chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: SMALL
Symptoms: Acute myocardial infarction, Cardiac failure congestive, Echocardiogram normal, Electrocardiogram normal, Left ventricular failure
Clinical narrative: Initial solicited report received on 08 March 2017 and follow up information received on 13 March 2017 from an investigator (Defense Health Agency/Immunization Healthcare Branch) in the trial. A 21 year-old male subject with no significant medical history. The subject's received one dose of Japanese Encephalitis as prophylactic vaccination on 25 March 2016. The subject received a dose of ACAM2000 (lot number and route, site of administration not reported) on 21 April 2016. On 05 May 2016, 14 days after vaccination the subject was diagnosed with I21.3 ST elevation (STEMI) myocardial infarction of unspecified site, on 03 May 2016, 12 days post vaccination the subject was diagnosed with I40.8 Other acute myocarditis/I40.9 Acute myocarditis, unspecified and 04 May 2016, 13 days after vaccination the subject was diagnosed with I50.40 Unspecified combined systolic (congestive) and diastolic (congestive) heart failure. The lab data included within 30 days post vaccination on 03 May 2016, the Troponin I was abnormal (highest value 16.50 ng/ml), ECG was normal, Echocardiogram was normal, MRI heart was abnormal on 13 May 2016, MRI (brain and spinal cord) and Lumbar puncture (spinal tap) were not performed. Treatments were not reported. The subject's outcome was not reported. Relationship to investigational product according to company: associated. Relationship to investigational product according to investigator: not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: none. Sender's Comments: This case involves a healthy 21-year-old male who developed ST segment elevation myocardial infarction, acute myocarditis unspecified and congestive heart failure with favorable temporal association post vaccination with ACAM2000. Subject had confounding factor as concomitant administrations of Japanese\ encephalitis vaccine. Myocardial infarction, Myocarditis and heart failure are listed adverse events that may occur following vaccination with live vaccinia virus smallpox vaccines. Alternative etiologies could be pulmonary edema, pulmonary embolism, aortic dissection, esophageal rupture. History of allergies or trauma was not reported. Based on missing additional information on confirmation of diagnosis with CK-MB assays, myocardial biopsy, role of study vaccine can not be ruled out.
Sex: M
Vaccine: SMALL
Symptoms: Myocarditis, Nuclear magnetic resonance imaging abnormal, Nuclear magnetic resonance imaging heart, Troponin I increased
Clinical narrative: Initial solicited report received on 08 March 2017 and follow up information received on 13 March 2017 from an investigator (Defense Health Agency/Immunization Healthcare Branch) in the trial. A 21 year-old male subject with no significant medical history. The subject's received one dose of Japanese Encephalitis as prophylactic vaccination on 25 March 2016. The subject received a dose of ACAM2000 (lot number and route, site of administration not reported) on 21 April 2016. On 05 May 2016, 14 days after vaccination the subject was diagnosed with I21.3 ST elevation (STEMI) myocardial infarction of unspecified site, on 03 May 2016, 12 days post vaccination the subject was diagnosed with I40.8 Other acute myocarditis/I40.9 Acute myocarditis, unspecified and 04 May 2016, 13 days after vaccination the subject was diagnosed with I50.40 Unspecified combined systolic (congestive) and diastolic (congestive) heart failure. The lab data included within 30 days post vaccination on 03 May 2016, the Troponin I was abnormal (highest value 16.50 ng/ml), ECG was normal, Echocardiogram was normal, MRI heart was abnormal on 13 May 2016, MRI (brain and spinal cord) and Lumbar puncture (spinal tap) were not performed. Treatments were not reported. The subject's outcome was not reported. Relationship to investigational product according to company: associated. Relationship to investigational product according to investigator: not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: none. Sender's Comments: This case involves a healthy 21-year-old male who developed ST segment elevation myocardial infarction, acute myocarditis unspecified and congestive heart failure with favorable temporal association post vaccination with ACAM2000. Subject had confounding factor as concomitant administrations of Japanese\ encephalitis vaccine. Myocardial infarction, Myocarditis and heart failure are listed adverse events that may occur following vaccination with live vaccinia virus smallpox vaccines. Alternative etiologies could be pulmonary edema, pulmonary embolism, aortic dissection, esophageal rupture. History of allergies or trauma was not reported. Based on missing additional information on confirmation of diagnosis with CK-MB assays, myocardial biopsy, role of study vaccine can not be ruled out.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: She does not recall the time, but she began having swelling and redness in the area that she received her vaccination approximately 1 day afterwards.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Soreness, redness, swelling.
Age: 80.0
Sex: M
Vaccine: PNC13
Symptoms: Swelling face, Wheezing
Clinical narrative: FACIAL SWELLING AROUND THE LIP AND JAW, ALSO SOME WHEEZING.
