chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Angiogram, Angiogram normal, Atrioventricular block, Bradycardia, Brain natriuretic peptide increased
Clinical narrative: The article notes a 36-year old male who presented for intolerance to exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, and edema, five weeks after smallpox vaccination. The patient was in mild distress, with severe orthopnea, tachypnea, tachycardia, bilateral crackles, and distant heart sounds. Electrocardiogram showed 2-to-1 AV block, with electrical cardioversion returning to sinus rhythm. A chest PA and lateral films revealed an enlarged cardiac silhouette. Laboratory investigation revealed an elevated brain natriuretic peptide (572pg/mL) and troponin (10.3ng/ml). An echocardiogram revealed an ejection fraction of 21%, an apical thrombus, pericardial effusion, diastolic dysfunction, global hypokenesis, and moderate tricuspid and mitral regurgitation. A CT Angiogram showed no evidence of coronary artery disease. A contrast MRI showed eosinophilic myocarditis. The patient was treated with furosemide, lisinopril, carvedilol, and rosuvastatin and the patient was discharged, sans carvedilol due to bradycardia. Lovenox was initiated for the LV thrombus and bridged to Warfarin for 6 months. As outpatient, cardiac function remains diminished with an EF of 20-25% with resolution of the thrombus. The patient's outcome was not reported in the article. No further information is expected.
Age: 36.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Cardiac function test abnormal, Cardiomegaly, Cardioversion, Chest X-ray abnormal, Diastolic dysfunction
Clinical narrative: The article notes a 36-year old male who presented for intolerance to exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, and edema, five weeks after smallpox vaccination. The patient was in mild distress, with severe orthopnea, tachypnea, tachycardia, bilateral crackles, and distant heart sounds. Electrocardiogram showed 2-to-1 AV block, with electrical cardioversion returning to sinus rhythm. A chest PA and lateral films revealed an enlarged cardiac silhouette. Laboratory investigation revealed an elevated brain natriuretic peptide (572pg/mL) and troponin (10.3ng/ml). An echocardiogram revealed an ejection fraction of 21%, an apical thrombus, pericardial effusion, diastolic dysfunction, global hypokenesis, and moderate tricuspid and mitral regurgitation. A CT Angiogram showed no evidence of coronary artery disease. A contrast MRI showed eosinophilic myocarditis. The patient was treated with furosemide, lisinopril, carvedilol, and rosuvastatin and the patient was discharged, sans carvedilol due to bradycardia. Lovenox was initiated for the LV thrombus and bridged to Warfarin for 6 months. As outpatient, cardiac function remains diminished with an EF of 20-25% with resolution of the thrombus. The patient's outcome was not reported in the article. No further information is expected.
Age: 36.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Exercise tolerance decreased, Heart sounds abnormal, Mitral valve incompetence, Nuclear magnetic resonance imaging thoracic abnormal, Oedema
Clinical narrative: The article notes a 36-year old male who presented for intolerance to exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, and edema, five weeks after smallpox vaccination. The patient was in mild distress, with severe orthopnea, tachypnea, tachycardia, bilateral crackles, and distant heart sounds. Electrocardiogram showed 2-to-1 AV block, with electrical cardioversion returning to sinus rhythm. A chest PA and lateral films revealed an enlarged cardiac silhouette. Laboratory investigation revealed an elevated brain natriuretic peptide (572pg/mL) and troponin (10.3ng/ml). An echocardiogram revealed an ejection fraction of 21%, an apical thrombus, pericardial effusion, diastolic dysfunction, global hypokenesis, and moderate tricuspid and mitral regurgitation. A CT Angiogram showed no evidence of coronary artery disease. A contrast MRI showed eosinophilic myocarditis. The patient was treated with furosemide, lisinopril, carvedilol, and rosuvastatin and the patient was discharged, sans carvedilol due to bradycardia. Lovenox was initiated for the LV thrombus and bridged to Warfarin for 6 months. As outpatient, cardiac function remains diminished with an EF of 20-25% with resolution of the thrombus. The patient's outcome was not reported in the article. No further information is expected.
Age: 36.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Orthopnoea, Palpitations, Pericardial effusion, Rales, Respiratory distress
Clinical narrative: The article notes a 36-year old male who presented for intolerance to exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, and edema, five weeks after smallpox vaccination. The patient was in mild distress, with severe orthopnea, tachypnea, tachycardia, bilateral crackles, and distant heart sounds. Electrocardiogram showed 2-to-1 AV block, with electrical cardioversion returning to sinus rhythm. A chest PA and lateral films revealed an enlarged cardiac silhouette. Laboratory investigation revealed an elevated brain natriuretic peptide (572pg/mL) and troponin (10.3ng/ml). An echocardiogram revealed an ejection fraction of 21%, an apical thrombus, pericardial effusion, diastolic dysfunction, global hypokenesis, and moderate tricuspid and mitral regurgitation. A CT Angiogram showed no evidence of coronary artery disease. A contrast MRI showed eosinophilic myocarditis. The patient was treated with furosemide, lisinopril, carvedilol, and rosuvastatin and the patient was discharged, sans carvedilol due to bradycardia. Lovenox was initiated for the LV thrombus and bridged to Warfarin for 6 months. As outpatient, cardiac function remains diminished with an EF of 20-25% with resolution of the thrombus. The patient's outcome was not reported in the article. No further information is expected.
