chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Swelling, Testicular swelling, Urine analysis normal
Clinical narrative: Increase swelling May 15, 2021 of hands, legs, feet and pain in all joints.  July 18/2021, rash above knees.  August 4, 2021, seen by Dr. office with edema both knees, bloodwork ordered, and leg cramps. Medication prescribed: Diclofenac 75 mg 2x's a day. August 6, 2021, labs drawn.  August 12, 2021, seen by Dr. with increase leg pain (swollen, stiffness, and in feet as well both legs), arthralgia of bil knees, added Lyme titer to blood work, (lump left side testicle, soft/moveable, no pain). Steroid taper ordered. September 20, 2021,seen by APRN-CNP with arthralgia of joints, swelling and prediabetes. Wearing compression socks bil legs. Given Triamcinolone acetonide/methylprednisolone acetate inj
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Constipation, Dyspepsia, Dyspnoea, Ear swelling
Clinical narrative: sharp headache, difficult breathing, body numb, extreme shaking, nausea, then whole body aching, tight all over, skin rash, very tired later, had to sleep immediately, swollen around ear,  neck and throat.  Sore gums, swollen and bleeding gums, vaginal bleeding, past menopause for 3 years.  constipation, irregular heartbeat, very acid stomach, symptoms started about 4 hours after shot . symptoms have continued  slowly diminushing
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Gingival bleeding, Gingival pain, Gingival swelling, Headache
Clinical narrative: sharp headache, difficult breathing, body numb, extreme shaking, nausea, then whole body aching, tight all over, skin rash, very tired later, had to sleep immediately, swollen around ear,  neck and throat.  Sore gums, swollen and bleeding gums, vaginal bleeding, past menopause for 3 years.  constipation, irregular heartbeat, very acid stomach, symptoms started about 4 hours after shot . symptoms have continued  slowly diminushing
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate irregular, Hypoaesthesia, Muscle tightness, Nausea, Pain
Clinical narrative: sharp headache, difficult breathing, body numb, extreme shaking, nausea, then whole body aching, tight all over, skin rash, very tired later, had to sleep immediately, swollen around ear,  neck and throat.  Sore gums, swollen and bleeding gums, vaginal bleeding, past menopause for 3 years.  constipation, irregular heartbeat, very acid stomach, symptoms started about 4 hours after shot . symptoms have continued  slowly diminushing
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pharyngeal swelling, Postmenopausal haemorrhage, Rash, Swelling, Tremor
Clinical narrative: sharp headache, difficult breathing, body numb, extreme shaking, nausea, then whole body aching, tight all over, skin rash, very tired later, had to sleep immediately, swollen around ear,  neck and throat.  Sore gums, swollen and bleeding gums, vaginal bleeding, past menopause for 3 years.  constipation, irregular heartbeat, very acid stomach, symptoms started about 4 hours after shot . symptoms have continued  slowly diminushing
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Constipation, Dyspnoea, Ear swelling, Fatigue, Gingival bleeding
Clinical narrative: sharp headache, difficult breathing, body numb, extreme shaking, nausea, then whole body aching, tight all over, skin rash, very tired later, had to sleep immediately, swollen around ear,  neck and throat.  Sore gums, swollen and bleeding gums, vaginal bleeding, past menopause for 3 years.  constipation, irregular heartbeat, very acid stomach, symptoms started about 4 hours after shot . symptoms have continued  slowly diminushing
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Gingival pain, Gingival swelling, Headache, Heart rate irregular, Hyperchlorhydria
Clinical narrative: sharp headache, difficult breathing, body numb, extreme shaking, nausea, then whole body aching, tight all over, skin rash, very tired later, had to sleep immediately, swollen around ear,  neck and throat.  Sore gums, swollen and bleeding gums, vaginal bleeding, past menopause for 3 years.  constipation, irregular heartbeat, very acid stomach, symptoms started about 4 hours after shot . symptoms have continued  slowly diminushing