Age: 12.0
Sex: F
Vaccine: FLU4, HPV9, MMR, MNQ
Symptoms: Wrong drug administered
Clinical narrative: I (RN) administered a single dose of MMR to the patient when she did not need MMR vaccine.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Whole left arm is painful without moving it. Pain med was sent (Norco) Recovered on 3/21/2017 in AM with no pain, arm felt normal.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received on 06-MAR-2017 from a female pharmacist, refers to multiple unknown patients (age and gender unknown) who on unknown dates were administered M-M-R II for prophylaxis. The patients' pertinent medical history, concomitant medications and drug allergies were not reported. The pharmacist reported that multiple unknown patients have been administered MMRII that "has been stored in the tube system for approximately 1 hour then administered by the nurse" on multiple unknown dates. No adverse effects reported. No further information was reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received on 02-MAR-2017 from a nurse and refers to multiple unknown patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided.  The nurse reported that multiple unknown patients were administered improperly stored vaccine of VAQTA (Lot number M0476587, expiration date 28-OCT-2017) on multiple unknown dates since 27-FEB-2017 for the indication of prophylaxis.  No adverse effects reported. Administered doses of VAQTA experienced temperature excursion from 0 to 2 degrees Celsius for 1 hour and 26 minutes. A digital data logger was involved. There were no previous temperature excursions. No further information was provided. his is one of several reports received from the same reporter.  Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Erythema, Laryngitis, Local reaction, Peripheral swelling
Clinical narrative: Information has been received from a retired licensed practical nurse concerning herself, an approximately 64 year old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, dose number, anatomical location, route of administration, lot number and expiration date were not provided) for prophylaxis. In approximately March 2007 (reported as: 10 years ago), the patient developed a local reaction described as "1 inch by 1 inch area that was red and swollen located above the elbow".  At the time of the report, the patient was recovered from the events. The relatedness between the events and the ZOSTAVAX was not reported. On 01-MAR-2017, the patient was vaccinated with a dose of PNEUMOVAX23 and experienced runny nose, laryngitis, cough, itching, swelling and erythema (MARRS 1703USA002923). Additional information has been requested. Sender's Comments: US-009507513-1703USA002923.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Rhinorrhoea, Swelling
Clinical narrative: Information has been received from a retired licensed practical nurse concerning herself, an approximately 64 year old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, dose number, anatomical location, route of administration, lot number and expiration date were not provided) for prophylaxis. In approximately March 2007 (reported as: 10 years ago), the patient developed a local reaction described as "1 inch by 1 inch area that was red and swollen located above the elbow".  At the time of the report, the patient was recovered from the events. The relatedness between the events and the ZOSTAVAX was not reported. On 01-MAR-2017, the patient was vaccinated with a dose of PNEUMOVAX23 and experienced runny nose, laryngitis, cough, itching, swelling and erythema (MARRS 1703USA002923). Additional information has been requested. Sender's Comments: US-009507513-1703USA002923.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Fall
Clinical narrative: Patient experienced dizziness and fell to the floor (not witnessed).
Age: 67.0
Sex: F
Vaccine: PNC13, FLU3, PNC13
Symptoms: Mobility decreased, Pain in extremity, Sleep disorder
Clinical narrative: Extreme soreness of the arm, unable to sleep on that arm, or raise above the head.
Age: 67.0
Sex: F
Vaccine: PNC13, FLU3, PNC13
Symptoms: Injected limb mobility decreased, Pain in extremity, Sleep disorder
Clinical narrative: Extreme soreness of the arm, unable to sleep on that arm, or raise above the head.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Mobility decreased, Pain
Clinical narrative: MODERATE PAIN AND UNABLE TO LIFT THE ARM OVER THE HEAD FOR 4 DAYS.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Abasia, Arthralgia, Dysstasia, Injection site erythema, Injection site pain
Clinical narrative: Swelling of my arm around the injection  Redness around the injection and hot to the touch. Tender to the touch around the injection. This lasted for one week  07/15/2015 I developed a fungus in my mouth.  I took medication for this problem.  07/28/2016 I woke with debilitating body pain all over--neck, shoulders, hips and knees--no swelling or discoloration.  Unable to walk, bend, sit or stand up.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Mobility decreased, Musculoskeletal pain, Neck pain
Clinical narrative: Swelling of my arm around the injection  Redness around the injection and hot to the touch. Tender to the touch around the injection. This lasted for one week  07/15/2015 I developed a fungus in my mouth.  I took medication for this problem.  07/28/2016 I woke with debilitating body pain all over--neck, shoulders, hips and knees--no swelling or discoloration.  Unable to walk, bend, sit or stand up.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral fungal infection, Pain
Clinical narrative: Swelling of my arm around the injection  Redness around the injection and hot to the touch. Tender to the touch around the injection. This lasted for one week  07/15/2015 I developed a fungus in my mouth.  I took medication for this problem.  07/28/2016 I woke with debilitating body pain all over--neck, shoulders, hips and knees--no swelling or discoloration.  Unable to walk, bend, sit or stand up.