Age: 36.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Scan with contrast abnormal, Tachycardia, Tachypnoea, Thrombosis, Tricuspid valve incompetence
Clinical narrative: The article notes a 36-year old male who presented for intolerance to exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, and edema, five weeks after smallpox vaccination. The patient was in mild distress, with severe orthopnea, tachypnea, tachycardia, bilateral crackles, and distant heart sounds. Electrocardiogram showed 2-to-1 AV block, with electrical cardioversion returning to sinus rhythm. A chest PA and lateral films revealed an enlarged cardiac silhouette. Laboratory investigation revealed an elevated brain natriuretic peptide (572pg/mL) and troponin (10.3ng/ml). An echocardiogram revealed an ejection fraction of 21%, an apical thrombus, pericardial effusion, diastolic dysfunction, global hypokenesis, and moderate tricuspid and mitral regurgitation. A CT Angiogram showed no evidence of coronary artery disease. A contrast MRI showed eosinophilic myocarditis. The patient was treated with furosemide, lisinopril, carvedilol, and rosuvastatin and the patient was discharged, sans carvedilol due to bradycardia. Lovenox was initiated for the LV thrombus and bridged to Warfarin for 6 months. As outpatient, cardiac function remains diminished with an EF of 20-25% with resolution of the thrombus. The patient's outcome was not reported in the article. No further information is expected.
Age: 36.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Troponin increased, Ventricular hypokinesia
Clinical narrative: The article notes a 36-year old male who presented for intolerance to exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, and edema, five weeks after smallpox vaccination. The patient was in mild distress, with severe orthopnea, tachypnea, tachycardia, bilateral crackles, and distant heart sounds. Electrocardiogram showed 2-to-1 AV block, with electrical cardioversion returning to sinus rhythm. A chest PA and lateral films revealed an enlarged cardiac silhouette. Laboratory investigation revealed an elevated brain natriuretic peptide (572pg/mL) and troponin (10.3ng/ml). An echocardiogram revealed an ejection fraction of 21%, an apical thrombus, pericardial effusion, diastolic dysfunction, global hypokenesis, and moderate tricuspid and mitral regurgitation. A CT Angiogram showed no evidence of coronary artery disease. A contrast MRI showed eosinophilic myocarditis. The patient was treated with furosemide, lisinopril, carvedilol, and rosuvastatin and the patient was discharged, sans carvedilol due to bradycardia. Lovenox was initiated for the LV thrombus and bridged to Warfarin for 6 months. As outpatient, cardiac function remains diminished with an EF of 20-25% with resolution of the thrombus. The patient's outcome was not reported in the article. No further information is expected.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis, Erythema, Peripheral swelling
Clinical narrative: Cellulitis, redness and swelling left deltoid.
Age: 1.58
Sex: M
Vaccine: FLU4, HEPA
Symptoms: Extra dose administered
Clinical narrative: Pt was accidentally given a 2nd flu shot this season when it was not indicated.
Age: 23.0
Sex: F
Vaccine: FLU4, HEP, TDAP
Symptoms: Blood glucose normal, Eye movement disorder, Malaise, Pulse absent, Skin discolouration
Clinical narrative: 1355: pt received Tdap, Flu, Hep B vaccine and PPD per HM2. Patient was getting her coat and then told HM2 that she didn't feel well. HM2 helped her to chair, her eyes deviated to left side, and she became unresponsive. No head trauma noted. HM2 held pt and called for help. RN and myself arrived to find patient gray, unresponsive and unable to find pulse. We both attempted sternal rub, decorticate posturing noted to left arm and then patient had urinary incontinence. Pt woke up quickly and was quite alert and able to answer questions and transferred to gurney with minimal help. See vitals section. 1405-patient oriented x 3 and able to tell us her husband's contact information and called her mother on her cell phone. Pt was in good spirits. No hx of past seizures or pertinent medical hx. Accucheck glucose level=91. 1420-IV started in right AC w/ 20 gauge per RN x 1 attempt with good blood return. NS 1000cc hung open. 1430-helped pt get into clean xray shorts and she continued to be in good humor and asking questions. Report called the MC per Dr. to Dr. 1435-911 called for transport and SBAR given. Patient advised that she must receive any future vaccines in a hospital setting and to follow up with us next week after evaluation in ER. Pt verbalized understanding and was very appreciative of care.
