chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: This is a spontaneous report from a contactable nurse who reported 10 cases for different patients. This is the 7th of 10 cases. A patient of unspecified age, race/ethnicity and gender received PREVNAR 13, via an unspecified route of administration, on an unspecified date, at 0.5 ml single, for immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date the patient reported that the injection hurt a lot with unknown outcome. Sender's Comments: Linked Report(s) : US-PFIZER INC-2017083713 same reporter/product, different patient.
Sex: M
Vaccine: PNC13
Symptoms: Injection site induration, Injection site swelling
Clinical narrative: This is a spontaneous report from a non-contactable Pharmacy student reporting on behalf of a Pharmacist. A male patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced reaction at the site that immediately swelled up and it became hard on an unspecified date with outcome of unknown. The reported stated that the patient is planned to have another vaccine in 3 months and I wanted to know if whether he should get that vaccine or not. No follow-up attempts are possible. No further information is expected.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Hypersensitivity, Injection site rash, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable office manager communicated to a Pfizer sales representative. A female patient of unknown age and race received PREVNAR 13 for immunization in Feb2017 via an unspecified route in the arm at single dose. The patient experienced an allergic reaction on the same day as the injection, swelling, breakout, and rash, all occurred at the injection site. The patient placed ice and all events resolved.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Blood test normal, Computerised tomogram normal, Cyanosis, Electrocardiogram normal, Eye movement disorder
Clinical narrative: 2/25/17 - seizure lasting for around 3 min. Fell to the ground shaking, eyes rolled back, lips turned blue. 911 called - taken to Hospital ER.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Fall, Seizure, Tremor
Clinical narrative: 2/25/17 - seizure lasting for around 3 min. Fell to the ground shaking, eyes rolled back, lips turned blue. 911 called - taken to Hospital ER.
Age: 64.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Arthralgia, Musculoskeletal pain, Pain in extremity
Clinical narrative: Moderate pain elbow to shoulder. Slight pain elbow to wrist. No treatment at this time.
Age: 64.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Pain in extremity
Clinical narrative: Moderate pain elbow to shoulder. Slight pain elbow to wrist. No treatment at this time.
Age: 15.0
Sex: F
Vaccine: FLU4
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 14.0
Sex: M
Vaccine: MENB
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Given Men B too soon.
Age: 36.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: Area became red, warm to touch, intermittently itchy. The redness began to grown along my arm down to the elbow. This got better with medication and time. Currently (2/28), there is some light pink/red color. I have noticed some of the same redness/warmth to touch on my knee and foot in the past 1-2 weeks on the same side of my body. Unsure if this is related to the vaccine.
Age: 15.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient reports swelling, warmth and tenderness to the injection site on the left deltoid.
Age: 56.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Dyspnoea
Clinical narrative: Vaccine given to patient on 2/20/17 and Patient came into the pharmacy on 2/28/17 stating that she has difficulty breathing and it is getting worse. Pt claimed/suspected it is due to vaccine. So we are reporting it.
Age: 57.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Heart rate decreased, Hypotension, Loss of consciousness
Clinical narrative: Minutes after receiving vaccines the patient lost consciousness abruptly. A EPIPEN was administered and moments later patient regained consciousness with improvement of pulse rate and blood pressure. After fifteen minutes patient was at baseline.
Age: 86.0
Sex: F
Vaccine: PPV
Symptoms: Bone pain, Feeling abnormal, Mobility decreased, Myalgia
Clinical narrative: Extreme muscle and bone pain for 4 days, then gradually letting up. Could not use arm. Used pain meds and heat. Affected whole body. Miserable for almost 2 weeks!
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Joint effusion, Pain, Peripheral swelling, Swelling
Clinical narrative: ELS (excessive limb swelling) from shoulder to elbow. Erythema, pain, swelling, and a "pocket of fluid" near the elbow as evidenced by ultrasound. Given KEFLEX in ER and script for 3x daily x7 days.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Ultrasound scan
Clinical narrative: ELS (excessive limb swelling) from shoulder to elbow. Erythema, pain, swelling, and a "pocket of fluid" near the elbow as evidenced by ultrasound. Given KEFLEX in ER and script for 3x daily x7 days.
Age: 57.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site pain, Joint range of motion decreased, Pain, X-ray limb abnormal
Clinical narrative: Pain to (L) deltoid, limited range of motion, pain with movement and when trying to reach something with (L) arm. X-ray was done shows wear and tear, degeneration. This happens after my flu shot.