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Nausea, Pain, Pharyngeal swelling, Postmenopausal haemorrhage
Clinical narrative: sharp headache, difficult breathing, body numb, extreme shaking, nausea, then whole body aching, tight all over, skin rash, very tired later, had to sleep immediately, swollen around ear,  neck and throat.  Sore gums, swollen and bleeding gums, vaginal bleeding, past menopause for 3 years.  constipation, irregular heartbeat, very acid stomach, symptoms started about 4 hours after shot . symptoms have continued  slowly diminushing
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Skin tightness, Somnolence, Swelling, Tremor
Clinical narrative: sharp headache, difficult breathing, body numb, extreme shaking, nausea, then whole body aching, tight all over, skin rash, very tired later, had to sleep immediately, swollen around ear,  neck and throat.  Sore gums, swollen and bleeding gums, vaginal bleeding, past menopause for 3 years.  constipation, irregular heartbeat, very acid stomach, symptoms started about 4 hours after shot . symptoms have continued  slowly diminushing
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: sharp headache, difficult breathing, body numb, extreme shaking, nausea, then whole body aching, tight all over, skin rash, very tired later, had to sleep immediately, swollen around ear,  neck and throat.  Sore gums, swollen and bleeding gums, vaginal bleeding, past menopause for 3 years.  constipation, irregular heartbeat, very acid stomach, symptoms started about 4 hours after shot . symptoms have continued  slowly diminushing
Age: 67.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: Angiogram pulmonary, Chest discomfort, Dizziness, Hyperhidrosis, Hypersensitivity
Clinical narrative: TDAP Given : 1513 At Approximately 1520 went to check on patient: Pt with c/o of "feeling weird" -- > allergic reaction, tightness in chest, dizziness, sweating, increased RR, O2 placed. Upon exam lungs CTA, no wheezing or retractions, no angioedema , no swelling or redness at the injection site:  Vitals:BP 160/100, HR 45-50, SPO2 93% 2 L, RR 24 Patient's own EPI pen given at 1525, exam unchanged 1530: HR 143, SPO2 92%2 L, RR 20 , exam unchanged 1533: HR 77, 91% SP02 RR 18, exam unchanged Patient transferred to ED via nursing staff for monitoring Reordered EPI pen
Age: 67.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: Angiogram, Chest discomfort, Dizziness, Feeling abnormal, Hyperhidrosis
Clinical narrative: TDAP Given : 1513 At Approximately 1520 went to check on patient: Pt with c/o of "feeling weird" -- > allergic reaction, tightness in chest, dizziness, sweating, increased RR, O2 placed. Upon exam lungs CTA, no wheezing or retractions, no angioedema , no swelling or redness at the injection site:  Vitals:BP 160/100, HR 45-50, SPO2 93% 2 L, RR 24 Patient's own EPI pen given at 1525, exam unchanged 1530: HR 143, SPO2 92%2 L, RR 20 , exam unchanged 1533: HR 77, 91% SP02 RR 18, exam unchanged Patient transferred to ED via nursing staff for monitoring Reordered EPI pen
Age: 67.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: Hypersensitivity, Respiratory rate increased
Clinical narrative: TDAP Given : 1513 At Approximately 1520 went to check on patient: Pt with c/o of "feeling weird" -- > allergic reaction, tightness in chest, dizziness, sweating, increased RR, O2 placed. Upon exam lungs CTA, no wheezing or retractions, no angioedema , no swelling or redness at the injection site:  Vitals:BP 160/100, HR 45-50, SPO2 93% 2 L, RR 24 Patient's own EPI pen given at 1525, exam unchanged 1530: HR 143, SPO2 92%2 L, RR 20 , exam unchanged 1533: HR 77, 91% SP02 RR 18, exam unchanged Patient transferred to ED via nursing staff for monitoring Reordered EPI pen
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Dizziness, Electrocardiogram QT prolonged, Electrocardiogram abnormal, Heart rate abnormal
Clinical narrative: Patient developed severe chest pain and nausea and went to ER. EKG showed QTc of 600. Patient received magnesium and repeat EKG showed normal sinus rhythm with a normal QTc. Other ER work up including troponin was unremarkable. Patient's symptoms lessened and he was discharged from the ER. Patient has been having intermittent chest pain symptoms in the weeks following. Echocardiogram and 2 week heart monitor has been ordered.