Age: 68.0
Sex: M
Vaccine: TYP
Symptoms: Diarrhoea, Incomplete course of vaccination, Nausea, Vomiting
Clinical narrative: A few hours after taking the first dose of Typhoid Vaccine Live Oral TY21A I experienced extreme diarrhea which continued for 12 hours (akin to the purge done for a colonoscopy), accompanied by periodic nausea leading to vomiting. The initial period of diarrhea and vomiting was followed by three days of less violent diarrhea. I informed the doctor and with his concurrence did not take the second and subsequent doses of the vaccine after experiencing the initial reaction.
Age: 22.0
Sex: M
Vaccine: HEP
Symptoms: Myalgia
Clinical narrative: Following a second dose of the ENGERIX Hepatitis B Vaccine, I experienced a mildly painful (but noticeable) pinching on my right lower leg muscles. This happened with the first dose as well, but the pain from the first dose lasted only an hour max, and this pain keep coming and going.
Age: 21.0
Sex: M
Vaccine: ANTH, FLU4, HEPAB, JEV1, SMALL, TYP
Symptoms: C-reactive protein, Discomfort, Full blood count, Injection site induration, Pruritus
Clinical narrative: Right shoulder with brisk response and robust take with approximately 5 inches of surrounding induration. No fluctuance noted. Associating itchiness, heavy feeling, +/- fever.
Age: 21.0
Sex: M
Vaccine: ANTH, FLU4, HEPAB, JEV1, SMALL, TYP
Symptoms: Pyrexia, Red blood cell sedimentation rate, Robust take following exposure to vaccinia virus
Clinical narrative: Right shoulder with brisk response and robust take with approximately 5 inches of surrounding induration. No fluctuance noted. Associating itchiness, heavy feeling, +/- fever.
Age: 51.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Headache, Photophobia, Pyrexia, Spinal pain
Clinical narrative: Pt. reports severe headache, spinal pain, fever, and sensitivity to light. Pt. reports she has Epstein-Barr but did not notify clinician at time vaccines were given. Advised pt. go immediately to ER.
Age: 13.0
Sex: F
Vaccine: TYP
Symptoms: Facial pain, Swelling face
Clinical narrative: Took oral Typhoid vaccine prescribed by MD and picked up at Pharmacy. Woke today with facial swelling with pain. I consulted with State epidemiologist.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Irritability, Pyrexia
Clinical narrative: 4 mo imms 3-20-17. Woke with fever to 102.1 - fussy. No other sx.
Age: 18.0
Sex: F
Vaccine: FLU4, HEPA, HPV4, MNQ
Symptoms: Loss of consciousness
Clinical narrative: Patient passed out after 4th vaccine given (HPV).
Age: 87.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain of skin, Skin warm
Clinical narrative: Arm became red, warm and tender.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 03-16-17- Dad called to say child's left arm is pink, swollen and warm to touch. No pain -child is using arm. Afebrile. Advised to use cool moist compress. 3-18-17- Dad called to say arm is still swollen, pink and warm to touch. Area is from shoulder to elbow. Afebrile - playing and using arm. T.C. to medical Dr. Dad to take to clinic if not better by tomorrow. 3-18-17 9:30AM -Dad called to let me know child's arm is much improved and doesn't need to see a Doctor.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV4, MNQ, TDAP
Symptoms: Dizziness, Erythema, Inflammation, Pain in extremity, Pyrexia
Clinical narrative: Fever (low grade), dizziness, having difficulty reading numbers on clock and left arm pain (red and inflamed). Rash on left arm since Monday (2/20/17) Patient had Influenza and TDaP in affected arm.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV4, MNQ, TDAP
Symptoms: Rash, Visual impairment
Clinical narrative: Fever (low grade), dizziness, having difficulty reading numbers on clock and left arm pain (red and inflamed). Rash on left arm since Monday (2/20/17) Patient had Influenza and TDaP in affected arm.
Age: 4.0
Sex: F
Vaccine: TYP, YF
Symptoms: Crying, Hyperhidrosis, Rash generalised
Clinical narrative: All over body rash, sweating and crying.
Age: 16.0
Sex: F
Vaccine: FLU4, MNQ, VARCEL
Symptoms: Malaise, Pyrexia, Urticaria, Viral upper respiratory tract infection
Clinical narrative: 03-20-17 - Grandmother of child called to report child has hives "all over her body." Started 03-14-17 on right arm. Has been giving BENADRYL OTC with no change. States child was "sick with cold x 3 days ago. Did have a fever (number unk) advised to see PCP ASAP. Grandmother called back 3 hours later to say PCP put child on a oral steroid. PCP thinks hives could have been from varicella vaccine.
