post vaccination. Outcome of all the events were not recovered.  Information about/lot batch number is requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Oropharyngeal pain, Pain, Peripheral swelling, Pruritus
Clinical narrative: excruciating pain in the bones; sharp neck pain; Headache; sore throat; Difficulty swallowing and breathing; Difficulty swallowing and breathing; Swollen and blistered on the right leg; Swollen and blistered on the right leg; itch and hurt; itch and hurt; This is a spontaneous report from a contactable consumer (patient). A 60-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) dose 2 via an unspecified route of administration in Arm Right on 04May2021 10:00 (at the age of 60 years old) as single for COVID-19 immunisation at Hospital. Medical history included lupus erythematosus, rheumatoid arthritis, fibromyalgia. Concomitant medication received within two weeks included baclofen (SOLOFEN), clonazepam (KLONOPIN), trazodone hydrochloride (TRAZODON) all taken for an unspecified indication, start and stop date were not reported and Plasma Capilar. The patient previously took tramadol and experienced allergies, ultacit and experienced allergies, ultram and experienced allergies. The patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in Arm Right on 13Apr2021 08:00 (at the age of 60 years old) as single for COVID-19 immunisation. Patient did not have COVID prior to vaccination. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced excruciating pain in the bones, sharp neck pain, headache, sore throat, difficulty swallowing and breathing, swollen and blistered on the right leg, itch and hurt on 06May2021 16:00. Event reported as, After three days excruciating pain in the bones. Still sharp neck pain. Headache and sore throat. Difficulty swallowing and breathing. Swollen and blistered on the right leg. They itch and hurt. The pain in the neck is excruciating. Adverse events resulted in emergency room/department or urgent care. Treatment given for adverse events included toradol, sodomedrol, ataraxia, norflex. Patient did not tested for COVID post vaccination. Outcome of all the events were not recovered.  Information about/lot batch number is requested.
Age: 51.0
Sex: U
Vaccine: COVID19
Symptoms: Condition aggravated, Thrombosis
Clinical narrative: Severe clotting in legs
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse events reported; administration of expired ROTATEQ; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided.     On 28-JUN-2021, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # 1684154 has been verified to be a valid lot number, expiration date was reported as 24-JUN-2021; strength and route were not reported) 2 ml for prophylaxis. No additional adverse events or product quality complaints were reported.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: None of the patients reported symptoms. No Additional AE's/PQC's were reported.; Improperly stored PEDVAXHIB has been administered to patients; This spontaneous report was received from a staff from an outpatient care, referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided.  From 24-MAY-2021 to 25-MAY-2021, a temperature excursion occurred as haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot# T026067 has been verified to be a valid lot number, expiration date was reported as 01-APR-2023) was stored under 54.3 Fahrenheit (F) for 1 hour and 20 minutes, 55.0 F for 7 hours and 10 minutes and 56.8 F for 2 hours and 35 minutes. The temperature excursion was recorded by digital data logger. There was no previous temperature excursion. On 10-JUN-2021, the patient was vaccinated with the improperly stored vaccine (strength and route were not reported) 1 (unit not provided) for prophylaxis. The patient did not report symptoms. No additional adverse events (AE) or product quality complaints (PQC) were reported.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: None of the patients reported symptoms. No Additional AE's/PQC's were reported.; Improperly stored PEDVAXHIB has been administered to patients; This spontaneous report was received from a staff from an outpatient care, referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided.  From 24-MAY-2021 to 25-MAY-2021, a temperature excursion occurred as haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot # T026067 has been verified to be a valid lot number, expiration date was reported as 01-APR-2023) was stored under 54.3 Fahrenheit (F) for 1 hour and 20 minutes, 55.0 F for 7 hours and 10 minutes and 56.8 F for 2 hours and 35 minutes. The temperature excursion was recorded by digital data logger. There was no previous temperature excursion. On 17-JUN-2021, the patient was vaccinated with the improperly stored vaccine (strength and route were not reported) 1 (unit not provided) for prophylaxis. The patient did not report symptoms. No additional adverse events (AE) or product quality complaints (PQC) were reported.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: None of the patients reported symptoms. No Additional AE's/PQC's were reported.; Improperly stored PEDVAXHIB has been administered to patients; This spontaneous report was received from a staff from an outpatient care, referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided.  From 24-MAY-2021 to 25-MAY-2021, a temperature excursion occurred as haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot # T026067 has been verified to be a valid lot number, expiration date was reported as 01-APR-2023) was stored under 54.3 Fahrenheit (F) for 1 hour and 20 minutes, 55.0 F for 7 hours and 10 minutes and 56.8 F for 2 hours and 35 minutes. The temperature excursion was recorded by digital data logger. There was no previous temperature excursion. On 18-JUN-2021, the patient was vaccinated with the improperly stored vaccine (strength and route were not reported) 1 (unit not provided) for prophylaxis. The patient did not report symptoms. No additional adverse events (AE) or product quality complaints (PQC) were reported.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: None of the patients reported symptoms. No Additional AE's/PQC's were reported.; Improperly stored PEDVAXHIB has been administered to patients; This spontaneous report was received from a staff from an outpatient care, referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided.  From 24-MAY-2021 to 25-MAY-2021, a temperature excursion occurred as haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot # T026067 has been verified to be a valid lot number, expiration date was reported as 01-APR-2023) was stored under 54.3 Fahrenheit (F) for 1 hour and 20 minutes, 55.0 F for 7 hours and 10 minutes and 56.8 F for 2 hours and 35 minutes. The temperature excursion was recorded by digital data logger. There was no previous temperature excursion. On 22-JUN-2021, the patient was vaccinated with the improperly stored vaccine (strength and route were not reported) 1 (unit not provided) for prophylaxis. The patient did not report symptoms. No additional adverse events (AE) or product quality complaints (PQC) were reported.  This is one of several reports received from the same reporter.