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hyperventilation, Hypopnoea, Nausea, Paraesthesia
Clinical narrative: Patient developed severe chest pain and nausea and went to ER. EKG showed QTc of 600. Patient received magnesium and repeat EKG showed normal sinus rhythm with a normal QTc. Other ER work up including troponin was unremarkable. Patient's symptoms lessened and he was discharged from the ER. Patient has been having intermittent chest pain symptoms in the weeks following. Echocardiogram and 2 week heart monitor has been ordered.
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Electrocardiogram abnormal, Nausea, Troponin normal
Clinical narrative: Patient developed severe chest pain and nausea and went to ER. EKG showed QTc of 600. Patient received magnesium and repeat EKG showed normal sinus rhythm with a normal QTc. Other ER work up including troponin was unremarkable. Patient's symptoms lessened and he was discharged from the ER. Patient has been having intermittent chest pain symptoms in the weeks following. Echocardiogram and 2 week heart monitor has been ordered.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Malaise, Pain
Clinical narrative: Feeling sick; tired; This is a spontaneous report from a Pfizer-sponsored program. A 74-year-old female patient received BNT162B2 (Pfizer COVID-19 Formulation: Solution for injection Batch/Lot Number: EN6201 Expiration Date: Unknown) via an unspecified route of administration on 17Feb2021 (age at vaccination: 74-year-old) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included diabetes mellitus. Patient had too many medicines (concomitant medication). On unspecified date patient felt sick and tired. Patient second dose was schedule more than 21 days (first dose took it on 17Feb2021 and the next one is in 12Mar2021). Patient didn't received treatment for AE. Outcome of all events was unknown.   No follow-up attempts are possible; No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Malaise
Clinical narrative: Feeling sick; tired; This is a spontaneous report from a Pfizer-sponsored program. A 74-year-old female patient received BNT162B2 (Pfizer COVID-19 Formulation: Solution for injection Batch/Lot Number: EN6201 Expiration Date: Unknown) via an unspecified route of administration on 17Feb2021 (age at vaccination: 74-year-old) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included diabetes mellitus. Patient had too many medicines (concomitant medication). On unspecified date patient felt sick and tired. Patient second dose was schedule more than 21 days (first dose took it on 17Feb2021 and the next one is in 12Mar2021). Patient didn't received treatment for AE. Outcome of all events was unknown.   No follow-up attempts are possible; No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vision blurred, Visual impairment
Clinical narrative: experienced totally blurry eyes / could not see herself in the mirror / eye is not yet clear; This is a spontaneous report from a contactable consumer (Patient). A (Age:69 ;Unit: Unknown) female patient received (BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 18Feb2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 21Feb2021 the patient experienced totally blurry eyes / could not see herself in the mirror / eye is not yet clear. The patient reported that she received the first dose of the pfizer covid 19 vaccine on 18Feb2021. Three days later she experienced totally blurry eyes. She stated that on Sunday 21Feb2021 she could not see herself in the mirror, she was on the sixth day and some better today but her right eye was not yet clear. She heard another person had the same problem. She wanted to know if this is a normal side effect. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vision blurred
Clinical narrative: experienced totally blurry eyes / could not see herself in the mirror / eye is not yet clear; This is a spontaneous report from a contactable consumer (Patient). A (Age:69 ;Unit: Unknown) female patient received (BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 18Feb2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 21Feb2021 the patient experienced totally blurry eyes / could not see herself in the mirror / eye is not yet clear. The patient reported that she received the first dose of the pfizer covid 19 vaccine on 18Feb2021. Three days later she experienced totally blurry eyes. She stated that on Sunday 21Feb2021 she could not see herself in the mirror, she was on the sixth day and some better today but her right eye was not yet clear. She heard another person had the same problem. She wanted to know if this is a normal side effect. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: little arm pain; This is a spontaneous report from a contactable consumer(patient).    