Age: 10.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Injection site erythema, Injection site inflammation, Injection site warmth
Clinical narrative: (R) arm became red, hot and inflamed from PEDIARIX vaccine. Pt never had a reaction to individual vaccines given in past.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, FLU4, PNC13, RV5
Symptoms: Rash
Clinical narrative: Rash on face and head.
Age: 1.67
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Eye swelling, Lethargy, Malaise, Pyrexia
Clinical narrative: Pt age 21 months here today with Mother for poss reaction to PCV-13. Was seen in Emergent Care records have been requested. Had vaccine 6 days ago and developed a fever of 102.0. Vomited and very lethargic. Rash and swelling in face. Rash also on torso and chest. No meds. Uses pharmacy. Pt is a 21 month old male patient here today with a possible reaction to a vaccine. he had the vaccine 6 days ago and developed a fever the day of. He vomited and is lethargic. His eyes were swollen and erythematous. There were faint dots on his chest and abdomen and below the eyes that occurred the second day but has slowly faded. The rash is faintly evident today. He took 4 naps yesterday. Today is the first day he has been afebrile. His twin brother received immunizations on the same day and did not have as extreme of a reaction. She denies SOB and anemia. This child has been getting care here for the past 6 months or so. His  parents are well known to me however. They're very reliable. Child received hep B, polio, HIB and DTaP on September 2, 2016. They reported vesicular appearing rash on September 13 but there has been another child that had a few on his body as well and it had the appearance initially that may be Varicella but then following that she noted that it was just like hives and they would come and go. It may have been a delayed hypersensitivity but it was not typical no fever noted with that. On November 21 had PCV 13 and there were not any significant problems reported. On January 4 received DTaP and had significant hives similar to the first exposure to multiple vaccines in September and they occurred the same day. March 15 received PCV 13 and has been sick ever since with fever up to 102, lethargy, swelling around the eyes, and a rash on the torso and chest erythematous slightly raised.
Age: 1.67
Sex: M
Vaccine: PNC13
Symptoms: Rash, Swelling face, Urticaria, Vomiting
Clinical narrative: Pt age 21 months here today with Mother for poss reaction to PCV-13. Was seen in Emergent Care records have been requested. Had vaccine 6 days ago and developed a fever of 102.0. Vomited and very lethargic. Rash and swelling in face. Rash also on torso and chest. No meds. Uses pharmacy. Pt is a 21 month old male patient here today with a possible reaction to a vaccine. he had the vaccine 6 days ago and developed a fever the day of. He vomited and is lethargic. His eyes were swollen and erythematous. There were faint dots on his chest and abdomen and below the eyes that occurred the second day but has slowly faded. The rash is faintly evident today. He took 4 naps yesterday. Today is the first day he has been afebrile. His twin brother received immunizations on the same day and did not have as extreme of a reaction. She denies SOB and anemia. This child has been getting care here for the past 6 months or so. His  parents are well known to me however. They're very reliable. Child received hep B, polio, HIB and DTaP on September 2, 2016. They reported vesicular appearing rash on September 13 but there has been another child that had a few on his body as well and it had the appearance initially that may be Varicella but then following that she noted that it was just like hives and they would come and go. It may have been a delayed hypersensitivity but it was not typical no fever noted with that. On November 21 had PCV 13 and there were not any significant problems reported. On January 4 received DTaP and had significant hives similar to the first exposure to multiple vaccines in September and they occurred the same day. March 15 received PCV 13 and has been sick ever since with fever up to 102, lethargy, swelling around the eyes, and a rash on the torso and chest erythematous slightly raised.
Sex: M
Vaccine: SMALL
Symptoms: Acute myocardial infarction, Echocardiogram normal, Electrocardiogram abnormal, Troponin I increased
Clinical narrative: Initial solicited report on 08 March 2017 and follow up information received on 13 March 2017 from an investigator (Defense Health Agency/Immunization Healthcare Branch) in the trial. A 20 year-old male subject with no significant medical history. The subject's concomitant medication was not reported. The subject received a dose of ACAM2000 (lot number and route, site of administration not reported) on 23 June 2016. On 03 July 2016, 10 days after vaccination the subject was diagnosed with I21.19 ST elevation (STEMI) myocardial infarction involving other coronary artery of inferior wall. And I21.4 non-ST elevation (NSTEMI) myocardial infarction. The subject's lab data included, on 04 July 2016, ECG was abnormal, Echocardiogram was normal and Troponin I result, highest value 07.31 ng/Ml was abnormal done. Treatments were not reported. The subject's outcome was not reported. Relationship to investigational product according to company: associated. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: none.; Sender's Comments: This case involves a healthy 20-year-old male who developed ST segment elevation myocardial infarction and non ST segment elevation myocardial infarction with favorable temporal association post vaccination with ACAM2000. Ischemic heart disease is a listed adverse event that may occur following vaccination with live vaccinia virus smallpox vaccines. Alternative etiologies could be pulmonary embolism, aortic dissection, esophageal rupture and tension pneumothorax. History of allergies or trauma was not reported. In the absence of additional information on confirmation of diagnosis with CK-MB assays, myocardial biopsy, role of study vaccine can not be ruled out.