Age: 57.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Burning sensation, Contusion, Injected limb mobility decreased, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Pain to (L) deltoid, limited range of motion, pain with movement and when trying to reach something with (L) arm. X-ray was done shows wear and tear, degeneration. This happens after my flu shot.
Age: 57.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: X-ray limb
Clinical narrative: Pain to (L) deltoid, limited range of motion, pain with movement and when trying to reach something with (L) arm. X-ray was done shows wear and tear, degeneration. This happens after my flu shot.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injected limb mobility decreased, Insomnia, Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: Vomiting, cold chills, shaking uncontrollably; unable to move left arm for two days, extremely painful; unable to sleep, undress or dress. Abated in 48 hrs but "poor" full-range of motion for 4 days.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Tremor, Vomiting
Clinical narrative: Vomiting, cold chills, shaking uncontrollably; unable to move left arm for two days, extremely painful; unable to sleep, undress or dress. Abated in 48 hrs but "poor" full-range of motion for 4 days.
Age: 67.0
Sex: M
Vaccine: UNK
Symptoms: Pain, Urticaria
Clinical narrative: Pain felt like I did when I came down with shingles. Also hives.
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea, Haematochezia, Irritability
Clinical narrative: Vaccine administered orally at 4 month WCC 2/10/17. On 2/12/17 pt. was fussy (mildly) and had loose bowel movement with blood. On 2/13/17 spoke with parents and only happened x1. Dad to give Probiotics 2x daily and bring in to see Dr. if happens again.
Age: 53.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site swelling, Injection site warmth
Clinical narrative: The day following the shot, the site became hot, raised 1/4 inch and red. Raised area and redness was 1 inch diameter. The area became a large hard knot. Remains today - 1 week post.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth, Myalgia
Clinical narrative: Left deltoid redness and swelling. Muscle in area and left side of neck tender. Warm to touch. Patient treated w/ KENALOG 40 mg - 1mL administered 2/13/17 at office visit. Rx of Prednisone 20mg #10 given.
Age: 1.5
Sex: M
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Rash. TX: BENADRYL.
Age: 71.0
Sex: F
Vaccine: TDAP
Symptoms: Mobility decreased, Neck pain
Clinical narrative: Monday night Feb 6, 17 my neck started hurting. Tues morning I could not move my head. Tues night I put ABSORBINE JR. on neck, Wed still in pain could not move neck. That night used heating pad. Thurs called doctor. Fri saw Dr. put me on methocarbamol 500 mg 2 times daily. Pain improved but not totally.
Age: 17.0
Sex: F
Vaccine: MENB, TYP
Symptoms: Asthenia, Chills, Headache, Pain, Tremor
Clinical narrative: Shaking chills, weakness, headache, generalized aches. Started approx. 4 hours post injection. Per mom, as of 02/24/17 all symptoms resolved.
Age: 20.0
Sex: F
Vaccine: HEPA, TDAP, TYP, YF
Symptoms: Rash, Rash pruritic
Clinical narrative: Rash, itchy, on top of both feet and ankles and on both thighs under buttocks. About 24 hrs after receiving YF-vax, Tdap, Typhoid, Hep A, rash resolving after 48 hrs.
Age: 74.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Balance disorder, Coordination abnormal, Electromyogram abnormal, Gait disturbance, Guillain-Barre syndrome
Clinical narrative: 11/9/16 body aches, 11/25/16 all over body aches, loss of coordination and balance, 11/29/16 difficulty walking, referred to Neuro, 12/1/16 Neuro study Dx Guillain Barre Syndrome.