A 72-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection Batch/Lot number was not reported), via an unspecified route of administration on 23Feb2021 (At the age of 72-year-old) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient experienced little arm pain on an unspecified date. The patient stated, on 23Feb2021(tuesday), he took his second shot and experienced a little arm pain for 20 to 25 minutes then it became really minor and did not feel anything else nothing and the patient friends after they received their shots, they did not feel well, but he felt nothing after patient second shot. The patient question is, is the vaccine expired or not properly delivered right or low temperature was the solution diminished. Do he need or should he take an antibody test in 3 weeks to see if he have antibodies, he don't want to get the virus he don't want to get sick. Is this normal for people not to feel anything, the patient issue is that I don't feel anything, If it's not a good. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: little arm pain; This is a spontaneous report from a contactable consumer(patient).    A 72-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection Batch/Lot number was not reported), via an unspecified route of administration on 23Feb2021 (At the age of 72-year-old) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient experienced little arm pain on an unspecified date. The patient stated, on 23Feb2021(tuesday), he took his second shot and experienced a little arm pain for 20 to 25 minutes then it became really minor and did not feel anything else nothing and the patient friends after they received their shots, they did not feel well, but he felt nothing after patient second shot. The patient question is, is the vaccine expired or not properly delivered right or low temperature was the solution diminished. Do he need or should he take an antibody test in 3 weeks to see if he have antibodies, he don't want to get the virus he don't want to get sick. Is this normal for people not to feel anything, the patient issue is that I don't feel anything, If it's not a good. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Chest pain, Dyspnoea, Pruritus, Rash
Clinical narrative: Chest pain; Shortness of breath; Rash; Itching; Diarrhea; This is a spontaneous report from a contactable healthcare professional, the patient. A 27-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: CUS16433) via intramuscular route of administration in the left arm on 03Oct2021 at 16:00 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. It was unknown if the patient had any other medical history and known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via intramuscular route of administration in the left arm on an unknown date as single dose for COVID-19 immunisation. On 05Oct2021 at 08:00, the patient experienced chest pain, shortness of breath, rash, itching, and diarrhea. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of events and included treatment with unspecified medication. The clinical outcome of the events chest pain, shortness of breath, rash, itching, and diarrhea was resolved on an unknown date in Oct2021.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: X-ray
Clinical narrative: Chest pain; Shortness of breath; Rash; Itching; Diarrhea; This is a spontaneous report from a contactable healthcare professional, the patient. A 27-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: CUS16433) via intramuscular route of administration in the left arm on 03Oct2021 at 16:00 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. It was unknown if the patient had any other medical history and known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via intramuscular route of administration in the left arm on an unknown date as single dose for COVID-19 immunisation. On 05Oct2021 at 08:00, the patient experienced chest pain, shortness of breath, rash, itching, and diarrhea. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of events and included treatment with unspecified medication. The clinical outcome of the events chest pain, shortness of breath, rash, itching, and diarrhea was resolved on an unknown date in Oct2021.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Diarrhoea, Dyspnoea, Pruritus, Rash
Clinical narrative: Chest pain; Shortness of breath; Rash; Itching; Diarrhea; This is a spontaneous report from a contactable healthcare professional, the patient. A 27-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: CUS16433) via intramuscular route of administration in the left arm on 03Oct2021 at 16:00 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. It was unknown if the patient had any other medical history and known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via intramuscular route of administration in the left arm on an unknown date as single dose for COVID-19 immunisation. On 05Oct2021 at 08:00, the patient experienced chest pain, shortness of breath, rash, itching, and diarrhea. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of events and included treatment with unspecified medication. The clinical outcome of the events chest pain, shortness of breath, rash, itching, and diarrhea was resolved on an unknown date in Oct2021.
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blindness, Influenza like illness, Laboratory test, Vision blurred
Clinical narrative: New onset blurred vision accompanied by flu like symptoms beginning on 10/26/2021. Flu like symptoms resolved; however, blurred vision did not subside. Patient seen external optometrist 10/27/2021 and 10/28/2021 - per patient, no significant findings found.