Sex: F
Vaccine: FLUX, PNC13, FLUX, PPV, FLUX, PNC13
Symptoms: Influenza, Pneumonia
Clinical narrative: Initial unsolicited case received from a consumer via other company Pfizer under the Manufacturer report number: 2016598475 on 08 Mar 2017. This case involves a female patient (age not reported) who was vaccinated with a dose of INFLUENZA VACCINE, a dose of PNEUMONIA SHOT (Batch number, expiry date, dose, doe in series, route and site of administration was not reported for both vaccines) on an unknown date. The patient medical history and concomitant medications were not reported. On an unknown date, following a flu and pneumonia shot the patient developed flu, and as well as Pneumonia. The patient lab tests and corrective treatment was not reported. The outcome of the events was not reported. Upon internal review the company considered the event as serious because of important medical event Pneumonia. List of documents held by sender: none. Sender's Comments: This is a case with minimum information. The patient had received a dose of PNEUMOCOCCAL VACCINE and INFLUENZA VACCINE (manufacturer unknown) and experienced pneumonia and flu. Time to onset is unknown and it is also not reported if the patient had received all the doses of vaccine. With the available information vaccination failure cannot be confirmed.
Age: 55.0
Sex: F
Vaccine: PPV, VARCEL, PPV, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information was received on 10-MAR-2017 from a Licensed Practical Nurse who was reporting on a 51 year old patient (gender unknown). No medical history or concomitant medications were reported. The nurse reported that on an unknown date, the patient was vaccinated with VARIVAX (lot, expiration, dose, site not reported) instead of ZOSTAVAX. No adverse symptoms reported. Follow-up information was received on 10-MAR-2017 from a nurse. The nurse reported that at the time of the VARIVAX administration, the patient had an active case of shingles. No other information was reported. Additional information is not expected. No additional information is available.
Age: 55.0
Sex: F
Vaccine: PPV, VARCEL, PPV, VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information was received on 10-MAR-2017 from a Licensed Practical Nurse who was reporting on a 51 year old patient (gender unknown). No medical history or concomitant medications were reported. The nurse reported that on an unknown date, the patient was vaccinated with VARIVAX (lot, expiration, dose, site not reported) instead of ZOSTAVAX. No adverse symptoms reported. Follow-up information was received on 10-MAR-2017 from a nurse. The nurse reported that at the time of the VARIVAX administration, the patient had an active case of shingles. No other information was reported. Additional information is not expected. No additional information is available.
Age: 73.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Cough, Erythema, Laryngitis, Local reaction, Local swelling
Clinical narrative: With 15 hrs of injection redness/itching on (L) upper arm, lower deltoid. Fri 3/3/17 developed runny nose, cough and continued local irritation - treated with BENADRYL 25 mg at bedtime. Cough worse, more frequent, local area decreased itching, 50 mg of BENADRYL on 3/5/17. Conjunctivitis bilateral, received meds for same. Cough ongoing 3/17/17. AUGMENTIN 875/125 tab, BID x 10 days and eye drops: Sulfacetamide 2 drops each eye 4 times daily x 10 days - still have coughing - 3/17/17.
Age: 73.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pruritus, Rhinorrhoea
Clinical narrative: With 15 hrs of injection redness/itching on (L) upper arm, lower deltoid. Fri 3/3/17 developed runny nose, cough and continued local irritation - treated with BENADRYL 25 mg at bedtime. Cough worse, more frequent, local area decreased itching, 50 mg of BENADRYL on 3/5/17. Conjunctivitis bilateral, received meds for same. Cough ongoing 3/17/17. AUGMENTIN 875/125 tab, BID x 10 days and eye drops: Sulfacetamide 2 drops each eye 4 times daily x 10 days - still have coughing - 3/17/17.
Age: 73.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Conjunctivitis, Cough, Injection site erythema, Injection site pruritus, Rhinorrhoea
Clinical narrative: With 15 hrs of injection redness/itching on (L) upper arm, lower deltoid. Fri 3/3/17 developed runny nose, cough and continued local irritation - treated with BENADRYL 25 mg at bedtime. Cough worse, more frequent, local area decreased itching, 50 mg of BENADRYL on 3/5/17. Conjunctivitis bilateral, received meds for same. Cough ongoing 3/17/17. AUGMENTIN 875/125 tab, BID x 10 days and eye drops: Sulfacetamide 2 drops each eye 4 times daily x 10 days - still have coughing - 3/17/17.