Age: 74.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Pain
Clinical narrative: 11/9/16 body aches, 11/25/16 all over body aches, loss of coordination and balance, 11/29/16 difficulty walking, referred to Neuro, 12/1/16 Neuro study Dx Guillain Barre Syndrome.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Confusional state, Diarrhoea, Frequent bowel movements, Headache, Nausea
Clinical narrative: Seen in ER on 2/17/17 at 930AM. Sx's began on 2/16/17 at 600PM. W/headache, confusion, vomiting, diarrhea, incontinence of U/A 3 stool. Rx: IV fluids, ZOFRAN for nausea, TYLENOL for H/A. Returned to ER at 12:00 noon on 2/17 w/ same Sx's. Rx: IV fluids. Dx: Vaccine adverse event. Seen by local physician on 2/20/17. Dx: Same. Instructed - no  more vaccines.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Urinary incontinence, Vaccination complication, Vomiting
Clinical narrative: Seen in ER on 2/17/17 at 930AM. Sx's began on 2/16/17 at 600PM. W/headache, confusion, vomiting, diarrhea, incontinence of U/A 3 stool. Rx: IV fluids, ZOFRAN for nausea, TYLENOL for H/A. Returned to ER at 12:00 noon on 2/17 w/ same Sx's. Rx: IV fluids. Dx: Vaccine adverse event. Seen by local physician on 2/20/17. Dx: Same. Instructed - no  more vaccines.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Hypoaesthesia, Induration, Limb mass, Skin warm
Clinical narrative: Hard lump (approximately 2 inches) formed in deltoid. Pt felt it move to bicep. Arm became red and hot. Fingers became numb. the following Tuesday, symptoms resolved.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site bruising, Injection site nodule, Injection site pain, Weight increased
Clinical narrative: Arm injected sore at site, arm hard to move, knot and bruise where shot was given that has remained for 12 days.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Dyspnoea, Hyperventilation
Clinical narrative: This spontaneous report was received from a supervising physician via a company representative and refers to a 12 year old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 29-AUG-2016, the patient was vaccinated intramuscularly with the first dose of GARDASIL 9 (dose, lot number and expiration date were not reported) for prevention of human papillomavirus (HPV). On 02-FEB-2017, the patient went to the office visit for a physical exam and was administered the second dose of GARDASIL 9 intramuscularly (dose, lot number and expiration date were not reported). After the second dose was administered, the patient began "hyperventilating". Therefore, an ambulance was called and the patient was taken to a unspecified hospital to the emergency room (ER). The physician of the ER stated that the patient was having an "anxiety attack" and the patient was discharged. An unspecified time later in February 2017, the patient experienced "paralysis in legs" and "could not feel her feet". As a result, she was admitted to an unspecified hospital in the intensive care unit (ICU) and was diagnosed with Guillain-Barre syndrome. On an unknown date in February 2017, the patient was discharged from the hospital. At the time of reporting, the patient had "depression" and she was using a walker and a wheelchair. The outcome of Guillain-Barre syndrome and depression was reported as not recovered. The outcome of hyperventilation and anxiety attack was not reported. The causal relationship between the suspect therapy and the events was not provided. Upon internal review, the event Guillain-Barre syndrome was considered to be medically significant and disabling. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Anxiety, Depression, Diplegia, Guillain-Barre syndrome, Hyperventilation
Clinical narrative: This spontaneous report was received from a supervising physician via a company representative and refers to a 12 year old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 29-AUG-2016, the patient was vaccinated intramuscularly with the first dose of GARDASIL 9 (dose, lot number and expiration date were not reported) for prevention of human papillomavirus (HPV). On 02-FEB-2017, the patient went to the office visit for a physical exam and was administered the second dose of GARDASIL 9 intramuscularly (dose, lot number and expiration date were not reported). After the second dose was administered, the patient began "hyperventilating". Therefore, an ambulance was called and the patient was taken to a unspecified hospital to the emergency room (ER). The physician of the ER stated that the patient was having an "anxiety attack" and the patient was discharged. An unspecified time later in February 2017, the patient experienced "paralysis in legs" and "could not feel her feet". As a result, she was admitted to an unspecified hospital in the intensive care unit (ICU) and was diagnosed with Guillain-Barre syndrome. On an unknown date in February 2017, the patient was discharged from the hospital. At the time of reporting, the patient had "depression" and she was using a walker and a wheelchair. The outcome of Guillain-Barre syndrome and depression was reported as not recovered. The outcome of hyperventilation and anxiety attack was not reported. The causal relationship between the suspect therapy and the events was not provided. Upon internal review, the event Guillain-Barre syndrome was considered to be medically significant and disabling. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Intensive care, Sensory loss, Walking aid user, Wheelchair user