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Influenza like illness, Vision blurred
Clinical narrative: New onset blurred vision accompanied by flu like symptoms beginning on 10/26/2021. Flu like symptoms resolved; however, blurred vision did not subside. Patient seen external optometrist 10/27/2021 and 10/28/2021 - per patient, no significant findings found.
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiogram pulmonary abnormal, Full blood count, Pulmonary embolism, Thrombocytopenia, Ultrasound scan
Clinical narrative: Headaches, occasional dizziness, and multiple areas of bruising throughout body
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiogram abnormal, Coagulation test, Contusion, Dizziness, Fibrin D dimer
Clinical narrative: Headaches, occasional dizziness, and multiple areas of bruising throughout body
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Heparin-induced thrombocytopenia test, Ultrasound scan
Clinical narrative: Headaches, occasional dizziness, and multiple areas of bruising throughout body
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Contusion, Pain
Clinical narrative: entire right arm from elbow to shoulder covered in petechiae
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Petechiae
Clinical narrative: entire right arm from elbow to shoulder covered in petechiae
Age: 90.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Blood sodium decreased, Confusional state, Dehydration, Dysarthria
Clinical narrative: Morning after vaccine difficulty moving legs & arms, fever 101.5, fell while trying to walk. went to ER & in hospital for 5 days.  Given prophylactic antiobiotics & IV fluids (dehydration).  Now home & walking with a walker & waiting for Physical Therapy
Age: 90.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Gait disturbance, Headache, Muscle disorder, Pyrexia
Clinical narrative: Morning after vaccine difficulty moving legs & arms, fever 101.5, fell while trying to walk. went to ER & in hospital for 5 days.  Given prophylactic antiobiotics & IV fluids (dehydration).  Now home & walking with a walker & waiting for Physical Therapy
Age: 90.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fall, Mobility decreased, Pyrexia
Clinical narrative: Morning after vaccine difficulty moving legs & arms, fever 101.5, fell while trying to walk. went to ER & in hospital for 5 days.  Given prophylactic antiobiotics & IV fluids (dehydration).  Now home & walking with a walker & waiting for Physical Therapy
Age: 60.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Axillary pain, Erythema, Immunodeficiency
Clinical narrative: Severe swelling, soreness, pain at and around injection site and umderarm, redness, hardness, warm to touch, skin discoloration
Age: 60.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Axillary pain, Erythema, Injection site pain, Pain, Skin discolouration
Clinical narrative: Severe swelling, soreness, pain at and around injection site and umderarm, redness, hardness, warm to touch, skin discoloration
Age: 60.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Skin warm, Swelling
Clinical narrative: Severe swelling, soreness, pain at and around injection site and umderarm, redness, hardness, warm to touch, skin discoloration
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Chills, Cough, Diarrhoea, Hypophagia
Clinical narrative: hospitalization (non-ICU)
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypotension, Malaise, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: hospitalization (non-ICU)
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: hospitalization (non-ICU)
Age: 17.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no additional AEs were reported; Medical assistant is reporting that a PROQUAD was given to a 17 year old patient.; This spontaneous report was received from a medical assistant and refers to a 17 years old patient of unknown gender. There was no information about the patient's concurrent conditions, allergies, drug reactions, concomitant therapies or medical history provided. On 07-OCT-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 1 dose, (lot # T030760, expiration date: 08-MAR-2022, albumin status:rHa) for prophylaxis (exact dose, dose number, route of administration and anatomical location were not reported). The vaccine was administered to patient in inappropriate age. No additional adverse events were reported. The outcome was unknown.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, Ill-defined disorder
Clinical narrative: patient was resident on the rehab floor; an expired dose of PNEUMOV AX 23 was administered; This spontaneous report has been received from a pharmacist referring to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided.  On 13-OCT-2021, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (1 dosage form, lot #: T010639, expire date: 31-AUG-2021; strength, route and anatomical Location  were not reported) for prophylaxis (expired product administered). The pharmacist stated that the dose was properly stored up through the time of administration. The patient was resident on the rehab floor (ill-defined disorder). No further information was provided.  The outcome and causality assessment for ill-defined disorder were not provided.