Age: 73.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Skin irritation
Clinical narrative: With 15 hrs of injection redness/itching on (L) upper arm, lower deltoid. Fri 3/3/17 developed runny nose, cough and continued local irritation - treated with BENADRYL 25 mg at bedtime. Cough worse, more frequent, local area decreased itching, 50 mg of BENADRYL on 3/5/17. Conjunctivitis bilateral, received meds for same. Cough ongoing 3/17/17. AUGMENTIN 875/125 tab, BID x 10 days and eye drops: Sulfacetamide 2 drops each eye 4 times daily x 10 days - still have coughing - 3/17/17.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Blood creatinine, Blood thyroid stimulating hormone, Erythema, Full blood count
Clinical narrative: Information has been received from a 64 year old female patient regarding herself. The concurrent condition included hypothyroid, high cholesterol, bipolar and general anxiety disorder and high blood pressure. Drug reactions or allergies include penicillin. Concomitant therapies included valacyclovir hydrochloride, levothyroxine sodium (manufacturer unknown), simvastatin (manufacturer unknown),  methylprednisolone, mupirocin ointment and hydrochlorothiazide. On 23-OCT-2015, the patient was vaccinated with ZOSTAVAX (dose/frequency: 1 time vaccine; strength, lot number and expiration date unknown) for prevention of shingles. On 16-FEB-2017, the patient noticed red itchy blisters coming up from her back right side running up to her right breast area. The patient felt pin prickly and a sensation like it was swollen and tender to the touch in that area. Lab diagnostics studies were performed: lipids, thyroid-stimulating Hormone (TSH), complete blood count (CBC), creatinine, metabolic panel, blood fecal sample, hemoglobin and vitamin b12, however, the results were not provided. Treatment was given for the events and the patient sought unspecified medical attention. The outcome of the event was unknown. The causal relationship between ZOSTAVAX and the events was not provided. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Haemoglobin, Lipids, Metabolic function test, Occult blood, Paraesthesia
Clinical narrative: Information has been received from a 64 year old female patient regarding herself. The concurrent condition included hypothyroid, high cholesterol, bipolar and general anxiety disorder and high blood pressure. Drug reactions or allergies include penicillin. Concomitant therapies included valacyclovir hydrochloride, levothyroxine sodium (manufacturer unknown), simvastatin (manufacturer unknown),  methylprednisolone, mupirocin ointment and hydrochlorothiazide. On 23-OCT-2015, the patient was vaccinated with ZOSTAVAX (dose/frequency: 1 time vaccine; strength, lot number and expiration date unknown) for prevention of shingles. On 16-FEB-2017, the patient noticed red itchy blisters coming up from her back right side running up to her right breast area. The patient felt pin prickly and a sensation like it was swollen and tender to the touch in that area. Lab diagnostics studies were performed: lipids, thyroid-stimulating Hormone (TSH), complete blood count (CBC), creatinine, metabolic panel, blood fecal sample, hemoglobin and vitamin b12, however, the results were not provided. Treatment was given for the events and the patient sought unspecified medical attention. The outcome of the event was unknown. The causal relationship between ZOSTAVAX and the events was not provided. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Swelling, Tenderness, Vitamin B12
Clinical narrative: Information has been received from a 64 year old female patient regarding herself. The concurrent condition included hypothyroid, high cholesterol, bipolar and general anxiety disorder and high blood pressure. Drug reactions or allergies include penicillin. Concomitant therapies included valacyclovir hydrochloride, levothyroxine sodium (manufacturer unknown), simvastatin (manufacturer unknown),  methylprednisolone, mupirocin ointment and hydrochlorothiazide. On 23-OCT-2015, the patient was vaccinated with ZOSTAVAX (dose/frequency: 1 time vaccine; strength, lot number and expiration date unknown) for prevention of shingles. On 16-FEB-2017, the patient noticed red itchy blisters coming up from her back right side running up to her right breast area. The patient felt pin prickly and a sensation like it was swollen and tender to the touch in that area. Lab diagnostics studies were performed: lipids, thyroid-stimulating Hormone (TSH), complete blood count (CBC), creatinine, metabolic panel, blood fecal sample, hemoglobin and vitamin b12, however, the results were not provided. Treatment was given for the events and the patient sought unspecified medical attention. The outcome of the event was unknown. The causal relationship between ZOSTAVAX and the events was not provided. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Breath sounds abnormal, Malaise