Age: 23.0
Sex: F
Vaccine: FLU4, HEP, TDAP
Symptoms: Unresponsive to stimuli, Urinary incontinence
Clinical narrative: 1355: pt received Tdap, Flu, Hep B vaccine and PPD per HM2. Patient was getting her coat and then told HM2 that she didn't feel well. HM2 helped her to chair, her eyes deviated to left side, and she became unresponsive. No head trauma noted. HM2 held pt and called for help. RN and myself arrived to find patient gray, unresponsive and unable to find pulse. We both attempted sternal rub, decorticate posturing noted to left arm and then patient had urinary incontinence. Pt woke up quickly and was quite alert and able to answer questions and transferred to gurney with minimal help. See vitals section. 1405-patient oriented x 3 and able to tell us her husband's contact information and called her mother on her cell phone. Pt was in good spirits. No hx of past seizures or pertinent medical hx. Accucheck glucose level=91. 1420-IV started in right AC w/ 20 gauge per RN x 1 attempt with good blood return. NS 1000cc hung open. 1430-helped pt get into clean xray shorts and she continued to be in good humor and asking questions. Report called the MC per Dr. to Dr. 1435-911 called for transport and SBAR given. Patient advised that she must receive any future vaccines in a hospital setting and to follow up with us next week after evaluation in ER. Pt verbalized understanding and was very appreciative of care.
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, Pelvic discomfort, Uterine pain
Clinical narrative: This spontaneous prospective pregnancy report was received from a 29 year old female patient, concerning herself. The patient had no medical history, concurrent conditions or concomitant medications. On 01-NOV-2017, the patient was vaccinated with the first dose of GARDASIL 9, intramuscularly for prevention of Human papillomavirus (HPV) (dose, lot number and expiration date were not provided). The patient stated that shortly after receiving GARDASIL 9, she was informed by her physician that she was pregnant (unspecified date). On an unknown date in November 2017, the patient experienced some pain in her womb area (uterine pain), but was not strong, just uncomfortable (pelvic discomfort). At the time of this report the patient was about 5 weeks pregnant, with a last menstrual period in approximately 11-OCT-2017. Estimated date of delivery was approximately 18-JUL-2018. The patient stated she had not seen her physician since she was told she was pregnant. At the reporting time, the outcome of uterine pain and pelvic discomfort was unknown. The pregnancy outcome was pending. The patient did not received any treatment for the events. She did not seek medical attention and no laboratory tests were performed. The reporter did not assess the causal relationship between therapy with GARDASIL 9, and the events pelvic discomfort and uterine pain.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Gait disturbance, Pain in extremity
Clinical narrative: This spontaneous report was received from a 72 years old female patient. The patient did not have any concomitant medication, pertinent medical history, drug reactions or allergies. On 13-NOV-2017, the patient was vaccinated with a PNEUMOVAX 23 injection, route of administration was reported as "for Intramuscular or Subcutaneous injection" (dose, lot # and expiry date were not provided) for prevention of pneumococcal disease. On an unknown date in November 2017, the patient experienced pain in left arm from the injection and she had pain generating from her left hip, down to her left leg and she had trouble with walking. No treatment was given for adverse events and no lab diagnostic was performed. The outcome of the all events was reported as not recovered/not resolved. The causality assessment was not provided.
Age: 30.0
Sex: M
Vaccine: FLUX, HEP, HEPA, TDAP
Symptoms: Underdose
Clinical narrative: This spontaneous report as received from two nurses refers to a 30-year-old male patient. The patient had no illness at the time of the vaccination, birth defects, medical conditions and pre-existing physician-diagnosed allergies. On 10-NOV-2017, the patient was vaccinated with a pediatric dose of RECOMBIVAX HB injection, lot # M029233, expiration date 09-AUG-2018, intramuscularly in the right arm for prophylaxis. On the same date, the patient was vaccinated also with diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid, influenza virus vaccine (unspecified), hepatitis a virus vaccine (unspecified) and hepatitis a virus vaccine (unspecified), hepatitis b virus vaccine. The reporter stated that the patient received the pediatric dose of the vaccine instead of a dose for an adult due to medication error that occurred during dispensing and administration. Wrong dose was given to the patient because another nurse did not verify the vaccination, because it was an adult patient.
Sex: M
Vaccine: VARZOS
Symptoms: Discomfort, Injection site pain, Injection site pruritus, Insomnia, Rash generalised
Clinical narrative: This spontaneous report was received from an 84-year-old male patient. The patient's medical history included herpes zoster on an unknown date. The patient had no concomitant medications or concurrent conditions. On an unknown date in 2015 (reported as "two years ago"), the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX intramuscular injection in the left arm (lot number and expiration date were not reported). The dose of the vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (dose, lot number and expiration date were not reported). On an unknown date in 2015, almost immediately after receiving the vaccine, the patient developed a light pain and itching around his upper left arm. Approximately 2 months after the vaccination, his itching progressively got worse and he started to develop a rash that eventually covered most of his body during an unspecified period of time. The rash spread to his arms, chest back, neck, head and legs. The patient stated that the initial light pain he felt immediately after the vaccination had went away, however, the itching and body rash still persisted at the time of the report. He also stated that his rash and itching sometimes got worse at night, which made it difficult and uncomfortable for him to sleep. The patient stated he had seen 5 different physicians for the past 2 years. He was prescribed topical triamcinolone as a treatment and also used several unspecified over-the-counter topical creams and "salve ointments". The patient did not recover from the events of rash and itching at the time of the report. The outcome of itching at injection site and sleeping difficult and uncomfortable was unknown. The relatedness between the events and ZOSTAVAX was not reported.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse, refers to a patient of unknown age and gender. There was no information about patient's concomitant medications or pertinent medical history. On 21-NOV-2017, the patient was vaccinated with a dose of ROTATEQ orally,  lot # M006112, expiration date 16-NOV-2017 (strength and dose were not reported) for prophylaxis.  The nurse stated that the expired vaccine did not have any temperature excursions prior to administration. No adverse symptoms were reported.