Age: 0.58
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional information available; Vaccine administered after temperature excursion; This spontaneous report was received from a registered nurse referring to a 7 months old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug allergies or reactions were not reported.   On 18-OCT-2021, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (strength was not reported, 2 ml, lot # T030458, expiration date: 11-APR-2022) oral for prophylaxis (product storage error).         It was reported that the suspect vaccine was exposed to a temperature of 35 F for a time frame of 30 minutes. No digital data logger was reported. There were no previous temperature excursions. No further adverse event (AE) information was provided (no adverse event).
Sex: F
Vaccine: FLUX, PPV
Symptoms: Dizziness, Injection site warmth, Nausea
Clinical narrative: injection site is very, very warm at the site; she has gotten nauseous twice; is feeling dizzy; This spontaneous report was received from a consumer, referring to their mother, a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On an unspecified day in October 2021 (also reported as less than 12 hours ago), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection and influenza vaccine (manufacturer unknown) injection (strengths, vaccination schemes, anatomical sites of vaccinations, routes of administration, lot numbers and expiration dates were not reported) as prophylaxis.  On an unspecified day October 2021, the injection site was very, very warm (vaccination site warmth), also she had gotten nauseous twice (nausea) and was feeling dizzy (dizziness).  The outcome of vaccination site warmth, dizziness and nausea was not reported. The causal relationship between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was reported as related. The causal relationship between the events and influenza vaccine (manufacturer unknown) was not reported.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: she denied further AE; VAQTA was administered to a patient after experiencing a temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.     On 03-OCT-2021, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) lot # T013204, expiration date on 03-DEC-2021 (conflicting information also reported as 13-DEC-2021) 0.5 milliliter, for prophylaxis (strength, route of administration and anatomical location were not reported); after experiencing a temperature excursion (product storage error).  Vaccine was improperly stored at 50°F during a time frame of 0 hours and 30 minutes. No previous temperature excursion were reported and medical assistant denied further Adverse Event (AE) (no adverse event). ; Sender's Comments:  US-009507513-2110USA007288: US-009507513-2110USA007310: US-009507513-2110USA007316: US-009507513-2110USA007379: US-009507513-2110USA007269: US-009507513-2110USA007272: US-009507513-2110USA006972:
Age: 1.25
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details available; vaccines were administered after experiencing temperature excursion; This spontaneous report was received from a Medical Assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported.  On 16-SEP-2021, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # T032317, expiry date: 22-SEP-2022 (strength, dose number, route and anatomical location were not provided) for prophylaxis.  The varicella virus vaccine live (oka/merck)(VARIVAX) was stored in temperature of 6°F to 14°F (8.5° F) for 0 hours l8 minutes O seconds; 6°F to 14°F (l l.9F) for 1 hour 0 minutes 0 seconds with a cumulative Timeframe: 1 hour and 18 minutes. There was no previous temperature excursion reported. No adverse effects were reported. No product quality complaint was involved.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: were administered after experiencing temperature excursion.; No additional AE details available.; This spontaneous report was received from a Medical Assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported.  On 10-SEP-2021, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # T032932, expiry date: 28-SEP-2022 (strength, dose number, route and anatomical location were not provided) for prophylaxis.  The varicella virus vaccine live (oka/merck)(VARIVAX) was stored in temperature of 6°F to 14°F (8.5° F) for 0 hours 18 minutes 0 seconds; 6°F to 14°F (11.9F) for 1 hour 0 minutes 0 seconds with a cumulative Timeframe: 1 hour and 18 minutes. There was no previous temperature excursion reported. No adverse effects were reported. No product quality complaint was involved.