Clinical narrative: This spontaneous report was received from a 69 year-old female patient referring to herself. The patient did not have concurrent conditions, medical history or concomitant medications reported. She reported "she always get sick from vaccines", the only vaccine the patient specified was an unspecified flu vaccine and she did not clarify what she meant by getting "sick from vaccines". On an unspecified date in February 2016 (reported as "about one year ago"), the patient was vaccinated with a dose of PNEUMOVAX 23 (0.5 ml one time, route reported as injection; lot # and expiration date were not reported) for prevention of pneumococcal disease. On an unspecified date in 2016 (reported as "exactly 2 weeks after the vaccination"), the patient "got kind of sick" (malaise) and she heard "bubbling" when she breathed. The patient not sought medical attention and no treatment was given to her. On an unspecified date, she recovered from the mentioned adverse events. No product quality complaint (PQC) was involved. The causality between the mentioned adverse events and PNEUMOVAX 23 was unknown. Additional information is not expected, as there was no consent to contact.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On 06-MAR-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 (dose, frequency and route of administration were not reported) (lot # M030380 and expiration date 01-FEB-2019) for prophylaxis. There were no adverse effects reported. Administered dose of vaccine experienced the temperature excursion below 32 degrees Fahrenheit, with a minimum temperature of 31 degrees Fahrenheit for 48 hours. Data logger was not involved. There were no previous excursions reported. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA009380:
Sex: U
Vaccine: HPV4
Symptoms: Adverse event
Clinical narrative: This solicited report was received from a consumer enrolled in a Market Research Program and refers to a patient of unknown age and gender. The patient's current conditions, medical history, known allergies and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with GARDASIL (dose, route of administration, lot number and expiration date were not reported) and was affected by it (onset date was not provided). The reporter stated that was why they did not feel it was safe (in response to the question "For what reason(s) are you not open to consider vaccinating your children against HPV in the future?"). The reporter also stated that they felt it was preventable by safe sex and routine doctor visits/monitoring. The outcome of adverse event was unknown. The causality between the adverse event and suspect therapy was reported as related. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 62 year old male patient. No information was provided about the patient's pertinent medical history, drug reactions or allergies. His concurrent conditions included issues with blood pressure. On 12-MAR-2017, the patient was vaccinated with a dose of ZOSTAVAX 0.65 ml, subcutaneously, lot # reported as M038351, expiration date 06-DEC-2017. The patient's concomitant medications included unspecified medication for blood pressure. On 12-MAR-2017, upon administration of ZOSTAVAX the patient experienced pain upon injection. The patient sought medical attention, he contacted the pharmacist and received an unspecified treatment for the event. The pharmacist also reported, that the patient could not remember if they had a previous dose of ZOSTAVAX in the past, he might have received 2 doses. The outcome of pain during injection and the relatedness between the event and ZOSTAVAX were not reported. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Herpes zoster, Pain, Vaccination failure
Clinical narrative: Information has been received from a consumer concerning his/her 77 year old mother. The patient did not have any medical history nor drug reactions/allergies. Her concurrent conditions and concomitant medications were not provided. On an unknown date in 2006, the patient was vaccinated with one dose of ZOSTAVAX (strength, dose number, frequency, route of administration, anatomical location, lot# and expiration date were not provided), for prevention of shingles. On 11-MAR-2017 (reported as over the weekend 11-MAR-2017-12-MAR-2017), the patient presented with the following symptoms: pain over the body and chest pain. On 12-MAR-2017, the patient went to an emergency room. She was then diagnosed with shingles (vaccination failure). Unspecified treatment was given for the adverse events and unspecified laboratory diagnostics tests were performed. The patient's outcome was reported as not recovered. The causality assessment between ZOSTAVAX and the adverse events was not provided. No product quality complaint was involved. Additional information is not expected as there is no consent to contact the reporter.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site mass, Injection site pain, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: This spontaneous report has been received from a pharmacist and a 66 years old female patient referring to the patient. Information about concurrent condition and concomitant medication was unknown. On unknown date in 2016, the patient received PREVNAR 13 and "did fine" after receiving PREVNAR 13. At 5 p.m. on 07-MAR-2017 the patient was vaccinated with PNEUMOVAX 23 (dose and lot number not provided) in a pre-filled syringe intramuscularly for prophylaxis. By 7 p.m., the patient's left arm was extremely sore, had a burning feeling, and a tiny lump, "like a mosquito bite" at the injection site. At around 8:30- 9 p.m., the patient stated that her arm was enormously painful and that she put ice on her arm and took TYLENOL. On 08-MAR-2017 the patient's arm was noticeable swollen, itching, and had a raised red rash at the injection site. She then talked to her physician who recommended to take an anti-inflammatory, an unspecified antihistamine and BENADRYL (dosage and manufacturer unspecified). On 09-MAR-2017, the day after, in the morning the patient stated that the itching had subsided but that it was still swollen and had spread to below her elbow. She then went to her physician who prescribed unspecified oral steroids. On Friday 10-MAR-2017, the pharmacist examined the patient's left arm, and the patient reported that her arm had improved. On 15-MAR-2017, the patient stated that the swelling was down, the redness was gone, and it "doesn't feel swollen," however she had not fully recovered. Upon internal review, the events were determined to be medically significant. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Rash erythematous