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from a physician assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 15-MAR-2015, the patient was vaccinated with the first dose of GARDASIL 9 for prophylaxis (dose, route of administration, lot number and expiration date were not reported). In July 2017, the patient was vaccinated with the second dose of GARDASIL 9 for prophylaxis (dose, route of administration, lot number and expiration date were not reported). On 22-NOV-2017, the patient received the third dose of GARDASIL 9 lot number N020139 and expiration date of 14-FEB-2020 for prophylaxis (dose and route of administration were not reported). There was not product quality complaint involved. This is one of the two reports received from the same reporter.; Sender's Comments: US-009507513-1712USA005271:
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Cellulitis, Ear pain, Erythema, Extremity contracture
Clinical narrative: This spontaneous report was received from a 73 year old female patient concerning to herself. The patient's medical history was reported as none. The patient's concomitant medications included losartan(manufacturer unknown), levothyroxine (manufacturer unknown), ZETIA and SYMBICORT. The patient drug reactions/allergies were reported as side effects to drugs. On 17-NOV-2017, the patient was vaccinated with PNEUMOVAX 23 injection for prophylaxis (route, lot# and expiration date were not provided). On 17-NOV-2017 in the night, the patient had her right arm red, swollen and painful and she stated that it "looked like cellulitis". On 18-NOV-2017, the patient was seen at an unspecified urgency care facility and was prescribed with MEDROL PACK. After the MEDROL PACK was finished the patient "started with the joints and muscles". In November 2017, the patient's right jaw got stiff and everything tightened behind the right ankle also, the patient's right ear, right knee and little finger on the right hand were sore. The patient is still in pain and the little finger is still bent over. The patient visited her physician and was on NAPROSYN 500 mg twice daily, that helped with the pain. The patient saw little improvement and she is walking a little better. The reporter did not assess the relatedness between PNEUMOVAX 23 and the adverse events. Upon internal review, the cellulitis was considered to be medically significant.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Gait disturbance, Joint stiffness, Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous report was received from a 73 year old female patient concerning to herself. The patient's medical history was reported as none. The patient's concomitant medications included losartan(manufacturer unknown), levothyroxine (manufacturer unknown), ZETIA and SYMBICORT. The patient drug reactions/allergies were reported as side effects to drugs. On 17-NOV-2017, the patient was vaccinated with PNEUMOVAX 23 injection for prophylaxis (route, lot# and expiration date were not provided). On 17-NOV-2017 in the night, the patient had her right arm red, swollen and painful and she stated that it "looked like cellulitis". On 18-NOV-2017, the patient was seen at an unspecified urgency care facility and was prescribed with MEDROL PACK. After the MEDROL PACK was finished the patient "started with the joints and muscles". In November 2017, the patient's right jaw got stiff and everything tightened behind the right ankle also, the patient's right ear, right knee and little finger on the right hand were sore. The patient is still in pain and the little finger is still bent over. The patient visited her physician and was on NAPROSYN 500 mg twice daily, that helped with the pain. The patient saw little improvement and she is walking a little better. The reporter did not assess the relatedness between PNEUMOVAX 23 and the adverse events. Upon internal review, the cellulitis was considered to be medically significant.
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 15-MAR-2015, the patient was vaccinated with the first dose of GARDASIL 9 for prophylaxis (dose, route of administration, lot number and expiration date were not reported). In July 2017, the patient was vaccinated with the second dose of GARDASIL 9 for prophylaxis (dose, route of administration, lot number and expiration date were not reported). On 22-NOV-2017, the patient received the third dose of GARDASIL 9 lot number N020139 and expiration date of 14-FEB-2020 for prophylaxis (dose and route of administration were not reported). No adverse effects were reported. There was not product quality complaint involved. This is one of the two reports received from the same reporter.; Sender's Comments:  US-009507513-1711USA010323:
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Blood pressure increased, Epistaxis, Injection site rash
Clinical narrative: Developed rash 2 days post injection at site. Also reported bloody nose & elevated BP. Continued elevated BP x 1 week & saw PCP. BP eventually normalized.
Age: 43.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Muscular weakness, Musculoskeletal pain, Pain in extremity
Clinical narrative: Possible Parsonage-Turner Syndrome-shoulder/arm with significant pain and weakness.
Age: 43.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Injection site pain, Muscular weakness
Clinical narrative: Possible Parsonage-Turner Syndrome-shoulder/arm with significant pain and weakness.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient had red/swollen/itching at site where vaccine was administered.