Clinical narrative: This spontaneous report was received from a supervising physician via a company representative and refers to a 12 year old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 29-AUG-2016, the patient was vaccinated intramuscularly with the first dose of GARDASIL 9 (dose, lot number and expiration date were not reported) for prevention of human papillomavirus (HPV). On 02-FEB-2017, the patient went to the office visit for a physical exam and was administered the second dose of GARDASIL 9 intramuscularly (dose, lot number and expiration date were not reported). After the second dose was administered, the patient began "hyperventilating". Therefore, an ambulance was called and the patient was taken to a unspecified hospital to the emergency room (ER). The physician of the ER stated that the patient was having an "anxiety attack" and the patient was discharged. An unspecified time later in February 2017, the patient experienced "paralysis in legs" and "could not feel her feet". As a result, she was admitted to an unspecified hospital in the intensive care unit (ICU) and was diagnosed with Guillain-Barre syndrome. On an unknown date in February 2017, the patient was discharged from the hospital. At the time of reporting, the patient had "depression" and she was using a walker and a wheelchair. The outcome of Guillain-Barre syndrome and depression was reported as not recovered. The outcome of hyperventilation and anxiety attack was not reported. The causal relationship between the suspect therapy and the events was not provided. Upon internal review, the event Guillain-Barre syndrome was considered to be medically significant and disabling. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 68-year-old retired female patient. No information on the patient's concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On 08-FEB-2017, the patient was vaccinated with PNEUMOVAX23, lot # M042785, in the right arm (reported as "R/A"), for prophylaxis (dose, route of administration and expiry date were not reported). On 10-FEB-2017, the patient experienced an enlarged and raised area the size of a quarter around the injection site. The patient did not have any illness at the time of vaccination. The pharmacist advised the patient to take diphenhydramine hydrochloride (BENADRYL) as directed. The outcome of the event was reported as recovered on an unknown date in February 2017. The relatedness between the event and PNEUMOVAX23 was not reported. Additional information has been requested.; Sender's Comments: US-009507513-1101USA00628:
Age: 0.17
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC13, RV5, DTAP, HEP, IPV, PNC13, RV5, DTAP, HEP, HIBV, IPV, PNC13, RV5
Symptoms: Death
Clinical narrative: This spontaneous report was received from an office manager via a company representative and refers to a 9 week old female patient. The patient had none medical history, concurrent conditions, concomitant therapies and drug reactions/allergies. On 18-JAN-2017, the patient was vaccinated with RECOMBIVAX HB (dose, frequency and anatomical location were not provided) (lot # reported as M019671 and expiration date not reported), intramuscularly and with ROTATEQ (dose, and frequency were not provided) (lot # M005733 and expiration date not reported) orally, both for local immunization requirement. On the same date, the patient was also vaccinated whit the following vaccines: PREVNAR 13 (dose, frequency and route not reported), an unspecified polio vaccine (dose, frequency and route not reported) and an unspecified diphtheria toxoid, pertussis acellular vaccine (dose, frequency and route not reported); all in the same appointment, for local immunization requirement. On 22-JAN-2017, the patient was found death by her mother and she noted that her baby threw up. No treatment was given to the subject. The same date, an autopsy was performed and revealed that there was no fluid in the patient's lungs; so it was ruled out that the patient had choked on her own vomit. At the time of the call, the autopsy was ongoing and the official cause of death was unknown. The causality between the patient's death and RECOMBIVAX HB and ROTATEQ was not reported. Upon internal review, the patient's death was considered medically significant. Lot number M019671 is an invalid lot number for hepatitis B vaccine (recombinant). Additional information has been requested. Reported Cause(s) of Death: Unknown.
Age: 0.17
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC13, RV5, DTAP, HEP, IPV, PNC13, RV5, DTAP, HEP, HIBV, IPV, PNC13, RV5
Symptoms: Autopsy, Death, Vomiting
Clinical narrative: This spontaneous report was received from an office manager via a company representative and refers to a 9 week old female patient. The patient had none medical history, concurrent conditions, concomitant therapies and drug reactions/allergies. On 18-JAN-2017, the patient was vaccinated with RECOMBIVAX HB (dose, frequency and anatomical location were not provided) (lot # reported as M019671 and expiration date not reported), intramuscularly and with ROTATEQ (dose, and frequency were not provided) (lot # M005733 and expiration date not reported) orally, both for local immunization requirement. On the same date, the patient was also vaccinated whit the following vaccines: PREVNAR 13 (dose, frequency and route not reported), an unspecified polio vaccine (dose, frequency and route not reported) and an unspecified diphtheria toxoid, pertussis acellular vaccine (dose, frequency and route not reported); all in the same appointment, for local immunization requirement. On 22-JAN-2017, the patient was found death by her mother and she noted that her baby threw up. No treatment was given to the subject. The same date, an autopsy was performed and revealed that there was no fluid in the patient's lungs; so it was ruled out that the patient had choked on her own vomit. At the time of the call, the autopsy was ongoing and the official cause of death was unknown. The causality between the patient's death and RECOMBIVAX HB and ROTATEQ was not reported. Upon internal review, the patient's death was considered medically significant. Lot number M019671 is an invalid lot number for hepatitis B vaccine (recombinant). Additional information has been requested. Reported Cause(s) of Death: Unknown.