Sex: F
Vaccine: HPV9
Symptoms: Coma, Diplopia, Endotracheal intubation, Headache, Impaired work ability
Clinical narrative: Metabolic encephalopathy (felt under the weather,seizure, coma, double vision, fever, headache); This spontaneous report as received from a physician via a company representative refers to a 36 or 37 years old female patient. The patient's historical vaccine included unspecified Covid-19 vaccine. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown date, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis         On an unknown date, 2 days after vaccination, the patient developed fever and headache. The patient was told to take ibuprofen or paracetamol (TYLENOL). The patient then felt "under the weather" and developed double vision so she went to an emergency room (ER). In the ER, she had seizures and went into a coma so she was admitted to the hospital. She was intubated to protect her airway. In the hospital, she was diagnosed with metabolic encephalopathy. The patient was discharged from the unspecified hospital about 2 weeks ago and she has been in a rehab. She could not work so she was just sitting at home.   The outcome of metabolic encephalopathy was unknown. Causality assessment was not provided.  Upon internal review, the event of metabolic encephalopathy was determined to be medically significant, disabling and life threatening.
Sex: F
Vaccine: HPV9
Symptoms: Malaise, Metabolic encephalopathy, Pyrexia, Seizure
Clinical narrative: Metabolic encephalopathy (felt under the weather,seizure, coma, double vision, fever, headache); This spontaneous report as received from a physician via a company representative refers to a 36 or 37 years old female patient. The patient's historical vaccine included unspecified Covid-19 vaccine. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown date, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis         On an unknown date, 2 days after vaccination, the patient developed fever and headache. The patient was told to take ibuprofen or paracetamol (TYLENOL). The patient then felt "under the weather" and developed double vision so she went to an emergency room (ER). In the ER, she had seizures and went into a coma so she was admitted to the hospital. She was intubated to protect her airway. In the hospital, she was diagnosed with metabolic encephalopathy. The patient was discharged from the unspecified hospital about 2 weeks ago and she has been in a rehab. She could not work so she was just sitting at home.   The outcome of metabolic encephalopathy was unknown. Causality assessment was not provided.  Upon internal review, the event of metabolic encephalopathy was determined to be medically significant, disabling and life threatening.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: not signs or symptoms reported. No other AE or PQC reported; a temperature excursion on ROTATEQ, ROTATEQ was administered; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender.  The patient's concomitant medication, pertinent medical history and drug allergies or reactions were not reported.   On 26-OCT-2021, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (strength was not reported, lot # T040208, expiration date was 19-JUL-2022) 1 time dose, orally for prophylaxis (product storage error).         It was reported that the suspect vaccine was exposed to a temperature of 34.03 F for a time frame of 5 minutes (on 26-OCT-2021). There were no previous temperature excursions. No digital data logger was reported. There was no not signs or symptoms reported. No further adverse event (AE) information was provided (no adverse event).   This is one of the several reports reported by the same reporter.; Sender's Comments:  US-009507513-2111USA000689: US-009507513-2111USA000688:
Sex: U
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: Temperature Excursion Heplisav-B Administered to 15 Patients; Initial Report Received on 14-Sep-2021 and 15-Sep-2021  A Registered Medical Assistant reported that approximately 15 patients (age, gender, race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization after the vaccine was out of temperature range with multiple excursions over a maximum of 10 days.  This report is for patient 1 of 15.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On an unspecified date, the patient 1 of 15 received a dose of HEPLISAV-B (Lot #, expiration date and NDC # not reported) after the vaccine was out of temperature range with multiple excursions over a maximum of 10 days. The route and site of vaccine administration were not reported.   No additional information was reported.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: Temperature Excursion Heplisav-B Administered to 15 Patients; Initial Report Received on 14-Sep-2021 and 15-Sep-2021  A Registered Medical Assistant reported that approximately 15 patients (age, gender, race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization after the vaccine was out of temperature range with multiple excursions over a maximum of 10 days.  This report is for patient 2 of 15.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On an unspecified date, the patient 2 of 15 received a dose of HEPLISAV-B (Lot #, expiration date and NDC # not reported) after the vaccine was out of temperature range with multiple excursions over a maximum of 10 days. The route and site of vaccine administration were not reported.   No additional information was reported.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: Temperature Excursion Heplisav-B Administered to 15 Patients; Initial Report Received on 14-Sep-2021 and 15-Sep-2021  A Registered Medical Assistant reported that approximately 15 patients (age, gender, race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization after the vaccine was out of temperature range with multiple excursions over a maximum of 10 days. This report is for patient 3 of 15.   