Age: 43.0
Sex: F
Vaccine: HEP, MMR, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Redness, warmth and pain reported at site of MMR vaccine. Measuring 3 inches x 1.8 inches. Vaccine administered 2 days prior. Site was marked and measured, will continue to monitor. Provider will prescribe KEFLEX tomorrow if not improved. Used Cephalexin QID x 7 days.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Face oedema, Feeling abnormal, Throat tightness
Clinical narrative: 10/10/17 0430 Employee called to notify that she was in the ER with facial edema/tight throat 10/5/17. She had received her flu shot 10/2/17. She was treated with epi and given steroids. Still not quite feeling 100%. She does have a hx of allergic reactions of this nature to Sulfa and other additives in foods.
Age: 64.0
Sex: F
Vaccine: FLUC4
Symptoms: Drug administered at inappropriate site, Mobility decreased, Pain in extremity
Clinical narrative: Patient came by the pharmacy a few days after the injection complaining that her arm was still very sore and that she could not lift it. She called about a month later saying her arm was still terribly sore. She went to ER and was given pain meds but they did not help. Administering pharmacist did note that the Vaccine was given a little high due to the shirt the patient was wearing --had to pull shirt off of shoulder instead of rolling up sleeve and the patient had limited mobility in other arm due to a stroke.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm
Clinical narrative: Pt came into pharmacy 2 days later to show me her arm had about a 3 inch diameter that was red and warm to touch. Pt did not report any pain. Pt was advised to continue to watch and contact her physician if symptoms did not improve or got worse. Pt went to the Dr. and was giving antibiotics.
Age: 65.0
Sex: M
Vaccine: PNC13, TDAP
Symptoms: Chills, Pain in extremity
Clinical narrative: Chills, Bilateral arm soreness.
Age: 59.0
Sex: F
Vaccine: FLUC4
Symptoms: Abdominal pain, Arthralgia, Fatigue, Headache, Myalgia
Clinical narrative: Low grade fever, fatigue, moderate abdominal pain/nauea, entire left side toes to head had mod-severe muscle and joint pain, headache for 3 days and gradually improved. Treated with tramadol and ketorolac. Other treatment: rest, warm packs to sore muscles and abdomen, and increased fluids.
Age: 59.0
Sex: F
Vaccine: FLUC4
Symptoms: Nausea, Pyrexia
Clinical narrative: Low grade fever, fatigue, moderate abdominal pain/nauea, entire left side toes to head had mod-severe muscle and joint pain, headache for 3 days and gradually improved. Treated with tramadol and ketorolac. Other treatment: rest, warm packs to sore muscles and abdomen, and increased fluids.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Vaccine was out of range (70 degrees Fahrenheit) due to maintenance issue with refrigerator. The dose was administered before the pharmacist discovered that the flu vaccine was in the refrigerator in spite of note being placed on the frig not to use. This is the only patient that received a dose.
Age: 58.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Feeling hot, Full blood count normal, Pain, Swelling
Clinical narrative: By evening she had redness, swelling, pain, and heat. Seen 12/4/17 and treated for possible cellulitis (vs. shot reaction) with BACTRIM DS two PO BID. By 12/8/17, much improved.
Age: 73.0
Sex: F
Vaccine: TDAP
Symptoms: Confusional state, Hallucination, Muscular weakness, Nausea, Palpitations
Clinical narrative: Nausea, heart palpitations, weakness in limbs, blurry vision, confusion, hallucinations.
Age: 73.0
Sex: F
Vaccine: TDAP
Symptoms: Vision blurred
Clinical narrative: Nausea, heart palpitations, weakness in limbs, blurry vision, confusion, hallucinations.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Oedema, Skin warm, Tenderness
Clinical narrative: Per client the erythema and edema started the day she received the injection. The area today measures 4 inches by 3 inches in width. Area is very warm to touch and per client is tender to touch.  Client has not done anything about the area other than watch it and then called Health Department today to come in. Injection was given on 12/07/2017. Instructed client to apply cool compresses to area 3 to 4 times per day and to go to urgent care if symptoms worsen. Today BP- 124/70, P- 84, R- 20, Temp- 97.7.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Vomiting
Clinical narrative: NAUSEA, THROWING UP.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain, Pain in extremity, X-ray limb normal
Clinical narrative: After receiving the flu shot on 10/22/17 the next day 10/23/17 I was unable to lift my arm. I had a sharp shooting pain running from my shoulder to my elbow. My arm has continually hurt and I cannot lift my arm above my head. I also cannot rotate my arm. I have a throbbing pain on a constant basis.
Age: 0.67
Sex: U
Vaccine: FLU4
Symptoms: Wrong drug administered
Clinical narrative: It is documented pt given FLUZONE peds lot # ut5897NA. Balancing inventory identified that the dose was pulled from U5913BA.
Age: 76.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: Patient's arm swelled at the site of the injection. Patient called on call provider at 5:30 PM and sent him a photo. Patient's arm was swelling above the Band-Aid and down his arm. No ecchymosis or erythema noted on his arm.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Chills, Cough, Dysphagia, Eye discharge
Clinical narrative: About 2 hours after high dose flu vaccine was administered in clinic, patient reported dry cough, chest tightness, and difficulty swallowing. Bilateral eyes red, itchy, with drainage. She developed full body chills later after being seen in the emergency department.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Eye pruritus, Ocular hyperaemia
Clinical narrative: About 2 hours after high dose flu vaccine was administered in clinic, patient reported dry cough, chest tightness, and difficulty swallowing. Bilateral eyes red, itchy, with drainage. She developed full body chills later after being seen in the emergency department.