Age: 14.0
Sex: F
Vaccine: DTPIPV, HEP, HEPA, MMRV
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Large golf ball size lump at injection site, hot red raised and tender to touch approximately 2.5in in diameter.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Anxiety, Fatigue, Headache, Hypoaesthesia, Injection site rash
Clinical narrative: Anxiety, tiredness, muscle pain, headache, nausea, fatigue, numbness of the hands and rash at injection site.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Myalgia, Nausea
Clinical narrative: Anxiety, tiredness, muscle pain, headache, nausea, fatigue, numbness of the hands and rash at injection site.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: Fever ranging from 101-103.5 for 2.5 days, extreme soreness and lack of ability to move arm where injection occurred, extreme swelling and redness that grew to cover entire upper arm over 3 days, arm pain for 9 days.  Prescribed 10 day course of antibiotics.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Fever ranging from 101-103.5 for 2.5 days, extreme soreness and lack of ability to move arm where injection occurred, extreme swelling and redness that grew to cover entire upper arm over 3 days, arm pain for 9 days.  Prescribed 10 day course of antibiotics.
Age: 53.0
Sex: M
Vaccine: PPV
Symptoms: Feeling hot, Injection site swelling, Rash, Skin discolouration, Swelling
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 53 year old male patient. The patient's medical historyallergy to trazodone (manufacturer unknown)with reactions of throat swelling, shortness of breath and rash (captured in MARRS case # 1702USA002231); allergy to lisinopril (manufacturer unknown) with anaphylaxis and angioedema (captured in MARRS case # 1702USA002230); history of rash with oxycodone and latex anaphylaxis. Concomitant therapies included nortriptyline hydrochloride (PAMELOR), omeprazole (PRILOSEC), pregabalin (LYRICA), morniflumate (FLOMAX ), warfarin sodium(COUMADIN), acetaminophen (TYLENOL), amlodipine besylate (NORVASC), dapagliflozin, diazepam (VALIUM), docusate sodium (COLACE), famotidine (PEPCID), insulin aspart (NOVOLOG), lovastatin (MEVACOR TABLET), magnesium, metformin hydrochloride (GLUCOPHAGE) and metoprolol succinate (TOPROL). On 27-JAN-2017 the patient was vaccinated with a dose of PNEUMOVAX23 intramuscular, lot # M036728 and expiration date: 20-MAY-2018 (strength, dose and anatomical location were not reported) for prophylaxis. On 28-JAN-2017, the patient experienced rash, feeling of heat (feeling hot), skin discolouration (pink and purple) and swelling that went from the injection site to the armpit. The patient received an unspecified treatment for the events; but no laboratory diagnosis were performed. At the time of reporting, the patient had not recovered from the events. The relationship between the aforementioned events and PNEUMOVAX23 was not established or mentioned by the reporter.  This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA002230: US-009507513-1702USA002231: US-009507513-1702USA000334:
Sex: U
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report has been received from a pharmacist referring to a multiple patients of unknown age and gender. Information regarding patient's medical history, drug reaction, allergies, concurrent conditions and concomitant  therapies was not provided. On an unknown date, the patient was vaccinated with PNEUMOVAX23 , (strength, dose, frequency, route of administration, lot#, and expiration date were not provided) for prophylaxis. On an unknown date, the patients experienced unspecified pain, swelling and warmth at the injection site. At the time of reporting the outcome of unspecified pain, swelling and warmth at the injection site was unknown. The relatedness between the events and PNEUMOVAX23 was not reported.   Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Nurse Practitioner referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.   On 08-NOV-2016, the patient received, in their immunization series, an unspecified dose of VARIVAX Lot # M006157 and expiration date: 05-FEB-2018 (dose and route of administration were not reported) for prophylaxis  that was improperly stored. It was reported a temperature of 8° Fahrenheit during a time frame of 1 hour. There was a previous temperature excursions of 8.6° Fahrenheit and 41° Fahrenheit for 1 hour 30 minutes and 17 hours and 50 minutes, respectively. The call was not because of a data logger. No adverse effects were reported.  There was no product quality complaint involved. This is one of several reports received by the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA009077: US-009507513-1702USA009079:
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. Information regarding patient's concurrent conditions, pertinent medical history or drug reactions was not provided. On 03-FEB-2017, the patient was vaccinated with an expired dose of VAQTA 0.5 ml, Intramuscularly, which had a lot # L048222 and expiry date on 19-DEC-2016 (anatomical location was not mentioned) for prophylaxis. However, at the reporting time no adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On 08-FEB-2017, the patient was vaccinated with an expired dose of ZOSTAVAX (lot#, dose, route and frequency were unspecified) for prophylaxis. No adverse effects were reported and no product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Breast pain, Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 29 year old female patient. The patient's concurrent condition included asthma. The patient had no drug reactions or allergies. On an unspecified date in October 2016, the patient was vaccinated with a dose of PNEUMOVAX23 intramuscular injection (dose, lot number and expiration date were not provided), due to increased risk of pneumoccocal disease due to asthma, and with a dose of an unspecified Flu vaccine (dose, route of administration and anatomical location were not provided). The patient did not take any concomitant medication. On an unknown date, the patient experienced redness, swelling, and soreness from the shoulder to the elbow, and soreness in the breast. The reporter could not verify whether either of the vaccines had been administered in the affected arm.. It was unknown by the reporter, whether any lab diagnostics studies have been performed. It was unknown if the patient received any treatment. The outcome of breast pain, pain in extremity, swelling and erythema was unknown. The relatedness between the supspect therapies and the events was not reported. No product quality complaint was involved.  This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1702USA006102: US-009507513-1702USA005964: US-009507513-1702USA006265:
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No medical history was provided. On 19-JAN-2017, the patient was vaccinated with the first dose of RECOMBIVAX HB (strength, dosage, route of administration, lot# and expiration date were not reported). On 13-FEB-2017, the patient received the second dose of RECOMBIVAX HB, which was reported as administered too early. No symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to two or three patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the doses of ZOSTAVAX (dose, route of administration, lot # and expiration date were not reported) for the prevention of shingles. On unknown dates, the patients experienced a mild case of shingles. The outcome of mild case of shingles was unknown. The relatedness between the mild case of shingles and ZOSTAVAX was not provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Nurse Practitioner referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.   On 06-DEC-2016, the patient received a dose of ZOSTAVAX Lot # M009773 and expiration date: 17-MAY-2017, Vial 19,400 Plaque Forming Units (PFU) (dose and route of administration were not reported) for prophylaxis that was improperly stored. It was reported a temperature of 8° Fahrenheit during a time frame of 1 hour. There was a previous temperature excursions of 8.6° Fahrenheit and 41° Fahrenheit for 1 hour 30 minutes and 17 hours and 50 minutes, respectively. The call was not because of a data logger. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received by the same reporter.  Additional information has been requested.; Sender's Comments:  US-009507513-1702USA001764:  US-009507513-1702USA009079:
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Nurse Practitioner referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.   On 13-DEC-2016, the patient received a dose of ZOSTAVAX Lot # M009773 and expiration date: 17-MAY-2017, Vial 19,400 Plaque Forming Units (PFU) (dose and route of administration were not reported) for prophylaxis that was improperly stored.  It was reported a temperature of 8° Fahrenheit during a time frame of 1 hour. There was a previous temperature excursions of 8.6° Fahrenheit and 41° Fahrenheit for 1 hour 30 minutes and 17 hours and 50 minutes, respectively. The call was not because of a data logger. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received by the same reporter.  Additional information has been requested.; Sender's Comments:  US-009507513-1702USA001764: US-009507513-1702USA009077:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an immunization coordinator refers to an unknown number of patients of unknown age and gender. No information regarding their pertinent medical history, concomitant medications, drug reactions, or allergies was provided. Since an unknown date in January 2017, the patient was receiving incorrectly stored doses of PROQUAD (Albumin status: recombinant human albumin (rHA); lot # M035145, expiration date: 30-JAN-2018; lot# M036295, expiration date: 13-FEB-2017; lot# M038862, expiration date: 13-MAR-2018; dose and route of administration were not provided). No adverse effects were reported. Administered doses of vaccine experienced the temperature excursion of above 46 degrees Fahrenheit (F) but below 77 F for an unspecified time. There was the following previous temperature excursions: above 14 F but below 46 F (above 10 degrees Celsius but below 8 degrees Celsius) for 23 hours, and above 46 F but below 77 F (above 8 degrees Celsius but below 25 degrees Celsius) for 12 hours. Digital Data Logger was involved. This is one of two reports received from the same reporter. Additional information is not expected, as there was no consent to contact the reporter. Sender's Comments: US-009507513-1703USA000248.