Clinical narrative: This spontaneous report has been received from a pharmacist and a 66 years old female patient referring to the patient. Information about concurrent condition and concomitant medication was unknown. On unknown date in 2016, the patient received PREVNAR 13 and "did fine" after receiving PREVNAR 13. At 5 p.m. on 07-MAR-2017 the patient was vaccinated with PNEUMOVAX 23 (dose and lot number not provided) in a pre-filled syringe intramuscularly for prophylaxis. By 7 p.m., the patient's left arm was extremely sore, had a burning feeling, and a tiny lump, "like a mosquito bite" at the injection site. At around 8:30- 9 p.m., the patient stated that her arm was enormously painful and that she put ice on her arm and took TYLENOL. On 08-MAR-2017 the patient's arm was noticeable swollen, itching, and had a raised red rash at the injection site. She then talked to her physician who recommended to take an anti-inflammatory, an unspecified antihistamine and BENADRYL (dosage and manufacturer unspecified). On 09-MAR-2017, the day after, in the morning the patient stated that the itching had subsided but that it was still swollen and had spread to below her elbow. She then went to her physician who prescribed unspecified oral steroids. On Friday 10-MAR-2017, the pharmacist examined the patient's left arm, and the patient reported that her arm had improved. On 15-MAR-2017, the patient stated that the swelling was down, the redness was gone, and it "doesn't feel swollen," however she had not fully recovered. Upon internal review, the events were determined to be medically significant. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report has received from a 26 year old female patient, who was referring to herself. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 13-MAR-2017, the patient was vaccinated with VARIVAX subcutaneous injection (dose, lot # and expiration date were not reported) for prevention of varicella. On 14-MAR-2017 (reported as the next day after receiving the injection), the patient found out that she was pregnant (unspecified duration). The last menstrual period (LMP) and estimated date of delivery (EDD) were not known and could not be calculated. The pregnancy outcome was pending. The fetal outcome was unknown. The patient stated she had not been able to reach her physician. No treatment was given. The patient did not seek medical attention. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Mumps
Clinical narrative: This spontaneous report was received from a registered nurse via a company representative and refers to unspecified patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On unknown dates, the patients were vaccinated with M-M-R II (dose, route of administration, lot# and expiration date were not reported) for prophylaxis. On unknown dates, an unspecified local university notified area clinics about an outbreak of mumps. The outcome of the event of mumps was unknown. The relatedness between the event of mumps and M-M-R II was not reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Vaccination failure
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. There was no information about the patient's concomitant medications, allergies and pertinent medical history reported. On 24-JAN-1992 and on 20-SEP-1997, the patient was vaccinated respectively with the first and second dose of M-M-R II therapy type: HSA (dose, strength, route of administration, lot# and expiry date were not reported). Since an unknown date, the patient "was no longer immune". The outcome of the event and the relatedness between the event and M-M-R II was not reported. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug allergies or concomitant therapies were not reported. On 16-MAR-2017 , the patient was vaccinated with an expired dose of GARDASIL 9 injection (strength, dose, and route were not reported) (lot number L004014; expiration date: 04-MAR-2017) for prophylaxis. No adverse effects were reported. Additional information has been requested.
Age: 0.08
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On 06-MAR-2017, the patient was vaccinated with improperly stored dose of ROTATEQ (dose, and frequency were not reported) (lot # M038209 and expiration date 23-APR-2018) orally for prophylaxis. There were no adverse effects reported. Administered dose of vaccine experienced the temperature excursion below 32 degrees Fahrenheit, minimum temperature 31 degrees Fahrenheit for 48 hours. Data logger was not involved. There were no previous excursions reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA003106.
Sex: F
Vaccine: PNC13
Symptoms: Pneumonia
Clinical narrative: This is a spontaneous report from a contactable pharmacist reporting for his wife via a Pfizer sales representative. A female patient of unspecified age and race/ethnicity received PREVNAR 13, via an unspecified route of administration, on an unspecified date, at single dose, for immunisation and PNEUMOVAX 23, via an unspecified route of administration, on an unspecified date, at unspecified dose (unit DF), for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced pneumonia on an unspecified date. The patient was hospitalized due to the event on an unspecified date, and was discharged at time of report. Outcome was recovering. Sender's Comments: Based on the information currently available, a lack of efficacy with PREVENAR 13 in this patient cannot be completely excluded. Further information like confirmative pathological/serotype results and vaccination schedule are needed for full medical assessment.