Age: 84.0
Sex: M
Vaccine: FLUA3
Symptoms: Injection site erythema, Pain in extremity
Clinical narrative: Arm soreness is severe based on arm movement soreness is intermittent. Slight redness at the injection site which is discernible. No other symptoms reported at this time.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cough, Fatigue, Headache, Influenza
Clinical narrative: I had no adverse events related to the flu shot itself. (oct.12, 2017). However, on Nov.27, 2017 I began to have symptoms of flu: sneezing, bad headache, bad head congestion, chills, fever (3degrees-4degrees above my normal), fatigue, coughing, running nose. My normal temp is 97.6 degrees F.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Rhinorrhoea, Sneezing, Upper respiratory tract congestion
Clinical narrative: I had no adverse events related to the flu shot itself. (oct.12, 2017). However, on Nov.27, 2017 I began to have symptoms of flu: sneezing, bad headache, bad head congestion, chills, fever (3degrees-4degrees above my normal), fatigue, coughing, running nose. My normal temp is 97.6 degrees F.
Age: 25.0
Sex: M
Vaccine: ANTH, SMALL, TD
Symptoms: Tooth discolouration, Tooth fracture
Clinical narrative: Graying of my front top 4 teeth, breaking off at the gum lines. Holes in teeth 8 teeth breaking apart. Last dental exam I was told that all but 2 teeth need work done, my problem areas are my top front teeth and the bottom back teeth on the left 8 right.
Age: 1.83
Sex: F
Vaccine: DTAP, HIBV, MMRV
Symptoms: Injection site erythema, Injection site papule, Pyrexia
Clinical narrative: Patient developed papule at PROQUAD injection site on 12/10/17. Stated same day redness at site and fever both went away next day.
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Fatigue, Feeling abnormal, Malaise
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative and refers to a female patient of unknown age. The patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions or allergies were not provided. On an unknown date in 2017 (reported as "within the last 2 months"), the patient was vaccinated with ZOSTAVAX, one injection, vial 19400 plaque-forming units (PFU) (exact dose and route of administration, lot # and expiration date were not reported) together with one injection of an unspecified flu quadrivalent vaccine (exact dose and route of administration, lot # and expiration date were not reported). On an unknown date in 2017, after receiving both vaccinations, the patient felt run-down, tired and very sick for an unspecified amount of time. The outcome of the events was unknown. The relatedness between the events and the suspect therapies was not assessed by the reporter.
Sex: F
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a consumer via Pfizer referring to herself as a 66 year old female. The patient's current condition included osteoporosis. The patient had breast cancer in 2016. On unknown dates in 2016, the patient had 2 surgeries for breast cancer and got recovered in 2016. On an unknown date, the patient received PREVNAR. The patient's concomitant medications included FOSAMAX 70 mg once weekly via oral route for osteoporosis. On March 2017 at 13:00, the patient was vaccinated with first dose of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (lot #, expiration date, route of administration were unknown) in the arm for prophylaxis, which was stored in an inappropriate temperature. The patient did not have any adverse events. The outcome of product storage error and no adverse event was unknown.
Sex: F
Vaccine: PPV
Symptoms: Immediate post-injection reaction, Injection site reaction, Injection site warmth, Pyrexia, Rash erythematous
Clinical narrative: This spontaneous report was received from a physician referring to a 70 year old female patient. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date the patient was vaccinated with PNEUMOVAX 23 prefilled syringe, lot # N023651, expiration date: 20-MAY-2019 (frequency, dosage and route of administration were not reported) for prophylaxis. The patient experienced a hot red rash (like a welt at the injection site) with a slight fever right after injection. At the time of this reaction, the patient was still in the physician's office. The physician recommended ZYRTEC for the reaction. The patient has not reported her condition since the PNEUMOVAX 23 administration; so the outcome of injection site rash and pyrexia was unknown. This is one of several reports received from the same reporter and the adverse event quality investigation process was requested as the physician "stopped using that box" (lot # N023651 and expiration date: 20-MAY-2019) of prefilled syringes after the second adverse reaction. The reporter considered injection site rash and pyrexia as life-threatening events and also be related to PNEUMOVAX 23. Sender's Comments: US-009507513-1711USA010076: US-009507513-1711USA010085.
Sex: F
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: This spontaneous report was received from a physician referring to a 70 year old female patient. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date the patient was vaccinated with PNEUMOVAX 23 prefilled syringe, lot # N023651, expiration date: 20-MAY-2019 (frequency, dosage and route of administration were not reported) for prophylaxis. The patient experienced a hot red rash (like a welt at the injection site) with a slight fever right after injection. At the time of this reaction, the patient was still in the physician's office. The physician recommended ZYRTEC for the reaction. The patient has not reported her condition since the PNEUMOVAX 23 administration; so the outcome of injection site rash and pyrexia was unknown. This is one of several reports received from the same reporter and the adverse event quality investigation process was requested as the physician "stopped using that box" (lot # N023651 and expiration date: 20-MAY-2019) of prefilled syringes after the second adverse reaction. The reporter considered injection site rash and pyrexia as life-threatening events and also be related to PNEUMOVAX 23. Sender's Comments: US-009507513-1711USA010076: US-009507513-1711USA010085.
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist via Poison & Drug Center (PDC) regarding a 60 year old female patient. The patient's pertinent medical conditions and concomitant medications were reported as unknown. On 09-DEC-2017, the patient was vaccinated with ZOSTAVAX lot # M032141, 1 syringe once, subcutaneous (strength was reported as unknown), expiry date: 02-OCT-2017 for prophylaxis (experienced expired product administered). It was reported that, the patient did not experience any adverse events. There was no relevant lab data. This is one of the two reports from same reporter.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4
Symptoms: Headache, Neck pain, Vision blurred
Clinical narrative: Initial unsolicited report received from a healthcare professional on 10-Nov-2017. This case involves a four-year-old male patient, who was vaccinated with a 0.5 mL dose one dosage of FLUZONE QIV (batch number: UI866AA, expiry date and dose in series was not reported) intramuscularly in right vastus lateralis (Right thigh) and with a dose of QUADRACEL (batch number: C5222AA and expiry date, dose, dose in series were not reported) intramuscularly in right vastus lateralis (right thigh); both on 09-Nov-2017. The patient medical history and concomitant medication were not reported. The patient was not ill at time of vaccination, no chronic illness and not known drug allergies (NKDA). On an unknown date, post vaccination, the patient was complained blurry vision, headache, and neck pain. No other symptoms reported. Relevant lab tests and corrective treatment was not reported. Outcome of the events was not recovered. List of documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Rash erythematous
Clinical narrative: Initial unsolicited report received from a nurse on 28-Nov-2017. This case involves a female patient of unknown age, who was vaccinated with a dose of FLUZONE QIV (batch number: U589DA, expiry date, dose, dose in series, route, site of administration were not reported) on an unknown date. Patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient developed large red rash. Laboratory tests and corrective treatment were not reported. The event outcome was not reported at the time of reporting. List of documents held by sender: none.
Age: 5.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Localized redness and swelling to left upper arm. Treatment: KEFLEX 250 mg/5mL, 4mL PO TID x 10 days.
Age: 58.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Hypersensitivity, Pruritus, Urticaria
Clinical narrative: Allergic reaction, face was really red, itching, hives all over the body.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Computerised tomogram, Feeling abnormal, Full blood count, Hypoaesthesia
Clinical narrative: 6o minutes after shot last patient started feeling bad. Seeing dots, numbness in finger and feet, feeling weak and progressing to inability to move. She was transferred to hospital she was given Epi and Benadryl and was watched for 24 hours by neurology.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Metabolic function test, Mobility decreased, Nuclear magnetic resonance imaging, Urine analysis, Visual impairment
Clinical narrative: 6o minutes after shot last patient started feeling bad. Seeing dots, numbness in finger and feet, feeling weak and progressing to inability to move. She was transferred to hospital she was given Epi and Benadryl and was watched for 24 hours by neurology.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, and warmth at the injection site, spreading dramatically over the thigh. Measured 11.5 x 12.5 cm at the time of assessment, over the past 24 hours it seems to have slowed its growth, and is less red and warm than it was the day before. Will watch for now but provided a safety net script of KEFLEX if it were to continue to worsen.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis, Coagulation test normal, Full blood count normal, Skin warm, Tenderness
Clinical narrative: Cellulitis measuring 6x8cm. Warm and tender on exam. Treated with KEFLEX 250mg TID.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood test, Chest X-ray, Chills, Fatigue, Headache
Clinical narrative: I. Body aches, headache, Fever, Chills, Leg swelling, rash on chest and legs, sores in mouth, and fatigue. II. IV steroids and oral steroids. III. Symptoms have resolved, but still taking steroids.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Peripheral swelling, Pyrexia, Rash, Stomatitis
Clinical narrative: I. Body aches, headache, Fever, Chills, Leg swelling, rash on chest and legs, sores in mouth, and fatigue. II. IV steroids and oral steroids. III. Symptoms have resolved, but still taking steroids.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Ultrasound scan, Urine analysis, X-ray
Clinical narrative: I. Body aches, headache, Fever, Chills, Leg swelling, rash on chest and legs, sores in mouth, and fatigue. II. IV steroids and oral steroids. III. Symptoms have resolved, but still taking steroids.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Cow's milk intolerance, Dermatitis diaper, Diarrhoea, Haematochezia, Injection site rash
Clinical narrative: One hour after immunization, local rash developed at injection site. Rash spread to legs, belly, back, ears, chin. Faded within 48 hours. Temp up to 102 rectal during that time. Date of vaccine saw N.P. who stated diaper rash and localized rash. Mother states diffuse rash occurred following visit to N.P. Received 4 month vaccinations - 11/2/17 - DTP, HIB, Polio, Hepatitis B. Rash started on chest and over his body. Presently on NUTRAMIGEN - stools with streak of blood. Stools are watery. Diaper rash. Using diaper rash cream with every diaper change. Boils bottles. Does get a tsp. of Rice cereal for 2 months. Low grade fever a couple of days ago 99 after immunizations - resolved. Teething. Small rash after 2 month immunization at site of injection - oatmeal bath recommended did not help but baking soda paste and did help. Right thigh most pronounced and where initial rash started and then progressed to remaining body. Face was swollen and rash all over body on 11/3/17. Rash has resolved since immunization except now has a diaper rash. Mom has hives from tetanus injection. Has lost weight since immunizations - down 6 oz. Has increased vomiting. Has pediatrician managing formula intolerance - diagnosed milk intolerance - believes he has been seen by GI in the past and had GI testing per Mom. Increased fussy.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Irritability, Pyrexia, Rash generalised, Swelling face, Vomiting
Clinical narrative: One hour after immunization, local rash developed at injection site. Rash spread to legs, belly, back, ears, chin. Faded within 48 hours. Temp up to 102 rectal during that time. Date of vaccine saw N.P. who stated diaper rash and localized rash. Mother states diffuse rash occurred following visit to N.P. Received 4 month vaccinations - 11/2/17 - DTP, HIB, Polio, Hepatitis B. Rash started on chest and over his body. Presently on NUTRAMIGEN - stools with streak of blood. Stools are watery. Diaper rash. Using diaper rash cream with every diaper change. Boils bottles. Does get a tsp. of Rice cereal for 2 months. Low grade fever a couple of days ago 99 after immunizations - resolved. Teething. Small rash after 2 month immunization at site of injection - oatmeal bath recommended did not help but baking soda paste and did help. Right thigh most pronounced and where initial rash started and then progressed to remaining body. Face was swollen and rash all over body on 11/3/17. Rash has resolved since immunization except now has a diaper rash. Mom has hives from tetanus injection. Has lost weight since immunizations - down 6 oz. Has increased vomiting. Has pediatrician managing formula intolerance - diagnosed milk intolerance - believes he has been seen by GI in the past and had GI testing per Mom. Increased fussy.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Weight decreased
Clinical narrative: One hour after immunization, local rash developed at injection site. Rash spread to legs, belly, back, ears, chin. Faded within 48 hours. Temp up to 102 rectal during that time. Date of vaccine saw N.P. who stated diaper rash and localized rash. Mother states diffuse rash occurred following visit to N.P. Received 4 month vaccinations - 11/2/17 - DTP, HIB, Polio, Hepatitis B. Rash started on chest and over his body. Presently on NUTRAMIGEN - stools with streak of blood. Stools are watery. Diaper rash. Using diaper rash cream with every diaper change. Boils bottles. Does get a tsp. of Rice cereal for 2 months. Low grade fever a couple of days ago 99 after immunizations - resolved. Teething. Small rash after 2 month immunization at site of injection - oatmeal bath recommended did not help but baking soda paste and did help. Right thigh most pronounced and where initial rash started and then progressed to remaining body. Face was swollen and rash all over body on 11/3/17. Rash has resolved since immunization except now has a diaper rash. Mom has hives from tetanus injection. Has lost weight since immunizations - down 6 oz. Has increased vomiting. Has pediatrician managing formula intolerance - diagnosed milk intolerance - believes he has been seen by GI in the past and had GI testing per Mom. Increased fussy.
Age: 82.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Patient said his arm muscle at the injection site sore, suggested to use TYLENOL OTC.
Age: 37.0
Sex: F
Vaccine: PPV
Symptoms: Contusion, Hypersensitivity, Immediate post-injection reaction, Induration, Injected limb mobility decreased
Clinical narrative: Immediately upon injection I felt a jolt of pain almost like I was shocked by electricity running down my arm. I knew to expect soreness and possible hardness, but as Friday evening wore on my upper left arm became completely engorged and sore. I looked like a body builder. I was barely able to move my arm. I took 2 TYLENOL and went to sleep thinking the swelling would go down. I woke up on Saturday morning and while the hardness had lessened some my arm was still extremely sore. I continued with TYLENOL and started icing my arm. When I went to change for bed on Saturday around 10 PM I noticed a large area of swelling and redness under my armpit extending halfway to my elbow. On Sunday I woke up and the pain continued to lessen, but the redness and swelling continued creeping closer to my elbow. I went to urgent care at 11 AM on Sunday where two doctors examined me to determine what was happening. As best they could tell it appeared to be an allergic reaction to the vaccine and not cellulitis. They were a bit puzzled why the underside of my arm was reacting and not the injection area. They marked my arm and told me to contact my regular physician and follow up. They prescribed prednisone, ALLEGRA, BENADRYL and an antibiotic if the redness spread. On Monday morning the redness had returned and the swelling had migrated outside the markings by the urgent care physicians. I sought help from PA. As the prednisone kicked in the swelling reduced and the redness dissipated. My arm began to bruise on Monday, 12/11/17.