Age: 13.0
Sex: F
Vaccine: FLU4, HEPA, HPV9
Symptoms: Asthenia, Blood test, Dark circles under eyes, Diarrhoea, Dizziness
Clinical narrative: This spontaneous report was received from the patient's mother and refers to a 13 year old non pregnant female patient. The patient's medical history included tonsillectomy about 4 years ago. The patient was allergic to penicillin. No other concurrent conditions were reported. On 12-JAN-2017, the patient was vaccinated with GARDASIL 9, dose 1, by "injection" route, (dose, anatomical location, lot number and expiration date were not reported), for "prevention of HPV". Concomitant therapies included ibuprofen and TYLENOL. On 13-JAN-2017, the patient experienced a frequent headache, diarrhoea, some muscle weakness in both arms (muscular weakness), lightheadedness (dizziness), and overall body weakness (asthenia); the patient was tired all of the time (fatigue), had flu-like symptoms (influenza like illness) and dark circles under both eyes; also the patient had "issues having a restful night sleep" (poor quality sleep) and "got out of breath easily" (dyspnoea). No product quality complain was involved. The patient sought medical attention and visited the office 2 times, and, received an unspecified treatment for the events. An unspecified anemia tests and various unspecified thyroid test were performed to the patient, however, the results were not reported. At the time of reporting, the patient only received one dose of GARDASIL 9 and the reporter stated that she would not receive the subsequent doses. On the same date, the outcome of muscular weakness, dizziness, headache, fatigue, diarrhoea, dyspnoea, poor quality sleep, dark circles under eyes and influenza like illness was not recovered/not resolved. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: FLU4, HEPA, HPV9
Symptoms: Dyspnoea, Fatigue, Headache, Incomplete course of vaccination, Influenza like illness
Clinical narrative: This spontaneous report was received from the patient's mother and refers to a 13 year old non pregnant female patient. The patient's medical history included tonsillectomy about 4 years ago. The patient was allergic to penicillin. No other concurrent conditions were reported. On 12-JAN-2017, the patient was vaccinated with GARDASIL 9, dose 1, by "injection" route, (dose, anatomical location, lot number and expiration date were not reported), for "prevention of HPV". Concomitant therapies included ibuprofen and TYLENOL. On 13-JAN-2017, the patient experienced a frequent headache, diarrhoea, some muscle weakness in both arms (muscular weakness), lightheadedness (dizziness), and overall body weakness (asthenia); the patient was tired all of the time (fatigue), had flu-like symptoms (influenza like illness) and dark circles under both eyes; also the patient had "issues having a restful night sleep" (poor quality sleep) and "got out of breath easily" (dyspnoea). No product quality complain was involved. The patient sought medical attention and visited the office 2 times, and, received an unspecified treatment for the events. An unspecified anemia tests and various unspecified thyroid test were performed to the patient, however, the results were not reported. At the time of reporting, the patient only received one dose of GARDASIL 9 and the reporter stated that she would not receive the subsequent doses. On the same date, the outcome of muscular weakness, dizziness, headache, fatigue, diarrhoea, dyspnoea, poor quality sleep, dark circles under eyes and influenza like illness was not recovered/not resolved. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: FLU4, HEPA, HPV9
Symptoms: Muscular weakness, Poor quality sleep, Thyroid function test
Clinical narrative: This spontaneous report was received from the patient's mother and refers to a 13 year old non pregnant female patient. The patient's medical history included tonsillectomy about 4 years ago. The patient was allergic to penicillin. No other concurrent conditions were reported. On 12-JAN-2017, the patient was vaccinated with GARDASIL 9, dose 1, by "injection" route, (dose, anatomical location, lot number and expiration date were not reported), for "prevention of HPV". Concomitant therapies included ibuprofen and TYLENOL. On 13-JAN-2017, the patient experienced a frequent headache, diarrhoea, some muscle weakness in both arms (muscular weakness), lightheadedness (dizziness), and overall body weakness (asthenia); the patient was tired all of the time (fatigue), had flu-like symptoms (influenza like illness) and dark circles under both eyes; also the patient had "issues having a restful night sleep" (poor quality sleep) and "got out of breath easily" (dyspnoea). No product quality complain was involved. The patient sought medical attention and visited the office 2 times, and, received an unspecified treatment for the events. An unspecified anemia tests and various unspecified thyroid test were performed to the patient, however, the results were not reported. At the time of reporting, the patient only received one dose of GARDASIL 9 and the reporter stated that she would not receive the subsequent doses. On the same date, the outcome of muscular weakness, dizziness, headache, fatigue, diarrhoea, dyspnoea, poor quality sleep, dark circles under eyes and influenza like illness was not recovered/not resolved. Additional information has been requested.