No relevant medical history was reported.    No relevant concomitant medications were reported.    On an unspecified date, the patient 3 of 15 received a dose of HEPLISAV-B (Lot #, expiration date and NDC # not reported) after the vaccine was out of temperature range with multiple excursions over a maximum of 10 days. The route and site of vaccine administration were not reported.   No additional information was reported.   Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: Temperature Excursion Heplisav-B Administered to 15 Patients; Initial Report Received on 14-Sep-2021 and 15-Sep-2021  A Registered Medical Assistant reported that a approximately 15 patients (age, gender, race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization after the vaccine was out of temperature range with multiple excursions over a maximum of 10 days. This report is for patient 4 of 15.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On an unspecified date, the patient 4 of 15 received a dose of HEPLISAV-B (Lot #, expiration date and NDC # not reported) after the vaccine was out of temperature range with multiple excursions over a maximum of 10 days. The route and site of vaccine administration were not reported.   No additional information was reported.   Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: Temperature Excursion Heplisav-B Administered to 15 Patients; Initial Report Received on 14-Sep-2021 and 15-Sep-2021  A Registered Medical Assistant reported that approximately 15 patients (age, gender, race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization after the vaccine was out of temperature range with multiple excursions over a maximum of 10 days. This report is for patient 5 of 15.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On an unspecified date, the patient 5 of 15 received a dose of HEPLISAV-B (Lot #, expiration date and NDC # not reported) after the vaccine was out of temperature range with multiple excursions over a maximum of 10 days. The route and site of vaccine administration were not reported.   No additional information was reported.   Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: Temperature Excursion Heplisav-B Administered to 15 Patients; Initial Report Received on 14-Sep-2021 and 15-Sep-2021  A Registered Medical Assistant reported that approximately 15 patients (age, gender, race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization after the vaccine was out of temperature range with multiple excursions over a maximum of 10 days. This report is for patient 6 of 15.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On an unspecified date, the patient 6 of 15 received a dose of HEPLISAV-B (Lot #, expiration date and NDC # not reported) after the vaccine was out of temperature range with multiple excursions over a maximum of 10 days. The route and site of vaccine administration were not reported.   No additional information was reported.   Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: Temperature Excursion Heplisav-B Administered to 15 Patients; Initial Report Received on 14-Sep-2021 and 15-Sep-2021  A Registered Medical Assistant reported that approximately 15 patients (age, gender, race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization after the vaccine was out of temperature range with multiple excursions over a maximum of 10 days. This report is for patient 7 of 15.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On an unspecified date, the patient 7 of 15 received a dose of HEPLISAV-B (Lot #, expiration date and NDC # not reported) after the vaccine was out of temperature range with multiple excursions over a maximum of 10 days. The route and site of vaccine administration were not reported.   No additional information was reported.   Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: Temperature Excursion Heplisav-B Administered to 15 Patients; Initial Report Received on 14-Sep-2021 and 15-Sep-2021  A Registered Medical Assistant reported that approximately 15 patients (age, gender, race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization after the vaccine was out of temperature range with multiple excursions over a maximum of 10 days. This report is for patient 8 of 15.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On an unspecified date, the patient 8 of 15 received a dose of HEPLISAV-B (Lot #, expiration date and NDC # not reported) after the vaccine was out of temperature range with multiple excursions over a maximum of 10 days. The route and site of vaccine administration were not reported.   No additional information was reported.   Company Comment:  The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: Temperature Excursion Heplisav-B Administered to 15 Patients; Initial Report Received on 14-Sep-2021 and 15-Sep-2021  A Registered Medical Assistant reported that approximately 15 patients  (age, gender, race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization after the vaccine was out of temperature range with multiple excursions over a maximum of 10 days.  This report is for patient 9 of 15.   No relevant medical history was reported.    No relevant concomitant medications were reported.    On an unspecified date, the patient 9 of 15 received a dose of HEPLISAV-B (Lot #, expiration date and NDC # not reported) after the vaccine was out of temperature range with multiple excursions over a maximum of 10 days. The route and site of vaccine administration were not reported.   No additional information was reported.   Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.