Age: 16.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a 16 year old patient of unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 25-SEP-2016 and 23-FEB-2017, the patient was vaccinated with the first dose and the second dose of GARDASIL 9 (strength, dose, frequency, route, lot# and expiration date were unknown) respectively for prophylaxis (Inappropriate age at vaccine administration). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Mumps
Clinical narrative: This spontaneous report was published in an online article, referring to multiple patients of unknown age and gender. The Centers for Disease Control and Prevention (CDC) currently recommended that children got two doses of M-M-R vaccine - for measles, mumps and rubella - with the first dose at 12 to 15 months of age and the second at 4 to 6 years. The mumps component of the M-M-R vaccine was about 88 percent effective when a person got two doses; one dose was about 78 percent effective. The country's mumps vaccination program began in 1967.  Federal health officials were evaluating the benefit of an additional dose of mumps vaccine because of the increasing number of mumps outbreaks since 2006. More than 5,000 cases of the contagious viral illness were reported last year, the most in a decade. Among the numerous outbreaks in recent years, 19 occurred last year at college campuses. A federal health official had been battling an outbreak that began in one community last summer and had since infected 2, 815 people, the largest ever recorded in a state. Unlike outbreaks of measles and whooping cough, which had taken place in populations with significant numbers of unvaccinaled people, the mumps outbreaks had been occurring in communities with high rates of immunization and residents who often had received both recommended doses of the vaccine (dose, dose number, route, lot# and expiration were unspecified). Although the disease had not been serious, the disruption and expense it had caused for local and state health officials has been significant. Two universities just reported the cases on an unknown date in February 2017(reported as the last three weeks).  The health officials said a major factor contributing to outbreaks was a crowded environment College campuses, where large numbers of students circulate in classes, dormitories and on sports teams, were prime for spreading the virus. In a state, the ongoing outbreak started in a community. The people in crowded housing conditions, often with 15 to 20 people in a single home. From there the outbreak quickly spread across the state to include broader communmes and all age groups.  Even with the large number of cases, the incidence of severe complications had been dramatically reduced, especially among vaccinated children and adults. The outcome of mumps was unknown. The relationship between the event and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) was not reported. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a 23 year old female patient. Information about concomitant therapy, concurrent condition, drug reactions/allergies and medical history was not reported. On 11-AUG-2016, the patient was vaccinated with a first dose of GARDASIL 9 (1 dose, lot #, expiration date, strength and route were unknown) for prophylaxis. On 15-OCT-2016, the patient was vaccinated with the second dose of GARDASIL (1 dose, lot #, expiration date, strength and route were unknown) for prophylaxis. On 17-JAN-2017, the patient was vaccinated with the third dose of GARDASIL (1 dose, lot #, expiration date, strength and route were unknown) for prophylaxis (interchange of vaccine products). No adverse effect was reported. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: This spontaneous report received from a pharmacist via Pfizer referred to a 70 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 PNEUMOVAX 23 (dose, lot number and expiry date not reported) for protection against pneumococcal pneumonia (prophylaxis). On an unspecified date, the patient had trouble in arm because it was severely swollen. Outcome and causality of the event were not reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report received from a pharmacist via Pfizer referred to around 65 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 PNEUMOVAX 23 (dose, lot number and expiry date not reported) for protection against pneumococcal pneumonia (prophylaxis). On an unspecified date, the patient experienced injection site bump. Outcome and causality of the event were not reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Eye irritation, Herpes zoster, Ophthalmic herpes zoster, Rash pruritic
Clinical narrative: This spontaneous report was received from a currently 64 year old female patient via a company representative. Concomitant medications included amlodipine, metformin and losartan. Concurrent conditions included high blood pressure.  Drug reactions/allergies inlcuded aspirin and hydromorphone (DILAUDID).  Sometime in 2014, the patient received ZOSTAVAX to prevent shingles (route and lot # not provided).  The patient reported since having the vaccine, she had the shingles three times and all three times developed an itchy rash on the left side of her face.  First onset was in the "Spring of 2015".  During the second bout of shingles (date unspecified), she went to the Emergency Room (ER) because the shingles virus had spread and irritated her left eye.  Her last episode of shingles was in February 2017 (reported as about three weeks ago).  All three episodes were treated with the same unspecified "7-day" medication.  She did seek medical attention described as "yes, doctors office visits".  The patient present status was recovered.  The patient was seeking compensation for treatment received at doctor's office and also the ER visit. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The concurrent conditions, drug reactions/allergies and medical history of the patients were not reported. On unknown dates,  the patients were vaccinated with an improperly stored dose of ZOSTAVAX with lot number M001747 and expiration date of 07-APR-2017 (strength, dose, route of administration and anatomical location were unknown) for prophylaxis, which was stored at more than -15 Celsius degrees (°C) but less than -10 °C (more than 5 Fahrenheit degrees (°F) but less than 14°F) for 69 minutes. There was a previous temperature excursion of more than -10°C but less than 8°C (more than 14°F but less than 46°F) for 185 minutes. The temperature excursions were detected by a data logger. No concomitant therapies nor adverse effects were reported. This is one of two cases from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1702USA012283: